Claims
- 1. A unit-dose combination composition for the treatment of diabetes comprising:
a high-dose, water-soluble, long-acting, orally active, hypoglycemic, antidiabetic agent; and a low-dose, water-insoluble, short-acting, orally active, hypoglycemic, antidiabetic agent; wherein the low-dose agent and the high-dose agent are released simultaneously from the unit-dose combination composition, and wherein the low-dose agent is released at a rate which is substantially similar to a release rate of the low-dose agent in individual form, and the high-dose agent is released at a rate which is substantially similar to a release rate of the high-dose agent in individual form.
- 2. The composition of claim 1, wherein the high-dose agent comprises a member selected from the group consisting of a biguanide and a pharmaceutically acceptable salt thereof.
- 3. The composition of claim 2, wherein the high-dose agent comprises a member selected from the group consisting of metformin, a pharmaceutically acceptable salt of metformin, buformin, a pharmaceutically acceptable salt of buformin, phenformin, and a pharmaceutically acceptable salt of phenformin.
- 4. The composition of claim 3, wherein the high-dose agent comprises metformin present in an amount of from about 100 mg to about 2000 mg.
- 5. The composition of claim 4, wherein the high-dose agent comprises metformin present in an amount of from about 250 mg to about 1000 mg.
- 6. The composition of claim 1, wherein the low-dose agent comprises a member selected from the group consisting of a meglinitide and a pharmaceutically acceptable salt thereof.
- 7. The composition of claim 6, wherein the low-dose agent comprises a member selected from the group consisting of repaglinide and nateglinide.
- 8. The composition of claim 7, wherein the low-dose agent comprises repaglinide present in an amount of from about 0.20 mg to about 5.0 mg.
- 9. The composition of claim 8, wherein the low-dose agent comprises repaglinide present in an amount of from about 0.5 mg to about 2.0 mg.
- 10. The composition of claim 7, wherein the low-dose agent comprises nateglinide present in an amount of from about 20 mg to about 200 mg.
- 11. The composition of claim 10, wherein the low-dose agent comprises nateglinide present in an amount of from about 60 mg to about 180 mg.
- 12. The composition of claim 1, wherein the low-dose agent is distributed uniformly in the high-dose agent.
- 13. The composition of claim 1, wherein the low-dose agent and the high-dose agent are both in the form of an immediate release formulation.
- 14. The composition of claim 1, wherein the low-dose agent is an immediate-release component and the high-dose agent is a controlled-release component.
- 15. The composition of claim 14, wherein the high-dose agent comprises metformin, and the controlled release of the metformin is achieved by a mechanism selected from the group consisting of osmosis, diffusion, swelling, bioerosion, biodegradation and a combination of any of these principals.
- 16. A method of simultaneously administering repaglinide and metformin to a mammal, said method comprising:
administering to the mammal a unit-dose combination composition comprising repaglinide and metformin, wherein the repaglinide and the metformin are released simultaneously from the unit-dose combination composition, and wherein the repaglinide is released at a rate which is substantially similar to a release rate of the repaglinide in individual form, and the metformin is released at a rate which is substantially similar to a release rate of the metformin in individual form.
- 17. A method of simultaneously administering nateglinide and metformin to a mammal, said method comprising:
administering to the mammal a unit-dose combination composition comprising nateglinide and metformin, wherein the nateglinide and the metformin are released simultaneously from the unit-dose combination composition, and wherein the nateglinide is released at a rate which is substantially similar to a release rate of the nateglinide in individual form, and the metformin is released at a rate which is substantially similar to a release rate of the metformin in individual form.
- 18. A method of treating diabetes mellitus in a patient, said method comprising:
administering to the patient an effective amount of a unit-dose combination composition comprising:
a high-dose, water-soluble, long-acting, orally active, hypoglycemic, antidiabetic agent; and a low-dose, water-insoluble, short-acting, orally active, hypoglycemic, antidiabetic agent; wherein the low-dose agent and the high-dose agent are released simultaneously from the unit-dose combination composition, and wherein the low-dose agent is released at a rate which is substantially similar to a release rate of the low-dose agent in individual form, and the high-dose agent is released at a rate which is substantially similar to a release rate of the high-dose agent in individual form.
REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional Application No. 60/385,786, filed on Jun. 3, 2002.
Provisional Applications (1)
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Number |
Date |
Country |
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60385786 |
Jun 2002 |
US |