Processes for the preparation of oral dosage formulations of modafinil
AssigneeRanbaxy Laboratories Limited
InventorsRomi Barat Singh, Pannanchukunnath Manoj Kumar, Vishnubhotla Nagaprasad, Sunilendu Bhushan Roy, Rajiv Malik
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Abstract
The invention relates to processes for preparing, and pharmaceutical compositions of, modafinil dosage forms for oral administration. The dosage forms include a mixture of coarse and fine particles of modafinil. The process for preparing modafinil oral dosage forms includes forming a dosage form that includes about 7%–25% by weight of modafinil particles having diameters greater than 220 μm and about 75%–93% by weight of modafinil particles having diameters less than 220 μm.
Claims13
An oral dosage form comprising:
- about 7% to 25% by weight of modafinil particles having diameters greater than 220 μm;
- about 93% to 75% by weight of modafinil particles having diameters less than 220 μm,
- wherein about 90% of the particles having diameters size less than 220 μm are further characterized in that they have diameters less than about 41 μm, and about 50% of the particles having diameters size less tan 220 μm are further characterized in that they have diameters less than about 21 μm.
An oral dosage form of modafinil comprising an intragranular and an extragranular portion:
- the intragranular portion comprising about 7% to 25% by weight of modafinil particles having diameters greater than 220 μm, about 93% to 75% by weight of modafinil particles having diameters less than 220 μm, wherein about 90% of the particles having diameters size less than 220 μm are further characterized in that they have diameters less than about 41 μm, and about 50% of the particles having diameters size less than 220 μm are further characterized in that they have diameters less than about 21 μm, and
- one or more pharmaceutically acceptable excipients;
- and
- an extragranular portion comprising one or more pharmaceutically acceptable excipients.
Dependencies are inferred from the claim text.