Dissolution test development for complex veterinary dosage forms: oral boluses.
Fundamental aspects of electrolyte chemistry were used to design an appropriate dissolution medium with the capacity to maintain sink conditions throughout the test. Dissolution of various bolus dosage forms was studied using USP Apparatus II at various stirring speeds. Complete dissolution of each drug in the designed medium was achieved, and there is evidence that such a dissolution test could be discriminating. This review details the development of potentially discriminating in vitro dissolution tests for veterinary boluses using USP Apparatus II and examines the potential role of such testing during product quality assessments, in the evaluation of postapproval manufacturing changes and for the establishment of the generic equivalence of veterinary products.
Fahmy
Raafat
R
Food and Drug Administration, Center for Veterinary Medicine, Office of New Animal Drug Evaluation, 7500 Standish Place, HFV 143, Rockville, MD 20855, USA. rfahmy@cvm.fda.gov
Marnane
Bill
B
Bensley
Dennis
D
Hollenbeck
R Gary
RG
D000284:Administration, Oral; D000818:Animals; D008954:Models, Biological; D012995:Solubility; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods; D019155:Veterinary Drugs / Q000008:administration & dosage* / Q000737:chemistry / Q000493:pharmacokinetics
D019155:Veterinary Drugs