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Claims for Patent: 5,595,760

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Claims for Patent: 5,595,760

Title: Sustained release of peptides from pharmaceutical compositions
Abstract:The invention features a method of administering a peptide to a patient and delivering the peptide continuously over an extended period of time of at least three days by obtaining a solid pharmaceutical composition including a soluble, gelable salt of the peptide and up to 30 percent, by weight, of a pharmaceutically acceptable, soluble, monomeric carrier, and parenterally administering the solid composition to the patient in one injection, wherein the solid composition automatically forms a gel after interaction with the patient's bodily fluids and releases the peptide continuously within the patient over an extended period of at least three days.
Inventor(s): Cherif-Cheikh; Roland (Issy-les-Moulineaux, FR)
Assignee: Delab (Paris, FR)
Application Number:08/400,610
Patent Claims: 1. A method of administering a peptide to a patient and delivering the peptide continuously over an extended period of time of at least three days, said method comprising

obtaining a solid pharmaceutical composition consisting essentially of a soluble, gelable peptide salt of said peptide and up to 30 percent, by weight, of a pharmaceutically acceptable, soluble, monomeric carrier, wherein said peptide salt and carrier are soluble in aqueous liquids, and

parenterally administering said solid composition to the patient in one injection, wherein said solid composition automatically forms a gel after interaction with the patient's bodily fluids, said gel releasing said peptide continuously within the patient over an extended period of at least three days.

2. A method of claim 1, wherein said solid composition is administered intramuscularly, subcutaneously, or intradermally.

3. A method of claim 1, wherein said peptide is somatostatin or a somatostatin analog.

4. A method of claim 1, wherein said peptide is a soluble luteinizing hormone-releasing hormone (LHRH) analog.

5. A method of claim 1, wherein said peptide is growth hormone releasing factor (GRF), parathyroid hormone (PTH), parathyroid hormone related protein (PTHrp), calcitonin, or a soluble, biologically active analog of GRF, PTH, PTHrp, or calcitonin.

6. A method of claim 1, wherein said solid composition comprises no carrier.

7. A method of claim 1, wherein the carrier is selected from the group consisting of mannitol, sorbitol, or lactose.

8. A method of claim 1, wherein said solid composition is in the form of a cylinder with a diameter of less than 3 mm.

9. A method of claim 1, wherein said gel releases said peptide continuously over a period of at least 14 days.

10. A method of administering a peptide to a patient continuously over an extended period of time of at least three days, said method comprising

obtaining a semisolid suspension consisting essentially of (1) a solid, soluble, gelable peptide salt of said peptide, and up to 30 percent, by weight, of a pharmaceutically acceptable, soluble, monomeric carrier, wherein said peptide salt and carrier are soluble in aqueous solvents; and (2) an aqueous solvent in an amount less than 50 percent of the amount of solvent required to dissolve said peptide salt and to provide said semisolid consistency; and

parenterally administering said semisolid suspension to the patient in one injection, wherein said semisolid suspension automatically forms a gel after interaction with the patient's bodily fluids, said gel releasing said peptide continuously within the patient over an extended period of at least three days.

11. A method of claim 10, wherein said peptide is somatostatin or a somatostatin analog.

12. A method of claim 10, wherein said peptide is a soluble luteinizing hormone-releasing hormone (LHRH) analog.

13. A method of claim 10, wherein said peptide is growth hormone releasing factor (GRF), parathyroid hormone (PTH), parathyroid hormone related protein (PTHrp), calcitonin, or a soluble, biologically active analog of GRF, PTH, PTHrp, or calcitonin.

14. A method of claim 10, wherein said amount of solvent is less than 10 percent of the amount of solvent required to dissolve said peptide salt.

15. A sustained-release gel formed within a patient, said gel comprising

a pharmaceutical composition consisting essentially of a soluble, gelable peptide salt and up to 30 percent, by weight, of a pharmaceutically acceptable, soluble, monomeric carrier, wherein said peptide salt and carrier are soluble in aqueous liquids, and

one or more bodily fluids of the patient, wherein said peptide salt automatically forms said gel after interaction with said bodily fluids, and said gel releases said peptide continuously within the patient over a period of at least three days after formation.

16. A gel of claim 15, wherein said pharmaceutical composition is a solid.

17. A gel of claim 15, wherein said pharmaceutical composition further comprises a solvent in an amount less than 50 percent of the amount of solvent required to dissolve said peptide salt and to provide said pharmaceutical composition with a semisolid consistency.

18. A solid, non-particulate, sustained-release pharmaceutical composition for parenteral administration to a patient, said composition consisting essentially of (1) a soluble, gelable peptide salt, and (2) up to 30 percent, by weight, of a pharmaceutically acceptable, monomeric, soluble carrier, compounded into a solid cylindrical form, wherein said peptide salt and carrier are soluble in aqueous liquids and said solid composition automatically forms a gel after interaction with the patient's bodily fluids, said gel releasing said peptide continuously within the patient over an extended period of at least three days.

19. A composition of claim 18, wherein said peptide is selected from the group consisting of somatostatin or a somatostatin analog; a soluble, hydrophobic luteinizing hormone releasing hormone (LHRH) analog; growth hormone releasing factor (GRF); parathyroid hormone (PTH); parathyroid hormone related protein (PTHrp); calcitonin; or a soluble, biologically active analog of GRF, PTH, PTHrp, or calcitonin.

20. A semisolid, sustained-release pharmaceutical suspension for parenteral administration to a patient, said suspension consisting essentially of

(1) a soluble, gelable peptide salt and up to 30 percent, by weight, of a pharmaceutically acceptable, soluble, monomeric carrier, wherein said peptide salt and said carrier are soluble in aqueous solvents; and

(2) an aqueous solvent in an amount less than 50 percent of the amount of solvent required to dissolve said peptide salt and to provide said semisolid consistency of said suspension, wherein said semisolid suspension automatically forms a gel after interaction with the patient's bodily fluids, said gel releasing said peptide continuously within the patient over an extended period of at least three days.

21. A suspension of claim 20, wherein said amount of solvent is less than 10 percent of the amount of solvent required to dissolve said peptide salt.

22. A suspension of claim 20, wherein said peptide is selected from the group consisting of somatostatin or a somatostatin analog; a soluble, hydrophobic luteinizing hormone releasing hormone (LHRH) analog; growth hormone releasing factor (GRF); parathyroid hormone (PTH); parathyroid hormone related protein (PTHrp); calcitonin; or a soluble, biologically active analog of GRF, PTH, PTHrp, or calcitonin.
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