Sustained release formulation containing tacrolimus

Details Sustained release formulation containing tacrolimus Sustained release formulation containing tacrolimus

2005-04-26

2005-04-26

Naff, David M. (Department: 1651)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S400000, C424S452000, C424S455000, C424S457000, C424S462000, C424S465000, C424S468000, C424S489000, C435S174000, C435S178000, C514S294000

Reexamination Certificate

active

06884433

ABSTRACT:
Sustained release formulation containing tacrolimus or its hydrate is provided. The time (T63.2%) required for 63.2% of the maximum amount of tacrolimus or its hydrate to be dissolved is 0.7 to 15 hours. The time is measured in accordance to the Japanes Pharmacopocia, the 13-th edition, Dissolution Test, No. 2 (Puddles method, 50 rpm) using an aqueous 0.005% hydroxypropyl cellulose solution. This aqueous test solution is adjusted to pH 4.5, accordingly. The formulation further comprises a solid base which is a water-soluble or water-insoluble polymer. The formulation is in the form of a powder, fine powder, granule, tablet or capsule. The formulation is administered to a patient once a day for preventing organ or tissue rejection by transplantation or autoimmune disease. In addition, a solid dispersion composition is provided. The solid dispersion comprises tacrolimus or its hydrate in a mixture containing water-soluble or water-insoluble polymer and an excipient.

REFERENCES:
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patent: 9-501939 (1997-02-01), None
patent: WO 9703654 (1997-02-01), None
A.H. Kibbe et al., American Pharmaceutical Association and Pharmaceutical Society of Great Britain, pp. 113-115 and 339-340, XP-002194848, “Handbook of Pharmaceutical Excipients,” 1986.
A. Burger et al., Hunnius Pharmazeutisches Worterbuch, p. 145, XP-002194849, “Arzneiformen MIT Protrahierier Wirkung,” 1993.

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