PRESERVATIVE-FREE OPHTHALMIC PHARMACEUTICAL FORMULATION

摘要

The present invention relates to a process for manufacturing an ophthalmic formulation of a carbonic anhydrase inhibitor, hydroxyl ethyl cellulose (HEC), and a beta-adrenergic antagonist for use in the treatment of ocular hypertension and glaucoma wherein the ophthalmic pharmaceutical formulation is devoid of benzalkonium chloride or any other preservatives. The present process for manufacturing is simpler, cost effective process to prepare the pharmaceutical ophthalmic formulation in a single tank, without the use of additional tanks that can be sterile filtered.

主权项

1. A method of manufacturing a sterile, preservative free ophthalmic formulation comprising:
a) heating a first mixture of hydroxyethyl cellulose in water to a temperature of about 94° C. to about 97° C. for sufficient time to produce a second mixture with a viscosity of about 100±10 centipoise; b) dissolving a carbonic anhydrase inhibitor in the second mixture to produce a third mixture; c) adjusting pH of the third mixture to between 5.5 to 6.0 to produce a fourth mixture; and d) sterilizing the fourth mixture by aseptic filtration to produce a fifth mixture which is a sterile, preservative free ophthalmic formulation.