Processes for the preparation of oral dosage formulations of modafinil
AssigneeRanbaxy Laboratories Limited
InventorsRomi Bharat 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.
Claims39
A process for preparing an oral dosage form containing modafinil, the process comprising:
- forming a dosage form comprising
- about 7%-25% by weight of modafinil particles have diameters greater than 220 μm;
- and
- about 75%-93% by weight of modafinil particles have diameters less than 220 μm.
An oral dosage form of modafinil comprising:
- about 7% to 25% by weight of modafinil particles have diameters greater than 220 μm;
- and
- about 93% to 75% by weight of modafinil particles have diameters less than 220 μm.
A method of treating a condition using modafinil, the method of treating comprising:
- providing an oral dosage form of modafinil comprising
- about 7% to 25% by weight of modafinil particles have diameters greater than 220 μm;
- and
- about 93% to 75% by weight of modafinil particles have diameters less than 220 μm.
An oral dosage form of modafinil comprising an intragranular portion 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, and one or more pharmaceutically acceptable excipients;
- and
- the extragranular portion comprising one or more pharmaceutically acceptable excipients.
Dependencies are inferred from the claim text.