Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Patent
1992-06-26
1995-07-04
Page, Thurman K.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
424499, 424501, 424502, A61K 916
Patent
active
054298253
ABSTRACT:
A process for producing granules by rotomelt granulation comprising mixing at least one powdered pharmaceutically active material and a powdered excipient material within a zone wherein both powdered materials are maintained in a fluidized state by a rising stream of gas in an apparatus having a rapidly rotating horizontal-disk located within a vertical vessel wherein said gas is at a temperature sufficient to cause at least one powdered material to at least partially melt thereby causing said powdered materials to aggregate and form granules.
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Handbook of Pharmaceutical Excipients, Am. Pharm. Assn., Washn. D.C., pp. 234 and 236, (1986).
The Merck Index, 11th Ed., Merck & Co., Rahway, N.J., pp. 7635, (1989).
The United States Pharmacopeia, USP XXII, NF XVII, U.S. Pharmacopeial Convention, Inc., Rockville, Md., p. 200 (1990).
Jager et al., "Effect of Material Motion on Agglomeration in the Rotary Fluidized-Bed Granulator", Drugs Made in Germany, vol. XXV, pp. 61-65, 1982.
Y. Haramushi et al., "Study on Fluidized Melt-Granulation I. Examination of the Factors on the Granulation", Yakugaku Zasshi, vol. 111, No. 9, pp. 515-523 (1991).
Reo Joseph P.
Roche Edward J.
Hulina Amy
Mc-Neil-PPC, Inc.
Page Thurman K.
Plantz Bernard F.
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