Pharmaceutical tablet of amiodarone salt

Details Pharmaceutical tablet of amiodarone salt Pharmaceutical tablet of amiodarone salt

1997-04-11

1998-07-28

Azpuru, Carlos A.

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

424489, 424479, 424474, 424463, A61K 920

Patent

active

057859957

ABSTRACT:
An orally administered tablet comprising a therapeutic amount of a pharmaceutically acceptable salt of amiodarone (e.g., an acid salt of amiodarone such as amiodarone hydrochloride) is described. Other ingredients include a disaccharide which is preferably a reducing disaccharide, pregelatinized starch, and an alkali metal starch glycolate. The tablet preferably also comprises at least one of the following: a) 2 to 6% by weight stearic acid, b) less than 1% by weight magnesium stearate, c) 2 to 25% by weight of wet binder, and d) less than 0.1% by weight of silica gel.

REFERENCES:
patent: 5085869 (1992-02-01), Olthoff et al.
patent: 5198228 (1993-03-01), Urban et al.
"Cordarone.TM. (amiodarone HCl) Tablets", Information Sheet from Wyeth Laboratories, Inc., Philadelphia, 2 pgs. (1994).
Wadke et al., "Preformulation Testing", In: Pharmaceutical Dosage Forms--Tablets, vol. 1, edited by H.A. Lieberman et al., Marcel Dekker, Inc., New York, pp. 13-16 (1980).
Lachman, L., et al., "Tablets--Wet Granulation", In: The Theory and Practice of Industrial Pharmacy, Lea & Febiger, Philadelphia, pp. 320-324 (1986).

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