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

Patent metadata

Field	Value
Publication number	US-9226996-B2
Application number	US-201414546925-A
Country	US
Kind code	B2
Filing date	Nov 18, 2014
Priority date	Nov 20, 2013
Publication date	Jan 5, 2016
Grant date	Jan 5, 2016

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 method for performing an endoscopic procedure, which comprises injecting a pharmaceutical composition in the form of an emulsion or a microemulsion to a target tissue of a patient in need of such a treatment in order to form a cushion, said pharmaceutical composition comprising:
(a) an aqueous phase;
(b) an oily phase;
(c) at least one surfactant;
(d) at least one of poloxamer 188, poloxamer 407, or a mixture of poloxamer 188 and poloxamer 407;
(e) methylene blue or indigo carmine; and
(f) at least one physiologically acceptable excipient;

wherein said at least one of poloxamer 188, poloxamer 407, or a mixture of poloxamer 188 and poloxamer 407 is present in an amount below the critical gelation concentration (CGC), and wherein said composition remains in liquid phase up to a temperature of about 40° C. in vitro.

2. The method according to claim 1 , wherein said composition has a viscosity below about 150 cP (centipoises).

3. The method according to claim 1 , wherein said at least one of poloxamer 188, poloxamer 407, or a mixture of poloxamer 188 and poloxamer 407 is present in an amount below about 15% by weight, with respect to the weight of the composition.

4. The method according to claim 1 , wherein said at least one of poloxamer 188, poloxamer 407, or a mixture of poloxamer 188 and poloxamer 407 is present in an amount between about 5% and about 11% by weight, with respect to the weight of the composition.

5. The method according to claim 1 , wherein said poloxamer 407 is present in an amount of about 9% by weight with respect to the weight of the composition.

6. The method according to claim 1 , wherein said poloxamer 188 is present in an amount of about 10% by weight with respect to the weight of the composition.

7. The method according to claim 1 , wherein said mixture of poloxamer 188 and poloxamer 407 is present in an amount of about 10% by weight with respect to the weight of the composition.

8. The method according to claim 1 , wherein said oily phase comprises at least one lipophilic compound.

9. The method according to claim 8 , wherein said at least one lipophilic compound is selected from medium-chain triglycerides and soybean oil.

10. The method according to claim 1 , wherein said at least one surfactant is selected from polysorbate 80, PEG-15 hydroxystearate, egg lecithin, hydrogenated phosphatidyl choline from egg lecithin, soybean lecithin and hydrogenated soybean lecithin.

11. The method according to claim 1 , wherein said cushion is subjected to a resection procedure.

12. The method according to claim 11 , wherein said resection procedure is performed during a gastrointestinal endoscopy.

13. The method according to claim 1 , wherein said endoscopic procedure is performed in the esophagous, stomach, small intestine, cecum, colon, sigmoid colon and/or rectum.

14. The method according to claim 11 , wherein said resection procedure is a polypectomy, an endoscopic mucosal resection (EMR) and/or an endoscopic submucosal dissection (ESD).

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

• A61K47/02 Primary

  Inorganic compounds · CPC title

• A61L31/06

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

• A61L2300/442

  Colorants, dyes · CPC title

• A61L24/0005

  Ingredients of undetermined constitution or reaction products thereof · CPC title