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Pharmaceutical composition containing peptide

A technology for pharmaceutical compositions and epitope peptides, which can be used in pharmaceutical combinations, medical preparations containing active ingredients, pharmaceutical formulations, etc., can solve problems such as increased patient burden, and achieve effective treatment and full anti-tumor effect.

Inactive Publication Date: 2014-11-26
ONCOTHERAPY SCI INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, in the case of administering multiple vaccine preparations, it is necessary to vaccinate multiple parts of the body, which increases the burden on patients

Method used

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  • Pharmaceutical composition containing peptide
  • Pharmaceutical composition containing peptide
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Examples

Experimental program
Comparison scheme
Effect test

Embodiment

[0124] Peptides for Injection:

[0125] The peptides described in Table 1 were synthesized as peptides for injection. As shown in Table 1, the predicted pI of these peptides is in the range of 5.2 to 10.4, and the solubility characteristics are expected to be different. These peptides are peptides derived from tumor-specific antigens confirmed to have the ability to induce cytotoxic T cells.

[0126] Water for injection: The water for injection uses the manufacturing water specified in the Japanese Pharmacopoeia.

[0127] [Table 1]

[0128] Peptide name

Embodiment 1

[0132] Embodiment 1 uses the preparation of the single peptide injection that sodium carbonate solution is arranged

[0133] Sodium carbonate decahydrate (Na 2 CO 3 10H 2 (0) 41 mg was dissolved in 1 mL of water for injection to obtain water for injection containing sodium carbonate. Regarding the peptides insoluble in water for injection in Comparative Example 1, peptides-1, 2, 4, 7, and 10 were added to 1 mL of sodium carbonate-containing water for injection in order to prepare a single preparation of each peptide. The total amount of the injected peptide was dissolved by stirring at room temperature to prepare a colorless and transparent peptide solution. Thereafter, the obtained peptide solution was subjected to filter sterilization (0.22 μm filter) to obtain an injection.

[0134]The dosage of the peptide was varied within the range of 5-20 mg, and injections were prepared at each concentration stage. As for peptides-2, 4, 7, and 10, injections could be obtained at a...

Embodiment 2

[0135] Embodiment 2 uses the preparation of the single peptide injection that has arginine solution

[0136] Dissolve 40 mg of L-arginine in 1 mL of water for injection to obtain arginine-containing water for injection. Regarding the peptides insoluble in water for injection in Comparative Example 1, peptides-1, 2, 4, 7, and 10 were added to 1 mL of arginine-containing water for injection in order to prepare a single preparation of each peptide. The total amount of the injected peptide was dissolved by stirring at room temperature to prepare a colorless and transparent peptide single solution. Thereafter, the obtained peptide solution was subjected to filter sterilization (0.22 μm filter) to obtain an injection.

[0137] The input amount of the peptide was changed within the range of 5-20 mg, and injections were prepared at each concentration stage. As for peptides-2, 4, 7, and 10, injections could be obtained at any input amount tested. With regard to peptide-1, it was con...

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PUM

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Abstract

The problem addressed by the present invention is to provide a means for easily formulating one or more types of peptide using the same solvent without selecting the solvent in accordance with the solubility of the peptide. The present invention provides: a pharmaceutical composition containing one or more peptides as active ingredients and containing a basic amino acid and / or a base; and a method for producing the pharmaceutical composition.

Description

technical field [0001] The present invention relates to a pharmaceutical composition containing peptide and its production method. Background technique [0002] In injectable preparations containing peptides, terminal sterilization by means of autoclaving cannot be performed because the peptides are not stable to heat. Therefore, in order to achieve sterility, a sterile filtration process is essential. The sterile filtration step is conventionally carried out by passing through a membrane filter having a guaranteed absolute pore diameter of 0.22 μm or less. Therefore, at the stage before filtration, it is necessary to prepare a peptide solution in which the peptide is completely dissolved. However, the solubility properties of peptides differ depending on their amino acid sequences, and therefore, appropriate solvents need to be selected according to the solubility properties of peptides. In particular, it is difficult to completely dissolve a highly hydrophobic peptide i...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K39/00A61K9/08A61K9/19A61K39/39A61K47/02A61K47/18A61P35/00A61P37/04
CPCA61K47/18A61K47/183A61K9/08A61K47/26A61K39/00A61K39/39A61K47/02A61K9/19A61K9/0019A61K39/0011A61P35/00A61P37/04A61K47/22A61K38/08A61K39/0005A61K2039/585
Inventor 冰见长夫渡边刚野上俊宏坂井雅美渡边雪乃
Owner ONCOTHERAPY SCI INC