Liquid composition in the form of emulsion or microemulsion for rectal administration containing at least one dye, and its use in a diagnostic endoscopic procedure of sigmoid colon and/or rectum

Patent metadata

Field	Value
Publication number	US-2016331848-A1
Application number	US-201515115200-A
Country	US
Kind code	A1
Filing date	Jan 29, 2015
Priority date	Jan 29, 2014
Publication date	Nov 17, 2016
Grant date	—

Abstract

The present invention provides a novel liquid composition in the form of an emulsion or microemulsion for rectal administration comprising at least one dye, at least one emulsifier, and at least one physiologically acceptable excipient, and its use in a diagnostic endoscopic procedure of sigmoid colon and/or rectum. Preferably, said diagnostic endoscopic procedure of sigmoid colon and/or rectum is an anoscopy, a proctoscopy, a rectoscopy and/or a sigmoidoscopy.

First claim

1 - 22 . (canceled)

23 . A method of a diagnostic endoscopic procedure for the identification of several pathological and/or non pathological forms of the intestinal mucosa of the intestinal mucosa of the sigmoid colon and/or rectum of a patient, the method comprises rectally administering a liquid composition to a patient undergoing a diagnostic endoscopic procedure and diagnosing the intestinal mucosa, wherein the liquid composition is in the form of an emulsion or microemulsion comprising at least one dye, at least one emulsifier, and at least one physiologically acceptable excipient.

24 . The method according to claim 23 , wherein said diagnostic endoscopic procedure of sigmoid colon and/or rectum is an anoscopy, a proctoscopy, a rectoscopy and/or a sigmoidoscopy.

25 . The method according to claim 23 , wherein said at least one dye is selected from the group comprising vital dyes, non-vital dyes, reactive dyes, or a mixture thereof.

26 . The method according to claim 23 , wherein said at least one dye is selected from the group comprising methylene blue, toluidine blue, Lugol's solution, cresyl violet, indigo carmine, Congo red, phenol red, fluorescein, or a mixture thereof.

27 . The method according to claim 23 , wherein said at least one dye is methylene blue, indigo carmine, or a mixture thereof.

28 . The method according to claim 23 , wherein said at least one emulsifier is a non-ionic, ionic, natural emulsifier, or a mixture thereof.

29 . The method according to claim 23 , wherein said at least one emulsifier is a non-ionic emulsifier.

30 . The method according to claim 23 , wherein said at least one emulsifier is a non-ionic emulsifier selected from poloxamer 407, caprylocaproyl macrogol-8 glycerides, polisorbate 80, PEG-40 stearate, propylene glycol monocaprylate, lauroyl macrogol-32 glycerides, polyoxyl-15-hydroxystearate, or a mixture thereof.

31 . The method according to claim 23 , wherein said at least one emulsifier is an ionic emulsifier.

32 . The method according to claim 23 , wherein said at least one emulsifier is the ionic emulsifier sodium lauryl sulfate.

33 . The method according to claim 23 , wherein said at least one emulsifier is a natural emulsifier.

34 . The method according to claim 23 , wherein said at least one emulsifier is a natural emulsifier selected from egg lecithin, soy lecithin, hydrogenated phosphatidylcholine, unsaturated phosphatidylcholine, or a mixture thereof.

35 . The method according to claim 23 , wherein said emulsion or microemulsion comprises at least one oily phase.

36 . The method according to claim 23 , wherein said oily phase comprises at least one lipophilic compound.

37 . The method according to claim 23 , wherein said oily phase comprises at least one lipophilic compound selected from soybean oil, oleic alcohol, isopropyl myristate, castor oil, ethyl oleate, medium chain triglycerides, simethicone, 30% simethicone emulsion, or a mixture thereof.

38 . The method according to claim 23 , wherein said emulsion or microemulsion comprises at least one inverse thermosensitive polymer.

39 . The method according to claim 23 , wherein said emulsion or microemulsion comprises at least one inverse thermosensitive polymer selected from a poloxamer.

40 . The method according to claim 23 , wherein said emulsion or microemulsion comprises at least one inverse thermosensitive polymer selected from poloxamer 124, poloxamer 188, poloxamer 237, poloxamer 338, poloxamer 407, or a mixture thereof.

41 . The method according to claim 23 , wherein said emulsion or microemulsion comprises at least one inverse thermosensitive polymer selected from poloxamer 188, poloxamer 407, or a mixture thereof.

42 . The method according to claim 23 , wherein said emulsion or microemulsion comprises at least one inverse thermosensitive polymer with a critical gelation temperature below 45° C.

43 . The method according to claim 23 , wherein said emulsion or microemulsion comprises at least one viscosity modifying agent.

44 . The method according to claim 23 , wherein said emulsion or microemulsion comprises at least one viscosity modifying agent selected from hydroxypropyl cellulose, hydroxypropylmethyl cellulose, hydroxyethyl cellulose, PEG 6000, a carbomer, a carboxyvinyl polymer, polyvinylpyrrolidone, or a mixture thereof.

45 . The method according to claim 23 , wherein the emulsion or microemulsion us formulated in the form of an enema and/or a cleansing solution.

46 . The method according to claim 23 , wherein said emulsion or microemulsion is an oil-in-water, water-in-oil, oil-in-water-in-oil or water-in-oil-in-water.

47 . The method according to claim 23 , wherein said diagnostic endoscopic procedure is directed to the identification of several pathological and/or non-pathological forms of the intestinal mucosa comprising inflammatory lesions, ulcers, polyps, pseudo-polyps, flat polyps, hyperplastic polyps, tightened lesions, adenomas, pre-neoplastic formations, neoplastic formations, tumors and/or carcinoma.

Assignees

• Cosmo Technologies Ltd

Inventors

• Moro Luigi
• Frimonti Enrico
• Longo Luigi Maria

Classifications

• A61K49/1806

  Suspensions, emulsions, colloids, dispersions · CPC title

• A61K49/0004

  Screening or testing of compounds for diagnosis of disorders, assessment of conditions, e.g. renal clearance, gastric emptying, testing for diabetes, allergy, rheuma, pancreas functions · CPC title

• A61K9/0031

  Rectum, anus · CPC title

• A61K49/0076

  dispersion, suspension, e.g. particles in a liquid, colloid, emulsion · CPC title

• A61K9/107

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