Abstract: The present invention relates to vaccine formulations comprising preservative systems. More particularly, the present invention relates to preservative systems for vaccine formulations which is free of thiomersal, and comprising 2-phenoxyethanol and at least one other preservative selected from m-cresol, benzyl alcohol, phenol and benzoic acid.
We claim:
1. A vaccine formulation comprising, a preservative system comprising 2-phenoxyethanol at a concentration in the range of 0.1% to 0.6 % and at least one other preservative selected from the group consisting of m-cresol, benzyl alcohol, phenol and benzoic acid.
2. The preservative system as claimed in claim 1, wherein the concentration of m-cresol, benzyl alcohol, phenol and benzoic acid is in a range from 0.005% to 0.3%.
3. The preservative system as claimed in claim 1, comprising one or more pharmaceutically acceptable carriers.
4. The vaccine formulation as claimed in claim 1, wherein the vaccine formulation is a monovalent vaccine or a multivalent combination vaccine.
5. A monovalent vaccine formulation as claimed in claim 4, wherein the monovalent vaccine formulation comprises antigens selected or isolated from a group comprising Streptococcus pneumonia (Pneumococcal capsular polysaccharide), Neisseria meningitides (Men A, C, W-135, X or Y), Salmonella typhi (Vi), Salmonella paratyphi (0:2), Haemophilus influenza (Hib-PRP), Corynebacterium Diptheriae (Diptheriae Toxoid-DT), Bordetella pertussis (wP/ aP), Clostridium tetani (Tetanus Toxoid), Hepatitis A Virus (HAV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Inactivated Japanese Encephalitis Virus, Rabies Virus and Inactivated Poliomyelitis Virus.
6. A multivalent vaccine formulation as claimed in claim 4, wherein the multivalent vaccine formulation is selected from a group comprising bivalent vaccine, trivalent vaccine, tetravalent vaccine, pentavalent vaccine, hexavalent vaccine and pneumococcal conjugate vaccine.
7. The multivalent vaccine formulation as claimed in claim 6 wherein bivalent vaccine is selected from a group comprising Td vaccine, Vi:02 conjugate and MR;
and, wherein trivalent vaccine is selected from a group comprising DTwP, Vi:02-HepA and MMR;
and, wherein tetravalent vaccine is selected from a group comprising DTwP-Hib, DTaP-Hib, DTwP-IPV, DTwP-HepB, ACW-135Y;
and, wherein pentavalent vaccine is selected from a group comprising DTwPHib-
HepB and DTaPHib-HepB;
and, wherein hexavalent vaccine is selected from a group comprising DTwPHib-HepB-IPV and DTaPHib-HepB-IPV.
8. The vaccine formulation as claimed in claim 6, wherein the pneumococcal conjugate vaccine comprises one or more pneumococcal capsular polysaccharide protein conjugates, preservative system as claimed in claim 1 and optionally, one or more pharmaceutically acceptable carriers.
9. The vaccine formulation as claimed in claim 8, wherein the pneumococcal capsular polysaccharide protein conjugates comprises Streptococcus pneumonia capsular polysaccharides selected from a group comprising serotype 1, 2, 3, 4, 5, 6A, 6B, 6C, 6D, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39 and 45; and, wherein each polysaccharide is conjugated to a carrier protein selected from PsaA, CRM197 and inactivated bacterial toxins selected from diphtheria toxoid (DT), tetanus toxoid (TT), pertussis toxoid, cholera toxoid and Haemophilus influenzae protein D, or combination thereof.
10. The vaccine formulation as claimed in claim 9 wherein each pneumococcal capsular polysaccharide is selected from Streptococcus pneumonia serotypes 1, 2, 3,4, 5, 6A, 6B, 6C, 7F, 8, 9N, 9V, 10A, 11A, 12F, 14, 15A, 15B, 15C, 16F, 17F, 18C, 19F, 19A, 20A, 20B, 22F, 23A, 23B, 23F, 24B, 24F, 31, 33F, 34, 35B, 35F, 38, 39, and 45 conjugated to a carrier protein and a preservative system as claimed in claim 1, wherein the preservative composition comprises 2-phenoxyethanol at a concentration in the range of 0.1% to 0.6 % and at least one other preservative selected from a group comprising m-cresol at a concentration in the range of 0.005% to 0.3%, benzyl alcohol at a concentration in the range of 0.01% to 1% and benzoic acid at a concentration in the range of 0.01% to 1% and one or more pharmaceutically acceptable carriers or excipients.
11. The vaccine formulation as claimed in claim 10, wherein the vaccine formulation is selected from one of the following:
a. 14 valent pneumococcal capsular polysaccharide protein conjugate vaccine
comprising capsular polysaccharides from Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6B, 7F, 9V, 14, 18C, 19A, 19F, 22F, 23F and 33F.
b. 20 valent pneumococcal capsular polysaccharide protein conjugate vaccine
comprising capsular polysaccharides from Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 6C/6D, 7F, 9V, 11A, 12F, 14, 15A, 18C, 19A,
19F, 22F, 23A, 23F and 35B.
c. 20 valent pneumococcal capsular polysaccharide protein conjugate vaccine
comprising capsular polysaccharides from Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 6C/6D, 7F, 9V, 14, 15A, 15C, 18C, 19A, 19F,
23A, 23B, 23F, 24F and 35B.
d. 24 valent pneumococcal capsular polysaccharide protein conjugate vaccine
comprising capsular polysaccharides from Streptococcus pneumoniae
serotypes 1, 3, 4, 5, 6A, 6B, 7F, 8, 9V, 10A, 11A, 12F, 14, 15A, 18C, 19A,
19F, 22F. 23A, 23B, 23F, 24F, 33F and 35B.
12. Use of a preservative system as claimed in claim 1 for the prevention of microbial or viral contamination in a vaccine formulation.
| # | Name | Date |
|---|---|---|
| 1 | 201841027285-FORM 3 [18-03-2025(online)].pdf | 2025-03-18 |
| 1 | 201841027285-PROVISIONAL SPECIFICATION [21-07-2018(online)].pdf | 2018-07-21 |
| 2 | 201841027285-FORM 18 [08-02-2022(online)].pdf | 2022-02-08 |
| 2 | 201841027285-FORM 1 [21-07-2018(online)].pdf | 2018-07-21 |
| 3 | 201841027285-REQUEST FOR CERTIFIED COPY [23-09-2019(online)].pdf | 2019-09-23 |
| 3 | Correspondence by Applicant_Form 1 And Form 2(Provisional Specification)_07-08-2018.pdf | 2018-08-07 |
| 4 | Correspondence by Agent_Power of Attorney_26-07-2019.pdf | 2019-07-26 |
| 4 | 201841027285-Proof of Right (MANDATORY) [20-08-2018(online)].pdf | 2018-08-20 |
| 5 | 201841027285-FORM-26 [20-08-2018(online)].pdf | 2018-08-20 |
| 5 | 201841027285-FORM 13 [24-07-2019(online)].pdf | 2019-07-24 |
| 6 | Correspondence by Agent_Form 1 And Form 26_28-08-2018.pdf | 2018-08-28 |
| 6 | 201841027285-FORM-26 [24-07-2019(online)].pdf | 2019-07-24 |
| 7 | 201841027285-DRAWING [19-07-2019(online)].pdf | 2019-07-19 |
| 7 | 201841027285-COMPLETE SPECIFICATION [19-07-2019(online)].pdf | 2019-07-19 |
| 8 | 201841027285-DRAWING [19-07-2019(online)].pdf | 2019-07-19 |
| 8 | 201841027285-COMPLETE SPECIFICATION [19-07-2019(online)].pdf | 2019-07-19 |
| 9 | Correspondence by Agent_Form 1 And Form 26_28-08-2018.pdf | 2018-08-28 |
| 9 | 201841027285-FORM-26 [24-07-2019(online)].pdf | 2019-07-24 |
| 10 | 201841027285-FORM 13 [24-07-2019(online)].pdf | 2019-07-24 |
| 10 | 201841027285-FORM-26 [20-08-2018(online)].pdf | 2018-08-20 |
| 11 | Correspondence by Agent_Power of Attorney_26-07-2019.pdf | 2019-07-26 |
| 11 | 201841027285-Proof of Right (MANDATORY) [20-08-2018(online)].pdf | 2018-08-20 |
| 12 | Correspondence by Applicant_Form 1 And Form 2(Provisional Specification)_07-08-2018.pdf | 2018-08-07 |
| 12 | 201841027285-REQUEST FOR CERTIFIED COPY [23-09-2019(online)].pdf | 2019-09-23 |
| 13 | 201841027285-FORM 18 [08-02-2022(online)].pdf | 2022-02-08 |
| 13 | 201841027285-FORM 1 [21-07-2018(online)].pdf | 2018-07-21 |
| 14 | 201841027285-PROVISIONAL SPECIFICATION [21-07-2018(online)].pdf | 2018-07-21 |
| 14 | 201841027285-FORM 3 [18-03-2025(online)].pdf | 2025-03-18 |
| 15 | 201841027285-FER.pdf | 2025-10-27 |
| 1 | 201841027285_SearchStrategyNew_E_SearchstratergyE_24-10-2025.pdf |