Stable granulates containing S-adenosylmethionine and...

Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form

Reexamination Certificate

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C424S490000, C424S494000

Reexamination Certificate

active

07048948

ABSTRACT:
A fluid bed granulation process for manufacturing non-hygroscopic, stable granulates containing a water-soluble salt of S-adenosylmethionine is described. Said process comprises:a) the simultaneous, sequential or alternate dispersion of at least a solution of a water-soluble salt of SAMe (A) and of a solution of a coating agent (B), on a fluid bed granulation carrier (C) andb) the fluid bed granulation of the mixture.Granulates obtainable by said process and solid oral pharmaceutical forms obtainable by said granulates are disclosed.

REFERENCES:
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patent: 5466678 (1995-11-01), Kawabata et al.
patent: 2004/0091529 (2004-05-01), Edgren et al.
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patent: 0162324 (1985-11-01), None
patent: 019133 (1986-08-01), None
patent: 0387757 (1990-09-01), None
patent: 0827964 (1998-03-01), None
patent: WO99/62524 (1999-12-01), None
Rambali et al. “Using experimental design to optimize the process parameters in fluidized bed granulation on a semi-full scale,” Int. J. Pharmaceutics (Jun. 4, 2001) 220 (1-2): 149-60.
Webster's II New Riverside University Dictionary (1994) (Houghton-Mifflin: Boston, MA) p. 120.

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