.

Pharmaceutical Business Intelligence

  • Anticipate P&T budget requirements
  • Evaluate market entry opportunities
  • Find generic sources and suppliers
  • Predict branded drug patent expiration

► Plans and Pricing

Upgrade to enjoy subscriber-only features like email alerts and data export. See the Plans and Pricing

DrugPatentWatch Database Preview

Details for Patent: 8,507,009

« Back to Dashboard

Details for Patent: 8,507,009

Title:Colonic purgative composition with soluble binding agent
Abstract: This invention relates to novel colonic purgative compositions in a solid dosage form, comprising at least one purgative and at least one soluble, or soluble, nonfermentable binder, such as polyethylene glycol. Further, this invention relates to methods of using the colonic purgative compositions. The present compositions and methods are designed to improve patient tolerance and compliance, while at the same time improving the quality of bowel cleansing. The formulations and methods of this invention are particularly useful to cleanse the bowel prior to diagnostic and surgical procedures and can also be employed in lower dosages as a laxative to promote elimination and/or to relieve constipation.
Inventor(s): Skiendzielewski; Stephen (Norristown, PA), Rose; Martin (Bethesda, MD), Do; Ngoc (Bel Air, MD)
Assignee: Salix Pharmaceuticals, Inc. (Raleigh, NC)
Filing Date:Jan 20, 2010
Application Number:12/690,384
Claims:1. A method of making a solid dosage colonic purgative formulation in a tablet form, comprising: heating a formulation comprising sodium phosphate and polyethylene glycol 8000 to a temperature not exceeding the melting point of the polyethylene glycol; and compressing the formulation into a tablet.

2. The method of claim 1, wherein the formulation comprises monobasic sodium phosphate and dibasic sodium phosphate.

3. The method of claim 1, wherein the method comprises cooling the formulation to below 30.degree. C. prior to compression.

4. The method of claim 3, wherein the method comprises cooling the formulation overnight at room temperature prior to compression.

5. The method of claim 1, wherein the formulation comprises a lubricant.

6. The method of claim 5, wherein the lubricant comprises magnesium stearate.

7. The method of claim 1, wherein the formulation comprises between 7.5% and 15% of polyethylene glycol by weight.

8. The method of claim 1, wherein the formulation comprises about 10% polyethylene glycol by weight.

9. The method of claim 1, wherein each tablet of the formulation comprises about 1100 milligrams of sodium phosphate monobasic.

10. The method of claim 9, wherein each tablet of the formulation comprises about 398 milligrams of sodium phosphate dibasic.

11. The method of claim 10, wherein each tablet of the formulation comprises about 8.4 milligrams of magnesium stearate.

12. A method of making a solid dosage colonic purgative tablet formulation, comprising: heating a formulation comprising 60%-90% sodium phosphate and 5% to 20% polyethylene glycol 8000 to a temperature not exceeding the melting point of polyethylene glycol; allowing the formulation to cool below 30.degree. C.; and compressing the formulation into tablets.

13. The method of claim 12, wherein each of said tablets comprises about 1102 milligrams of sodium phosphate monobasic and about 398 milligrams of sodium phosphate dibasic.

14. The method of claim 12, comprising adding magnesium stearate after the formulation has cooled below 30.degree. C.

15. The method of claim 12, wherein the mixture is allowed to cool down overnight prior to compressing the formulation into tablets.

16. The method of claim 12, wherein each of the tablets comprises about 10% w/w of polyethylene glycol 8000.

17. The method of claim 12, wherein the heating comprises heating the formulation to a temperature of about 54.degree. C. to 55.degree. C.

18. The method of claim 12, wherein the tablets weigh about 1676 mg following compression.

19. The method of claim 12, wherein the formulation comprises about 90% sodium phosphate.

20. The method of claim 12, wherein the formulation comprises about 10% polyethylene glycol 8000.

21. The method of claim 1, wherein the step of heating a formulation comprising sodium phosphate and polyethylene glycol to the melting point of the polyethylene glycol further comprises mixing the formulation at a speed of about 10 rpm to about 100 rpm.

22. The method of claim 12, wherein the step of heating a formulation comprising 60%-90% sodium phosphate and 5% to 20% polyethylene glycol 8000 to a temperature not exceeding the melting point of polyethylene glycol further comprises mixing the formulation at a speed of about 10 rpm to about 100 rpm.
« Back to Dashboard

For more information try a trial or see the database preview and plans and pricing

How are People Using DrugPatentWatch?

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

`abc