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Details for Patent: 4,547,358

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Details for Patent: 4,547,358

Title: Sustained release tablet containing at least 95 percent theophylline
Abstract:Non-disintegrating theophylline tablets having a pair of opposing substantially planar surfaces and a very thin cross-section have a high bioavailability on ingestion and a relatively steady release rate permitting a 12 hr. dosing interval for maintenance of non-toxic therapeutic blood theophylline concentrations. Excipients or tableting aids are not required, but trace amounts of a tableting lubricant are preferably included to facilitate continuous large scale production.
Inventor(s): David; Stephen T. (Evansville, IN), Brooke; Dana (Evansville, IN), Gallian; Claude E. (Evansville, IN)
Assignee: Mead Johnson & Company (Evansville, IN)
Filing Date:Jun 04, 1984
Application Number:06/616,982
Claims:1. A sustained release pharmaceutical tablet comprising 95% to 99.8% by weight of theophylline, and the remainder conventional pharmaceutical tablet ingredients selected to provide a tablet that remains intact during dissolution, said tablet having a pair of substantially planar opposing faces joined by edge walls and a thickness of from 0.08 to 0.12 inches which when administered to a human in a therapeutically effective amount at consecutive 12 hour intervals affords a continuous blood serum concentration of from 10 mcg/ml to 20 mcg/ml of theophylline during said intervals.

2. The pharmaceutical tablet of claim 1 containng 100 mg to 500 mg of theophylline.

3. The pharmaceutical tablet of claim 1 having a thickness of 0.09 to 0.11 inches.

4. The pharmaceutical tablet of claim 1 containing from 0.2% to 0.6% by weight of magnesium stearate as tableting lubricant.

5. The pharmaceutical tablet of claim 1 containing 0.3% to 0.5% by weight of magnesium stearate as tableting lubricant.

6. The pharmaceutical tablet of claim 1 consisting essentially of 99.6% by weight of theophylline and 0.4% by weight of magnesium stearate.

7. The pharmaceutical tablet of claim 6 containing 300 mg of theophylline.

8. A sustained release pharmaceutical tablet consisting essentially of 99.4% to 99.8% by weight of theophylline and 0.1% to 0.6% by weight of a tableting lubricant selected to provide a tablet that remains intact during dissolution, said tablet having a pair of substantially planar opposing faces joined by edge walls and a thickness of from 0.08 to 0.12 inches which when administered to a human in a therapeutically effective amount at consecutive 12 hour intervals affords a continuous blood serum concentration of from 10 mcg/ml to 20 mcg/ml of theophylline during said intervals.

9. The tablet of claim 8 where the tableting lubricant is magnesium stearate.

10. A pharmaceutically tablet for the maintenance of a therapeutically effective blood concentration of theophylline during a dosage interval of up to 12 hours following ingestion thereof in therapeutically effective amount comprised of at least 95% by weight of theophylline and the remainder conventional pharmaceutical tablet ingredients selected to provide a tablet which dissolves without first disintegrating when contacted with water during a period of about 4 hours to the extent of from 83% to 100% by weight, wherein said tablet has a pair of substantially planar opposing faces joined by edge walls and a thickness of from 0.08 to 0.12 inches and the therapeutically effective theophylline blood serum concentration maintained by said tablet is substantially within the range of from about 10 mcg/ml to 20 mcg/ml.

11. The pharmaceutical tablet of claim 10 containing from about 100 mg to 500 mg of theophylline.

12. The pharmaceutical tablet of claim 10 which when administered to a human in bronchodilative effective amount at consecutive intervals of from about 8 to 12 hours maintains a bronchodilative effective blood serum concentration of theophylline during said interval.

13. The pharmaceutical tablet of claim 10 having a thickness of 0.09 to 0.11 inches.

14. The pharmaceutical tablet of claim 10 containing at least 99% by weight of theophylline and a tableting lubricant.

15. The pharmaceutical tablet of claim 14 containing from 0.1% to 0.6% by weight of magnesium stearate as tableting lubricant.

16. The pharmaceutical tablet of claim 14 containing from 0.3% to 0.5% by weight of magnesium stearate as tableting lubricant.

17. The pharmaceutical tablet of claim 10 consisting essentially of 99.6% by weight of theophylline and 0.4% by weight of magnesium stearate.

18. The pharmaceutical tablet of claim 10 containing 300 mg of theophylline.

19. The pharmaceutical tablet of claim 10 wherein said tablet consists essentially of 99.4% to 99.8% by weight of theophylline and 0.1% to 0.6% weight of magnesium stearate.

20. The method for maintaining a therapeutically effective blood serum concentration of theophylline during an extended treatment period which comprises orally administering a therapeutically effective dose of theophylline to a patient requiring theophylline therapy said dose consisting of one or more pharmaceutical tablets which dissolve without first disintegrating when contacted with water for a period of at least 4 hours said tablets being comprised of at least 95% by weight of theophylline, and the remainder conventional pharmaceutical tablet ingredients selected to provide a tablet that remains intact while dissolving, said tablet having a pair of substantially planar opposing faces joined by edge walls and a thickness of from 0.08 to 0.12 inches wherein said tablet is administered on a repeat dose schedule at dose intervals of up to 12 hours.

21. The method of claim 20 wherein said therapeutically effective dose is a bronchodilative effective dose and said therapeutically effective blood serum concentration is substantially within the range of from about 10 mcg/ml to 20 mcg/ml.

22. The method of claim 20 wherein said dosage interval is within the range of about 8 to 12 hours.

23. The method of claim 20 wherein said tablet contains from 100 mg to 500 mg of theophylline.

24. The method of claim 20 wherein said tablet has a thickness of 0.09 to 0.11 inches.

25. The method of claim 20 wherein said tablet contains at least 99% by weight of theophylline and a tableting lubricant.

26. The method of claim 20 wherein said tablet contains from 0.1% to 0.6% by weight of magnesium stearate as tableting lubricant.

27. The method of claim 20 wherein said tablet contains from 0.3% to 0.5% by weight of magnesium stearate as tableting lubricant.

28. The method of claim 20 wherein said tablet consists essentially of 99.4% to 99.8% by weight of theophylline and 0.1% to 0.6% by weight of magnesium stearate.

29. The method of claim 20 wherein said tablet consists essentially of 99.6% by weight of theophylline and 0.4% by weight of magnesium stearate.
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