.

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: 6,495,157

« Back to Dashboard

Claims for Patent: 6,495,157

Title: Intravaginal clindamycin ovule composition
Abstract:A highly storage-stable composition for vaginal administration of clindamycin is disclosed which is useful for the treatment of bacterial vaginosis. The composition is a vaginal suppository containing an antimicrobially effective amount of clindamycin dispersed in a Hard Fat NF suppository base. Hard Fat NF suppository bases provide a clindamycin product having long term storage stability while providing efficacy against bacterial vaginosis which is equivalent to clindamycin vaginal creams.
Inventor(s): Pena; Lorraine Elisabeth (Kalamazoo, MI), Bowman; Phil Bryan (Kalamazoo, MI), Chao; Robert Shih-Liang (Portage, MI), Pesheck; Carolyn V. (Kalamazoo, MI)
Assignee: Pharmacia & Upjohn Company (Kalamazoo, MI)
Application Number:09/619,930
Patent Claims: 1. A suppository composition for vaginal administration of clindamycin which composition comprises an antimicrobially effective amount of clindamycin, or a pharmaceutically acceptable salt or ester thereof, in the form of drug particles dispersed in a Hard Fat suppository base, wherein the drug particles have a volume median diameter of about 0.5 .mu.m to about 10 .mu.m.

2. The composition of claim 1 wherein the composition contains 10 to 800 mg of clindamycin, or its salt or ester expressed as the free base, whereby said clindamycin, or its salt or ester, is present in said composition in an amount from about 0.1% by weight of the entire composition to about 60% by weight of the entire composition.

3. The composition of claim 2 wherein the composition has a flow point in the range from 30.degree. C. to 40.degree. C.

4. The composition of claim 3 wherein said composition contains 25 to 300 mg of clindamycin, or its salt or ester expressed as the free base, wherein said clindamycin, or its salt or ester, is present in said composition in an amount from about 0.5 % by weight of the entire composition to about 30% by weight of the entire composition.

5. The composition of claim 4 wherein said Hard Fat has a .beta. polymorphic form which has a flow point of 37.degree. C. or less.

6. The composition of claim 5 wherein the Hard Fat is a mixture of glyceride esters of vegetable C.sub.12 -C.sub.18 saturated fatty acids containing more than 50% triglyceride esters.

7. The composition of claim 6 wherein said composition contains 50 to 200 mg of clindamycin, or its salt or ester expressed as the free base, wherein said clindamycin, or its salt or ester, is present in said composition in an amount from about 1.5% by weight of the entire composition to about 10% by weight of the entire composition.

8. The composition of claim 7 wherein the clindamycin is a clindamycin salt or ester.

9. The composition of claim 6 wherein said composition contains 50 to 150 mg of the clindamycin salt or ester expressed as the free base and is present in said composition in an amount from about 1.5% by weight of the entire composition to about 7.5% by weight of the entire composition.

10. The composition of claim 9 wherein the clindamycin is clindamycin phosphate.

11. The composition of claim 1 wherein the Hard Fat is Hard Fat NF grade which has the following additional properties: Open-tube melting point: 31.0-33.0.degree. C. (.alpha. polymorphic form) Solidification point: 30.0-32.5.degree. C. (.alpha. polymorphic form) Hydroxyl value max. 3 mg potassium hydroxide/g Saponification value: 240-250 mg potassium hydroxide/g Diglycerides max. 15% by weight Monoglycerides max 1% by weight.
« 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