IPMMA Magazine : April - June 2021

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CONTENTS

An official Publica on of Indian Pharma Machinery Manufacturers’ Associa on (IPMMA) 4 President's desk
6
Vol 11 | Issue 1 | April - June 2021 Oral Solid Dosage Form - Expert's views
Leaders In-Sight - Sandeep Mhatre
An official Publica on of IPMMA Group Managing Director, Thermolab Group
Wisdom Nuggets - Sa sh Agrawal, President - Ajanta Pharma Limited
Indian Pharma Machinery 12 Women in Pharma - Adi Kare Panandikar
Manufacturers’ Associa on - Managing Director, Indoco Remedies Limited
Solid Oral Dosage Forms: What Future Beholds
PUBLISHER 16
IPMMA 22 Rotor technology for dry powder coa ng
28 Building Robustness in Coa ng through Equipment
EDITOR 36 and Process considera ons
Mahendra Mehta 40 Building Trust - Engineering To Quality & Valida on
44 5 Ways to Increase Capacity Despite Talent Shortages with Digital
TRUSTEE 48 Manufacturing Technology
Bhavna Shah 52 Why should India adopt IoT for the pharma supply chain?
Rajesh Shah
Ratan Singhania Good Distribu on Prac ce (GDP) - Q&A
Vinod Padia
News
PRESIDENT
Mahendra Mehta Product Showcase

VICE PRESIDENT www.ipmma.org
Shehul Sheth

HON. SECRETARY
Harshit Shah

ADVISOR
Kaushik Desai

EDITORIAL SUPPORT
Harish Panchal
Parag Jawale

ACCOUNTS
Anil Kumar Mehta

CIRCULATION
Rajkumar Prajapati

CORRESPONDENCE ADDRESS 56
Indian Pharma Machinery 58
Manufacturers’ Associa on 62
(IPMMA) 61

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Vikhroli (West), Mumbai 400 083, INDIA

Phone No : +91-9004377743
Email: [email protected]
Web: www.ipmma.org

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President's desk

Mahendra Mehta

Dear Readers,

I am proud that our machine manufacturing industry with the pharmaceu cals industry has well contributed to
the development and delivery of Covid-19 vaccines. We all have managed to sustain our opera ons during the
second wave and as per current analysis the third wave is predicted towards end of this year. A bigger relief for us
manufacturers is the arrival of vaccines across all age groups. In addi on to the current safety precau ons, this
will ensure be er safety of our workforce and families. With this, we urge everybody to get vaccinated and we
hope to bid goodbye to Covid-19 soon.

Earlier virtual mee ngs were looked at as a new way, but now it's a 'normal way' of communica on. This certainly
proved to be a hidden blessing that even with much normal opera ons we are s ll connected any me anywhere
through virtual pla orms. This indeed helped us to hold all IPMMA commi ee mee ngs seamlessly. Digi za on
and automa on are being rapidly adapted by our industry to match the growing pace of healthcare industry.

We at IPMMA, firmly believe 'Charity begins at home' and we did our bit by contribu ng to the PM CARES fund
aimed at strengthening the fight against Covid-19. All members are welcome to contribute to the PM CARES fund
as an IPMMA representa ve.

We are con nuously monitoring and analysing the ground level reali es for holding our flagship expo Pharma
Pro&Pack 2021. However, keeping stakeholder's safety in mind, we will soon be taking a decision based on the run-

me pandemic scenario.

I thank Ins tute of Packaging Machinery of India (IPMMI) for their collabora on and conduc ng the webinars like
“Intui on and Decision making”. I request the members to join such future programs and take the benefit from
these learnings. We plan to conduct many more such programs for the benefit of the industry.

As always, our IPMMA team strives to provide value services to our members. I am glad to share that the new
'Surplus' sec on on our IPMMA website is func onal and we urge members to take advantage of this new feature.

We are always thankful and grateful for all our members who supported us and each other in every situa on
keeping up with collabora ve spirit during challenging mes and thriving not just sustaining.

Happy Reading !

Your Truly,

Mahendra Mehta www.ipmma.org
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We

Our Customers

THANK YOU FOR GIVING US BUSINESS

On completion of 2 decades, we would love to share this message to our customers -
It is because of you all, we are leaders today in clean room furniture and technology.
The world is full of choices, Thank you for choosing us. Allegro Team loves you all.

www.allegroindia.com Clean Room Furniture Expert
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COVER STORY Oral Solid Dosage Form
- Expert's views

Q: The global OSD pharmaceu cal formula on market is forecasted to grow from $493 billion in 2017
to $926 billion by the end of 2027, according to Future Market Insights. With the global market
perspec ve, where do you see the Indian Pharma Industry in the OSD arena 5 years down the line?

Shankar Gupta will lead to much innova on and integra on of OSD
COO, manufacturing in India.
ACG Worldwide
However, the key will also be to develop and grow
India is o en referred to as the back end indigenously – Which is the raw
the pharmacy-of-the-world. materials, excipients and APIs. Our over
This has been proved during dependence on overseas sources can create a
the COVID-19 pandemic when India con nued to challenge in our endeavour to grow the OSD
provide cri cal life-saving drugs and machines to the manufacturing. But I am sure that both Government
world. The Indian pharma industry has shown and Pharma Industry will put adequate focus in that
tremendous resilience in its ability to serve people in direc on.
India as well as across the globe ensuring
accessibility and most importantly affordability of Sreekanth Mu neni
the quality medicines. President & Global
Formula on
While the world's a en on today is focused on Manufacturing Head,
developing possible vaccines, numerous OSD Alkem Laboratories Ltd.
products have begun to share the spotlight as
promising treatments for the symptoms of Oral Solid Dosages - An Odyssey
COVID-19. By numbers, oral solid dosage (OSD)
products remain the largest segment of the OSD form has a long history of over 100 years and
pharmaceu cal market. The key drivers that cause s ll going strong due to its ease of administra on,
OSDs to be a significant part of this volume are their safe, effec ve usage by the consumers. Even today
cost-effec veness, rela vely easy to manufacture, its dominance is crystal clear over the parenteral
compara vely smaller me for se ng up and drugs and biological products and it would con nue
manufacturing and most importantly, pa ent- to dominate in coming decades too. But this is not to
friendliness. OSDs have also seen a significant surge indicate the dosage form has no challenges! Such
in innova on of form and technology. The Indian Con nuous Manufacturing process can be great
Pharma Industry is therefore uniquely posi oned for Space Savers too, as the Tradi onal batch processes
growth due to its compe ve value, low-cost would require mul ple equipments to handle the
combined with cu ng-edge R&D. Also, our ability to various processes, demanding larger facili es with
manufacture high volumes will be extremely higher u lity and manpower costs etc.
important factor in our ability to serve the Global
Pharmaceu cal market, this is especially, backed by With the advantage of online tes ng possibili es,
strong ini a ves such as the government's PLI
scheme and FDI inflows the industry is expected to
a ract investments in excess of US$ 1.3 billion which

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flexibility with batch sizes aided with lesser process current COVID situa on, upcoming pharmaceu cal COVER STORY
me, the overall Speed to reach the product to the manufacturing plants, expansions and increasing
health awareness among ci zens, we need to at
market gets faster than the current batch processes. least double our Produc on capacity to cope up
The speed of product development on con nuous with the enquiries and deadlines.
manufacturing skid can be much faster compared to
tradi onal methods, helping in taking mul ple trials (References: Personal Experience, Consolidated FDI
in less me. Process becomes robust and post Policy, Press Informa on Bureau (PIB), Media
commercialisa on; the product poses less or no Reports, Pharmaceu cals Export Promo on
challenges on Quality front. Council, AIOCD-AWACS, IQVIA)”

I am sure the me ahead will bring more players in Dilip M. Parikh
this OSD arena towards con nuous manufacturing President,
& more novel concepts. Dpharma Group Inc,
USA
P. H. Vachhrajani
Sr. Vice President, The global oral solid
CADMACH Machinery dosage pharmaceu cal
Co. Pvt. Ltd. formula on market is
projected to grow from US$ 493.2 Billion in 2017 to
We have observed during US$ 926.3 Billion by 2027 end. This represents a
na on lockdown a er Compound Annual Growth Rate (CAGR) of 6.5%
March 2020 that Pharma over the forecast period 2017– 2027. North
sector and few other essen als were the only one America will remain the largest market for OSD
that were allowed to operate. While all other formula ons, followed by Asia Pacific (excluding
industries were closed down, Pharmaceu cals were Japan) and Western Europe.
speeding through a great race in the mid of the
pandemic in order to cope up with the medicine The market in India and China is growing at a
requirement of the na on. This situa on highly significantly high rate (around 7% CAGR), due to
encouraged many Entrepreneurs to move ahead rising number of contract manufacturing
towards OSD/Pharmaceu cal manufacturing start- organiza ons and low manufacturing costs in these
ups and hence a great number of Pharma Green- countries indica ng that these markets will
field Projects and Expansions were approved across represent highly lucra ve growth opportuni es
the na on. during the forecast period.

Even according to the Economic Survey 2020-21, the Tradi onally, the industry has focused on chemical
domes c market is expected to grow 3x in the next en es that were compa ble with the
decade. India's domes c pharmaceu cal market is manufacturing processes of solid dosage forms.
es mated at US$ 41 billion in 2021 and likely to However, with the growth of new and complex drug
reach US$ 65 billion by 2024. Medicine spending in en es of biologic or non-biologic origin comes the
India is projected to grow 9.12% over the next five requirement for alterna ve delivery systems to
years, leading India to become one of the top 10 meet delicate stability needs. OSD must keep pace
countries in terms of medicine spending. with other advancements in the pharma industry
and evolve and embrace innova ve technologies
I must say, in the next five years, looking to the

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COVER STORY and sta s cal techniques for data mining, Mahendra Mehta
predic ve modeling, and machine learning to CEO & MD,
improve data analysis capabili es along with newer Parle Global Technologies
pla orm technologies like 3D prin ng, to retain Pvt. Ltd
their posi on in the market.
Oral solids remain the
BVRKS Srinivas Rao preferred drug delivery
Vice President & Site Head route due to their cost-effec veness, ease of
Roorkee, manufacturing and pa ent-friendly dose op ons.
Jubilant Generics Limited India has emerged as the “World's Pharmacy”. This
is not just because of its Cost Efficiency and Skilled
Indian Pharma Industry have Manpower, but also due to Process Innova on.
grown leaps and bounds in the
recent past. One of the main and important reasons Over the next 5 years, Process Innova ons in Oral
for this growth can be a ributed to the support Solid Dosage arena will see increased adop on of
given by Indian Pharma Machinery industry by con nuous manufacturing process as opposed to
delivering right quality of the equipment in record the current Batch Processing. In order to address
me. The way Indian Pharma Industry is growing, the challenge of poor bioavailability, amorphous
opportuni es are there even for Pharma Machinery solid dispersion technology will become more
Industry to grow in the similar way. I also see sophis cated, necessita ng use of Granula on
tremendous capability and willingness in this area processes like Powder Coa ng and direct API
from the Indian Pharma Machinery Industry. Coa ng on Granules and Tablets.
Currently equipment manufactured by Indian
Manufacturers are being exported to various An increasingly pa ent-centric approach is ramping
countries and also some of the world-renowned up the trend for modified release (MR) oral solid
brands started their Manufacturing units in India. dose products. Introduc on of complex molecules
This suggests the availability of poten al, with aimed at delivering targeted therapies will see the
respect to skill level & Knowledge present here in shi ing of more products towards Dry Granula on
India. process.
Mul par culate drug delivery systems for
One thing I would also like to point out here is, our controlled release profiles using mul -layer and
equipment is mechanically equivalent to any world tablet-in-tablet technology. This can be used to
class equipment. We need to spend me and money create fixed dose combina ons, mul -API
in developing automa on of the equipment to suit products, with the doses of each API designed to be
to the relevant requirements of 21 CFR Part 11 and released at different rates. Such complex table ng
Annexe 11. As we all know, future, by looking at the will demand specialized Tooling materials with
expecta ons of Regulatory Requirements, is customized surface treatment.
AUTOMATION. Combina on of this would definitely
keep the Indian Pharma Machinery Industry Liquid Filling in hard gela n Capsules, as also
compe ng and even bea ng world top brands in the combina on fills of Granules/Pellets/Tablets.
years to come. Prin ng / Coding on Tablets and Automated Visual
Inspec on of tablets and capsules to meet stringent
regulatory requirements and as counterfei ng
measures.

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COVER STORY Effec ve iden fica on, mely adop on of such l Dust collector
technologies and first mover advantage will ensure l Containment feature (if needed)
that the Indian pharmaceu cal sector maintains its
primacy in the global market. The recent advancement in core table ng to
accommodate increase in the demand allowed
Ratan Singhania machines to perform in more precise manner. And
Director, advancement in tooling allows the tablet designers to
Singhania Table ng expand and discover newer ways of product
developments ensuring improvements in oral solid
Global standardiza on for dosage forms.
tablet compression tooling
in the pharma industry has Dev Ashish Bakshi
come into prac ce since MD,
1971. The IPT Manual (standard guideline manual) Tapasya Engineering
supported by the American Pharmaceu cal Works Pvt. Ltd.
Associa on, today is known as TSM - Table ng
Specifica on Manual, and currently in its 7th edi on. As very rightly put in the
Innova on in Tablet tooling like maintenance systems World Economic Forum by
made Punches and dies more durable: our Honourable PM that
India is the Pharmacy of the
l Mono-block Punches and Dies world.
l Carbide Dies
l Coa ngs Like CRN, MCRN, DLC, TIN etc. to prevent In the same context we from India have a lot to offer to
the world when it comes to
s cking/ abrasion / corrosion
l Automa c Punches and Dies Polisher / Inspec on 1. Supplying finished OSD formula ons
l Ultrasonic Punches and Dies cleaner 2. Machinery for manufacturing the same.
l Customized Punches and Dies storage cabinets,
We in India are second to none when it comes to the
trays etc. machine manufacturing, as now even the renowned
l Tools management systems European and American Machine manufacturers are
present in India directly or through JVs . The ques on
The innova on in tablet compression equipment is why are they here ?
involves new features:
What we bring uniquely to the table is a young, skilled
l Force Feeder and qualified work force who not only have the KNOW
l Pre- Compression HOW but what we also uniquely have is the KNOW
l Automa c Tablet weight control WHY. This is predominantly due to the fact that our
l Automa c Thickness & Hardness control country churns the highest number of Engineers and
l Machine with changeable turret Pharmacists second to none in the world. We in India
l Integra on with SCADA / PLCs / HMIs / VFDs have the lowest cost of R & D, prototyping and
l Bilayer Table ng machine Commercializa on. The costs of the Alfa & Beta
l Auto sampling Tes ng's are also low thus giving us the unique
l Auto rejec on of single tablet posi on to cater to the world requirements. Going
l Supported with vacuumed loader forward I see a quantum growth in the next 2 to 5 years
in not only a surge in global demand of quality low-cost
A er compression also, machine affixed with generic drugs manufactured out of India but also a
surge in demand for the Pharma machines made in
l Metal Detector India.
l Tablet de-duster

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LEADERS IN-SIGHT Sandeep Mhatre

Group Managing Director, Thermolab Group

Q. How has been your journey in Thermolab Group There are challenges ahead and we are fully geared
from Individual and company growth perspec ve? to meet them.

A. Thermolab, a laboratory equipment Q. From your rich experience of close to three
manufacturer since 1967, started its upward decades, what were the 3 major challenges you
journey in the beginning of this century. Thermolab came across in taking Thermolab Group to the next
group concentrated their focus into pharmaceu cal level and mi ga on of challenges?
sector and diversified into walk-in Stability tes ng
chambers, Cold rooms and Freezers. Later on, we A. We consider the biggest transforma on within
forayed into Pharma manufacturing, Analy cal lab, Thermolab to have been the people and culture.
Calibra on/Valida on services and Interna onal One of our first ac ons were to increase our
business. Together, we provide tailored solu ons to strength in terms of R&D produc vity. Digitaliza on
meet the need of our clients. has been embracing almost all spheres of modern
life. It will help not only accelerate many processes
Q. In spite of venturing into various markets of but also prevent losing important data and
scien fic equipment's, analy cs, tes ng and op mizes the workflow. We have improved our
healthcare, how was Innova on in the work internet-based communica on network to
culture nurtured? overcome client dissa sfac on due to travel
restric ons. Due to the general fear surrounding
A. Real assets of a technology-based company are its Covid-19, adequate precau ons have to be taken
people. Thermolab group boasts of personnel in for technicians' travels to clients' premises.
con nuous employment for several decades. Maintaining appropriate safe staffing levels and
Instead of res ng on past achievements and awards, healthcare safety of our workers will be our
the en re technical team strives to innovate and paramount priority.
improve the designs. We believe that quality of
components is the real measure of produc vity. Q. What are the three key human and
Quality by Design (QbD) is what I try to inculcate in management quali es that an industry leader
our personnel. We incen vize people to come out must possess?
with innova ve ideas, however trivial they are. With
all these possibili es we begin to follow our hunches A. An Industry leader is o en determined by three
to their logical conclusions, picking one or two and core variables: People, Product and Pipeline. When
applying all our knowledge, know- you have the right people and the right leader,
how,technology,etc. to manifest Innova on. Posi ve transforma on will occur. We focus on
corporate goals, compassion towards employees
Q. Post-pandemic, what is your outlook towards a and trea ng clients as business partners. Working
strategic growth a er 2021? alongside their teams, encouraging and

A. The year 2020 was an unprecedented year
disrupted by Covid-19 pandemic. Next few years will
have to take the brunt of this microorganism which
turned many lives and livelihoods upside down.
From our roots as an Indian company, we have
blossomed into a growing interna onal player
within the areas of scien fic equipment's, analy cal,
tes ng and health care. As a group, we lived up to
the expecta ons of our employees, our clients and
the society. We are suppor ng the Pharmaceu cal
Industry in the distribu on of vaccines by adop ng
innova ve techniques in Cold Chain management.

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LEADERS IN-SIGHT par cipa ng in collabora on,
reques ng opinions and ac vely
listening are just a few a ributes. never before. Digital transforma on will enhance
Not only do they believe in the the compe veness of the pharmaceu cal industry
future of their industry, but they and accelerate its role to be at par with global
should value the people that will markets. Smartly connected companies will be able
get them there and help them to improve its produc on quality with the support
believe in the same future as of analy cs tools to and be er produc on planning.
well. An Industry leader knows Updated so ware support for efficient machinery
where their lessons are and what connect will prove to be an invaluable tool for the
to learn from them. Choosing to Indian Pharmaceu cal Industry and the machinery
learn from your losses and not sector.
become discouraged by every
setback makes a big difference Q. With the rapid growth in the last few years,
where do you see Indian Pharmaceu cal industry
Sensi vity towards the well- five years down the line?
being, health and safety of their
workforce is the pressing priority A. The Indian Pharmaceu cal Industry has
for an industry leader in these challenging mes. contributed in a large way during the pandemic in
the areas of preven ve healthcare, sanita on,
Q. Where do you foresee India's growth as a na on providing quaran ne facili es, medicines, etc.
for the Pharma manufacturing industry? Despite several constraints, the Indian
Pharmaceu cal Industry has helped to fulfil the
A. The Indian Pharmaceu cal Industry is the 3rd healthcare needs of India and 120+ countries.
largest pharmaceu cal market in terms of volume Exper se in produc on, collabora on, Enhanced
and 10th largest in terms of value, contribu ng Infrastructure and R&Dwill lead the industry to
towards 10% of global produc on. India is rapidly maintain a unique leadership posi on in the near
growing in global pharmaceu cals. It is the largest future. This pandemic era has seen a shi towards
provider of generic medicines globally, occupying a manufacturing in India to reduce dependencies on
20% share in global supply by volume, and also a single supplier. That may allow a comeback of API
supplies 62% of global demand for vaccines. manufacturing in India. The Indian Pharmaceu cal
Medicine spending in India is projected to grow 9- Industry tapping the short-long term opportuni es
12% over the next five years, leading India to will move from a me of transi on towards a bright
become one of the top 15 countries in in terms of future.
medicine spending resul ng into be er domes c
sales. India proved its me le when many countries
were seen queuing up for Covid Vaccines.

Q. What is the role of digi za on in the Indian
Pharmaceu cal industry, can we leverage it to be at
par with global markets?

A. Indian Pharmaceu cal companies are becoming a
preferred choice, as supply-chain disrup ons due to
the Covid-19 pandemic are causing drug shortages
across the world. The global business community
has been receiving the right dri to invest in Indian
pharmaceu cals industry. Online Pharmacy, Video
Conferencing Apps, Social Media, Sales derived
Customer Rela onship Management with Cloud
compu ng are used to sell, service and market like

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WISDOM NUGGETS Satish Agrawal

President, Ajanta Pharma Limited

Q: What was the mission and vision with which understand the responsibility of serving unmet
Ajanta Pharma was established? And how does it needs of pa ents and we know that there is s ll a
feel to serve in a company touching its five decades long way to go.
of serving healthcare?
Q: In your journey, what are the three key aspects
A: Ajanta Pharma had a modest beginning when it that helped Ajanta Pharma to emerge as a market
started its opera on in 1973 with a mission of leader in Branded Generics?
'Serving Global Healthcare Needs Through Empathy,
Innova on and Technology'. Over these five A: When we entered branded generics market
decades, Ajanta Pharma has made a dis nct mark about two decades ago, our strategy was to bring
for itself not only in Indian pharmaceu cals industry, 1st to market products, to get the a en on of
but also in the global arena. Today, while serving doctors in an already crowded market.
healthcare, we have been able to add value to the
pa ents by providing them convenience and quality This made us to iden fy the specialty therapies
products through our innova on. where possibility of innova ons was high. Second
aspect was to build R&D capabili es to develop
To ensure sustained growth, we used empathy to differen ated products. Our an -hypertension
understand our customers' needs and used cu ng brand Met-XL, the extended release version of
edge technology to present innova ve solu ons Metoprolol came with such efforts.
with cost-effec ve approach. This mission was led
by the vision 'To Be A Niche Player In Global Pharma Another important aspect was to build specialised
Space And To Enhance Value For All Stakeholders'. on ground marke ng presence to educate the
doctors as well as get prompt feedback on unmet
This was supported by building strong R&D pa ent needs.
capabili es to deliver differen ated products in the
market. Ajanta Pharma launched many first to the As we entered various emerging markets, we
market products for pa ents both in India and replicated the same model with iden fying therapy
across 30 countries in the world. areas based on pa ent needs & possibility for
innova ons. We also kept dedicated R&D teams for
In the Indian market, Ajanta iden fied the therapies these markets and became pioneer in building on
where it could bring the 1st to market products ground presence of field-force in overseas markets.
through innova on. This helped Ajanta become 2nd
largest in Ophthalmology, 15th largest in Derma,
18th largest in Cardio and 33rd largest in Pain
Management, as per IQVIA MAT 2021.

Ajanta has a meaningful presence in the world's
largest pharma market, USA with 36 products on the
shelf. Our strategy of selec ve play in the market
with the launch of limited compe on products has
helped us achieve this.

As we approach our fi y years of opera ons, the
journey certainly feels very sa sfying. But we also

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WISDOM NUGGETS

Q: Ajanta Pharma is a pioneer in an -malarial drug an cipa ng product approval melines for US and
and a preferred supplier by WHO. Considering the other overseas markets. A er that we planned
challenges, what is the strategy for R&D to sustain Guwaha which was mainly for India market and
and be market leader in some of the emerging last came the Pithampur facility again to cater to
segments? emerging markets.

A: Yes, we were the 1st generic company to get the Certainly, one of the major challenges we faced
approval from WHO for the an -malarial drug. while expanding produc on facili es was the
Ajanta's success story is clearly dependent on its
pioneering R&D capabili es. But with increasing melines for approval from the authori es, both for
compe on and regulatory costs involved, it is very facility and products. Second challenge was the
important to have right focus based on risk and adverse clima c condi ons specially at Guwaha ,
reward. We believe that for sustained growth like heavy rains leading to flooding of sites, etc. The
product selec on is the key. We need to have higher third challenge was mee ng the strict deadlines for
selec on rate from a smaller number of possible comple on of project, to be eligible for the benefits
candidates than the reverse. offered at these loca ons. However, with a
me culous planning and strict execu on
Q: Which were the three major challenges in monitoring, we could overcome all these challenges
expanding Ajanta Pharma to now 8 state-of-the-art successfully.
manufacturing facili es and how they were
strategized? Q: With steady growth in past few years, Ajanta
Pharma now has a 7000+ people workforce. In
A: Ajanta management had always been proac ve your opinion, what is the key to managing the
in its assessment of infrastructure requirement for talent in Indian pharmaceu cals industry?
growth and implemen ng it seamlessly. First it was
the project at Dahej -Gujarat, which was established A: We believe the key lies in providing the right
environment and training for the employees.

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WISDOM NUGGETS Scien fic and on the job training provided to our Q: What are the strategies planned to stay ahead
different teams is one of the best in the industry. of the curve in pharma domain?
This helps us in achieving the 'Buy in' from every
Ajantaite across the globe for the vision and mission A: We believe that our strategy to put the customer
of the top management. first by iden fying and fulfilling unmet pa ent
needs, and bringing differen ated products for
Q: What role does automa on & digi za on play each market, will keep us ahead of the curve for a
while expanding within India and interna onally? long run in pharma domain.
How this is leveraged in your company?
Q: In your opinion, what would be future of India
A: Today a er more than one year in pandemic, the posi on in generics globally? What strategies
role of automa on & digi za on cannot be industry should adopt to con nue our posi on of
undermined. It is the automa on & digi za on, Pharmacy of the World?
which enabled us to serve our customers without
any interrup on. We could con nue to make A: Indian pharma companies are already working to
available lifesaving medicines across the world establish sustainable revenue streams and cost
thanks to automa on & digi za on. leadership strategies to maintain its global posi on.

Ajanta Pharma has leveraged the technology in One of the most important strategies is ra onalising
every aspect of its opera on. Be it R&D, the generic drugs por olio. In response to the
procurement, manufacturing, marke ng, supply erosion of generic drugs prices in the US and
chain, finance, HR or any other area of opera on, Europe, generic drug manufacturers in India are
we have been able to automate & digi ze every exi ng drug por olios where margins are deemed
single step. We have been ahead of the curve in this unsustainable. Currently, the leading companies
respect and have reaped immense benefits during are focusing on developing differen ated generics.
this difficult me. In spite of severe restric ons due
to pandemic, we con nued to be in touch with our This shi in focus towards differen ated generics
customers digitally. Thanks to our proac ve requires companies to increase their R&D
approach in automa on and digi sa on, our en re investment. While doing this the focus on cost
team was connected to our network and was able op misa on should not be lost.
to serve without any interrup on even for a day.
In addi on, it is also important to build culture of
Q: How the next genera on in Ajanta Pharma is quality and compliance excellence. This means
shaping up the growth and con nuity? strengthening technical elements of quality
management system (QMS), including data
A: Managing Director Mr. Yogesh Agrawal and Joint reliability, good documenta on prac ces, process
Managing Director Mr. Rajesh Agrawal come from valida on and upskilling talent across all levels to
the second genera on of the promoter family. They leverage digital technologies which can help in
have been the force behind the strategy shi building on the culture of quality and compliance
toward branded generic business made about two excellence.
decades ago. Their strategic mindset and reless
efforts have helped the Company achieve new With these efforts, I am confident that India will
success milestones. We are confident that the con nue to retain the pres gious posi on of being
Company will con nue to achieve new heights 'Pharmacy of the World.'
under their leadership.

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WOMEN IN PHARMA Aditi Kare Panandikar

Managing Director, Indoco Remedies Limited

Q: Brief history of Indoco Remedies and the values believes that every
on which the Company was established. organisa on has a
social obliga on to
A: In 1945, Late Mr. Govind Ramnath Kare founded give back to the society
'Indo-Con nental Trading Company' in Goa, the what it has earned
principal business of which was to import from it. Indoco is
pharmaceu cal formula ons from Europe and commi ed to its social
distribute them in the Western India. However, in responsibility and
1947 a er India's independence, one of the first strives to make a
endeavors of the Indian Government was to foster posi ve contribu on
manufacturing of indigenous products. To to the under-privileged
encourage this, import of various items including communi es in India in
several pharmaceu cal products were banned. the areas of Health, Educa on, Sanita on and
Thus, Late Mr. Kare ventured into the manufacturing Environment.
of pharmaceu cals and accordingly on 23rd August
1947, a week a er India's independence, Indoco Q: As a third-genera on entrepreneur, in your
was founded with the intent to manufacture and sell journey of close to a decade in leadership posi on,
pharmaceu cal products. That is how Indo what are the key aspects that helped Indoco
“Con nental Trading Company” became Indoco Remedies to emerge as one of the successful
Remedies Limited. companies in today's compe ve scenario and
what is the future outlook?
Indoco started in a very small way by se ng up a
pharmaceu cal unit in Thane, Mumbai. Today, it has A: Change is the dominant factor in every business
grown into a large organiza on with 9 today. The Pharma industry is dynamic and one has
manufacturing facili es spread across India, R&D to constantly upgrade themselves to face the
centre at Navi Mumbai and a CRO at Hyderabad. The challenges going forward. It is our constant
turnover of the Company has exceeded endeavor to an cipate changes and make the right
Rs.1200 crores in the previous financial year and the moves at the right me. Today we are a successful
Company is well placed on the growth trajectory. Company in the domes c as well as interna onal
market, in spite of tough compe on.
Indoco has strong values with respect to ethics,
people and the society. Efforts of countless Exper se in Research & Development, backward
individuals are cumula vely responsible for the integra on in API in select molecules, own CRO set-
existence and growth of a company. 'People' up, excellence in finished dosages manufacturing
con nue to be the most significant of the 3 Ps and a strong customer base has ensured consistent
(People, Product and Profit) needed for any business growth of the Company.
to succeed. It is the vision of Indoco to improve the
quality of life by making available products of The Company's Interna onal Business is expected
highest quality at affordable price. Making profits is to grow speedily as ANDAs (Abbreviated New Drug
the basic principle of any business. However, one Applica on) would be commercialized at regular
should aim to grow their business further, without intervals. EU approval of newly acquired solid
compromising on their ethics. Indoco strongly dosages manufacturing facility at Baddi and

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WOMEN IN PHARMA expected Marke ng Authoriza ons (MAs), against mainly injectables, ophthalmic suspensions and
EU CTD dossiers filed, will also pave the way for mul -par culate formula on for US markets with
higher growth in the European market. Products its strong technical exper se. Today we have a
developed at our R&D centre are applied for number of injectable products in US market, which
registra on not only in US, but also in Europe, South have been developed at our R&D centre and
Africa, New Zealand, Australia, etc. While surging manufactured in the USFDA approved plant in Goa.
ahead in the Regulated Markets, Indoco is also
consolida ng its posi on in the Emerging Markets Q: With Indoco Remedies inves ng heavily to be
through ac ve brand promo on in Africa, Asia and a compliant with many interna onal norms, how is
few La n American countries. Robust pipeline in the innova on factor nurtured in due course?
mul ple dosage forms, including niche ophthalmic
products, will enable the Company to have an upper A: Indoco's manufacturing facili es are fully
edge over its compe tors in the interna onal compliant with interna onal norms and cGMP
business. standards. We have accredita ons for our facili es
from various regulatory authori es like, USFDA,
Q: How was the journey of developing niche UKMHRA, SAHPRA South Africa, TGA Australia,
segments of ophthalmics and injectables for the US TFDA Tanzania, DRU Botswana, FMHACA Ethiopia,
markets leaving a footprint in the interna onal ANVISA Brazil, MOH Yemen, etc. The Company has
markets? also nurtured its innova on and has from me to

A: Indoco, though has primarily relied on organic me added to its ki y of Intellectual Property, by
growth, also has a track record of acquisi ons. These obtaining patents for its innova ve manufacturing
acquisi ons provided opportuni es to diversify in processes. The patent applica ons are filed in
different therapeu c segments and business areas. respec ve countries based on the market poten al.

In the year 1999, Indoco Remedies acquired Warren Status of patents applica ons filed:
Pharmaceu cals Ltd (WPL) and Warren Laboratories
Ltd (WLL). Both these companies were opera ng as Patent Applica ons India PCT Europe USA Japan Total
100% subsidiary companies of Indoco a er
acquisi on and were merged with Indoco in 2002 APIs 42 18 5 4 1 70
into two separate domes c marke ng divisions. FDFs 29 3 2 2 - 36
These companies were majorly opera ng in Total 71 21 7 6 1 106
Ophthalmic and Dental therapeu c segment areas.
Immediately on the acquisi ons, Indoco used the Indoco's IPR cell is ac vely involved in filing and
acquired exper se to build a state-of-the-art facility prosecu on of Patent applica ons in different
in Goa to manufacture sterile products. The territories. It is well equipped with different patent
Company received its first USFDA approval for search tools and has access to various scien fic
Ophthalmic facility in 2006. Encouraged by this, we journals.
started filing ANDAs with the USFDA for Ophthalmic
and other dosages. This helped us forge an alliance Q: What are the factors that have shown posi ve
with Watson Inc., USA (now TEVA) for marke ng and results for managing talent within the company?
distribu on of our Ophthalmic products in US. Today
we can boast of having launched the first and the A: Contribu ng posi vely to the quality of life of
only generic in US for one of the ophthalmic Indocoites is the fundamental approach of HR at
products through TEVA. Indoco.

Indoco con nues to develop complex generics Indoconfirmly believes that people are the
Company's greatest assets and adopt best prac ces
to ensure healthy employee rela ons, employee

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WOMEN IN PHARMA growth and development as well as work Q: How do you think Indian Pharma Industry can
sa sfac on. The Company recognizes that people leverage its R&D poten al to be at par with
are the primary source of compe veness and interna onal markets?
achievement. Team HR extends its valuable
support and mely co-ordina on with all Indian Pharma Industry is always known for its
departments and loca ons of the organiza on. development, innova ve capabili es and low cost
During these challenging mes, various Training manufacturing. India's Pharma R&D has huge
Programs and Employee Welfare ini a ves scien fic and technical pool to support local and
con nued online, thereby strengthening the bond interna onal market needs. With such vast
and ensuring that special connect. experience of chemical, pharma sector and vaccine
development, the pharma industry will leverage its
We strongly believe in 'Crea ng Leaders from poten al in the interna onal markets.
within' and under its mentoring and coaching
ini a ve GEMS (Guiding, Empowering, Mentoring, Q: In your opinion, what are the three key quali es
Suppor ng) – a group of employees are selected of a leader to thrive not just to sustain during
based on predefined criteria and these Individuals disrup ve period?
are encouraged to grow and maximize their
poten al, improve their skills through mentoring, A: The Covid-19 wave has brought in anxiety and
classroom training, various in-bound / out-bound uncertainty to human lives and the economy. As an
training programs, etc. enterprise manufacturing essen al medicines, our
challenges knew no bounds. From ge ng people to
To create and maintain a healthy, stress free work a end work in the manufacturing sites, ge ng sales
environment, Indoco under its ini a ve IMPACT orders to mobilizing movement of goods across the
Indoco's Management Program for Achieving supply chain, has been one herculean task. However,
Compe ve Talent) conducts various internal Indocoites rose to the occasion and ensured
training programmes on various so skill modules con nuity in the supply chain so that no human being
to promote learning within the organiza on. CLIMB was le without the availability of medicines.
(Cluster of Learning for Mutual Benefit) is another
ini a ve to bring together employees from various Leaders have to broaden their approach towards the
departments for cross func onal, knowledge business to adopt a systems-based approach. A goal-
sharing, team building and sharing their individual directed approach and a posi ve outlook will
exper se gained in their respec ve func onal certainly fetch the desired results. More focus should
areas. be on the society and their unmet needs. Mee ng the
increasing demand is an intricate challenge and shall
Q: How Indoco Remedies plans to leverage the certainly create enormous opportuni es for
evolving era of digi za on and automa on in the inven on.
coming years suppor ng growth?
The ability to adapt to change, connect with the
A: Indoco Remedies envisions to u lize the power people and demand of the market is to be taken into
of digi za on for enhancing reach to the Doctors considera on for the sustainability going forward.
and for spreading awareness about diseases to
pa ents as well as for reaching out to other In the new normal, in order for the organiza on to
stakeholders in the supply chain. We are thrive and succeed, Leaders will have to be agile in
transforming to use the latest technology for decision making and on top of the dynamic
automa on in every sphere of our business to ease environmental factors. Con nuous monitoring and
the business process for intelligent and faster screening of business, environment risks and quick
ac ons with the help of automa on, ar ficial decision making will be needed.
Intelligence and machine learning.

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ACADEMIA Solid Oral Dosage Forms:
What Future Beholds

Ms. Anjali K. Pandya Dr. (Mrs.) Vandana B. Patravale
Ph.D. (Tech.) DST INSPIRE Research Fellow
Professor of Pharmaceu cs
(Pharmaceu cs)
VBP Research Group Department of Pharmaceu cal Sciences and
Department of Pharmaceu cal Sciences and Technology,

Technology, Ins tute of Chemical Technology, Mumbai
Ins tute of Chemical Technology, Mumbai

Introduc on friendly solid oral dosage forms. With this move in
picture, there is an ever-increasing emphasis on
Pharmaceu cal industry is advancing towards a 505(b)(2) based strategies involving change in dosage
new genera on of therapeu cs ranging from form. Innova ve solid oral dosage forms including
nano-formula ons, personalized medicines, as powders and granules for recons tu on for pediatric and
well as bio-degradable and compa ble medical devices. geriatric pa ents, freeze dried nutraceu cals like
This being said, pa ent compliance is considered as the probio cs are on an all- me rise. With the advent of co-
topmost priority while designing any product right from processed and func onal excipients, the research on
pharmaceu cals and nutraceu cals to cosme cs. Along advanced site-specific delivery systems is being explored
with that, cost effec veness, ease of manufacturing and with an aim of overcoming the drawbacks associated
a ainment of desired bio availability are some of the with conven onal solid orals in previous years. The
most crucial factors for dosage form design. versa lity of solid orals to go from conven onal generics
Pharmaceu cal companies have to shed a lot in terms of to specialized and sophis cated delivery systems is what
resources while development of a new chemical en ty makes them one of the most sought-a er dosage forms.
which takes almost a decade to pass the regulatory
norms. Companies are under a constant pressure to Challenges in Oral Drug Delivery
u lize full poten al of the drug candidate at the ini al
stages of formula on development using apt dosage The drugs entering via oral route face three main
forms. The exercise is even more important when physiological barriers including Gastrointes nal Tract
companies are planning to extend patent life of a drug by (GIT) lumen, mucous, and ssue. The lumen is the site
delivering it in modified dosage forms or when the bearing harsh pH condi ons due to the presence of acids
problem of pa ent compliance is being catered to. and enzymes from both gastric and pancrea c origin. The
drugs have to penetrate the epithelial ssue that lines the
Solid oral dosage form is one of the most versa le delivery lumen either paracellularly or transcellularly and is
systems with maximum acceptance rate. The global usually dependent on the lipophilicity of the system.
market for solid oral dosage form is es mated to reach Along with these common factors, there also exists an
over USD 926.1 billion by 2027 from 2020 at a CAGR of inter-subject variability which influences formula on
more than 6.5%, a figure demanding extensive a en on. residence and transit me followed by its subsequent
Though a sec on of market is now moving towards absorp on in GIT. A major challenge is delivery of
delivery of biologics and small molecules which are biomolecules via the oral route ci ng their inherent
primarily delivered parenterally, it is not a surprise to see proper es like hydrophilicity, poor membrane
major biopharmaceu cal companies inves ng in permeability, and suscep bility to degrada on by gastric
conver ng these parenteral formula ons into pa ent- proteases. Systems designed for delivery of biomolecules

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ACADEMIA proteins, pep des, or vaccines are highly sensi ve to modula on of dosage form design has garnered
changes in pH, mucous membrane composi on, and immense a en on. Gastro reten ve drug delivery
enzymes that exist in the GIT, making it difficult for them systems have witnessed several modifica ons including
to permeate and induce desired pharmacological expandable dosage forms that increase in size in the
responses. Absorp on mechanism of drugs via the gastric stomach and are designed to a ain a diameter of more
route is complex and subject to a lot of condi ons, both than 15 mm so as to retain it from crossing the pylorus
physiological and delivery system based. The and achieve gastric reten on . Another varia on is muco
mechanisms of absorp on in the GIT include adhesive dosage forms like intes nal patches intended to
transcellular, paracellular, carrier-mediated and adhere to the intes nal walls and enable drug
facilitated transport . The drugs not only have to face the absorp on. But these also show certain limita ons due
GIT but also have to encounter the barriers posed by the to the risk of being washed away due to digested food
hepa c systems. The hepa c first pass metabolism is the boluses, GIT fluids as well as mucous turnover .
major reason why all the emergency medica ons need to
be given parenterally in order to overcome these serial Scien sts have now shi ed their explora ons towards
barriers. Thus, oral delivery of macromolecules especially use of Nano Par cle (NP) based formula ons with a
those from the biopharmaceu cal category is s ll an ra onale that reduc on in par cle size would enable
unresolved challenge on mul ple fronts. be er targe ng as well as enhanced uptake across the
biological membranes. Solid Lipid Nano par cles (SLNs),
Advances in Oral Drug Delivery Systems for example, are known to promote solubility, stability,
epithelium permeability, bio availability, prolonged the
Researchers from both academic and industrial half-life, and ssue targe ng upon oral administra on .
backgrounds have been working relessly towards pH sensi ve polymeric curcumin loaded NPs made from
con nuous improvement of non-invasive routes of drug a combina on of PLGA and Eudragit S100 were
delivery owing to their high acceptance rate. Oral drug developed to preferen ally accumulate at the inflamed
delivery pla orms can also be modified in order to u lize colonic sites making them an a rac ve alterna ve for
advantages of the mucosal lining throughout the GIT as treatment of inflammatory bowel disease. Nano
well as oral cavity for buccal and sublingual delivery. The par cles made with biodegradable polymers like PLGA
later have been developed over the past decade in order and chitosan have also been used for inducing
to bypass the first pass metabolism and deliver microbiota responsive colon targeted delivery. Systems
biomolecules. Regional delivery of drugs in different like Eudragit S100 coated PLGA NPs have been developed
segments of GIT is a sought-out approach while designing for colon targe ng of etoricoxib and it was shown to
systems for oral administra on. There are numerous exhibit 4.23% fold increase in oral bio availability in
strategies that have been tried, in order to work on the pharmacokine c assessments in human volunteers.
challenges, which include a) regional delivery using pH Similarly, chitosan coated PLGA NPs were fabricated
modula on, b) delayed release dosage forms that rely on wherein PLGA NPs helped improve solubility and bio
GI transit me, and c) exploita on of the metabolic availability of the an -ulcer ac ve diosmin whereas
pathways in the colonic microbiota . pH responsive chitosan coat enabled enhanced gastric reten on and
polymers like methacrylic resins (eg. Eudragit ) and HPMC cellular uptake . We, at VBP Research Group, ICT Mumbai
deriva ves are used alone or in combina on in the form have also developed two interes ng oral delivery
of coa ngs . These polymers can trigger pH responsive pla orms, namely NanOsorb (patent) and SMETs
release, can be used as enteric coa ng and can also be (registered trademark),based on nano technology.
u lized to delay or extend the drug release. Time NanOsorb is a solid micro emulsion preconcentrate
dependent dosage form is another system that is pla orm that induces change in micro environment for
designed depending on the GI transit me for example acid labile drugs while also retaining its nano-size in the
use of hydrophilic swelling polymers like ethyl cellulose or biological milieu. It was formulated for delivery of
HPMC as coa ng or matrix. Biodegradable polymers like an malarial drug artemether and it performed
those from polysaccharide origin are used for regional significantly in comparison to the marketed formula on
targe ng because of their similarity to colonic bacterial with respect to both safety and efficacy. The SMETs
flora. These biodegradable polymers are cleaved by the pla orm is composed of Self Micro Emulsifying Drug
colonic enzymes by either azo-reduc on or hydrolysis of Delivery System (SMEDDS) that has been converted into
glycosidic bonds – . However, these strategies may not Self Micro Emulsifying Tablets (SMETs). SMEDDS are
work always ci ng the issues pertaining to inter-subject known to enhance the bio availability of drugs, especially
variability in GI physiology, pathological changes in bio molecules due to their nano-size range and they also
microflora content due to disease condi ons, as well as pose an addi onal advantage of not being influenced by
dosage form design. In order to tackle these obstacles, food uptake. With the growing interest of industries

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Tel. : +91 - 22 - 4041 3131 / +91 - 22 - 4161 3122

Website : www.electrolabgroup.com | E-mail : [email protected]

www.ipmma.org PHARMA PRO & PACK | APRIL - JUNE 2021 35

INNOVATION Rotor technology for dry powder coating

Ankita Shah, Ph.D. concentra on to an acceptable limit. Further, the
Process Development Scien st, use of large amounts of organic solvents and their
Freund-Vector Corpora on expensive recovery adds a significant cost to
manufacturing.
Tradi onally, pharmaceu cal film coa ng of
ac ve pharmaceu cal ingredient (API) or In the past 10 to 15 years, researchers and process
func onal excipients and polymer on to inert engineers have made significant progress in
or ac ve cores has been carried out by atomizing developing alternate technologies to apply high API
coa ng dispersions or solu ons of varying percent loading or func onal coa ng with reduced amounts
solid concentra ons. These coa ng systems are of coa ng solvents at significantly less processing
either aqueous or organic solvent based and require
some considera ons: APIs must be stable in mes. One such process is rotor technology or rotor
dispersing solvents, need for a common solvent to processor. Due to its unique design, the rotor
dissolve/disperse API and excipients, solids must technology offers a pla orm for dry powder coa ng,
remain homogenously dispersed or dissolved spherical granula on, and conven onal solu on or
throughout the coa ng process, and handling of suspension coa ng.
highly viscous solu ons/suspensions. In addi on,
such coa ng processes are o en me-consuming as The rotor processor is a one-pot insert where dry
use of high amounts of coa ng solvents require API coa ng/dry func onal polymer coa ng,
longer drying cycles to achieve residual solvent solu on coa ng/seal coa ng, and drying can all be
carried out stepwise without need for transferring
the product to different processing equipment.

It is also possible to generate ac ve API cores or

36 PHARMA PRO & PACK | APRIL - JUNE 2021 www.ipmma.org

www.ipmma.org PHARMA PRO & PACK | APRIL - JUNE 2021 37

INNOVATION pellets through spherical granula on from raw cri cal process parameters to achieve cri cal
powder blends to increase drug load followed by dry quality a ributes of a final product is crucial. These
API coa ng and so on. Since 100% dry powder blend process parameters include rotor speed, slit air flow
instead of the tradi onal lower % solid dispersion or and temperature, binder spray rate, spray nozzle
solu on is applied during coa ng, overall processing atomiza on air pressure, powder addi on rate,
eductor air pressure to disperse powder blend, ra o
me is significantly reduced, and produc vity of binder to powder addi on rate, product
increased. temperature, drying airflow and temperature, and
drying me. The dry powder coa ng is carried out at
The rotor processor includes a sta onary chamber rela vely colder temperatures compared to other
with a rotatable conical rotor or disc in which coa ng processes. In many instances, only slit
par cles are circulated for coa ng or powder airflow is ac vated during the coa ng process to
layering. The rotor has a perimeter edge spaced avoid unnecessary drying of substrate or cores. The
closely to the interior wall of the chamber. This gap ra o of binder to powder addi on will depend on
or slit supplies airflow at a specific temperature. An the type of solvent involved (organic versus
expansion chamber provides housing for drying aqueous), powder blend (hydrophilic versus
airflow duct for moving product inside the rotor hydrophobic),and core material proper es.
chamber.
The powder-coated pellets or mul -par culates are
Over the years, the rotor technology has been o en further coated with func onal polymers to
evolved from flat rotor design to conical rotor to achieve modified drug release or protec ve
provide be er product movement for efficient moisture barrier for stability. The cri cal quality
coa ng and simultaneous drying. A spray gun is a ributes of the product will include par cle size
mounted on the wall of the stator chamber above distribu on, bulk density, residual solvent
the slit to apply binder spray into the rotor chamber concentra on, par cle shape and morphology,
in the direc on of moving par cles. Similarly, a content uniformity, and drug release profile.
powder gun connected with a powder feeding
system is mounted in the stator chamber which Due to the flexibility of the rotor processor, it is
directs dry powder into the rotor chamber. The possible to coat different APIs in different layers in
spray gun and powder feed system are spaced apart case of chemical incompa bility. With
circumferen ally to define a dis nct spray zone and advancement in process analy cal technologies, it
powder zone. is also possible to monitor and control dynamic and
complex processes like dry powder layering in real
Depending on the scale of equipment (laboratory
R&D versus produc on), number of spray and me.
powder guns are increased in a similar order. For
uniform coa ng or layering, compressed air is added This technology offers a great flexibility to produce
to the powder feed line to disperse or atomize immediate or modified release pellets, granules, or
powder blend before it enters the rotor chamber. mul -par culates with high API loading with high
During this process, micronized API and excipient efficiency and at significantly lower processing
blend or dry polymer is coated successively in a
layer-by-layer fashion onto the cores with help of mes. Based on current processing data available,
small quan es of binder solu on. The process is this process technology is capable to achieve
con nued un l the desired weight gain is achieved. >500%w/w weight gain and product yields of > 95%
with high bulk density. It is truly a processing
To improve flow ability, flow-aids are o en added to blessing for product manufacturers to avoid me-
the powder blend. Like other processing consuming intermediate product transfers and
technologies, close monitoring and op miza on of storage.

38 PHARMA PRO & PACK | APRIL - JUNE 2021 www.ipmma.org

www.ipmma.org PHARMA PRO & PACK | APRIL - JUNE 2021 39

QUALITY Building Robustness in Coating through
Equipment and Process considerations

Atul Auluck Shantanu Damle

Principal Area Technical Manager Technical Director - South Asia
Colorcon Asia Pvt. Ltd. Colorcon Asia Pvt. Ltd.

In t h e p h a r m a c e u ca l a n d n u t r i o n a l difficult to make changes to the core and coa ng
supplement industries, film coa ng is formula on, even though these may be the root
considered to be the preferred method to causes. Selec ng an op mized fully formulated
provide product differen a on through the addi on coa ng system early in the development process
of brand elements, such as color and finish. In some will be first me approach to achieve flawless
coa ng and smooth transi on from scale up to
cases, it is designed to improve consumer's produc on.
(pa ent)ability to recognize different drug products
and enhance their experience and acceptability - In this ar cle, key elements of equipment set-up
through visual impact, ease of handling and swallow and process parameters are discussed to outline
ability. Film coa ngs also support tablet their importance for enhancing overall coa ng
performance characteris cs, including mechanical process control for a perfect tablet finish.
integrity, moisture protec on, and sustained or
enteric release. Coa ng Dispersion Prepara on is first and
For op mal efficiency and a perfect tablet finish, the important step in coa ng opera on. Care must be
film coa ng process requires a balance of the taken in selec ng proper vessel size, blade type,
complex interac ons between the tablet substrate s rred posi on and mixing speed for dispersion
(the core), the coa ng formula on and the coa ng prepara on.
process and equipment.
Coa ng problems are o en iden fied at scale-up or Key elements to ensure the best performance for
technology transfer stage, by which me it may be coa ng dispersion prepara on are:

l Height (h) of liquid (level)equalsthe diameter (d)
of the vessel.

40 PHARMA PRO & PACK | APRIL - JUNE 2021 www.ipmma.org

l Diameter of impeller (ds)= 1/3rd diameter of the QUALITY

vessel.
l Use of variable speed s rrer to create a vortex.
l Op mal vortex depth and speed for minimal

air entrapment.

Product Temp.

Coa ng Pan Load: The correct load for the coa ng temperature as this is an independent parameter
pan depends on the machine size and design along that remains constant from laboratory scale to
with the size, shape and density of core tablets. commercial scale.

The batch size (kg) of tablets will be determined by The product temperature requires a balance
the coa ng machine type and available pan size. A between key process parameters such as airflow,
correctly filled pan will have the tablet bed covering inlet temperature and spray rate.
the exhaust plenum completely whereas a par ally
filled pan will result in incomplete coverage of the Airflow: Of the three parameters (airflow, inlet
pan. With a lower pan load, the drying air will then temp and spray rate) airflow is most important
take the path of least resistance and bypass the parameter. Airflow is the volume of air that cycles
tablet bed altogether. In this scenario, the exhaust through the coa ng pan and evaporates the water /
temperature will be higher than the actual product solvent during the coa ng process. Higher airflow
temperature in the process leading to poor drying helps in effec ve drying during the coa ng process.
and ul mately over we ng defects. If low pan loads
are required, exhaust plenum adjustment and Airflow, as measured in cfm, is measured at
reducing baffles can be beneficial to overcome this different inlet damper se ngs. It is preferable to
but a correctly filled pan goes a long way in ensuring keep the inlet damper open to maximize the volume
defect-free coa ng. of air available. As shown in the figure, irrespec ve

Every coa ng process will Low Airflow - 150 cfm High Airflow - 350 cfm
have an op mum coa ng
temperature depending on
the nature of the substrate,
the solids content of the
coa ng and the solvent
system used. The coa ng
temperature is most
accurately represented by
the tablet product

www.ipmma.org PHARMA PRO & PACK | APRIL - JUNE 2021 41

QUALITY of the inlet temperature set point, higher airflow monitor this parameter in real- me throughout the
(350 cfm) helped achieve higher bed temperature process. The spray rate for the coa ng is o en
compared to lower air flow (150 cfm) across recorded as the spray pump (rpm), but this does not
different spray rate range. provide an accurate applica on rate. One of the
simplest alterna ves is to mount the coa ng
Inlet Temperature/ Exhaust Temperature: suspension tank on a digital balance, or load cell
pla orm, and record the loss in weight over me to
The inlet air temperature controls the amount of get a good indica on of the applica on rate during
energy available to heat and evaporates the the process. It's important to select right spray rate
solvent. Se ng the right inlet air temperature is according to coa ng formula on and drying
key to achieve the target product temperature. In condi ons for desired tablet finish.
most cases, exhaust and product temperature are
closely related and, in some equipment, exhaust Conclusion
temperature is measured but not product
temperature. Some modern types of coa ng Achieving a perfect finish for your coated tablet
equipment measure exhaust temperature, then comes down to selec ng the right partner to not
automa cally adjus ng the inlet temperature by only provide the op mal coa ng system for your
using an integrated feedback loop control system. product but also provide support to ensure op mal
This simplifies the process by the equipment process parameters. Selec ng fully formulated
controlling and adjus ng for any variability due to coa ng system designed for use across a wide
environmental condi ons or minor process processing range makes the coa ng process more
changes. In case of par al load, exhaust adaptable and easy to transfer. Colorcon, as world
temperature may be different from the actual leaders in the development, supply and support of
product temperature in the process. It is therefore innova ve coa ngs systems will help you choose
recommended to monitor product temperatures the right coa ng system for your applica on and
always for be er process control. provide specialist support to ensure understanding
and control of equipment and process variables to
Spray Rate i.e. the rate of applica on of the coa ng result in defect-free and smooth-coated tablets.
suspension is a cri cal control parameter for the
film coa ng opera on. Hence it's important to

s

CVC Technologies India Pvt. Ltd.

602, Manmandir Suraksha, Nahur Village, Mulund (West),
Mumbai - 400 080, Maharashtra
www.cvctechnologies.com

ROMACO

204-205, Sen nel, Hiranandani Business Partk, Opposite IIT Bombay,
Powai, Mumbai - 400076 Maharashtra
www.romaco.com

42 PHARMA PRO & PACK | APRIL - JUNE 2021 www.ipmma.org

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www.ipmma.org PHARMA PRO & PACK | APRIL - JUNE 2021 43

QUALITY Building Trust - Engineering To
Quality & Validation

Over the years, the roles and responsibili es of construc on quality, commissioning, issue/punch list
Engineering and Quality/Valida on have evolved management, and asset management – comprise an
for Commissioning and Qualifica on (C&Q) Engineering Quality Process that underpins the C&Q
ac vi es. Now more than ever, risk-based approaches process. Appropriate engineering SMEs define system
rely heavily on Engineering Subject Ma er Experts (SMEs) requirements and then specify, design, and verify the
and the applica on of Good Engineering Prac ces (GEPs) system in an efficient, effec ve, integrated approach. By
as an Engineering Quality Process to underpin C&Q. relying on a robust, mature Engineering Quality Process
built on GEP, the Quality unit – and analogous Quality
Under the Quality Risk Management (QRM) model, all Systems, including quality change control, good
tes ng adds value as verifica on ac vi es; tes ng is documenta on prac ce, document control, devia on
commensurate with product risk; GEPs and Engineering management, CAPA, etc. – can adequately focus on
SMEs are emphasized in the process; and Quality is product quality and pa ent safety.
focused on the iden fica on, mi ga on, control of risks
to product quality and verifica on of the process risk Using this approach, responsibili es, and focus can be
control strategy. Under this model, GEPs as an aligned effec vely and efficiently:
Engineering Quality Process (EQP) enable the C&Q
process. l The Engineering responsibility is system delivery,
with an emphasis on documen ng system fitness for
However, historically, the Quality unit has not had purpose.
sufficient trust in GEPs to facilitate their effec ve use in
risk-based C&Q. Why has that trust been missing, and l The Quality unit responsibility is product quality, with
how can it be built? a focus on verifying cri cal system fitness for
purpose.
Good Engineering Prac ce as a QRM-Based Integrated
C&Q-Enabling Process Current Industry GEP

How does Good Engineering Prac ce enable QRM-based In prac ce, GEP is generally not viewed as an Engineering
integrated C&Q? Quality Process necessary to support Quality/Valida on.
GEPs may be followed as a ma er of procedure or seen as
GEP ensures that: a non-value-added hindrance to project progress. In
general, GEP systems lack in robustness, maturity,
Systems are specified, designed, installed, and operate in implementa on, and/or compliance, and are therefore
a manner that meets opera onal, maintenance, safety, not suitable for underpinning a QRM-based integrated
health, environmental, ergonomic, industry, statutory, C&Q approach.
and regulatory requirements – including GxP
requirements This state of affairs leads to two significant outcomes:

l Process risks to product quality are iden fied, l Many current C&Q approaches produce an “it's only
assessed, and mi gated in system design, Commissioning, it will be verified during
installa on, and opera on Qualifica on” mindset that results in the bulk of
engineering SME commissioning effort being
l Appropriate planning, specifica on, design,
installa on, verifica on, acceptance, and
maintenance documenta on is created throughout
the system life cycle

l Suitable oversight and control are provided for
construc on, installa on, and execu on verifica on
ac vi es

In short, the GEP systems that enable QRM-based
integrated C&Q – including design review, engineering
change management, good documenta on prac ce,
document/drawing control, vendor qualifica on,

44 PHARMA PRO & PACK | APRIL - JUNE 2021 www.ipmma.org

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QUALITY focussed on aspects of the system that do not impact instrument services through automa on but not
product quality – exactly the opposite of where considered to be valid verifica on tes ng since it was
engineering SME effort should be focussed. not performed using a Quality pre-approved
protocol, that is repeated by the C&Q or Automa on
l The Quality unit, without sufficient trust in GEP as an team.
Engineering Quality Process, then requires analogous
Quality Systems to be used to provide appropriate The Engineering mindset of “get the project done and
oversight and control of all C&Q ac vi es. The result valida on will find the problems and provide the
is addi onal, less efficient, and more costly processes documenta on” cannot be maintained. Engineering
as well as addi onal documenta on, tes ng, and must embrace the efficiency gained through a robust,
effort with no commensurate, addi onal reduc on GEP-based Engineering Quality Process.
or mi ga on of product quality risk.
The New Capital Project Reality
In other words, Engineering and Quality are focussed on
exactly the wrong things, hindering their ability to fulfill Capital project melines are shrinking due to the
their responsibili es effec vely or efficiently. accelerated approval process, agile manufacturing, and
pressure to increase speed to market. Corporate
The Cost of Poor (Engineering) Quality engineering is challenged to deliver projects in record

So, what happens as a result? Some real-world examples: me. The typical phase-gate model is being replaced by
agile and/or concurrent ac vi es and value-engineering
l A turnover package (TOP) found as unacceptable by approaches, and there is much less tolerance for
Valida on, which takes a “we cannot start protocol repeated tes ng and issue discovery during startup,
genera on un l the TOP is ready” stance without debug, and engineering runs. Companies execu ng
assessing impact to product quality, resul ng in a capital projects need to find ways to acceptably cut the
day-for-day slip of protocol genera on, which can equipment tes ng melines dras cally (maybe even by
quickly impact the overall project schedule. half) to achieve their product launch goals.

l Hundreds of discrepancies observed during Building Trust Between Engineering and Quality
Engineering verifica on tes ng, using mul ple-page
forms with mul ple steps and signatures for issues Building trust between Engineering and Quality may
that have no impact on product quality, such as require procedural and cultural change for Engineering
incorrect make or model number. In the end, the as well as a paradigm shi for Quality. GEP systems need
conclusion is “as-installed meets requirements, to be viewed as a good business prac ce that ul mately
update the specifica on.” Such Quality oversight delivers the project earlier with fewer issues and as a
adds li le to the resolu on of these discrepancies cri cal component of QRM-based integrated C&Q.
while adding considerable churn and me to the
project. Systems may need to be developed or matured (a
spreadsheet on an engineer's computer will not suffice
l Drawing redlines during field walks months a er for engineering change management). The suitability of
receipt and installa on, resul ng in a determina on GEP systems to support and enable QRM-based
that OQ cannot start un l IQ is complete without integrated C&Q may need to be demonstrated through
assessing the acceptability of as-found condi ons or engineering product quality on trial or pilot projects. And
impact to product quality, and causing delay due to the Quality unit will need to change from a project
drawing review and update. quality mindset to a product quality focus.

l The belief that func onal or opera onal verifica on The good news is, in most cases, both Engineering and
(tradi onally called OQ) cannot start un l all Quality welcome and desire this change. Engineering
predecessor systems are “qualified”. For example, wants to deliver systems that meet requirements, and
requiring all feed and intermediate systems in a the Quality unit wants to focus on product quality instead
pharmaceu cal water train (municipal water supply, of having their effort diluted by overseeing aspects of
so water, RO water, WFI) to be qualified as a project delivery that do not impact product quality.
prerequisite to qualifying a clean steam generator,
resul ng in a false cri cal path. Source: Chip Benne , Project Management Professional
(PMP)-cagents (CAI), USA
l Con nuity and loop checks performed by the
electrical vendor with poor or no documenta on or
not approved by Quality, that are repeated by the
C&Q team. In-place loop calibra on performed by

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