Claims for Patent: 12,558,328

Summary for Patent: 12,558,328

Title:	Solid-forming topical formulations for pain control
Abstract:	Methods of applying a solid forming local anesthetic formulations can include applying a layer of a solid-forming formulation to a skin surface, wherein the solid-forming local anesthetic formulation includes from 4 wt % to 30 wt % of a local anesthetic, less than 36 wt % dicalcium phosphate, water, and a polymer. These methods can further include maintaining the layer of the formulation on the skin surface for a period of time sufficient to allow the layer of the formulation to transition from a semi-solid to a cohesive film and to topically deliver the local anesthetic to the skin surface, and removing the layer of the formulation from the skin surface by peeling the layer of the formulation off the skin surface. The layer of the formulation can be operable to be removed as a single piece or two to three large pieces.
Inventor(s):	Jie Zhang, Wade Hull, Ngoc Truc-Chi Vo
Assignee:	Crescita Therapeutics Inc
Application Number:	US17/669,421
Patent Claims:	1. A method of applying a solid forming local anesthetic formulation, comprising: applying a layer of a solid-forming formulation to a skin surface, the solid-forming local anesthetic formulation comprising 4 wt % to 30 wt % of a local anesthetic, 18 wt % to 36 wt % of a filler that is dicalcium phosphate, an emollient, an emulsifying agent, water and a polymer, wherein the polymer is polyvinyl alcohol (PVA) and the solid-forming topical formulation includes a ratio of water to PVA of about 2.16 to about 3.16; maintaining the layer of the formulation on the skin surface for a period of time sufficient to allow the layer of the formulation to transition from a semi-solid to a cohesive film and to topically deliver the local anesthetic to the skin surface; and removing the layer of the formulation from the skin surface by peeling the layer of the formulation off the skin surface as a single piece or two to three large pieces. 2. The method of claim 1, wherein the layer of the solid-forming local anesthetic formulation and the cohesive film formed therefrom is free of a backing layer, a backing film, or other support substrates. 3. The method of claim 1, wherein the solid-forming topical formulation includes more than 25.94 wt % water. 4. The method of claim 1, wherein the PVA has an average mass ranging from 20,000 to 100,000 Daltons. 5. The method of claim 1, wherein the PVA has a molecular mass ranging from 30,000 to 80,000 Daltons. 6. The method of claim 1, wherein the solid-forming topical formulation includes a ratio of water to PVA of greater than 2.4. 7. The method of claim 1, wherein the solid-forming topical formulation includes a ratio of water to PVA of greater than 2.5. 8. The method of claim 1, wherein the local anesthetic in the formulation comprises lidocaine and tetracaine. 9. The method of claim 8, wherein the lidocaine and tetracaine are each in their base form. 10. The method of claim 8, wherein the lidocaine and tetracaine are in the form of a eutectic mixture at about 2:1 to 1:2 weight ratio. 11. The method of claim 10, wherein the lidocaine and tetracaine are in the form of a eutectic mixture at about 1:1 weight ratio. 12. The method of claim 1, wherein the dicalcium phosphate is present in an amount of 18 to 32.4 wt %. 13. The method of claim 1, wherein the formulation is applied at a thickness of 1 mm or more. 14. The method of claim 1, wherein the formulation remains on the skin surface for a period of at least 20 minutes. 15. The method of claim 1, wherein the formulation remains on the skin surface for a period of at least 30 minutes. 16. The method of claim 1, wherein the formulation remains on the skin surface for a period of at least 45 minutes. 17. The method of claim 1, wherein the formulation is for local anesthesia. 18. The method of claim 1, wherein the emollient is petrolatum. 19. The method of claim 1, wherein the emulsifying agent is sorbitan ester. 20. The method of claim 1, the emollient is petrolatum and the emulsifying agent is sorbitan ester. 21. The method of claim 1, wherein the solid-forming formulation has an initial viscosity from about 40,000 centipoise to about 800,000 centipoise.