We Claim:
1. A stabilizer composition for preparation of lyophilized viral vaccines, comprising:
a. one or more sugar(s), excluding sucrose;
5 b. one or more amino acid(s);
c. one or more protein(s) or peptide(s);
d. one or more mineral salt(s); and
e. one or more buffer(s).
2. The stabilizer composition as claimed in claim 1, wherein the sugar(s) is present at a
10 concentration of about 1 % w/v to about 15 % w/v; the amino acid(s) is present at a
concentration of about 0.01 % w/v to about 10 % w/v; the protein(s) or peptide(s) is present
at a concentration of about 0.05% w/v to about 10% w/v; and/or the mineral salt(s) is
present at a concentration of about 0.1 % w/v to about 10% w/v.
3. The stabilizer composition as claimed in any one of claims 1 to 2, wherein the sugar(s) is
15 selected from a group comprising monosaccharide(s), disaccharide(s), polysaccharide(s),
sugar alcohol(s), and their derivatives or any combination thereof.
4. The stabilizer composition as claimed in claim 3, wherein the monosaccharide(s) is
selected from a group comprising fructose, galactose, glucose, D-mannose, sorbose, and
their derivatives or any combination thereof; the disaccharide(s) is selected from a group
20 comprising lactose, maltose, trehalose/ trehalose dihydrate, cellobiose, and their
derivatives or any combination thereof; the polysaccharide(s) is selected from a group
comprising raffinose, melezitose, maltodextrins, dextrans, starches, and their derivatives
or any combination thereof; and the sugar alcohol(s) is selected from a group comprising
mannitol, xylitol, maltitol, lactitol, sorbitol, myoinositol, and their derivatives or any
25 combination thereof.
5. The stabilizer composition as claimed in any one of claims 1-4, wherein the sugar(s) is a
combination of sorbitol and trehalose/ trehalose dihydrate; wherein sorbitol and
trehalose/trehalose dihydrate are each present at a concentration of about 1 % w/v to about
10 % w/v.
30 6. The stabilizer composition as claimed in any one of claims 1-5, wherein the amino acid(s)
is a non-acidic amino acid(s); wherein the amino acid(s) is selected from a group
comprising Alanine, Arginine, Asparagine, Cysteine, Glutamine, Glycine, Histidine,
tartrate buffers, histidine buffer, succinate buffer, phosphate – citrate buffer, HEPES
buffer, and borate buffer or any combination thereof.
14. The stabilizer composition as claimed in claim 13, wherein the buffer(s) is phosphate –
citrate buffer; wherein the phosphate concentration in the buffer is in the range of about 5
5 mM to about 15 mM and the citrate concentration in the buffer is in the range of about 0.5
mM to about 5 mM.
15. The stabilizer composition as claimed in any one of claims 1-14, wherein the pH of the
stabilizer composition is in the range of about 5 to about 8.
16. The stabilizer composition as claimed in any one of claims 1-15, further comprising
10 carrier(s) is selected from a group comprising aqueous and/or non-aqueous carrier(s).
17. A method for preparing the stabilizer composition for preparation of lyophilized viral
vaccines as claimed in any one of claims 1-16, comprising mixing:
a. one or more sugar(s);
b. one or more amino acid(s);
15 c. one or more protein(s) or peptide(s);
d. one or more mineral salt(s); and
e. one or more buffer(s),
in the presence of carrier(s) to obtain the stabilizer composition.
18. A stabilized immunogenic composition comprising the stabilizer composition as claimed
20 in any one of claims 1-16 and one or more live attenuated or inactivated virus.
19. The stabilized immunogenic composition as claimed in claim 18, wherein the virus(es) is
selected from a group comprising Measles, Mumps, Rubella, Varicella Zoster, Polio,
Hepatitis, Herpes Simplex 1, Herpes Simplex 2, Parainfluenza Types 1, 2, 3 And 4,
Pneumoviruses, Influenza A, Influenza B, Influenza C viruses, Dengue virus, and any part
25 thereof or any combination thereof.
20. The stabilized immunogenic composition as claimed in claim 19, wherein the virus(es) is
selected from a group comprising Measles, Mumps, Rubella, and Varicella zoster, or any
combination thereof.
21. The stabilized immunogenic composition as claimed in claim 19, wherein the virus(es) is
30 selected from a group comprising Measles, Mumps, and Rubella.
22. The stabilized immunogenic composition as claimed in claim 19, wherein the virus(es) are
selected from a group comprising Measles and Rubella.
23. The stabilized immunogenic composition as claimed in any of claims 19 - 22, wherein the
Measles virus strain is selected from a group comprising AIK-C, Schwarz, Moraten,
5 CAM70, TD97, Leningrad- 16, Shanghai-191, Edmonston Zagreb, a recombinant or a
genetically modified form of any of these virus strains, or any combination thereof; and/or
wherein the Rubella virus strain is selected from a group comprising Matsuba, DCRB19,
Takahashi, Matsuura, TO-336, RA 27/3 Wistar, a recombinant or a genetically modified
form of any of these virus strains, or a combination thereof.
10 24. The stabilized immunogenic composition as claimed in claim 23, wherein the Measles
virus strain is live attenuated Edmonston Zagreb strain; and/or wherein the Rubella virus
strain is live attenuated RA 27/3 Wistar strain.
25. The stabilized immunogenic composition as claimed in any one of claims 18-24, wherein
the attenuated Measles virus particles is present in the range of 3.0 Log CCID50/dose to
15 6.0 Log CCID50/dose; and/or wherein the live attenuated Rubella virus particles is present
in the range of 3.0 Log CCID50/dose to 6.0 Log CCID50/dose.
26. The stabilized immunogenic composition as claimed in any one of claims 18-25, wherein
the stabilized immunogenic composition is lyophilized.
27. The stabilized immunogenic composition as claimed in any one of claims 18-26, wherein
20 the stabilized immunogenic composition is a vaccine.
28. A method for preparing the stabilized immunogenic composition as claimed in any one of
claims 18-27, comprising combining the stabilizer composition as claimed in any one of
claims 1-16 with the one or more live attenuated or inactivated virus as defined in any one
of claims 19-25, in presence of the carrier(s) as defined in claim 16, to obtain the stabilized
25 immunogenic composition.
29. The method as claimed in claim 28, further comprising subjecting the stabilized
immunogenic composition to lyophilization.
30. A kit comprising the stabilized immunogenic composition as claimed in any one of claims
18-28.
30 31. The kit as claimed in claim 30, further comprising means for administration of the
stabilized immunogenic composition and/or an aqueous solution for reconstituting the