# US 10,369,190 B2 · Non-protein clostridial toxin compositions

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- Number: US 10,369,190 B2
- Document ID: US10369190B2
- Status: Granted
- Kind: B2
- Application number: 15/703,527
- Filed: 2017-09-13
- Published: 2018-03-15
- Granted: 2019-08-06
- Earliest claimed: 2016-09-13
- Assignees: Allergan, Inc.
- Applicants: Allergan, Inc.
- Inventors: Maurice Abiad; Bhas Dani; Evgenyi Shalaev
- Web page: https://patentgrep.com/patent/US10369190B2

## CPC

- A61K 38/4893: {Botulinum neurotoxin (3.4.24.69)}
- A61K 9/0019: {Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner (non-active ingredients are additionally classified in A61K47/00)}
- A61K 9/19: lyophilised {, i.e. freeze-dried, solutions or dispersions (lyophilised products with subsequent particle size reduction A61K9/14; granules or pellets made by lyphilisation A61K9/1682; solid oral dosage forms made by lyophilisation A61K9/2095; lyophilisation additives A61K47/00)}
- A61K 38/164: {from bacteria}
- A61K 38/48: acting on peptide bonds (3.4)
- A61K 47/10: Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
- A61K 47/183: {Amino acids, e.g. glycine, EDTA or aspartame}
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- 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
- A61P 9/06: Antiarrhythmics
- A61P 13/00: Drugs for disorders of the urinary system
- A61P 21/00: Drugs for disorders of the muscular or neuromuscular system
- A61P 25/24: Antidepressants
- A61P 29/00: Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
- Y02A 50/30: Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
- 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
- Y02A: TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE

## Abstract

Pharmaceutical compositions that stabilize a Clostridial toxin active ingredient are described. The compositions can be liquid or solid compositions, and comprise a surfactant and an antioxidant. In some embodiments, the compositions comprise a surfactant selected from a poloxamer and a polysorbate; an antioxidant selected from methionine, N-acetyl cysteine, ethylenediaminetetraacetic acid and combinations thereof, and, optionally, a tonicity agent and/or a lyoprotector selected from, for example, trehalose, sucrose.

## Claims

### Claim 1

A lyophilized pharmaceutical composition comprising a Clostridial toxin active ingredient, 8 w/w % trehalose, 4 w/w % poloxamer 188 and 0.2 w/w % methionine.

### Claim 2 (depends on 1)

The lyophilized pharmaceutical composition of claim 1, wherein the Clostridial toxin active ingredient is a botulinum toxin.