Waiver of in vivo bioequivalence studies for betastine immediate release tablets based on the biopharmaceutical classification system (BCS)
Publication Type
Conference Paper

Betahistine dihydrochloride (BHD) is frequently used in treating attacks of vertigo in MÈnireís syndrome. This study was conducted to classify BHD into biopharmaceutical classification system (BCS) and assess the suitability of using in vitro release profiles in demonstrating similarity between a generic and the innovator product. The solubility of BHD in aqueous media over the pH range of 1-7.5 was determined. Molecular descriptors like PSA, Log P, log D, and pKa were calculated using software packages. Tablets were tested for weight and content uniformity, friability and disintegration. The in vitro release profiles and dosage form performance of the generic were compared with the innovator. BHD was very highly soluble in aqueous media over the pH range of 1-7.5 and the dose number ranged from 0.0016 to 0.0048. The high permeability of BHD was predicted by molecular weight, number of hydrogen bond acceptors, number of hydrogen bond donors and the low PSA of 24.92 . Both, innovator and generic showed good dosage form performance and released more than 85% of their contents in less than 15 min. Our study demonstrated that BHD was a BCS class I drug and thus eligible for biowaiver applications. Similarity between immediate release oral dosage forms can be established using suggested in vitro dissolution methods. 

Conference Title
Palestinian conference on postgraduate students research
Conference Country
Conference Date
April 22, 2014 - April 23, 2014
Conference Sponsor
Birzeit University