title: Dissolution profile of novel composite pellet cores based on different ratios of microcrystalline cellulose and isomalt.
abstract: There is a growing interest towards the application of inert cores as starting materials for pharmaceutical pellet manufacturing. They serve as alternatives to develop and adapt a relatively simple manufacturing technology compared with an extrusion/spheronisation process. The major objective of this study was to investigate the effect of the compositions of core materials on the drug release profile. Pure microcrystalline cellulose (MCC), isomalt and different types of novel composite MCC-isomalt cores were layered with model drug (sodium diclofenac) and were coated with acrylic polymer. The effect of the osmolality in the gastrointestinal tract was simulated using glucose as osmotically active agent during in vitro dissolution tests. The results demonstrated the dependence of drug dissolution profile on the ratio of MCC and isomalt in the core and the influence of osmotic properties of the dissolution medium. Isomalt used in the composite core was able to decrease the vulnerability of the dissolution kinetics to the changes in the osmotic environment.
authors.affiliation: Südzucker AG, Central Department Research, Development and Technological Services, Department of Product Technology, Pharmaceutical Technology, Obrigheim 67283, Germany.
authors.forename: Oliver
authors.initials: O
authors.lastname: Luhn
authors.forename: Nikolett
authors.initials: N
authors.lastname: Kállai
authors.forename: Zsombor Kristóf
authors.initials: ZK
authors.lastname: Nagy
authors.forename: Kristóf
authors.initials: K
authors.lastname: Kovács
authors.forename: Bodo
authors.initials: B
authors.lastname: Fritzsching
authors.forename: Imre
authors.initials: I
authors.lastname: Klebovich
authors.forename: István
authors.initials: I
authors.lastname: Antal
mesh_terms: D000894:Anti-Inflammatory Agents, Non-Steroidal / Q000008:administration & dosage*; D002482:Cellulose / Q000737:chemistry*; D004008:Diclofenac / Q000008:administration & dosage*; D004187:Disaccharides / Q000737:chemistry*; D004337:Drug Carriers / Q000737:chemistry*; D005079:Excipients / Q000737:chemistry*; D006801:Humans; D009994:Osmolar Concentration; D012995:Solubility; D013402:Sugar Alcohols / Q000737:chemistry*
chemical_list: D000894:Anti-Inflammatory Agents, Non-Steroidal; D004187:Disaccharides; D004337:Drug Carriers; D005079:Excipients; D013402:Sugar Alcohols; D004008:Diclofenac; C016640:Palatinit; D002482:Cellulose; C109691:microcrystalline cellulose