Evaluation of extended-release applications for solid dispersion hot-melt fluid bed coatings utilizing hydrophobic coating agents

Pharmaceutical Development and Technology
J P Kennedy, P J Niebergall

Abstract

A new hot-melt fluid bed coating method was evaluated for potential extended-release applications. Chlorpheniramine maleate (CPM) USP was chosen as a model drug. The assays for drug release and content uniformity were dictated by the USP Official Monograph for a Chlorpheniramine Maleate Extended-Release Capsule. The fluid bed chamber was charged with CPM-loaded nonpareils and hydrophobic coating agents in the solid state. The method consists of four processing stages: (a) warming, (b) preheating, (c) melting-spreading, and (d) cooling-congealing. Various hydrophobic coating agent candidates were evaluated for extended-release potential by a preliminary screen at a coating agent level of 1.5% (w/w). A beeswax coating agent was identified as the most promising candidate of the preliminary screen. After the level of beeswax was increased to 2.0%, the dissolution profile met all of the specifications of the USP Drug Release Test 1 for a CPM Extended-Release Capsule. The potency and content uniformity remained unchanged by the process. Dual coatings demonstrated a cumulative extension of release superior to the capability of a single coat. The new method is a viable alternative to hot-melt spray-coating methodologies. Organic solven...Continue Reading

References

May 23, 1970·Nature·J H Brazell
Apr 1, 1996·Pharmaceutical Development and Technology·J P Kennedy, P J Niebergall

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Citations

Nov 24, 2004·Drug Development and Industrial Pharmacy·Lorenzo RodriguezLorella Giovannelli
Oct 24, 2012·International Journal of Pharmaceutics·Vincent Jannin, Yvonne Cuppok
Dec 21, 2010·European Journal of Pharmaceutics and Biopharmaceutics : Official Journal of Arbeitsgemeinschaft Für Pharmazeutische Verfahrenstechnik E.V·Farhad TajarobiSusanna Abrahmsén-Alami
May 19, 2007·Pharmaceutical Development and Technology·Sagarika Bose, Robin H Bogner
Jan 18, 2013·Pharmaceutical Development and Technology·Loan Pham, John M Christensen
Mar 20, 2015·Pharmaceutical Research·Karin BeckerAndreas Zimmer
Jul 15, 2017·Drug Development and Industrial Pharmacy·Anastasia Anna FoppoliAndrea Gazzaniga
Oct 21, 2016·Applied Microbiology and Biotechnology·Laura Capolupo, Vincenza Faraco
Oct 5, 2020·International Journal of Pharmaceutics·Rober HabashyMohamed A Alhnan

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