Measurement of agitation force in dissolution test and mechanical destructive force in disintegration test. 2003

Masaharu Kamba, and Yasuo Seta, and Nao Takeda, and Takeshi Hamaura, and Akira Kusai, and Hisanori Nakane, and Kenji Nishimura
Pharmacokinetics and Drug Delivery Research Laboratories, Sankyo Co., Ltd., 2-58, 1-chome, Hiromachi, Shinagawa-ku, Tokyo 140, Japan. kmasah@shina.sankyo.co.jp

The purpose of this study was to investigate the effect of the agitation force and mechanical destructive force on the drug dissolution of a tablet in the paddle rotation dissolution test and in the disintegration test. The agitation in the paddle method and the mechanical destructive force in the disintegration test were considered to be conclusive factors for drug dissolution. The dissolution rate of planar-constant-release tablets increased with increasing paddle rotation speed and increased with increasing distance from the center of the vessel bottom. Separately, the fluid resistance (agitation force) in the vessel was measured using a modified paddle method apparatus equipped with a fluid resistance sensor. The fluid resistance was 0.03 x 10(-3) N/(64 mm(2)) when the paddle rotation speed was 50 rpm at a position 4 mm away from the center. A considerable position-dependent change in agitation force intensity was seen with the fluid resistance sensor. The impulsive force (mechanical destructive force) in the disintegration test apparatus was measured using a modified basket-rack assembly with a strain gauge transducer. The fluid resistance was measured using the basket-rack assembly with a different sensor probe and amplifier. The impulsive force applied by the auxiliary disk was 0.31 N and the fluid resistance at the bottom of the basket-rack assembly was 1.66 x 10(-3) N/(64 mm(2)).

UI MeSH Term Description Entries
D012995 Solubility The ability of a substance to be dissolved, i.e. to form a solution with another substance. (From McGraw-Hill Dictionary of Scientific and Technical Terms, 6th ed) Solubilities
D013607 Tablets Solid dosage forms, of varying weight, size, and shape, which may be molded or compressed, and which contain a medicinal substance in pure or diluted form. (Dorland, 28th ed) Tablet
D013678 Technology, Pharmaceutical The application of scientific knowledge or technology to pharmacy and the pharmaceutical industry. It includes methods, techniques, and instrumentation in the manufacture, preparation, compounding, dispensing, packaging, and storing of drugs and other preparations used in diagnostic and determinative procedures, and in the treatment of patients. Technology, Pharmacy,Pharmaceutic Technology,Pharmaceutical Technology,Pharmacy Technology,Technology, Pharmaceutic

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