AN ORODISPERSIBLE PHARMACEUTICAL SOLID DOSAGE FORM OF RASAGILINE

The present invention relates to an orodispersible pharmaceutical solid dosage form comprising a therapeutically effective amount of rasagiline or a pharmaceutically acceptable salt thereof a pharmaceutically acceptable polymer suitable for forming a matrix with rasagiline or a pharmaceutically acce...

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Hauptverfasser: FORMOSA MÁRQUEZ, Xavier, DOMÍNGUEZ FERNÁNDEZ, Almudena, TORREA GOÑI, Diego, LLUCH LORES, María Carmen
Format: Patent
Sprache:eng
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Zusammenfassung:The present invention relates to an orodispersible pharmaceutical solid dosage form comprising a therapeutically effective amount of rasagiline or a pharmaceutically acceptable salt thereof a pharmaceutically acceptable polymer suitable for forming a matrix with rasagiline or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable excipients, wherein rasagiline or a pharmaceutically acceptable salt thereof is trapped within the matrix, and wherein said dosage form exhibits a dissolution profile according to which (i) after 2 minutes at pH=7.0, less than 12% w/w of the rasagiline relative to the total rasagiline content of the dosage form is dissolved, and (ii) after 15 minutes at pH=1.2, more than 75% w/w of the rasagiline relative to the total rasagiline content of the dosage form is dissolved, and (iii) after 40 minutes at pH=1.2, at least 90% w/w of the rasagiline relative to the total rasagiline content of the dosage form is dissolved, and wherein said orodispersible pharmaceutical solid dosage form is disintegrated in less than 3 minutes.