Formulation and evaluation of oral extended release analgesic drug

Abstract

Extended Release tablets containing Acetaminophen(N-Acetyl-p- Aminophenol:APAP) of 650mg strength was formulated for oral route as monolithic matrix tablets having a comparable biphasic release pattern with that of the commercially available marketed bi-layered tablets (Tylenol, Lanol ER).Wet granulation method was adopted, using excipients in sufficient quantities, using Povidone (PVP) in water as the granulating fluid which is mixed with acetaminophen, hydroxyl propyl methyl cellulose (HPMC), a wicking agent e.g. microcrystalline cellulose (MCC), then drying and milling the granulation and blending with dry powdered erosion promoter, e.g. pregelatinized starch (PREGEL), lubricant e.g. magnesium stearateresulting in a stable reproducible, simple,cost effective treatment for the management of Pain.It exhibits about 65 percent acetaminophen dissolution at one hours and substantially complete dissolution of acetaminophen in eight hours. Each unit dose of tablets gives an extended relief over a period of eight hours.