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Abstract

SOLUBILITY ENHANCEMENT OF PRAVASTATIN SODIUM BY SOLID DISPERSION METHOD

Abhishek kumar Yadav, R. S. Kushwaha*, Sushmita Vishwakarma, Awadhesh Kumar Yadav, Jang Bahadur Yadav and Mohammad Shawwal

Abstract

Solubility is the phenomenon of dissolution of solid in liquid phase to give a homogenous system and is one of the important parameter to achieve desired concentration of drug in systemic circulation for pharmacological response. The insufficient dissolution rate of the drug is the limiting factor in the oral bioavailability of poorly water soluble compounds. Throughout the past decade, in the development and commercialization of new pharmaceutical products, the formulation and delivery of active pharmaceutical ingredients (APIs) have played a crucial role. To overcome low bioavailability, many of the modern oral drug delivery systems emphasize on formulation strategies such as alteration of solvent composition, carrier systems as well as chemical and physical modifications. Solid dispersion of drug in a water soluble polymer has been shown to be one of the most promising strategies to improve solubility. Increasing the bioavailability of a poorly soluble drug is a challenging aspect of drug development. Because of the poor aqueous solubility the drug possess dissolution problems due to which the in vivo absorption of the drug is reduced and thus the bioavailability is reduced, making the drug inappropriate for oral consumption and therefore solubility enhancement become necessary for such drug candidate. Solid dispersion is a most simple and efficient technique for increasing the aqueous solubility of a drug. Pravastatin is a cholesterol-lowering agent that belongs to a class of medications known as statins. It was derived from microbial transformation of mevastatin, the first statin discovered for the treatment of hypercholesterolemia and to reduce the risk of cardiovascular disease. It is a ring hydroxyl group that does not require in vivo activation. Hence the objective of the present work was to obtained faster onset of action and successfully enhanced the bioavailability by developing solid dispersion. Various techniques are used for the improvement of the aqueous solubility, dissolution rate, and bioavailability of poorly water soluble drugs include micronization, chemical modification, pH adjustment, solid dispersion, complexation, cosolvency, micellar solubilization, hydrotropy etc.

Keywords: Pravastatin, Bioavailability, Solubility Enhancement, Solid-dispersion.


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