IP Library Granted Patent US 12,097,186
Granted Patent B2
US 12,097,186 · App. 16/856,363 · Granted Sep 24, 2024

Topical analgesic compositions

Inventors: Debanjan Das (Morristown, NJ); Emanuel Vizzotti (Millburn, NJ); Thomas Dann (Palm Harbor, FL); Renee Nelson (Brandon, FL); Courtney C. Haynes (Dunedin, FL); Soundarya Vaithianathan (Parsippany, NJ); Reginald Bradley (Bedminster, NJ); Reinhard Walter (Morristown, NJ); Gerard Meisel (Budd Lake, NJ)
Assignee: Bayer HealthCare LLC
A61K31/4164A61K31/045A61K31/125A61K47/44
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Quick Facts
Patent No.
US 12,097,186
App. No.
16/856,363
Granted
Sep 24, 2024
Kind
B2
Abstract

Provided are topical analgesic compositions and methods of preparing topical analgesic compositions comprising a stable nano-encapsulating matrix film. The topical analgesic compositions and methods of preparing topical analgesic compositions may be suited for roll-on applicators. Topical analgesic compositions may include 12 to 16 wt. % menthol; 4 to 8 wt. % camphor; 2 to 15 wt. % film-forming polymer; and 50 to 70 wt. % solvent. To be used in a roll-on applicator, the topical analgesic composition has a viscosity from 800 to 1400 centipoise.

Claims (36)

1. A topical analgesic composition comprising:

12 to 16 wt. % menthol;

4 to 8 wt. % camphor;

2 to 15 wt. % film-forming polymer comprising hydroxypropyl cellulose; and

50 to 70 wt. % an alcohol solvent,

wherein the topical analgesic composition has a viscosity from 800 to 1400 centipoise and comprises:

a film-forming matrix comprising the film-forming polymer and the alcohol solvent; and

droplets comprising the menthol and the camphor, wherein the droplets are dispersed in the film-forming matrix, and wherein the droplets have an average droplet size of 800-1500 nanometers.

2. The composition of claim 1 , further comprising 0.025 to 0.250 wt. % histamine dihydrochloride.

3. The composition of claim 1 , wherein the amount of menthol and the amount of camphor comprises 21 wt. % of the composition.

4. The composition of claim 1 , having a pH from 6.0 to 7.0.

5. The composition of claim 1 , having a specific gravity from 0.7 to 1.0.

6. The composition of claim 1 , wherein the 2 to 15 wt. % film-forming polymer further comprises one or more of a terpolymer of vinylpyrrolidone, vinyl caprolactum and dimethylaminoethyl methacrylate, and a terpolymer of poly(isobutylene-alt-maleic anhydride), dimethylaminopropylamine, and methoxy-PEG/PPG-31/9-2-propylamine.

7. The composition of claim 1 , wherein the 12 to 16 wt. % menthol and the 5-10 wt. % camphor form a eutectic mixture.

8. The composition of claim 1 , further comprises 1.5 to 9 wt. % sensate.

9. The composition of claim 8 , wherein the sensate includes one or more of menthoxypropanediol, isopulegol, and vanillyl butyl ether.

10. The composition of claim 1 , further comprises 0.5 to 3.0 wt. % of one or more essential oils.

11. The composition of claim 10 , wherein the one or more essential oils comprises one or more of peppermint ( Mentha piperita ) oil, eucalyptus ( Eucalyptus globulus ) oil, rosemary ( Rosmarinus officinalis ) oil, clove ( Eugenia caryophyllata ) oil, Spanish marjoram ( Thymus mastichina ) oil, and frankincense ( Olibanum or Boswellia carterii ) oil.

12. The composition of claim 1 , further comprises 0.1 to 5 wt. % linseed oil.

13. The composition of claim 1 , further comprises 0.5 to 3.0 wt. % fragrance.

14. A method for treating muscle and joint ache or pain, comprising administering to a patient in need thereof a topical analgesic composition according to claim 1 .

15. A roll-on topical analgesic product comprising:

a roll-on applicator; and

a topical analgesic composition comprising:

12 to 16 wt. % menthol;

4 to 8 wt. % camphor;

2 to 15 wt. % film-forming polymer comprising hydroxypropyl cellulose; and

50 to 70 wt. % an alcohol solvent,

wherein the topical analgesic composition has a viscosity from 800 to 1400 centipoise contained within the roll-on applicator to form a roll-on topical analgesic product and comprises:

a film-forming matrix comprising the film-forming polymer alcohol and the solvent; and

droplets comprising the menthol and the camphor, wherein the droplets are dispersed in the film-forming matrix, and wherein the droplets have an average droplet size of 800-1500 nanometers.

16. A method of preparing a topical analgesic composition, the method comprising:

mixing 12 to 16 wt. % menthol and 4 to 8 wt. % camphor; and

adding 50 to 70 wt. % of an alcohol a solvent and 2 to 15 wt. % of a film-forming polymer comprising hydroxypropyl cellulose to the mixture comprising said menthol and said camphor to form a topical analgesic composition wherein the topical analgesic composition has a viscosity from 800 to 1400 centipoise and comprises: a film-forming matrix comprising the film-forming polymer and the alcohol solvent; and droplets comprising the menthol and the camphor, wherein the droplets are dispersed in the film-forming matrix, and wherein the droplets have an average droplet size of 800-1500 nanometers.

17. The method of claim 16 , wherein the topical analgesic composition has a pH of 6.0-7.0.

18. The composition of claim 1 , wherein an amount of camphor in the composition is 5 to 8 wt. %.

Assignments (3)
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 14, 2020
From: HAYNES, COURTNEY C.; NELSON, RENEE; DANN, THOMAS
To: FORMULATED SOULTIONS, LLC
Reel/Frame 053495/0487 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 14, 2020
From: FORMULATED SOLUTIONS, LLC
To: BAYER HEALTHCARE LLC
Reel/Frame 053495/0709 →
ASSIGNMENT OF ASSIGNOR'S INTEREST Recorded Aug 14, 2020
From: DAS, DEBANJAN; VIZZOTTI, EMANUEL; VAITHIANATHAN, SOUNDARYA; BRADLEY, REGINALD; WALTER, REINHARD; MEISEL, GERARD
To: BAYER HEALTHCARE LLC
Reel/Frame 053496/0238 →
Continuity (2)
Provisional Application 62841091 · Apr 30, 2019
Related Publication 20200345696A1 · Nov 5, 2020
Cited By (1)
US 12,582,615