A process for the manufacture of pharmaceutical tablets containing paroxetine hydrochloride anhydrate

Pharmaceutical tablets containing crystalline paroxetine hydrochloride anhydrate are prepared using a process comprising an initial wet granulation process in which an aqueous granulation liquid is added to a mixture of said anhydrate an excipients under high-shear conditions and the thus obtained w...

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Hauptverfasser: SOREN BOLS PEDERSEN, KRISTIAN LUND HENRIKSEN, NIELS CHRISTIAN FELUMB
Format: Patent
Sprache:eng
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Zusammenfassung:Pharmaceutical tablets containing crystalline paroxetine hydrochloride anhydrate are prepared using a process comprising an initial wet granulation process in which an aqueous granulation liquid is added to a mixture of said anhydrate an excipients under high-shear conditions and the thus obtained wet granules are dried using a fluidized bed technique to obtain a water activity within a specified range, after which the dried granules after addition of further adjuvants are compressed into stable tablets each having an identical composition.