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Claims for Patent: 6,495,534

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Claims for Patent: 6,495,534

Title: Stabilized aqueous suspensions for parenteral use
Abstract:A pharmaceutical aqueous suspension formulation for parenteral administration having substantially stabilized pH, comprising a biologically active compound and a pH controlling effective concentration of L-Methionine. Preferably, the biologically active compound is a steroidal compound, for instance exemestane, medroxyprogesterone acetate and estradiol cypionate or a combination of medroxyprogesterone acetate and estradiol cypionate.
Inventor(s): Colombo; Giuseppe (Milan, IT), Martini; Alessandro (Milan, IT), Fox; Lloyd E. (Richland, MI)
Assignee: Pharmacia & Upjohn SpA (Milan, IT) Pharmacia & Upjohn Company (Kalamazoo, MI)
Application Number:09/571,395
Patent Claims: 1. A pharmaceutical aqueous suspension formulation for parenteral administration having substantially stabilized pH comprising a biologically active steroidal compound and a pH controlling effective concentration of L-Methionine.

2. A pharmaceutical formulation according to claim 1, wherein the pH controlling effective concentration of L-Methionine is from about 0.005% w/v or w/w to about 5% w/v or w/w.

3. A pharmaceutical composition according to claim 1, wherein the pH range of the formulation is from about pH3.0 to about pH8.0.

4. A pharmaceutical composition according to claim 3, wherein the biologically active steroidal compound is exemestane, medroxyprogesterone acetate or estradiol cypionate or a mixture of medroxyprogesterone acetate and estradiol cypionate.

5. A pharmaceutical aqueous suspension formulation for parenteral administration having substantially stabilized pH, comprising a biologically active steroidal compound, a buffering agent and L-Methionine in concentrations effective to produce a pH controlling superadditive effect.

6. A pharmaceutical composition according to claim 5, wherein the buffering agent is a phosphoric acid salt in a concentration lower than 0.4% w/v or w/w.

7. A pharmaceutical composition according to claim 6, wherein the concentration of the phosphoric acid salts is lower than 0.2% w/v or w/w.

8. A pharmaceutical composition according to claim 7 wherein the pH range of the formulation is from about pH 3.0 to about pH 8.0.

9. A pharmaceutical composition according to claim 1 wherein the biologically active steroidal compound is at least one compound selected from the group consisting of medroxyprogesterone acetate, exemestane, estradiol cypionate, methylprednisolone acetate, oxabolone cypionate, clostebol acetate and testosterone cypionate or a pharmaceutical acceptable salt thereof.

10. A pharmaceutical formulation according to claim 3 wherein the biologically active steroidal compound is medroxyprogesterone acetate.

11. A pharmaceutical formulation according to claim 3 wherein the biologically active steroidal compound is methylprednisolone acetate.

12. A pharmaceutical formulation according to claim 3 wherein the biologically active steroidal compound is exemestane.

13. A pharmaceutical formulation according to claim 3 wherein the biologically active steroidal compound is a mixture of medroxyprogesterone acetate and estradiol cypionate.

14. A pharmaceutical formulation according to claim 10 wherein the concentration of medroxyprogesterone acetate is about 1% w/v to about 40% w/v.

15. A pharmaceutical formulation according to claim 12 wherein the concentration of exemestane is about 1% w/v to about 25% w/v.

16. A pharmaceutical formulation according to claim 13 wherein the concentration of medroxyprogesterone acetate is from about 1% w/v to 40% w/v and the concentration of estradiol cypionate is from about 0.1% w/v to about 5% w/v.

17. A pharmaceutical formulation according to claim 1 containing at least one material selected from the group consisting of surfactants, suspending agents, thickening agents and density adjusting agents.

18. A pharmaceutical formulation according to claim 1 containing a preservative selected from the group consisting of phenol, chlorobutanol, benzylalcohol, methyl paraben, propyl paraben, benzalkonium chloride and cetylpyridinium chloride.

19. A pharmaceutical formulation according to claim 1 containing an antioxidant selected from the group consisting of ascorbic acid, erythorbic acid, sodium ascorbate, thioglycerol, cysteine, acetylcysteine, cystine, dithioerythreitol, dithiothreitol, gluthathione, tocopherols, butylated hydroxyanisole, butylated hydroxytoluene, sodium bisulfite, acetone sodium bisulfite, sodium metabisulfite, sodium sulfite, sodium formaldehyde sulfoxylate, sodium thiolsulfate and nordihydroguaiareticacid.

20. Process for the preparation of a pharmaceutical aqueous suspension formulation having substantially stabilized pH, for parenteral administration of a biologically active steroidal compound, comprising adding a pH controlling effective concentration of L-Methionine thereto.

21. A process for the preparation of a pharmaceutical aqueous suspension formulation having substantially stabilized pH, for parenteral administration of biologically active steroidal compound, comprising adding L-Methionine and a buffering agent thereto in concentrations effective to produce a pH controlling superadditive effect.
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