Comparative Biowaiver Study of Moxifloxacin in Immediate Release of Oral Solid Dosage Form

Abstract

Biowaiver is based on a Bio-pharmaceutical Classification System (BCS), and it is used to waive in-vivo studies of test products that are intended for registration from drug regulatory authorities. After certain in-vitro testing, the BCS tells whether the test product is “bioequivalent” to the reference or innovator product or not. Bioequivalence is needed to check the risks arising from the presence of different excipients in the formulation and due to manufacturing variables being deemed to be low. Moxifloxacin is a fluoroquinolone antibiotic drugs with a wide therapeutic index. It shows a broad spectrum of antibacterial activity against both Gram-positive and Gram-negative pathogens. Here, In-vitro biowaiver study of moxifloxacin was conducted based on Biopharmaceutical Classification System (BCS). Out of four BCS classes, moxifloxacin falls in class I which represents high solubility and high permeability. One innovator and five test brands of Moxifloxacin tablets were collected from the local market and their in-vitro dissolution study was performed by using pharma test DT 70 apparatus at different time (15, 30, 45 and 60 minutes), in three buffer systems i.e., hydrochloric acid buffer (pH 1.2), acetate buffer (pH 4.5) and phosphate buffer (pH 6.8). Biowaiver of moxifloxacin tablet is scientifically justified the dosage form of the reference product is rapidly dissolving (85% in 15 min) in all three buffers. Interestingly, we found low-cost alternative test products that show similar dissolution profiles to the reference product in these buffers. Therefore, the biowaiver study of moxifloxacin provides evidence that the test products are bioequivalent with innovator products which leads to provision of cost effective and alternative drug product.