Evaluation on Biorelevant Dissolution Behavior of Propranolol HCl Encapsulated in Various Capsules

Two-piece hard capsules continuously serve as widely used oral drug and dietary supplement dosage forms. Hard gelatin capsules are used in 20% of all oral dosage forms but have numerous shortcomings especially with potential crosslinking with the active ingredient, the growing consumer preference for non-animal products and concerns about bovine spongiform encephalopathy (BSE or mad cow disease). The most common polymer used to replace gelatin in hard capsules is hydroxypropyl methylcellulose (HPMC) or hypromellose. In this study, Propranolol HCl was used to evaluate dissolution behavior and to assess equivalence of HPMC capsules with gelatin capsules using biorelevant testing. DuPont’s FloVitro TM technology was used to simulate a biomimetic system utilizing a flow through approach with a series of solid transfer cells that incorporates drug pharmacokinetic characteristics. It is a biorelevant in vitro test that reflects physiological environment in the test conditions with a purpose of correlating in vitro with in vivo drug absorption. FloVitro TM has the unique ability to generate dissolution curves that match plasma profiles directly without the need for mathematical modeling. Therefore, both Modified USPII and FloVitro TM technology were used to study dissolution behavior of Propranolol HCl in various commercial gelatin and HPMC capsules.