NZ739195B2 - Drospirenone-based contraceptive for a female patient affected with excess weight - Google Patents
Drospirenone-based contraceptive for a female patient affected with excess weightInfo
- Publication number
- NZ739195B2 NZ739195B2 NZ739195A NZ73919516A NZ739195B2 NZ 739195 B2 NZ739195 B2 NZ 739195B2 NZ 739195 A NZ739195 A NZ 739195A NZ 73919516 A NZ73919516 A NZ 73919516A NZ 739195 B2 NZ739195 B2 NZ 739195B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- drospirenone
- daily active
- daily
- amount
- active dosage
- Prior art date
Links
- METQSPRSQINEEU-UHFFFAOYSA-N dihydrospirorenone Natural products CC12CCC(C3(CCC(=O)C=C3C3CC33)C)C3C1C1CC1C21CCC(=O)O1 METQSPRSQINEEU-UHFFFAOYSA-N 0.000 title claims abstract 16
- METQSPRSQINEEU-HXCATZOESA-N drospirenone Chemical compound C([C@]12[C@H]3C[C@H]3[C@H]3[C@H]4[C@@H]([C@]5(CCC(=O)C=C5[C@@H]5C[C@@H]54)C)CC[C@@]31C)CC(=O)O2 METQSPRSQINEEU-HXCATZOESA-N 0.000 title claims abstract 16
- 229960004845 drospirenone Drugs 0.000 title claims abstract 16
- 239000003433 contraceptive agent Substances 0.000 title claims abstract 5
- 230000002254 contraceptive effect Effects 0.000 title claims abstract 5
- 239000004615 ingredient Substances 0.000 claims abstract 2
- 238000000034 method Methods 0.000 claims 16
- 238000004806 packaging method and process Methods 0.000 claims 5
- 229940068196 placebo Drugs 0.000 claims 2
- 239000000902 placebo Substances 0.000 claims 2
- 208000008589 Obesity Diseases 0.000 claims 1
- 239000007894 caplet Substances 0.000 claims 1
- 239000002775 capsule Substances 0.000 claims 1
- 238000007922 dissolution test Methods 0.000 claims 1
- 229940011871 estrogen Drugs 0.000 claims 1
- 239000000262 estrogen Substances 0.000 claims 1
- 239000008187 granular material Substances 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 235000020824 obesity Nutrition 0.000 claims 1
- 239000002245 particle Substances 0.000 claims 1
- 239000006187 pill Substances 0.000 claims 1
- 239000003826 tablet Substances 0.000 claims 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/56—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids
- A61K31/58—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin
- A61K31/585—Compounds containing cyclopenta[a]hydrophenanthrene ring systems; Derivatives thereof, e.g. steroids containing heterocyclic rings, e.g. danazol, stanozolol, pancuronium or digitogenin containing lactone rings, e.g. oxandrolone, bufalin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/18—Feminine contraceptives
Abstract
Drospirenone as the sole contraceptive ingredient comprised in a daily active dosage unit in an amount of at least 3 mg for use as a contraceptive for a female patient with a BMI over 30
Claims (14)
1. A method of providing contraception to a female patient affected with obesity, the method comprising treating the patient with drospirenone as the sole contraceptive ingredient comprised in a daily active dosage unit in an amount of at least 3 mg drospirenone, wherein the female patient has a BMI of 30 kg/m or greater.
2. The method according to claim 1, wherein the daily active dosage unit is comprised within a contraceptive kit comprising one or more packaging units wherein each packaging unit comprises 21 to 28 daily active dosage units and wherein: a. the amount of drospirenone in each daily active dosage unit is at least 3 mg without estrogen, and b. each daily active dosage unit comprises drospirenone in a form such that: i. no more than 50% of the drospirenone initially present in the said daily active dosage unit is dissolved within 30 minutes and ii. at least 50% of the said drospirenone is dissolved in a time range from 3 hours to 4 hours, when the daily active dosage unit is subjected to an in vitro dissolution test according to the USP XXIII Paddle Method, the percentages of drospirenone being related to the amount of drospirenone initially present in the said daily active dosage unit.
3. The method according to claim 1 or claim 2, wherein the amount of drospirenone in each daily active unit dosage ranges from about 3.5 mg to 4.5 mg.
4. The method according to claim 2 or claim 3, wherein the one or more packaging units further comprise from 1 to 7 daily dosage units of a pharmaceutically acceptable placebo.
5. The method according to any one of claims 2 to 4, wherein each packaging unit comprises 24 daily active dosage units.
6. The method according to any one of claims 2 to 5, wherein each packaging unit comprises 4 daily placebo dosage units.
7. The method according to any one of claims 1 to 6, wherein the drospirenone is in a crystalline form.
8. The method according to any one of claims 1 to 7, wherein the drospirenone is in a non-micronized form.
9. The method according to any one of claims 1 to 8, wherein the drospirenone has a d of less than 70 µm.
10. The method according to any one of claims claim 1 to 9, wherein the drospirenone in a particle form has a specific surface area from about 2,000 cm /g to about 8,500 cm /g.
11. The method according to any one of claims 1 to 10, wherein the daily active dosing unit comprises drospirenone in an amount of 4 mg.
12. The method according to any one of claims 1 to 11, wherein the daily active dosing unit is in a galenic form suitable for oral administration.
13. The method according to claim 12, wherein the galenic form suitable for oral administration is selected from tablets, capsules, granules, caplets and pills.
14. A method according to any one of claims 1 to 13, substantially as herein described with reference to any example thereof.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN201510348953.1A CN106265694A (en) | 2015-06-23 | 2015-06-23 | Drospirenone-based contraceptives for overweight female patients |
| EP15305965.4A EP3108889A1 (en) | 2015-06-23 | 2015-06-23 | Drospirenone-based contraceptive for a female patient affected with excess weight |
| PCT/EP2016/064574 WO2016207298A1 (en) | 2015-06-23 | 2016-06-23 | Drospirenone-based contraceptive for a female patient affected with excess weight |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| NZ739195A NZ739195A (en) | 2024-04-26 |
| NZ739195B2 true NZ739195B2 (en) | 2024-07-30 |
Family
ID=
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