Abstract
The present study was to find the role of prostaglandin (PG) analogue (Latanoprost) and an effort to develop its anti-glaucoma ophthalmic solution (using solubility agents via safe preservative system). To formulate the eye drops of Latanoprost wherein benzalkonium chloride (BKC; cause external disturbance of the corneal epithelium) was replaced with sodium perborate as the preservative using optimize concentration of surfactant’s for better aqueous solubility and evaluated its effectiveness in ocular drug delivery system. The results obtained during the optimization of process in conjunction with process parameters are showed maximum solubility and stability with Tween-80 (Polysorbate-80) in water (0.25% w/v) in phosphate buffer at pH 6.8. In the presence of phosphonic acid, sodium perborate (0.3 mg) has maximum stability at pH ranging from six to seven which gave optimum preservative action during the preservative efficacy test (PET). Due to the results of the assay of the drug and preservative content, and minimizes leaching of impurities Eto sterilized vials were used for storage as compared to gamma sterilized vials. Also, the stability study (short term excursion, freeze thaw and thermal cycling studies), there is no significant change has been observed. The formulation was stable enough with better shelf-life and potency, withstand in extreme temperature condition during shipment.
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