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DEVELOPMENT AND CHARACTERIZATION OF TOPICAL DRUG DELIVERY SYSTEM CONTAINING FLUCONAZOLE MICROSPONGE
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| Author:
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SHAH DHIREN P, SHAH CHAINESH, SHRUTI CHAUDHARY
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| Abstract:
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Microsponge Delivery System (MDS) has been introduced in topical drug products to facilitate the controlled release of active drug into the skin in order to reduce the systemic exposure and minimize local cutaneous reactions to active drugs. Micro-sponges are porous, polymeric microspheres that are designed to deliver pharmaceutical active ingredient or bioactive material. Formulations of topical agents utilizing the MDS technology have shown little or no irritancy in patients with acne, photo damaged skin, hyper pigmentation, without sacrificing the efficacy of the agents. Microsponge drug delivery systems offers entrapment of ingredients and is believed to contribute towards reduced side effects, improved stability, reduces systemic exposure and minimize local cutaneous reactions, increased elegance, and enhanced formulation flexibility. Fluconazole (FLZ) is a synthetic triazole antifungal drug for the treatment of superficial and systemic fungal infections with itching in topical therapy. When given orally the major drawbacks of this drug are, high doses (100-200 mg/day for 2- 6 weeks) which might be used to treat led to potential side effects varying from headache, nausea to liver dysfunction and hepatic failure. Oral administration of FLZ often produces gastric irritation, heartburn, vomiting and sometimes patient can develop ulceration and there is less patient compliance with long term therapy. In order to minimize these adverse effects, topical delivery of FLZ in Microspongic gel drug delivery system is beneficial. Amongst the topical formulations clear transparent gels have been widely accepted in both cosmetics and pharmaceuticals. Fluconazole Microsponges were prepared by quasi emulsion solvent diffusion method using Eudragit RS 100 and Ethylcellulose as a polymer, polyvinyl alcohol, Acetone as Internal phase volume and Liquid paraffin as External phase volume. Optimization of Fluconazole loaded Microsponge was done by Application of 22 Factorial Designs. Independent variable of formulation was Drug Concentration and PVA Concentration. The selected dependent variables were % Drug Content (Y1), Particle size (Y2), %CDR (Y3). The optimized batch of Fluconazole loaded Microsponge was evaluated by particle size, surface morphology and topography by SEM, Drug-Excipients compatibility study using FTIR Spectrum and DSC thermogram. The prepared optimized batch of Microsponge contains particle size 1124 nm and the SEM Study showed porous and spherical nature. The prepared optimized batch of Microsponge was incorporated in to Carbopol 934 gel. The prepared Microspongic gel showed desired % Drug Content, Spreadability, PH, Viscosity, Diffusion Study, Sensitivity Study on animal and Kinetic Model Study of gel.
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| Keyword:
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Microsponge, Factorial design, Fluconazole, Microspongic gel
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| EOI:
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| DOI:
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