KR101987783B1 - Biodegradable polymeric microparticle and method for preparing the same, and biodegradable polymeric filler comprising the same - Google Patents
Biodegradable polymeric microparticle and method for preparing the same, and biodegradable polymeric filler comprising the same Download PDFInfo
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- KR101987783B1 KR101987783B1 KR1020150183676A KR20150183676A KR101987783B1 KR 101987783 B1 KR101987783 B1 KR 101987783B1 KR 1020150183676 A KR1020150183676 A KR 1020150183676A KR 20150183676 A KR20150183676 A KR 20150183676A KR 101987783 B1 KR101987783 B1 KR 101987783B1
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- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/58—Materials at least partially resorbable by the body
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
- A61K9/0024—Solid, semi-solid or solidifying implants, which are implanted or injected in body tissue
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/22—Polypeptides or derivatives thereof, e.g. degradation products
- A61L27/24—Collagen
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/40—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material
- A61L27/44—Composite materials, i.e. containing one material dispersed in a matrix of the same or different material having a macromolecular matrix
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- C08J—WORKING-UP; GENERAL PROCESSES OF COMPOUNDING; AFTER-TREATMENT NOT COVERED BY SUBCLASSES C08B, C08C, C08F, C08G or C08H
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- C08J3/126—Polymer particles coated by polymer, e.g. core shell structures
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- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L101/00—Compositions of unspecified macromolecular compounds
- C08L101/16—Compositions of unspecified macromolecular compounds the macromolecular compounds being biodegradable
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Abstract
The present invention relates to a biodegradable polymeric microparticle, a method for producing the biodegradable polymeric microparticle, and a biodegradable polymeric filler comprising the biodegradable polymeric microparticle. More particularly, the present invention relates to a biodegradable polymeric core and a collagen- The present invention relates to a biodegradable polymeric microparticle capable of preventing a decrease in volume at the initial stage of treatment when applied as a filler and having a longer maintenance period than that of a hyaluronic acid filler at the same time, a method for producing the same, and a biodegradable polymeric filler comprising the biodegradable polymeric filler.
Description
The present invention relates to a biodegradable polymeric microparticle, a method for producing the biodegradable polymeric microparticle, and a biodegradable polymeric filler comprising the biodegradable polymeric microparticle. More particularly, the present invention relates to a biodegradable polymeric core and a collagen- The present invention relates to a biodegradable polymeric microparticle capable of preventing a decrease in volume at the initial stage of treatment when applied as a filler and meeting a longer maintenance period than a hyaluronic acid filler at the same time, a method for producing the biodegradable polymeric microparticle, and a biodegradable polymeric filler containing the same.
In the era aiming at the eradication of disease, in the age of trying to realize the desire to live longer, and in the age of trying to live healthily with it, the era has come to reflect the situation of living young and beautiful recently .
Aging is a universal and essential life phenomenon of all human beings. As life spans are prolonged, interest in anti-aging has been focused. In recent years, young people Demand for anti-aging is increasing rapidly. In other words, as anti-aging trends that pursue youth and beauty are rapidly spreading, the concept of beauty also evolves from glamor to youth.
Since 2000, anti-aging industry customers such as skin care, functional cosmetics, fillers and botulinum toxins and beauty services have been expanding from middle-class and general public to those who are interested in beauty such as high-income earners and entertainers. The interest in anti-aging has been increasing throughout society. The academic world is a technology that slows down the aging process. The medical industry is used as diagnosis and treatment for geriatric diseases, and the products are used as products and services that make the industry harder.
The anti-aging market can be divided into consumer goods such as cosmetics, medicine, and service. In the medical field, many drugs and biomaterials such as botulinum toxin and hyaluronic acid filler have been developed, leading to growth. In the case of botulinum toxin, which has been used for the treatment of strabismus due to muscle relaxation effect, the beauty purpose of the medical institution in Korea has reached 90%, and the filler market is also growing rapidly as safe materials such as hyaluronic acid, collagen etc. .
The development of fast-growing filler products can be divided into four generations.
The first generation is a collagen-based filler, which has been used most extensively in the past, but it is a product that is already in decline due to side effects such as a short maintenance period of only 1 to 3 months and collagen- to be.
The second generation is hyaluronic acid (HA) filler, which is a growing product with 90% market share in the filler market. Although hyaluronic acid is biocompatible and has no toxicity, it has excellent properties as a filler material. However, it is pointed out as a disadvantage in relatively short duration of body maintenance that it is difficult to fill a year, so that existing hyaluronic acid filler manufacturers We are continually devoting our efforts. However, when increasing the degree of crosslinking of hyaluronic acid to increase the maintenance period, that is, when the crosslinking agent is used in a large amount, there is a side effect that the biocompatibility is deteriorated due to the toxicity of the crosslinking agent itself. Thus, a technical challenge is required to increase the degree of crosslinking while using less crosslinking agent In fact.
The third-generation filler using calcium or polymethylmethacrylate (PMMA) has not been biodegraded and has a semi-permanent advantage. As a result of safety problems, it has turned into a disadvantage.
Followed by biodegradable polymer fillers as fourth-generation fillers are entering the market. International patent publications WO 1998/56431 and WO 2009/014441 disclose fillers using biodegradable polymers such as PLA and PCL, and commercially available products using the fillers disclosed in these patents have been put on the market. Biodegradable polymer filler is a volume of the product itself, unlike conventional hyaluronic acid filler that supports skin tissue, biodegrades polymer to induce self collagen production to support tissue and wrinkle spreading, volume is natural, hyaluronic acid filler Although it has the advantage of a longer maintenance period, it is known that the initial volume is greatly reduced within one week after the procedure, and that the volume is gradually re-expressed over a period of 6 to 6 months.
Therefore, even though it is a biodegradable polymer material that induces self-collagen production and has a long period of maintenance in the body, the demand for a new polymer filler expressing volume from the time immediately after the procedure like a conventional hyaluronic acid filler is not satisfied, Development is needed.
Disclosure of the Invention The present invention has been made to solve the problems of the prior art described above, and it is an object of the present invention to provide a biodegradable polymer material which induces self collagen production when applied to a living body, And a biodegradable polymer filler containing the same.
In order to solve the above technical problems, the present invention provides a biodegradable polymer core; And a collagen-inducing substance coated on the core surface.
According to another aspect of the present invention, there is provided a method of manufacturing a biodegradable polymer core comprising: providing a biodegradable polymer core; And coating a collagen-inducing substance on the surface of the biodegradable polymer core.
According to another aspect of the present invention, there is provided a biodegradable polymer microparticle of the present invention; And a biologically acceptable polymeric filler comprising a pharmaceutically acceptable carrier.
The filler containing biodegradable polymeric microparticles according to the present invention exhibits a longer maintenance period than the hyaluronic acid filler by inducing long-term self collagen production of surrounding tissues while slowly biodegrading the core portion of the biodegradable polymeric microparticles when applied to a living body , The core-coated collagen inducing substance induces self collagen production before biodegradation of the core starts, thereby preventing the initial volume reduction of the conventional polymer filler and thereby generating a constant volume such as a hyaluronic acid filler.
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic view illustrating a structure in which a collagen-inducing substance is coated on the surface of a biodegradable polymer core of biodegradable polymeric microparticles according to one embodiment of the present invention. FIG.
Hereinafter, the present invention will be described in detail.
The biodegradable polymeric microparticles of the present invention include a biodegradable polymer core.
The biodegradable polymer core is a microparticle / microparticle made of a neutral polymer having biocompatibility and biodegradability and preferably exhibits a body maintenance period (or absorption period) of 18 months or longer.
It is preferable that the biodegradable polymer core has a diameter of 20 mu m or more so as not to be pumped by macrophages in living tissue. Further, it is preferable that the diameter is not more than 100 탆 so that the injection can smoothly be performed at a pressure of 60 N or less in a thin needle of 27 G or more and can not be felt by the touch of the fingertip after injection without causing pain to the patient as much as possible. Mu m or less.
The biodegradable polymer core may preferably be selected from polycaprolactone, polylactic acid, polyglycolic acid and copolymers thereof, and more specifically polylactic acid, poly-D-lactic acid, polycaprolactone Or copolymers thereof. The biodegradable polymer preferably has a weight average molecular weight of 200,000 to 800,000 because it can achieve a sustained period of 24 months or more.
The biodegradable polymer microparticles of the present invention include a collagen inducing substance coated on the surface of the biodegradable polymer core.
In one embodiment, the collagen-inducing material coated on the core may be selected from a calcium ion (Ca 2 + ) feeder, ascorbic acid, a biodegradable polymer having a lower molecular weight than the biodegradable polymer core, and combinations thereof. More specifically, the calcium ion (Ca 2+ ) feeder may be selected from hydroxyapatite, beta-TCP (tricalcium phosphate), calcium carbonate, and combinations thereof, and biodegradable The polymer may be selected from polyglycolic acid, polylactic acid, polycaprolactone, polydioxanone, and copolymers thereof.
The weight average molecular weight of the biodegradable polymer used as the collagen inducing material is lower than that of the biodegradable polymer used as the core within the range of, for example, 10,000 to less than 200,000, for example, 10,000 to 190,000, It represents speed.
There is no particular limitation on the amount of the collagen-inducing substance coated on the core. For example, 1 to 10 parts by weight of the collagen-inducing substance may be coated on the basis of 100 parts by weight of the core, but is not limited thereto.
According to another aspect of the present invention, there is provided a method of manufacturing a biodegradable polymer core comprising: providing a biodegradable polymer core; And coating a collagen-inducing substance on the surface of the biodegradable polymer core.
As a method for producing the biodegradable polymer core, a solvent evaporation method, a precipitation method, a cooling milling method, or other polymer microparticle / microparticle production method generally used in this technical field can be used. .
As a method of coating the collagen-inducing material on the core surface, solid layering, solution method, precipitation method, bottom spray coating, etc. commonly used in this technical field can be used. The present invention is not limited by the method.
Biodegradable polymer cores are maintained in the body for a long period of time, but the time for biodegradation to start is slow. Therefore, collagen synthesis can not be induced until the volume of the skin is reduced, since it is absorbed in only a few days after it is injected into the body together with a carrier (for example, an aqueous solution of carboxymethyl cellulose (CMC)). This is the cause of the drastic decrease in the initial volume of the procedure, which is the most fatal disadvantage of the existing polymer filler.
On the other hand, in the present invention, by coating a material capable of inducing collagen production early on biodegradation faster than biodegradable polymer cores on the surface of the core, volume reduction at the initial stage of treatment prevents the coating material from inducing collagen, It is possible to produce an ideal filler having a longer holding period than the hyaluronic acid filler without the volume reduction at the initial stage of the treatment by maintaining the biodegradation action of the core.
Therefore, according to another aspect of the present invention, there is provided a biodegradable polymer microparticle of the present invention; And a biologically acceptable polymeric filler comprising a pharmaceutically acceptable carrier.
As the above pharmaceutically acceptable carrier for injectable use, for example, a physiological saline solution, a phosphate buffer and the like can be used. The carrier may further include one or more lubricants such as cellulose derivatives such as carboxymethylcellulose (CMC) and hydroxypropylmethylcellulose (HPMC), solutes such as hyaluronic acid, and glycerin, but are not limited thereto .
In one embodiment, the content of each component contained in the biodegradable polymeric filler of the present invention is 20 to 50% by weight of the biodegradable polymeric microparticles, 10 to 69% by weight of the aqueous solution, 1 to 10% by weight, and the dispersing agent may be 10 to 30% by weight.
The pellet formulation of the present invention can be obtained by suspending biodegradable polymeric microparticles coated with collagen inducing material on a carrier, which can be provided in a sterile syringe or a sterilizing vial ready for use with an injection needle.
The biodegradable polymeric filler of the present invention does not require any pretreatment and is highly convenient to use. Since it is 100% biodegradable over a predetermined period of time after injection, it is safe because it does not leave any foreign material in the living tissue and does not contain any animal- . In addition, it is more suitable as a facial filler, because it has a longer maintenance period than a hyaluronic acid filler even when there is no volume reduction at the initial stage of the procedure.
The present invention will be described in more detail with reference to the following examples, but the present invention is not limited thereto.
[Example]
Example 1
12 g of polylactic acid (weight average molecular weight: 410,000) was dissolved in 200 ml of an organic solvent (dichloromethane), and this solution was gradually injected into 500 ml of water containing 10 g of polyvinyl acetate, And stirred continuously at high speed until phosphorus particles were formed. The formed microparticles were collected by sedimentation, filtration and drying. Then, hydroxyapatite as a collagen-inducing substance was coated on the microparticles by solid layering, and the mixture was put into a carrier containing physiological saline solution and carboxymethylcellulose (2 wt.%), Gently stirred and dispensed .
Example 2
500 g of polycaprolactone (weight-average molecular weight: 240,000) was cooled and pulverized and then fractionated to obtain fine particles having a final particle diameter of 20 to 40 占 퐉 and an average particle diameter of 30 占 퐉. Then, the microparticles were coated with a solution of polyglycolic acid-polylactic acid copolymer (PGLA) (weight average molecular weight: 130,000) as a collagen inducing substance by a solution method, and then the cells were treated with phosphate buffer, carboxymethylcellulose (2 wt.%) And glycerin (20 wt. %), And the mixture was gently stirred and then dispensed.
Comparative Example 1
The same procedure as in Example 1 was performed, omitting only the coating process.
Comparative Example 2
The same procedure as in Example 2 was performed, omitting only the coating process.
An animal efficacy test was carried out using the hairless mouse on the filler formulations obtained in Examples 1 and 2 and Comparative Examples 1 and 2, and the results are shown in Table 1 below.
As can be seen from Table 1, in the case of the filler formulations of the Examples including the polymer fine particles coated with the collagen inducer, the initial volume reduction of the procedure was remarkably improved.
Claims (10)
A pharmaceutically acceptable carrier; and a pharmaceutically acceptable carrier,
Wherein the collagen-inducing material coated on the core is a biodegradable polymer having a lower molecular weight than the biodegradable polymer core,
Biodegradable polymeric filler.
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Cited By (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| KR102178306B1 (en) | 2020-05-25 | 2020-11-16 | 주식회사 울트라브이 | Fabrication method of orgnaic-inorganic composite microparticle for filler, and Fabrication method of injection comprising the same |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| KR102034872B1 (en) * | 2018-01-10 | 2019-10-21 | 주식회사 지투지바이오 | Dermal filler of polycaprolactone microspheres containing collagen peptide and method for preparing the same |
| US11590258B2 (en) | 2018-01-10 | 2023-02-28 | G2Gbio, Inc. | Vitamin C-containing polycaprolactone microsphere filler and preparation method therefor |
| KR102047984B1 (en) * | 2018-01-10 | 2019-11-22 | 주식회사 지투지바이오 | Dermal filler of porous and homogeneous polycaprolactone microspheres and method for preparing the same |
| KR102266385B1 (en) * | 2021-01-22 | 2021-06-21 | 주식회사 울트라브이 | Biogradable polymer fine particle for filler, preparing method thereof, freeze-dried product for filler including the same, and injection for filler including the same |
Citations (3)
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| KR100700674B1 (en) | 2004-08-25 | 2007-03-30 | 연세대학교 산학협력단 | Collagen conduit coated with synthetic biodegradable polymer and method for the production thereof |
| KR101142234B1 (en) * | 2009-12-28 | 2012-07-09 | 한남대학교 산학협력단 | Injectable Porous Microparticle Filler System |
| KR101271721B1 (en) | 2010-08-18 | 2013-06-04 | 한국기계연구원 | The coated scaffold for regeneration of hard tissue with hydroxyapatite and/or collagen containing mesoporous bioactive glass and the method thereof |
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| KR20140147950A (en) * | 2013-06-20 | 2014-12-31 | 서울대학교산학협력단 | Composition comprising filler and botulinum toxin for improving skin wrinkle, ageing or treating neuromuscular disease |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
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| KR100700674B1 (en) | 2004-08-25 | 2007-03-30 | 연세대학교 산학협력단 | Collagen conduit coated with synthetic biodegradable polymer and method for the production thereof |
| KR101142234B1 (en) * | 2009-12-28 | 2012-07-09 | 한남대학교 산학협력단 | Injectable Porous Microparticle Filler System |
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| Publication number | Priority date | Publication date | Assignee | Title |
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| KR102178306B1 (en) | 2020-05-25 | 2020-11-16 | 주식회사 울트라브이 | Fabrication method of orgnaic-inorganic composite microparticle for filler, and Fabrication method of injection comprising the same |
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