Title of Invention	A PROCESS FOR PRODUCING A SYNERGESTIC PHARMACEUTICAL COMPOSITION FOR ENHANCING HAEMOGLOBIN SYNTHESIS AND ZINC ASSIMILATION
Abstract	We Claim: 1. A process for producing a synergestic pharmaceutical composition for enhancing haemoglobin synthesis and zinc , assimilation which comprises blending the compounds listed hereinunder in the range specified thereagainst with known i adjuvants and/or excipients. Ferrous Fumarate - 115 to 185 mg L Histidine HCL - 3 to 5 mg L Lysine Hydrochloride - 19 to 31 mg Glycine - 7.5 to 12.5 mg Vitamin B^ mononitrate - 3.75 to 6.25 mg Riboflavin (vitamin B2) - 2.25 to 3.75 mg

Title of Invention

A PROCESS FOR PRODUCING A SYNERGESTIC PHARMACEUTICAL COMPOSITION FOR ENHANCING HAEMOGLOBIN SYNTHESIS AND ZINC ASSIMILATION

Abstract

We Claim: 1. A process for producing a synergestic pharmaceutical composition for enhancing haemoglobin synthesis and zinc , assimilation which comprises blending the compounds listed hereinunder in the range specified thereagainst with known i adjuvants and/or excipients. Ferrous Fumarate - 115 to 185 mg L Histidine HCL - 3 to 5 mg L Lysine Hydrochloride - 19 to 31 mg Glycine - 7.5 to 12.5 mg Vitamin B^ mononitrate - 3.75 to 6.25 mg Riboflavin (vitamin B2) - 2.25 to 3.75 mg

Full Text	This invention relates to a process for produoing a synergestio pharmaceutical composition for enhancing haemoglobin synthesis and Zinc assimilation. This pharmaceutical composition consists of vitamins of the Group B, Vitamin C, three essential amino acids, necessary for haemoglobin synthesis metabolism and Zinc and iron salts which compliment: and assist in haemoglobin synthesis thereby promoting growth and reducing the rest of immunodeficiency. Vitamins are heterogenous organic compounds esential in small quantities for maintaining normal health, promoting growth and reducing the risk of infeotion. Human metabolic activity does not result in the synthesis of vitamins and as such they are to form a part of dietary intake regularly. Vitamins are either water soluble or oil soluble. Oil soluble vitamins are retained by the human system for a relatively longer period than the water soluble vitamins which are eliminated from the system easily. The need arises, therefore, to supplement the vitamins required by the system regularly. Most important water soluble vitamins belong to the vitamin 'B' group and vitamin %C. Deficiency of vitamin B group is known to oause weight loss, Pellagra, Neuromuscular disorders, Beri beri, anaemia and the like. Vitamin C is yet another water soluble vitamin which needs to be supplemented almost daily. Scurvy and anaemia may result if vitamin C is deficient in dietary Intake- Further it has also been established that a combination of vitamin C and iron enhances iron assimilation by the system. Proteins are complex nitrogen containing compounds formed mainly by amino aoid residues joined by peptide linkage. Complex proteins like glycoproteins, nucleo proteins, lipoproteins, chromo proteins and the like have residues of carbohydrates, fats and nuoleo acids conjugated with amino acid residues. Haemoglobin, the oxygen carrying protein present in red blood cells is a conjugate protein of Tour haemo groups which are organo metallic compounds containing iron. It is observed the diminution of the amount of total haemoglobin circulating in the blood stream results in anaemia. Absence of iron in food intake or improper assimilation of iron by the system causes anaemia. Growing children, women, nureiug mothers and oonvalesoents require more haemoglobin and their diets should be supplimented by iron containing compounds. Haemoglobin deficiency and resultant anaemia are more common in the developing and under-developed countries due to imbalanced intake of vitamins and minerals. Out of the twenty three amino acids generaly found in human metabolism, as building blocks for proteins, only eight are not produced by the system during metabolic activity. It has already been established that these eight amino aoids should find a place in the daily intake of food for maintaining proper growth and vitality. Out of these eight vital anino acids, three are found essential in haenoglobin synthesis metabolically. They are glycine, histidine and lysine. It has also been established that a composition of these three anino acids and an iron source increases the netabolic production of haenoglobin. Fron the above description it is clear that a conbination of the three anino aoids, vitanin B complex, vitamin C and a souroe of iron facilitates haenoglobin synthesis and easy assimilation of iron. Zinc is another essential trace element which plays a vital role in physiological processes. Many enzymes required for human netabolic activity are netallo enaynen having one or more inorganic elements as their constituents Zinc is found to be an important trace elenent that form a part of certain vital metallo enzymes involved in the metabolic pathways of synthesising carbohydrates, lipids and proteins. Zinc containing enzymes are also found to be beneficial in cell mediated immunity in convalescing patients. It is found that breast fed infants consume about 5 mg of zinc per day. During pregnancy and lactation increased intake of zinc is recommended. Zinc also is found to play a role in reducing hair fall and the process of aging in humans. We have now found that a combination of the three amino acids that go in the making of haemoglobin, B group of vitamins, vitamin C, a source of iron and a source of zinc enhances haemoglobin synthesis and increases assimilation of thhe trace elements, iron and zinc, during metabolic activity. We have also found that such a composition exhibits properties fundamentally different from the compounding ingredients and shows reinforced properties as the different components compliment each other in enhancing haemoglobin synthesis in the increased assimilation of essential minerals like 2inc and iron. The composition is found to be a synergestic dietary supplement resulting in augmenting immunity, promoting growth and health. This invention provides a process for producing a synergestic pharmaceutical composition for enhancing haemoglobin synthesis and zinc assimilation which comprises blending the compounds listed hereinunder in the range specified thereagainst with known adjuvants and/or excipients. Ferrous Fumarate - 115 to 185 mg L Histidine HCL - 3 to 5 mg L Lysine Hydrochloride - 18 to 31 mg Glycine - 7.5 to 12.5 mg Vitamin B1 mononitrate - 3.75 to 6.25 mg Riboflavin (vitamin B2) - 2.25 to 3.75 mg Vitamin Bg Hydrochloride - 1.2 to 1.8 mg Vitamin B12 - 1.9 to 3.1 meg Folio acid - 0.38 to 0.62 mg Ascorbic acid (Vitamin C) - 30 to 58 ng Zinc Sulphate - 35 to 86 ng Conventional additives, colourants, and exoipients nay be added depending upon the nature of the> oonposition to be prepared. For instance, if a liquid oomposition is required pharnaceutically acceptable liquid oarriers are added to the compounding ingredients which are subsequently dissolved or enulsified. Flavouring and colouring agents nay also be added to the conposition. Tablets and capsules can be prepared by nixing the above ingredients with pharnaoeutically acceptable carriers which are direotly tabletted or spheronised either together or in the desired groups which are then encapsulated in shells nade of pharnaoeutically acceptable biologically degradable materials. In a preferred embodiment compatible components of the conposition are grouped together, spheronised, dried and encapsulated together in the desired range. A conposition nay contain a plurality of granules, the total content of whioh is i within the range specified herein above For example, a single capsule may contain pink, orange, yellow, blue and brown granules of the oomposition specified herein below: 1. Pink Granules: • Vitamin B1 mononitrate - 6 mg Vitamin Bg hydrochloride - 1.578 mg Lactose - 0.5 mg Maize starch - 2.75 mg Colourant Erythrocin - 0.01 mg Microcrystalline cellulose - 2.0 mg Distilled water - 0.01 ml I The above ingredients are blended to form a uniform mass, extruded and then spheronised to form granules. The granules are then dried at 45° in a fluidised bed to a moisture content of 1.1 or below and are stored in a cool place till required. 2. Orange Granules: Riboflavin (Vitamin B2) - 3.3 mg Folic acid - 0.65 mg Vitamin B12 - 0.0025 mg Lactose - 6 mg Maize starch - 11 mg Micro crystalline cellulose - 4 mg Polyethylene glycol - 0.4 mg Sodium carboxy methyl cellulose- 0.3 mg Methhyl cellulose - 0.75 mg Distilled water - 0.1 ml All the ingredients are mixed and processed as stated in the case Of pink granules, and are stored in a cool place till required. 3. Yellow Granules: L Histidine Hydrochloride 4 mg Glycine - 113 mg L Lysine monohydroohhloride - 26 mg Laotose - 10 ml Maize starch - 16 mg Micro crystalline cellulose - 10 mg Methyl cellulose - 3 mg Colour Tartrazine - 0.3 mg Distilled water - 0.01 ml The above components are granulated and stored as stated under the pink granules. All the ingredients are blended and granulated as mentioned under the pink granules and are stored in a cool place till required. 5. Brown Granules: Ferrous Fumerate - 161 mg Maize starch - 27 mg Micro crystalline cellulose - 4.8 mg Sodium Carboxy methyl cellulose- 1 mg Sucrose - 33 mg Distilled water - 0.01 ml Methyl cellulose 3 mg Acetone - 0.039 ml Methyline chloride - 0.039 ml Castor oil - 0.38 mg All the above ingredients are homogenised and processed as stated under the pink granules. 6. Zinc Granules: i Zinc Sulphate - 50 mg Lactose - 197 mg Starch - 45 mg Micro crystalline cellulose - 75.5 mg Methyl Cellulose - 5 mg Distilled water - As required 0 All the above ingredients are homogenised to a uniform mass, wich I is extruded, spheronised to form granules. The granules are dried at 45°C in a fluidised bed drier to a moisture oontent of less than 1%. The dried granules may be stored in a oool, dry place till required. Required quantities of all the above 8 granules are blended and then encapsulated in pharmaceutically acceptable capsules. Required overage doeses of vitamins are to be included while preparing the composition. Obvious modifications and alterations known to persons skilled in the art are within the scope of this invention and the appended claims. We Claim: 1. A process for producing a synergestic pharmaceutical composition for enhancing haemoglobin synthesis and zinc , assimilation which comprises blending the compounds listed hereinunder in the range specified thereagainst with known i adjuvants and/or excipients. Ferrous Fumarate - 115 to 185 mg L Histidine HCL - 3 to 5 mg L Lysine Hydrochloride - 19 to 31 mg Glycine - 7.5 to 12.5 mg Vitamin B^ mononitrate - 3.75 to 6.25 mg Riboflavin (vitamin B2) - 2.25 to 3.75 mg Vitamin Bg Hydrochloride - 1.2 to 1.8 mg Vitamin B12 ~ 1.9 to 3.1 meg Folic acid - 0.38 to 0.62 mg Ascorbic acid (Vitamin C) - 30 to 56 mg Zinc Sulphate - 35 to 65 mg 2. The process as claimed in claim 1, wherein the said compounds are blended to form an emulsion, suspension or solution in known pharmaceutically acceptable adjuvants or oarriers. 3. The process as claimed in claim 1 wherein the compounds are blended and tabletted. 4. The process as olaimed in claim 1 wherein the compounds are blended, granulated and encapsulated in a parmaceutically acceptable bio degradable casing. 5. The process as claimed in claims 1 and 4 wherein compatible compounds are blended together, spheronised and then further blended in the required amount before encapsulation. 6. The process as claimed in the above claims wherein pharmaceutical^ acceptable oolourants are added. 7. The process as claimed in claims 1, 5 and 6 wherein different colourants are added to separate groups of compatible compounds. 8. The process as claimed in claims 1, 4 and 5 wherein the granules are dried in a fluidised bed drier to a moisture content of less than IX. 9. A prooess for producing a synergestic pharmaceutical composition for enhancing haemoglobin synthesis and zinc assimilation substantially as herein described.

Full Text

This invention relates to a process for produoing a synergestio pharmaceutical composition for enhancing haemoglobin synthesis and Zinc assimilation. This pharmaceutical composition consists of vitamins of the Group B, Vitamin C, three essential amino acids, necessary for haemoglobin synthesis metabolism and Zinc and iron salts which compliment: and assist in haemoglobin synthesis thereby promoting growth and reducing the rest of immunodeficiency.
Vitamins are heterogenous organic compounds esential in small quantities for maintaining normal health, promoting growth and reducing the risk of infeotion. Human metabolic activity does not result in the synthesis of vitamins and as such they are to form a part of dietary intake regularly. Vitamins are either water soluble or oil soluble. Oil soluble vitamins are retained by the human system for a relatively longer period than the water soluble vitamins which are eliminated from the system easily. The need arises, therefore, to supplement the vitamins required by the system regularly. Most important water soluble vitamins belong to the vitamin 'B' group and vitamin %C. Deficiency of vitamin B group is known to oause weight loss, Pellagra, Neuromuscular disorders, Beri beri, anaemia and the like. Vitamin C is yet another water soluble vitamin which needs to be supplemented almost daily. Scurvy and anaemia may result if vitamin C is deficient in dietary Intake- Further it has also

been established that a combination of vitamin C and iron enhances iron assimilation by the system.
Proteins are complex nitrogen containing compounds formed mainly by amino aoid residues joined by peptide linkage. Complex proteins like glycoproteins, nucleo proteins, lipoproteins, chromo proteins and the like have residues of carbohydrates, fats and nuoleo acids conjugated with amino acid residues. Haemoglobin, the oxygen carrying protein present in red blood cells is a conjugate protein of Tour haemo groups which are organo metallic compounds containing iron. It is observed the diminution of the amount of total haemoglobin circulating in the blood stream results in anaemia. Absence of iron in food intake or improper assimilation of iron by the system causes anaemia. Growing children, women, nureiug mothers and oonvalesoents require more haemoglobin and their diets should be supplimented by iron containing compounds. Haemoglobin deficiency and resultant anaemia are more common in the developing and under-developed countries due to imbalanced intake of vitamins and minerals. Out of the twenty three amino acids generaly found in human metabolism, as building blocks for proteins, only eight are not produced by the system during metabolic activity. It has already been established that these eight amino aoids should find a place in the daily intake of food for maintaining proper growth and vitality. Out of these eight

vital anino acids, three are found essential in haenoglobin synthesis metabolically. They are glycine, histidine and lysine. It has also been established that a composition of these three anino acids and an iron source increases the netabolic production of haenoglobin.
Fron the above description it is clear that a conbination of the three anino aoids, vitanin B complex, vitamin C and a souroe of iron facilitates haenoglobin synthesis and easy assimilation of iron.
Zinc is another essential trace element which plays a vital role in physiological processes. Many enzymes required for human netabolic activity are netallo enaynen having one or more inorganic elements as their constituents Zinc is found to be an important trace elenent that form a part of certain vital metallo enzymes involved in the metabolic pathways of synthesising carbohydrates, lipids and proteins. Zinc containing enzymes are also found to be beneficial in cell mediated immunity in convalescing patients. It is found that breast fed infants consume about 5 mg of zinc per day. During pregnancy and lactation increased intake of zinc is recommended. Zinc also is found to play a role in reducing hair fall and the process of aging in humans. We have now found that a combination of the three amino acids that go in the making of haemoglobin, B group

of vitamins, vitamin C, a source of iron and a source of zinc enhances haemoglobin synthesis and increases assimilation of thhe trace elements, iron and zinc, during metabolic activity. We have also found that such a composition exhibits properties fundamentally different from the compounding ingredients and shows reinforced properties as the different components compliment each other in enhancing haemoglobin synthesis in the increased assimilation of essential minerals like 2inc and iron. The composition is found to be a synergestic dietary supplement resulting in augmenting immunity, promoting growth and health.
This invention provides a process for producing a synergestic pharmaceutical composition for enhancing haemoglobin synthesis and zinc assimilation which comprises blending the compounds listed hereinunder in the range specified thereagainst with known adjuvants and/or excipients.
Ferrous Fumarate - 115 to 185 mg
L Histidine HCL - 3 to 5 mg
L Lysine Hydrochloride - 18 to 31 mg
Glycine - 7.5 to 12.5 mg
Vitamin B1 mononitrate - 3.75 to 6.25 mg
Riboflavin (vitamin B2) - 2.25 to 3.75 mg
Vitamin Bg Hydrochloride - 1.2 to 1.8 mg
Vitamin B12 - 1.9 to 3.1 meg

Folio acid - 0.38 to 0.62 mg
Ascorbic acid (Vitamin C) - 30 to 58 ng
Zinc Sulphate - 35 to 86 ng
Conventional additives, colourants, and exoipients nay be added depending upon the nature of the> oonposition to be prepared. For instance, if a liquid oomposition is required pharnaceutically acceptable liquid oarriers are added to the compounding ingredients which are subsequently dissolved or enulsified. Flavouring and colouring agents nay also be added to the conposition. Tablets and capsules can be prepared by nixing the above ingredients with pharnaoeutically acceptable carriers which are direotly tabletted or spheronised either together or in the desired groups which are then encapsulated in shells nade of pharnaoeutically acceptable biologically degradable materials.
In a preferred embodiment compatible components of the conposition are grouped together, spheronised, dried and encapsulated together in the desired range. A conposition nay
contain a plurality of granules, the total content of whioh is
i
within the range specified herein above For example, a single capsule may contain pink, orange, yellow, blue and brown granules of the oomposition specified herein below:
1. Pink Granules:
• Vitamin B1 mononitrate - 6 mg
Vitamin Bg hydrochloride - 1.578 mg

Lactose - 0.5 mg
Maize starch - 2.75 mg
Colourant Erythrocin - 0.01 mg
Microcrystalline cellulose - 2.0 mg
Distilled water - 0.01 ml
I The above ingredients are blended to form a uniform mass,
extruded and then spheronised to form granules. The granules are
then dried at 45° in a fluidised bed to a moisture content of 1.1
or below and are stored in a cool place till required.
2. Orange Granules:
Riboflavin (Vitamin B2) - 3.3 mg
Folic acid - 0.65 mg
Vitamin B12 - 0.0025 mg
Lactose - 6 mg
Maize starch - 11 mg
Micro crystalline cellulose - 4 mg
Polyethylene glycol - 0.4 mg
Sodium carboxy methyl cellulose- 0.3 mg
Methhyl cellulose - 0.75 mg
Distilled water - 0.1 ml
All the ingredients are mixed and processed as stated in the case Of pink granules, and are stored in a cool place till required.

3. Yellow Granules:
L Histidine Hydrochloride 4 mg
Glycine - 113 mg
L Lysine monohydroohhloride - 26 mg
Laotose - 10 ml
Maize starch - 16 mg
Micro crystalline cellulose - 10 mg
Methyl cellulose - 3 mg
Colour Tartrazine - 0.3 mg
Distilled water - 0.01 ml
The above components are granulated and stored as stated under
the pink granules.

All the ingredients are blended and granulated as mentioned under the pink granules and are stored in a cool place till required.
5. Brown Granules:
Ferrous Fumerate - 161 mg
Maize starch - 27 mg
Micro crystalline cellulose - 4.8 mg
Sodium Carboxy methyl cellulose- 1 mg
Sucrose - 33 mg
Distilled water - 0.01 ml
Methyl cellulose 3 mg
Acetone - 0.039 ml
Methyline chloride - 0.039 ml
Castor oil - 0.38 mg
All the above ingredients are homogenised and processed as stated under the pink granules.
6. Zinc Granules:
i
Zinc Sulphate - 50 mg
Lactose - 197 mg
Starch - 45 mg
Micro crystalline cellulose - 75.5 mg
Methyl Cellulose - 5 mg
Distilled water - As required

0
All the above ingredients are homogenised to a uniform mass, wich I is extruded, spheronised to form granules. The granules are dried at 45°C in a fluidised bed drier to a moisture oontent of less than 1%. The dried granules may be stored in a oool, dry place till required.
Required quantities of all the above 8 granules are blended and then encapsulated in pharmaceutically acceptable capsules. Required overage doeses of vitamins are to be included while preparing the composition.
Obvious modifications and alterations known to persons skilled in the art are within the scope of this invention and the appended claims.

We Claim:
1. A process for producing a synergestic pharmaceutical
composition for enhancing haemoglobin synthesis and zinc
, assimilation which comprises blending the compounds listed
hereinunder in the range specified thereagainst with known
i adjuvants and/or excipients.
Ferrous Fumarate - 115 to 185 mg
L Histidine HCL - 3 to 5 mg
L Lysine Hydrochloride - 19 to 31 mg
Glycine - 7.5 to 12.5 mg
Vitamin B^ mononitrate - 3.75 to 6.25 mg
Riboflavin (vitamin B2) - 2.25 to 3.75 mg
Vitamin Bg Hydrochloride - 1.2 to 1.8 mg
Vitamin B12 ~ 1.9 to 3.1 meg
Folic acid - 0.38 to 0.62 mg
Ascorbic acid (Vitamin C) - 30 to 56 mg
Zinc Sulphate - 35 to 65 mg
2. The process as claimed in claim 1, wherein the said
compounds are blended to form an emulsion, suspension or solution
in known pharmaceutically acceptable adjuvants or oarriers.
3. The process as claimed in claim 1 wherein the compounds are
blended and tabletted.

4. The process as olaimed in claim 1 wherein the compounds are blended, granulated and encapsulated in a parmaceutically acceptable bio degradable casing.
5. The process as claimed in claims 1 and 4 wherein compatible compounds are blended together, spheronised and then further blended in the required amount before encapsulation.

6. The process as claimed in the above claims wherein pharmaceutical^ acceptable oolourants are added.
7. The process as claimed in claims 1, 5 and 6 wherein different colourants are added to separate groups of compatible compounds.
8. The process as claimed in claims 1, 4 and 5 wherein the granules are dried in a fluidised bed drier to a moisture content of less than IX.
9. A prooess for producing a synergestic pharmaceutical composition for enhancing haemoglobin synthesis and zinc assimilation substantially as herein described.

Documents:

1203-mas-1996 others.pdf

1203-mas-1996 claims.pdf

1203-mas-1996 correspondence others.pdf

1203-mas-1996 description (complete).pdf

1203-mas-1996 form-1.pdf

1203-mas-1996 form-26.pdf

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Patent Number

182574

Indian Patent Application Number

1203/MAS/1996

PG Journal Number

30/2009

Publication Date

24-Jul-2009

Grant Date

03-Dec-1999

Date of Filing

09-Jul-1996

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	MULLATH ARAVINDAKSHAN	NEF-2 GRIHALAKSHMI APARTMENTS 640/643 TH ROAD, CHENNAI-600 081
2	DR. MALLADI SURYA PRAKASHSASTRY	A-13 GRIHALAKSHMI APARTMENT 640-643 TH ROAD, CHENNAI-600 081

PCT International Classification Number

A61K33/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA