FREEZE-DRIED PREPARATION CONTAINING HIGH-PURITY PTH AND METHOD FOR PRODUCING SAME
First Claim
1. A freeze-dried preparation containing high-purity PTH peptide as an active ingredient, wherein “
- high-purity”
means at least that the amount of at least one PTH analog versus the sum of the amount of PTH peptide and the total amount of PTH analogs in the preparation is 1.0% or less and/or that the total amount of PTH analogs versus the sum of the amount of PTH peptide and the total amount of PTH analogs is 5.0% or less;
the freeze-dried preparation containing PTH peptide being produced by a method characterized in that the exposure of the solution containing PTH peptide prior to freeze drying to air environments within a pharmaceutical production facility is controlled.
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Accused Products
Abstract
[Problem] Provided is a freeze-dried preparation containing high-purity PTH peptide and a method for the production thereof. Also provided is a test method for PTH analogs to confirm the purity of a freeze-dried preparation containing PTH peptide, and the like.
[Solution] In the present invention, the presence of PTH analogs produced during the manufacturing process of a freeze-dried preparation containing PTH peptide was confirmed. The production of these PTH analogs was also discovered to be markedly prevented or reduced by controlling exposure of the solution containing PTH peptide and the like to air environments within a pharmaceutical production facility.
4 Citations
49 Claims
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1. A freeze-dried preparation containing high-purity PTH peptide as an active ingredient, wherein “
- high-purity”
means at least that the amount of at least one PTH analog versus the sum of the amount of PTH peptide and the total amount of PTH analogs in the preparation is 1.0% or less and/or that the total amount of PTH analogs versus the sum of the amount of PTH peptide and the total amount of PTH analogs is 5.0% or less;
the freeze-dried preparation containing PTH peptide being produced by a method characterized in that the exposure of the solution containing PTH peptide prior to freeze drying to air environments within a pharmaceutical production facility is controlled. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 37, 38, 41, 42, 43, 44, 45, 46, 47, 48, 49)
- high-purity”
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20. A freeze-dried preparation containing high-purity PTH peptide as an active ingredient, the PTH-peptide-containing freeze-dried preparation manufactured using a method characterized in that exposure of a solution containing PTH peptide to air environments within a pharmaceutical production facility prior to freeze drying is controlled during loading into the freeze-drying means;
- wherein “
high-purity”
means at least that the amount of at least one PTH analog versus the sum of the amount of PTH peptide and the total amount of PTH analogs in the preparation is 1.0% or less and/or that the total amount of PTH analogs versus the sum of the amount of PTH peptide and the total amount of PTH analogs is 5.0% or less;
the loading step is a step that spans three or more hours;
the air environment is an environment that maintains one-way air flow of clean air that has passed through an HEPA filter downward from above; and
the velocity of the air flow 20 cm directly under the HEPA filter is 0.2-1.0 m/s.
- wherein “
- 21. A method for producing a freeze-dried preparation containing PTH peptide, the method being characterized in that exposure of the solution containing PTH peptide to air environments within a pharmaceutical production facility is controlled in one or more steps from the beginning of the step for preparing a solution containing PTH peptide to the end of the step for loading into the freeze-drying means.
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40. A method for producing a freeze-dried preparation containing high-purity PTH peptide as an active ingredient, the method characterized in that exposure of a solution containing PTH peptide to air environments within a pharmaceutical production facility prior to freeze drying is controlled during loading into the freeze-drying means;
- wherein “
high-purity”
means at least that the amount of at least one PTH analog versus the sum of the amount of PTH peptide and the total amount of PTH analogs is 1.0% or less and/or that the total amount of PTH analogs versus the sum of the amount of PTH peptide and the total amount of PTH analogs is 5.0% or less in the preparation;
the loading step is a step that spans three or more hours;
the air environment is an environment in which clean air that has passed through an HEPA filter is maintained as a one-way air flow downward from above; and
the velocity of the air flow 20 cm directly under the HEPA filter is 0.2-1.0 m/s.
- wherein “
Specification