TADALAFIL ORAL SUSPENSION

The present invention relates to a tadalafil oral suspension comprising 0.01-5 % w/v of tadalafil, a cyclodextrin, coprocessed microcrystalline cellulose and sodium carboxymethyl cellulose, xanthan gum and water as vehicle. The suspensions are chemically and physically stable and show a dissolution...

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Bibliographische Detailangaben
Hauptverfasser:	DUART GONZÁLEZ, Ester, RUBIO MENCO, Guillermo, MUÑOZ RUIZ, Ángel, GÓMEZ CALVO, Antonia, PORTOLÉS PÉREZ, Antonio, HORCAJADA CÓRDOBA, Raquel, SANZ MENÉNDEZ, Nuria, VARGAS CASTRILLÓN, Emilio, IGLESIAS SÁNCHEZ, José Carlos, SANTÉ SERNA, Luis Narciso
Format:	Patent
Sprache:	eng ; fre ; ger
Schlagworte:	HUMAN NECESSITIES HYGIENE MEDICAL OR VETERINARY SCIENCE PREPARATIONS FOR MEDICAL, DENTAL, OR TOILET PURPOSES SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS ORMEDICINAL PREPARATIONS
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Beschreibung
Zusammenfassung:	The present invention relates to a tadalafil oral suspension comprising 0.01-5 % w/v of tadalafil, a cyclodextrin, coprocessed microcrystalline cellulose and sodium carboxymethyl cellulose, xanthan gum and water as vehicle. The suspensions are chemically and physically stable and show a dissolution profile equivalent to that of commercial tadalafil film-coated tablets. The tadalafil suspensions are suitable for treating male erectile dysfunction and benign prostatic hyperplasia. The invention also relates to a fixed-dose combination dosage forms comprising said tadalafil suspension and either tamsulosin, in particular, in the form of modified-release pellets, or dutasteride. Said combined forms are useful for treating lower urinary tract symptoms associated with benign prostatic hyperplasia. The invention also relates to a process for the preparation of said tadalafil composition.