A combination liquid solution for pre-endoscopy

Abstract

This invention relates to a Pre-Endoscopy Drink, wherein the drink is an aqueous solution comprising four different agents having different uses, wherein the agents are a Defoamer agent, a Mucolytic agent, an Anti-peristaltic agent, and an Anesthetic agent, wherein the Defoamer agent is Simethicone, the mucolytic agent is N-acetylcysteine, the anti-peristaltic agent is Levomenthol and the anesthetic agent Lidocaine, wherein the solution is administered to the patient who is in need to undergo an endoscopy process for bowel preparation.

Description

[Corrected under Rule 26, 23.04.2025]A COMBINATION LIQUID SOLUTION FOR PRE-ENDOSCOPY

[0001] A Combination Liquid Solution for Pre-EndoscopyRELATED APPLICATION

[0002] This application claims the benefit of application IN 202411031512, filed on 19thApril, 2024, the disclosure of which is hereby incorporated herein by reference in its entirety.

[0003] This invention relates to a Pre-Endoscopy Drink, wherein the drink is an aqueous solution comprising four different agents, wherein the agents are a Defoamer agent, a Mucolytic agent, an Anti-peristaltic agent, and an Anesthetic agent, wherein the Defoamer agent is Simethicone, the mucolytic agent is N-acetylcysteine, the anti-peristaltic agent is Levomenthol and the anesthetic agent is Lidocaine, wherein the solution is administered to the patient who is in need to undergo an endoscopy process for bowel preparation.BACKGROUND OF THE INVENTION

[0004] Endoscopic procedures, such as colonoscopy and upper gastrointestinal endoscopy, play a crucial role in diagnosing and treating various gastrointestinal disorders, including colorectal cancer, inflammatory bowel disease, and peptic ulcers. A good mucosal preparation is an essential pre-requisite to detect and manage such underlying health issues. Major hindrances to good quality endoscopy include luminal bubbles, saliva, mucus, rapid peristalsis, and a sensitive gag reflex.

[0005] As a standard practice in India, the only pre-requisite mandated before endoscopy is complete fasting. However, in a fasting state, foam and sticky mucus frequently impair mucosal visualization during endoscopy.

[0006] The successful endoscopic examination largely depends on adequate bowel preparation.

[0007] Traditional bowel preparation methods include compositions that are provided to patients, however such compositions are associated with poor patient tolerance, unpleasant taste, and significant discomfort, leading to suboptimal cleansing and compromised examination quality.

[0008] Efforts to improve patient compliance and enhance bowel preparation for endoscopy have led to the development of pre-endoscopy drinks. These formulations typically consist of laxatives and electrolytes aimed at inducing bowel movements and clearing the gastrointestinal tract before the procedure.

[0009] CN102470183 discloses a composition comprising dimethicone / simethicone and acetylcysteine or pharmaceutically acceptable salts thereof. The CN102470183 discloses the combination of simethicone and acetylcysteine only.

[0010] CN107441508 discloses a composition comprising simethicone and acetylcysteine, wherein the ratio of simethicone to acetylcysteine in percentage by weight is (65:1000) to (95:1000). The CN107441508 discloses the combination of simethicone and acetylcysteine only.

[0011] CN112569410 discloses a lubricating mucilage comprising carbomer, propylene glycol, sodium hydroxide, lidocaine hydrochloride, sodium carboxymethyl cellulose, chitosan, simethicone, glycerol, Lmenthol, glacial acetic acid, chymotrypsin, sodium bicarbonate, and purified water. The CN112569410 discloses mucilage comprising many ingredients and is not an aqueous solution.

[0012] Peter et al, Endosc Int Open 2016; 04(11): E1197-E1202 discloses a pre-procedure drink containing simethicone and NAC significantly improves mucosal visibility during gastroscopy and reduces the need for flushes during the procedure. However, Peter et al do not mention anything about four different ingredients as desired by the present invention.

[0013] Shrihari et al, J Digest Endosc 2021;12:11–18 discloses a pre-endoscopy drink of NAC with simethicone can significantly improve mucosal visibility during UGIE. However, Shrihari et al do not mention anything about the four different ingredients as desired by the present invention.

[0014] The major challenges of using N-acetylcysteine in a liquid pre-mixed formulation are its strong sulfur odor (rotten egg smell) and oxygen-sensitive nature.

[0015] Further, ongoing peristalsis of the gastrointestinal tract is another major hindrance for careful lumen examination and also for therapeutic endoscopic resections (EMR, ESD, etc.). In India, most of the centers use injectable drugs like Hyoscine Butyl Bromide for antiperistaltic effect as and when needed. It frequently causes tachycardia and other anticholinergic side effects and is not recommended in patients with cardiac co-morbidities. Glucagon is occasionally used in some centers, but it is prohibitively expensive.

[0016] From the above, it can be said that the standard practice in the medicinal field for endoscopy involves the use of simethicone, simethicone and N-acetylcysteine, laxative, and electrolytes in large volumes, while existing pre-endoscopy drinks have shown some efficacy in bowel cleansing, they often suffer from palatability issues, causing patient reluctance and dissatisfaction and have side effects and are not cost-effective.

[0017] Therefore, there remains a need for a pre-endoscopy drink formulation that addresses the shortcomings of existing products by prioritizing patient comfort, palatability, and efficacy in bowel preparation. Such a formulation would not only improve patient experience but also enhance endoscopic visualization, reduce procedural risks, and ultimately contribute to better diagnostic and therapeutic outcomes.

[0018] OBJECT OF THE INVENTION

[0019] The principal object of this invention is to provide a Pre-Endoscopy drink, wherein the drink is an aqueous solution comprising four different agents having different uses, wherein the agents comprise a Defoamer agent, a Mucolytic agent, an Anti peristaltic agent, and an Anesthetic agent.

[0020] Another object of this invention is to provide a Pre-Endoscopy drink, wherein a Defoamer agent is Simethicone.

[0021] Another object of this invention is to provide a Pre-Endoscopy drink, wherein a Mucolytic agent is N-acetylcysteine.

[0022] Another object of this invention is to provide a Pre-Endoscopy drink, wherein an Anti peristaltic agent is Levomenthol.

[0023] Another object of this invention is to provide a Pre-Endoscopy drink, wherein an Anesthetic agent is Lidocaine.

[0024] Another object of this invention is to provide a Pre-Endoscopy drink, wherein the drink is an aqueous solution comprising four different agents having different uses, wherein the agents comprise Simethicone, N-acetylcysteine, Levomenthol, and Lidocaine.

[0025] Another object of this invention is to provide a Pre-Endoscopy drink comprising:5 - 25 ml of dispersion containing combination comprising 50 - 300 mg Simethicone and 300 - 900 mg N acetylcysteine;5 - 40 ml of 0.2% - 1.6% solution of Levomenthol;5 - 25 ml of 0.5 - 4% Lidocaine viscous solution; andWater;wherein water is added to make total volume to 100 ml.

[0026] Another object of this invention is to provide a Pre-Endoscopy drink comprising:5 - 25 ml of dispersion containing combination comprising100 - 200 mg Simethicone and 500 - 700 mg N acetylcysteine;5 - 40 ml of 0.6% - 1% solution of Levomenthol;5 - 25 ml of 1% - 3% Lidocaine viscous solution; andWater;wherein water is added to make total volume to 100 ml.

[0027] Another object of this invention is to provide a Pre-Endoscopy drink comprising:5 - 25 ml of dispersion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;5 - 40 ml of 0.8% solution of Levomenthol;5 - 25 ml of 2% Lidocaine viscous solution; andWater;wherein water is added to make total volume to 100 ml.

[0028] Another object of this invention is to provide a Pre-Endoscopy drink comprising:15 ml of dispersion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;20 ml of 0.8% solution of Levomenthol;10 ml of 2% Lidocaine viscous solution; andWater;wherein water is added to make total volume to 100 ml.

[0029] Another object of this invention is to provide a Pre-Endoscopy drink consisting essentially of:5 - 25 ml of dispersion containing combination comprising 50 - 300 mg Simethicone and 300 - 900 mg N-acetylcysteine;5 - 40 ml of 0.2% - 1.6% solution of Levomenthol;5 - 25 ml of 0.5 - 4% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml.

[0030] Another object of this invention is to provide a Pre-Endoscopy drink consisting essentially of:5 - 25 ml of dispersion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;5 - 40 ml of 0.8% solution of Levomenthol;5 - 25 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml.

[0031] Another object of this invention is to provide a Pre-Endoscopy drink consisting essentially of:10-20 ml of dispersion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;15-25 ml of 0.8% solution of Levomenthol;5-15 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml.

[0032] Another object of this invention is to provide a Pre-Endoscopy drink consisting essentially of:15 ml of dispersion containing combination comprising150 mg Simethicone and 600 mg N acetylcysteine;20 ml of 0.8% solution of Levomenthol;10 ml of 2% Lidocaine viscous solution; andwaterwherein water is added to make total volume to 100 ml

[0033] Another object of this invention is to provide a Pre-Endoscopy drink comprising:15 ml of Emulsion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;20 ml of 0.8% solution of Levomenthol;10 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml; and

[0034] wherein the drink does not require any other medicine for pre-endoscopy preparation.

[0035] Another object of this invention is to provide a Pre-Endoscopy drink consisting essentially of:15 ml of Emulsion containing combination comprising 150 mg Simethicone and 600 mg N acetylcysteine;20 ml of 0.8% solution of Levomenthol;10 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml; and

[0036] wherein the drink does not require any other medicine for pre-endoscopy preparation.

[0037] The further object of this invention is to provide a Pre-Endoscopy drink for bowel preparation for Endoscopy.

[0038] The further object of this invention is to provide a Pre-Endoscopy drink, wherein the drink is supplied as a single small-volume solution.

[0039] The further object of this invention is to provide a Pre-Endoscopy drink, wherein the drink is supplied as a single small-volume solution, wherein the drink comprises Simethicone, N-acetylcysteine, Levomenthol, and Lidocaine.

[0040] The further object of this invention is to provide a Pre-Endoscopy drink, wherein the drink is supplied as a single small-volume solution, wherein the drink consisting essentially of Simethicone, N-acetylcysteine, Levomenthol, and Lidocaine.SUMMARY OF THE INVENTION

[0041] This invention relates to a Pre-Endoscopy Drink, wherein the drink is an aqueous solution comprising four different agents having different uses, wherein the agents comprising a Defoamer agent, a Mucolytic agent, an Anti-peristaltic agent, and an Anesthetic agent, wherein the Defoamer agent is Simethicone, the mucolytic agent is N-acetylcysteine, the anti-peristaltic agent is Levomenthol and the anesthetic agent Lidocaine, wherein the solution is administered to the patient who is in need to undergo an endoscopy process for bowel preparation. The Pre-Endoscopy Drink overcomes the limitations of existing formulations and we have excellent patient tolerance with reduced gag events and negligible gastroduodenal peristalsis during the procedures.

[0042] DETAILED DESCRIPTION OF THE INVENTION

[0043] The detailed description and the examples provided herein are exemplary and any modification or variation within the scope of the invention will be apparent to a person skilled in the art. Further, unless otherwise defined, all the technical and scientific terms used herein shall bear the meaning as understood by a person who is ordinarily skilled in the art.

[0044] According to the present invention, the term “Pre-Endoscopy drink” means a drink, which is an aqueous solution comprising a Defoamer agent, a Mucolytic agent, an Anti-peristaltic agent, and an Anesthetic agent.

[0045] The present invention provides a Pre-Endoscopy drink, wherein the drink is an aqueous solution comprising four different agents having different uses, wherein the agents are a Defoamer agent, a Mucolytic agent, an Anti-peristaltic agent, and an Anesthetic agent.

[0046] The present invention provides a Pre-Endoscopic drink wherein defoamer agent comprises Simethicone, mucolytic agent comprises N-acetylcysteine, anti-peristaltic agent comprises Levomenthol and; anesthetic agent comprises Lidocaine.

[0047] According to the present invention, the Defoamer agent is Simethicone, the Mucolytic agent is N-acetylcysteine, the Anti-peristaltic agent is Levomenthol and the Anesthetic agent is Lidocaine.

[0048] In one of the embodiments, the present invention provides a Pre-Endoscopy drink comprising:5 - 25 ml of dispersion containing combination comprising 50 - 300 mg Simethicone and 300 - 900 mg N-acetylcysteine;5 - 40 ml of 0.2% - 1.6% solution of Levomenthol;5 - 25 ml of 0.5 - 4% Lidocaine viscous solution; andWater;wherein water is added to make total volume to 100 ml.

[0049] According to the present invention, the Pre-Endoscopy drink comprises 5 - 25 ml, 5-20 ml, 5-15 ml, 10-20 ml, 12-17 ml or 15 ml dispersion , wherein dispersion is a combination comprising 50 - 300 mg Simethicone and 300 - 900 mg N-acetylcysteine.

[0050] According to the present invention, the Pre-Endoscopy drink comprises 5 - 25 ml of dispersion containing 50 - 300 mg, 50-200 mg, 100-200 mg, 125-175 mg, or 150 mg of Simethicone.

[0051] According to the present invention, the Pre-Endoscopy drink comprises 5 - 25 ml of dispersion containing 300 - 900 mg, 300-700 mg, 400-700 mg, 500-700 mg, 550 650 mg, or 600 mg of N-acetylcysteine.

[0052] According to the present invention, the Pre-Endoscopy drink comprises 5 - 40 ml, 5-30 ml, 10-30 ml, 15-25 ml, or 20 ml; of 0.2% - 1.6% solution of Levomenthol.

[0053] According to the present invention, the Pre-Endoscopy drink comprises 5 - 40 ml; of 0.2-1.6%, 0.4-1.4%, 0.4-1.2%, 0.4-1%, 0.6-1%, or 0.8% solution of Levomenthol.

[0054] According to the present invention, the Pre-Endoscopy drink comprises 5 - 25 ml, 5-20 ml, 1-15 ml, 7-13 ml or 10 ml; of 0.5 - 4% Lidocaine viscous solution.

[0055] According to the present invention, the Pre-Endoscopy drink comprises 5 - 25 ml; of 0.5-4%, 0.5-3%, 1-3%, 1.5-2.5%, or 2% Lidocaine viscous solution.

[0056] According to the present invention, the volume of the final solution is 50-150 ml, 60-140 ml, 70-130 ml, 80-120 ml, 90-110 ml, or preferably 100 ml.

[0057] According to the present invention, the solution can be filled in a bottle or can be supplied in a suitable container.

[0058] According to the present invention the solution is administered to a patient orally or intravenously or as a flush.

[0059] In one of the embodiments, the present invention provides a Pre-Endoscopy drink comprising:5 - 25 ml of dispersion containing combination comprising 100 - 200 mg Simethicone and 500 - 700 mg N-acetylcysteine;5 - 40 ml of 0.6% - 1% solution of Levomenthol;5 - 25 ml of 1% - 3% of Lidocaine viscous solution; andWater;wherein water is added to make total volume to 100 ml.

[0060] In one of the embodiments, the present invention provides a Pre-Endoscopy drink comprising:5 - 25 ml of dispersion containing combination comprising 150 mg Simethicone and 600 mg N acetylcysteine;5 - 40 ml of 0.8% solution of Levomenthol;5 - 25 ml of 2% Lidocaine viscous solution; andWater ;wherein water is added to make total volume to 100 ml.

[0061] In one of the embodiments, the present invention provides a Pre-Endoscopy drink comprising:15 ml of dispersion containing combination comprising of 150 mg Simethicone and 600 mg N acetylcysteine;20 ml of 0.8% solution of Levomenthol;10 ml of 2% Lidocaine viscous solution; andWater;wherein water is added to make total volume to 100 ml.

[0062] In one of the embodiments, the present invention provides a Pre-Endoscopy drink consisting essentially of:5 - 25 ml of dispersion containing combination comprising 50 - 300 mg Simethicone and 300 - 900 mg N-acetylcysteine;5 - 40 ml of 0.2% - 1.6% solution of Levomenthol;5 - 25 ml of 0.5 - 4% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml.

[0063] In one of the embodiments, the present invention provides a Pre-Endoscopy drink consisting essentially of:5 - 25 ml dispersion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;5 - 40 ml of 0.8% solution of Levomenthol;5 - 25 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml.

[0064] In one of the embodiments, the present invention provides a Pre-Endoscopy drink consisting essentially of:10-20 ml of dispersion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;15-25 ml 0.8% solution of Levomenthol;5-15 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml.

[0065] In one of the embodiments, the present invention provides a Pre-Endoscopy drink consisting essentially of:15 ml of dispersion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;20 ml of 0.8% solution of Levomenthol;10 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml.

[0066] In one of the embodiments, the present invention provides a Pre-Endoscopy drink comprising:15 ml of Emulsion containing combination comprising 150 mg Simethicone and 600 mg N acetylcysteine;20 ml of 0.8% solution of Levomenthol;10 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml; and wherein the drink does not require any other medicine for pre-endoscopy preparation.

[0067] In one of the embodiments, the present invention provides a Pre-Endoscopy drink consisting essentially of:15 ml of Emulsion containing combination comprising 150 mg Simethicone and 600 mg N-acetylcysteine;20 ml of 0.8% solution of Levomenthol;10 ml of 2% Lidocaine viscous solution; andwater;wherein water is added to make total volume to 100 ml; and wherein the drink does not require any other medicine for pre-endoscopy preparation.

[0068] In another embodiment, the present invention provides a Pre-Endoscopy drink that can be used for bowel preparation for Endoscopy without the need for any other medicament for that purpose.

[0069] In another embodiment the present invention provides use of the pre-endoscopic drink for bowel preparation.

[0070] In yet another embodiment the present invention provides use of combination comprising Simethicone, N-acetylcysteine; Levomenthol and Lidocaine as pre-endoscopic drink.

[0071] In yet another embodiment the present invention provides method to administering the pre-endoscopic drink into a patient.

[0072] In another embodiment, the present invention provides a Pre-Endoscopy drink, wherein the drink can be supplied as a single small-volume solution.

[0073] In another embodiment pre-endoscopic drink is a solution.

[0074] In another embodiment pre-endoscopic drink is administered into patient who is need to undergo endoscopy.

[0075] In another embodiment the Pre-Endoscopy drink is administered 10 minutes to 20 minutes before scheduled gastrointestinal endoscopic procedures.

[0076] In another embodiment the method or procedure of oral administration steps comprises:Keeping initial small amount of the solution in an oral cavity and rinsing for 30 seconds;followed by swallowing of the entire solution.

[0077] In another embodiment the procedure or method comprises administration while patient is under conscious sedation with Midazolam.

[0078] In another embodiment no additional pre-endoscopic anesthetic spray or any other medication or flush is needed.

[0079] In another embodiment, the present invention provides a Pre-Endoscopy drink, wherein the drink can be supplied as a single small-volume solution, wherein the drink comprises Simethicone, N-acetylcysteine, Levomenthol, and Lidocaine.

[0080] In another embodiment, the present invention provides a Pre-Endoscopy drink, wherein the drink can be supplied as a single small-volume solution, wherein the drink consisting essentially of Simethicone, N-acetylcysteine, Levomenthol, and Lidocaine.

[0081] In another embodiment the present invention provides method to prepare the Pre-Endoscopy drink comprising mixing of actives in following proportions:15 ml of dispersion containing combination comprising 150 mg Simethicone + 600 mg N-acetylcysteine;20 ml of 0.8% L-Menthol solution (160 mg);10 ml of 2% Lidocaine viscous solution; andWater (i.e. to make up the total volume up to 100 ml).

[0082] According to the present invention, the method to prepare the Pre-Endoscopy drink comprises mixing the active in the following proportion:15 ml of emulsion containing combination comprising150 mg Simethicone + 600 mg N-acetylcysteine;20 ml of 0.8% L-Menthol solution (160 mg);10 ml of 2% Lidocaine viscous solution; andWater (i.e. to make up the total volume up to 100 ml).

[0083] In another embodiment the pre-endoscopic drink provides significantly improved Mucosal visibility or lumen visibility.

[0084] In another embodiment the pre-endoscopic drink provides reduced gag events.

[0085] In yet another embodiment the pre-endoscopic drink provides negligible gastroduodenal peristalsis during the procedures.

[0086] In yet another embodiment the pre-endoscopic drink solution is stable and very palatable.

[0087] In yet another embodiment the pre-endoscopic drink does not cause any aspiration.

[0088] In yet another embodiment the pre-endoscopic drink improves endoscopic procedures.

[0089] In yet another embodiment the pre-endoscopic drink makes endoscopic procedure simple, safe, effective, and convenient.

[0090] In another embodiment a method of preparing the Pre-Endoscopy drink comprises:Mixing the dispersion of combination comprising N acetylcysteine and Simethicone;Levomenthol solution;Lidocaine solution; andwater;wherein water is added to make up the volume up to 100 ml.

[0091] In another embodiment the method of preparing the Pre-Endoscopy drink comprises:mixing the emulsion comprising combination of N acetylcysteine and Simethicone;Levomenthol solution;Lidocaine solution; andwaterwherein water is added to make up the volume up to 100 ml.

[0092] In yet another embodiment the dispersion includes emulsion, suspension, and colloidal solution and like thereof.EXAMPLES

[0093] The present invention has been described by way of example only, and it is to be recognized that modifications thereto filling within the scope and spirit of appended claims, and which would be obvious to a person skilled in the art based upon the disclosure herein, are also considered to be within the scope of this invention.

[0094] Example 1: 100 ml Pre-Endoscopy drinkSr. No.Ingredient(s)Quantity for 100 ml fillvolume (ml)1Emulsion containing 150 mgSimethicone + 600 mg N-acetylcysteine per 15 ml of the composition15 ml20.8 % w / v Levomenthol solution20 ml32% w / v Lidocaine viscous solution10 ml4Drinking waterq.s. to 100 ml

[0095] Example 2: 100 ml Pre-Endoscopy drinkSr. No.Ingredient(s)% w / v1NAC0.1-12Simethicone0.01 – 0.43Levomenthol0.01 – 0.44Lidocaine0.05 – 0.45Drinking Waterq.s to 100 ml

[0096] Example 3: 100 ml Pre-Endoscopy drinkSr. No.Ingredient(s)Quantity for 100 ml fill volume (mg)1NAC6002Simethicone1503Levomenthol1604Lidocaine2005Drinking Waterq.s to 100 mlExample 4:

[0097] Endoscopic pre-drink of example 1 was prepared by mixing the ingredients 1-4 of example 1.

[0098] The prepared drink was administered orally to the patients where patients were asked to keep initial small amount of the solution in oral cavity and rinse for 30 seconds followed by swallowing of the entire solution.

[0099] The patients were then asked to keep wait for 20-30 minutes before conducting the endoscopy.Observations:

[0100] A total of 32(n) patients were tested and the observations obtained are as below:

[0101] Satisfaction SurveyAfter Treatment, n(%)22 (69)

[0102] Comment - Good Patient Satisfaction

[0103] B. Mucosal VisibilityAfter Treatment, n(%)Stomach29 (90)Duodenum28 (87)

[0104] Comment - Excellent Mucosal Visibility

[0105] C. PeristalsisAfter Treatment, n(%)Stomach13 (40)Duodenum18 (55)

[0106] Comment: No or Mild Peristalsis

[0107] However, there were some patients who were not comfortable or allergic to lidocaine and thus did not take the drink, whereas patient who took the drink did not show any gag response.

[0108] The pre-endoscopic drink is very cost-effective and did not add any much cost to the procedure however, ensured better results.

[0109] Example 5:

[0110] The pre-drink of example 1 was provided as flush during the procedure of endoscopy and following observations were obtained:

[0111] Satisfaction SurveyAfter Treatment, %65%

[0112] Comment - Good Patient Satisfaction

[0113] B. Mucosal VisibilityAfter Treatment, %Stomach85%Duodenum85%

[0114] Comment - Excellent Mucosal Visibility

[0115] C. PeristalsisAfter Treatment, %Stomach40%Duodenum55%

[0116] Comment: No or Mild Peristalsis

[0117] % in above table shows the positive outcome.

[0118] The pre-drink of the instant disclosure has shown positive patient satisfaction, better mucosal visibility and reduced peristalsis whether provided as pre-drink before endoscopy or as flush.

Claims

A Pre-Endoscopy drink, wherein the drink is an aqueous solution comprising a combination of a Defoamer agent, a Mucolytic agent, an Anti-peristaltic agent, and an Anesthetic agent.The drink as claimed in claim 1 wherein defoamer agent comprises Simethicone, mucolytic agent comprises N-acetylcysteine, anti-peristaltic agent comprises Levomenthol and; anesthetic agent comprises Lidocaine.The drink as claimed in claim 2 comprises:5 - 25 ml of dispersion comprising 50 - 300 mg of Simethicone;5 - 25 ml of dispersion comprising 300 - 900 mg of N-acetylcysteine;5 - 40 ml of 0.2% - 1.6% solution of Levomenthol;5 - 25 ml of 0.5 - 4% Lidocaine viscous solution; andwaterwherein water is added to make total volume upto 100 ml.The drink as claimed in any of the preceding claims is administered to a patient orally or intravenously or as a flush.The pre-endoscopic drink as claimed in claim 4 is administered to a patient at an interval of 10 minutes to 20 minutes before scheduled gastrointestinal endoscopic procedures.The pre-endoscopic drink as claimed in claim 4 is administered orally wherein the steps of administration comprises:keeping initial small amount of the solution in an oral cavity and rinsing for 30 seconds;followed by swallowing of the entire solution.A method of preparing a pre-endoscopic drink wherein the method comprises mixing of actives followed by addition of water; wherein the actives are taken in following proportion:5 - 25 ml of dispersion comprising 50 - 300 mg of Simethicone;b) 5 - 25 ml of dispersion comprising 300 - 900 mg of N-acetylcysteine;b) 5 - 40 ml of 0.2% - 1.6% solution of Levomenthol;c) 5 - 25 ml of 0.5 - 4% Lidocaine viscous solution; andd) waterwherein water is added to make total volume upto 100 ml.The pre-endoscopic drink as claimed in claim 1-7 is stable and palatable.The pre-endoscopic drink as claimed in claim 1-8 improves lumen visibility, reduce gag events and peristalsis movement of intestine.The pre-endoscopic drink as claimed in claim 1-8 is cost-effective.The dispersion as claimed in claim 1-8 comprises emulsion, suspension, and colloidal solution.