Pharmaceutical formulation comprising levothyroxine sodium

Details Pharmaceutical formulation comprising levothyroxine sodium Pharmaceutical formulation comprising levothyroxine sodium

2011-06-07

2011-06-07

Vu, Jake M. (Department: 1618)

Drug, bio-affecting and body treating compositions

Preparations characterized by special physical form

Tablets, lozenges, or pills

C514S567000

Reexamination Certificate

active

07955621

ABSTRACT:
There is provided a stable pharmaceutical formulation comprising (a) an effective amount of levothyroxine sodium, (b) microcrystalline cellulose which has a mean particle size of less than 125 μm and is present in an amount of 60 to 85% w/w based upon the total weight of the formulation, and (c) pregelatinised starch present in an amount of 5 to 30% w/w based upon total weight of the formulation. There is also provided a process for the preparation of such a formulation.

REFERENCES:
patent: 5955105 (1999-09-01), Mitra et al.
patent: 5958979 (1999-09-01), Lahr et al.
patent: 5976600 (1999-11-01), Ruszkay et al.
patent: 6190696 (2001-02-01), Groenewoud
patent: 6555581 (2003-04-01), Franz et al.
patent: 2003/0032675 (2003-02-01), Franz et al.
patent: 11-286456 (1999-10-01), None
patent: 2001-064177 (2001-03-01), None
patent: 2001-163770 (2001-06-01), None
patent: WO95/20954 (1995-08-01), None
patent: WO01/74448 (2001-10-01), None
European (European Pharmacopoeia (2002) p. 1438).
Handbook (Handbook of Pharmaceutical Excipients: 5th edition. p. 134, 725 and 731 (2006)).
MSDS (Material Safety Data Sheet: L-Thyroxine, sodium salt).
Handbook (Handbook of Pharmaceutical Excipients: 5th edition. p. 732 (2006)).
Hager's Handbuch de Pharmazeutischen Praxis, 5., vollständig neubearbeitete Auflage, Springer-Verlag Berlin Heidelberg pp. 733-734, 1993.
Rolski, Chemia Srodkow Lecznichzych, str. 654-655, PZWL, Warszawa 1968.
Iskandarani et al. “Scale-up feasibility in high-shear mixers: Determination through statistical procedures” Drug Dev. and Industr. Pharm. 27:651-657 (2001).

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