Tofacitinib orally disintegrating tablets
AssigneeUnichem Laboratories Ltd
InventorsSaurabh Gupta, Saiesh P. Phaldesai, NSK. Senthil Kumar, Milind Vinayak Sathe
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Abstract
The present invention relates to Orally Disintegrating Tablets (ODT) of Tofacitinib and its pharmaceutically acceptable salts and the process to produce the ODT. The invention further relates to ODTs comprising Tofacitinib and its pharmaceutically acceptable salts, at least one sweetening agent, at least one disintegrant and optionally other excipients. The weight of the Orally Disintegrating tablets is 200 mg or less. The invention further relates to Orally Disintegrating Tablets of Tofacitinib Citrate.
Claims13
An orally disintegrating tablet comprising Tofacitinib or its pharmaceutically acceptable salts.
An orally disintegrating tablet comprising Tofacitinib or its pharmaceutically acceptable salt with at least one sweetening agent and at least one disintegrant optionally with other excipients.
A process to produce orally disintegrating tablet containing Tofacitinib or its pharmaceutically acceptable salts comprising the steps of
- a. Mixing Tofacitinib or its pharmaceutically acceptable salt, Disintegrant, Sweetener optionally with Diluent and flavor in suitable blender to produce pre-lubricated blend;
- b. Optionally mixing lubricant with pre-lubricated blend obtained in step a., to produce lubricated blend;
- c. Compressing pre-lubricated blend obtained in step a. or lubricated blend obtained in step b. to form tablets.
An orally disintegrating tablet comprising Tofacitinib Citrate, Mannitol, Microcrystalline Cellulose, Crospovidone, Sucralose and flavor.
A process to produce orally disintegrating tablet comprising
- a. Blending of Tofacitinib Citrate, Mannitol, Microcrystalline Cellulose, Crospovidone, Sucralose and flavor in a blender to produce pre-lubricated blend,
- b. Mixing magnesium stearate with pre-lubricated blend obtained in step a. to produce lubricated blend,
- c. Compressing Lubricated blend obtained in step b. to form tablets.
Dependencies are inferred from the claim text.