Topical drops

Topical drops are sterile, liquid, semi-solid, or solid preparations that may contain one or more active pharmaceutical ingredient(s) intended for application to the conjunctiva, the conjunctival sac or the eyelids. The choice of base and any excipients used for the preparation of ophthalmic preparations must be proven through product development studies not to affect adversely either the stability of the final product or the availability of the active ingredients at the site of action. Unless the active ingredient itself has antimicrobial activity, ophthalmic preparations supplied as multidose preparations may include a suitable antimicrobial agent. The antimicrobial activity should remain effective throughout the entire period of use.

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