Pharmaceutical composition comprising a triazole antifungal agent and method for preparation thereof
AssigneePharmathen S.A.
InventorEvangelos Karavas
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Abstract
The present invention relates to a stable pharmaceutical formulation of solid dosage forms for oral administration comprising a therapeutically effective amount of a triazole antifungal agent or pharmaceutical acceptable salt thereof, in particular Voriconazole and an effective amount of a solubility enhancing agent. It also relates to a process for the preparation thereof.
Claims6
A solid pharmaceutical composition for oral administration comprising:
- Voriconazole or pharmaceutically acceptable salt thereof and an effective amount of colloidal silicon dioxide as a solubility enhancing agent;
- wherein the solid pharmaceutical composition comprises an internal phase and an external phase;
- wherein the internal phase comprises particles having a dimension less than 100 micrometers and wherein each particle of the internal phase comprises the colloidal silicon dioxide intimately mixed and incorporated with the Voriconazole;
- and
- wherein the external phase is located outside the internal phase and comprises excipients that are not intimately mixed with the Voriconazole;
- and
- wherein one of said excipients incorporated in the external phase comprises magnesium stearate.
A process for the preparation of a tablet composition comprising Voriconazole or pharmaceutically acceptable salt thereof and an effective amount of colloidal silicon dioxide as a solubility enhancing agent comprising the steps of:
- Dissolving of povidone in water;
- Blending Voriconazole with pregelatinized starch, lactose monohydrate, croscarmellose sodium and colloidal silicon dioxide;
- Kneading with povidone solution;
- Drying the wetted mass;
- Sizing the granules;
- Adding magnesium stearate to the mixture;
- Compressing the obtained mixture into tablet dosage form;
- Optionally, applying a film-coating on the core.
Dependencies are inferred from the claim text.