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

Patent metadata

Field	Value
Publication number	US-2018236087-A1
Application number	US-201815962458-A
Country	US
Kind code	A1
Filing date	Apr 25, 2018
Priority date	Nov 20, 2013
Publication date	Aug 23, 2018
Grant date	—

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

1 . 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 pharmaceutical composition in liquid phase up to a temperature of about 40° C. in vitro, wherein the pharmaceutical composition is for use in submucosal lift of gastrointestinal mucosal lesions in a patient undergoing a gastrointestinal endoscopic procedure.

2 . The pharmaceutical composition according to claim 1 , wherein the at least one poloxamer is poloxamer 124.

3 . The pharmaceutical composition according to claim 1 , wherein the at least one poloxamer is poloxamer 188.

4 . The pharmaceutical composition according to claim 1 , wherein the at least one poloxamer is poloxamer 237.

5 . The pharmaceutical composition according to claim 1 , wherein the at least one poloxamer is poloxamer 338.

6 . The pharmaceutical composition according to claim 1 , wherein the at least one poloxamer is poloxamer 407.

7 . The pharmaceutical composition according to claim 1 , further comprising methylene blue or indigo carmine.

8 . The pharmaceutical composition according to claim 1 , further comprising sodium chloride.

9 . The pharmaceutical composition according to claim 1 , wherein the composition has a viscosity below about 150 centipoises.

10 . The pharmaceutical composition according to claim 1 , wherein the composition has a viscosity below about 100 centipoises.

11 . The pharmaceutical composition according to claim 1 , wherein the composition has a viscosity below about 50 centipoises.

12 . The pharmaceutical composition according to claim 1 , wherein the composition has a viscosity below about 20 centipoises.

13 . The pharmaceutical composition according to claim 1 , wherein the composition has a viscosity below about 10 centipoises.

14 . The pharmaceutical composition according to claim 1 , wherein the gastrointestinal mucosal lesions are selected from inflammatory tissue, polyps, pseudo-polyps, flat polyps, serrated lesions, adenomas, ulcerations, dysplasias, pre-neoplastic and neoplastic formations, and tumors.

15 . The pharmaceutical composition according to claim 1 , wherein the gastrointestinal endoscopic procedure is endoscopic mucosal resection or endoscopic submucosal dissection.

16 . 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.

17 . The kit according to claim 16 , wherein the container is selected from an ampoule, a vial, a bottle, and a pre-filled syringe.

18 . The kit according to claim 17 , wherein the container is an ampoule.

19 . The kit according to claim 18 , wherein the ampoule contains from 10 mL to 50 mL of the pharmaceutical composition.

20 . The kit according to claim 17 , wherein the container is a vial.

21 . The kit according to claim 20 , wherein the vial contains from 10 mL to 50 mL of the pharmaceutical composition.

22 . The kit according to claim 17 , wherein the container is a bottle.

23 . The kit according to claim 17 , wherein the container is a pre-filled syringe.

24 . The kit according to claim 23 , wherein the pre-filled syringe contains from 5 mL to 10 mL of the pharmaceutical composition.

25 . 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.

26 . The method according to claim 25 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 124.

27 . The method according to claim 25 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 188.

28 . The method according to claim 25 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 237.

29 . The method according to claim 25 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 338.

30 . The method according to claim 25 , wherein the at least one poloxamer in the pharmaceutical composition is poloxamer 407.

31 . The method according to claim 25 , wherein the pharmaceutical composition further comprises methylene blue or indigo carmine.

32 . The method according to claim 25 , wherein the pharmaceutical composition further comprises sodium chloride.

33 . The method according to claim 25 , wherein the pharmaceutical composition is injected into the submucosal tissue of the patient using a needle.

34 . The method according to claim 33 , wherein the needle is an endoscopic injection needle.

35 . The method according to claim 34 , 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

Inventors

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

Classifications

• A61P41/00

  Drugs used in surgical methods, e.g. surgery adjuvants for preventing adhesion or for vitreum substitution · CPC title

• A61K49/006

  Biological staining of tissues in vivo, e.g. methylene blue or toluidine blue O administered in the buccal area to detect epithelial cancer cells, dyes used for delineating tissues during surgery · 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

• A61K47/22

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