Formulation development and evaluation of in situ ophthalmic gel of sodium cromoglycate

The poor bioavailability of ophthalmic solutions caused by dilution and drainage from the eye can be overcome by using In situ forming ophthalmic drug delivery system prepared from polymer that exhibit reversible liquid–gel phase transition. The objective of the study was to develop optimized formulation of in situ ophthalmic gel of Sodium cromoglycate, anti-allergic drug, using ion activated polymer, gelrite (gellan gum) as a gelling polymer and HPMC E-15LV (hydroxyl propyl methyl cellulose) as release retardant. The 32 full factorial design was employed to optimize the formulation considering Gelrite and HPMC as independent variables. The formulations were assessed for appearance, gelling ability, sterility, pH, drug content, viscosity, rheology, release through cellophane membrane & corneal membrane of goat, ocular irritation study & stability study as per ICH guidelines. Formulations F4 and F8 were selected and again analysed by grid analysis and F4 was found to be the best formulation from the nine formulation developed by 32 factorial design. The study revealed that the In situ system of sodium cromoglycate sustained the effect of drug to 12 hours. The formulation F4 extended the release of drug upto 12 hours as compare to marketed preparation of sodium cromoglycate, Cromal(solution), which gives 98.11% drug release within 6 hours.
Author(s): Talat Farheen, Sadhana R Shahi, Azmat M Shaikh, Nityanand Zudbuke and Syed A Ali

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