JPS596843B2 - 薬剤供給体の製造法 - Google Patents
薬剤供給体の製造法Info
- Publication number
- JPS596843B2 JPS596843B2 JP48063287A JP6328773A JPS596843B2 JP S596843 B2 JPS596843 B2 JP S596843B2 JP 48063287 A JP48063287 A JP 48063287A JP 6328773 A JP6328773 A JP 6328773A JP S596843 B2 JPS596843 B2 JP S596843B2
- Authority
- JP
- Japan
- Prior art keywords
- drug
- wall
- release
- delivery
- rate
- 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.)
- Expired
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F6/00—Contraceptive devices; Pessaries; Applicators therefor
- A61F6/06—Contraceptive devices; Pessaries; Applicators therefor for use by females
- A61F6/14—Contraceptive devices; Pessaries; Applicators therefor for use by females intra-uterine type
- A61F6/142—Wirelike structures, e.g. loops, rings, spirals
- A61F6/144—Wirelike structures, e.g. loops, rings, spirals with T-configuration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F9/00—Methods or devices for treatment of the eyes; Devices for putting-in contact lenses; Devices to correct squinting; Apparatus to guide the blind; Protective devices for the eyes, carried on the body or in the hand
- A61F9/0008—Introducing ophthalmic products into the ocular cavity or retaining products therein
- A61F9/0017—Introducing ophthalmic products into the ocular cavity or retaining products therein implantable in, or in contact with, the eye, e.g. ocular inserts
-
- 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
- A61K9/0002—Galenical forms characterised by the drug release technique; Application systems commanded by energy
- A61K9/0004—Osmotic delivery systems; Sustained release driven by osmosis, thermal energy or gas
Landscapes
- Health & Medical Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Vascular Medicine (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Pharmacology & Pharmacy (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Ophthalmology & Optometry (AREA)
- Epidemiology (AREA)
- Reproductive Health (AREA)
- Agricultural Chemicals And Associated Chemicals (AREA)
- Medicinal Preparation (AREA)
- Containers And Packaging Bodies Having A Special Means To Remove Contents (AREA)
- Feeding, Discharge, Calcimining, Fusing, And Gas-Generation Devices (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
Description
【発明の詳細な説明】
本発明は有用な薬剤を調節された速度で供給するための
薬剤供給体の製造法に関する。
薬剤供給体の製造法に関する。
薬物および農薬といった多くの有用な薬剤は、それらが
長期にわたり調節された速度で供給されたときに、改善
された効率をもって作用する。
長期にわたり調節された速度で供給されたときに、改善
された効率をもって作用する。
過去において、徐々に侵食し薬剤を解放する被覆または
膜の中に薬剤を限定することにより、あるいは薬剤が徐
々に拡散しうる膜の中に薬剤を封入することにより、薬
剤の調節された解放速度が主として達成された。
膜の中に薬剤を限定することにより、あるいは薬剤が徐
々に拡散しうる膜の中に薬剤を封入することにより、薬
剤の調節された解放速度が主として達成された。
浸透および浸透圧も過去において薬剤を供給するのに使
用されたが、これはAus tral . J . E
xp ,Biol , Vol .3 0、415−4
20(1955)に記載のように、複雑化された多重室
をもつ可動障壁装置の使用を必要とする。
用されたが、これはAus tral . J . E
xp ,Biol , Vol .3 0、415−4
20(1955)に記載のように、複雑化された多重室
をもつ可動障壁装置の使用を必要とする。
この参考文献の装置は三つの区画を有する。
一つは水で満され、半透膜により第二の区画から分離さ
れている。
れている。
二番目の区画はコンゴーレッド溶液を含む。
コンゴーレツド溶液は第一室から膜を通して浸透的に水
を引く。
を引く。
第二室の体積が増すにつれて、これは薬剤を含む第三室
に圧力をかげ、薬剤を放出させる。
に圧力をかげ、薬剤を放出させる。
薬剤供給体を提供する他の従来の試みは米国特許第36
04417号明細書に記載されている。
04417号明細書に記載されている。
該特許に記載の装置は半透膜、ならびに可動ピストンに
より薬剤溶液から分離された浸透的に有効な溶質を必要
とする。
より薬剤溶液から分離された浸透的に有効な溶質を必要
とする。
可動ピストンが浸透圧により駆動され、装置から薬剤を
押出す。
押出す。
この運動すルヒストンの要求は、装置の形をきびしく限
定し、装置の使用を制限する構造問題を提起する。
定し、装置の使用を制限する構造問題を提起する。
以前の技術は、長時間にわたり活性薬剤の調節された持
続的解放を許す、可動部分をもたない構造の簡単な浸透
装置を提供したことがない。
続的解放を許す、可動部分をもたない構造の簡単な浸透
装置を提供したことがない。
本発明の主たる目的はこのような浸透供給体を提供する
ことにある。
ことにある。
それ故本発明は簡単な浸透供給体を提供するものである
。
。
この供給体は、活性薬剤からなる浸透的に有効な溶質を
包囲し含有する壁から成立ち、該壁は活性薬剤含有溶質
および装置外部と連結する小さい通路をもつ。
包囲し含有する壁から成立ち、該壁は活性薬剤含有溶質
および装置外部と連結する小さい通路をもつ。
装置の壁は、少なくとも一部は、使用環境に共通の外部
液体に対して半透性そして活性薬剤に対しては本質的に
不透過性である材料から成る。
液体に対して半透性そして活性薬剤に対しては本質的に
不透過性である材料から成る。
使用時は、外部液体(通常は水〕は壁の半透性部分を透
過し、壁内に包まれた活性薬剤を含む浸透的に有効な溶
質の一部を溶かす。
過し、壁内に包まれた活性薬剤を含む浸透的に有効な溶
質の一部を溶かす。
もつと液体が壁を透過するにつれて、浸透圧が発生し、
これが薬剤を小さい通路を通して放出させる因となる。
これが薬剤を小さい通路を通して放出させる因となる。
任意に、ある環境で侵食する材料の被覆を半透膜上に付
けて解放速度を緩和する(該被覆は露出した半透性材料
の面積を変化させることができる)。
けて解放速度を緩和する(該被覆は露出した半透性材料
の面積を変化させることができる)。
供給体の内部に未溶解浸透溶質が存在する限り、供給体
内の浸透的に有効な溶質の溶液は飽和状態に保たれ、ま
た半透膜の面積が一定である限り、溶解した薬剤が供給
体から解放される速度は=定に留まるであろう、即ちゼ
ロ次の時間依存を有する解放速度があるであろう。
内の浸透的に有効な溶質の溶液は飽和状態に保たれ、ま
た半透膜の面積が一定である限り、溶解した薬剤が供給
体から解放される速度は=定に留まるであろう、即ちゼ
ロ次の時間依存を有する解放速度があるであろう。
活性薬剤が粒子(例えば、微粒化された)形で解放され
る場合には、活性薬剤の解放速度は浸透溶質の解放と完
全には平行しないかもしれない。
る場合には、活性薬剤の解放速度は浸透溶質の解放と完
全には平行しないかもしれない。
活性薬剤対浸透溶質の比を調節することにより、薬剤の
一定速度解放を得ることができる。
一定速度解放を得ることができる。
本発明の特色と長所は、本発明の以下の詳細な記述から
、また次の図面(ここで等しい引用数字は同様の部分を
示す)から明らかになるであろう。
、また次の図面(ここで等しい引用数字は同様の部分を
示す)から明らかになるであろう。
本発明は長い供給期間にわたり使用環境へ活性薬剤を調
節しつつ連続して供給するための浸透供給体を提供する
。
節しつつ連続して供給するための浸透供給体を提供する
。
この供給体は半透性材料から形成された壁から成り立ち
、該材料は供給期間中その完全さを維持し、使用環境に
おいて外部液体の通過に対し透過性であり、そして活性
薬剤の通過に対し実質的に不透過性であるという特徴が
あり、該壁は区画、該区画内に存在する活性薬剤を含む
浸透的に有効な溶質、供給体から活性薬剤を解放するた
め区画および供給体の外部と連結する少なくとも一つの
前以て定められた小さい通路を囲みかつその輪郭をきめ
、そしてまた、供給体が使用環境におかれたとき、使用
環境からの外部液体は壁の半透性材料を通して区画の中
に、半透膜を横切る浸透圧勾配により決定される速度で
浸透し、区画内に圧力が発生し、そしてこの圧力は長時
間にわたり調節された一様な速度で活性薬剤を通路を経
て使用環境へ押し出すものである。
、該材料は供給期間中その完全さを維持し、使用環境に
おいて外部液体の通過に対し透過性であり、そして活性
薬剤の通過に対し実質的に不透過性であるという特徴が
あり、該壁は区画、該区画内に存在する活性薬剤を含む
浸透的に有効な溶質、供給体から活性薬剤を解放するた
め区画および供給体の外部と連結する少なくとも一つの
前以て定められた小さい通路を囲みかつその輪郭をきめ
、そしてまた、供給体が使用環境におかれたとき、使用
環境からの外部液体は壁の半透性材料を通して区画の中
に、半透膜を横切る浸透圧勾配により決定される速度で
浸透し、区画内に圧力が発生し、そしてこの圧力は長時
間にわたり調節された一様な速度で活性薬剤を通路を経
て使用環境へ押し出すものである。
本発明に係る新規浸透供給体を第1図に番号10により
示す。
示す。
供給体10は本体部分11を有する。
本体部分11は、開いた区分13により示されるように
、区画15を囲む壁14を有する。
、区画15を囲む壁14を有する。
区画15は活性薬剤を、または活性薬剤含有混合物(図
示せず)を含む要素である。
示せず)を含む要素である。
顆12が本体11に取付げられ、本体11と一体に形成
されることもできるし、あるいは別々に製造し次に本体
11へ結合することもできる。
されることもできるし、あるいは別々に製造し次に本体
11へ結合することもできる。
供給体10の壁14は少なくとも一部は半透性材料から
なる。
なる。
壁140半透性材料はそのすべての寸法にまたがって一
様な性質を有する、即ち、このものは実質的に無孔であ
り実質的に均質である。
様な性質を有する、即ち、このものは実質的に無孔であ
り実質的に均質である。
操作に際し、供給体10を外部液体環境においたとき、
外部液体分子は壁140半透性材料中に溶けかつこれを
通して拡散する。
外部液体分子は壁140半透性材料中に溶けかつこれを
通して拡散する。
次に外部液体は活性薬剤または薬剤含有混合物上接触す
゛る。
゛る。
薬剤または混合物の成分は浸透的に活性な溶質でなげれ
ばならず、また外部液体中に溶けて壁14の半透性材料
を横切り液体活性勾配を生じなげればならない。
ばならず、また外部液体中に溶けて壁14の半透性材料
を横切り液体活性勾配を生じなげればならない。
この活性勾配は更に溶媒分子を区画15中に拡散させ、
その結果浸透圧を発生し、浸透性溶質分子(および活性
薬剤)を含む溶媒は供給体10から通路16を経て環境
17に放出される。
その結果浸透圧を発生し、浸透性溶質分子(および活性
薬剤)を含む溶媒は供給体10から通路16を経て環境
17に放出される。
供給体10からの薬剤放出速度は、未溶解浸透溶質が区
画15内に留まっている限り一定に保たれるであろう。
画15内に留まっている限り一定に保たれるであろう。
第2 , 3 , 4および5図においては、他の典型
的な本発明供給体、供給体10が種々な図として示され
ている。
的な本発明供給体、供給体10が種々な図として示され
ている。
本発明のこの具体例およびその操作の記述にまた他の具
体例に当てはまる。
体例に当てはまる。
この供給体10はンラマメ形をした眼科用薬物供給体で
ある。
ある。
第4図にはっきり示したように、供給体10は外壁14
と18および内壁19の積層された組み合わせによって
囲まれ形をきめられた中空の区画を有する。
と18および内壁19の積層された組み合わせによって
囲まれ形をきめられた中空の区画を有する。
壁19はまた、中空供給体10の内部区画から外部の眼
科使用環17への小さい通路17を定めている。
科使用環17への小さい通路17を定めている。
内部の区画(第3図の15)は外部の眼環境の液体中に
少なくとも一部は可溶、かつ薬物(第3図の20)を含
む組成物を含有する。
少なくとも一部は可溶、かつ薬物(第3図の20)を含
む組成物を含有する。
内部区画15を包囲する供給体10の壁、即ち壁14,
18および19の少ないとも=部は半透性であり、眼の
環境からの液体(この場合には水)を内部区画15中に
拡散によって選択的に透過させることができる。
18および19の少ないとも=部は半透性であり、眼の
環境からの液体(この場合には水)を内部区画15中に
拡散によって選択的に透過させることができる。
壁14,18および19の何れか、または全部が記載の
ように半透性でよい。
ように半透性でよい。
区画15を囲む壁の半透性でない部分は、外部眼環境の
液体および区画15の内容物に対して本質的に非透過性
でなげればならない。
液体および区画15の内容物に対して本質的に非透過性
でなげればならない。
壁14,18および19の材料は、薬物解放の期間中眼
液中に実質的に不溶、非アレルギー性、かつ生物学的に
本活性でなげればならない。
液中に実質的に不溶、非アレルギー性、かつ生物学的に
本活性でなげればならない。
供給体10の壁が不溶性材料のものであるとき(′i,
薬物供給をしつ《した後供給体をとり除《必要がある。
薬物供給をしつ《した後供給体をとり除《必要がある。
薬物解放の期間中ずつと無傷であり、その後はじめて無
害な最終生成物に生物腐蝕される壁を用いることにより
この除去を省くことが可能である。
害な最終生成物に生物腐蝕される壁を用いることにより
この除去を省くことが可能である。
供給体100区画15中に眼科薬物からなる浸透的に有
効な組成物が封入されている。
効な組成物が封入されている。
浸透的に有効であるためには、組成物のある成分が、供
給体10の壁を透過する外部環境の液体中に溶けなげれ
ばならない(第3図中の21に示した)。
給体10の壁を透過する外部環境の液体中に溶けなげれ
ばならない(第3図中の21に示した)。
第2−5図の眼科装置においては、透過しうる液体が涙
からの水であり、そのため組成物の成分は水溶性でなげ
ればならない。
からの水であり、そのため組成物の成分は水溶性でなげ
ればならない。
この溶解性が要求されるのは、組成物を浸透的に有効な
溶質として働らかせることを可能ならしめるためである
、即ち半透壁をまたいで水活性勾配を生じさせ、供給体
10の内部に浸透圧を発生させるためである。
溶質として働らかせることを可能ならしめるためである
、即ち半透壁をまたいで水活性勾配を生じさせ、供給体
10の内部に浸透圧を発生させるためである。
透過性溶体一可溶性薬物だけで区画15中の組成物をつ
くり上げることができる。
くり上げることができる。
追加された浸透的に有効な溶質と混合して不溶性薬物を
用いることができる。
用いることができる。
使用時には、第2−5図の眼科用供給体10を第5図に
示したような眼の盲嚢に入れる。
示したような眼の盲嚢に入れる。
第5図において、供給体10は薬物を眼29へ浸透的に
投与するため眼球33と直ぐ接触して位置する。
投与するため眼球33と直ぐ接触して位置する。
眼29は眼瞼30および31、昧毛32および36、お
よび眼球33からなり、後者はその後部領域の大部分が
掌膜34により、そしてその中心域のところは角膜35
により覆はれている。
よび眼球33からなり、後者はその後部領域の大部分が
掌膜34により、そしてその中心域のところは角膜35
により覆はれている。
眼瞼30および31は上皮膜または眼瞼結膜に沿って並
ぶ(示していない)。
ぶ(示していない)。
掌膜34は球状結膜で覆われている。
上方眼瞼30およびその下にある球状結膜部分と並ぶ眼
瞼結膜部分は上方盲嚢を定め(第5図に示していない)
、他方、下方眼瞼31およびその下にある球状結膜の部
分と並ぶ眼瞼結膜部分は、破線38により示された下方
盲嚢をきめる。
瞼結膜部分は上方盲嚢を定め(第5図に示していない)
、他方、下方眼瞼31およびその下にある球状結膜の部
分と並ぶ眼瞼結膜部分は、破線38により示された下方
盲嚢をきめる。
第2−4図の供給体10ぱ何れの盲嚢に挿入することも
でき、第5図には破線で活動位置に示してある。
でき、第5図には破線で活動位置に示してある。
本発明浸透供給体は種々様々は活性薬剤の解放に使用で
きる。
きる。
本明細書ならびに特許請求の範囲で使用した「活性薬剤
」なる用語は、分散されたとき液体を含む使用環境に所
定の有益かつ有用な結果を生ずる化合物または組成物を
包含する。
」なる用語は、分散されたとき液体を含む使用環境に所
定の有益かつ有用な結果を生ずる化合物または組成物を
包含する。
活性薬剤には、例えばペスチサイド、除草剤、殺菌剤、
殺生物剤、殺藻剤、殺鼠(そ)剤、殺カビ剤殺虫剤、酸
化防止剤、植物生長促進剤および抑制剤、保存料、表面
活性剤、消毒剤、触媒、発酵剤栄養剤、薬物、植物鉱物
質、性不姓剤、植物ホルモン、空気浄化剤、微生物減弱
剤などが含まれる.本発明供給体は、所望の液体を含む
環境、例えば体腔、流れ、養魚池、畑、および貯水池に
これら薬剤を解放するための適当な形と大きさをとりう
る。
殺生物剤、殺藻剤、殺鼠(そ)剤、殺カビ剤殺虫剤、酸
化防止剤、植物生長促進剤および抑制剤、保存料、表面
活性剤、消毒剤、触媒、発酵剤栄養剤、薬物、植物鉱物
質、性不姓剤、植物ホルモン、空気浄化剤、微生物減弱
剤などが含まれる.本発明供給体は、所望の液体を含む
環境、例えば体腔、流れ、養魚池、畑、および貯水池に
これら薬剤を解放するための適当な形と大きさをとりう
る。
これら環境の大部分においては、例えば農業的または生
埋学的環境においては、水が存在し、これが供給体の半
透壁を透過するより抜きの液体である。
埋学的環境においては、水が存在し、これが供給体の半
透壁を透過するより抜きの液体である。
このように、本発明供給体の壁の半透部分をつ《る材料
は水に対して透過性であるが、溶質に対して実質的に不
透過性な材料である。
は水に対して透過性であるが、溶質に対して実質的に不
透過性な材料である。
壁を形成するための典型的材料には、浸透および逆浸透
膜、例えば、非可塑化酢酸セルロース、可塑化三酢酸セ
ルロース、酢酸寒天、アミロース三アセテート、ベータ
ーグルカンアセテート、ベーターグルカン三アセテート
、−アセトアルデヒドジメチルアセテート、セルロース
アセテートエチル力ルバメート、セルロースアセテート
フタレート、セルロースアセテートメチル力ルバメート
、セルロースアセテートスクシネート、セルロースアセ
テートジメタミノアセテート、セルロースアセテートエ
チルカルボネート、セルロースアセテートクロルアセテ
ート、セルロースアセテートエチルオキサレート、セル
ロースアセテートメチルスルホネート、セルロースアセ
テートブチルスルホネート、セルロースエーテル類、セ
ルロースアセテートグロピオネート、ポリ(ビニルメチ
ル)エーテル共重合体、セルロースアセテートジエチル
アミノアセテート、セルロースアセテートオクテート、
セルロースアセテートラウレート、メチルセルロース、
セルロースアセテートp−}ルエンスルホネート、ロカ
ストビーンガムのトリアセテート、アセチル化されたヒ
ドロキシエチルセルロースを含む酢酸セルロース、ヒド
ロキシル化エチレンビニルアセテート、水透過性を示し
溶質通過を本質的に示さない芳香族窒素含有重合体膜、
重合エポキシドからつくられた浸透膜、アルキレンオキ
シドとアルキルグリシジルエーテルとの共重合体からつ
くられた浸透膜が含まれる。
膜、例えば、非可塑化酢酸セルロース、可塑化三酢酸セ
ルロース、酢酸寒天、アミロース三アセテート、ベータ
ーグルカンアセテート、ベーターグルカン三アセテート
、−アセトアルデヒドジメチルアセテート、セルロース
アセテートエチル力ルバメート、セルロースアセテート
フタレート、セルロースアセテートメチル力ルバメート
、セルロースアセテートスクシネート、セルロースアセ
テートジメタミノアセテート、セルロースアセテートエ
チルカルボネート、セルロースアセテートクロルアセテ
ート、セルロースアセテートエチルオキサレート、セル
ロースアセテートメチルスルホネート、セルロースアセ
テートブチルスルホネート、セルロースエーテル類、セ
ルロースアセテートグロピオネート、ポリ(ビニルメチ
ル)エーテル共重合体、セルロースアセテートジエチル
アミノアセテート、セルロースアセテートオクテート、
セルロースアセテートラウレート、メチルセルロース、
セルロースアセテートp−}ルエンスルホネート、ロカ
ストビーンガムのトリアセテート、アセチル化されたヒ
ドロキシエチルセルロースを含む酢酸セルロース、ヒド
ロキシル化エチレンビニルアセテート、水透過性を示し
溶質通過を本質的に示さない芳香族窒素含有重合体膜、
重合エポキシドからつくられた浸透膜、アルキレンオキ
シドとアルキルグリシジルエーテルとの共重合体からつ
くられた浸透膜が含まれる。
=般に、使用温度において区画内容物の飽和溶液に対し
大気圧下で0.01から1 0 CC/cn4時間また
は田以上の液体透過性を有し、他方同時に溶質に対して
は高度の不透過性を有する材料が本発明装置の半透壁の
製造に便利である。
大気圧下で0.01から1 0 CC/cn4時間また
は田以上の液体透過性を有し、他方同時に溶質に対して
は高度の不透過性を有する材料が本発明装置の半透壁の
製造に便利である。
特に適当な材料は、周囲温度において5%より犬そして
30重量%未滴の水吸収性を有する。
30重量%未滴の水吸収性を有する。
本発明装置内に含まれかつ装置から浸透的に放出される
組成物は既に記したような広範囲の「活性薬剤」を含有
する。
組成物は既に記したような広範囲の「活性薬剤」を含有
する。
本装置により供給できる活性薬剤の一群は薬物である。
「薬物」なる用語は、広義には、投与位置において、あ
るいは施薬点から遠い部位において、局所的または全身
的効果を生ずる生埋学的または薬理学的に活性のある物
質を包含する。
るいは施薬点から遠い部位において、局所的または全身
的効果を生ずる生埋学的または薬理学的に活性のある物
質を包含する。
投与しうる薬物には無機および有機化合物、例えば、中
枢神経系に作用する薬物、例えば催眠剤および鎮静剤、
即ち、ベントバルビタールナトリウム、およびフエノバ
ルビタール、精神興奮剤、例えばインカルボキサジドお
よびナイアラミド、トランキライザー、例えばクロルグ
ロマジンおよびプロマジン、抗けいれん剤、筋弛緩剤お
よび抗パーキンソン剤、解熱剤および消炎剤、例えばア
スピリン、局所麻酔剤、例えばプロ力イン、鎮剤および
抗潰剤、例えばスコポラミン、グロスタクランジン、例
えばPGE,、PGE2、PGE1α、およびPGA;
抗微生物剤、例えばペニシリン:ホルモン剤、例エハグ
レドニソロン;エストロゲンステロイド、例えば17β
〜エスト7ドイルおよびチニルエストラシオール;黄体
ホルモンステロイド、例えば避姫川、例えば17α−ヒ
ドロキシプロゲステロンアセテート、19−ノループロ
ゲステロン、ノレチンドロン、など:交感神経興奮薬物
:心臓血管薬物:利尿剤:駆虫剤:血糖減少剤;および
目薬、例えばピロカルピン塩基、塩酸ピロカルピン、硝
酸ピロカルピンが含まれる。
枢神経系に作用する薬物、例えば催眠剤および鎮静剤、
即ち、ベントバルビタールナトリウム、およびフエノバ
ルビタール、精神興奮剤、例えばインカルボキサジドお
よびナイアラミド、トランキライザー、例えばクロルグ
ロマジンおよびプロマジン、抗けいれん剤、筋弛緩剤お
よび抗パーキンソン剤、解熱剤および消炎剤、例えばア
スピリン、局所麻酔剤、例えばプロ力イン、鎮剤および
抗潰剤、例えばスコポラミン、グロスタクランジン、例
えばPGE,、PGE2、PGE1α、およびPGA;
抗微生物剤、例えばペニシリン:ホルモン剤、例エハグ
レドニソロン;エストロゲンステロイド、例えば17β
〜エスト7ドイルおよびチニルエストラシオール;黄体
ホルモンステロイド、例えば避姫川、例えば17α−ヒ
ドロキシプロゲステロンアセテート、19−ノループロ
ゲステロン、ノレチンドロン、など:交感神経興奮薬物
:心臓血管薬物:利尿剤:駆虫剤:血糖減少剤;および
目薬、例えばピロカルピン塩基、塩酸ピロカルピン、硝
酸ピロカルピンが含まれる。
有機および無機化合物を含めて、種々な浸透的に有効な
溶質添加物を、もし浸透する液体、即ち水における溶解
度が限られた活性薬剤を解放することが望まれるならば
、活性薬剤へ添加すると有利である。
溶質添加物を、もし浸透する液体、即ち水における溶解
度が限られた活性薬剤を解放することが望まれるならば
、活性薬剤へ添加すると有利である。
ここで用いた「限られた溶解度」という用語は、薬剤が
液体中に約1重量%未満の溶解度を有することを意味す
る。
液体中に約1重量%未満の溶解度を有することを意味す
る。
浸透的に有効な、有用な添加溶質には塩類、例えば硫酸
マグネシウム、塩化マグネシウム、塩化ナトリウム、塩
化リチウム、硫酸カリウム、炭酸ナトリウム、亜硫酸ナ
トリウム、硫酸リチウム、塩化カリウム、重炭酸サルシ
ウム、硫酸ナトリウム、硫酸カルシウム、酸性リン酸カ
リウム、および乳酸カルシウム;種々な化合物、例えば
d−マンニトール、尿素、イノシトール、酒石酸、ラフ
イノース、シヨ糖、グルコースおよびα一d一乳糖一水
和物が含まれる。
マグネシウム、塩化マグネシウム、塩化ナトリウム、塩
化リチウム、硫酸カリウム、炭酸ナトリウム、亜硫酸ナ
トリウム、硫酸リチウム、塩化カリウム、重炭酸サルシ
ウム、硫酸ナトリウム、硫酸カルシウム、酸性リン酸カ
リウム、および乳酸カルシウム;種々な化合物、例えば
d−マンニトール、尿素、イノシトール、酒石酸、ラフ
イノース、シヨ糖、グルコースおよびα一d一乳糖一水
和物が含まれる。
これら溶質添加物の種々な量を限られた溶解度の活性薬
剤へ添加することにより、半透壁をまたいで増加した水
活性勾配が生じ、同時に壁を通る液体の一方向の流れお
よび薬剤放出速度が増す。
剤へ添加することにより、半透壁をまたいで増加した水
活性勾配が生じ、同時に壁を通る液体の一方向の流れお
よび薬剤放出速度が増す。
これら添加溶質はまたより可溶性の薬剤へ添加してそれ
らの浸透放出速度を調節することもできる。
らの浸透放出速度を調節することもできる。
溶質は区画に充填する前にあるいは区画に充填後自己混
合することにより、活性薬剤と混合することによって用
いるのが便利である。
合することにより、活性薬剤と混合することによって用
いるのが便利である。
薬剤が可溶であるとき、それは壁を浸透して透過する液
体中の飽和溶液として解放されるのが普通である。
体中の飽和溶液として解放されるのが普通である。
薬剤が限られた溶解度のものであるとき、流れる液体中
のけん濁液としてそれを放出することが望ましいかもし
れない。
のけん濁液としてそれを放出することが望ましいかもし
れない。
この後者の場合には、薬剤を放出開口を通過するのに十
分小さい粒子にすることが必要である。
分小さい粒子にすることが必要である。
これら粒子は放出通路の寸法の3/4から1/10以下
とすべきことが好ましい。
とすべきことが好ましい。
薬剤溶質へ保護コロイドまたは分散剤を添加することに
より、液体中のけん濁を増進することがしばしば望まし
い。
より、液体中のけん濁を増進することがしばしば望まし
い。
代表的コロイドまたは分散剤には、水溶性ガム、カルボ
キシメチルセルロース、ポリ(ビニルアルコール)ゼラ
チンおよび無毒性の表面活性剤、例えばグリセリルモノ
ステアレート、レシチンおよびソルビタンモノオレエー
トが含まれる。
キシメチルセルロース、ポリ(ビニルアルコール)ゼラ
チンおよび無毒性の表面活性剤、例えばグリセリルモノ
ステアレート、レシチンおよびソルビタンモノオレエー
トが含まれる。
供給体中に最初に存在する活性薬剤の量は一般に制限が
なく、供給体を浸透的に働らかせるのに必要な薬剤量と
、それに加うるに、供給体から解放されたとき薬剤の所
望の効果をもたらすのに有効な薬剤量の合計に等しいか
あるいはそれより大きい量である。
なく、供給体を浸透的に働らかせるのに必要な薬剤量と
、それに加うるに、供給体から解放されたとき薬剤の所
望の効果をもたらすのに有効な薬剤量の合計に等しいか
あるいはそれより大きい量である。
本発明は各種の用途に向く種々な寸法および形状の種々
な供給体を企図しているので、供給体中に加えられる薬
剤の量に対して厳密な上限はない。
な供給体を企図しているので、供給体中に加えられる薬
剤の量に対して厳密な上限はない。
下限は浸透活性、生成物の解放の長さおよび薬剤の活性
に依存する。
に依存する。
一般に、供給体は0.01%から90重量%またはそれ
以上の薬剤または薬剤一溶質混合物を含むであろう。
以上の薬剤または薬剤一溶質混合物を含むであろう。
典型的には、供給体は、液中に含まれた生成物0.01
ccから5cc/時間を数時間、数田数ケ月またはそれ
以上解放するような寸法と形状のものでよい。
ccから5cc/時間を数時間、数田数ケ月またはそれ
以上解放するような寸法と形状のものでよい。
「通路」および「と連絡する通路」という表現は、供給
体の浸透によるポンプ送り速度の下で、供給体から生成
物を解放する手段を定義する。
体の浸透によるポンプ送り速度の下で、供給体から生成
物を解放する手段を定義する。
この表現には、それを通って生成物が移動しうるすき間
、オリフイスおよび多孔質要素が含まれる。
、オリフイスおよび多孔質要素が含まれる。
この表現はまた使用環境で腐蝕して通路を生じる生物腐
蝕性材料も含む。
蝕性材料も含む。
通路の寸法は、通路に存QD ,
在する液体中の拡散による供給薬剤速度一か、t
QP
通路を経てのポンプ送りによる速度一より常にt
QD QP
小であるようでなければならない。
−ぱーよ11
QP
り相当に小さいのがよい(例えば一の0.1倍)。
t
QP ,QD
−か一より大きい本発明供給体においては、11
その供給体は本質的に浸透の動力供給された供給体であ
る。
る。
本発明供給体からのポンプ送り速度は次式により与えら
れる: ただし、Am=膜の面積、tm一膜の厚さ、そしてkは
次式で定義される透過係数である:所望の浸透機構を確
かめるには、通路の最大寸法を次の式: 〔ただし、Asは通路の横断面積であり、hは通路の長
さであり(膜を通る通路をもつ装置に対しては、これは
膜の厚さに相当する)、Dは供給体中に浸透により引き
込まれた溶液中の活性薬剤の拡散係数であり、Sはf/
ccで表わした溶解度でQP/t あり、F=−(Fは常に少なくとも2の値、Qd/t なるべくは10より犬、例えば10ないし1000の値
をもつべきである)により調節されるべきである。
れる: ただし、Am=膜の面積、tm一膜の厚さ、そしてkは
次式で定義される透過係数である:所望の浸透機構を確
かめるには、通路の最大寸法を次の式: 〔ただし、Asは通路の横断面積であり、hは通路の長
さであり(膜を通る通路をもつ装置に対しては、これは
膜の厚さに相当する)、Dは供給体中に浸透により引き
込まれた溶液中の活性薬剤の拡散係数であり、Sはf/
ccで表わした溶解度でQP/t あり、F=−(Fは常に少なくとも2の値、Qd/t なるべくは10より犬、例えば10ないし1000の値
をもつべきである)により調節されるべきである。
通路の最小寸法は、供給体内に生ずる過剰の静水圧ΔP
を防止するように定める。
を防止するように定める。
この最小寸法は一般式:
〔ただし、Asは通路の横断面積であり、ηは通路内の
溶液の粘度であり、ΔPは供給体内外の間の静水圧の差
であって、なるべ《は20気圧未満がよく、Lは通路の
長さであり、V/tは供給体からの液体の流速である〕
により決定できる。
溶液の粘度であり、ΔPは供給体内外の間の静水圧の差
であって、なるべ《は20気圧未満がよく、Lは通路の
長さであり、V/tは供給体からの液体の流速である〕
により決定できる。
本発明供給体は少なくとも一つの通路を有するようにつ
《られる。
《られる。
通路の数は累積寸法が上記制限を満足する限り変更でき
る。
る。
第1図には一般浸透供給体を示しまた第2図には眼科用
薬物供給体を示したが、本発明供給体は、調節された速
度で種々な領域および環境へ広範囲の活性薬剤を投与す
るため、種々様々な形状、寸法および形式をとることが
できる。
薬物供給体を示したが、本発明供給体は、調節された速
度で種々な領域および環境へ広範囲の活性薬剤を投与す
るため、種々様々な形状、寸法および形式をとることが
できる。
例えば、本発明は、例えば生物薬剤のような薬剤を畑の
ような環境へ投与するためにグリル、丸薬、錠剤、棒、
シート、および顆粒の形をとりうる。
ような環境へ投与するためにグリル、丸薬、錠剤、棒、
シート、および顆粒の形をとりうる。
あるいは、薬物供給環境において、錠剤および丸剤のよ
うな経口薬物供給体、膣装置、挿入針(管)、頬装置、
補形、顆環、子宮内配置、に容易に役立つ幾何学形の子
宮内装置、および眼の盲嚢中に不快感なく留めるための
都合のよい幾何学的形状の眼科薬物供給体の形をとりう
る。
うな経口薬物供給体、膣装置、挿入針(管)、頬装置、
補形、顆環、子宮内配置、に容易に役立つ幾何学形の子
宮内装置、および眼の盲嚢中に不快感なく留めるための
都合のよい幾何学的形状の眼科薬物供給体の形をとりう
る。
第6図において、供給体10は抗受精剤を浸透的に供給
するための子宮内装置としてつ《られている。
するための子宮内装置としてつ《られている。
供給体10はrHJ形状をもつ。このものは子宮腔内の
配置および側面23と子宮250子宮底24との接触に
向いている。
配置および側面23と子宮250子宮底24との接触に
向いている。
除去組26が供給体10の索引端27に付けられている
。
。
供給体10は生成物区画15を囲む半透膜から形成され
た壁14から成る。
た壁14から成る。
通路16が子宮23内の区画15と連絡している。
区画15は、半透壁14を通I一て区画に入る子宮液に
溶解しかつこれに対して浸透圧勾配を示す抗受精剤20
を含む。
溶解しかつこれに対して浸透圧勾配を示す抗受精剤20
を含む。
この薬剤はまた浸透性液体中に限られた溶解度を有し、
この場合、子宮液に可溶、かつ外部子宮液に対して浸透
圧勾配を示す浸透的に有効な溶質をこれと混合すること
になろう。
この場合、子宮液に可溶、かつ外部子宮液に対して浸透
圧勾配を示す浸透的に有効な溶質をこれと混合すること
になろう。
壁14は子宮液または水をその透過性によって調節され
る速度で室15の中に透過させる。
る速度で室15の中に透過させる。
室15に入る液体は薬剤20の分散した粒子を溶かしあ
るいはひろい上げる。
るいはひろい上げる。
それ以上の液体が室15に入るにつれて、薬剤のこの飽
和溶液または分散液は、壁をまたいでの浸透圧勾配によ
って表わされるように、液体への浸透的引力により支配
される液体の膜透過速度に相当する速度で、通路16を
経て子宮に放出される。
和溶液または分散液は、壁をまたいでの浸透圧勾配によ
って表わされるように、液体への浸透的引力により支配
される液体の膜透過速度に相当する速度で、通路16を
経て子宮に放出される。
第γ図はもう一つの本発明分配供給体10を示している
。
。
供給体10は薬剤20を肛門管(示していない)内に投
与するために設計されている。
与するために設計されている。
供給体10はリード端8およびテーリング端9を有する
オペリスクに似た形をした半透フイルム14の壁から成
る。
オペリスクに似た形をした半透フイルム14の壁から成
る。
壁14は貯蔵部160輪廓をきめる生成物の区画15を
包囲する。
包囲する。
貯蔵部16は固体薬物20を含む。
薬物20は出口17のところで終る通路16を経て、長
時間にわたり計られた速度で供給体10から解放される
。
時間にわたり計られた速度で供給体10から解放される
。
壁14は等方性でも異方性でもよい。
この浸透性坐薬において、薬物は既述の機構により解放
される。
される。
第8図において、本発明供給体10が示されている。
供給体10は薬剤の経口投与に向いた投薬形である。
供給体10は少なくとも一部は半透性材料から形成され
た壁14を有する。
た壁14を有する。
通路16は供給体の外部と連絡し、浸透作用に応じて医
薬20を供給体外部へ解放する。
薬20を供給体外部へ解放する。
供給体10は一つより多くの通路を有しうる。
ここに記述した供給体に存在する活性薬剤の量は、最初
は供給体の内部に存在した液体に溶けうる量より過剰に
ある。
は供給体の内部に存在した液体に溶けうる量より過剰に
ある。
この物理的状態の下で(薬物が過剰にあるとき)、供給
体は本質的にゼロ次の解放速度を与えるように浸透的に
働くであろう。
体は本質的にゼロ次の解放速度を与えるように浸透的に
働くであろう。
薬剤の解放速度は、必要に応じ、半透性材料の少なくと
も一部をパターン速度調節材料で覆うことにより変える
ことができる。
も一部をパターン速度調節材料で覆うことにより変える
ことができる。
パターン速度調節材料は環境内で腐食し、種々な量の半
透性材料を露出する。
透性材料を露出する。
これにより液体が供給体に入る速度、従って活性薬剤の
放出速度が変わる。
放出速度が変わる。
このようなパターン速度調節被覆の使用が第9図に描か
れている(供給体10の断面を示す)。
れている(供給体10の断面を示す)。
第9図の供給体はパターン速度被覆を追加した第3図の
供給体に似ている。
供給体に似ている。
第9図の供給体10は内部区画15を定める壁14,1
8および19を有する。
8および19を有する。
区画15内に配置されて活性薬剤20および液体21が
ある。
ある。
壁14および18は半透性であり、もし被覆されていな
いなら、使用環境からの外部液体を区画15の中に透過
させ、薬剤20を小通路(示していない)を経て浸透的
に解放するであろう。
いなら、使用環境からの外部液体を区画15の中に透過
させ、薬剤20を小通路(示していない)を経て浸透的
に解放するであろう。
壁14および18はパターン速度調節被覆9により覆わ
れている。
れている。
被覆9は急速なあるいは遅い腐食性を有しかつ外部液体
の通過に対し不透過性である合成または天然に生ずる材
料から形成される。
の通過に対し不透過性である合成または天然に生ずる材
料から形成される。
被覆9は可溶化、加水分解などといった過程により環境
中で腐食を受ける半透性材料の異なる領域を異なるパタ
ーン速度調節被覆で被覆し、半透性材料の種々な領域を
露出させ、それに応じて薬物放出速度を変えることがで
きる。
中で腐食を受ける半透性材料の異なる領域を異なるパタ
ーン速度調節被覆で被覆し、半透性材料の種々な領域を
露出させ、それに応じて薬物放出速度を変えることがで
きる。
有効なパターン速度被覆は半透壁を透過する液体に対し
不透過性である。
不透過性である。
薬物に対する経口投薬形に最も役立つパターン速度調節
材料に適した一r群の材料は、胃液の作用に抵抗して壁
を通して浸透する水を防止し、一方腸内で崩壊して装置
内に液体を入れることにより予定の解放速度輪廓を与え
る腸溶性被覆である。
材料に適した一r群の材料は、胃液の作用に抵抗して壁
を通して浸透する水を防止し、一方腸内で崩壊して装置
内に液体を入れることにより予定の解放速度輪廓を与え
る腸溶性被覆である。
本発明に適した腸溶性被覆物には、消化管中で酵素によ
り消化されうる材料イオン化しうるポリ酸、しばしばイ
オン化しうるカルボキシル基を有する長鎖重合体を含む
材料などが包含される。
り消化されうる材料イオン化しうるポリ酸、しばしばイ
オン化しうるカルボキシル基を有する長鎖重合体を含む
材料などが包含される。
腸溶性被覆物を形成するための典型的な材料には、ケラ
チン、サンダラツクトル上のケラチン:スチレン、メタ
クリル酸とマレイン酸のブチル半エステルとの三成分共
重合体、などが含まれる。
チン、サンダラツクトル上のケラチン:スチレン、メタ
クリル酸とマレイン酸のブチル半エステルとの三成分共
重合体、などが含まれる。
典型的な腸溶性被覆物はレミントンの’− Pharm
aceutical Science J、 13版
、604−605頁、1965年、マツク出版社(Ma
ch Publishing Co.)、イートン、ペ
ンシルバニア州に記述されている。
aceutical Science J、 13版
、604−605頁、1965年、マツク出版社(Ma
ch Publishing Co.)、イートン、ペ
ンシルバニア州に記述されている。
半透性壁14の上にある被覆9は、環境液体中予定され
た速度で徐々に腐食し、従って半透壁を周囲の液体にさ
らす時間解放グロフィル材料からもつ《られる。
た速度で徐々に腐食し、従って半透壁を周囲の液体にさ
らす時間解放グロフィル材料からもつ《られる。
被覆の厚さを加減することにより所望の解放プロフィル
を計画できる。
を計画できる。
代表的材料には液体にゆっくり溶ける材料、および体液
中で加水分解する被覆材料、例えば式 の重合性、本質的に線状の二塩基酸無水物が含まれる。
中で加水分解する被覆材料、例えば式 の重合性、本質的に線状の二塩基酸無水物が含まれる。
他の被覆物にはカバシン酸およびアゼライン酸のポリ無
水物重合体、およびポリヒドロキシ酢酸が含まれる。
水物重合体、およびポリヒドロキシ酢酸が含まれる。
被覆9はまた各8から22炭素原子に対し平均一つのイ
オン化しうる水素を有する疎水性ホリ(カルボン酸)か
ら成りうる。
オン化しうる水素を有する疎水性ホリ(カルボン酸)か
ら成りうる。
これらポリ酸被覆はカルボン酸水素イオン化の過程によ
り腐食する。
り腐食する。
この腐食は長期間にわたって継続し、相当する長期間に
わたり半透壁を露出させる。
わたり半透壁を露出させる。
被覆物として役立つ代表的なポリ(カルボン酸)材料は
、一般式: (ただし、Rは各カルボン酸水素に対し、平均して8か
ら22全炭素原子を与えるように独立的に選ばれた有機
基である)により表わされる疎水性ポリ酸である。
、一般式: (ただし、Rは各カルボン酸水素に対し、平均して8か
ら22全炭素原子を与えるように独立的に選ばれた有機
基である)により表わされる疎水性ポリ酸である。
この範囲内でのこの比の変動はこれら重合体酸からつく
られた腐食速度を変化しうる。
られた腐食速度を変化しうる。
R1、R2、・・・・・・H,nにより表わされる有機
基は、炭化水素残基、およびヘテロ原子含有有機残基か
ら選ばれる。
基は、炭化水素残基、およびヘテロ原子含有有機残基か
ら選ばれる。
R1、R2、・・・・・・Rnに用いるのに適したヘテ
ロ原子は酸素、窒素、イオウ、およびリンならびに他の
へテロ原子を含む。
ロ原子は酸素、窒素、イオウ、およびリンならびに他の
へテロ原子を含む。
本発明浸透供給体を被覆するために用いられる一群の被
覆材料は、アクリル酸、単量体単位一つ当り4から6炭
素原子,の低級アルキルアクリル酸およびマレイン酸か
ら選ばれる酸の、単独、あるいは酸1モルにつき約2モ
ルまでの共重合したオレフィン性不飽和化合物、例えば
エチレンまたは低級(例えば1−4炭素)アルキルビニ
ルエーテルと共重合した疎水性重合体からなり、該重合
体において、酸基の約20%から90%は1から約10
炭素原子のアルカノールでエステル化され、全炭素原子
対酸性カルボン酸水素の比は約9:1から約20:1の
範囲にある。
覆材料は、アクリル酸、単量体単位一つ当り4から6炭
素原子,の低級アルキルアクリル酸およびマレイン酸か
ら選ばれる酸の、単独、あるいは酸1モルにつき約2モ
ルまでの共重合したオレフィン性不飽和化合物、例えば
エチレンまたは低級(例えば1−4炭素)アルキルビニ
ルエーテルと共重合した疎水性重合体からなり、該重合
体において、酸基の約20%から90%は1から約10
炭素原子のアルカノールでエステル化され、全炭素原子
対酸性カルボン酸水素の比は約9:1から約20:1の
範囲にある。
また、適当な被覆物には、アクリル酸、メタクリル酸ま
たはマレイン酸と、酸1モルにつき0.2から15モル
のエチレンまたは低級(1−4炭素)アルキルビニルエ
ーテルとの疎水性部分エステル化共重合体が含まれ、こ
のものはその全カルボン酸基の約35%から約70%が
約3から約10炭素原子の低級アルカノールでエステル
化され、該共重合体ハ約101から約15:1の炭素対
酸性カルボン酸水素比を有する。
たはマレイン酸と、酸1モルにつき0.2から15モル
のエチレンまたは低級(1−4炭素)アルキルビニルエ
ーテルとの疎水性部分エステル化共重合体が含まれ、こ
のものはその全カルボン酸基の約35%から約70%が
約3から約10炭素原子の低級アルカノールでエステル
化され、該共重合体ハ約101から約15:1の炭素対
酸性カルボン酸水素比を有する。
被覆物には更にマレイン酸とマレイン酸1モルにつき約
1モルのエチレンまたはメチルビニルエーテルとの疎水
性共重合体が含まれ、該共重合体はその全力ルボキシル
基の約半分が4から8炭素原子を有する低級モノアルカ
ノールでエステル化され、炭素対酸性力ルボキシル水素
比は約10:1から約14:1の値を有する。
1モルのエチレンまたはメチルビニルエーテルとの疎水
性共重合体が含まれ、該共重合体はその全力ルボキシル
基の約半分が4から8炭素原子を有する低級モノアルカ
ノールでエステル化され、炭素対酸性力ルボキシル水素
比は約10:1から約14:1の値を有する。
他の時間遅延材料には、10から22炭素を有する脂肪
酸、10から22炭素原子を有する脂肪酸から生じたモ
ノー、ジー、またはトリグリセリルエステルのエステル
、シリコーンおよび置換シリコーンン誘導体などが含ま
れる。
酸、10から22炭素原子を有する脂肪酸から生じたモ
ノー、ジー、またはトリグリセリルエステルのエステル
、シリコーンおよび置換シリコーンン誘導体などが含ま
れる。
これら速度パターン被覆物は、第10図の供給体10の
ような薬物に対する浸透経口投薬形について特に効果的
である。
ような薬物に対する浸透経口投薬形について特に効果的
である。
前以て選ばれた環境へゼロ次速度で医薬品を解放する供
給体10は医薬品の経口投与に対し特にかなっている。
給体10は医薬品の経口投与に対し特にかなっている。
供給体10は薬物をとり囲む膜を形成する半透膜から完
全にあるいは少なくとも一部がつくられた壁14から成
る。
全にあるいは少なくとも一部がつくられた壁14から成
る。
胃腸管内で侵食する、あるいは溶解する一定の、または
種々の厚さを有する被覆9を半透壁14上に被覆する。
種々の厚さを有する被覆9を半透壁14上に被覆する。
被覆9は腸溶性被覆でよい。
これに胃内で崩壊しないが、上方腸管中では容易に溶解
する。
する。
これはまた供給体が胃腸管内を移動するにつれて、徐々
にそして連続して侵食する、あるいは溶解する材料でも
よい。
にそして連続して侵食する、あるいは溶解する材料でも
よい。
通路16は薬物を供給体の外部へ放出する。
供給体10は少な《とも一つの通路を有し、そしてこれ
は宿主へ、あるいは環境へ、種々な浸透ポンプ送り速度
で同量の薬物、またはより多くの薬物を放出するため更
に追加された通路を有しうる。
は宿主へ、あるいは環境へ、種々な浸透ポンプ送り速度
で同量の薬物、またはより多くの薬物を放出するため更
に追加された通路を有しうる。
第11図において、供給体10は薬物20および通路1
6をとり囲む半透性、非消化性、無毒性、生物学的に不
活性な壁14を示す開いた断面として見られる。
6をとり囲む半透性、非消化性、無毒性、生物学的に不
活性な壁14を示す開いた断面として見られる。
時間解放プロフィル被覆9が壁14上にある。
浸透供給体における薬物20の量は、当然のことながら
、宿主によって、また体から放出される前に宿主に留め
ようとする時間によって変化するであろう。
、宿主によって、また体から放出される前に宿主に留め
ようとする時間によって変化するであろう。
本発明を次の実施例により更に説明する。
実施例 1
第2,3および4図に実質的に従い、浸透薬物供給体を
つくる。
つくる。
このものは楕円形を有し、薬物を含めるための区画を定
める中心領域を有する内部中央壁19に各々融合した二
つの外側半透壁(図面の14と18)から成立つ。
める中心領域を有する内部中央壁19に各々融合した二
つの外側半透壁(図面の14と18)から成立つ。
薬物解放通路16は内部区画から供給体の外部へ通じて
いる。
いる。
第一に、二つの半透壁に向く材料は、ポリウレタンエー
テル(BFグッドリッチ( Goodrich )社の
EstaneR5 7 1 4 ) 1部とテトラヒド
o7ラン3部とを十分よく混合し、この混合物をシリコ
ーン解放紙の上で0. 2 5 mm厚フイルムを引く
ことにより形成される。
テル(BFグッドリッチ( Goodrich )社の
EstaneR5 7 1 4 ) 1部とテトラヒド
o7ラン3部とを十分よく混合し、この混合物をシリコ
ーン解放紙の上で0. 2 5 mm厚フイルムを引く
ことにより形成される。
フイルムを室温で風乾して厚さ約0.06mmの材料を
得る。
得る。
このフィルムから供給体用の二枚の楕円形半透壁(各々
約16mmX6.75mm)を切取る。
約16mmX6.75mm)を切取る。
次に、エチレンビニルアセテート20部、塩化メチレン
80部、および青レーキ9.1部を混合し、フイルムを
流延することにより(これは乾くと厚さ0.10mmで
ある)、中央壁材料をつくる。
80部、および青レーキ9.1部を混合し、フイルムを
流延することにより(これは乾くと厚さ0.10mmで
ある)、中央壁材料をつくる。
このフィルムを0. 5 mm幅のくぼみで1 6mm
X 6. 7 5 mvt楕円に切る。
X 6. 7 5 mvt楕円に切る。
中央壁を真空ラミネータにより半透壁の一方に積層する
。
。
水溶性の( 0.2 5 P/cc)浸透的に有効な薬
物硝酸ピロカルピン、をエチレン/ビニルアセテートに
分散し、中央壁の区画に入れる。
物硝酸ピロカルピン、をエチレン/ビニルアセテートに
分散し、中央壁の区画に入れる。
中央環の上に多孔質の絹縫合縣を置き、縫合絖と中央環
の上に第三の壁を積層する。
の上に第三の壁を積層する。
この供給体をヒトの眼に入れると、涙液からの水が半透
膜を通して直ちに浸透的に装置の中央区画の中に引かれ
、そこで薬物を溶かす。
膜を通して直ちに浸透的に装置の中央区画の中に引かれ
、そこで薬物を溶かす。
もつと多くの水が引き込まれるにつれて、迅速に浸透圧
が発生し、これが多孔質の絹の縫合縣に沿って薬物を外
に分配する。
が発生し、これが多孔質の絹の縫合縣に沿って薬物を外
に分配する。
該縫合縣は中央区画から供給体外部への通路を効果的に
定める。
定める。
この供給体からの硝酸ピロカルピンの解放速度は一定に
調節されて30μ?/時間である。
調節されて30μ?/時間である。
実施例 2
活性薬剤、塩化カリウムを浸透的に解放する浸透供給体
をつくる。
をつくる。
(塩化カリウムは薬物として有用であるが、氷および雪
の除去剤としてまたイオン強度調節剤としての用途も見
出される)。
の除去剤としてまたイオン強度調節剤としての用途も見
出される)。
塩化カリウム結晶と結合剤とを5 0 0m9/ 9.
5mrn直径の錠剤に圧縮成形する。
5mrn直径の錠剤に圧縮成形する。
この錠剤をWurster空気浮遊装置とジオキサン中
重合体の5%溶液を使用して酢酸セルロース(イースト
マン・コダックE−320)で被覆する。
重合体の5%溶液を使用して酢酸セルロース(イースト
マン・コダックE−320)で被覆する。
被覆の厚さは約0.25mmである。
被覆された各錠剤の塩化カリウム芯に、機械的穿孔によ
り、あるいは外側被覆をレーザー穿孔することにより通
路を切る。
り、あるいは外側被覆をレーザー穿孔することにより通
路を切る。
通路の直径は0.10mmないし0.27mrnにわた
る。
る。
この供給体を水性試験環境に置くと、これらは半透性外
部被覆を通して水を吸収する。
部被覆を通して水を吸収する。
この水は活性薬剤を溶かす。
活性薬剤の溶液は、浸透圧下に放出されるKCl26q
±5%/時間の速度で放出される。
±5%/時間の速度で放出される。
この速度は第11図に示したように長期間にわたり一定
に留まる。
に留まる。
この速度に試験された範囲にわたり通路の寸法に依存し
ない。
ない。
また別の試験において、通路の寸法を0.0025mm
以下に下げるか、または0.50m砂上に増すと、しば
しば通路の寸法に比例して変化する速度で浸透解放が起
る。
以下に下げるか、または0.50m砂上に増すと、しば
しば通路の寸法に比例して変化する速度で浸透解放が起
る。
実施例 3
実施例2に準じて供給体をつくる。
供給体を秤量し、色の暗号をつける。
一連の八個の暗号のついた供給体を規則的な時間間隔で
二匹の犬に投与する。
二匹の犬に投与する。
最初の供給体を投与してから12時間後に犬を殺し、供
給体を回収し、洗浄し、乾燥し、秤量する。
給体を回収し、洗浄し、乾燥し、秤量する。
各供給体から解放されたKCI の重量を第12図にプ
ロットした。
ロットした。
KCI 解放の平均速度は24.3m9/時間で、この
値は実施例2で測定された値と一致する。
値は実施例2で測定された値と一致する。
実施例 4
フエノバルビタールナトリウムの700〜部分をカプセ
ル形の芯に圧縮する。
ル形の芯に圧縮する。
この芯材を直径0.4關の針金に突き刺し、次にジオキ
サン中酢酸セルロース(イーストマン・コダックE−3
76)の溶液でツケ塗し乾燥する。
サン中酢酸セルロース(イーストマン・コダックE−3
76)の溶液でツケ塗し乾燥する。
乾いた酢酸セルロース被覆物の厚さは約0. 2 8
mmである。
mmである。
針金を除くと直径0. 4 mmの通路が得られる。
これら供給体はフエノバルビタールを一定速度で浸透機
構により解放する。
構により解放する。
これら供給体を擬似胃液中に2時間、次に擬似腸液中に
入れたとき(米国薬局方、第18改訂版、1026、1
027頁、1970年に記述)、第13図に示したよう
にpHに無関係の解放速度が観察された。
入れたとき(米国薬局方、第18改訂版、1026、1
027頁、1970年に記述)、第13図に示したよう
にpHに無関係の解放速度が観察された。
実施例 5
実施例1の供給体の製造をくり返す。
次に供給体を追加の処理加工工程にかげる。
半透壁に疎水性重合体の水不透過性解放速度プロフィル
被覆をつける。
被覆をつける。
このプロフィル被覆はエチレンー無水マレイン酸共重合
体のn−ペンタノール半エステルである。
体のn−ペンタノール半エステルである。
共重合体は次のようにしてつくられる:エチレンー無水
マレイン酸共重合体( Monsanto EMA、品
等31)12.6グラム( 0. 1 0当量)をn−
ペンチルアル−z−/L/5 0ml( 0.6モ/l
/) 1 2 0 −125℃で7時間かきまぜる。
マレイン酸共重合体( Monsanto EMA、品
等31)12.6グラム( 0. 1 0当量)をn−
ペンチルアル−z−/L/5 0ml( 0.6モ/l
/) 1 2 0 −125℃で7時間かきまぜる。
溶液を冷却し、塩化メチレンを加えて生成物を沈殿させ
る(全体積3立)。
る(全体積3立)。
沈殿を分離し、アセトン75TLlに溶かす。アセトン
を除《と重合体生成物を生じ、分析したところ、元の無
水物共重合体の酸性のペンチル半エステルであることが
見出された。
を除《と重合体生成物を生じ、分析したところ、元の無
水物共重合体の酸性のペンチル半エステルであることが
見出された。
この重合体を最少量のアセトンに溶解し、ドクターフレ
ードを用いて供給体の半透壁土にひろげ、乾かす。
ードを用いて供給体の半透壁土にひろげ、乾かす。
被覆された生成物をヒトの眼に入れたとき、最初は、水
不透過性解放速度グロフィル被覆が半透壁を通る水の通
過を防止し、従って浸透圧または薬物の浸透ポンプ送り
が起らないので、内部区画からの薬物の解放がない。
不透過性解放速度グロフィル被覆が半透壁を通る水の通
過を防止し、従って浸透圧または薬物の浸透ポンプ送り
が起らないので、内部区画からの薬物の解放がない。
しかし、プロフィル被覆が腐食するので、その結果最初
のある期間後、半透壁が水に対して露出し、調節された
長期にわたる薬物の浸透供給が始まる。
のある期間後、半透壁が水に対して露出し、調節された
長期にわたる薬物の浸透供給が始まる。
実施例 6
実施例2でつくられた幾つかの酢酸セルロースー被覆供
給体に追加の外部被覆を与える。
給体に追加の外部被覆を与える。
この被覆は腸溶性被覆であって、胃の酸性に抵抗し、区
画に入る液体および供給体からの薬物の解放を防止する
が、腸内のアルカリ性によって崩壊し浸透による薬物の
解放を可能にする。
画に入る液体および供給体からの薬物の解放を防止する
が、腸内のアルカリ性によって崩壊し浸透による薬物の
解放を可能にする。
使用できる有用な腸溶性被覆には、ケラチン、アルギン
酸カルシウム、シエラツクなどが含まれる。
酸カルシウム、シエラツクなどが含まれる。
この供給体に対する解放プロフィルは、第14図に示し
たように、最初胃の中で非解放状態であり、被覆の崩壊
後、腸内で解放状態となる。
たように、最初胃の中で非解放状態であり、被覆の崩壊
後、腸内で解放状態となる。
実施例 7
例えば、実施例1に準じ二つの半透膜を有する浸透係給
装置を、一つの膜上にだけ、薬物解放速度プロフィル腸
溶性被覆物(シエラツクーステアリン酸n−ブチル混合
物)で被覆する。
装置を、一つの膜上にだけ、薬物解放速度プロフィル腸
溶性被覆物(シエラツクーステアリン酸n−ブチル混合
物)で被覆する。
この供給体を経口的にとり胃に通ると、薬物は一定速度
で浸透的に解放され、供給体が腸に通ると、腸溶性被覆
が崩壊して更に半透膜を露出するので、浸透による解放
速度は新しい一定速度に比例して増加する。
で浸透的に解放され、供給体が腸に通ると、腸溶性被覆
が崩壊して更に半透膜を露出するので、浸透による解放
速度は新しい一定速度に比例して増加する。
第1図は本発明供給体の切断面であり、第2図は眼科薬
物供給体として具体化された本発明供給体の上面図であ
り、第3図は第2図の供給体の3−3のところの拡大横
断面図であり、第4図は第2図の供給体の分解配列遠近
図であり、第5図は使用位置における、第2図の供給体
を有するヒトの眼の図解的正面図であり、第6図は子宮
腔に位置した本発明供給体を示す該腔の横断面前面図で
あり、第7図は本発明浸透仁肛門部薬物供給体の部分横
断面図であり、第8図は浸透経口投与形として具体化さ
れた本発明供給体の横断図図であり、第9図は、供給体
からの薬剤解放速度を変えるため、半透膜上に仮の侵食
性被覆を有する本発明の具体例の断面図であり、第10
図は侵食性外部被覆をもつ浸透経口薬物投与形として具
体化された本発明供給体の横断面図である、第1014
図は本発明供給体によって得られる薬剤解放のパターン
を示すグラフである8
物供給体として具体化された本発明供給体の上面図であ
り、第3図は第2図の供給体の3−3のところの拡大横
断面図であり、第4図は第2図の供給体の分解配列遠近
図であり、第5図は使用位置における、第2図の供給体
を有するヒトの眼の図解的正面図であり、第6図は子宮
腔に位置した本発明供給体を示す該腔の横断面前面図で
あり、第7図は本発明浸透仁肛門部薬物供給体の部分横
断面図であり、第8図は浸透経口投与形として具体化さ
れた本発明供給体の横断図図であり、第9図は、供給体
からの薬剤解放速度を変えるため、半透膜上に仮の侵食
性被覆を有する本発明の具体例の断面図であり、第10
図は侵食性外部被覆をもつ浸透経口薬物投与形として具
体化された本発明供給体の横断面図である、第1014
図は本発明供給体によって得られる薬剤解放のパターン
を示すグラフである8
Claims (1)
- 【特許請求の範囲】 1 長期間使用環境に薬剤組成物を調節下連続放出する
透過性供給体の製造において、薬剤組成物を圧縮して芯
をつくり、その芯に半透性物質含有溶液を被覆し、つい
でその被覆芯を乾燥して、芯の周りに半透性壁を形成し
、そして浸透性供給体から薬剤を放出させるために、壁
中の供給体の区画と外部とを連通ずる少な《とも1つの
所定の小さい通路を穴を開けてつくり、この通路は、過
剰の高圧が供給体内に発生するのを防ぎ、かつ上記圧力
に感応して主としてポンプ作用により供給体から薬剤組
成物が分配するような大きさに作られ、その通路の最小
寸法は次式: (式中、Asは通路の断面積であり、Lは壁を通る通路
の長さであり、V/tは液体の流速であり、ηは通路中
の溶液の粘度であり、ΔPは装置の内部と外部間の静水
圧であり、望ましくは20気圧未満である)により調節
され、そして通路の最大寸法は次式: (式中、Asは上記の定義の通りであり、hは通路の長
さであり、Dは供給体内で生成した溶解状の活性薬剤の
拡散係数であり、Sは溶解度@/ccであり、Fは少な
くとも2であり、Qp/tはポンプ速度である)により
調節され、この方法により形成した浸透性供給体を使用
環境においたとき、使用環境の外部液体が、半透膜に対
し浸透圧勾配により決定される速度で、半浸透性壁を通
って供給体に浸透し、長期間にわたり調節された連続速
度で通路から薬剤組成物を使用環境に押出す圧力が供給
体内に発生することを特徴とする、上記薬剤供給体の製
造法。
Applications Claiming Priority (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US00259469A US3845770A (en) | 1972-06-05 | 1972-06-05 | Osmatic dispensing device for releasing beneficial agent |
Publications (2)
Publication Number | Publication Date |
---|---|
JPS4961325A JPS4961325A (ja) | 1974-06-14 |
JPS596843B2 true JPS596843B2 (ja) | 1984-02-15 |
Family
ID=22985088
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
JP48063287A Expired JPS596843B2 (ja) | 1972-06-05 | 1973-06-05 | 薬剤供給体の製造法 |
Country Status (12)
Country | Link |
---|---|
US (1) | US3845770A (ja) |
JP (1) | JPS596843B2 (ja) |
AR (1) | AR199301A1 (ja) |
BR (1) | BR7304196D0 (ja) |
CH (1) | CH578464A5 (ja) |
ES (1) | ES415568A1 (ja) |
FR (1) | FR2188568A5 (ja) |
GB (1) | GB1415210A (ja) |
IE (1) | IE39952B1 (ja) |
IL (1) | IL42418A (ja) |
NL (1) | NL163721C (ja) |
ZA (1) | ZA733734B (ja) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPS61153350U (ja) * | 1985-03-13 | 1986-09-22 |
Families Citing this family (2040)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3948254A (en) * | 1971-11-08 | 1976-04-06 | Alza Corporation | Novel drug delivery device |
US3996933A (en) * | 1972-10-02 | 1976-12-14 | Morton Gutnick | Intrauterine contraceptive devices and processes |
US4325388A (en) * | 1973-02-05 | 1982-04-20 | Louis Bucalo | Apparatus for collecting and processing body fluids |
US3971376A (en) * | 1973-02-26 | 1976-07-27 | Ceskoslovenska Akademie Ved | Method and apparatus for introducing fluids into the body |
US4177256A (en) * | 1973-04-25 | 1979-12-04 | Alza Corporation | Osmotic bursting drug delivery device |
GB1465684A (en) * | 1973-07-27 | 1977-02-23 | Emmett L | Contraceptive device |
US4111196A (en) * | 1973-07-27 | 1978-09-05 | Lionel C. R. Emmett | Intrauterine contraceptive device of c or omega form with tubular inserter and method of placement |
US4018220A (en) * | 1974-07-19 | 1977-04-19 | Lionel C. R. Emmett | Method of insertion for intrauterine device of C or omega form with tubular inserter |
US4172446A (en) * | 1974-12-20 | 1979-10-30 | Louis Bucalo | Apparatus for collecting body fluids |
US4096238A (en) * | 1974-12-23 | 1978-06-20 | Alza Corporation | Method for administering drug to the gastrointestinal tract |
US3946734A (en) * | 1975-02-19 | 1976-03-30 | The United States Of America As Represented By The Secretary Of State | Apparatus for controlling the release of a drug |
AU1147476A (en) * | 1975-03-19 | 1977-09-01 | Procter & Gamble | Controlled release article |
US3977404A (en) * | 1975-09-08 | 1976-08-31 | Alza Corporation | Osmotic device having microporous reservoir |
US4034758A (en) * | 1975-09-08 | 1977-07-12 | Alza Corporation | Osmotic therapeutic system for administering medicament |
US4036228A (en) * | 1975-09-11 | 1977-07-19 | Alza Corporation | Osmotic dispenser with gas generating means |
US3987790A (en) * | 1975-10-01 | 1976-10-26 | Alza Corporation | Osmotically driven fluid dispenser |
US4077407A (en) * | 1975-11-24 | 1978-03-07 | Alza Corporation | Osmotic devices having composite walls |
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-
1972
- 1972-06-05 US US00259469A patent/US3845770A/en not_active Expired - Lifetime
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1973
- 1973-05-31 IL IL42418A patent/IL42418A/xx unknown
- 1973-06-01 NL NL7307699.A patent/NL163721C/xx active
- 1973-06-04 ZA ZA733734A patent/ZA733734B/xx unknown
- 1973-06-04 GB GB2655773A patent/GB1415210A/en not_active Expired
- 1973-06-05 BR BR4196/73A patent/BR7304196D0/pt unknown
- 1973-06-05 CH CH812973A patent/CH578464A5/xx not_active IP Right Cessation
- 1973-06-05 ES ES415568A patent/ES415568A1/es not_active Expired
- 1973-06-05 AR AR248402A patent/AR199301A1/es active
- 1973-06-05 IE IE885/73A patent/IE39952B1/xx unknown
- 1973-06-05 JP JP48063287A patent/JPS596843B2/ja not_active Expired
- 1973-06-05 FR FR7320317A patent/FR2188568A5/fr not_active Expired
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JPS61153350U (ja) * | 1985-03-13 | 1986-09-22 |
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BR7304196D0 (pt) | 1974-07-25 |
IE39952B1 (en) | 1979-02-14 |
GB1415210A (en) | 1975-11-26 |
FR2188568A5 (ja) | 1974-01-18 |
NL163721C (nl) | 1980-10-15 |
AR199301A1 (es) | 1974-08-23 |
NL163721B (nl) | 1980-05-16 |
US3845770A (en) | 1974-11-05 |
NL7307699A (ja) | 1973-12-07 |
IL42418A (en) | 1975-07-28 |
CH578464A5 (ja) | 1976-08-13 |
IL42418A0 (en) | 1973-07-30 |
ES415568A1 (es) | 1976-05-16 |
IE39952L (en) | 1973-12-05 |
JPS4961325A (ja) | 1974-06-14 |
ZA733734B (en) | 1974-06-26 |
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