JP5775032B2 - エンボス加工可能で書き込み可能な多層裏地構造物 - Google Patents
エンボス加工可能で書き込み可能な多層裏地構造物 Download PDFInfo
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- JP5775032B2 JP5775032B2 JP2012153859A JP2012153859A JP5775032B2 JP 5775032 B2 JP5775032 B2 JP 5775032B2 JP 2012153859 A JP2012153859 A JP 2012153859A JP 2012153859 A JP2012153859 A JP 2012153859A JP 5775032 B2 JP5775032 B2 JP 5775032B2
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Description
本出願は2002年8月30日出願の米国仮出願第60/407,126号の権利を主張する。
(a)エンボス加工可能で書き込み可能な材料を含んで成る外側層、
(b)外側層の皮膚に近位の面上に配置されたタイ層および
(c)タイ層の皮膚に近位の面上に配置された基底層、
を含んで成る多層裏地構造物に関する。
(a)微孔質層もしくは微小繊維層である、エンボス加工可能で書き込み可能な材料を含んで成る外側層、
(b)外側層の皮膚に近位の面上に配置された、二次薬剤含有レザボアを含んで成るタイ層および
(c)タイ層の皮膚に近位の面上に配置された基底層、
を含んで成る。
(a)微孔質層もしくは微小繊維層であり、更に薬剤放出速度制御手段である、エンボス加工可能で書き込み可能な材料を含んで成る外側層、
(b)外側層の皮膚に近位の面上に配置されたアンタゴニスト含有レザボアを含んで成るタイ層および
(c)タイ層の皮膚に近位の面上に配置された基底層、
を含んで成る。
(a)微孔質層もしくは微小繊維層である、エンボス加工可能で書き込み可能な材料を含んで成る外側層、
(b)有益な薬剤を含んで成り、外側層の皮膚に近位の面上に配置された、二次薬剤含有レザボアを含んで成るタイ層および
(c)薬剤放出速度制御手段である、タイ層の皮膚に近位の面上に配置された基底層、
を含んで成る。
(a)微孔質層もしくは微小繊維層である、エンボス加工可能で書き込み可能な材料を含んで成る外側層、
(b)二次薬剤含有レザボアを含んでもよい、外側層の皮膚に近位の面上に配置された多層タイ層および
(c)タイ層の皮膚に近位の面上に配置された基底層、
を含んで成る。
Netherlandsにより製造されるSoluporTM)、微孔質ポリプロピレン、例えばCelgard微孔質PP 3401フィルム(CelgardTMフィルム、Celgard,Inc.,Charlotte,NC)、RoTrac Polyester Capillary Pore Membranes(OYPHEN GmbH,Germany)、スパンレースポリエステル、ポリプロピレンもしくはポリエチレンから成る群から選択される微孔質層を含んで成る。
Elastomersからの)、エチレン−ビニルアセテート・コポリマー(EVA)、低密度ポリエチレン(LDPE)、中密度ポリエチレン(MDPE)、スチレンブロック・コポリマー熱可塑性エラストマーの非感圧性調製物等から形成される。好ましい態様において、タイ層は下記に更に詳細に説明されるエチレンオクテン・コポリマーから形成される。
本発明はその一番外側層がエンボス加工可能で、ペンもしくは鉛筆でその上に書き込むことができる多層裏地構造物を有する経皮システムに関する。本発明の多層裏地構造物の一番外側層はとりわけ、タイ層により基底層に張り合わせられた、微孔質もしくは微小繊維フィルムのようなエンボス加工可能で書き込み可能な材料を含む。
本発明を説明し、請求する際に、以下の用語を以下の定義に従って使用するであろう。
放出を制御/調節するための手段を意味する。
本発明は、その一番外側層がエンボス加工可能な、書き込み可能な材料を有する、経皮薬剤送達システムのための多層裏地構造物を提供する。
ル、ポリプロピレンもしくはポリエチレンから成る群から選択される微孔質層を含んで成る。外側層はどんな接着体をも含まず、感圧性接着体に直接張り合わせられない。あるいはまた、外側層は低レベルの界面活性剤、例えばプルロニックのポリエチレンオキシド−ポリプロピレンオキシド・ブロックコポリマー等でコートして、下層のタイ層からの薬剤放出速度に対して更に制御をもたらすことができる。
ン、ナロキソン、ナルブフィン、ナルブフィン、ナロルフィン、ナロルフィンジニコチネート、ナルメフェン、ナジド、レバロルファンおよびシクロゾシンである。薬剤が有益な薬剤のアンタゴニストである時は、二次薬剤含有レザボアは約20〜約70重量%の薬剤、より好ましくは約40〜約65重量%の薬剤、そして更により好ましくは約50〜約60重量%の薬剤を含んで成る。二次薬剤含有レザボア5を形成する材料は総ポリマー組成物の約0重量%〜約1重量%の薬剤溶解度、より好ましくは約0重量%〜約0.8重量%、そして更により好ましくは総ポリマー組成物の約0重量%〜約〜0.5重量%の薬剤溶解度を有する。
chpak 9735(PET−PEラミネート,3M)、Mediflex 1500(PET−顔料添加EVAラミネート,Mylan Technologies,Saint Albans,VT)、Mediflex 1200(PET−EVAラミネート,Mylan Technologies,Saint Albans,VT)];Mediflex 1000(半透明ポリオレフィンフィルム、Mylan Technologies,Saint Albans,VT)、Medifilm 500シリーズ(EVA膜材料、Mylan Technologies,Saint Albans,VT)];ポリエチレン[例えば低密度ポリエチレン(LDPE)、中密度ポリエチレン(MDPE)、高密度ポリエチレン(HDPE)]、エチレンメチルアクリレート・コポリマー(EMA)、エチレンエチルアクリレート・コポリマー(EEA)またはエチレンブチルアクリレート・コポリマー(EBA)のコポリマー類、から成る群から選択されるポリマー材料から成る。基底層は約0.01mm(0.4mil)〜約0.125mm(5mil)、好ましくは0.025mm(1mil)〜約0.1mm(4mil)、より好ましくは0.0625mm(1.5mil)〜約0.0875mm(3.5mil)、そして更により好ましくは0.025mm(1mil)〜約0.05mm(2mil)の厚さを有する。
本発明の多層裏地構造物は以下のように製造される。薬剤含有レザボアは以下により詳細に説明される周知の方法に従って製造される。
第二の薬剤含有レザボア(以下、「二次薬剤含有レザボア」ということもある)は薬剤をポリマー材料、好ましくは熱成形可能な材料と、高い応力および高温下で、シグマブレード混合装置もしくは押し出し装置のような装置を使用してバッチ状でもしくは連続的のいずれかで乾燥混合することにより形成することができる。押し出し物を放出ライナー(release liners)間で所望の厚さにカレンダーにかけ、次にバリヤーフィルムおよび/もしくは鎮痛速度制御手段に高温で張り付ける。下記の実施例に示すように、薬剤負荷量、薬剤含有レザボアの厚さ、速度制御手段のための膜の選択および速度制御手段の界面活性剤修飾のようなパラメーターを変更して、薬剤の目標の放出速度を達成することができる。好ましい態様において、界面活性剤を膜材料上にコートして、浸漬被覆、グラヴィア被覆等のような方法を使用して速度制御手段を形成する。
多層裏地構造物は概括的に以下のように製造される。例えば、図1に具体的に示されるように、タイ層を基底層に張り付け、次に外側層を高温および高圧下で基底層に遠位のタイ層の面上に張り付ける。あるいはまた、双方の張り付けを、張り付けの前に外側層と基底層間に直接、必要な幅および厚さでタイ層を押し出すことにより単一操作で実施することができると考えられる。張り付けを概括的に約70℃から約120℃の範囲の温度で、50psiから約120psiの範囲の圧力で、約2fpmから約20fpmの範囲の速度で実施する。
07エチレン−オクテン・コポリマーによりSolupor微小繊維フィルムP01に張り付ける。張り付けに要した条件は80℃、90psiおよび3fpmである。生成される経皮裏地材料を、それもまたエンボス加工および書き込みのための表面を提供する少ない伸長性のSolupor層のためにウェブ張力下で少ない伸長を伴って加工することができる。更にこの裏地材料を一次薬剤含有接着性マトリックスに張り付ける時、薬剤はSolupor層の微小繊維性のために、多層裏地をとおしてパウチ材料の熱シール層中に浸透することができない。
(b)外側層の皮膚に近位の面上に配置されたタイ層、および
(c)タイ層の皮膚に近位の面上に配置された基底層:
を含んで成る多層裏地構造物。
層裏地構造物。
(b)外側層の皮膚に近位の面上に配置された、二次薬剤含有レザボアを含んで成るタイ層、および
(c)タイ層の皮膚に近位の面上に配置された基底層:
を含んで成る多層裏地構造物。
(b)外側層の皮膚に近位の面上に配置されたアンタゴニスト含有レザボアを含んで成るタイ層、および
(c)タイ層の皮膚に近位の面上に配置された基底層:
を含んで成る多層裏地構造物。
(b)有益な薬剤を含んで成り、外側層の皮膚に近位の面上に配置された、二次薬剤含有レザボアを含んで成るタイ層、および
(c)薬剤放出速度制御手段である、タイ層の皮膚に近位の面上に配置された基底層:
を含んで成る多層裏地構造物。
(b)外側層の皮膚に近位の面上に配置された多層のタイ層、および
(c)タイ層の皮膚に近位の面上に配置された基底層:
を含んで成る多層裏地構造物。
(i)外側層の皮膚に近位の面上に配置された第1層、
(ii)第1層の皮膚に近位の面上に配置された第2層、
(iii)第2層の皮膚に近位の面上に配置された第3層、および
(iv)二次薬剤含有レザボア:
を含んで成る13.の多層裏地構造物。
Claims (9)
- 第一の薬剤含有レザボアと共に使用するための多層裏地構造物であって、
該裏地構造物が、
(a)エンボス加工可能で呼吸可能で書き込み可能な材料を含んで成る外側層、
(b)外側層の皮膚に近位の面上に配置された、第二の薬剤含有レザボアを含んでなるタイ層、および
(c)タイ層の皮膚に近位の面上に配置された基底層:
を含んで成り、
タイ層が疎水性、親油性もしくは非極性のポリマー材料およびそれらの組み合わせ物を含んで成る、上記多層裏地構造物。 - タイ層がエチレンオクテン・コポリマー、エチレン−ビニルアセテート・コポリマー(EVA)、低密度ポリエチレン(LDPE)、中密度ポリエチレン(MDPE)、スチレンブロック・コポリマーもしくは熱可塑性エラストマーの非感圧性調製物およびそれらの組み合わせ物を含んで成る請求項1の多層裏地構造物。
- 第一の薬剤含有レザボアと共に使用するための多層裏地構造物であって、
該裏地構造物が、
(a)エンボス加工可能で書き込み可能な材料を含んで成る外側層、
(b)外側層の皮膚に近位の面上に配置された、アンタゴニストを含んでなる第二の薬剤含有レザボアを含んで成るタイ層、および
(c)タイ層の皮膚に近位の面上に配置された基底層:
を含んで成り、
アンタゴニストが基底層をとおって放出可能でない形態にあり、外側層がアンタゴニスト放出速度制御手段であり、
外側層が界面活性剤でコートされている、上記多層裏地構造物。 - 第一の薬剤含有レザボアと共に使用するための多層裏地構造物であって、
該裏地構造物が、
(a)エンボス加工可能で書き込み可能な材料を含んで成る外側層、
(b)有益な薬剤を含んで成り、外側層の皮膚に近位の面上に配置された、治療剤を含んでなる第二の薬剤含有レザボアを含んで成るタイ層、および
(c)治療剤放出速度制御手段である、タイ層の皮膚に近位の面上に配置された基底層:
を含んで成る多層裏地構造物。 - 第一の薬剤含有レザボアと共に使用するための多層裏地構造物であって、
該裏地構造物が、
(a)エンボス加工可能で書き込み可能な材料を含んで成る外側層、
(b)外側層の皮膚に近位の面上に配置された、第二の薬剤含有レザボアを含んでなる多層のタイ層、および
(c)タイ層の皮膚に近位の面上に配置された基底層:
を含んで成る、上記多層裏地構造物。 - 多層のタイ層が
(i)外側層の皮膚に近位の面上に配置された第1層、
(ii)第1層の皮膚に近位の面上に配置された第2層、
(iii)第2層の皮膚に近位の面上に配置された第3層、および
(iv)第二の薬剤含有レザボア:
を含んで成る請求項5の多層裏地構造物。 - 第1層がエチレン−ビニルアセテート・コポリマー(EVA)もしくは低密度ポリエチレン(LDPE)層であり、第2層がポリエチレンテレフタレート(PET)層であり、第3層がエチレン−ビニルアセテート・コポリマー(EVA)、低密度ポリエチレン(LDPE)もしくはポリウレタン層である、請求項6の多層裏地構造物。
- 第二の薬剤含有レザボアが治療剤を含んで成り、基底層が治療剤放出速度制御手段である、請求項5もしくは請求項6の多層裏地構造物。
- 第二の薬剤含有レザボアがアンタゴニストを含んで成り、基底層がアンタゴニスト放出速度制御手段である請求項5もしくは請求項6の多層裏地構造物。
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