Formulation, Optimization and Evaluation of Glycerogelatin In Situ Film Containing Ethanolic Leaf Extract of Calotropis gigantea for Arthritis


The aim of the study was to design, optimize and evaluate transdermal glycerogelatin in situ film containing Calotropis gigantea leaves extract for the treatment of Arthritis. Skin is considered as an important route of administration for both local and systemic effects. Topical film forming systems are developing drug delivery system ment for topical application to the skin, which adhere to the body, forming a thin transparent elastic film which provide delivery of active ingredient to the body tissue. The formulation was optimized by mixture design (design expert software, version 11.03) with glycerin, gelatin, water as the factors and spreadability, elasticity, drying time, and tensile strength as the responses. Calotropis gigantea having significant anti-inflammatory potential and its ethanolic extract was incorporated into the optimized formula of glycerogelatin in situ film. The optimized formula contained 1.5% of drug extract and showed a drug release of 79% at 8th hour, and 96% in 24 hour time period.

Arthritis is a chronic inflammatory disease that affects people of age ≥ 60. It is reported to affect 14-47% of Indian population [1,2]. Hormonal, genetic, aging, metabolic and mechanical factors regulate the biology of the articular cartilage by complex molecular mechanisms [3]. Rheumatoid arthritis is both an extravascular immune complex disease and a disorder of cell-mediated immunity leads to chronic inflammation, granuloma formation and joint destruction. Calotropis gigantea R.Br (Asclepiadaceae) known as Arka and Jayanti in Ayurveda, have been widely documented in the Ayurveda and traditional medical literature for various therapeutics applications. Traditionally extracts and preparations from roots and leaves are used against rheumatism, wounds, piles, tuberculosis and cancer.

Film Forming Systems (FFS) are novel approach which can be used as an alternative to the conventional topical and transdermal formulations. The polymeric solution applied to the skin as a liquid turn to a film in situ by solvent evaporation with in few minutes [4-6].

Transdermal Drug Delivery System (TDDS) can provide some desirable performances, such as avoiding gut and hepatic first-pass metabolism, improving drug bioavailability, reducing dose frequency and stabilizing drug delivery profiles, easy application, avoid fluctuation of drug level spreads easily. Glycerogelatins are melted before application, cooled to slightly above body temperature and applied to the affected area [7-9]. Following application, the glycerogelatin hardens, is usually covered with a bandage. The formulation was optimized by design expert (11.03) with gelatin, glycerin, water is factors spreadability, elasticity, drying time, and tensile strength is responses. 14 formulations were prepared and evaluated for tensile strength, percentage moisture content, percentage moisture uptake, spreadability, elasticity, drying time. One of the formulae suggested by the software having desirability=1 as optimal and was prepared and evaluated to conform the responses. To the optimized formula 1.5% drug extract was incorporated and further evaluated for drug content and in vitro drug release study.

Calotropis gigantea using glycerogelatin in situ films were successfully developed and evaluated. In situ film was prepares by solvent evaporation method using gelatin, glycerin, water, tween 80, it was evaluated for the spreadability, elasticity, drying time, tensile strength. The results were fed to the software and it suggested n-number of compositions and corresponding responses. One among the different compositions with desirability one was selected as optimum. That was then prepared and the drug extract was incorporated into it. The prepared in situ film was evaluated and the responses were very close to the predicted. Further the permeation was also evaluated with and without permeation enhancers. The optimized in situ film showed good permeation.

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