Pharmaceutical composition for injection
The present invention provides an injectable pharmaceutical composition containing the following components: (a) one or more kinds of peptides selected from a peptide represented by the formula (1): wherein the bond between Cys and Cys is a disulfide bond, Leu-OH shows that the C-terminal of Leu is a free carboxyl group, and other bond is a peptide bond, a peptide consisting of the amino acid sequence shown by Trp-Ala-Pro-Val-Leu-Asp-Phe-Ala-Pro-Pro-Gly-Ala-Ser-Ala-Tyr-Gly-Ser-Leu (SEQ ID NO: 1) and salts thereof, (b) trehalose or trehalose hydrate, and (c) a pH adjuster.
1. An injectable pharmaceutical composition comprising the following components:
(a) one or more kinds of peptides selected from the group consisting of:
(i) the peptide represented by the formula (1):
wherein the bond between Cys and Cys is a disulfide bond, Leu-OH shows that the C-terminal of Leu is a free carboxyl group, and other amino acids in formula (I) are linked by peptide bonds,
(ii) the peptide consisting of the amino acid sequence shown by Trp-Ala-Pro-Val-Leu-Asp-Phe-Ala-Pro-Pro-Gly-Ala-Ser-Ala-Tyr-Gly-Ser-Leu (SEQ ID NO: 1) and
(iii) salts thereof,
(b) trehalose or trehalose hydrate, and
(c) a pH adjuster.
2. The composition according to claim 1 , wherein the component (a) is one or more kinds of peptides selected from the group consisting of (i) the peptide represented by the formula (1) and (ii) a salt thereof.
3. The composition according to claim 2 , further comprising mannitol.
4. The composition according to claim 3 , wherein the mannitol is D-mannitol.
5. The composition according to claim 2 , further comprising methionine.
6. The composition according to claim 2 , which has a pH of 1-3.
7. The composition according to claim 1 , wherein the component (a) is one or more kinds of peptides selected from the group consisting of (i) the peptide consisting of the amino acid sequence shown by Trp-Ala-Pro-Val-Leu-Asp-Phe-Ala-Pro-Pro-Gly-Ala-Ser-Ala-Tyr-Gly-Ser-Leu (SEQ ID NO: 1) and (ii) a salt thereof.
8. The composition according to claim 7 , further comprising a solubilizing agent.
9. The composition according to claim 8 , wherein the solubilizing agent is tartaric acid.
10. The composition according to claim 8 , which has a pH of 2-3.
11. The composition according to claim 7 , which has a pH of 5-10.
12. The composition according to claim 1 , wherein the pH adjuster is hydrochloric acid and/or sodium hydroxide.
13. The composition according to claim 7 , wherein the acid used as the pH adjuster is a weak acid.
14. The composition according to claim 1 , wherein the component (a) comprises
one or more kinds of peptides selected from the group consisting of (i) the peptide represented by the formula (1) and (ii) a salt thereof, and
one or more kinds of peptides selected from the group consisting of (iii) the peptide consisting of the amino acid sequence shown by Trp-Ala-Pro-Val-Leu-Asp-Phe-Ala-Pro-Pro-Gly-Ala-Ser-Ala-Tyr-Gly-Ser-Leu (SEQ ID NO: 1) and (iv) a salt thereof.
15. The composition according to claim 14 , further comprising mannitol.
16. The composition according to claim 14 , further comprising methionine.
17. The composition according to claim 14 , further comprising a solubilizing agent.
18. The composition according to claim 14 , which has a pH of 2-3.
19. The composition according to claim 1 , which is a liquid formulation, a suspension formulation, or a freeze-dried formulation.
20. The composition according to claim 14 , which is produced by adding an injectable pharmaceutical composition comprising the following components:
(a) one or more kinds of peptides selected from the group consisting of:
(i) the peptide consisting of the amino acid sequence shown by Trp-Ala-Pro-Val-Leu-Asp-Phe-Ala-Pro-Pro-Gly-Ala-Ser-Ala-Tyr-Gly-Ser-Leu (SEQ ID NO: 1) and
(ii) a salt thereof,
(b) trehalose or trehalose hydrate, and
(c) a pH adjuster, which is in the form of a liquid formulation, to an injectable pharmaceutical composition comprising the following components:
(a′) one or more kinds of peptides selected from the group consisting of
(iii) the peptide represented by the formula (1):
wherein the bond between Cys and Cys is a disulfide bond, Leu-OH shows that the C-terminal of Leu is a free carboxyl group, and other amino acids in formula (I) are linked by peptide bonds, and
(iv) a salt thereof,
(b′) trehalose or trehalose hydrate, and
(c′) a pH adjuster,
which is in the form of a freeze-dried formulation.
21. The composition according to claim 20 , which is a liquid formulation or a suspension formulation.
22. A cancer vaccine composition comprising a composition according to claim 2 .