Pharmaceutical formulations of compacted granulates of .beta.-Lactam antibiotics
AssigneeSmithKline Beecham Corporation
InventorsLuis Carvajal Martin, Juan Dedios Romero
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Abstract
The present invention discloses tablet formulations, produced by dry roller compaction comprising compacted granulates of a mixture of a medicament and an intra-granular disintegrant. The granulates are compacted together into a tablet with an extra-granular disintegrant, an optional extragranular lubricant and excipients.
Claims26
A process for the manufacture of a pharmaceutical tablet, in which granulates comprising a medicament which comprises amoxycillin optionally in combination with a salt of clavulanic acid in a weight ratio equivalent to amoxycillin:
- clavulanic acid in the range 12:1 to 1:1, optionally together with an intra-granular disintegrant;
- which granulates are prepared by dry roller compaction, are mixed with an extra-granular disintegrant and optionally with an extra-granular lubricant and excipients, provided that if a lubricant is present it amounts to less than 0.5% by weight of the mixture, and the mixture is compressed into tablets.
A process for the manufacture of a pharmaceutical granulate, in which a medicament which is amoxycillin together in combination with a .beta.-lactamase inhibitor is dry roller compacted, and with an intra-granular disintegrant.
A process for the manufacture of a pharmaceutical granulate, in which a medicament which is amoxycillin is dry roller compacted together with an intra-granular disintegrant.
Dependencies are inferred from the claim text.