# US 10,441,592 B2 · Pharmaceutical formulations and uses thereof in the treatment of female sexual dysfunction

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- Number: US 10,441,592 B2
- Document ID: US10441592B2
- Status: Granted
- Kind: B2
- Application number: 15/620,576
- Filed: 2017-06-12
- Published: 2017-09-28
- Granted: 2019-10-15
- Earliest claimed: 2004-05-11
- Assignees: Eb IP Lybrido B.V.
- Applicants: Eb IP Lybrido B.V.
- Inventors: Jan Johan Adriaan Tuiten
- Web page: https://patentgrep.com/patent/US10441592B2

## CPC

- 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 9/006: {Oral mucosa, e.g. mucoadhesive forms, sublingual droplets; Buccal patches or films; Buccal sprays}
- A61K 31/4985: Pyrazines or piperazines ortho- or peri-condensed with heterocyclic ring systems
- A61K 31/519: ortho- or peri-condensed with heterocyclic rings
- A61K 31/53: having six-membered rings with three nitrogens as the only ring hetero atoms, e.g. chlorazanil, melamine (melarsoprol A61K31/555 {; with four nitrogen atoms A61K31/495})
- A61K 31/724: Cyclodextrins
- A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
- A61K 47/40: Cyclodextrins; Derivatives thereof
- A61P 5/26: Androgens
- A61P 15/00: Drugs for genital or sexual disorders (for disorders of sex hormones A61P5/24); Contraceptives
- A61P 15/08: for gonadal disorders or for enhancing fertility, e.g. inducers of ovulation or of spermatogenesis
- A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
- G16H 20/10: relating to drugs or medications, e.g. for ensuring correct administration to patients
- G16H 70/40: relating to drugs, e.g. their side effects or intended usage
- 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
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA

## Abstract

The present invention relates to the use of a combination of a PDE5-inhibitor and testosterone for the preparation of a medicament for the treatment of Female Sexual Dysfunction.

## Claims

### Claim 1

A pharmaceutical formulation comprising testosterone or dihydrotestosterone (DHT) and a PDE5 inhibitor, wherein said testosterone provides a peak level in the patient's blood circulation of free testosterone or DHT of at least 0.010 nmol/l and
wherein said formulation is designed to release the testosterone within a time interval of 120 seconds upon administration and wherein said PDE5-inhibitor is released 1.5-4.5 hours after the testosterone or DHT is released.

### Claim 2 (depends on 1)

The pharmaceutical formulation according to claim 1, wherein the testosterone or DHT is provided in the form of a sublingual formulation.

### Claim 3 (depends on 2)

The pharmaceutical formulation according to claim 2, wherein said sublingual formulation further comprises cyclodextrin.