Evaluation of Ophthalmic preparation

Supervised by :

Dr. Roshan IsaraniH.O.D of Pharmaceutics

Submitted by :Sunil SainiM.pharm. 1st sem.Pharmaceutics

Lachoo Memorial College of Science & Technology, Jodhpur (Rajasthan)

Evaluation is test of finish Parenteral product,that either these preparation are free from micro-organism or not.

Evaluation of the ophthalmic product is done by following tests:

1. Sterility Test

2. Clarity Test

3. Leaker Test

4. Metal particles in ophthalmic ointment

Drug product quality tests and drug product performance tests

Procedures and acceptance criteria for testing ophthalmic

preparations are divided into two categories:

those that assess general quality attributes, for example,

identification, potency, purity, (and impurities), sterility and

particulate matter.

those that assess in vitro product performance, i.e., dissolution

or drug release of the active drug substance from the drug

product.

Quality tests assess the integrity of the dosage form, whereas the

performance tests assess drug release and other attributes that

relate to in vivo drug performance.

Taken together, quality and performance tests assure the identity,

strength, quality , purity and efficacy of the drug product.

Drug Product Quality Tests—Universal Tests

Identification

Identification tests should establish the identity of the drug or

drugs present in the drug product and should discriminate

between compounds of closely related structures that are likely

to be present. Identity tests should be specific for the drug

substance(s) (e.g., infrared spectroscopy).

Assay

A specific and stability-indicating test should be used to determine

the strength (content) of the drug product.

pH

The pH and buffering capacity of an ophthalmic preparation are

probably of equal importance to proper preservation, since the

stability of most commonly used ophthalmic drugs is largely

controlled by the pH of their environment.

Osmolarity

In formulating ophthalmic preparations, it is more important to

consider the sterility, stability, and preservative aspects, and not

jeopardize these aspects to obtain a precisely isotonic solution.

In practice, the tonicity limits may range from 0.5%–5% sodium

chloride, equivalent to a range from about 171 mOsm/kg to

about 1711 mOsm/kg, without marked discomfort to the eye.

Bacterial Endotoxins

All injected ophthalmic drug products shall be prepared in a

manner designed to minimize bacterial endotoxins.

as defined in Bacterial Endotoxins Test and Pyrogen Test.

Uniformity of Dosage Units

This test is applicable for dosage forms packaged in single-unit

containers. Uniformity of dosage units typically is demonstrated

by one of two procedures: content uniformity or weight variation

Drug Product Quality Tests—Specific Tests

Viscosity

In the preparation of ophthalmic solutions a suitable thickening

agent is frequently added to increase the viscosity. Although they

reduce surface tension significantly, their primary benefit is to

increase the ocular contact time, thereby decreasing the drainage

rate and increasing drug bioavailability.

Viscosity for ophthalmic solutions is considered optimal in the range

of 15–25 cp

For testing procedures Viscosity—Capillary Viscometer Methods,

Rotational Rheometer Methods, and Rolling Ball Viscometer

Method

Drop Size

The volume of a drop is dependent on the physicochemical

properties of the formulation, particularly surface tension, the

design and geometry of the dispensing orifice, and the angle at

which the dispenser is held in relation to the receiving surface.

Drop sizes may typically range from 20–70 μL

References :

USP. USP 36–NF 31, Ophthalmic Ointments 771 . Rockville, MD: USP; 2013.

Vadlapudi AD, Patel A, Cholkar K, Mitra AK. Recent patents on emerging

therapeutics for the treatment of glaucoma, age related macular

degeneration and uveitis. Recent Patents Biomed Eng. 2012; 5(1):83–101.

Gaudana R, Ananthula HK, Parenky A, Mitra AK. Ocular drug delivery. AAPS

J. 2010; 12(3):348–360.

Gaudana R, Jwala j, Boddu SHS, Mitra AK. Recent perspectives in ocular

drug delivery. Pharm Res. 2009; 26(5):1197–1216.

Wilson CG, Zhu YP, Kurmala P, Rao LS, Dhillon B. Ophthalmic drug

delivery. In: Hillery AM, Lloyd AW, Swarbrick J. Drug Delivery and

Targeting. New York: Taylor & Francis; 2001:329–354.

Thank You