Emulsions or microemulsions for use in endoscopic mucosal resectioning and/or endoscopic submucosal dissection

Patent metadata

Field	Value
Publication number	US-10849979-B2
Application number	US-201916536572-A
Country	US
Kind code	B2
Filing date	Aug 9, 2019
Priority date	Nov 20, 2013
Publication date	Dec 1, 2020
Grant date	Dec 1, 2020

Abstract

The present invention relates to a pharmaceutical composition in form of emulsion or microemulsion and the use thereof as aid during endoscopic procedures in which it is injected in a target tissue in order to form a cushion. More in details, the invention relates to a method for performing an endoscopic procedure, which comprises injecting said pharmaceutical composition in form of emulsion or microemulsion in a target tissue of a patient, in order to form a cushion, which cushion is then optionally subjected to an endoscopic surgical procedure, such as a resection.

First claim

The invention claimed is:

1. A kit comprising a pharmaceutical composition in a container, wherein the pharmaceutical composition comprises:
(a) at least one poloxamer selected from poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338, and poloxamer 407, or a mixture thereof; and
(b) means for keeping the pharmaceutical composition in liquid phase up to a temperature of about 40° C. in vitro.

2. The kit according to claim 1 , wherein the container is selected from an ampoule, a vial, a bottle, and a pre-filled syringe.

3. The kit according to claim 2 , wherein the container is an ampoule.

4. The kit according to claim 3 , wherein the ampoule contains from 10 mL to 50 mL of the pharmaceutical composition.

5. The kit according to claim 2 , wherein the container is a vial.

6. The kit according to claim 5 , wherein the vial contains from 10 mL to 50 mL of the pharmaceutical composition.

7. The kit according to claim 2 , wherein the container is a bottle.

8. The kit according to claim 2 , wherein the container is a pre-filled syringe.

9. The kit according to claim 8 , wherein the pre-filled syringe contains from 5 mL to 10 mL of the pharmaceutical composition.

10. A method for creating a cushion in a submucosal tissue in the gastrointestinal tract of a patient, comprising injecting into the submucosal tissue a pharmaceutical composition comprising:
(a) at least one poloxamer selected from poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338, and poloxamer 407, or a mixture thereof; and
(b) means for keeping the composition in liquid phase up to a temperature of about 40° C. in vitro.

11. The method according to claim 10 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 124.

12. The method according to claim 10 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 188.

13. The method according to claim 10 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 237.

14. The method according to claim 10 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 338.

15. The method according to claim 10 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 407.

16. The method according to claim 10 , wherein the pharmaceutical composition further comprises methylene blue or indigo carmine.

17. The method according to claim 10 , wherein the pharmaceutical composition further comprises sodium chloride.

18. The method according to claim 10 , wherein the pharmaceutical composition is injected into the submucosal tissue of the patient using a needle.

19. The method according to claim 18 , wherein the needle is an endoscopic injection needle.

20. The method according to claim 19 , wherein the endoscopic injection needle is inserted into the working channel of an endoscope that is inserted into the patient during a gastrointestinal endoscopic procedure.

Assignees

• Cosmo Technologies Ltd
• Cosmo Tech Limited

Inventors

• Moro Luigi
• Longo Luigi Maria
• Frimonti Enrico
• Repici Alessandro

Classifications

• A61K47/34 Primary

  Macromolecular compounds obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyesters, polyamino acids, polysiloxanes, polyphosphazines, copolymers of polyalkylene glycol or poloxamers (A61K47/10 takes precedence) · CPC title

• A61K47/22

  Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones · CPC title

• A61L31/06

  obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds {(A61L31/041 takes precedence)} · CPC title

• A61K9/107

  Emulsions {; Emulsion preconcentrates; Micelles (composition of emulsions A61K47/00)} · CPC title

• A61L2400/06

  Flowable or injectable implant compositions · CPC title