title: Drug-beta-cyclodextrin containing pellets prepared with a high-shear mixer.
abstract: This work was aimed at investigating the preparation of beta-cyclodextrin-microcrystalline cellulose pellets by means of a high-shear mixer, both in the absence or in the presence of ibuprofen as model drug. Drug loading of pellets was accomplished by means of two alternative techniques: 1) solution layering or 2) powder layering. The prepared pellets were characterised in terms of size distribution, shape factor, friability and dissolution rate. The interaction between ibuprofen and beta-cyclodextrin was monitored by Differential Scanning Calorimetry (DSC). Micro Fourier Transform Infrared spectroscopy (MicroFTIR) was applied to determine the distribution of components within each pellet on a micro scale. Pellets with narrow size distribution and containing up to about 90% of BCD were prepared using water as binder. The process yield resulted around 84 and 63% for drug-free and medicate pellets respectively. Drug loaded pellets with favourable technological and biopharmaceutical characteristics can be obtained both by powder or solution layering techniques. The latter proved to be more suitable for producing pellets with high drug contents, reduced friability and high drug dissolution rates.
authors.affiliation: Department of Pharmacy, University of Parma, Parma, Italy.
authors.forename: Alessandro
authors.initials: A
authors.lastname: Gainotti
authors.forename: Ruggero
authors.initials: R
authors.lastname: Bettini
authors.forename: Andrea
authors.initials: A
authors.lastname: Gazzaniga
authors.forename: Paolo
authors.initials: P
authors.lastname: Colombo
authors.forename: Ferdinando
authors.initials: F
authors.lastname: Giordano
mesh_terms: D002482:Cellulose / Q000737:chemistry; D002626:Chemistry, Pharmaceutical / Q000379:methods; D004055:Differential Thermal Analysis / Q000379:methods; D004337:Drug Carriers / Q000737:chemistry* / Q000493:pharmacokinetics / Q000592:standards; D004338:Drug Combinations; D004339:Drug Compounding / Q000379:methods; D007052:Ibuprofen / Q000737:chemistry / Q000493:pharmacokinetics; D010316:Particle Size; D012995:Solubility / Q000187:drug effects; D013678:Technology, Pharmaceutical / Q000295:instrumentation* / Q000379:methods; D047392:beta-Cyclodextrins / Q000737:chemistry* / Q000493:pharmacokinetics
chemical_list: D004337:Drug Carriers; D004338:Drug Combinations; D047392:beta-Cyclodextrins; D002482:Cellulose; C109691:microcrystalline cellulose; D007052:Ibuprofen