A multiparticulate drug-delivery system based on pellets incorporated into congealable polyethylene glycol carrier materials.
As a novel alternative to the incorporation into hard gelatin capsules or tablets, extended-release (Aquacoat- or Eudragit RS-coated) or enteric (Eudragit L-coated) pellets were embedded into congealed tablet-shaped PEG-plugs of different molecular weights, which rapidly released the pellets upon contact with aqueous fluids. The lower-molecular-weight PEGs (600 and 1000) were not suitable carrier materials: they dissolved the coatings or significantly increased their permeability. The release characteristics of the original pellets were maintained after embedding the pellets into the higher-molecular-weight PEGs 4000 or 10000. The shelf-life stability was a function of storage temperature and coating material. Stored at 40 degrees C, Aquacoat-coated pellets embedded in PEG 4000 exhibited a decreased drug release because of curing effects, while storage at 20 degrees C or below resulted in stable release profiles over a 3 month period. Eudragit RS-coated pellets, stored at room temperature or above, showed an increased release, and the carrier material possibly migrated into the film, thus increasing its permeability. At 4 degrees C, the release was stable over a 6 month period.
College of Pharmacy, Freie Universität Berlin, Kelchstrasse 31, 12169 Berlin, Germany.
C
C
Schmidt
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R
Bodmeier
D000180:Acrylic Resins; D002626:Chemistry, Pharmaceutical; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D016503:Drug Delivery Systems; D004355:Drug Stability; D011092:Polyethylene Glycols; D011109:Polymethacrylic Acids; D013806:Theophylline / Q000008:administration & dosage*
D000180:Acrylic Resins; D003692:Delayed-Action Preparations; D004337:Drug Carriers; D011109:Polymethacrylic Acids; C038300:methylmethacrylate-methacrylic acid copolymer; D011092:Polyethylene Glycols; D013806:Theophylline