# US 2017/0281645 A1 · Steroid hormone pharmaceutical composition

> Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt

- Number: US 2017/0281645 A1
- Document ID: US20170281645A1
- Status: Published application
- Kind: A1
- Application number: 15/473,733
- Filed: 2017-03-30
- Published: 2017-10-05
- Earliest claimed: 2016-04-01
- Assignees: TherapeuticsMD, Inc.
- Applicants: TherapeuticsMD, Inc.
- Inventors: Annette SHADIACK; Peter H.R. PERSICANER; Philip B. INSKEEP; Thorsteinn THORSTEINSSON; Frederick D. SANCILIO; Jason D. LEGASSIE
- Web page: https://patentgrep.com/patent/US20170281645A1

## CPC

- A61K 31/57: substituted in position 17 beta by a chain of two carbon atoms, e.g. pregnane or progesterone
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- A61K 9/1075: {Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers (A61K9/0026 takes precedence)}
- A61K 9/4858: {Organic compounds}
- A61K 9/4866: {Organic macromolecular compounds}
- A61K 9/4875: {Compounds of unknown constitution, e.g. material from plants or animals (oils, fats, waxes, shellac A61K9/4858)}
- A61K 31/565: not substituted in position 17 beta by a carbon atom, e.g. estrane, estradiol
- A61K 47/06: Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- A61K 47/22: Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
- A61K 47/26: Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
- A61K 47/44: Oils, fats or waxes according to two or more groups of A61K47/02-A61K47/42; Natural or modified natural oils, fats or waxes, e.g. castor oil, polyethoxylated castor oil, montan wax, lignite, shellac, rosin, beeswax or lanolin (synthetic glycerides, e.g. medium-chain triglycerides, A61K47/14)
- A61P 5/24: of the sex hormones
- A61P 5/34: Gestagens
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/12: for climacteric disorders
- A61P 19/10: for osteoporosis
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS

## Abstract

This disclosure provides a novel pharmaceutical composition for delivering steroid hormones to a patient in need thereof.

## Claims

### Claim 1

A pharmaceutical composition suitable for administering a steroid hormone to a subject in need thereof, the pharmaceutical composition comprising a steroid hormone, a lipophilic surfactant system comprising a first lipophilic surfactant and a second lipophilic surfactant, wherein the first and second lipophilic surfactants are different from each other, a hydrophilic surfactant system comprising first and second hydrophilic surfactants, and an optional terpene, wherein the pharmaceutical composition is completely or substantially free of fractionated vegetable oils.

### Claim 2 (depends on 1)

The pharmaceutical composition of claim 1, wherein the first lipophilic surfactant is a first partial triglyceride and wherein the second lipophilic surfactant is a second partial triglyceride.

### Claim 3 (depends on 2)

The pharmaceutical composition of claim 2, wherein the first and second partial triglycerides are selected from the group consisting of IMWITOR 988, IMWITOR 742, IMWITOR 308, CAPMUL MCM NF, CAPMUL 708G, and glyceryl dilaurate.

### Claim 4 (depends on 3)

The pharmaceutical composition of claim 3, wherein the first partial triglyceride is CAPMUL MCM NF and the second partial triglyceride is CAPMUL 708G and wherein the first hydrophilic surfactant is a polyoxyethylene sorbitan fatty acid derivative.

### Claim 5 (depends on 4)

The pharmaceutical composition of claim 4, wherein the polyoxyethylene sorbitan fatty acid derivative is TWEEN 20 or TWEEN 80.

### Claim 6 (depends on 4)

The pharmaceutical composition of claim 4, wherein the second hydrophilic surfactant is a castor oil or hydrogenated castor oil ethoxylate.

### Claim 7 (depends on 6)

The pharmaceutical composition of claim 6, wherein the castor oil or hydrogenated castor oil ethoxylate is CREMOPHOR EL, CREMOPHOR RH40, ETOCAS 40, CRODURET 60, or KOLLIPHOR HS 15.

### Claim 8 (depends on 7)

The pharmaceutical composition of claim 7, wherein the castor oil or hydrogenated castor oil ethoxylate is CREMOPHOR RH40.

### Claim 9 (depends on 1)

The pharmaceutical composition of claim 1, wherein the second hydrophilic surfactant is TPGS.

### Claim 10 (depends on 1)

The pharmaceutical composition of claim 1, wherein the terpene is not optional and is d-limonene.

### Claim 11 (depends on 1)

The pharmaceutical composition of claim 1, wherein the steroid hormone is progesterone and wherein the progesterone is fully solubilized.

### Claim 12 (depends on 1)

A method of treating a disease or condition associated with reduced progesterone levels, the method comprising administering to a subject in need thereof a pharmaceutical composition according to claim 1.

### Claim 13 (depends on 12)

The method of claim 12, wherein the first lipophilic surfactant is a first partial triglyceride and wherein the second lipophilic surfactant is a second partial triglyceride.

### Claim 14 (depends on 13)

The method of claim 13, wherein the first and second partial triglycerides are selected from the group consisting of IMWITOR 988, IMWITOR 742, IMWITOR 308, CAPMUL MCM NF, CAPMUL 708G, and glyceryl dilaurate.

### Claim 15 (depends on 14)

The method of claim 14, wherein the first partial triglyceride is CAPMUL MCM NF and the second partial triglyceride is CAPMUL 708G and wherein the first hydrophilic surfactant is a polyoxyethylene sorbitan fatty acid derivative.

### Claim 16 (depends on 15)

The method of claim 15, wherein the polyoxyethylene sorbitan fatty acid derivative is TWEEN 20 or TWEEN 80.

### Claim 17 (depends on 15)

The method of claim 15, wherein the second hydrophilic surfactant is a castor oil or hydrogenated castor oil ethoxylate.

### Claim 18 (depends on 17)

The method of claim 17, wherein the castor oil or hydrogenated castor oil ethoxylate is CREMOPHOR EL, CREMOPHOR RH40, ETOCAS 40, CRODURET 60, or KOLLIPHOR HS 15.

### Claim 19 (depends on 18)

The method of claim 18, wherein the castor oil or hydrogenated castor oil ethoxylate is CREMOPHOR RH40.

### Claim 20 (depends on 15)

The method of claim 15, wherein the second hydrophilic surfactant is TPGS.

### Claim 21 (depends on 12)

The method of claim 12, wherein the terpene is not optional and is d-limonene.

### Claim 22 (depends on 12)

The method of claim 12, wherein the disease or condition associated with reduced progesterone levels is selected from the group consisting of menopause, endometrial hyperplasia; secondary amenorrhea; prevention of preterm birth; and osteoporosis.