Inventi Rapid: Pharm Tech

Inventi:prpt/82058/25

Development and Optimization of Cyclobenzaprine Hydrochloride-Loaded Cubosomal Gel Using Quality by Design Approach

This research aimed to improve the delivery of cyclobenzaprine HCl, a drug used for muscle spasms. This drug has low permeability, which limits its effectiveness. To overcome this, the novel delivery system called cubosomes has been used. Cubosomal drug delivery system was preferred due to improved permeability and site-specific action and it carries significant quantity of drug, thus enhancing the permeation of drug. The different non- ionic surfactants namely Poloxamer 407 and GMO were used in different combinations at different ratios for the preparation of cubosomes by constructing Central Composite Design using DoE software. The cubosomes were prepared using top-down technique and evaluated for morphology, drug content, percentage entrapment efficiency and in-vitro release study. Formulation F14 with drug and non-ionic surfactants GMO and Poloxamer 407 in the ratio of 30:4 was found to be optimized formulation based on the values given by DoE. The optimized formulation was further evaluated for SEM, drug content, entrapment efficiency and in-vitro release. The optimized cubosomal formulation (F14) was incorporated into gel for transdermal application and evaluated for spreadability, pH measurement, viscosity measurement, in-vitro drug release and kinetic model studies. The optimized cubosomal gel formulation showed in-vitro drug release of 92.56% at the end of 8th hour. The optimized formulation showed maximum in-vitro drug release which indicates improved drug permeation and thereby a possible enhancement in bioavailability....