JP6868913B2 - マイクロニードルパッチ用のベース組成物及びこのベース組成物を含むマイクロニードルパッチ - Google Patents
マイクロニードルパッチ用のベース組成物及びこのベース組成物を含むマイクロニードルパッチ Download PDFInfo
- Publication number
- JP6868913B2 JP6868913B2 JP2019228368A JP2019228368A JP6868913B2 JP 6868913 B2 JP6868913 B2 JP 6868913B2 JP 2019228368 A JP2019228368 A JP 2019228368A JP 2019228368 A JP2019228368 A JP 2019228368A JP 6868913 B2 JP6868913 B2 JP 6868913B2
- Authority
- JP
- Japan
- Prior art keywords
- base
- less
- microneedle patch
- microneedle
- weight
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Active
Links
- 239000000203 mixture Substances 0.000 title description 37
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 claims description 70
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 claims description 70
- 239000000243 solution Substances 0.000 claims description 55
- 229920000036 polyvinylpyrrolidone Polymers 0.000 claims description 21
- 235000013855 polyvinylpyrrolidone Nutrition 0.000 claims description 21
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 claims description 19
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 claims description 19
- 238000000034 method Methods 0.000 claims description 12
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 9
- 229920001577 copolymer Polymers 0.000 claims description 5
- 239000001267 polyvinylpyrrolidone Substances 0.000 claims description 5
- 125000002887 hydroxy group Chemical group [H]O* 0.000 claims 1
- 229920000609 methyl cellulose Polymers 0.000 claims 1
- 239000001923 methylcellulose Substances 0.000 claims 1
- 235000010981 methylcellulose Nutrition 0.000 claims 1
- 239000006104 solid solution Substances 0.000 claims 1
- 230000000052 comparative effect Effects 0.000 description 48
- 239000007864 aqueous solution Substances 0.000 description 18
- 238000004519 manufacturing process Methods 0.000 description 16
- 239000000126 substance Substances 0.000 description 15
- 239000004205 dimethyl polysiloxane Substances 0.000 description 13
- 229920000435 poly(dimethylsiloxane) Polymers 0.000 description 13
- 210000003491 skin Anatomy 0.000 description 11
- 238000001035 drying Methods 0.000 description 8
- 239000007787 solid Substances 0.000 description 8
- 238000003860 storage Methods 0.000 description 8
- 239000011248 coating agent Substances 0.000 description 7
- 238000000576 coating method Methods 0.000 description 7
- 239000004372 Polyvinyl alcohol Substances 0.000 description 6
- 229920002451 polyvinyl alcohol Polymers 0.000 description 6
- 239000003153 chemical reaction reagent Substances 0.000 description 5
- 238000011156 evaluation Methods 0.000 description 5
- 239000004579 marble Substances 0.000 description 5
- 239000000463 material Substances 0.000 description 5
- 238000012360 testing method Methods 0.000 description 5
- WHGYBXFWUBPSRW-FOUAGVGXSA-N beta-cyclodextrin Chemical compound OC[C@H]([C@H]([C@@H]([C@H]1O)O)O[C@H]2O[C@@H]([C@@H](O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O[C@H]3O[C@H](CO)[C@H]([C@@H]([C@H]3O)O)O3)[C@H](O)[C@H]2O)CO)O[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@@H]3O[C@@H]1CO WHGYBXFWUBPSRW-FOUAGVGXSA-N 0.000 description 4
- -1 polydimethylsiloxane Polymers 0.000 description 4
- 239000004480 active ingredient Substances 0.000 description 3
- 230000000694 effects Effects 0.000 description 3
- 210000002615 epidermis Anatomy 0.000 description 3
- 238000002156 mixing Methods 0.000 description 3
- 238000007764 slot die coating Methods 0.000 description 3
- 210000000434 stratum corneum Anatomy 0.000 description 3
- 229920002134 Carboxymethyl cellulose Polymers 0.000 description 2
- 229920000858 Cyclodextrin Polymers 0.000 description 2
- 239000001116 FEMA 4028 Substances 0.000 description 2
- MVORZMQFXBLMHM-QWRGUYRKSA-N Gly-His-Lys Chemical compound NCCCC[C@@H](C(O)=O)NC(=O)[C@@H](NC(=O)CN)CC1=CN=CN1 MVORZMQFXBLMHM-QWRGUYRKSA-N 0.000 description 2
- HDTRYLNUVZCQOY-LIZSDCNHSA-N alpha,alpha-trehalose Chemical compound O[C@@H]1[C@@H](O)[C@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-LIZSDCNHSA-N 0.000 description 2
- 238000005452 bending Methods 0.000 description 2
- 235000011175 beta-cyclodextrine Nutrition 0.000 description 2
- 229960004853 betadex Drugs 0.000 description 2
- 238000005119 centrifugation Methods 0.000 description 2
- 239000013078 crystal Substances 0.000 description 2
- 230000007547 defect Effects 0.000 description 2
- 238000011049 filling Methods 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 239000002904 solvent Substances 0.000 description 2
- HDTRYLNUVZCQOY-UHFFFAOYSA-N α-D-glucopyranosyl-α-D-glucopyranoside Natural products OC1C(O)C(O)C(CO)OC1OC1C(O)C(O)C(O)C(CO)O1 HDTRYLNUVZCQOY-UHFFFAOYSA-N 0.000 description 1
- HDTRYLNUVZCQOY-WSWWMNSNSA-N Trehalose Natural products O[C@@H]1[C@@H](O)[C@@H](O)[C@@H](CO)O[C@@H]1O[C@@H]1[C@H](O)[C@@H](O)[C@@H](O)[C@@H](CO)O1 HDTRYLNUVZCQOY-WSWWMNSNSA-N 0.000 description 1
- 239000001768 carboxy methyl cellulose Substances 0.000 description 1
- 235000010948 carboxy methyl cellulose Nutrition 0.000 description 1
- 239000008112 carboxymethyl-cellulose Substances 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
- 238000012669 compression test Methods 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 238000005520 cutting process Methods 0.000 description 1
- 238000003618 dip coating Methods 0.000 description 1
- 238000006073 displacement reaction Methods 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000002347 injection Methods 0.000 description 1
- 239000007924 injection Substances 0.000 description 1
- 238000007641 inkjet printing Methods 0.000 description 1
- 238000005259 measurement Methods 0.000 description 1
- 239000002184 metal Substances 0.000 description 1
- 229910052751 metal Inorganic materials 0.000 description 1
- 210000000653 nervous system Anatomy 0.000 description 1
- 229920000191 poly(N-vinyl pyrrolidone) Polymers 0.000 description 1
- 238000002360 preparation method Methods 0.000 description 1
- 238000007639 printing Methods 0.000 description 1
- 239000002994 raw material Substances 0.000 description 1
- 230000001953 sensory effect Effects 0.000 description 1
- 239000010703 silicon Substances 0.000 description 1
- 229910052710 silicon Inorganic materials 0.000 description 1
- 238000007767 slide coating Methods 0.000 description 1
- 230000007847 structural defect Effects 0.000 description 1
- 238000010254 subcutaneous injection Methods 0.000 description 1
- 239000007929 subcutaneous injection Substances 0.000 description 1
- 239000000758 substrate Substances 0.000 description 1
- 229960005486 vaccine Drugs 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
- 239000011800 void material Substances 0.000 description 1
Classifications
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L1/00—Compositions of cellulose, modified cellulose or cellulose derivatives
- C08L1/08—Cellulose derivatives
- C08L1/26—Cellulose ethers
- C08L1/28—Alkyl ethers
- C08L1/284—Alkyl ethers with hydroxylated hydrocarbon radicals
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61K9/0021—Intradermal administration, e.g. through microneedle arrays, needleless injectors
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/32—Macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. carbomers, poly(meth)acrylates, or polyvinyl pyrrolidone
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L29/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by an alcohol, ether, aldehydo, ketonic, acetal or ketal radical; Compositions of hydrolysed polymers of esters of unsaturated alcohols with saturated carboxylic acids; Compositions of derivatives of such polymers
- C08L29/14—Homopolymers or copolymers of acetals or ketals obtained by polymerisation of unsaturated acetals or ketals or by after-treatment of polymers of unsaturated alcohols
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L39/00—Compositions of homopolymers or copolymers of compounds having one or more unsaturated aliphatic radicals, each having only one carbon-to-carbon double bond, and at least one being terminated by a single or double bond to nitrogen or by a heterocyclic ring containing nitrogen; Compositions of derivatives of such polymers
- C08L39/04—Homopolymers or copolymers of monomers containing heterocyclic rings having nitrogen as ring member
- C08L39/06—Homopolymers or copolymers of N-vinyl-pyrrolidones
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0023—Drug applicators using microneedles
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M37/00—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin
- A61M37/0015—Other apparatus for introducing media into the body; Percutany, i.e. introducing medicines into the body by diffusion through the skin by using microneedles
- A61M2037/0053—Methods for producing microneedles
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C39/00—Shaping by casting, i.e. introducing the moulding material into a mould or between confining surfaces without significant moulding pressure; Apparatus therefor
- B29C39/22—Component parts, details or accessories; Auxiliary operations
- B29C39/42—Casting under special conditions, e.g. vacuum
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29C—SHAPING OR JOINING OF PLASTICS; SHAPING OF MATERIAL IN A PLASTIC STATE, NOT OTHERWISE PROVIDED FOR; AFTER-TREATMENT OF THE SHAPED PRODUCTS, e.g. REPAIRING
- B29C41/00—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor
- B29C41/02—Shaping by coating a mould, core or other substrate, i.e. by depositing material and stripping-off the shaped article; Apparatus therefor for making articles of definite length, i.e. discrete articles
- B29C41/04—Rotational or centrifugal casting, i.e. coating the inside of a mould by rotating the mould
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2031/00—Use of polyvinylesters or derivatives thereof as moulding material
- B29K2031/04—Polymers of vinyl acetate, e.g. PVAc, i.e. polyvinyl acetate
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2039/00—Use of polymers with unsaturated aliphatic radicals and with a nitrogen or a heterocyclic ring containing nitrogen in a side chain or derivatives thereof as moulding material
- B29K2039/06—Polymers of N-vinyl-pyrrolidones
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29K—INDEXING SCHEME ASSOCIATED WITH SUBCLASSES B29B, B29C OR B29D, RELATING TO MOULDING MATERIALS OR TO MATERIALS FOR MOULDS, REINFORCEMENTS, FILLERS OR PREFORMED PARTS, e.g. INSERTS
- B29K2883/00—Use of polymers having silicon, with or without sulfur, nitrogen, oxygen, or carbon only, in the main chain, as mould material
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/753—Medical equipment; Accessories therefor
- B29L2031/7544—Injection needles, syringes
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B29—WORKING OF PLASTICS; WORKING OF SUBSTANCES IN A PLASTIC STATE IN GENERAL
- B29L—INDEXING SCHEME ASSOCIATED WITH SUBCLASS B29C, RELATING TO PARTICULAR ARTICLES
- B29L2031/00—Other particular articles
- B29L2031/756—Microarticles, nanoarticles
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2203/00—Applications
- C08L2203/02—Applications for biomedical use
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/02—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group
- C08L2205/025—Polymer mixtures characterised by other features containing two or more polymers of the same C08L -group containing two or more polymers of the same hierarchy C08L, and differing only in parameters such as density, comonomer content, molecular weight, structure
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08L—COMPOSITIONS OF MACROMOLECULAR COMPOUNDS
- C08L2205/00—Polymer mixtures characterised by other features
- C08L2205/03—Polymer mixtures characterised by other features containing three or more polymers in a blend
-
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10T—TECHNICAL SUBJECTS COVERED BY FORMER US CLASSIFICATION
- Y10T428/00—Stock material or miscellaneous articles
- Y10T428/13—Hollow or container type article [e.g., tube, vase, etc.]
- Y10T428/1352—Polymer or resin containing [i.e., natural or synthetic]
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- Pharmacology & Pharmacy (AREA)
- Epidemiology (AREA)
- Engineering & Computer Science (AREA)
- Inorganic Chemistry (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Organic Chemistry (AREA)
- Polymers & Plastics (AREA)
- Biomedical Technology (AREA)
- Hematology (AREA)
- Heart & Thoracic Surgery (AREA)
- Anesthesiology (AREA)
- Medical Informatics (AREA)
- Medicinal Preparation (AREA)
- Compositions Of Macromolecular Compounds (AREA)
- Cosmetics (AREA)
- Materials For Medical Uses (AREA)
Description
1.第1ヒドロキシプロピルメチルセルロース(第1HPMC)
(1)65SH−400、粘度:400cP、信越化学工業より購入
(2)65SH−1500、粘度:1,500cP(@20℃、2%水溶液)、信越化学工業より購入
(3)90SH−4000、粘度:4,000cP(@20℃、2%水溶液)、信越化学工業より購入
(4)90SH−4000SR、粘度:4,000cP(@20℃、2%水溶液)、信越化学工業より購入
(5)65SH−4000、粘度:4,000cP(@20℃、2%水溶液)、信越化学工業より購入
(6)60SH−4000、粘度:4,000cP(@20℃、2%水溶液)、信越化学工業より購入
(7)60SH−10000、粘度:10,000cP(@20℃、2%水溶液)、信越化学工業より購入
2.第2ヒドロキシプロピルメチルセルロース(第2HPMC)
(1)ファーマコート603、粘度:3cP(@20℃、2%水溶液)、信越化学工業より購入
(2)SB−4、粘度:4cP(@20℃、2%水溶液)、信越化学工業より購入
(3)ファーマコート645、粘度:4.5cP(@20℃、2%水溶液)、信越化学工業より購入
(4)ファーマコート606、粘度:6cP(@20℃、2%水溶液)、信越化学工業より購入
(5)ファーマコート615、粘度:15cP(@20℃、2%水溶液)、信越化学工業より購入
(6)メトローズ65SH−50、粘度:50cP(@20℃、2%水溶液)、信越化学工業より購入
(7)メトローズ60SH−50、粘度:50cP(@20℃、2%水溶液)、信越化学工業より購入
3.ポリビニルアルコール、日本合成化学工業より購入
4.ポリビニルピロリドン/酢酸ビニル共重合体、製品名:Kollidon(登録商標)、BASF社より購入
5.トレハロース、製品名:TREHA(登録商標)、株式会社林原より購入
6.カルボキシメチルセルロース(CMC)、シグマ・アルドリッチ社より購入
7.β−シクロデキストリン(β−CD)、製品名:β−シクロデキストリン、Yiyang Industrial社より購入
製造プロセスにおいて、上述の各実施例及び比較例のベース溶液を用い、マイクロニードルパッチを以下の方法で作製した。
本試験例は、ベース及びベース上に形成された針先を有するマイクロニードル構造がPDMSマスタ型から離型される状況を観察する目的で実施された。マイクロニードルパッチを製造する段階で、ベースの構造を損傷することなくPDMSマスタ型からマイクロニードル構造をスムーズに離型できた場合、以下の表3に「○」を記載した。PDMSマスタ型からマイクロニードル構造をスムーズに離型できなかった場合、又はベースが脆弱で離型中に破損又は損傷した場合、以下の表3に「×」と記載した。
本試験例では、マイクロニードルパッチの製造の完了後、5名による目視観察及び実体験により、各マイクロニードルパッチの柔軟性及び皮膚接着性を評価した。また、同5名による観察結果及び感覚反応も、以下の表3に記載した。
Claims (6)
- 第1ヒドロキシプロピルメチルセルロースと、第2ヒドロキシプロピルメチルセルロースと、ポリビニルピロリドン/酢酸ビニル共重合体と、水とを含むベース溶液であって、
上記ベース溶液の総重量基準で、上記第1ヒドロキシプロピルメチルセルロース及び上記第2ヒドロキシプロピルメチルセルロースの総量が、0.1重量%以上3重量%以下であり、上記第1ヒドロキシプロピルメチルセルロースの上記第2ヒドロキシプロピルメチルセルロースに対する重量比が、1:0.1以上1:1.2以下であり、上記ポリビニルピロリドン/酢酸ビニル共重合体の量が、0.25重量%以上2重量%以下であり、
上記第1ヒドロキシプロピルメチルセルロースの粘度が、400センチポアズ以上10,000センチポアズ以下であり、上記第2ヒドロキシプロピルメチルセルロースの粘度が、1センチポアズ以上100センチポアズ以下であり、上記ベース溶液の粘度が、1センチポアズ以上200,000センチポアズ以下であり、上記ベース溶液の表面張力が、25dyne/cm以上50dyne/cm以下であり、
上記ベース溶液の固形分が、0.35重量%以上60重量%以下であるベース溶液。 - 上記第1ヒドロキシプロピルメチルセルロース及び上記第2ヒドロキシプロピルメチルセルロースの総量が、0.2重量%以上2.5重量%以下である請求項1に記載のベース溶液。
- 上記第1ヒドロキシプロピルメチルセルロースの上記第2ヒドロキシプロピルメチルセルロースに対する重量比が、1:0.2以上1:1以下である請求項1又は請求項2に記載のベース溶液。
- 上記第1ヒドロキシプロピルメチルセルロースの粘度が、1,000センチポアズ以上8,000センチポアズ以下であり、上記第2ヒドロキシプロピルメチルセルロースの粘度が、2センチポアズ以上50センチポアズ以下である請求項1から請求項3のいずれか1項に記載のベース溶液。
- 上記ベース溶液が、上記第1ヒドロキシプロピルメチルセルロースと、上記第2ヒドロキシプロピルメチルセルロースと、上記ポリビニルピロリドン/酢酸ビニル共重合体と、水とからなる請求項1から請求項4のいずれか1項に記載のベース溶液。
- 複数のマイクロニードル構造を備えるマイクロニードルパッチであって、各マイクロニードル構造が、ベース及びこのベースに形成される針先を有し、上記ベースが、請求項1から請求項5のいずれか1項に記載のベース溶液から作られるマイクロニードルパッチ。
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
TW108125602A TWI692499B (zh) | 2019-07-19 | 2019-07-19 | 用於微針貼片之針底組成物及包含其之微針貼片 |
TW108125602 | 2019-07-19 |
Publications (2)
Publication Number | Publication Date |
---|---|
JP2021017543A JP2021017543A (ja) | 2021-02-15 |
JP6868913B2 true JP6868913B2 (ja) | 2021-05-12 |
Family
ID=68180313
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP2019228368A Active JP6868913B2 (ja) | 2019-07-19 | 2019-12-18 | マイクロニードルパッチ用のベース組成物及びこのベース組成物を含むマイクロニードルパッチ |
Country Status (5)
Country | Link |
---|---|
US (1) | US10793701B1 (ja) |
EP (1) | EP3766479B1 (ja) |
JP (1) | JP6868913B2 (ja) |
CN (1) | CN110339474B (ja) |
TW (1) | TWI692499B (ja) |
Families Citing this family (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN111939458A (zh) * | 2020-08-25 | 2020-11-17 | 四川大学 | 一种具有超薄柔性背衬层的微针贴片及其制备方法 |
Family Cites Families (13)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US5126145A (en) * | 1989-04-13 | 1992-06-30 | Upsher Smith Laboratories Inc | Controlled release tablet containing water soluble medicament |
DE4226753A1 (de) * | 1992-08-13 | 1994-02-17 | Basf Ag | Wirkstoffe enthaltende Zubereitungen in Form fester Teilchen |
JP3716901B2 (ja) * | 1999-04-14 | 2005-11-16 | シオノギクオリカプス株式会社 | セルロースエーテルフィルム |
US8647664B2 (en) * | 2006-07-14 | 2014-02-11 | Hisamitsu Pharmaceutical Co., Inc. | Adhesive preparation |
US20080260836A1 (en) * | 2007-04-18 | 2008-10-23 | Thomas James Boyd | Films Comprising a Plurality of Polymers |
MX2011002790A (es) * | 2008-09-25 | 2011-04-05 | Isp Investments Inc | Composiciones de recubrimiento de tabletas con alto contenido de solidos, lisas. |
GB201019577D0 (en) * | 2010-11-18 | 2010-12-29 | Univ Cork | Method |
EP2680823B1 (en) * | 2011-02-28 | 2024-05-15 | Nano4M Ltd | Binder powders |
KR101724655B1 (ko) * | 2014-06-02 | 2017-04-13 | 주식회사 아모라이프사이언스 | 마이크로 니들 패치 및 그의 제조 방법 |
CN206934352U (zh) * | 2015-06-03 | 2018-01-30 | 南京三迭纪医药科技有限公司 | 药品剂型 |
CN107412943A (zh) | 2017-04-17 | 2017-12-01 | 中国人民解放军军事医学科学院微生物流行病研究所 | 一种可溶性微针贴片及其制备方法 |
CN109200012A (zh) * | 2017-07-06 | 2019-01-15 | 中科微针(北京)科技有限公司 | 一种含有无机盐的分层溶解微针 |
CN108969880B (zh) * | 2018-06-12 | 2021-03-09 | 上海白衣缘生物工程有限公司 | 一种可溶性微针膜及其制备方法 |
-
2019
- 2019-07-19 TW TW108125602A patent/TWI692499B/zh active
- 2019-07-26 CN CN201910681808.3A patent/CN110339474B/zh active Active
- 2019-11-15 EP EP19209380.5A patent/EP3766479B1/en active Active
- 2019-11-27 US US16/698,875 patent/US10793701B1/en active Active
- 2019-12-18 JP JP2019228368A patent/JP6868913B2/ja active Active
Also Published As
Publication number | Publication date |
---|---|
TWI692499B (zh) | 2020-05-01 |
CN110339474B (zh) | 2021-07-06 |
US10793701B1 (en) | 2020-10-06 |
EP3766479B1 (en) | 2024-01-24 |
CN110339474A (zh) | 2019-10-18 |
JP2021017543A (ja) | 2021-02-15 |
EP3766479A1 (en) | 2021-01-20 |
TW202104411A (zh) | 2021-02-01 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
KR102064503B1 (ko) | 경피 흡수용 마이크로구조체 및 이의 제조방법 | |
KR101610598B1 (ko) | 잇몸 굴곡에 맞게 유연하며 치과용 물질 전달을 위한 마이크로 니들 및 그 제작방법 | |
TWI718576B (zh) | 溶解特性優秀的透明質酸微結構體 | |
JP5992333B2 (ja) | 可溶性マイクロニードル | |
US9919141B2 (en) | Needle-shaped body and method for manufacturing needle-shaped body | |
TWI629073B (zh) | Microneedle patch manufacturing method | |
TWI633901B (zh) | 醫美微針貼片之製作方法 | |
CN109069815B (zh) | 用于有效的皮肤穿孔的微针结构 | |
US10456378B2 (en) | Fast acting orally disintegrating film | |
JP6868913B2 (ja) | マイクロニードルパッチ用のベース組成物及びこのベース組成物を含むマイクロニードルパッチ | |
WO2019088227A1 (ja) | 歯科用局所麻酔マイクロニードルアレイ | |
WO2014175310A1 (ja) | 針状体の製造方法 | |
KR101590613B1 (ko) | 항온항습형 마이크로니들 패치 | |
JP6277953B2 (ja) | 針状体の製造方法 | |
KR102006071B1 (ko) | 마이크로 니들 및 이의 제조방법 | |
CN116212215A (zh) | 多层结构微针贴片及其制作方法 | |
KR20220141235A (ko) | 마이크로니들 어레이 및 이의 제조방법 | |
EP4129269B1 (en) | Multi-layered microneedle patch and method of manufacturing the same | |
WO2022215693A1 (ja) | 歯科用局所麻酔マイクロニードルアレイ | |
KR101629007B1 (ko) | 접촉각 조절이 가능한 마이크로니들 패치의 베이스필름 | |
KR20230010586A (ko) | 마이크로니들용 조성물, 마이크로니들 어레이 및 이를 포함하는 경피 패치 |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
A621 | Written request for application examination |
Free format text: JAPANESE INTERMEDIATE CODE: A621 Effective date: 20191218 |
|
A131 | Notification of reasons for refusal |
Free format text: JAPANESE INTERMEDIATE CODE: A131 Effective date: 20201027 |
|
A521 | Request for written amendment filed |
Free format text: JAPANESE INTERMEDIATE CODE: A523 Effective date: 20210113 |
|
TRDD | Decision of grant or rejection written | ||
A01 | Written decision to grant a patent or to grant a registration (utility model) |
Free format text: JAPANESE INTERMEDIATE CODE: A01 Effective date: 20210323 |
|
A61 | First payment of annual fees (during grant procedure) |
Free format text: JAPANESE INTERMEDIATE CODE: A61 Effective date: 20210406 |
|
R150 | Certificate of patent or registration of utility model |
Ref document number: 6868913 Country of ref document: JP Free format text: JAPANESE INTERMEDIATE CODE: R150 |
|
R250 | Receipt of annual fees |
Free format text: JAPANESE INTERMEDIATE CODE: R250 |