IN VITRO DISSOLUTION AND PILOT PHARMACOKINETIC STUDIES OF ACETYLSALICYLIC ACID FROM AN ORALLY DISINTEGRATING TABLET FORMULATION OF LOW-DOSE ASPIRIN
Journal Title: International Journal of Medical and Clinical Research - Year 2011, Vol 2, Issue 2
Abstract
Purpose: Low-dose aspirin (acetylsalicylic acid; ASA) is in routine use today in preventing myocardial infarction and cardiovascular events. Fasprin® (ASA, 81 mg) is a new orally disintegrating tablet formulation of low-dose ASA (ODA) that was designed as a fast-acting, quick-dissolving solid dosage form. The purpose of this work was to (1) evaluate, comparatively, the in vitro dissolution, and (2) evaluate the absorption kinetics of ASA in healthy adults following oral administration of the ODA product. Methods: USP type II dissolution apparatus was implemented in the dissolution studies. For the pharmacokinetic studies, a single ODA dose was administered and blood samples were collected and analyzed for ASA content using a validated HPLC method. Absorption-related pharmacokinetic parameters were estimated using WinNonlin®. Results: Dissolution rate and extent of ASA from the ODA formulation were either higher than or similar to those from leading aspirin-containing products. Noncompartmental pharmacokinetic analysis of ASA plasma profiles from the ODA product revealed a lag-time of at least three minutes. The maximum concentration (Cmax) of ASA was 0.61 µg/mL and the time of Cmax (tmax) ranged from 15 - 75 minutes. The elimination rate constant of ASA was 0.0245 min-1, corresponding to a terminal t½ of 28.3 minutes. Conclusion: The ODA product demonstrated favorable dissolution compared to some leading ASA-containing products. It also provided systemic concentration of ASA at a relatively early time. While the overall absorption kinetics of the ODA product was generally comparable to those from other low-dose ASA-containing products, a direct product comparison is warranted.
Authors and Affiliations
ROJEAB YOUSIF, MARTIN B. SHANE, ROBIN WHITE, SUSAN MONTENERY, MARY MCWILLIAMS, MARJORIE WALKER, DAVID KISOR
Keywords
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- EP ID EP170030
- DOI 10.9735/0976-5530.2.2.72-77
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