Medroxyprogesterone acetate injectable compositions and methods of use

11911,500

17/489982

September 30, 2021

The disclosure is directed to medroxyprogesterone compositions suitable for subcutaneous injection comprising about 360 mg/ml to 440 mg/ml medroxyprogesterone acetate, 1.35 mg/ml to 1.65 mg/ml docusate sodium, polyethylene glycol, and water. Methods of using these compositions are also described.

Family Health International (Durham, NC, US)

Family Health International (Durham, NC, US)

1. A method for preventing pregnancy or for treating endometriosis-associated pain, renal carcinoma, or endometrial carcinoma in a female patient comprising subcutaneously administering to the patient a composition comprising medroxyprogesterone acetate at a concentration of about 360 mg/ml to 440 mg/ml, docusate sodium at a concentration of about 1.35 mg/ml to 1.65 mg/ml, polyethylene glycol, and water.

2. The method according to claim 1 , wherein the composition is administered once every four months.

3. The method according to claim 1 , wherein the composition is administered once every five months.

4. The method according to claim 1 , wherein the composition is administered once every six months.

5. The method according to claim 1 , wherein the polyethylene glycol is at a concentration of about 18 mg/ml to 23 mg/ml.

6. The method according to claim 1 , wherein the polyethylene glycol is polyethylene glycol 3350.

7. The method according to claim 1 , wherein the composition further comprises a sulfate salt or a sodium salt.

8. The method according to claim 7 , wherein the sulfate salt is sodium sulfate and the sodium salt is sodium chloride.

9. The method according to claim 1 , wherein the composition further comprises a stabilizer.

10. The method according to claim 9 , wherein the stabilizer is methionine.

11. The method according to claim 9 , wherein the stabilizer is thioglycerol, monothioglycerol, lipoic acid, propyl gallate, cysteine, sodium formaldehyde sulfoxylate, or dihydrolipoic acid.

12. The method according to claim 1 , wherein the composition further comprises a buffering salt.

13. The method according to claim 12 , wherein the buffering salt is a phosphate salt or a combination of phosphate salts.

14. The method according to claim 13 , wherein the buffering salt is monobasic sodium phosphate, dibasic sodium phosphate, or a combination thereof.

15. The method according to claim 1 , wherein the composition is in a form of a single unit dose.

16. The method according to claim 1 , wherein the composition has a pH of about 4.0 to about 7.0.

17. The method according to claim 1 , wherein the composition has a pH of 6.6 to 6.7.

18. The method according to claim 1 , wherein the composition comprises sodium sulfate, methionine, monobasic sodium phosphate, and dibasic sodium phosphate.

19. The method according to claim 1 , wherein the composition is in the form of an aqueous suspension.

20. The method according to claim 1 , wherein the composition is for extended release up to 6 months, comprising medroxyprogesterone acetate at a concentration of about 360 mg/ml to 440 mg/ml, docusate sodium at a concentration of about 1.35 mg/ml to 1.65 mg/ml, polyethylene glycol 3350 at a concentration of about 18 mg/ml to 23 mg/ml, sodium sulphate, and methionine in an aqueous suspension.

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Anonymous: “depo-subQ provera 104 medroxyprogesterone acetate injectable suspension 104 mg/0.65 ml”, Jan. 1, 2015 (Jan. 1, 2015), XP55374545, Retrieved from the Internet: URL:https://dailymed.nlm.nih.gov/dailymed/archives/fdaDrugInfo.cfm? archiveid=168634 [retrieved on May 19, 2017]. cited by applicant
Docusate Sodium, A pharmaceutical Guide of Excipients, https://www.pharmaexcipients.com/news/docusate-sodium-a-pharmaceutical-grade-excipient/, 2017 (Year: 2017). cited by applicant

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