Abstract

TO REVIEW ON OPTHALMIC PREPARATION OF EYE

*Rohini Jadhav and Ashwini Chandile

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Abstract

Ophthalmic preparations are sterile liquid, semi-solid, or solid preparations intended for application to the conjunctiva, the conjunctival sac, or the eyelids. Sterility is a key issue in manufacture and use of ophthalmic products. Preservative selection is a critical activity in product design. Other important aspects requiring assessment in the manufacture of ophthalmic products include sterility, tonicity, pH, buffering, drug toxicity, solubility, stability, viscosity, aseptic filling, packaging and storage. Microbial content or bioburden of the raw materials, in-process intermediates, and drug substance or active product ingredient are potential sources of contamination and require incoming testing of ingredients. Most ophthalmic products are sterilized by aseptic filtration through a 0.22μm filter. Preservatives in the ophthalmic solution will, to varying degrees, bind or be adsorbed onto many common membrane filter materials. Most commercial liquid ophthalmic products are packaged in plastic containers fitted with nozzles for drop wise administration. Plastic containers are generally sterilized by gamma irradiation or ethylene oxide. Facilities used to prepare ophthalmic preparations are required to operate within a controlled environment using HEPA filtration to minimize contact of airborne contamination with critical sites such as open product prior to application of closures, injection ports, and vial septa. Aseptic filling ophthalmic medications is typically achieved through the use of blow-fill-seal (BFS) technology in which product containers are formed from plastic granules on-line and then filled with drug solution and sealed in one operation. Blow-fill-seal-technology has a theoretically lower risk of microbial contamination compared with conventional aseptic filling. Quality control of these products includes traditional tests such as identification, potency, purity, impurities, sterility, and particulate matter and performance tests such as dissolution or drug release. Physical or chemical instability will be demonstrated by noticeable changes in the dosage form such as changes in color, consistency, agglomerates, grittiness, emulsion breakdown, crystal growth, shrinking due to evaporation of water, or evidence of microbial growth. The finished product must also be subject to the sterility test and endotoxin tests.

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