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Injectable homogeneous gels comprising multiple forms of hyaluronic acid and methods for manufacturing thereof

A technology of hyaluronic acid and cross-linked hyaluronic acid, used in medical and pharmaceutical applications, can solve problems such as poor in vivo stability

Pending Publication Date: 2022-01-28
阿根廷制药国际有限公司
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, natural hyaluronic acid has poor in vivo stability due to rapid enzymatic degradation and hydrolysis

Method used

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  • Injectable homogeneous gels comprising multiple forms of hyaluronic acid and methods for manufacturing thereof
  • Injectable homogeneous gels comprising multiple forms of hyaluronic acid and methods for manufacturing thereof
  • Injectable homogeneous gels comprising multiple forms of hyaluronic acid and methods for manufacturing thereof

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0055] Example 1 - A three-component gel composed of 89.55% CL-gel-1, 9.95% NCL-gel-1 and 0.5% DHCL-1 glue

[0056] Step 1: Preparation of hyaluronic acid-based DHCL-1. Add 6.54 g of sodium hyaluronate (HA) with a molecular weight of 1.3-2.0 MDa (pharmaceutical grade) to 54.12 g of water and 1.96 g of 1,4-butanediol diglycidyl ether (BDDE), and mix the mixture manually, It was then homogenized by a Thinky planetary mixer at 2000 rpm. Thereafter, 11.23 g of 1M sodium hydroxide (NaOH) solution was added to the mixture, bringing it to a total of 73.85 g. The mixture was then homogenized at 300 rpm for 120 minutes. The mixture was then placed in an oven set at 45°C for 3 hours and then in a 25°C oven for an additional 15 hours. The mixture was ground and then 70.59 g of the gel was neutralized by adding phosphate buffer at a pH of about 7.3 and adjusting to a final pH with 1 N HCl solution (103.29 g of neutralizing solution in total) to give a pH of about 7. Final pH. The...

Embodiment 2

[0065] Example 2 - Three components consisting of 49.75% CL-gel-1, 49.75% NCL-gel-1 and 0.5% DHCL-1 gel

[0066] DHCL-1, CH-Gel 1 and NCL-Gel 1 were prepared as described in Example 1.

[0067] Step 4: Prepare the final body.

[0068] 100 g of CL-gel-1 was added to 100 g of NCL-gel-1. 1 g of DHCL-1 was added to the mixture and the mass was manually mixed and then homogenized at 2000 rpm. Finally the gel was degassed in vacuo by subjecting it to vacuum for 30 min, then milled and filled into 1.25 mL glass syringes which were sterilized by steam autoclave at 121°C for 20 min. minute. Viscous and viscoelastic gels are formed.

[0069] The pH of the final gel was about 7. The gel is easily injectable through a needle: 20 to 40 N of force is required to push the gel through a 25G / 16mm PIC needle at a push rate of 1 mL / min.

Embodiment 3

[0070] Example 3 - Three-component gel consisting of 89.1% CL-gel-1, 9.9% NCL-gel-1 and 1% DHCL-1

[0071] DHCL-1, CH-Gel 1 and NCL-Gel 1 were prepared as described in Example 1.

[0072] Step 4: Prepare the final body.

[0073] 13.50 g CL-gel-1 was added to 1.50 g NCL-gel-1. 0.15g DHCL-1 was added to the mixture and the mass was mixed manually and then homogenized at 2000rpm. Finally the gel was degassed in vacuo by subjecting it to vacuum for 30 min, then milled and filled into 1.25 mL glass syringes which were sterilized by steam autoclave at 121°C for 20 min. minute. Viscous and viscoelastic gels are formed.

[0074] The pH of the final gel was about 7. The gel is easily injectable through a needle: an injection force of 34N is required to push the gel through a 25G / 16mm PIC needle at a push rate of 1 mL / min. The viscosity of the gel was 197 Pa*s and G' and G" measured at 0.5% shear strain at 1 Hz were 125 Pa and 46 Pa, respectively.

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Abstract

Provided herein are compositions, comprising hyaluronic acid in three different forms. The compositions are in a form of an essentially homogeneous gel with improved rheological properties enabling improved clinical performance.

Description

technical field [0001] The present invention relates to homogeneous compositions comprising processed hyaluronic acid composites, methods of making such homogeneous compositions and their use in cosmetic applications as well as in medical and pharmaceutical applications. Background technique [0002] Hyaluronic acid is a natural polysaccharide that is a common component of cosmetic preparations and is used in various cosmetic procedures, especially as a dermal filler. However, natural hyaluronic acid has poor in vivo stability due to rapid enzymatic degradation and hydrolysis. Various chemical modifications, such as cross-linking, have been proposed in an attempt to improve the poor stability of native hyaluronic acid. [0003] Dehydration of cross-linked hydrogels can sometimes be exploited to improve the mechanical properties of the hydrogels, as can be seen in patent application US20160376382 A1. According to said document, an efficient cross-linking process involves ac...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61K8/73A61L27/54A61K8/04A61Q19/08A61K9/00A61K31/738A61L27/52A61L27/50A61L27/26A61K31/728A61K47/36
CPCA61L27/26A61L27/52A61K31/738A61K31/728A61Q19/08A61L2400/06A61K9/06A61K47/08A61K8/735A61K2800/91A61K8/042A61K2800/5922A61P17/00C08L5/08A61K2300/00A61L27/20A61L2300/802A61L2430/34
Inventor D·D·西格尔L·戈德沙德-兹米利L·斯拉诺夫斯基E·戈德堡
Owner 阿根廷制药国际有限公司
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