| Development and in vitro/in vivo Evaluation of Extended Release Propranolol Tablets Part I: Development and in vitro evaluation Elena Draganoiu and Adel Sakr Industrial Pharmacy Program, University of Cincinnati, Cincinnati, Ohio (USA) Correspondence: Prof. Dr. Adel Sakr, College of Pharmacy, University of Cincinnati Medical Center, Cincinnati, OH 45267-0004 (USA), Fax +1 513 558 72 57, e-mail: Adel.Sakr@Uc.Edu Dedicated to Prof. Dr. Wolfgang Suess, Chairman, Department of Pharmaceutical Technology, Institute of Pharmacy, University of Leipzig (Germany), on the occasion of his 65th birthday
The objective of this study was to develop and evaluate propranolol (CAS 318-98-9) extended release tablets, using polyvinylacetate/povidone as matrix forming excipient. The effects of varying polymer content, addition of methacrylic acid copolymer, compression force, and influence of pH of dissolution media were studied. The similarities in release profiles were evaluated by applying the FDA recommended model independent approach using similarity factor f2.
The results demonstrated a pH independent propranolol release, following a square root of time kinetics. Increasing the polymer concentration led to increased tablet hardness and slower drug release. Compression forces above 2000 lbs 8.9 kN did not additionally influence the tablet properties and drug release. Polyvinylacetate/povidone excipient was the main release controlling agent in the presence of the methacrylic acid copolymer in the matrix, and successfully extended the release of propranolol over a period of 24 h.
Further in vivo studies will be the subject of the next communication (Part II).
Key words Bioequivalence • CAS 318-98-9 • Extended release tablets • Methacrylic acid copolymer • Propranolol • Polyvinylacetate/povidone excipient |
