Carvedilol-galenics

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

Reexamination Certificate

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Details

C424S490000

Reexamination Certificate

active

06852337

ABSTRACT:
The invention relates to a process for the preparation of fast-dissolving pharmaceutical preparations from difficultly soluble active substances, wherein an aqueous suspension is made from the active substance and one or more water-soluble adjuvants and then the resulting aqueous suspension is processed, with removal of the water, by methods conventional per se, to form solid pharmaceutical preparations. The invention also relates to fast-dissolving pharmaceutical preparations of active substances having a dissolution rate of at least 70% after 30 minutes, prepared in accordance with the process of the invention.

REFERENCES:
patent: 4601895 (1986-07-01), Streuff et al.
patent: 5643591 (1997-07-01), Mehra et al.
patent: 5948438 (1999-09-01), Staniforth et al.
patent: 6224909 (2001-05-01), Opitz et al.
patent: WO 9613251 (1996-05-01), None
patent: WO 9810754 (1998-03-01), None
Remington: The Science and Practice of Pharmacy, Chapter 91 Powders, 19th Edition, vol. II, 1995, pp. 1598-1614, 1627-1628.*
DAB (Deutsches Arzneibuch) 9 commentary, vol. 1, 9thed., 1986.
USP (United States Pharmacopoea) 24, p. 2254.
Registration documents for Carvedilol-12.5 mg; Part II: Chemical Pharmaceutical and Biological Documentation, vol. 1 of 2; Part IIC: Control of Starting Materials.
Patent Abstracts of Japan, Japanese Patent Publication (KOKAI) No. 76516/1995, Toyobo Co., Ltd., Mar. 20, 1995.

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