Abstract

FORMULATION AND COMPARATIVE DISSOLUTION STUDY OF ILAPRAZOLE ENTERIC COATED TABLETS WITH A REFERENCE PRODUCT

Prashanta Basnet*

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Abstract

Ilaprazole is a Proton Pump Inhibitor (PPI), an anti-acidic drug used in the treatment of dyspepsia, peptic and duodenal ulcer diseases, and gastro-esophageal reflux disease (GERD). Ilaprazole at oral doses of 10 mg has shown higher suppression of gastric acid secretion and more prolonged plasma half-life, and similar safety compared to 20 mg omeprazole. However, Ilaprazole is a class II drug as per BCS (Biopharmaceutical Classification System) which means it has a low aqueous solubility and high permeability. It is of utmost importance to understand the release profiles of such drugs to relate with the in vivo availability. Hence, the study was developed to compare the in vitro dissolution profiles of Ilaprazole enteric coated tablets (Ilatop-10) with a Reference product available in Nepalese market (Lupila 10) by applying bio-relevant medium (pH 1.2 and 6.8 buffers). In vitro dissolution profiles were evaluated in bio-relevant medium in dissolution apparatus and the dissolution curves were compared by the similarity factor (f2). The dissolution profiles of the test and the reference products demonstrated similar disposition in both bio-relevant media. Therefore, dissolution profiles in bio-relevant media in dissolution apparatus may be used as a tool to predict and correlate in vivo disposition of formulations of Ilaprazole. Furthermore, it can be argued that bio-waiver can be granted for enteric coated tablets of Ilaprazole on the basis of in vitro dissolution profile.

Keywords: Ilaprazole, enteric coated tablets, BCS, dissolution profile.