Paroxetine compositions and processes for making the same
AssigneeSynthon BCT Technologies, LLC
InventorsJacobus M. Lemmens, Theodorus H. A. Peters, Frantisek Picha, Johannes J. Platteeuw, Frans van Dalen
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Abstract
Paroxetine salt compositions having improved stability are formed by controlling the pH to 6.5 or less. The compositions can be made with the aide of water without significant coloration problems. The paroxetine salts include paroxetine hydrochloride salts but preferably use paroxetine sulfonate salts such as paroxetine methane sulfonate.
Claims36
A solid unit dose paroxetine composition comprising a pharmaceutically effective amount of a paroxetine hydrochloiride, an acidic calcium phosphate, and a disintegrant wherein said composition has a pH within the range of 4.5 to 6.0.
A granulate formed by mixing water, paroxetine sulfonate, and at least one excipient and drying the resulting mixture, wherein said mixing was accomplished by adding together an aqueous solution having at least about a 10 wt % concentration of paroxetine sulfonate with said at least one excipient.
A process, which comprises:
- mixing an aqueous solution containing at least 10 wt % of a paroxetine sulfonate with at least one solid excipient;
- and
- drying to form a granulate.
Dependencies are inferred from the claim text.