JP2007501768A - Skin or transdermal therapeutic system comprising an ormocer having a blocking effect on a cover film - Google Patents
Skin or transdermal therapeutic system comprising an ormocer having a blocking effect on a cover film Download PDFInfo
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Abstract
本発明は、気体、臭気及び易揮発性物質に対して遮断効果を有するカバーフォイルを備えた皮膚又は経皮治療システムに関する。本発明は、カバーフォイルに少なくとも一つの基体、及び無機−有機ハイブリッドポリマー(オルモサー)から構成された少なくとも一つの層が設けられていることを特徴とする。
【選択図】 図2
The present invention relates to a skin or transdermal therapeutic system provided with a cover foil having a blocking effect on gases, odors and volatile substances. The present invention is characterized in that the cover foil is provided with at least one substrate composed of at least one substrate and an inorganic-organic hybrid polymer (ormoser).
[Selection] Figure 2
Description
本発明は、気体、芳香剤及び易揮発性物質に対して遮断効果を有するカバーフィルムを備えた、皮膚又は経皮治療システムに関し、同システムは、カバーフィルムが少なくとも一つの支持層と、無機−有機ハイブリッドポリマー(オルモサー(ormocer))から構成された層とから構成されていることを特徴とする。 The present invention relates to a skin or transdermal treatment system with a cover film having a barrier effect against gases, fragrances and easily volatile substances, said system comprising a cover film comprising at least one support layer and an inorganic- and a layer composed of an organic hybrid polymer (ormocer).
皮膚治療システムは、薬剤の、局所的に作用する物質を、皮膚患部又はその下方に位置する筋肉患部に接触させるシステムであり、いわゆる薬用硬膏剤の全てがこのカテゴリーに所属する。一方、経皮治療システムは、皮膚を介して活性化合物を血液循環中に運搬し、その結果として全身に作用させる。 A skin treatment system is a system in which a medicinal, locally acting substance is brought into contact with the affected skin or underlying muscle, all so-called medicated plasters belong to this category. Transdermal therapeutic systems, on the other hand, deliver active compounds through the skin into the circulation, resulting in systemic effects.
両方のシステムは、本来、カバーフィルム(支持層)と、活性化合物の貯蔵部又は活性化合物を含有するマトリクスと、剥離可能な保護フィルム(レリースライナー)とから構成されている。カバーフィルムは、貼付中でも皮膚又は経皮治療システム上に残留して、一方では活性化合物含有マトリクス若しくは貯蔵部を機械的に保護し、他方では活性化合物を気体、例えば酸素及び水蒸気の作用から保護し、又は易揮発性の活性化合物の部分的な蒸発を防止する。 Both systems essentially consist of a cover film (support layer), a reservoir of active compound or a matrix containing the active compound and a peelable protective film (release liner). The cover film remains on the skin or on the transdermal therapeutic system even during application and on the one hand mechanically protects the active compound-containing matrix or reservoir and on the other hand protects the active compound from the action of gases such as oxygen and water vapor. , or to prevent partial evaporation of readily volatile active compounds.
支持層として作用するカバーフィルム及び剥離可能な保護フィルムの双方は、概して有機ポリマーから構成されている。これらフィルムの適当な材料の例は、低密度ポリエチレン(LDPE)及び高密度ポリエチレン(HDPE)、ポリプロピレン(PP)、ポリアミド(PA)、ポリ塩化ビニル(PVC)、ポリビニルエステル、ポリエチレンテレフタレート(PET)、これらポリマーの少なくとも二種から構成されるコポリマー、又はこれらポリマーの混合物である。カバーフィルムは、システム使用中、皮膚上に残留するため、患者により貼付される間、適度な心地よさを確実にするために出来る限りの可撓性及び伸縮性を有する必要がある。非可撓性のフィルムは、折り目の形成を招き、皮膚内に切り込まれる。特にLDPE及びHDPEは、適度な可撓性及び伸縮性を備えたカバーフィルムを形成する。しかしながら、上述したポリマーの全部、及び特に二種のポリエチレンは、程度は異なるが、活性化合物の良好な貯蔵システムを構成する不都合を有している。その結果、貯蔵中及び/又は使用中に、活性化合物は、その飽和濃度に到達するまで、気体空間を経由して貯蔵部又は活性化合物含有マトリクスからカバーフィルム中へ移動し得る。それによって、皮膚を介して浸透するための、マトリクス又は貯蔵部内に存在する活性化合物の量が最小となり、また皮膚又は経皮治療システムの放出動力学が最小となる。 Both the cover film, which acts as a support layer, and the peelable protective film are generally composed of organic polymers. Examples of suitable materials for these films are low density polyethylene (LDPE) and high density polyethylene (HDPE), polypropylene (PP), polyamide (PA), polyvinyl chloride (PVC), polyvinyl ester, polyethylene terephthalate (PET), It is a copolymer composed of at least two of these polymers, or a mixture of these polymers. Since the cover film remains on the skin during system use, it should be as flexible and stretchable as possible to ensure adequate comfort while being applied by the patient. Non-flexible films lead to crease formation and cuts into the skin. LDPE and HDPE in particular form cover films with moderate flexibility and stretchability. However, all of the polymers mentioned above, and in particular the two types of polyethylene, have the disadvantage that, to varying degrees, they constitute good storage systems for active compounds. As a result, during storage and/or use, the active compound can migrate from the reservoir or the active compound-containing matrix into the cover film via the gas space until reaching its saturation concentration. This minimizes the amount of active compound present in the matrix or reservoir for penetration through the skin and also minimizes the release kinetics of the skin or transdermal therapeutic system.
独国特許公開第19922368A1号には、薬剤支持材用の材料としての、水溶性ポリマーと、重合により結合された結合二酸化ケイ素構成単位(bound silicon dioxide building blocks)とから構成されているポリマー組成物が開示されている。しかしながら、この組成物はオルモサーに該当するものではない。 DE 199 22 368 A1 describes polymer compositions composed of water-soluble polymers and bound silicon dioxide building blocks bound by polymerization as materials for drug carriers. is disclosed. However, this composition does not correspond to an ormocer.
独国特許第19519593号には、揮発性活性化合物の放出用の経皮治療システムが開示されており、該システムは、活性化合物に対して本質的に不浸透性を有し、熱可塑性の有機ポリマーから構成されている支持層を備えている。 DE 19519593 discloses a transdermal therapeutic system for the release of volatile active compounds, which system is essentially impermeable to active compounds and consists of a thermoplastic organic It has a support layer composed of a polymer.
国際特許出願第95/07817号には、酸素及び湿度に対して不浸透性を有し、ナイロン、並びに/又は、エチレン及びビニルアルコールから構成されたコポリマーを、熱可塑性有機ポリマーと共に抽出して製造される、多数層フィルムが開示されている。 International Patent Application No. 95/07817 discloses an oxygen and humidity impermeable nylon and/or copolymer composed of ethylene and vinyl alcohol prepared by extraction with a thermoplastic organic polymer. A multi-layer film is disclosed.
例えばアルミニウム又は金属酸化物等で被覆する等、ポリマーを金属層と組み合わせることによって、可撓性又は伸縮性のポリマー層に対する気体又は揮発性活性化合物の浸透性を低減するか、又は完全に防止することが既に提案されている。しかしながら残念なことに、このような組合せは、このシステムの可撓性、特に伸縮性を著しく損なう。 By combining the polymer with a metal layer, for example coating it with aluminum or metal oxides, etc., the permeability of the flexible or stretchable polymer layer to gases or volatile active compounds is reduced or completely prevented. has already been proposed. Unfortunately, however, such a combination severely impairs the flexibility, especially stretchability, of the system.
従って、本発明の目的は、良好な可撓性を備えるとともに、易揮発性の、又は高蒸気圧を有する活性化合物に対して抜群の遮断効果を有する、皮膚又は経皮治療システムを開発することにある。 It was therefore an object of the present invention to develop a dermal or transdermal therapeutic system with good flexibility and an outstanding barrier effect for active compounds that are readily volatile or have a high vapor pressure. It is in.
本発明によれば、この目的は、無機−有機ハイブリッドポリマー、即ちいわゆるオルモサーで被覆された有機ポリマーから構成されたカバーフィルムを使用することによって達成される。 According to the invention, this object is achieved by using a cover film composed of an inorganic-organic hybrid polymer, ie an organic polymer coated with a so-called ormocer.
無機−有機ハイブリッドポリマー、即ちいわゆるオルモサーは、ここ数年知られている。オルモサーは、以下の方法にて二ステップで製造される:最初に、有機修飾酸化ケイ素を制御下で加水分解及び縮合して無機網状構造を合成する。その際、他の金属アルコキシド(Ti、Zr及びAlアルコキシド)との共縮合も可能である。次のステップでは、無機網状構造に結合した重合可能な基が、熱又はUV処理の結果として互いに反応する。それ故、このようなハイブリッドポリマーは、図1に概略的に示す構造式を有する。 Inorganic-organic hybrid polymers, so-called ormocers, have been known for several years. Ormocers are produced in two steps in the following manner: first, organically modified silicon oxides are hydrolyzed and condensed under controlled conditions to synthesize an inorganic network. Co-condensation with other metal alkoxides (Ti, Zr and Al alkoxides) is then also possible. In the next step the polymerizable groups attached to the inorganic network react with each other as a result of thermal or UV treatment. Such hybrid polymers therefore have the structural formula shown schematically in FIG.
オルモサーの製造及び性質は、以下の公報に開示されている:欧州特許公開第0358011A2号、欧州特許公開第0373451A1号、欧州特許公開第0610831A2号、欧州特許第0644908B1号、欧州特許公開第0792846A1号、欧州特許公開第0934989A号。これらの公報は、本開示の一部として本願にて明白に挙げられる。 The preparation and properties of ormocers are disclosed in the following publications: EP 0358011 A2, EP 0373451 A1, EP 0610831 A2, EP 0644908 B1, EP 0792846 A1, European Patent Publication No. 0934989A. These publications are expressly incorporated herein as part of this disclosure.
以前は、良好な遮断特性と共に満足すべき伸縮性を有する皮膚又は経皮システム用のカバーフィルムを製造することは不可能であったが、驚くべき事に、良好な遮断効果が既知であるオルモサーでポリマーフィルムを被覆すると、伸縮性が損なわれていない、又は無視できる程度に損なわれたカバーフィルムが形成されることが見いだされた。1μm〜10μmの厚さを有するオルモサー層が、特に適当である。 Previously, it was not possible to produce cover films for dermal or transdermal systems with satisfactory elasticity combined with good barrier properties, but surprisingly Ormocer, which is known to have a good barrier effect was found to form a cover film with unimpaired or negligible stretchability. An ormocer layer having a thickness of 1 μm to 10 μm is particularly suitable.
支持層として作用するカバーフィルム及び剥離可能な保護フィルムの双方は、一般には有機ポリマーで構成されることが好ましい。これらフィルムに適した材料の例は、低密度ポリエチレン(LDPE)及び高密度ポリエチレン(HDPE)、ポリプロピレン(PP)、ポリアミド(PA)、ポリ塩化ビニル(PVC)、ポリビニルエステル、ポリエステル、ポリエチレンテレフタレート(PET)、これらポリマーの少なくとも二種から構成されるコポリマー、又はこれらポリマーの混合物である。カバーフィルムは、システム使用中、皮膚上に残留するため、患者により貼付される間、適度な心地よさを確実にするために出来る限りの可撓性及び伸縮性を有する必要がある。非可撓性フィルムは、折り目の形成を招き、皮膚内に切り込まれる。特にLDPE及びHDPEは、適度な可撓性及び伸縮性を備えたカバーフィルムを形成する。 Both the cover film, which acts as a support layer, and the peelable protective film are generally preferably composed of organic polymers. Examples of suitable materials for these films are low density polyethylene (LDPE) and high density polyethylene (HDPE), polypropylene (PP), polyamide (PA), polyvinyl chloride (PVC), polyvinylester, polyester, polyethylene terephthalate (PET). ), copolymers composed of at least two of these polymers, or mixtures of these polymers. Since the cover film remains on the skin during system use, it should be as flexible and stretchable as possible to ensure adequate comfort while being applied by the patient. Non-flexible films are subject to crease formation and cut into the skin. LDPE and HDPE in particular form cover films with moderate flexibility and stretchability.
オルモサー被覆可撓性カバーフィルムの適合性を研究するため、厚さ175μmのHDPEフィルムに、上述した組成物からなるオルモサーラッカーを被覆した。両面被覆されたフィルムを、ニコチンを含む気体空間内に導入して、40℃で4〜8週間インキュベートした後の、フィルムによる活性化合物の取り込みを測定した。この研究の結果を図2に示す。 To study the suitability of the Ormocer-coated flexible cover film, a 175 μm thick HDPE film was coated with an Ormocer lacquer consisting of the composition described above. The uptake of active compound by the film was measured after the double-sided coated film was introduced into a gas space containing nicotine and incubated at 40° C. for 4-8 weeks. The results of this study are shown in FIG.
同様に本発明によるカバーフィルムは、良好な伸長性を有し、即ちその結果良好な伸縮性を有し、伸長状態においても遮断性が保存されることも証明し得る。この証明のために、ハイブリッドポリマーオルモサーで被覆されたHDPEフィルムを3%伸長して、ニコチンに4〜8週間露出した後の活性化合物の取り込みを測定した。結果を表3に示す。 It can likewise be demonstrated that the cover films according to the invention have good extensibility, i.e. as a result good stretchability, and that the barrier properties are preserved even in the stretched state. For this demonstration, hybrid polymer ormocer-coated HDPE films were stretched 3% and the uptake of active compound was measured after 4-8 weeks of exposure to nicotine. Table 3 shows the results.
支持層として作用するカバーフィルム及び剥離可能な保護フィルムの双方は、概して有機ポリマーから構成されている。これらフィルムの適当な材料の例は、低密度ポリエチレン(LDPE)及び高密度ポリエチレン(HDPE)、ポリプロピレン(PP)、ポリアミド(PA)、ポリ塩化ビニル(PVC)、ポリビニルエステル、ポリエチレンテレフタレート(PET)、これらポリマーの少なくとも二種から構成されるコポリマー、又はこれらポリマーの混合物である。カバーフィルムは、システム使用中、皮膚上に残留するため、患者により貼付される間、適度な心地よさを確実にするために出来る限りの可撓性及び伸縮性を有する必要がある。非可撓性のフィルムは、折り目の形成を招き、皮膚内に切り込まれる。特にLDPE及びHDPEは、適度な可撓性及び伸縮性を備えたカバーフィルムを形成する。しかしながら、上述したポリマーの全部、及び特に二種のポリエチレンは、程度は異なるが、活性化合物の良好な貯蔵システムを構成する不都合を有している。その結果、貯蔵中及び/又は使用中に、活性化合物は、飽和濃度に到達するまで、気体空間を経由して貯蔵部又は活性化合物含有マトリクスからカバーフィルム中へ移動し得る。それによって、皮膚を介して浸透するための、マトリクス又は貯蔵部内に存在する活性化合物の量が最小となり、また皮膚又は経皮治療システムの放出動力学が最小となる。 Both the cover film, which acts as a support layer, and the peelable protective film are generally composed of organic polymers. Examples of suitable materials for these films are low density polyethylene (LDPE) and high density polyethylene (HDPE), polypropylene (PP), polyamide (PA), polyvinyl chloride (PVC), polyvinyl ester, polyethylene terephthalate (PET), It is a copolymer composed of at least two of these polymers, or a mixture of these polymers. Since the cover film remains on the skin during system use, it should be as flexible and stretchable as possible to ensure adequate comfort while being applied by the patient. Non-flexible films lead to crease formation and cuts into the skin. LDPE and HDPE in particular form cover films with moderate flexibility and stretchability. However, all of the polymers mentioned above, and in particular the two types of polyethylene, have the disadvantage that, to varying degrees, they constitute good storage systems for active compounds. As a result, during storage and/or use, the active compound can migrate from the reservoir or the active compound-containing matrix into the cover film via the gas space until a saturation concentration is reached. This minimizes the amount of active compound present in the matrix or reservoir for penetration through the skin and also minimizes the release kinetics of the skin or transdermal therapeutic system.
独国特許公開第19922368A1号には、薬剤支持材用の材料としての、水溶性ポリマーと、重合により結合された結合二酸化ケイ素構成単位(bound silicon dioxide building blocks)とから構成されているポリマー組成物が開示されている。しかしながら、この組成物はオルモサーに該当するものではない。
独国特許第19519593号には、揮発性活性化合物の放出用の経皮治療システムが開示されており、該システムは、活性化合物に対して本質的に不浸透性を有し、熱可塑性の有機ポリマーから構成されている支持層を備えている。
国際特許出願第95/07817号には、酸素及び湿度に対して不浸透性を有し、ナイロン、並びに/又は、エチレン及びビニルアルコールから構成されたコポリマーを、熱可塑性有機ポリマーと共に抽出して製造される、多数層フィルムが開示されている。
DE 199 22 368 A1 describes polymer compositions composed of water-soluble polymers and bound silicon dioxide building blocks bound by polymerization as materials for drug carriers. is disclosed. However, this composition does not correspond to an ormocer.
DE 19519593 discloses a transdermal therapeutic system for the release of volatile active compounds, which system is essentially impermeable to active compounds and consists of a thermoplastic organic It has a support layer composed of a polymer.
International Patent Application No. 95/07817 discloses an oxygen and humidity impermeable nylon and/or copolymer composed of ethylene and vinyl alcohol prepared by extraction with a thermoplastic organic polymer. A multi-layer film is disclosed.
独国特許公開第19958554A号には、活性化合物に対して不浸透性を有する支持層と、内部に含まれたマイクロ貯蔵部と少なくとも一種の活性化合物とを有する少なくとも一つのポリマー層と、使用に先立って除去される保護層とを備えた経皮治療システムが開示されている。支持層の材料は、ポリエチレン、ポリプロピレン若しくはポリエステル等のフィルム、又は異なるポリマーからなる積層体から構成されている。
Amberg-Schwab S.等による刊行物“Inorganic-organic polymers as migration barriers against liquid and volatile compounds”, Journal of Sol-Gel Science and Technology 26, 699-703, 2003には、ゾル−ゲル技術をベースに合成され、印刷可能性、摩耗耐性、及びパッケージング産業における静電気防止に関して良好な性質を有する、移動包装材料として使用するための新規な被覆材料としての、異なった、光化学的に硬化可能なハイブリッドポリマーの研究が開示されている。
DE 199 58 554 A discloses a support layer which is impermeable to active compounds, at least one polymer layer with microreservoirs contained therein and at least one active compound, and A transdermal therapeutic system is disclosed with a protective layer that is previously removed. The material of the support layer consists of films such as polyethylene, polypropylene or polyester, or laminates of different polymers.
In the publication "Inorganic-organic polymers as migration barriers against liquid and volatile compounds" by Amberg-Schwab S. et al., Journal of Sol-Gel Science and Technology 26, 699-703, 2003, synthesis based on sol-gel technology of different, photochemically curable hybrid polymers as novel coating materials for use as mobile packaging materials, having good properties with respect to printability, abrasion resistance, and antistatic properties in the packaging industry. Studies have been disclosed.
国際特許出願公開第WO02/34510A1号には、気体、水蒸気及び芳香剤に対して遮断性を有するフィルム又はフィルム複合材から構成され、かつ支持フィルムと、同フィルム上に配置されて、その上部に無機−有機ハイブリッドポリマーから構成されている機能層が適用された薄いセラミック層とから構成された、可撓性を有する無菌商品パッケージング材が開示されている。この材料は、高温での滅菌に適している。
Knittel D.等による刊行物“Surface of Textiles and the Human Skin: 1. Surface Modification of Fibers as Therapeutic and Diagnostic Systems”, Exogenous Dermatology 2003; 2, 11-16には、布地の表面上にシクロデキストリンを固着させることによって、布地の皮膚に向いた面を改良する新規な方法が開示されている。これに加えて、制御放出のための貯蔵所として作用する活性化合物含有無機−有機ハイブリッドシステムで布地を機能化することも提案されている。
International Patent Application Publication No. WO 02/34510 A1 describes a film or film composite which is barrier to gases, water vapor and fragrances, and which is composed of a support film and disposed on the same film, on top of which A flexible, aseptic commodity packaging material is disclosed that is composed of a thin ceramic layer to which is applied a functional layer composed of an inorganic-organic hybrid polymer. This material is suitable for sterilization at high temperatures.
In the publication by Knittel D. et al., "Surface of Textiles and the Human Skin: 1. Surface Modification of Fibers as Therapeutic and Diagnostic Systems", Exogenous Dermatology 2003; A novel method is disclosed for improving the skin-facing side of a fabric by allowing it to swell. In addition to this, it has also been proposed to functionalize fabrics with active compound-containing inorganic-organic hybrid systems that act as reservoirs for controlled release.
Claims (10)
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DE10336211 | 2003-08-07 | ||
DE10336211.8 | 2003-08-07 | ||
DE102004028415.6 | 2004-06-11 | ||
DE102004028415A DE102004028415B4 (en) | 2003-08-07 | 2004-06-11 | Dermal or transdermal therapeutic system containing a cover with barrier effect |
PCT/EP2004/008221 WO2005016320A1 (en) | 2003-08-07 | 2004-07-23 | Dermal or transdermal therapeutic system comprising an ormocer with barrier effect on a cover foil |
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JP2007501768A true JP2007501768A (en) | 2007-02-01 |
JP4925824B2 JP4925824B2 (en) | 2012-05-09 |
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JP2006522271A Expired - Fee Related JP4925824B2 (en) | 2003-08-07 | 2004-07-23 | Skin or transdermal therapeutic system comprising an ormocer having a blocking effect on a cover film |
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JP2010536898A (en) * | 2007-08-29 | 2010-12-02 | エルテーエス ローマン テラピー−ジステーメ アーゲー | Transdermal therapeutic system containing an elongated hollow body |
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JP2001329064A (en) * | 2000-03-31 | 2001-11-27 | Degussa Dental Gmbh & Co Kg | Ormocer, method for preparing the same, and use of the same |
WO2002034510A1 (en) * | 2000-10-20 | 2002-05-02 | Alcan Technology & Management Ag | Packaging material for sterile items |
US20020169270A1 (en) * | 1997-12-23 | 2002-11-14 | Sabine Amberg-Schwab | Film-forming specifically detachable material |
US6503634B1 (en) * | 1996-02-28 | 2003-01-07 | Fraunhofer-Gesellschaft Zur Foerderung Der Angewandten Forschung E.V. | Barrier films |
US20030077462A1 (en) * | 1996-02-28 | 2003-04-24 | Helmar Utz | Barrier films |
Family Cites Families (3)
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US5567489A (en) * | 1993-09-16 | 1996-10-22 | The Dow Chemical Company | Multilayer halogen-free barrier film for ostomy and transdermal drug delivery applications |
DE19519593C1 (en) * | 1995-05-29 | 1996-08-29 | Horstmann Michael | Transdermal therapeutic system with thermoplastic back layer |
DE19922368A1 (en) * | 1999-05-14 | 2000-11-16 | Few Chemicals Gmbh | New hybrid polymer composition, useful as carrier for controlled drug release, comprising water-soluble polymers and silicon oxide units bonded via polymerizable groups |
-
2004
- 2004-06-11 DE DE102004028415A patent/DE102004028415B4/en not_active Expired - Fee Related
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Publication number | Priority date | Publication date | Assignee | Title |
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US6503634B1 (en) * | 1996-02-28 | 2003-01-07 | Fraunhofer-Gesellschaft Zur Foerderung Der Angewandten Forschung E.V. | Barrier films |
US20030077462A1 (en) * | 1996-02-28 | 2003-04-24 | Helmar Utz | Barrier films |
US20020169270A1 (en) * | 1997-12-23 | 2002-11-14 | Sabine Amberg-Schwab | Film-forming specifically detachable material |
JP2001329064A (en) * | 2000-03-31 | 2001-11-27 | Degussa Dental Gmbh & Co Kg | Ormocer, method for preparing the same, and use of the same |
WO2002034510A1 (en) * | 2000-10-20 | 2002-05-02 | Alcan Technology & Management Ag | Packaging material for sterile items |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
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JP2010536898A (en) * | 2007-08-29 | 2010-12-02 | エルテーエス ローマン テラピー−ジステーメ アーゲー | Transdermal therapeutic system containing an elongated hollow body |
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DE102004028415B4 (en) | 2005-08-11 |
DE102004028415A1 (en) | 2005-03-03 |
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