Chitosan beads and filler comprising such beads

a technology of chitosan beads and fillers, which is applied in the field of chitosan beads, can solve the problems of irregular microparticle formation, poor syringeability, and high cost of collagen and hyaluronic acid based fillers treatment, and achieves the effects of long-lasting effect, easy degradation, and rapid regrowth of volum

Inactive Publication Date: 2014-12-25
MERZ PHARMA GMBH & CO KGAA
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

The present invention introduces a novel filler with the following technical effects: rapid restoration of volume with no scar, sustained volume augmentation, long-lasting effect with minimal side effects, stable volume augmentation without degradation by human enzymes or absorption in the body, improved syringeability, and non-homogeneous distribution of particles at the injection site. This filler composition is also more cost-effective and avoids aggregation of particles in packaging.

Problems solved by technology

The unfavorable effect of fillers comprising hyaluronic acid is the short-lasting result and the need for multiple injections for an observable effect.
Thus, treatments with collagen and hyaluronic acid based fillers are costly and painful due to the prerequisite of multiple injections and allergy tests.
Further reported complications for the fillers is poor syringeability due to high viscosity, aggregation of the particles in the packaging and non-homogeneous distribution of the particles at the injection site.
However, when citrate was added to an emulsion of chitosan in acetic acid-containing solution, only irregular microparticles were formed, and microspheres could only be obtained when gelatin was added and co-emulsified (Shu, X. Z and Zhu, K. J., “Chitosan / gelatin microspheres prepared by modified emulsification and ionotropic gelation”, J. Microencapsulation 2001; 18; 237).

Method used

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  • Chitosan beads and filler comprising such beads
  • Chitosan beads and filler comprising such beads

Examples

Experimental program
Comparison scheme
Effect test

example 1

Manufacturing of Chitosan Beads and / or a Filler Comprising such Beads

[0110]Chitosan (Chitopharm L) is dispersed in deionized water. The appropriate amount of acid is added to the dispersion under constant stirring (0.05 mol per 10 g of chitosan). The dispersion is stirred until a clear solution is obtained. Having obtained a clear solution the pH of the obtained chitosan solution is stabilized from pH 1 to 5. With the help of a 30 Gauge syringe the chitosan solution is dropped into the following solutions having a pH from 5 to 11 and the obtained beads are let for 1 h in solution.

Crosslinking media1M Citrate1M citrate1M citrate1M citratepH of the media891011ObservationFormation ofFormation ofFormation ofFormation ofafter droppingcircular beadscircular beadscircular beadscircular beadsObservationElastic, flexibleElastic, flexibleLess flexible,Less flexible,after 1 h crosslinkingbeadsbeadsmore rigidmore rigidbeadsbeads

[0111]The obtained chitosan beads were investigated by employing a ...

example 2

Loading of Chitosan Beads with Active Pharmaceutical Ingredients

[0112]Chitosan is dispersed in deionized water. The appropriate amount of acid is added to the dispersion under a constant stirring. The dispersion is stirred until a clear solution is obtained. As a second solution, lidocaine hydrochloride USP (2% weight per weight) is dissolved in the chitosan solution. With the help of a 30 Gauge syringe the chitosan lidocaine solution is dropped into the following solutions having a pH from 1 to 5 and the obtained beads with lidocaine encapsulated are let for 1 h in solution.

example 3

Administration of the Filler Comprising Chitosan Beads

[0113]The filler prepared according to example 1 is injected to a 50-year old female patient into nasolabial folds.

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Abstract

The present invention pertains to chitosan beads consisting of chitosan cross-linked with citrate ions. The present invention furthermore pertains to a filler comprising such chitosan-citrate beads. In one embodiment of the instant invention the filler is a dermal filler. In one further embodiment of the present invention the dermal filler is for the treatment of wrinkles and / or folds. In another embodiment of the instant invention the filler is for use in the treatment of a medical condition. The filler provided in the present invention may further comprise one or more active pharmaceutical ingredients. Further, the present invention pertains to a process for preparing the filler as claimed herein.

Description

FIELD OF THE INVENTION[0001]The present invention pertains to chitosan beads consisting of chitosan cross-linked with citrate ions. The present invention furthermore pertains to a filler comprising such chitosan-citrate beads. In one embodiment of the instant invention the filler is a dermal filler. In one further embodiment of the present invention the dermal filler is for the treatment of wrinkles and / or folds. In another embodiment of the instant invention the filler is for use in the treatment of a medical condition. The filler provided in the present invention may further comprise one or more active pharmaceutical ingredients. Further, the present invention pertains to a process for preparing the filler as claimed herein.BACKGROUND OF THE INVENTION[0002]Treatment with fillers is known since 1980s. Today's most preferred fillers can be classified as hyaluronic acid-based fillers (Hylaform®, Hylaform® Plus, Restylane®, Perlane®, Juvederm®, Juvederm® Ultra, Juvederm® Ultra Plus, P...

Claims

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Application Information

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Patent Type & Authority Applications(United States)
IPC IPC(8): A61K8/02A61K31/167A61Q19/08A61K8/73
CPCA61K8/0204A61K8/736A61K31/167A61Q19/08A61K2800/72A61K2800/30A61K2800/654A61K2800/54A61K8/735A61K9/1652A61L31/042A61K8/365A61K8/025A61K2800/56A61L27/20Y10T428/2982C08L5/08
Inventor KIEHM, KEVINHAUPTMEIER, BERNHARDBODERKE, PETER
Owner MERZ PHARMA GMBH & CO KGAA
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