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Development and evaluation of oral osmotic pump of butorphanol tartrate

Abstract Butorphanol is potent analgesic useful in pain management. However, because of high first-pass metabolism butorphanol is not available in market as oral dosage form. Drugs that undergo extensive first-pass metabolism can be delivered orally if protected in the stomach, and proximal small intestine. An oral controlled porosity osmotic pump (CPOP) was designed to deliver butorphanol tartrate that can maintain therapeutic blood concentration up to 24 h. The target release profile for extended release formulation was calculated by Wagner Nelson de-convolution using published immediate release blood concentration data for oral route. Composition of the core and coating were optimized using USFDA approved ingredients by evaluation of the drug release. Drug release from the developed system was inversely proportional to the weight gain and directly related to the level of pore former. Scanning electron microscopy (SEM) confirmed the formation of pores in the coating membrane on contact with water which lead to drug to release. Kinetic models were applied to drug release data to establish the drug release mechanism. The developed osmotic system effectively delivers selected drug at a predetermined rate for extended period.