# US 11,304,960 B2 · Steroidal compositions

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- Number: US 11,304,960 B2
- Document ID: US11304960B2
- Status: Granted
- Kind: B2
- Application number: 12/350,930
- Filed: 2009-01-08
- Published: 2010-07-08
- Granted: 2022-04-19
- Earliest claimed: 2009-01-08
- Applicants: Chandrashekar Giliyar; Nachiappan Chidambaram; Mahesh V. Patel; Srinivasan Venkateshwaran
- Inventors: Chandrashekar Giliyar; Nachiappan Chidambaram; Mahesh V. Patel; Srinivasan Venkateshwaran
- Web page: https://patentgrep.com/patent/US11304960B2

## CPC

- A61K 31/569: substituted in position 17 alpha, e.g. ethisterone
- A61K 9/0053: {Mouth and digestive tract, i.e. intraoral and peroral administration}
- 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 31/568: substituted in positions 10 and 13 by a chain having at least one carbon atom, e.g. androstanes, e.g. testosterone
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/14: Esters of carboxylic acids, e.g. fatty acid monoglycerides, medium-chain triglycerides, parabens or PEG fatty acid esters
- 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 5/26: Androgens
- A61P 15/10: for impotence
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- 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

Provided herein are steroid containing compositions suitable for providing therapeutically effective amounts of at least one steroid to individuals. Also provided herein are compositions comprising testosterone and/or testosterone derivatives suitable for providing therapeutically effective and safe amounts of testosterone over periods of time. Further provided are methods of treating andro- and/or testosterone deficiency in individuals by administering to the individuals compositions described herein.

## Claims

### Claim 1

An oral pharmaceutical composition comprising: (i) testosterone undecanoate at about 15 weight/weight percent (w/w %) of said pharmaceutical composition; (ii) a lipophilic carrier comprising glyceryl monolinoleate said lipophilic carrier present at 50-70 w/w % of the pharmaceutical composition; (iii) 10-20 w/w % of polyoxl 40 hydrogenated castor oil; and (iv) a solidifying agent; wherein said pharmaceutical composition is a jelly, solid, semi-solid or paste-like.

### Claim 2 (depends on 1)

The oral pharmaceutical composition of claim 1, providing a plasma testosterone concentration in the range of about 250 ng/dL to about 1200 ng/dL at steady state when orally administered as one or multiple unit dosage forms, twice daily with a meal to a hypogonadal male.