Storage stable thyroxine active drug formulations and...

Details Storage stable thyroxine active drug formulations and... Storage stable thyroxine active drug formulations and...

2005-08-30

2005-08-30

Page, Thurman K. (Department: 1615)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C424S464000, C424S468000, C424S489000, C424S499000, C424S502000, C514S567000

Reexamination Certificate

active

06936274

ABSTRACT:
This invention provides a storage-stable dosage form of a thyroxine active drug composition which exhibits an improved stability. The formulation contains a thyroxine active drug substance, an alditol, and a saccharide, and, optionally, additional pharmaceutically accepted excipients. Levothyroxine sodium is the preferred active drug substance, mannitol is the preferred alditol, and sucrose is the preferred saccharide. Additional preferred excipients include, for example, microcrystalline cellulose, crospovidone, magnesium stearate, colloidal silicon dioxide, and sodium lauryl sulfate.

REFERENCES:
patent: 4415547 (1983-11-01), Yu et al.
patent: 4666703 (1987-05-01), Kopf
patent: 4910023 (1990-03-01), Botzolakis et al.
patent: 5004613 (1991-04-01), Radebaugh et al.
patent: 5032405 (1991-07-01), Huang et al.
patent: 5073380 (1991-12-01), Babu et al.
patent: 5200193 (1993-04-01), Radebaugh et al.
patent: 5202128 (1993-04-01), Morella et al.
patent: 5225202 (1993-07-01), Hodges et al.
patent: 5225204 (1993-07-01), Chen et al.
patent: 5330766 (1994-07-01), Morella et al.
patent: 5378474 (1995-01-01), Morella et al.
patent: 5456851 (1995-10-01), Liu et al.
patent: 5462747 (1995-10-01), Radebaugh et al.
patent: 5490990 (1996-02-01), Grabowski et al.
patent: 5543155 (1996-08-01), Fekete et al.
patent: 5571840 (1996-11-01), Mayor et al.
patent: 5585115 (1996-12-01), Sherwood et al.
patent: 5635209 (1997-06-01), Groenewoud et al.
patent: 5681583 (1997-10-01), Conte et al.
patent: 5725883 (1998-03-01), Staniforth et al.
patent: 5725884 (1998-03-01), Sherwood et al.
patent: 5741524 (1998-04-01), Staniforth et al.
patent: 5747068 (1998-05-01), Mendizabal
patent: 5753254 (1998-05-01), Khan et al.
patent: 5780057 (1998-07-01), Conte et al.
patent: 5800834 (1998-09-01), Spireas et al.
patent: 5858412 (1999-01-01), Staniforth et al.
patent: 5866166 (1999-02-01), Staniforth et al.
patent: 5948438 (1999-09-01), Staniforth et al.
patent: 5948926 (1999-09-01), Takeo et al.
patent: 5955105 (1999-09-01), Mitra et al.
patent: 6056975 (2000-05-01), Mitra et al.
patent: 6190696 (2001-02-01), Groenewoud
patent: 6372255 (2002-04-01), Saslawski et al.
patent: 6399101 (2002-06-01), Frontanes et al.
patent: 6645526 (2003-11-01), Hanshew et al.
patent: 2002284679 (2002-10-01), None
patent: WO 99/63969 (1999-12-01), None
patent: WO 01/13936 (2001-03-01), None
patent: WO 01/80822 (2001-11-01), None
patent: WO 02/28364 A2 (2002-04-01), None
patent: WO 02/28365 A2 (2002-04-01), None
patent: WO 02/064093 (2002-08-01), None
patent: WO 02/067854 (2002-09-01), None
patent: WO 03/013441 (2003-02-01), None
patent: WO 03/028624 (2003-04-01), None
patent: WO 03/061557 (2003-07-01), None
patent: WO 03/070217 (2003-08-01), None
U.S. Appl. No. 60/311,523, filed Aug. 10, 2001, Franz et al.
U.S. Appl. No. 60/311,552, filed Aug. 10, 2001, Franz et al.
U.S. Appl. No. 60/311,522, filed Aug. 10, 2001, Franz et al.
U.S. Appl. No. 60/311,524, filed Aug. 10, 2001, Franz et al.
U.S. Appl. No. 60/312,114, filed Aug. 14, 2001, Franz et al.
U.S. Appl. No. 60/312,113, filed Aug. 14, 2001, Franz et al.
U.S. Appl. No. 60/312,287, filed Aug. 14, 2001, Franz et al.
U.S. Appl. No. 60/312,184, filed Aug. 14, 2001, Franz et al.
U.S. Appl. No. 60/312,273, filed Aug. 14, 2001, Franz et al.
V. Das Gupta et al., “Effect of Excipients on the Stability of Levothyroxine Sodium Tablets,”J. Clin. Pharm.&Therap.15: 331-336 (1990).
Steven L Richheimer et al., “Stability-Indicating Assay, Dissolution, and Content Uniformity of Sodium Levothyroxine in Tablets,”J. Pharm. Sci72(11): 349-51 (1983).
“Levothyroxine Loses Potency With Age,”JAMA255(14): 1881-82 (1986).
Chong Min Won, “Kinetics of Degradation of Levothyroxine in Aqueous Solution and in Solid State,”Pharm. Research9(1):131-37 (1992).
Reilly, W. J., “Remington: The Science and Practice of Pharmacy,” vol. II, Chapter 80, Pharmaceutical Necessities, p. 1380 (1995).

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