title: Comparative dissolution study of drug and inert isomalt based core material from layered pellets.
abstract: Layered and coated pellets were formulated to control the release of the diclofenac sodium selected as model drug. A highly water soluble isomalt inert pellet core material was used to osmotically modulate the drug release through the swellable polyvinyl acetate coating layer. Image analysis was applied to determine the shape parameters and the swelling behavior of the pellets. UV-spectroscopy and liquid chromatography with refractive index detection were applied to measure the concentration of the model drug and the core materials. Simultaneous dissolution of both the diclofenac sodium and isomalt was observed. Relationship was found between the dissolution profile of the drug and the core material which linear correlation was independent on the coating level. The latter enables the modulation of drug release beside the permeability control of the swelled coating polymer.
authors.affiliation: Department of Pharmaceutics, Semmelweis University, Hőgyes E. Street 7-9, 1092 Budapest, Hungary.
authors.forename: Nikolett
authors.initials: N
authors.lastname: Kállai-Szabó
authors.affiliation: Südzucker AG, Central Department Research, Development and Technological Services, Department of Product Technology, Pharmaceutical Technology, Wormser Street 11, 67283 Obrigheim, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Luhn
authors.affiliation: Südzucker AG, Central Department Research, Development and Technological Services, Department of Product Technology, Pharmaceutical Technology, Wormser Street 11, 67283 Obrigheim, Germany.
authors.forename: Joerg
authors.initials: J
authors.lastname: Bernard
authors.affiliation: Formulation R&D, Gedeon Richter Ltd., Gyömrői Street 19-21, 1103 Budapest, Hungary.
authors.forename: Barnabás
authors.initials: B
authors.lastname: Kállai-Szabó
authors.affiliation: University Pharmacy Department of Pharmacy Administration, Semmelweis University, Hőgyes E. Street 7-9, 1092 Budapest, Hungary.
authors.forename: Romána
authors.initials: R
authors.lastname: Zelkó
authors.affiliation: Department of Pharmaceutics, Semmelweis University, Hőgyes E. Street 7-9, 1092 Budapest, Hungary. Electronic address: antal.istvan@pharma.semmelweis-univ.hu.
authors.forename: István
authors.initials: I
authors.lastname: Antal
mesh_terms: D002626:Chemistry, Pharmaceutical / Q000379:methods; D004008:Diclofenac / Q000737:chemistry*; D004187:Disaccharides / Q000737:chemistry*; D004343:Drug Implants / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry; D010539:Permeability; D011108:Polymers / Q000737:chemistry; D011145:Polyvinyls / Q000737:chemistry; D012995:Solubility; D013402:Sugar Alcohols / Q000737:chemistry*
chemical_list: D004187:Disaccharides; D004343:Drug Implants; D005079:Excipients; D011108:Polymers; D011145:Polyvinyls; D013402:Sugar Alcohols; D004008:Diclofenac; C013215:polyvinyl acetate; C016640:Palatinit
keywords: Diclofenac sodium; Drug and excipient dissolution; Inert pellet core; Isomalt; Multiparticulate system; Sugaralcohol