Application of tumbling melt granulation method to prepare controlled-release beads by coating with mixture of functional non-meltable and meltable materials.
A new coating method for use in preparing controlled-release beads was developed by modifying the tumbling melt granulation technique. The dissolution rate of the drug from the beads was controlled by coating the mixture of meltable and non-meltable materials by heating in a centrifugal fluidizing granulator without using any solvent. In experiments using talc as the non-meltable material, the resultant beads showed the sufficient ability to suppress the dissolution of the drug and no change in the dissolution characteristics by wetting agent and in a stability test at high temperature. Using functional polymer as the non-meltable material, the controlled-release beads with various dissolution characteristics could be prepared: entero-soluble-release beads using entero-soluble polymer, and zero-order-release beads using hydrophilic gel-forming agent and talc.
Maejima
T
T
Pharmaceutics Research Laboratory, Tanabe Seiyaku Co., Ltd., Osaka, Japan.
Osawa
T
T
Nakajima
K
K
Kobayashi
M
M
D003692:Delayed-Action Preparations; D004337:Drug Carriers / Q000737:chemistry*; D004339:Drug Compounding / Q000379:methods*; D011108:Polymers / Q000737:chemistry
D003692:Delayed-Action Preparations; D004337:Drug Carriers; D011108:Polymers