Ophthalmic Preparation 2021

VI Container

1. Single application containers
Minims unit

2. Multiple application containers
2.1 Polyethylene droptainers

(Container) sterilised by ethylene oxide
gas / ionizing radiation (cold method)

(drug solution) sterile in glass container
aseptically mixed

Disadvantages
difficult to sterilise, adsorb preservative
and drug, release plasticizer or antioxidant,
difficult to make bacterial proof seal

VI Container

2. Multiple application containers
2.2 Glass dropper container
(Solution +container) sterilised by
autoclaving/steaming
Disadvantages
easily contaminated after
multiple use

Minims unit

Glass dropper
bottle

PE drop-tainer

VII Labelling

Objective of Labelling

1. Prevent Use of a Contaminated Product
Household E.D.
4 weeks after opening
2 weeks after opening (aseptically
prepared E.D.
i.e. Chloramphenicol E.D.)
E.D. used in ER
Discard within the day of opening
E.D. used in IPD
Discard within a week after opening
E.D. used in OR (i.e. Fluorescein E.D.)
Use fresh E.D. (no preservative)
Discard after using one time

VII Labelling

Objective of Labelling

2. Prevent Damage to The Eye

-Specify the name and conc of preservative

used

3. Prevent Use of an Incorrect Preparation /
Strength

-Specify the name of preparation and conc
of drug

4. Ensure Full Potency at Time of Use

-Specify the storage condition that maintain
activity

-If shelf life (t90 %)is short , specify expiry
date

Ex Adrenaline, Chloramphenicol,
cyclopentolate, hydrocortisone acetate,
Proxymetacaine should be kept in

cool place

VII Labelling

Objective of Labelling

Chloramphenicol E.D.
maintain activity 4 months ( 25 C)
maintain activity 18 months ( 2-8 C)

****Should not be dispensed after 3 months of
storage ( 25 C)

****Should not be dispensed after 17 months of
storage ( 2-8 C)

5. Prevent Adverse Physical Change
**Eye Suspension Dosage Form**
-Do not freeze
-Shake well before use



Ophthalmic Ointment

About Ophthalmic Ointment

- Increase contact time

- Base : White petrolatum +
mineral oil (melt at body temp)

- Base : water-miscible agent :
wool fat

- Base should not irritate the eye
and drug can be released from
base

- Base : water soluble agent (rare)

Ophthalmic Ointment

Preparation

1. Base sterilised by dry heat
Drug and additives (solution, micronized
pwd) sterilised by suitable means
aseptically mixed

2. Cobalt 60 ( radiation)
Sterilise finished product (base + drug)
Ex Tetracycline HCl Ointment
Chlortetracycline HCl Ointment

Ophthalmic Ointment

Quality Control Requirement

- Meet Sterility test
- Limit of number and size of

metal particle in ointment

Disadvantages
- Blurred vision



Ophthalmic Suspension

Compare to E.D.

- Increase contact time

- Use in smaller amount

About Ophthamic Suspension

- Prepare when

- Drug cannot be dissolved in vehicle

- Drug is not stable in solution

- Sterility test must be met

- Preservation, Isotonic, Buffer, Viscosity,
Packaging must be considered

- Drug does not contribute to the tonicity of
vehicle

- Particles must be small enough that they are
non-irritating to the eyes / do not
agglomerate upon storage

Ophthalmic Suspension

About Ophthamic Suspension

- Sterile solid is from dry heat or
crystallization

- Vehicle is sterilised by autoclaving

Ex Steroidal formulation

-Oxytetracycline and Hydrocortisone
Acetate Ophthalmic Suspension

-Tobramycin and Dexamethasone
Ophthalmic Suspension

Eye Lotion

Eye lotion are usually applied with an
eye bath, which, for first aid
purposes, that allows a large volume
of fluid to flow quickly over the eye

Eye Lotion B.P.C.

a. Sterile aq solutions containing no
bactericide

- First aid to remove foreign particles

- Discard within 24 hr after opening

- Official Eye Lotion
“ Sodium chloride Eye Lotion

B.P.C.”

Eye Lotion

Sterilisation

Official Lotion

- Autoclaving, filtration

- To assist in preserving sterility

a. Containers are labelled as
“Avoid contamination during use”
and “Discard any unused part 24
hr after first opening”

b. Lotions should not be
diluted.

Eye Lotion

Eye Lotion B.P.C.

b. Aqueous solutions containing
bactericide

- Used for intermittent
domiciliary administration up to 7
days
- “Soothing lotions for tired
eyes”
- Ex Optrex® Optal®

Eye Lotion

Formulation of Eye Lotion
- Simple solution
**** Isotonic is much more
important than E.D.****





Ophthalmic Inserts

-Ocular drug delivery system
-Ocusert® (Alza)
-Reduce frequency & increase
pt compliance
Ocusert system
-Ocular delivery system
-Release drug with constant rate
-1 disc for 7 days
-Elliptical with the dimensions of 13.4

by 5.7 mm and 0.3 mm in thickness
-Pilocarpine Insert for glaucoma





Ophthalmic Inserts

Lacrisert® system
- Merck product
- Sterile, rod-shaped, translucent,
water-soluble form of
hydroxypropylcellulose (HPC)
- Inserted into inferior cul-de-sac of the
eye
- For patients with dry eye states
- once or twice a day
- Stabilize and thicken precorneal tear
film and delay break-up



Accessories
suredrop

Accessories
Eye bottle squeezer

Reference

1. Cooper and Gunn’s Dispensing for
Pharmaceutical Students 12th ed., 1987

2. Pharmaceutical Dosage Forms and Drug
Delivery Systems 6th ed., 1995.

3. Sterile Dosage Forms : their preparation
and clinical application, 4/E 4th ed.,
1994.

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