Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Tablets – lozenges – or pills
Reexamination Certificate
2002-07-24
2009-06-30
Hartley, Michael G (Department: 1618)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Tablets, lozenges, or pills
C424S464000, C424S468000
Reexamination Certificate
active
07553499
ABSTRACT:
The present invention relates to a sustained release tablet containing indapamide and the process of manufacturing sustained release tablet containing indapamide. The tablet contains indapamide in the amount of 1.5 to 2.5% of the total mass of the tablet, lactose monohydrate in the amount of 30 to 80% of the total mass of the tablet, copovidone in the amount of 2 to 10% of the total mass of the tablet, hypromellose in the amount of 20 to 65% of the total mass of the tablet and lubricants in the amount of 0.1 to 5% of the total mass of the tablet. The process of manufacturing the sustained release tablet consists in mixing of indapamide with lactose monohydrate and copovidone and then, the mixture is moistened by purified water and the granulation process of it is performed. Next the granulate is dried, cooled, mixed with hypromellose and lubricants and compressed in tableting machine.
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Damien et al, Galenic Development and Pharmacokinetic Profile of indapamide Sustained Release 1.5mg, 1999, Clin Pharmaco, 37, Suppl 1 (XP009004369).
G. Damien et al., Clinical Pharmacokinetics, vol. 37, Suppl. 1, pp. 12-19, 1999.
Foley & Lardner LLP
Hartley Michael G
Pliva Krakow, Zaklady Farmaceutyczne S.A.
Young Micah-Paul
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