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Claims for Patent: 4,465,660

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Claims for Patent: 4,465,660

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)
Application Number:06/451,891
Patent 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 and wherein said tablet has a bisect score on one of said planar faces and a pair of trisect scores on the opposing planar face.

2. The pharmaceutical tablet of claim 1 containing 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. The pharmaceutical tablet of claim 7 wherein said edge walls define a rectangle.

9. 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 and wherein said tablet has a bisect score on one side of said planar faces and a pair of trisect scores on the opposing planar face.

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

11. A pharmaceutical 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 and wherein said tablet has score lines arranged for both bisecting and trisecting the tablet.

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

13. The pharmaceutical tablet of claim 11 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.

14. The pharmaceutical tablet of claim 11 having a thickness of 0.09 to 0.11 inches.

15. The pharmaceutical tablet of claim 11 containing at least 99% by weight of theophylline and a tableting lubricant.

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

17. The pharmaceutical tablet of claim 15 containing from 0.3% to 0.5% by weight of magnesium stearate as tableting lubricant.

18. The pharmaceutical tablet of claim 11 consisting essentially of 99.6% by weight of theophylline and 0.4% by weight of magnesium stearate.

19. The pharmaceutical tablet of claim 11 containing 300 mg of theophylline.

20. The pharmaceutical tablet of claim 11 having a bisect score line on one of said planar faces and a pair of trisect score lines on the opposing planar face.

21. The pharmaceutical tablet of claim 11 wherein said edge walls define a rectangle.

22. The pharmaceutical tablet of claim 11 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.

23. The pharmaceutical tablet of claim 21 having a thickness of 0.1 inches.
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