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Last Updated: October 18, 2019

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Claims for Patent: 9,707,182

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Summary for Patent: 9,707,182
Title:Oral pharmaceutical dosage forms of budesonide
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.
Inventor(s): Thennati; Rajamannar (Baroda, IN), Kulkarni; Shirish (Baroda, IN), Kulkarni; Amol (Baroda, IN), Kaneria; Vimal (Bopal, IN), Sharma; Mukesh (Baroda, IN)
Assignee: Sun Pharmaceutical Industries LTD. (Maharashtra, IN)
Application Number:15/261,420
Patent Claims: 1. A sustained release pharmaceutical dosage form in the form of a capsule, sachet or pouch, comprising: a) an inert core, b) a first sustained release sugar matrix layer surrounding the inert core, the sugar matrix layer comprising budesonide, a water insoluble polymer and sugar, wherein the ratio of sugar to water insoluble polymer is greater than 3:1; and c) a second delayed release film coating surrounding the sustained release sugar matrix layer, wherein, the sustained release pharmaceutical dosage form when tested for dissolution in a USP Apparatus II at 75 rpm in 1000 ml of 0.1 N 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.

2. A sustained release pharmaceutical dosage form as in claim 1, wherein the water insoluble polymer is ethyl cellulose.

3. A sustained release pharmaceutical dosage form as in claim 1, wherein the sugar matrix layer comprises sugar in an amount from about 50 to about 80% of the total weight of sugar matrix layer.

4. A sustained release pharmaceutical dosage form as in claim 1, wherein the water insoluble polymer is present in an amount from about 5 to about 15% of the total weight of the sugar matrix layer.

5. A sustained release pharmaceutical dosage form of claim 1, wherein delayed release film coating comprises copolymers of acrylic acid and methacrylic acid esters.

6. A sustained release pharmaceutical dosage form of claim 1, wherein the amount of budesonide is in the range of from about 6mg to about 9mg.

7. A sustained release pharmaceutical dosage form of claim 1, wherein budesonide is present in an amount from about 15% to about 25% of the total weight of the sugar matrix layer.

8. A sustained release pharmaceutical dosage form of claim 1, wherein budesonide is present in an amount from about 1.5% to about 3.5% of the total weight of sustained release pharmaceutical dosage form.

9. A sustained release pharmaceutical dosage form of claim 1, for use in the treatment of Crohn's disease.

10. A sustained release pharmaceutical dosage form of claim 1, for use in the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon.

11. A sustained release dosage form in the form of a capsule, sachet or pouch comprising: a) an inert core, b) a first sustained release sugar matrix layer surrounding the inert core, the sugar matrix layer comprising budesonide, a water insoluble polymer and sugar, wherein the ratio of sugar to water insoluble polymer is greater than 3:1; and c) a second delayed release film coating surrounding the sustained release sugar matrix layer, the sustained release pharmaceutical dosage form when tested for dissolution in a USP Apparatus II at 75 rpm in 1000 ml of 0.1 N HCl for 2 hours followed by a change to pH 5.5 buffer, exhibiting 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 0.1 N 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.

12. A sustained release pharmaceutical dosage form of claim 11, for use in the treatment of Crohn's disease.

13. A sustained release pharmaceutical dosage form of claim 11, for use in the maintenance of clinical remission of mild to moderate Crohn's disease involving the ileum and/or the ascending colon.

14. A sustained release pharmaceutical dosage form as in claim 11, wherein the sugar matrix layer comprises sugar in an amount from about 50 to about 80% of the total weight of sugar matrix layer, and the water insoluble polymer is present in an amount from about 5 to about 15% of the total weight of the sugar matrix layer.

15. A sustained release pharmaceutical dosage form of claim 11, wherein delayed release film coating comprises copolymers of acrylic acid and methacrylic acid esters.

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