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|Title:||Pharmaceutical compositions comprising colloidal silicon dioxide|
|Abstract:||A pharmaceutical composition comprising a macrolide solid dispersion, a disintegrant and colloidal silicon dioxide, wherein the composition comprises 1 to 5% colloidal silicon dioxide by weight.|
|Inventor(s):||Haeberlin; Barbara (Munchenstein, CH), Kramer; Andrea (Reute, DE), Heuerding; Silvia (Basel, CH)|
|Assignee:||Novartis AG (Basel, CH)|
1. A pharmaceutical composition in the form of a dispersible tablet to be dispersed in an ingestible liquid before administration to a patient, comprising a solid
dispersion of 40-O-(2-hydroxy)ethyl-rapamycin, a disintegrant comprising cross-linked polyvinylpyrrolidone and colloidal silicon dioxide, wherein the composition comprises 1 to 5% colloidal silicon dioxide by weight and 10 to 30% of cross-linked
polyvinylpyrrolidone by weight, and wherein the tablet has a disintegration time of 3 minutes or less and a hardness of 35 to 80N.
2. The pharmaceutical composition according to claim 1, wherein 250 mg of the composition, when compressed using a force of 8 to 11 kN with a 9 mm die and standard flat punches, forms the dispersible tablet.
3. A method of administering the pharmaceutical composition of claim 1 to a patient in need of said composition which comprises (i) contacting the composition with an aqueous solution (ii) allowing the composition to disperse in the aqueous solution to form a dispersed mixture and (iii) ingesting the dispersed mixture.
4. A composition according to claim 1, wherein the tablet has a disintegration time of 90 seconds or less.
5. A composition according to claim 1, wherein the composition is used as an immunosuppressant.
6. A process for producing the pharmaceutical composition according to claim 1, comprising preparing the solid dispersion comprising 40-O-(2-hydroxy)ethyl-rapamycin, mixing the solid dispersion comprising 40-O-(2-hydroxy)ethyl-rapamycin with the disintegrant comprising cross-linked polyvinylpyrrolidone and colloidal silicon dioxide to form the pharmaceutical composition and compressing the pharmaceutical composition to form the dispersible tablet.
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