Leakage inhibitor for local injections, local injection containing the same, and method for manufacturing local injections.

Abstract

A leakage inhibiting agent comprising a gelatin hydrolysate having a weight average molecular weight of 5000 or less, wherein the viscosity, at 25°C, of a first solution, obtained by dissolving the gelatin hydrolysate in phosphate buffered saline such that the concentration of the gelatin hydrolysate becomes 40 mass%, is 20 mPa·s or less.

Claims

1. Contains gelatin hydrolysate with a weight-average molecular weight of 5000 or less. A leakage inhibitor for local injection, wherein the gelatin hydrolysate is dissolved in phosphate-buffered saline, and the viscosity of the first solution, in which the gelatin hydrolysate is concentrated at 40% by mass, is 20 mPa·s or less at 25°C.

2. The leakage inhibitor according to claim 1, wherein the leakage inhibitor comprises the gelatin hydrolysate.

3. The leakage inhibitor according to claim 1 or claim 2, wherein the leakage inhibitor is for use as a local injection agent that is filled into a syringe equipped with an injection needle having an outer diameter of 23G or more and 37G or less.

4. The leakage inhibitor according to claim 1 or claim 2, wherein the leakage inhibitor is for use as a local injection agent that is filled into a syringe equipped with an injection needle having an outer diameter of 23G or more and 27G or less.

5. A local injection comprising the leakage inhibitor described in Claim 1 or Claim 2.

6. The local injection contains 5% by mass or more and 40% by mass or less of the leakage inhibitor. The local injection according to claim 5, wherein the viscosity of the local injection at 25°C is 2 mPa·s or more and 20 mPa·s or less.

7. The local injection contains 5% by mass or more and 40% by mass or less of the leakage inhibitor. The local injection according to claim 5, wherein the viscosity of the local injection at 25°C is 2 mPa·s or more and 10 mPa·s or less.

8. The local injection contains 5% by mass or more and 40% by mass or less of the leakage inhibitor. The local injection according to claim 5, wherein the viscosity of the local injection at 25°C is 8 mPa·s or more and 20 mPa·s or less.

9. A method for producing a local injection according to Claim 5, The process involves preparing the aforementioned leakage inhibitor, an aqueous solvent, and an active ingredient. A method for producing a local injection, comprising the step of mixing the leakage inhibitor and the active ingredient in the aqueous solvent at a temperature of 1°C to 30°C to obtain a local injection.

10. The process of obtaining the aforementioned local injection agent is as follows: A step to obtain a first injectable precursor by mixing the leakage inhibitor with the aqueous solvent, and then obtain a local injectable by mixing the active ingredient with the first injectable precursor, or A step to obtain a second injectable precursor by mixing the active ingredient with the aqueous solvent, and then obtain a local injectable by mixing the leakage inhibitor with the second injectable precursor, or A method for producing a local injection according to claim 9, wherein the method is to obtain a local injection by simultaneously mixing the leakage inhibitor and the active ingredient in the aqueous solvent.

Images