DISSOLUTION METHOD DEVELOPMENT AND ENHANCEMENT OF SOLUBILITY OF CLOPIDOGREL BISULFATE

Abstract

Dissolution of drug is the rate determining step for oral absorption of the poorly water soluble drugs and solubility is the basic requirement for the
absorption of the drug from GIT. The development of a soulful dissolution procedure for drug products with lower water solubility has been a
provocation to both the pharmaceutical industry and the agencies that regulate them. This study demonstrates the systematic development of a
discriminatory dissolution method for clopidogrel bisulfate, a BCS class II drug exhibiting highly pH-dependent solubility. The method was
developed by testing solubility of clopidogrel bisulfate in different concentrations of sodium lauryl sulfate. The results showed 900 ml of 0.1 N HCl
and phosphate buffer pH 6.8 containing 1% SLS with a paddle speed of 50 rpm was selected as discriminative dissolution test conditions for
clopidogrel bisulfate tablets. In conclusion surfactants and pH changes are very effective ways to increase solubility. The in vitro dissolution must
serve as both a quality control tool and a potential surrogate marker of drug bioavailability and bioequivalence.