Topiramate Tablet Formulation
OwnerFjalar Johannsoninventor
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Abstract
The invention provides pharmaceutical compositions comprising as active ingredient topiramate, which are suitable for manufacturing tablet formulations by direct compression. The compositions preferably comprise spray-dried granulated mannitol and provide tablets of desired friability and hardness.
Claims25
A tablet formulation, produced by direct compression comprising:
- in the range of about 5-35 wt % topiramate, and
- in the range of about 25-70 wt % spray-dried granulated mannitol.
A process for producing a topiramate tablet formulation, comprising the steps of mixing to homogeneity topiramate, granulated spray-dried mannitol, a disintegrant and a lubricant, and optionally one or more further excipients, wherein the topiramate comprises in the range of 5-35 wt % of the final composition, and said spray-dried mannitol comprises about 25-70 wt % of the final composition, optionally sieving the mix once or more to remove unwanted agglomerates, compressing the mix in a tablet punching machine with a tablet punch of suitable size to obtain compressed tablets of a size which will give tablets having a desired dose of topiramate.
Dependencies are inferred from the claim text.