Taste masked sumatriptan tablets and processes for their preparation
OwnerRajeev Mathur, T. Kumar +2inventors
InventorsRajeev Mathur, T. Kumar, Sunilendu Roy, Rajiv Malik
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Abstract
The technical field of the present invention relates to uncoated, taste masked sumatriptan tablets for oral administration and processes for their preparation. It also relates to wax polished sumatriptan tablets and processes for their preparation.
Claims54
A process for preparing an uncoated sumatriptan tablet for oral administration, the process comprising the steps of:
- granulating sumatriptan or a pharmaceutically acceptable salt with one or more diluents and/or binders to form granules;
- mixing the granules with one or more pharmaceutically acceptable excipients to form a mixture;
- and
- compressing the mixture to form a tablet.
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A process for preparing uncoated sumatriptan tablets for oral administration, the process comprising the steps of:
- spraying a solution or suspension of sumatriptan or a pharmaceutically acceptable salt in a solvent onto inert cores to form a first layer;
- blending the core having the first layer with one or more pharmaceutically acceptable excipients to form a blend;
- and
- compressing the blend to form a tablet.
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A wax polished dosage form of sumatriptan, the dosage form comprising:
- sumatriptan or a pharmaceutically acceptable salt;
- one or more pharmaceutically acceptable carriers or excipients;
- and
- a wax polish on the dosage form.
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An uncoated, wax polished sumatriptan tablet comprising:
- a tablet core comprising about 10-200 mg of sumatriptan or a physiologically acceptable salt and one or more pharmaceutically acceptable carriers or excipients, and
- a wax polish on the tablet core,
- wherein the wax polish comprises an amount of from about 2 to 10% weight/weight of the tablet.
An uncoated, taste-masked sumatriptan tablet for oral administration, the uncoated tablet comprising:
- an intragranular portion comprising granules of sumatriptan or a pharmaceutically acceptable salt and one or more diluents and/or binders present in a sufficient amount to cause taste-masking of the sumatriptan or pharmaceutically acceptable salt;
- and
- an extragranular portion comprising one or more pharmaceutically acceptable excipients around the intragranular granules.
A method of treating or prophylactically treating a human suffering from a migraine condition, the method comprising orally administering a wax polished dosage form of sumatriptan, the oral dosage form comprising:
- sumatriptan or a physiologically acceptable salt and a pharmaceutically acceptable carrier or excipient;
- one or more pharmaceutically acceptable carriers or excipients;
- and
- a wax polish on the dosage form.
A method of treating or prophylactically treating a human suffering from a migraine condition, the method comprising orally administering an uncoated, taste-masked tablet of sumatriptan, the uncoated tablet comprising:
- an intragranular portion comprising granules of sumatriptan or a pharmaceutically acceptable salt and one or more diluents and/or binders present in a sufficient amount to cause taste-masking of the sumatriptan or pharmaceutically acceptable salt;
- and
- an extragranular portion comprising one or more pharmaceutically acceptable excipients around the intragranular granules.
Dependencies are inferred from the claim text.