Abstract

Objective: The objective of this study was to find the best base mixture composition (poloxamer 407 and HPMC) of chloramphenicol in situ gel formula based on in vitro property (Cumulative amount of drug release).
 Methods: The in vitro diffusion of chloramphenicol in situ gel study was carried out using franz diffusion cells to know the effect of the Critical Process Parameters (CPPs) as independent variables (poloxamer 407 and hydroxypropyl methylcellulose (HPMC)) on the Critical Quality Attribute (CQA) as dependent variable (cumulative amount of drug release) with 22 factorial design.
 Results: 22 factorial design of chloramphenicol in situ gel yielded 4 variations of poloxamer 407 and HPMC bases component in %w/v as follows, F1 (5:0.45), F2 (10:0.45) F3 (5:1) and F4 (10:1). The amount of drug release results from in vitro dissolution assay were 30.60% (F1), 45.64% (F2), 58.30% (F3), and 22.50%) (F4).
 Conclusion: Formula 3 (F3) was considered as the best formula component in terms of in vitro assay of chloramphenicol in situ gel with a desirability value of 0.58.

Highlights

  • Conventional ophthalmic solutions are often rapidly eliminated after administration and usually cannot provide and maintain sufficient drug concentrations in the pre-corneal region

  • The in vitro diffusion assay was done by using the principle of franz diffusion cells

  • The in vitro drug release results of chloramphenicol in situ gel formula after 8 h were shown on fig. 1

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Summary

Introduction

Conventional ophthalmic solutions are often rapidly eliminated after administration and usually cannot provide and maintain sufficient drug concentrations in the pre-corneal region. Given that the increase in viscosity of ophthalmic formulations frequently causes blurred vision, it is important to achieve the optimum viscosity range and the most proper rheological behavior to ensure good efficacy and tolerance [4, 6, 7, 9]. To cope with these drawbacks, in situ gel systems have emerged as one of the best novel drug delivery systems. As an ocular drug delivery system, in situ gel can be instilled as drops into the cul-desac of the eye and get transformed into a gel [14]

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