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Method for manufacturing pre-filling type syringe comprising local anesthetic and hyaluronic acid hydrogel

A technology of local anesthetic and hyaluronic acid, applied in syringes, ampoule syringes, medical preparations containing active ingredients, etc., can solve problems such as slow release of lidocaine, and achieve the effect of excellent initial dissolution rate

Active Publication Date: 2020-10-16
DAE HWA PHARMA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, the problem with these formulations is the slow release of lidocaine

Method used

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  • Method for manufacturing pre-filling type syringe comprising local anesthetic and hyaluronic acid hydrogel
  • Method for manufacturing pre-filling type syringe comprising local anesthetic and hyaluronic acid hydrogel
  • Method for manufacturing pre-filling type syringe comprising local anesthetic and hyaluronic acid hydrogel

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Embodiment 1: Comparative test of the release rate of lidocaine carried out according to the method of adding lidocaine

[0052] 1. Purpose of the experiment

[0053] The release rate according to the method of adding lidocaine to the hyaluronic acid (hereinafter referred to as "HA") cross-linked composition was compared to confirm the stability.

[0054] 2. Test Substances and Preparation

[0055] 2.1 Test substances

[0056] Table 1

[0057] category HA concentration (mg / mL) Lidocaine concentration (%) for mixing 24 0.03 for spray 24 10.0

[0058] 2.2 Preparation of test substances

[0059] According to the method of adding lidocaine hydrochloride, test substances were prepared as follows.

[0060] (1) Gel mixed type

[0061] After 0.03 g of lidocaine hydrochloride was dissolved in 100 mL of PBS, 2.4 g of cross-linked hyaluronic acid was added thereto for swelling to prepare a hydrogel.

[0062] (2) In-syringe spray type

[0063...

Embodiment 2

[0096] Example 2: Comparison of loading and dissolution rates of lidocaine according to syringe material / syringe volume

[0097] In order to compare the loading rate and dissolution rate of lidocaine according to the syringe material / syringe volume, experiments were performed to determine the loading rate and dissolution rate of lidocaine according to the following conditions.

[0098] 1) Syringe material: cycloolefin copolymer (COC)

[0099] 2) Syringe volume: 1mL, 3mL, 10mL

[0100]

[0101] -PBS solution, 37°C

[0102] - Lidocaine solution concentration: 10%

[0103] -Method: After spraying in a syringe 3 times, dry in a drying oven at 70°C

[0104] -Number of spray repetitions: based on 9

[0105] The loading and dissolution rates of lidocaine by syringe volume are shown in Tables 4 and 5 below.

[0106] Table 4 compares the loading rates of lidocaine solutions by syringe volume

[0107] category Lidocaine concentration (mg / mL) COC 1mL 3.23 C...

Embodiment 3

[0113] Example 3: Confirmation of the effect of the composition of the lidocaine spray solution

[0114] In order to confirm whether injections can be produced according to the hyaluronic acid concentration of the lidocaine spray solution, the lidocaine spray solution was prepared in PBS and sprayed according to the following concentrations, and the results are shown in Table 7 below.

[0115] Table 7

[0116]

[0117] As can be seen from Table 7, when the concentration of hyaluronic acid was 0.1 (w / v)% or more and less than 1.0, it was confirmed that injections could be prepared by proper spraying even if the concentration of lidocaine was the same.

[0118] Subsequently, according to the number of sprays of the lidocaine spray solution containing 0.1 and 0.5 (w / w)% hyaluronic acid, the loading rate and the dissolution rate showing the desired spray effect of lidocaine were determined. The experimental conditions are as follows. The results are shown in Tables 8 and 9 be...

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Abstract

The present invention relates to a method for manufacturing a pre-filling type syringe comprising a hyaluronic acid hydrogel containing a local anesthetic and a pre-filling type syringe manufactured thereby and, more specifically, to a pre-filling type syringe and a method for manufacturing the same, wherein a local anesthetic, such as lidocaine, or a pharmaceutically acceptable salt thereof is allowed to be adsorbed on an inner wall of a syringe and then coated on a hydrogel surface, thereby exhibiting an excellent initial release of the local anesthetic or pharmaceutically acceptable salt thereof at the time of operation or injection, so that the syringe of the present invention can exhibit an anesthetic effect promptly at the time of injection of a skin filler or the like even when distributed and stored for a long time.

Description

technical field [0001] Cross References to Related Applications [0002] This application claims the benefit of Korean Patent Application No. 10-2017-0175282 filed with the Korean Intellectual Property Office on December 19, 2017, the entire contents of which are hereby incorporated by reference. [0003] The present invention relates to a method for the manufacture of a prefilled syringe comprising a hyaluronic acid hydrogel and a local anesthetic, and more particularly, to a method that allows the local anesthetic to be adsorbed on the inner wall of the syringe and then coated on the hydrogel Superficially, thereby exhibiting an excellent initial release of lidocaine during handling or injection, prefilled syringes and methods of making the same. Background technique [0004] The most common aesthetic signs of facial aging include visible skin lines, deep nasolabial folds, tarsal lines, marionette lines, buccal commissures, and perioral wrinkles. These aging changes are...

Claims

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Application Information

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IPC IPC(8): A61M5/28A61F2/00B65B3/00A61K9/00A61K31/167A61K8/73
CPCA61K31/167A61K2800/91A61Q19/08A61K8/735A61K8/042A61K8/42A61K31/445A61K31/245A61K31/46A61K31/47A61K31/24A61K9/0019A61K9/06A61K47/36A61M5/28A61F2/0059A61F2/0095B65B3/003A61K9/0024
Inventor 李智演宋寅范孙旼希李仁铉
Owner DAE HWA PHARMA
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