.

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

Claims for Patent: 4,517,179

« Back to Dashboard

Claims for Patent: 4,517,179

Title: Rapid dissolving, uniform drug compositions and their preparation
Abstract:Rapid dissolving uniform compositions of low water solubility drugs are formed from a dry mixture of the drug having a reduced particle size in combination with properly selected and sized excipients including microcrystalline cellulose, dibasic calcium phosphate, starches and a lubricant.
Inventor(s): Raghunathan; Yegnasawami (Fairport, NY)
Assignee: Pennwalt Corporation (Philadelphia, PA)
Application Number:06/586,605
Patent Claims: 1. A rapid dissolving pharmaceutical composition prepared from a dry mixture comprising from about 0.05 to 12.5 weight percent of a low solubility drug having a particle size distribution such that the major portion by weight of the particles are less than about 155 .mu.m in diameter, from about 10 to 90 weight percent of microcrystalline cellulose, from about 10 to 90 weight percent of unmilled or coarse milled dibasic calcium phosphate, from about 0.1 to 3.0 percent of lubricant, and from about 1 to 20 weight percent of starch.

2. The composition of claim 1 wherein the drug is metolazone.

3. The composition of claim 1 wherein the lubricant is a fatty acid or a fatty acid salt.

4. The composition of claim 3 wherein 84 percent by weight of the drug particles are less than about 100 .mu.m in diameter.

5. The composition of claim 1 wherein the amount of microcrystalline cellulose ranges from about 40 to 50 weight percent and the amount of dibasic calcium phosphate ranges from about 35 to 50 weight percent.

6. The composition of claim 5 wherein the tablet contains from about 0.25 to 50 mg of drug.

7. The composition of claim 5 wherein the tablet contains from about 0.25 to 2.5 mg. of metolazone.

8. The composition of claim 1 wherein the mixture contains coarse milled dibasic calcium phosphate wherein 50 percent by weight of the dibasic calcium phosphate particles have a diameter of less than about 100 .mu.m.

9. A process for forming rapid dissolving pharmaceutical compositions containing a low solubility drug comprising mixing the drug with microcrystalline cellulose, starch, unmilled or coarse milled dibasic calcium phosphate, and a lubricant so as to form a uniform, free flowing, dry mixture comprising from about 0.05 to 12.5 weight percent of drug having a particle size distribution such that the major portion by weight of the particles are less than about 155 .mu.m in diameter, from about 10 to 90 weight percent microcrystalline cellulose, from about 1 to 20 weight percent starch, from about 10 to 90 weight percent unmilled or coarse milled dibasic calcium phosphate and from about 0.1 to 3.0 weight percent of lubricant and then compressing the mixture to form tablets or filling the mixture into capsules.

10. The process of claim 9 including the step of fine milling the drug prior to mixing.

11. The composition of claim 1 in the form of a compressed tablet.

12. The composition of claim 1 wherein the drug is triamterene.

13. The composition of claim 1 wherein the drug has a particle size distribution such that the major portion by weight of the particles are less than about 100 .mu.m in diameter.

14. The composition of claim 1 wherein the drug has a water solubility at a temperature of about 25.degree. C. of about 1 part by weight or less in 100 parts by weight of water.
« Back to Dashboard

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

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