Indian Patents. 230899:"NOVEL POLIO VACCINE FORMULATIONS CONTAINING SABIN STRAIN DERIVED INACTIVATED POLIO VACCINE AND PROCESS FOR THEIR PREPARATION"

Title of Invention	"NOVEL POLIO VACCINE FORMULATIONS CONTAINING SABIN STRAIN DERIVED INACTIVATED POLIO VACCINE AND PROCESS FOR THEIR PREPARATION"
Abstract	Novel multivalent vaccine formulation comprising sabin strain derived inactivated polio vaccine containing one or more types of polio viruses absorbed on an adjuvant alongwith a number 'n' of one or more other antigen(s) absorbed on an adjuvant, wherein the value of 'n' is between 1 to 10 is described.

Full Text	The present invention relates to of novel Polio Vaccine Formulation containing Sabin strain derived inactivated polio vaccine and process for their preparation. More particularly the present invention relates to Polio Vaccine. Formulations containing Sabin strain derived inactivated polio vaccine and number of other antigens effective against one or more of the pathogens like Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Bacille Calmette Guerin, Tuberculosis, Human Immunodeficiency Virus, Anthrax or the like. The Polio Vaccine Formulations prepared according to the present invention are very beneficial for children primararily immunized because it not only prevents polio infection but also to other types of infection to which the children are generally susceptible. The formulations prepared according to the present invention may be administered through the route such as Oral, Transdermal, Injection, Nasal, Mucosal, Subcutaneous, Intramuscular and the like. BACKGROUND OF THE INVENTION Polio is caused by three strains of quite stable viruses belonging to the family of entroviruses. There are different types of polio vaccines available in the market. These vaccines are trivalent containing a mixture of all the three strains of polio virus so as to confer immunity against all of them. Although different types of polio vaccines are known in the art but there is no prior art disclosure of a polio vaccine formulation containing Sabin strain derived inactivated polio vaccine and other antigens effective against pathogens causing infections among children. It is an object of the present invention to provide a stable and effective multivalent Polio Vaccine Formulations which on administration provides immunization not only against polio infection but also against other pathogens causing Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Bacille Camette Guerin, Tuberculosis, Human Immunodeficiency Virus, Anthrax or the like to which the children are generally susceptible. Accordingly the present invention provides a stable and effective multivalent Polio Vaccine formulations comprising Sabin strain derived inactivated polio vaccine and a number 'n' of other antigens, as herein described, wherein the value of n is 1 or greater than 1 and one or more conventional adjuvants. Preferably the value of 'n' is 1 to 10. More preferably the value of 'n' is 2, 3, 4, 5 or 6. The present invention also provides a process for the preparation of stable and effective multivalent Polio Vaccine Formulations which comprises mixing Sabin strain derived inactivated polio vaccine adsorbed on a conventional adjuvant with a number 'n' of other antigens as herein described, adsorbed on conventional adjuvant(s) wherein the value of n is one or greater than one. Preferably the value of 'n' is 1 to 10. More preferably the value of 'n' is 2, 3, 4, 5 or 6. The Sabin strain derived Polio vaccine used in the Formulations according to the present invention may be trivalent containing a mixture of all the three types namely Type 1, Type 2 and Type 3 of Polio virus or may be a mixture of any two said Types. The other antigens present in the Polio Vaccine Formulations according to the present invention are selected from those which provide immunity against one or more of the pathogens causing infections like Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Tuberculosis, Human Immunodeficiency Virus, Anthrax or the like to which the children are susceptible. As adjuvant(s), any Aluminium salt may be used. Preferably Aluminium Hydroxide or Aluminium Phosphate is used. The term 'multivalent' used herein means a vaccine formulation comprising more than two antigens, for example three, four, five or six antigens. The administration of the Polio Vaccine Formulations prepared according to the present invention would overcome or at least mitigate the problems associated with multiple injections of the different antigens. The Formulations provided by the present invention are stable and highly immunogenic which are particularly suitable for administration to children. ADVANTAGE OF THE POLIO VACCINE FORMULATIONS ACCORDING TO THE PRESENT INVENTION ARE : 1. Advantage of effective immunization against many diseases with single injection. 2. Sabin strain derived inactivated polio vaccine does not require growing of virulent strain of polio virus and hence its production process does not involve accidental release of live virulent polio viruses in the environment. 3. Sabin~~strain derived inactivated polio vaccine does not have disadvantages like vaccine associated paralytic poliomyelitis and vaccine derived virus. 4. Worldwide availability of production facilities. 5. Monovalent bulk available easily. 6. The Formulation combines the advantages of both Oral Polio Vaccine and Salk Inactivated Polio Vaccine. 7. Sabin strain derived inactivated polio vaccine can be effectively combined with other antigens. The Polio vaccine prepared from Sabin strain, as stated above, may be stabilized & inactivated, according to present invention, by the following process. STABILIZATION PROCESS: The monovalent bulk of poliovirus is to be initially stabilized by adding stabilizer like Sucrose or Trehalose or Arginine hydrochloride or Gelatin to retain the antigenicity of the vaccine during inactivation process. INACTIVATION PROCESS: Inactivation process is to be initiated immediately. Inactivation of each of filtered & purified monovalent pool is to be carried out by adding formaldehyde (formalin) at 0.025% concentration and incubation upto 37°C upto 12 days. FORMULATION AND MANUFACTURING OF THE VACCINE : The inactivated monovalent viruses may be mixed with stabilizer or/and preservative to make monovalent, bivalent or trivalent inactivated vaccine. The final vaccine may be spray dried & resuspended in ready-to-inject liquids like perfluorocarbons, requiring no refrigeration for storage or preparation before injection. The present invention is illustrated by the following example EXAMPLE 1: ' The Polio vaccine obtained by the standardized methods is used to provide a vaccine formulation comprising sabin strain derived inactivated Polio vaccine ( SIPV ) and a number ( n ) of other antigens in combination with an adjuvant comprising one or more aluminium salts in which the value of n is 1 or greater than 1. Preferably n is 1 to 10. More preferably n is 2,3,4,5 or 6. EXAMPLE 2 : In another aspect, the invention provides a vaccine formulation comprising Sabin strain derived inactivated Polio vaccine (SIPV) absorbed to Aluminium Phosphate (AP) and an antigen absorbed to AP or to Aluminium Hydroxide (AH) or any other suitable adjuvant selected from an antigen providing immunity against one or more of the following pathogens : Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Bacille Calmette Guerin, Tuberculosis, Human Immunodeficiency Virus, Anthrax or the like. EXAMPLE 3 : In another formulation, SIPV compatible antigens like antigens against Meningitis B, Meningitis A and C, and otitis media may also be included. EXAMPLE 4 : In a further aspect of the invention tnere is proviaea a siauie emu effective vaccine formulation directed to the prevention of more than two diseases, comprising SIPV and at least two other antigens selected from Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Tuberculosis, Human Immunodeficiency Virus and Anthrax. We claim: 1. Novel multivalent vaccine formulation comprising sabin strain derived inactivated polio vaccine containing one or more types of pollo viruses viruses absorbed on adjuvant alongwith a number 'n' of one or more other antigen(s) absorbed on an adjuvant, wherein the value of 'n' is between 1 to 10. 2. The multivalent vaccine formulation as claimed in claim 1, wherein the sabin strain derived inactivated polio vaccine is trivalent containing a mixture of all the three types of polio virus namely Type 1, Type 2 and Type 3. 3. The multivalent vaccine formulation as claimed in claim 1, wherein the sabin strain derived inactivated polio vaccine is divalent containing a mixture of any two types of polio virus namely Type 1 and Type 2, or Type 2 and Type 3, or Type 1 and Type 3. 4. A multivalent vaccine formulation as claimed in claim 1, wherein the adjuvant is an Aluminium salt. 5. A multivalent vaccine formulation as claimed in claim 4, wherein an Aluminium salt is Aluminium hydroxide or Aluminium phosphate. 6. A multivalent vaccine formulation as claimed in claims 1 to 5, wherein the one or more other antigen(s) are selected from the group comprising Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Bacille Calmette Guerin, Tuberculosis, Human Immunodeficiency Virus or Anthrax. 7. Novel multivalent vaccine formulations substantially as herein described and exemplified by the examples herein.

Full Text

The present invention relates to of novel Polio Vaccine Formulation containing Sabin strain derived inactivated polio vaccine and process for their preparation.
More particularly the present invention relates to Polio Vaccine. Formulations containing Sabin strain derived inactivated polio vaccine and number of other antigens effective against one or more of the pathogens like Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Bacille Calmette Guerin, Tuberculosis, Human Immunodeficiency Virus, Anthrax or the like.
The Polio Vaccine Formulations prepared according to the present invention are very beneficial for children primararily immunized because it not only prevents polio infection but also to other types of infection to which the children are generally susceptible.
The formulations prepared according to the present invention may be administered through the route such as Oral, Transdermal, Injection, Nasal, Mucosal, Subcutaneous, Intramuscular and the like.
BACKGROUND OF THE INVENTION
Polio is caused by three strains of quite stable viruses belonging to the family of entroviruses. There are different types of polio vaccines available in the market. These vaccines are trivalent containing a
mixture of all the three strains of polio virus so as to confer immunity against all of them.
Although different types of polio vaccines are known in the art but there is no prior art disclosure of a polio vaccine formulation containing Sabin strain derived inactivated polio vaccine and other antigens effective against pathogens causing infections among children.
It is an object of the present invention to provide a stable and effective multivalent Polio Vaccine Formulations which on administration provides immunization not only against polio infection but also against other pathogens causing Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Bacille Camette Guerin, Tuberculosis, Human Immunodeficiency Virus, Anthrax or the like to which the children are generally susceptible.
Accordingly the present invention provides a stable and effective multivalent Polio Vaccine formulations comprising Sabin strain derived inactivated polio vaccine and a number 'n' of other antigens, as herein described, wherein the value of n is 1 or greater than 1 and one or more conventional adjuvants.
Preferably the value of 'n' is 1 to 10. More preferably the value of 'n' is 2, 3, 4, 5 or 6.
The present invention also provides a process for the preparation of stable and effective multivalent Polio Vaccine Formulations which comprises mixing Sabin strain derived inactivated polio vaccine adsorbed on a conventional adjuvant with a number 'n' of other antigens as herein described, adsorbed on conventional adjuvant(s) wherein the value of n is one or greater than one.
Preferably the value of 'n' is 1 to 10. More preferably the value of 'n' is 2, 3, 4, 5 or 6.
The Sabin strain derived Polio vaccine used in the Formulations according to the present invention may be trivalent containing a mixture of all the three types namely Type 1, Type 2 and Type 3 of Polio virus or may be a mixture of any two said Types.
The other antigens present in the Polio Vaccine Formulations according to the present invention are selected from those which provide immunity against one or more of the pathogens causing infections like Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Tuberculosis, Human Immunodeficiency Virus, Anthrax or the like to which the children are susceptible.
As adjuvant(s), any Aluminium salt may be used. Preferably Aluminium Hydroxide or Aluminium Phosphate is used.
The term 'multivalent' used herein means a vaccine formulation comprising more than two antigens, for example three, four, five or six antigens.
The administration of the Polio Vaccine Formulations prepared according to the present invention would overcome or at least mitigate the problems associated with multiple injections of the different antigens. The Formulations provided by the present invention are stable and highly immunogenic which are particularly suitable for administration to children.
ADVANTAGE OF THE POLIO VACCINE FORMULATIONS ACCORDING TO THE PRESENT INVENTION ARE :
1. Advantage of effective immunization against many diseases with single injection.
2. Sabin strain derived inactivated polio vaccine does not require growing of virulent strain of polio virus and hence its production process does not involve accidental release of live virulent polio viruses in the environment.
3. Sabin~~strain derived inactivated polio vaccine does not have disadvantages like vaccine associated paralytic poliomyelitis and vaccine derived virus.
4. Worldwide availability of production facilities.
5. Monovalent bulk available easily.
6. The Formulation combines the advantages of both Oral Polio Vaccine and Salk Inactivated Polio Vaccine.
7. Sabin strain derived inactivated polio vaccine can be effectively combined with other antigens.
The Polio vaccine prepared from Sabin strain, as stated above, may be stabilized & inactivated, according to present invention, by the following process.
STABILIZATION PROCESS:
The monovalent bulk of poliovirus is to be initially stabilized by adding stabilizer like Sucrose or Trehalose or Arginine hydrochloride or Gelatin to retain the antigenicity of the vaccine during inactivation process.
INACTIVATION PROCESS:
Inactivation process is to be initiated immediately. Inactivation of each of filtered & purified monovalent pool is to be carried out by adding formaldehyde (formalin) at 0.025% concentration and incubation upto 37°C upto 12 days.
FORMULATION AND MANUFACTURING OF THE VACCINE :
The inactivated monovalent viruses may be mixed with stabilizer or/and preservative to make monovalent, bivalent or trivalent inactivated vaccine.
The final vaccine may be spray dried & resuspended in ready-to-inject liquids like perfluorocarbons, requiring no refrigeration for storage or preparation before injection.
The present invention is illustrated by the following example
EXAMPLE 1: '
The Polio vaccine obtained by the standardized methods is used to provide a vaccine formulation comprising sabin strain derived inactivated Polio vaccine ( SIPV ) and a number ( n ) of other antigens in combination with an adjuvant comprising one or more aluminium salts in which the value of n is 1 or greater than 1. Preferably n is 1 to 10. More preferably n is 2,3,4,5 or 6.
EXAMPLE 2 :
In another aspect, the invention provides a vaccine formulation comprising Sabin strain derived inactivated Polio vaccine (SIPV) absorbed to Aluminium Phosphate (AP) and an antigen absorbed to AP or to Aluminium Hydroxide (AH) or any other suitable adjuvant selected from an antigen providing immunity against one or more of the following pathogens :
Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Bacille Calmette Guerin, Tuberculosis, Human Immunodeficiency Virus, Anthrax or the like.
EXAMPLE 3 :
In another formulation, SIPV compatible antigens like antigens against Meningitis B, Meningitis A and C, and otitis media may also be included.
EXAMPLE 4 :
In a further aspect of the invention tnere is proviaea a siauie emu
effective vaccine formulation directed to the prevention of more than
two diseases, comprising SIPV and at least two other antigens
selected from Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A,
Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox,
Typhoid, Tuberculosis, Human Immunodeficiency Virus and
Anthrax.

We claim:
1. Novel multivalent vaccine formulation comprising sabin strain derived inactivated polio vaccine containing one or more types of pollo viruses viruses absorbed on adjuvant alongwith a number 'n' of one or more other antigen(s) absorbed on an adjuvant, wherein the value of 'n' is between 1 to 10.
2. The multivalent vaccine formulation as claimed in claim 1, wherein the sabin strain derived inactivated polio vaccine is trivalent containing a mixture of all the three types of polio virus namely Type 1, Type 2 and Type 3.
3. The multivalent vaccine formulation as claimed in claim 1, wherein the sabin strain derived inactivated polio vaccine is divalent containing a mixture of any two types of polio virus namely Type 1 and Type 2, or Type 2 and Type 3, or Type 1 and Type 3.
4. A multivalent vaccine formulation as claimed in claim 1, wherein the adjuvant is an Aluminium salt.
5. A multivalent vaccine formulation as claimed in claim 4, wherein an Aluminium salt is Aluminium hydroxide or Aluminium phosphate.
6. A multivalent vaccine formulation as claimed in claims 1 to 5, wherein the one or more other antigen(s) are selected from the group comprising Hepatitis C, Hepatitis D, Hepatitis E, Meningitis A, Meningitis B, Meningitis C, Meningitis W, Meningitis Y, Smallpox, Typhoid, Bacille Calmette Guerin, Tuberculosis, Human Immunodeficiency Virus or Anthrax.
7. Novel multivalent vaccine formulations substantially as herein described and exemplified by the examples herein.

Documents:

104-del-2002-abstract.pdf

104-del-2002-claims.pdf

104-del-2002-complete specification (granted).pdf

104-del-2002-correspondence-others.pdf

104-del-2002-correspondence-po.pdf

104-del-2002-description (complete).pdf

104-del-2002-description (provisional).pdf

104-del-2002-form-1.pdf

104-del-2002-form-13.pdf

104-del-2002-form-19.pdf

104-del-2002-form-2.pdf

104-del-2002-form-4.pdf

104-del-2002-form-5.pdf

104-del-2002-gpa.pdf

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Patent Number

230899

Indian Patent Application Number

104/DEL/2002

PG Journal Number

13/2009

Publication Date

27-Mar-2009

Grant Date

28-Feb-2009

Date of Filing

11-Feb-2002

Name of Patentee

PANACEA BIOTEC LIMITED

Applicant Address

B-1, EXT. A/27 MOHAN CO-OPERATIVE INDUSTRIAL ESTATE, MATHURA ROAD, NEW DELHI-110044, INDIA.

Inventors:

#	Inventor's Name	Inventor's Address
1	MISRA CHANDRANATH	PANACEA BIOTEC LIMITED., B-1, EXTN. A/27 MOHAN CO-OP. INDUSTRIAL ESTATE, MATHURA ROAD, NEW DELHI-110044, INDIA
2	CHAWLA ANIL KUMAR	PANACEA BIOTEC LIMITED., B-1, EXTN. A/27 MOHAN CO-OP. INDUSTRIAL ESTATE, MATHURA ROAD, NEW DELHI-110044, INDIA
3	KUMRAJ GANESH RAMACHANDRA	PANACEA BIOTEC LIMITED., B-1, EXTN. A/27 MOHAN CO-OP. INDUSTRIAL ESTATE, MATHURA ROAD, NEW DELHI-110044, INDIA
4	SINGH JASPREET	PANACEA BIOTEC LIMITED., B-1, EXTN. A/27 MOHAN CO-OP. INDUSTRIAL ESTATE, MATHURA ROAD, NEW DELHI-110044, INDIA

PCT International Classification Number

C12N 005/00

PCT International Application Number

N/A

PCT International Filing date

PCT Conventions:

#	PCT Application Number	Date of Convention	Priority Country
1			NA