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The article discusses a research study on Argentine propolis ear drop formulation and its therapeutic effects for canine otitis externa as topical treatment. Assigned for the trial were 48 dogs with otitis externa symptoms and treated with propolis ear drop formulation compared to control group given placebo in a microbiological analysis for ear exudates of dogs. Results showed the antimicrobial activity of propolis formulation against microorganism Staphylococcus aureus at 43.8%. more...

Literature data relevant to the decision to allow a waiver of in vivo bioequivalence (BE) testing for the approval of immediate release (IR) solid oral dosage forms containing acetazolamide are reviewed. Acetazolamide's solubility and permeability characteristics according to the Biopharmaceutics Classification System (BCS), as well as its therapeutic use and therapeutic index, its pharmacokinetic properties, data related to the possibility of excipient interactions and reported BE/bioavailability (BA) problems are taken into consideration. The available data on solubility, on oral absorption and permeability are not sufficiently conclusive to classify acetazolamide with certainty. Taking a conservative approach, no biowaiver is considered justified for the registration of new multisource drug products. However, SUPAC level 1 and level 2 postapproval changes and most EU Type I variations can be approved waiving in vivo BE studies. © 2008 Wiley-Liss, Inc. and the American Pharmacists Association J Pharm Sci 97:3691–3699, 2008 [ABSTRACT FROM AUTHOR] more...