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Comparison of Three Dissolution Apparatuses for Testing Calcium Phosphate Pellets used as Ibuprofen Delivery Systems
Authors:Emilie Chevalier  Marylène Viana  Aymeric Artaud  Lisette Chomette  Samir Haddouchi  Gille Devidts  Dominique Chulia
Affiliation:(1) Laboratoire de Pharmacie Galénique, Faculté de Pharmacie, CNRS SPCTS UMR 6638, Université de Limoges, 2 rue du Dr Marcland, 87025 Limoges Cedex, France;(2) SPS Pharma Services, 28, Place Henri Dunant, 63000 Clermont-Ferrand, France;(3) Varian S.A., 7, avenue des Tropiques, ZA Courtaboeuf 2, BP 12, 91941 LES ULIS Cedex, France
Abstract:Porous calcium phosphate pellets were produced according to two granulation processes (low and high shear wet granulations) and drug loaded with five ibuprofen contents (1.75%, 7%, 12.5%, 22%, and 36%) in order to ensure both bone defect filling and local drug delivery. The drug-release kinetics from the two types of pellets was studied using three dissolution apparatuses: paddle apparatus, reciprocating cylinder, and flow-through cell. The paper compared the three dissolution methods and considered the effect of the granulation process on the ibuprofen-release kinetics. Dissolution data were analyzed using the Weibull function as well as the difference (f1) and similarity (f2) factors. Dissolution kinetics was not influenced by the granulation process, regardless of the dissolution apparatus and of the drug content. The comparison of the three dissolution devices indicated that ibuprofen was released faster from granules loaded with 36% of drug content with the reciprocating apparatus, due to the disintegration of the granules occurring during the dissolution test. For the other drug contents, dissolution profiles were not significantly different from one apparatus to another. However, the flow-through cell seemed to be more suitable for the drug-release study of implantable materials.
Keywords:calcium phosphate pellets  flow-through cell  ibuprofen delivery system   in vitro drug release  paddle apparatus  reciprocating cylinder
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