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Process for obtaining heat sterilizable injectable hydrogels based on hyaluronic acid containing lidocaine and alkaline agents added in powder form

A technology of hyaluronic acid and lidocaine, applied in the field of therapy and cosmetology, which can solve the problems of injectable hydrogels changing flow properties and methods not fully satisfactory

Active Publication Date: 2020-03-27
ANTEIS SA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

[0019] However these methods are not entirely satisfactory as they also actually lead to dilution and significantly altered flow properties of the injectable hydrogel

Method used

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  • Process for obtaining heat sterilizable injectable hydrogels based on hyaluronic acid containing lidocaine and alkaline agents added in powder form
  • Process for obtaining heat sterilizable injectable hydrogels based on hyaluronic acid containing lidocaine and alkaline agents added in powder form
  • Process for obtaining heat sterilizable injectable hydrogels based on hyaluronic acid containing lidocaine and alkaline agents added in powder form

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0071] Example 1: Structural differences after moist heat sterilization demonstrated by rheology between hyaluronic acid-based gels with and without lidocaine hydrochloride and with lidocaine hydrochloride and sodium hydroxide

[0072] Let the cross-linked NaHA based gel be A.

[0073] This gel is obtained as follows: Molecular mass 2.5 x 10 hydrated in 1 mass % aqueous sodium hydroxide soda solution 6 Da of sodium hyaluronate, crosslinking agent BDDE added to obtain a degree of crosslinking of 9%, crosslinking for 2 h at 50° C. and dialyzing the gel for 24 h (regenerated cellulose, separation limit: molar mass = 60 kDa). The gel thus obtained had a sodium hyaluronate concentration of 22.5 mg / ml and a pH of 7.07.

[0074] After mixing with a spatula for 10 minutes, the gel A thus obtained was divided into three portions (50 g) of equal mass.

[0075] Let part 1 be B. In this part, 0.3% lidocaine hydrochloride is added as a powder. The gel was mixed with a spatula for 5 m...

Embodiment 2

[0087] Example 2: Structural differences after moist heat sterilization demonstrated by rheology between hyaluronic acid-based gels with and without lidocaine hydrochloride and with lidocaine hydrochloride and sodium hydroxide

[0088] Let the cross-linked NaHA based gel be E.

[0089] This gel is obtained as follows: Molecular mass 2.5 x 10 hydrated in 1 mass % sodium hydroxide solution 6Da of sodium hyaluronate, crosslinking agent BDDE added to obtain a degree of crosslinking of 11%, crosslinking for 2 h at 50° C. and dialyzing the gel for 24 h (regenerated cellulose, separation limit: molar mass = 60 kDa). The gel thus obtained had a sodium hyaluronate concentration of 22.7 mg / ml and a pH of 7.12.

[0090] After mixing with a spatula for 10 minutes, the gel E thus obtained was divided into three portions (50 g) of equal mass.

[0091] Let part 1 be F. In this part, 0.3% lidocaine hydrochloride is added as a powder. The gel was mixed with a spatula for 5 minutes. Then...

Embodiment 5

[0112] Example 5: Stability of the gels of the present invention - comparison with prior art stable gels

[0113] The cross-linked NaHA-based gel was prepared as follows: Hydration molecular mass 3.1 × 10 in 1 mass % aqueous sodium hydroxide solution 6 Da of sodium hyaluronate, crosslinking agent BDDE added to obtain a degree of crosslinking of 9.2%, crosslinking for 2 hours at 50 and dialysis for 24 hours (regenerated cellulose, separation limit: molar mass = 60 kDa). The gel thus obtained had a sodium hyaluronate concentration of 24.9 mg / ml and a pH of 7.08.

[0114] Next 0.3% lidocaine hydrochloride was added and the gel was mixed with a spatula for 5 minutes. The pH was found to be 6.77.

[0115] Finally, 144 μl of a 2 mass % aqueous sodium hydroxide solution was added and mixed with a spatula for 5 minutes. The final pH was 7.26.

[0116] The thus prepared gel was introduced into a glass syringe and then heat sterilized (131°C, 2 min).

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Abstract

The object of the present invention is a method for obtaining injectable hydrogels based on hyaluronic acid containing lidocaine hydrochloride and alkaline agents added in powder or solution form, said hydrogels being heat sterilized, having a transparent The hyaluronic acid concentration and flow properties were equivalent to the corresponding hydrogels based on hyaluronic acid without any lidocaine hydrochloride. The present invention also relates to various uses of the aforementioned hydrogels.

Description

technical field [0001] The present invention relates to a method for the manufacture of a heat-sterilized injectable hydrogel based on hyaluronic acid containing lidocaine and an alkaline agent, the gel obtained therefrom and its use in the therapeutic and cosmetic fields. Background technique [0002] Injectable hydrogels based on hyaluronic acid are commonly used to isolate, replace or fill biological tissue or increase the volume of said tissue, and also supplement or replace biological fluids. [0003] Therefore, viscoelastic products based on hyaluronic acid are used in many therapeutic applications and in the field of dermatology. [0004] For example, these products based on cross-linked or non-cross-linked hyaluronic acid are used in: [0005] - Rheumatology, as a substitute for synovial fluid, a temporary supplement, [0006] - urology / gynecology, as an agent to increase the volume of the sphincter or urethra, [0007] - Ophthalmology, as an aid in cataract surge...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): A61K9/00A61K9/06A61K31/167A61K8/73
CPCA61L27/20A61K9/0019A61K9/0024A61K9/06A61K31/167A61K2800/91A61L27/52A61L2300/402A61L2430/22A61L2430/34A61K8/42A61K8/735A61Q19/08A61K8/042A61L2400/06A61L27/54A61P23/02C08L5/08A61K8/73A61K9/00A61K31/728A61K9/0048A61K47/36A61L27/50A61L2430/02
Inventor S·加瓦德
Owner ANTEIS SA
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