Title of Invention	A PROCESS FOR PREPARING A SYNREGISTIC COMPOSITION FOR THE CURE OF ULCERS AND GASTRITES
Abstract	1 . A process for preparing a synergistic composition for the cure of ulcers and gastrites comprisisng blending sodium azulene sulphonate and L-glutamine in the range of 1mg to 5mg and 800 mg to 1200 mg respectively with conventional colourants, additives and excipients. 2. The process as claimed in claim 1, wherein said sodium azulene sulphonate and L-glutamine are blended to form an emulsion or suspenion in pharmaceutically acceptable carriers or adjuvants. 3. The process as claimed in claim 1 wherein said blend is tabletted in a known manner.

Title of Invention

A PROCESS FOR PREPARING A SYNREGISTIC COMPOSITION FOR THE CURE OF ULCERS AND GASTRITES

Abstract

1 . A process for preparing a synergistic composition for the cure of ulcers and gastrites comprisisng blending sodium azulene sulphonate and L-glutamine in the range of 1mg to 5mg and 800 mg to 1200 mg respectively with conventional colourants, additives and excipients. 2. The process as claimed in claim 1, wherein said sodium azulene sulphonate and L-glutamine are blended to form an emulsion or suspenion in pharmaceutically acceptable carriers or adjuvants. 3. The process as claimed in claim 1 wherein said blend is tabletted in a known manner.

Full Text	This invention relates to a prooess for preparing a synergistic composition for the cure of Ulcers and Gastrites, Ulcer is a localized destruction of an epithelial surface resulting in an open sore. Ulcers are usually formed on the skin or in the stomach lining and in the duodenal area of the intestine. Uloers are usually formed due to infection. Gastric ulcers may also be formed due to erosion of the muoous membrane of the stomach owing to hyperacidity of the gastric .juices. Human gastric .juices consist mainly of water free hydrochloric acid (about 0.2%) in addition to salts and organic matter including enzymes. Increase in the percentage of acid level in the gastric juices may result in the damage of mucous membrane. This may lead to infection resulting in ulcerated intestinal walls. Inflammation of the mucous membrane is medically known as gastrites. Conventional treatment for gastritis include an antacid for reducing the acidity of the gastric juices. Antiinflammatory agents are also often used in the treatment of ulcers. However, ideal curative treatment is to be directed towards the control of inflammation and the regeneration of the damaged cells. It has now been found that a combination of sodium azulene sulphonate and L-glutamine directly acts on the inflammation of gastric mucosa while regenerating the already ulcerated tissues. This composition exhibits accelerated healing potential against various types of ulcers. The defensive factors of the components are potentiated in this composition thereby reducing inflammation while reconstructing the mucous membrane. This composition also restrains further formation of ulcers which may be attributed to the enhanced tissue reconstruction faoiliated by L -glutamine. It is also observed that this composition reduces significantly, the generation of pepsinogen in the stomach mucosa by 75% at pH 2 and by about 78% at pH 3.5. Accordingly, this invention relates to a process for preparing a synergistic composition for the cure of ulcers and gastrites which comprises blending sodium azulene sulphonate and L-glutamine in the range of Img to 5mg and 800mg to 1200mg respectively with conventional colourants, additives and exci p i ents Connventional additives and excipients are added depending upon the type of composition desired. For instance, if a liquid composition is required, adjuvants like distilled water and pharmaceutically acceptable solvents are used. The blend of sodium azulene sulphonate and L-glutamine nay be dissolved or emulsified in the solvents to produce the composition. Tablets, capsules and granules are prepared by substituting suitable solid adjuvants and processing the composition in a known manner. (!ommonly used colourants adjuvants and excipients are given herein after. Tartrazine, Indigo carmine, Erythrocine, sunset yellow, Titanium dioxide, lactose, starch, microcrystalline cellulose, hydroxy propyl methyl cellulose, carboxy methyl cellulose, methylcellulose, ethyl cellulose, hydroxy propyl cellulose, industrial methylated spirit, polyvinyl pyrolodine, polyethylene glycol, isopropylalcohol distilled water and the like. This invention will be exemplfieid by the nonlimiting example given below. 3mg of sodium azulene sulphonate and 990mg of L-glutamine are wetted with hydroxy propyl methyl cellulose solution in distilled water. This mass is extruded and murmerised into cylindrical rods of 1 to 4mm. These granules are filled in sachets or capsules as per the dose desired. Obvious alterations and modifications known to persons skilled in the art are well within scope of this invention and the appended claims. WE CLAIM: 1 . A process for preparing a synergistic composition for the cure of ulcers and gastrites comprisisng blending sodium azulene sulphonate and L-glutamine in the range of 1mg to 5mg and 800 mg to 1200 mg respectively with conventional colourants, additives and excipients. 2. The process as claimed in claim 1, wherein said sodium azulene sulphonate and L-glutamine are blended to form an emulsion or suspenion in pharmaceutically acceptable carriers or adjuvants. 3. The process as claimed in claim 1 wherein said blend is tabletted in a known manner. 4. The process as claimed in claim 1, wherein said blend is extruded, granulated and/or encapsulated in a pharmaceutically acceptable casing in a known manner. 5. The process as claimed in claims 1 to 4, wherein 3 mg of sodium azulene sulphonate is blended with 990mg of L-glutamine, said blend is wetted with an aqueous solution of hydroxy propyl methyl cellulose, and then extruded, granulated or murmerised and thereafter filled in sachets in dosage form. 6 A process for preparing a synergistic composition for the cure of ulcers and gastrites substantially as herein described

Full Text

This invention relates to a prooess for preparing a synergistic composition for the cure of Ulcers and Gastrites,
Ulcer is a localized destruction of an epithelial
surface resulting in an open sore. Ulcers are usually formed on
the skin or in the stomach lining and in the duodenal area of
the intestine. Uloers are usually formed due to infection.
Gastric ulcers may also be formed due to erosion of the muoous
membrane of the stomach owing to hyperacidity of the gastric
.juices. Human gastric .juices consist mainly of water free hydrochloric acid (about 0.2%) in addition to salts and
organic matter including enzymes. Increase in the percentage of
acid level in the gastric juices may result in the damage of
mucous membrane. This may lead to infection resulting in
ulcerated intestinal walls. Inflammation of the mucous membrane
is medically known as gastrites.
Conventional treatment for gastritis include an antacid for reducing the acidity of the gastric juices. Antiinflammatory agents are also often used in the treatment of ulcers. However, ideal curative treatment is to be directed towards the control of inflammation and the regeneration of the damaged cells. It has now been found that a combination of sodium azulene sulphonate and L-glutamine directly acts on the inflammation of gastric mucosa while regenerating the already ulcerated tissues. This composition exhibits accelerated healing

potential against various types of ulcers. The defensive factors of the components are potentiated in this composition thereby reducing inflammation while reconstructing the mucous membrane. This composition also restrains further formation of ulcers which may be attributed to the enhanced tissue reconstruction faoiliated by L -glutamine. It is also observed that this composition reduces significantly, the generation of pepsinogen in the stomach mucosa by 75% at pH 2 and by about 78% at pH 3.5.
Accordingly, this invention relates to a process for preparing a synergistic composition for the cure of ulcers and gastrites which comprises blending sodium azulene sulphonate and L-glutamine in the range of Img to 5mg and 800mg to 1200mg respectively with conventional colourants, additives and exci p i ents
Connventional additives and excipients are added depending upon the type of composition desired. For instance, if a liquid composition is required, adjuvants like distilled water and pharmaceutically acceptable solvents are used. The blend of sodium azulene sulphonate and L-glutamine nay be dissolved or emulsified in the solvents to produce the composition.
Tablets, capsules and granules are prepared by substituting suitable solid adjuvants and processing the composition in a known manner. (!ommonly used colourants adjuvants and excipients are given herein after.

Tartrazine, Indigo carmine, Erythrocine, sunset yellow, Titanium dioxide, lactose, starch, microcrystalline cellulose, hydroxy propyl methyl cellulose, carboxy methyl cellulose, methylcellulose, ethyl cellulose, hydroxy propyl cellulose, industrial methylated spirit, polyvinyl pyrolodine, polyethylene glycol, isopropylalcohol distilled water and the like.
This invention will be exemplfieid by the nonlimiting example given below.
3mg of sodium azulene sulphonate and 990mg of L-glutamine are wetted with hydroxy propyl methyl cellulose solution in distilled water. This mass is extruded and murmerised into cylindrical rods of 1 to 4mm. These granules are filled in sachets or capsules as per the dose desired.
Obvious alterations and modifications known to persons skilled in the art are well within scope of this invention and the appended claims.

WE CLAIM:
1 . A process for preparing a synergistic composition for the cure of ulcers and gastrites comprisisng blending sodium azulene sulphonate and L-glutamine in the range of 1mg to 5mg and 800 mg to 1200 mg respectively with conventional colourants, additives and excipients.
2. The process as claimed in claim 1, wherein said sodium azulene sulphonate and L-glutamine are blended to form an emulsion or suspenion in pharmaceutically acceptable carriers or adjuvants.
3. The process as claimed in claim 1 wherein said blend is tabletted in a known manner.

4. The process as claimed in claim 1, wherein said blend is extruded, granulated and/or encapsulated in a pharmaceutically acceptable casing in a known manner.
5. The process as claimed in claims 1 to 4, wherein 3 mg of sodium azulene sulphonate is blended with 990mg of L-glutamine, said blend is wetted with an aqueous solution of hydroxy propyl methyl cellulose, and then extruded, granulated or murmerised and thereafter filled in sachets in dosage form.

6 A process for preparing a synergistic composition for
the cure of ulcers and gastrites substantially as herein described

Documents:

0888-mas-1999 claims.pdf

0888-mas-1999 correspondence-others.pdf

0888-mas-1999 description(complete).pdf

0888-mas-1999 form-1.pdf

0888-mas-1999 form-26.pdf

0888-mas-1999 form-3.pdf

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Patent Number

189186

Indian Patent Application Number

888/MAS/1999

PG Journal Number

30/2009

Publication Date

24-Jul-2009

Grant Date

31-Dec-2003

Date of Filing

08-Sep-1999

Name of Patentee

M/S. TABLETS (INDIA) LIMITED

Applicant Address

179 T H ROAD, CHENNAI 600 081

Inventors:

#	Inventor's Name	Inventor's Address
1	RAJAGOPAL THIRUVENGADAM,	E-9 GRIHALAKSHMI APARTMENTS 640/643 T H ROAD, CHENNAI-600 081
2	MULLATH ARAVINDAKSHAN,	F-2 GRIHALAKSHMI APARTMENTS,640/643 TH ROAD, CHENNAI-600 081

PCT International Classification Number

C07C143/46

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA