Title of Invention

PHARMACEUTICAL INJECTION FOR TREATMENT OF JOUNDICE & ANAEMIA

Abstract An injectable pharmaceutical formulation for treatment of jaundice and anaemia, the injectable pharmaceutical formulation each one mi comprising: Each one ml of Injection contains iron dextran IP equivalent to elemental iron IP 12.5 mg to 70 mg Cyanacobalamine IP 100 meg to 1000 meg Folic acid IP 2.5 mg to 15 mg Niacinamide IP 20mg to 100 mg Thiamine hydrochloride IP 20 mg to lOOmg Riboflavin phosphate sodium IP equivalent to riboflavin IP 3 mg to 15 mg Pyridoxins hydrochloride IP 5 mg to 25 mg D Panthenol IP 5mg to 50 mg Choline chloride IP 2mg to 10 mg DL Methionine BP 2mg to 10 mg Benzyl alcohol IP (as preservative)2% V/V to 3% V/V; Chlorocresol IP (as preservative)0.1%V/V and Water for injection IP q.s.
Full Text FORM 2
THE PATENT ACT 1970
(30 of 1970)
&
The Patents Rules, 2003
COMPLETE SPECIFICATION
(See section 10 and rule13)
1, TITLE OF THE INVENTION Pharmaceutical, injectable formulation for tretment of jaundice &Anaenmia
2. APPLICANT (S)

(a)NAME: Shivshankar Baburao Biedae.

(b)NATIONALITY: Indian

(c) ADDRES: Samata Nagar,Shahu Chawk, Dam Rd.Udgie
Pin : 413513 DBt ,Latutr.
PREAMBLE TO THE DESCRIPTlON
The following specification particularly describes
the invention and the manner in which it is to be
performed.

4. DESCRIPTION (Description shall start from next page.)
5. CLAIMS (not applicable for provisional specification. Claims should start with the preamble —
"l/we claim" on separate page)
6. DATE AND SIGNATURE (to be given at the end of last page of specification)
7. ABSTRACT OF THE INVENTION (to be given along with complete specification on separate
page)
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*To be signed by the applicant(s) or by authorized registered patent agent. .
*'Name of the applicant should be given In full family name In the beginning .
*Complete address of the applicant should be given stating the postal Index no./code, state and
country.
Pharmaceutical Injectable Formulation for Treatment of Jaundice and Anaemia
Field of Invention
The present invention relates to a pharmaceutical division, and more particularly, to a pharmaceutical formulation for treatment of jaundice and anaemia.
Conventional methods of treatment of jaundice and anaemia are lengthy, expensive and vary according to patient to patient. Generally, physicians use oral haematinics to treat anaemic patients. Alternatively, intramuscular injection of vitamin B12 and Folic acid are given for a long duration to treat anaemia. Further, in extreme anaemic conditions, blood transfusion is advised followed by oral haematinics and intravascular saline therapy.
For the treatment of jaundice (Hepatitis A), patients are treated in hospitals symptomatica I ly.
Line of treatment includes oral/injectable antibiotics, antacids and liquid protein preparations given by intravenous route. Alternatively, patients may be treated as outpatients by giving certain type of liver tonics along with antacids and digestive preparations.
However, the treatment given for jaundice as well as anaemia is symptomatic and route causes of the diseases are not treated. The patient may feel better after

receiving symptomatic treatment but may experience loss of appetite, gaseous disturbances and indigestion. Further, in patients suffering from anaemia and jaundice, the rate of destruction or breakdown of red bold cells (RBC) is high and platelet count is also reduced due to which patient needs blood transfusion. Furthermore, liver function is also affected due to which Serum bilirubin levelx Serum Glutamic Pyruvic Transaminase (SGPT), and Serum Glutamic Oxaloacetic Transaminase (SGOT) levels are also high.
Existing medications do not act immediately to raise the red blood cells levels in the body. Further, the oral therapy or injectables mentioned above are not capable of curing fatigue, toss of appetite, generalized disability of the patients due to jaundice or anaemia. Even after the treatment by abovementioned methods, patients still suffer from nausea, vomiting, gaseous disturbances, and spasm.
Accordingly, there exists a need for a formulation which overcomes all the drawbacks of the conventional methods of treatment.
Objects of the invention
An object of the present invention is to provide a pharmaceutical formulation capable of improving patients overall disability caused by jaundice and anaemia.
Another object of the present invention is to provide a pharmaceutical formulation which decreases loss of appetite, fatique,sleepleesness,general debility,nausea,

vomiting, gaseous disturbances, and colic spasm of the patient suffering from jaundice and anaemia.
Yet another object of the present invention is to provide a pharmaceutical formulation which decreases the rate of destruction of red blood cells in patients suffering from jaundice and anaemia.
Summary of the invention
Accordingly, the present invention provides an injectable pharmaceutical formulation for treatment of jaundice and anaemia, the injectable pharmaceutical formulation comprising:
Each one ml contains :-
iron dextran IP equivalent to elemental iron IP 12.5mg to 70 mg;
Cyanacobalamin IP 100 to 1000 meg;
Folic acid IP 2.5 mg to 15 mg;
Niacinamide IP 20 mg to 100 mg;
Thiamine hydrochloride IP 20 mg to 100 mg;
Riboflavin phosphate sodium IP equivalent to riboflavin IP 3mg to 15 mg;
Pyridoxine hydrochloride IP 5 mg to 25mg;
D Panthenol IP 5mg to 50 mg;
Choline chloride IP 2 mg to 10 mg;
DL methionine BP 2 mg to 10 mg;
Benzyl alcohol IP 2%V/V to 3 % V/V;
Chlorocresol IP 0.1%V/V and

Typically, wherein the route of administration is Intramuscular Route.
Detailed description of the invention
The foregoing objects of the invention are accomplished the problems and shortcomings associated with prior art techniques and approaches are overcame by the present invention as described below in the preferred embodiment.
The present invention provides a pharmaceutical formulation capable of improving patients overall dibility caused by jaundice and anaemia. Further, the pharmaceutical formulation decreases nausea, vomiting, gaseous disturbances, and colic spasm etc. of the patients suffering from jaundice and anaemia. Furthermore, the pharmaceutical formulation decreases the rate of destruction of red blood cells, in patients suffering from jaundice and anemia.
Accordingly, the present invention provides an injectable pharmaceutical formulation (hereinafter referred as the "formulation") for treatment of jaundice and anaemia in accordance with the present invention. The formulations comprises Iron dextran IP equivalent to elemental iron IP 12.5mg to 70 mg, Cyanacobalamin IP 100 to 1000 meg, Folic acid IP 2.5 mg to 15 mg, Niacinamide IP 20 mg to 100 mg, Thiamine hydrochloride IP 20 mg to 100 mg, Riboflavin phosphate sodium IP equivalent to riboflavin IP 3 mg to 15 mg, Pyridoxine hydrochloride IP 5 mg to 25 mg, D Panthenol IP 5 mg to 50 mg, Choline chloride IP 2 mg to 10 mg, DL methionine BP 2 mg to 10 mg, Benzyl alcohol IP 2%V/V to 3% V/V, Chlorocresol IP 0.1% V/V and Water for injection quantity sufficient to make one ml of the injectable formulation.
The formulation of the present invention is given intramuscularly. However, it may be evident to those skilled in the art to give the injectable formulation by at least

one route of administration selected from intravascular in drip, subcutaneous and intradermal route which may provide good bioavailability. Specifically, the formulation is given 2ml/50kg body weight.
The formulation of the present invention gives a feeling of Hunger to the patients suffering from jaundice and anaemia within 3-4 hours of administration. Specifically, the symptom of loss of appetite is overcome within same day of administration of the formulation. Further, generalized dibility of the patients suffering from jaundice and anaemia is reduced by 70% on the same day of administration of the formulation. Further, liver function tests (LFT) such as Serum bilirubin level, Serum Glutamic Pyruvic Transaminase (SGPT), and Serum Glutamic Oxaloacetic Transaminase (SGOT) levels becomes normal within 8-15 days of the treatment with the formulation of the present invention.
The formulation of the present invention provides iron dextran equivalent to elemental iron along with folic acid and other vitamins mentioned above in combination rather than giving them individually, which makes the treatment of the jaundice and anaemia easy. As the individual use of above mentioned integrants seemed to be incapable of giving desired results in these patients.
Further, the patients with treatment with the formulation rarely need IV fluid supplements to correct electrolyte imbalance. Furthermore, due to immediate symptomatic relief, patients are not required to be hospitalized and the patients can be treated on outpatient basis. The results of clinical trials for jaundice and anemia performed using the formulation of the present invention are as follows.

1. Clinical trial results for jaundice
100 patients suffering from jaundice were studied before and after administration of the formulation of the present invention.
Out of 100 patients, 70 patients were having Serum Billirubin Level (SBL) above 15mg/dl before administration of the formulation. After administration of the formulation of the present invention, the SBL level came down to 7mg/dl within 8 days. Further, the SBL level became normal ofter 15 days of the administration of the formulation.
The remaining 30 patients were having SBL level more than 20mg/dl to 30 mg/dl. Out of 30 patients, 25 patients attained the normal SBL level after administration of the three doses of the formulation keeping 8 days gap between each dose administration.
Further, the remaining 5 patients were referred to hospitals without administration of the formulation, as these patients were suffering from Ascitis, Hepatic coma and could not be treated with the formulation of the present invention as their general conditions were very poor.
2. Clinical trial results for anaemia
100 patients suffering from anaemia were studied before and after administration of the formulation of the present invention.

Out of 100 patients, 60 patients were having Haemoglobin level (HB%) between 5 gm%_to 9 gm%. After administration of the formulation of the present invention, the Haemoglobin level was raised by 2 gm% within 8 days. Further, the haemoglobin level became normal after subsequent administration of the formulation after next 8 days.
The 30 patients having haemoglobin level between 9 gm% to 11 gm% became normal with their haemoglobin level within 8 days after administration of the formulation followed by oral haematinic therapy.
Further, the remaining 10 patients were referred to hospitals for blood transfusion without administration of the formulation, as these patients were having haemoglobin levels between 2 gm% to 4 gm% and could not be treated on outpatient basis as their general condition were very poor.
3. Clinical trial results for jaundice and anaemia
100 patients suffering from jaundice and anaemia were studied before and after administration of the formulation of the present invention.
Out of 100 patients, 60 patients were having Serum Billirubin Level (SBL) between 15mg/dl to 20 mg/dl and Haemoglobin level between 5 gm% to 9 gm%. After administration of the formulation of the present invention, the SBL level came down to 7mg/dl to lOmg/dl and haemoglobin level was raised to 7gm% to 10 gm% within 8 -10 days.

Almost all patients approached their normal SBL and haemoglobin level by two injections of the formulation with 8 days gap between two administrations and followed by oral routine therapy.
The remaining 30 patients having SBL level between 20mg/dl to 25 mg/dl and haemoglobin level between 4 gm% to 7 gm% attained the normal SBL and haemoglobin level after administration of the formulation three to four times with 8 days gap between each administration and followed by oral routine therapy.
Further, the remaining 10 patients were referred to Higher center for hospitalization without administration of the formulation, as these patients were having haemoglobin levels between 2 gm% to 4 gm% and SBL 25 mg/dl to 35 mg/dl. The patients were suffering from severe Anaemia and Ascitis, Hepatic coma, Intermittent high grade fever so could not be treated with the formulation of the present invention.
The following examples show the use of the formulation with exact content of each ingredient for treatment of jaundice and anaemia.
Example 1
Grade I Jaundice (SBL 2mg/dl to 7mg/dl) and Grade I Anaemia (haemoglobin level 8 gm% to 11 gm%) were treated by using the following formulation in accordance with the present invention
iron dextran IP equivalent to elemental iron IP 12.5 mg
Cyanacobalamine IP 250 meg

Folic acid IP 2.5 mg
Niacinamide IP 20 mg
Thiamine hydrochloride IP 20 mg
Riboflavin phosphate sodium IP equivalent to riboflavin IP 3 mg
Pyridoxine hydrochloride IP 5 mg
DPanthenol IP 5mg
Choline chloride IP 2 mg
DL methionine BP 2mg
Benzyl alcohol IP 2%V/V;
Chlorocreso! IP 0.1%V/V and
Water for injection IP q.s.
Example 2
Grade II Jaundice (SBL 7mg/dl tol5 mg/dl) and Grade II Anaemia (haemoglobin
level 5gm% to 8gm%) were treated by using the following formulation in
accordance with the present invention,
Each one ml of Injection contains
Iron dextran IP equivalent to elemental iron IP 70 mg
Cyanacobalamine IP 500 meg
Folic acid IP 10 mg
Niacinamide IP 50 mg
Thiamine hydrochloride IP 50 mg
Riboflavin phosphate sodium IP equivalent to riboflavin IP 10 mg

Pyridoxine hydrochloride IP 15 mg
DPanthenol IP 30 mg
Choline chloride IP 5 mg
DL Methionine BP 5 mg
Benzyl alcohol IP (as preservative) 3% V/V;
Chlorocresol IP (as preservative) 0.1%V/V and
Water for injection IP qs.
Example 3 :
Grade III Jaundice (SBL 15mg/dl to 30 mg/dl) and Grade III Anaemia (haemoglobin level 4gm% to 5gm%) were treated by using the following formulation in accordance with the present invention,
Each one ml of Injection contains
Iron dextran IP equivalent to elemental iron IP 70 mg
Cyanacobalamine IP 1000 meg
Folic acid IP 15 mg
Niacinamide IP 100 mg
Thiamine hydrochloride IP 100 mg
Riboflavin phosphate sodium IP equivalent to riboflavin IP 15 mg
Pyridoxine hydrochloride IP 25 mg
D Panthenol IP 50 mg
Choline chloride IP 10 mg

DL Methionine BP 10 mg
Benzyl alcohol IP (as preservative) 3%V/V;
Chlorocresol IP (as preservative) 0.1%V/V arid
Water for injection IP q.s.
The foregoing descriptions of specific embodiments of the present invention have been presented for purposes of illustration and description, They are n I clairQ
1. An injectable pharmaceutical formulation for treatment of jaundice
and anaemia, the injectable pharmaceutical formulation each one ml comprising:
Each one ml of injection contains
Iron dextran IP equivalent to elemental iron IP 12.5 mg to 70 mg
Cyanacobalamine IP 100 meg to 1000 meg
Folic acid IP 2.5mgtol5mg
Niacinamide IP 20mg to 100 mg
Thiamine hydrochloride IP 20 rng to lOOrng

Riboflavin phosphate sodium IP equivalent to riboflavin IP 3 mg to 15 mg
Pyridoxine hydrochloride IP 5 mg to 25 mg
DPanthenol IP 5mg to 50mg
Choline chloride IP 2mg to l0mg
DL Methionine BP 2mg to 10 mg
Benzyl alcohol IP (as preservative) 2% V/V to 3% V/V;
Chlorocresol IP (as preservative) 0.1%V/V and
Water for injection IP q.s.
2. The injectable pharmaceutical formulation of claim 1, wherein the route of administration is intramuscular route.

Documents:

634-MUM-2011-ABSTRACT(30-5-2013).pdf

634-mum-2011-abstract.doc

634-mum-2011-abstract.pdf

634-MUM-2011-CLAIMS(AMENDED)-(30-5-2013).pdf

634-mum-2011-claims.doc

634-mum-2011-claims.pdf

634-mum-2011-description(complete).pdf

634-mum-2011-form 1.pdf

634-MUM-2011-FORM 18.pdf

634-mum-2011-form 2(title page).pdf

634-mum-2011-form 2.doc

634-mum-2011-form 2.pdf

634-mum-2011-form 3.pdf

634-mum-2011-form 5.pdf

634-MUM-2011-FORM 9.pdf

634-MUM-2011-OTHER DOCUMENT(30-5-2013).pdf

634-MUM-2011-REPLY TO EXAMINATION REPORT(30-5-2013).pdf

634-MUM-2011-SPECIFICATION(AMENDED)-(30-5-2013).pdf


Patent Number 257794
Indian Patent Application Number 634/MUM/2011
PG Journal Number 45/2013
Publication Date 08-Nov-2013
Grant Date 05-Nov-2013
Date of Filing 07-Mar-2011
Name of Patentee BIRADAR SHIVSHANKAR BABURAO
Applicant Address SAMTA NAGAR, NEAR SHAHU CHOWK, UDGIR, DIST LATUR
Inventors:
# Inventor's Name Inventor's Address
1 BIRADAR SHIVSHANKAR BABURAO SAMTA NAGAR, NEAR SHAHU CHOWK, UDGIR, DIST LATUR
PCT International Classification Number A61K31/00,A61K9/00
PCT International Application Number N/A
PCT International Filing date
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 NA