Oral pharmaceutical dosage forms of budesonide
AssigneeSun Pharmaceutical Industries Limited
InventorsRajamannar Thennati, Shirish Kulkarni, Amol Kulkarni, Vimal Kaneria, Mukesh Sharma
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Abstract
The present invention relates to novel oral sustained release pharmaceutical dosage forms for delivery of budesonide to the lower gastrointestinal tract for the treatment of Crohn's disease.
Claims13
1-13. (canceled)
A method of treating Crohn's disease comprising delivering budesonide to the lower gastrointestinal tract by orally administering a single unit sustained release dosage form in the range of from about 6 mg to about 9 mg, said sustained release dosage form when tested for dissolution in a USP Apparatus II at 75 rpm in 1000 ml of 0.1N HCl for 2 hours followed by a change to pH 5.5 buffer, exhibits the following dissolution profile
- a) less than 5% of total budesonide is released after 2 hours;
- b) from about 5% to about 15% of total budesonide is released after 3 hours;
- c) from about 15% to about 20% of total budesonide is released after 4 hours;
- d) from about 30% to about 40% of total budesonide is released after 6 hours;
- e) from about 40% to about 50% of total budesonide is released after 8 hours;
- f) not less than 50% of total budesonide is released after 10 hours
- and
- when tested for dissolution in a USP Apparatus II at 75 rpm in 1000 ml of 0.1N HCl for 2 hours followed by a change to pH 7.5 buffer, exhibits the following dissolution profile,
- a) less than 5% of total budesonide is released after 2 hours;
- b) from about 30% to about 50% of total budesonide is released after 3 hours;
- c) from about 40% to about 60% of total budesonide is released after 4 hours;
- d) from about 65% to about 85% of total budesonide is released after 6 hours;
- e) not less than 80% of total budesonide is released after 8 hours.
Dependencies are inferred from the claim text.