JP6360494B2 - 積層型貼付剤 - Google Patents
積層型貼付剤 Download PDFInfo
- Publication number
- JP6360494B2 JP6360494B2 JP2015552488A JP2015552488A JP6360494B2 JP 6360494 B2 JP6360494 B2 JP 6360494B2 JP 2015552488 A JP2015552488 A JP 2015552488A JP 2015552488 A JP2015552488 A JP 2015552488A JP 6360494 B2 JP6360494 B2 JP 6360494B2
- Authority
- JP
- Japan
- Prior art keywords
- layer
- adhesive layer
- drug reservoir
- rivastigmine
- patch
- 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.)
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- SMZOUWXMTYCWNB-UHFFFAOYSA-N 2-(2-methoxy-5-methylphenyl)ethanamine Chemical compound COC1=CC=C(C)C=C1CCN SMZOUWXMTYCWNB-UHFFFAOYSA-N 0.000 claims description 14
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- WFWLQNSHRPWKFK-ZCFIWIBFSA-N tegafur Chemical compound O=C1NC(=O)C(F)=CN1[C@@H]1OCCC1 WFWLQNSHRPWKFK-ZCFIWIBFSA-N 0.000 description 1
- 229960001674 tegafur Drugs 0.000 description 1
- 229960004084 temocapril Drugs 0.000 description 1
- FIQOFIRCTOWDOW-BJLQDIEVSA-N temocapril Chemical compound C([C@@H](C(=O)OCC)N[C@@H]1C(N(CC(O)=O)C[C@H](SC1)C=1SC=CC=1)=O)CC1=CC=CC=C1 FIQOFIRCTOWDOW-BJLQDIEVSA-N 0.000 description 1
- KFVSLSTULZVNPG-UHFFFAOYSA-N terbutaline sulfate Chemical compound [O-]S([O-])(=O)=O.CC(C)(C)[NH2+]CC(O)C1=CC(O)=CC(O)=C1.CC(C)(C)[NH2+]CC(O)C1=CC(O)=CC(O)=C1 KFVSLSTULZVNPG-UHFFFAOYSA-N 0.000 description 1
- 229960005105 terbutaline sulfate Drugs 0.000 description 1
- KKEYFWRCBNTPAC-UHFFFAOYSA-L terephthalate(2-) Chemical compound [O-]C(=O)C1=CC=C(C([O-])=O)C=C1 KKEYFWRCBNTPAC-UHFFFAOYSA-L 0.000 description 1
- IMCGHZIGRANKHV-AJNGGQMLSA-N tert-butyl (3s,5s)-2-oxo-5-[(2s,4s)-5-oxo-4-propan-2-yloxolan-2-yl]-3-propan-2-ylpyrrolidine-1-carboxylate Chemical compound O1C(=O)[C@H](C(C)C)C[C@H]1[C@H]1N(C(=O)OC(C)(C)C)C(=O)[C@H](C(C)C)C1 IMCGHZIGRANKHV-AJNGGQMLSA-N 0.000 description 1
- WUBVEMGCQRSBBT-UHFFFAOYSA-N tert-butyl 4-(trifluoromethylsulfonyloxy)-3,6-dihydro-2h-pyridine-1-carboxylate Chemical compound CC(C)(C)OC(=O)N1CCC(OS(=O)(=O)C(F)(F)F)=CC1 WUBVEMGCQRSBBT-UHFFFAOYSA-N 0.000 description 1
- 229960003604 testosterone Drugs 0.000 description 1
- 229960002494 tetracaine hydrochloride Drugs 0.000 description 1
- 229960002180 tetracycline Drugs 0.000 description 1
- 229930101283 tetracycline Natural products 0.000 description 1
- 235000019364 tetracycline Nutrition 0.000 description 1
- 150000003522 tetracyclines Chemical class 0.000 description 1
- 229960002784 thioridazine Drugs 0.000 description 1
- 229960002961 ticlopidine hydrochloride Drugs 0.000 description 1
- MTKNGOHFNXIVOS-UHFFFAOYSA-N ticlopidine hydrochloride Chemical compound [H+].[Cl-].ClC1=CC=CC=C1CN1CC(C=CS2)=C2CC1 MTKNGOHFNXIVOS-UHFFFAOYSA-N 0.000 description 1
- 229960004402 tiopronin Drugs 0.000 description 1
- OGIDPMRJRNCKJF-UHFFFAOYSA-N titanium oxide Inorganic materials [Ti]=O OGIDPMRJRNCKJF-UHFFFAOYSA-N 0.000 description 1
- 229960002388 tizanidine hydrochloride Drugs 0.000 description 1
- 229960005371 tolbutamide Drugs 0.000 description 1
- 229960003553 tolterodine tartrate Drugs 0.000 description 1
- 229960002051 trandolapril Drugs 0.000 description 1
- 229960003991 trazodone Drugs 0.000 description 1
- PHLBKPHSAVXXEF-UHFFFAOYSA-N trazodone Chemical compound ClC1=CC=CC(N2CCN(CCCN3C(N4C=CC=CC4=N3)=O)CC2)=C1 PHLBKPHSAVXXEF-UHFFFAOYSA-N 0.000 description 1
- 229960002622 triacetin Drugs 0.000 description 1
- VSQQQLOSPVPRAZ-RRKCRQDMSA-N trifluridine Chemical compound C1[C@H](O)[C@@H](CO)O[C@H]1N1C(=O)NC(=O)C(C(F)(F)F)=C1 VSQQQLOSPVPRAZ-RRKCRQDMSA-N 0.000 description 1
- 229960004479 trihexyphenidyl hydrochloride Drugs 0.000 description 1
- QDWJJTJNXAKQKD-UHFFFAOYSA-N trihexyphenidyl hydrochloride Chemical compound Cl.C1CCCCC1C(C=1C=CC=CC=1)(O)CCN1CCCCC1 QDWJJTJNXAKQKD-UHFFFAOYSA-N 0.000 description 1
- 229960004846 tulobuterol hydrochloride Drugs 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 230000002485 urinary effect Effects 0.000 description 1
- RUDATBOHQWOJDD-UZVSRGJWSA-N ursodeoxycholic acid Chemical compound C([C@H]1C[C@@H]2O)[C@H](O)CC[C@]1(C)[C@@H]1[C@@H]2[C@@H]2CC[C@H]([C@@H](CCC(O)=O)C)[C@@]2(C)CC1 RUDATBOHQWOJDD-UZVSRGJWSA-N 0.000 description 1
- 229960001661 ursodiol Drugs 0.000 description 1
- NQPDZGIKBAWPEJ-UHFFFAOYSA-N valeric acid Chemical compound CCCCC(O)=O NQPDZGIKBAWPEJ-UHFFFAOYSA-N 0.000 description 1
- 229960004699 valsartan Drugs 0.000 description 1
- SJSNUMAYCRRIOM-QFIPXVFZSA-N valsartan Chemical compound C1=CC(CN(C(=O)CCCC)[C@@H](C(C)C)C(O)=O)=CC=C1C1=CC=CC=C1C1=NN=N[N]1 SJSNUMAYCRRIOM-QFIPXVFZSA-N 0.000 description 1
- 229960000881 verapamil hydrochloride Drugs 0.000 description 1
- 229960005080 warfarin Drugs 0.000 description 1
- PJVWKTKQMONHTI-UHFFFAOYSA-N warfarin Chemical compound OC=1C2=CC=CC=C2OC(=O)C=1C(CC(=O)C)C1=CC=CC=C1 PJVWKTKQMONHTI-UHFFFAOYSA-N 0.000 description 1
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 description 1
- 239000002759 woven fabric Substances 0.000 description 1
- JOLJIIDDOBNFHW-UHFFFAOYSA-N xanomeline Chemical compound CCCCCCOC1=NSN=C1C1=CCCN(C)C1 JOLJIIDDOBNFHW-UHFFFAOYSA-N 0.000 description 1
- 229950006755 xanomeline Drugs 0.000 description 1
- 239000008096 xylene Substances 0.000 description 1
- 239000011787 zinc oxide Substances 0.000 description 1
- GVJHHUAWPYXKBD-IEOSBIPESA-N α-tocopherol Chemical class OC1=C(C)C(C)=C2O[C@@](CCC[C@H](C)CCC[C@H](C)CCCC(C)C)(C)CCC2=C1C GVJHHUAWPYXKBD-IEOSBIPESA-N 0.000 description 1
Classifications
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- 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
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7084—Transdermal patches having a drug layer or reservoir, and one or more separate drug-free skin-adhesive layers, e.g. between drug reservoir and skin, or surrounding the drug reservoir; Liquid-filled reservoir patches
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/13—Amines
- A61K31/135—Amines having aromatic rings, e.g. ketamine, nortriptyline
- A61K31/137—Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine or methadone
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/21—Esters, e.g. nitroglycerine, selenocyanates
- A61K31/27—Esters, e.g. nitroglycerine, selenocyanates of carbamic or thiocarbamic acids, meprobamate, carbachol, neostigmine
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/325—Carbamic acids; Thiocarbamic acids; Anhydrides or salts thereof
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/55—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole
- A61K31/551—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having seven-membered rings, e.g. azelastine, pentylenetetrazole having two nitrogen atoms, e.g. dilazep
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- 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
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/70—Web, sheet or filament bases ; Films; Fibres of the matrix type containing drug
- A61K9/7023—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms
- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
- A61K9/7046—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds
- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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- A61K9/703—Transdermal patches and similar drug-containing composite devices, e.g. cataplasms characterised by shape or structure; Details concerning release liner or backing; Refillable patches; User-activated patches
- A61K9/7038—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer
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- A61K9/7053—Transdermal patches of the drug-in-adhesive type, i.e. comprising drug in the skin-adhesive layer the adhesive comprising macromolecular compounds obtained by reactions only involving carbon to carbon unsaturated bonds, e.g. polyvinyl, polyisobutylene, polystyrene
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- A61P25/00—Drugs for disorders of the nervous system
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
Description
支持体層、薬物貯留層及び粘着層を備える積層型貼付剤であって、
前記薬物貯留層が、リバスチグミン及びその薬学的に許容される塩からなる群から選択される少なくとも1種の薬物と、ヒドロキシ基を有するアクリル系高分子(A)とを含有しており、
前記粘着層が、カルボキシ基を有する(メタ)アクリル酸アルキルエステル共重合体及びアクリル酸単独重合体からなる群から選択される少なくとも1種のアクリル系高分子(B)と、ゴム系粘着基剤とを含有しており、
前記薬物貯留層における前記薬物のリバスチグミンフリー体に換算した含有量が前記薬物貯留層の全質量に対して15〜45質量%であり、かつ、
前記粘着層における前記アクリル系高分子(B)の総含有量が前記粘着層の全質量に対して7〜18質量%であるものである。
支持体層、薬物貯留層及び粘着層を備える積層型貼付剤であって、
前記薬物貯留層が、リバスチグミン及びその薬学的に許容される塩からなる群から選択される少なくとも1種の薬物と、ヒドロキシ基を有するアクリル系高分子(A)とを含有しており、
前記粘着層が、カルボキシ基を有する(メタ)アクリル酸アルキルエステル共重合体及びアクリル酸単独重合体からなる群から選択される少なくとも1種のアクリル系高分子(B)と、ゴム系粘着基剤とを含有しており、
前記薬物貯留層における前記薬物のリバスチグミンフリー体に換算した含有量が前記薬物貯留層の全質量に対して15〜45質量%であり、かつ、
前記粘着層における前記アクリル系高分子(B)の総含有量が前記粘着層の全質量に対して7〜18質量%である。
本発明に係る支持体層としては、前記薬物貯留層及び前記粘着層を支持し得るものであれば特に制限されず、貼付剤の支持体層として公知のものを適宜採用することができる。このような支持体層の材質としては、例えば、ポリエチレンテレフタレート、ポリブチレンテレフタレート、ポリエチレンナフタレート等のポリエステル;ポリエチレン、ポリプロピレン等のポリオレフィン;ポリウレタン;エチレン−酢酸ビニル共重合体といった合成樹脂や、アルミニウム等の金属及び紙が挙げられる。また、このような材質からなる支持体層の形態としては、例えば、フィルム;発泡シート、多孔シート、微多孔シート等のシート;織布、編布、不織布等の布帛;箔;及びこれらの積層体が挙げられる。本発明に係る支持体層としては、薬物を透過しないものであることが好ましく、中でも、柔軟性及び薬物非透過性に優れるという観点から、ポリエステルフィルムが好ましい。また、前記支持体層の厚さとしても特に制限されないが、通常2〜600μm程度であることが好ましい。
本発明に係る薬物貯留層は、リバスチグミン及びその薬学的に許容される塩からなる群から選択される少なくとも1種の薬物と、ヒドロキシ基を有するアクリル系高分子(A)とを含有する。このような薬物貯留層の厚さとしては、100〜500g/m2となる厚さであることが好ましく、150〜300g/m2となる厚さであることがより好ましい。薬物貯留層の厚さが前記下限未満であると、リバスチグミンの十分な皮膚透過速度及び徐放性を長期間維持することが困難となる傾向にあり、他方、前記上限を超えると、薬物貯留層がいわゆるコールドフローを起こしやすくなり、十分な厚みや形状を保つことが困難となる傾向にある。
本発明に係る薬物貯留層は、薬物としてリバスチグミンを含有する。リバスチグミンとしては、フリー体(遊離塩基)であってもリバスチグミンの薬学的に許容される塩の形態であってもよく、これらのうちの1種であっても2種以上が混合されていてもよい。前記リバスチグミンの薬学的に許容される塩としては、例えば、塩酸、硫酸、酢酸、硝酸、臭化水素酸、リン酸、メタンスルホン酸、フマル酸、マレイン酸、クエン酸、酒石酸、ベシル酸、コハク酸、タンニン酸等の酸付加塩が挙げられる。本発明においては、これらの中でも、皮膚透過性及び徐放性がいずれも向上するという観点から、リバスチグミンのフリー体であることがより好ましい。本発明では、このように皮膚透過性が高いフリー体のリバスチグミンを用いた場合であっても、十分な徐放性が発揮される。
本発明に係る薬物貯留層は、ヒドロキシ基を有するアクリル系高分子(A)を更に含有する。本発明においては、このようなアクリル系高分子(A)及びリバスチグミンが含有された薬物貯留層と下記に詳述する粘着層とを組み合わせることにより、優れたリバスチグミンの徐放性が発揮される。なお、本発明において、「アクリル系高分子(A)」及び「ヒドロキシ基を有するアクリル系高分子(A)」とは、「ヒドロキシ基を有するアクリル系高分子」のことを指し、前記薬物貯留層に含有される。
本発明に係る粘着層は、カルボキシ基を有する(メタ)アクリル酸アルキルエステル共重合体及びアクリル酸単独重合体からなる群から選択される少なくとも1種のアクリル系高分子(B)と、ゴム系粘着基剤とを含有する。このような粘着層の厚さとしては、50〜200g/m2となる厚さであることが好ましく、100〜175g/m2となる厚さであることがより好ましく、100〜170g/m2となる厚さであることがさらに好ましい。粘着層の厚さが前記下限未満であると、リバスチグミンの十分な皮膚透過速度及び徐放性を長期間維持することが困難となる傾向にあり、他方、前記上限を超えると、粘着層がいわゆるコールドフローを起こしやすくなり、十分な厚みや形状を保つことが困難となる傾向にある。
本発明に係る粘着層は、カルボキシ基を有する(メタ)アクリル酸アルキルエステル共重合体及びアクリル酸単独重合体からなる群から選択される少なくとも1種のアクリル系高分子(B)を含有する。本発明においては、このようなアクリル系高分子(B)が含有された粘着層と前記薬物貯留層とを組み合わせることにより、優れたリバスチグミンの徐放性が発揮される。なお、本発明において、「アクリル系高分子(B)」とは、「カルボキシ基を有する(メタ)アクリル酸アルキルエステル共重合体及び/又はアクリル酸単独重合体」のことを指し、前記粘着層に含有される。
本発明に係る粘着層は、ゴム系粘着基剤を更に含有する。前記ゴム系粘着基剤は、前記粘着層に粘着性を付与し得る粘着基剤であり、例えば、スチレン−イソプレン−スチレンブロック共重合体(以下、場合により「SIS」と略す)、スチレン−ブタジエン−スチレンブロック共重合体(以下、場合により「SBS」と略す)、スチレン−エチレン・ブチレン−スチレンブロック共重合体、スチレン−ブタジエン共重合体等のスチレン系ブロック共重合体;天然ゴム;ポリイソブチレン(以下、場合により「PIB」と略す);ポリイソプレンが挙げられ、これらのうちの1種を単独で用いても2種以上を組み合わせて用いてもよい。中でも、リバスチグミンのより十分な皮膚透過速度及び徐放性をより長期間維持することができるという観点から、前記ゴム系粘着基剤としては、スチレン−イソプレン−スチレンブロック共重合体、スチレン−ブタジエン−スチレンブロック共重合体、スチレン−ブタジエン共重合体、ポリイソブチレン、及びポリイソプレンからなる群から選択される少なくとも1種であることが好ましく、スチレン−イソプレン−スチレンブロック共重合体及びポリイソブチレンを組み合わせて用いることがより好ましい。
以下、本発明の積層型貼付剤の構成について、図面を参照しながら本発明の好ましい形態を例に挙げて詳細に説明するが、本発明はこれに限定されるものではない。なお、以下の説明及び図面中、同一又は相当する要素には同一の符号を付し、重複する説明は省略する。
本発明の積層型貼付剤は、特に制限されず、従来公知の方法によって製造することができる。例えば、先ず、リバスチグミン及び/又はその塩、前記アクリル系高分子(A)及び必要に応じて溶剤を含有する薬物貯留層組成物を調製し、これを前記支持体層の一方の面上に所望の厚さで塗布した後に必要に応じて前記溶剤を除去し、前記支持体層の一方の面上に前記薬物貯留層を形成せしめる。次いで、前記アクリル系高分子(B)、前記ゴム系粘着基剤及び必要に応じて溶剤を含有する粘着層組成物を調製し、これを前記薬物貯留層の前記支持体層と反対の面上に所望の厚さで塗布した後に必要に応じて前記溶剤を除去し、前記粘着層を形成せしめることにより製造することができる。または、本発明の積層型貼付剤が前記剥離ライナーを更に備える場合には、先に前記剥離ライナーの一方の面上に前記粘着層組成物を塗布して前記粘着層を形成せしめ、更に前記薬物貯留層組成物を塗布して前記薬物貯留層を形成せしめた後、前記剥離ライナーとは反対の面上に前記支持体層を積層してもよい。或いは、前記剥離ライナーの一方の面上に形成せしめた前記粘着層と、前記支持体層の一方の面上に形成せしめた前記薬物貯留層とを貼り合わせて積層してもよい。
先ず、凍結ヒト皮膚切片を室温にて解凍し、皮下脂肪を除去した後、ダーマトームを用いて約500μmの厚さに切断して脂肪除去皮膚片を得た。次いで、各実施例及び比較例で得られた貼付剤を3cm2角に切断して剥離ライナーを除去し、これを前記脂肪除去皮膚片の角質側に貼付して真皮側がレセプター槽側になるようにフランツ型フロースルーセルに装着した。前記フロースルーセルの外周部に32℃の温水を循環させつつレセプター槽にリン酸緩衝溶液(PBS)を2.5ml/hrの流量でフローさせ、6時間毎に168時間までレセプター槽から試料液を採取した。採取したそれぞれの試料液について高速液体クロマトグラフ法により薬物(リバスチグミン)の濃度を定量し、各時間毎の皮膚片を透過した薬物の量(薬物透過量)から、薬物の皮膚透過速度(Flux:μg/cm2/hr)を、以下の式:
Flux(μg/cm2/hr)=[薬物濃度(μg/ml)×流量(ml)]/貼付剤面積(cm2)/時間(hr)
により算出した。さらに、168時間の測定時間内における皮膚透過速度の最大値(Jmax)と測定開始から168時間後の皮膚透過速度(J168)との比(J168/Jmax)を求めた。なお、薬物の最大皮膚透過速度(Jmax)が大きい貼付剤は薬物の皮膚透過性に優れるものと認められ、J168/Jmaxが0.8以上の貼付剤は薬物の徐放性に優れるものと認められる。
先ず、アクリル系高分子−1(ヒドロキシ基を有するアクリル系高分子、アクリル系高分子(A))の酢酸エチル溶液(Duro−Tak 87−2516、ヘンケル社製、アクリル系高分子−1:60質量部)にリバスチグミン(フリー体)40質量部を添加して薬物貯留層組成物を得た。得られた薬物貯留層組成物を離型処理が施されたポリエチレンテレフタレートフィルム(剥離ライナー)の一方の面上に塗布した後、酢酸エチルを乾燥除去して厚みが300g/m2の薬物貯留層を得た。次いで、得られた前記薬物貯留層と離型処理が施されていないポリエチレンテレフタレートフィルム(支持体層)とを貼り合わせ、剥離ライナーは除去した。
前記薬物貯留層及び前記粘着層の組成が表1に示す組成となるようにしたこと以外は実施例1と同様にして各貼付剤(積層型貼付剤)をそれぞれ得た。なお、表1中、「ポリアクリル酸」としては、重量平均分子量100万のポリアクリル酸(アクリル酸単独重合体、アクリル系高分子(B))を用いた。得られた各貼付剤について徐放性評価を行った結果を薬物貯留層及び粘着層の各組成とあわせて表1に示す。
薬物貯留層組成物におけるアクリル系高分子−1を70質量部、リバスチグミン(フリー体)を30質量部とし、厚みが200g/m2となるようにしたこと以外は実施例1と同様にして薬物貯留層を形成し、得られた前記薬物貯留層と離型処理が施されていないポリエチレンテレフタレートフィルム(支持体層)とを貼り合わせ、剥離ライナーは除去した。次いで、実施例1と同様にして得られた粘着層と前記薬物貯留層の前記支持体層とは反対の面とを貼り合わせて貼付剤(積層型貼付剤)を得た。
前記薬物貯留層の組成を表1に示す組成とし、厚みが200g/m2となるようにしたこと以外は実施例1と同様にして薬物貯留層を形成し、離型処理が施されたポリエチレンテレフタレートフィルム(剥離ライナー)、薬物貯留層、及び支持体層の順に積層された貼付剤(単層型貼付剤)をそれぞれ得た。なお、表1中、「アクリル系高分子−3」としては、カルボキシ基を有しかつヒドロキシ基を実質的に有さないアクリル系高分子の酢酸エチル溶液(Duro−Tak 87−2852、ヘンケル社製)を前記アクリル系高分子−3が表1に示す質量部となるように用いた。得られた各貼付剤について徐放性評価を行った結果を薬物貯留層の各組成とあわせて表1に示す。
前記薬物貯留層及び前記粘着層の組成が表1に示す組成となるようにしたこと以外は実施例1と同様にして各貼付剤(積層型貼付剤)をそれぞれ得た。得られた各貼付剤について徐放性評価を行った結果を薬物貯留層及び粘着層の各組成とあわせて表1に示す。
前記薬物貯留層及び前記粘着層の組成が表2に示す組成となるようにしたこと以外は実施例1と同様にして各貼付剤(積層型貼付剤)をそれぞれ得た。なお、表2中、「アクリル系高分子−4」としては、カルボキシ基を実質的に有さないメタクリル酸共重合体(Eudragit EPO、エボニック社製)を用い、クロスポビドンとしては1−ビニル−2−ピロリドンの架橋重合物を用いた。得られた各貼付剤について徐放性評価を行った結果を薬物貯留層及び粘着層の各組成とあわせて表2に示す。
Claims (7)
- 支持体層、薬物貯留層及び粘着層を備える積層型貼付剤であって、
前記薬物貯留層が、リバスチグミン及びその薬学的に許容される塩からなる群から選択される少なくとも1種の薬物と、ヒドロキシ基を有するアクリル系高分子(A)とを含有しており、
前記粘着層が、カルボキシ基を有する(メタ)アクリル酸アルキルエステル共重合体及びアクリル酸単独重合体からなる群から選択される少なくとも1種のアクリル系高分子(B)と、ゴム系粘着基剤とを含有しており、
前記薬物貯留層における前記薬物のリバスチグミンフリー体に換算した含有量が前記薬物貯留層の全質量に対して15〜45質量%であり、かつ、
前記粘着層における前記アクリル系高分子(B)の総含有量が前記粘着層の全質量に対して7〜18質量%である、積層型貼付剤。 - 前記アクリル系高分子(A)が、(メタ)アクリル酸ヒドロキシアルキルエステル共重合体である請求項1に記載の積層型貼付剤。
- 前記粘着層が前記アクリル系高分子(B)として前記カルボキシ基を有する(メタ)アクリル酸アルキルエステル共重合体を含有している請求項1又は2に記載の積層型貼付剤。
- 前記(メタ)アクリル酸アルキルエステル共重合体がエステル基1モルに対して0.75モル以上のカルボキシ基を有する請求項3に記載の積層型貼付剤。
- 前記ゴム系粘着基剤が、スチレン−イソプレン−スチレンブロック共重合体、スチレン−ブタジエン−スチレンブロック共重合体、スチレン−ブタジエン共重合体、ポリイソブチレン、及びポリイソプレンからなる群から選択される少なくとも1種である請求項1〜4のうちのいずれか一項に記載の積層型貼付剤。
- 前記粘着層の厚みが100〜175g/m2となる厚みである請求項1〜5のうちのいずれか一項に記載の積層型貼付剤。
- 前記薬物貯留層と前記粘着層との質量比が10:1〜1:2である請求項1〜6のうちのいずれか一項に記載の積層型貼付剤。
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