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Dermal filler based on crosslinked hyaluronic acid and carboxymethyl cellulose lubricant

一种羧甲基纤维素、填充剂的技术，应用在麻醉剂、泌尿系统疾病、医药科学等方向，能够解决填充效果降低等问题

Active Publication Date: 2017-08-01
MERZ PHARMA GMBH & CO KGAA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

However, since the CMC carrier of microceramics is rapidly absorbed in vivo (within approximately 3 months), collagen neogenesis and CMC elimination may not occur simultaneously, thus causing a potential and transient reduction in filling effect
Furthermore, there are currently no antidotes (reversal agents) capable of partial repair of the CMC following the application of fillers

Method used

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  • Dermal filler based on crosslinked hyaluronic acid and carboxymethyl cellulose lubricant
  • Dermal filler based on crosslinked hyaluronic acid and carboxymethyl cellulose lubricant
  • Dermal filler based on crosslinked hyaluronic acid and carboxymethyl cellulose lubricant

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0094] Preparation of HA colloids (MHAG colloids and MHAI colloids) without lubricating phase and with or without CaHAP particles (compare colloid)

[0095] Preparation of crosslinking solution

[0096] The HA "cake" was prepared by dissolving 43 g of sodium hyaluronate (average molecular weight about 2.8 MDa) in 270.35 g of phosphate buffer. The resulting HA blocks can be stored in the refrigerator until needed. Alternatively, an alkaline solution was prepared by dissolving 3.31 g of solid sodium hydroxide in 10 ml of buffer. In addition, a BDDE solution was prepared by mixing 12.5 g of 2M sodium hydroxide solution with 88.5 g of phosphate buffer, and then mixing 8.21 ml of the resulting solution with 3.395 ml of BDDE.

[0097] cross-linking

[0098] The HA mass was manually broken into small pieces and all of the alkaline solution was added to the cup followed by mixing at 12 rpm for 30 to 40 minutes. Next, the BDDE solution was added to the cup and mixing was co...

Embodiment 2

[0106] Preparation of HA colloids with 15% CMC as lubricating phase (colloids of the invention)

[0107] Solution "LB1" was prepared by adding 62.75 g of glycerol to 2.150 g of lidocaine hydrofluoric acid and dissolving the mixture in 135.142 g of phosphate buffer. Next, stir gently using a magnetic stirrer until complete dissolution.

[0108] Next, 2.764 g of sodium carboxymethylcellulose (NaCMC) was vigorously mixed with 105.24 g of LB1 in a cup for 1 hour. After degassing, 392.025 g of the MHAG colloid prepared in Example 1 was added and mixed moderately for 1.5 hours. After an additional degassing step, 1 ml syringes were filled and sterilized at 127°C for 4 minutes.

Embodiment 3

[0110] Preparation of HA colloids with 15% (v / v) free HA as lubricating phase (comparative colloids)

[0111] Solution "LB2" was prepared by dissolving 1.131 g of lidocaine hydrochloride in 72.743 g of phosphate buffer. Next, 1.170 g of sodium hyaluronate (2.5-3.0 MDa) was added. After complete dissolution, 33.005 g of glycerol was added. The mixture was then stirred at a moderate speed for 1 hour and 30 minutes and maintained at 5°C until used.

[0112] HA gel with 15% (v / v) free HA lubricant was prepared by mixing 106.721 g of LB2 with 387.357 g of the MHAG gel prepared in Example 1. Moderate mixing was maintained for 2 hours. After degassing, the mixture was transferred to a 1 ml syringe and sterilized at 127°C for 4 minutes.

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Abstract

The present invention relates to injectable dermal filler compositions in the form of a gel, comprising hyaluronic acid (HA), carboxymethyl cellulose (CMC) and, optionally, microparticles such as calcium hydroxyapatite (CaHAP) microparticles. The injectable dermal filler compositions have improved rheological properties while at the same time have low extrusion forces. The present invention further relates to a method for preparing such injectable dermal filler compositions and their use for cosmetic and therapeutic purposes.

Description

technical field [0001] The present invention relates to an injectable dermal filler composition in the form of a colloid comprising cross-linked hyaluronic acid (HA), carboxymethylcellulose (CMC), and optionally microparticles ( Such as calcium hydroxyapatite (CaHAP) microparticles). Injectable dermal filler compositions have improved rheological properties combined with low extrusion forces. The invention also relates to a process for the preparation of such injectable dermal filler compositions and their use for cosmetic and therapeutic purposes. Background technique [0002] Achieving and maintaining a youthful appearance is a common denominator of beauty today. However, over time, the skin starts to lose its youthful appearance, especially on the face. The most prevalent aesthetic indicators of facial aging include visible skin wrinkles, deep nasolabial folds, frown lines, marionette lines, buccal seam lines, and mouth circumference wrinkles. [0003] These aging cha...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): A61L27/20A61L27/26A61L27/52C08L5/08
CPCA61L27/20A61L27/26A61L27/52C08L5/08C08B37/0072A61L2400/06A61P11/04A61P13/02A61P13/10A61P23/00A61L27/46A61L27/446A61L27/48A61L27/58A61L27/54C08L1/286A61L2430/34
Inventor 纳丁·哈格多恩罗兰·施特拉吉斯弗兰克·维兰卢宾·贝尔克维拉迪亚·埃尔-班纳
Owner MERZ PHARMA GMBH & CO KGAA
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