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 μm to about 10 μm.
- 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° C. to 40° 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 β polymorphic form which has a flow point of 37° C. or less.
- 6. The composition of claim 5 wherein the Hard Fat is a mixture of glyceride esters of vegetable C12-C18 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° C. (α polymorphic form) Solidification point: 30.0-32.5° C. (α 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.
CROSS REFERENCE TO RELATED APPLICATIONS
The present patent application claims the benefit of the following provisional application: U.S. Serial No. 60/147,561, filed Aug. 6, 1999, under 35 USC 119(e)(i).
Foreign Referenced Citations (1)
Number |
Date |
Country |
WO-9744032 |
Nov 1997 |
WO |
Provisional Applications (1)
|
Number |
Date |
Country |
|
60/147561 |
Aug 1999 |
US |