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The development of a stable, coated pellet formulation of a water-sensitive drug, a case study: development of a stable core formulation.

Fitzpatrick, S; Taylor, S; Booth, SW; Newton, MJ; (2006) The development of a stable, coated pellet formulation of a water-sensitive drug, a case study: development of a stable core formulation. Pharm Dev Technol , 11 (4) pp. 521-528. 10.1080/10837450600941079.

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Abstract

A development program has been carried out to provide a stable extrusion/spheronisation pellet formulation for a highly water-soluble drug, sitagliptin, which undergoes a change in physical form on processing and is subject to hydrolytic decomposition. A conventional extrusion/spheronization formulation resulted in significant degradation of the drug. The inclusion of glyceryl monostearate into the formulation was found to reduce the water levels required to such a level that there was no significant degradation of the drug during processing to form pellets. The use of a ram extruder to screen formulations with small quantities minimizes the need for the drug in the formulation-screening process, and the results from this method of extrusion were found to be translatable to the use of a screen extruder, which allowed scale-up of the process.

Type: Article
Title: The development of a stable, coated pellet formulation of a water-sensitive drug, a case study: development of a stable core formulation.
Location: England
DOI: 10.1080/10837450600941079
Keywords: Chemistry, Pharmaceutical, Coated Materials, Biocompatible, Drug Delivery Systems, Drug Stability, Glycerides, Hydrolysis, Microspheres, Pyrazines, Sitagliptin Phosphate, Triazoles, Water
UCL classification: UCL > School of BEAMS
UCL > School of BEAMS > Faculty of Engineering Science
URI: http://discovery.ucl.ac.uk/id/eprint/1343766
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