.

Make Better Decisions

  • Analyze global market entry opportunities
  • Identify first generic entrants
  • Obtain formulation and manufacturing information

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

Serving leading biopharmaceutical companies globally:

Covington
Cipla
Julphar
Boehringer Ingelheim
Mallinckrodt
Fish and Richardson
US Army
Argus Health
Novartis
Harvard Business School

Generated: November 23, 2017

DrugPatentWatch Database Preview

Details for Patent: ► Subscribe

« Back to Dashboard

Details for Patent: ► Subscribe

Title: Pharmaceutical excipient having improved compressibility
Abstract:A microcrystalline cellulose-based excipient having improved compressibility, whether utilized in direct compression, dry granulation or wet granulation formulations, is disclosed. The excipient is an agglomerate of microcrystalline cellulose particles and from about 0.1% to about 20% silicon dioxide particles, by weight of microcrystalline cellulose, wherein the microcrystalline cellulose and silicon dioxide are in intimate association with each other. The silicon dioxide utilized in the novel excipient has a particle size from about 1 nanometer to about 100 microns. Most preferably, the silicon dioxide is a grade of colloidal silicon dioxide. An extra low moisture excipient is provided which exhibits improved compressibility as compared to conventional microcrystalline cellulose, while providing a moisture content of from about 0.5 to 2.5% LOD, preferably between about 0.5 and about 1.8%, more preferably between 0.8 and 1.5%, and most preferably between about 0.8 and about 1.2 %.
Inventor(s): Staniforth; John N. (Bath, GB), Sherwood; Bob E. (Amenia, NY), Hunter; Edward A. (Cadosia, NY)
Assignee: Edward Mendell Co., Inc. (Patterson, NY)
Filing Date:Aug 27, 1999
Application Number:09/384,130
Claims:1. A method for preparing a pharmaceutical excipient, comprising: forming an aqueous slurry containing a mixture of microcrystalline cellulose in the form of a wet cake and silicon dioxide having a surface area from about 10 m.sup.2 /g to about 500 m.sup.2 /g, wherein said slurry comprises from about 0.5% to about 25% by weight microcrystalline cellulose in the form of a wet cake; and drying said slurry to obtain an excipient comprising a plurality of agglomerated particles of microcrystalline cellulose and said silicon dioxide, the amount of silicon dioxide being from about 0.1% to about 20% relative to the amount of microcrystalline cellulose, by weight.

2. The method of claim 1, wherein said slurry contains from about 15% to about 20% microcrystalline cellulose in the form of a wet cake.

3. The method of claim 1, wherein said slurry contains from about 17% to about 19% microcrystalline cellulose in the form of a wet cake.

4. The method of claim 1, wherein said silicon dioxide is colloidal silicon dioxide.

5. The method of claim 1, wherein said drying further comprises drying the slurry of microcrystalline cellulose and silicon dioxide by a method selected from the group consisting of flash drying, ring drying, spray drying, and micron drying.

6. The method of claim 1, wherein said drying further comprises drying said slurry of microcrystalline cellulose and silicon dioxide by spray drying.

7. The method of claim 1, wherein said drying further comprises drying said slurry to obtain excipient particles having an average particle size from about 10 .mu.m to about 1,000 .mu.m.

8. The method of claim 1, wherein said drying further comprises drying said slurry to obtain excipient particles having a particle size of from about 10 .mu.m to about 500 .mu.m.

9. The method of claim 1, wherein said drying further comprises drying said slurry to obtain excipient particles having a moisture content of from about 0.5 to about 15%.

10. The method of claim 1, wherein said drying further comprises drying said slurry to obtain excipient particles having a moisture content of from about 0.5 to about 2.5%.

11. The method of claim 1, wherein said drying further comprises drying said slurry to obtain excipient particles having a moisture content of from about 0.5 to about 1.8%.

12. The method of claim 1, wherein said drying further comprises drying said slurry to obtain excipient particles having a moisture content of from about 0.8 to about 1.5%.

13. The method of claim 1, wherein said drying further comprises drying said slurry to obtain excipient particles having a moisture content of from about 0.8 to about 1.2%.

14. The method of claim 1, wherein said drying further comprises drying said slurry to obtain excipient particles having a particle size of from about 30 .mu.m to about 250 .mu.m.

15. The method of claim 1, further comprising adding an additional material to said slurry, said material being selected from the group consisting of non-silicon metal oxides starches, starch derivatives, surfactants, polyalkylene oxides, celluloses, cellulose ethers, and mixtures thereof.

16. A method for preparing a pharmaceutical excipient, comprising: forming an aqueous slurry containing a mixture of microcrystalline cellulose in the form of a wet cake and silicon dioxide having an average primary particle size from about 1 nm to about 100 .mu.m, wherein said slurry comprises from about 0.5% to about 25% by weight microcrystalline cellulose in the form of a wet cake, the solids content of said slurry being from about 0.5% to about 25%, by weight; and, drying said slurry to obtain an excipient comprising a plurality of agglomerated particles of microcrystalline cellulose and silicon dioxide, the amount of silicon dioxide being from about 0.1% to about 20% relative to the amount of microcrystalline cellulose, by weight.

17. The method of claim 16, wherein said slurry contains from about 15% to about 20% microcrystalline cellulose in the form of a wet cake.

18. The method of claim 16, wherein said slurry contains from about 17% to about 19% microcrystalline cellulose in the form of a wet cake.

19. The method of claim 16, wherein said silicon dioxide is colloidal silicon dioxide.

20. The method of claim 16, wherein said drying further comprises drying the slurry of microcrystalline cellulose and silicon dioxide by a method selected from the group consisting of flash drying, ring drying, spray drying, and micron drying.

21. The method of claim 1, wherein said drying further comprises drying the slurry by a method selected from the group consisting of flash drying, ring drying, spray drying, fluid bed drying, micron drying, and combinations thereof.

22. The method of claim 1, wherein said drying further comprises drying the slurry by a method selected from the group consisting of flash drying, ring drying, spray drying, fluid bed drying, micron drying, and combinations thereof.

23. The method of claim 16, wherein said drying further comprises drying said slurry such that the resultant excipient particles have a moisture content of from about 0.5 to about 2.5%.

24. The method of claim 16 wherein said drying further comprises drying said slurry such that the resultant excipient particles have a moisture content of from about 0.5 to about 1.8%.

25. The method of claim 16, wherein said drying further comprises drying said slurry such that the resultant excipient particles have a moisture content of from about 0.8 to about 1.5%.

26. The method of claim 16, wherein said drying further comprises drying said slurry such that the resultant excipient particles have a moisture content of from about 0.8 to about 1.2%.
« Back to Dashboard

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

Serving leading biopharmaceutical companies globally:

Teva
Deloitte
Mallinckrodt
UBS
Chinese Patent Office
Daiichi Sankyo
Merck
Boehringer Ingelheim
Queensland Health
AstraZeneca

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.

Copyright 2002-2017 thinkBiotech LLC
ISSN: 2162-2639

Secure SSL Encrypted
Privacy and Cookies
Terms & Conditions

Follow DrugPatentWatch:



Google
Twitter
Google Plus
botpot