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Embossable and Writable Multilaminate Backing (19) & (11) EP 1 534 508 B1 (12) EUROPEAN PATENT SPECIFICATION (45) Date of publication and mention (51) Int Cl.: of the grant of the patent: B32B 7/06 (2006.01) B32B 33/00 (2006.01) 24.12.2008 Bulletin 2008/52 G09F 3/10 (2006.01) A61K 9/70 (2006.01) (21) Application number: 03754410.3 (86) International application number: PCT/US2003/026545 (22) Date of filing: 22.08.2003 (87) International publication number: WO 2004/020189 (11.03.2004 Gazette 2004/11) (54) EMBOSSABLE AND WRITABLE MULTILAMINATE BACKING CONSTRUCTION PRÄGBARE UND BESCHREIBBARE VERBUNDRÜCKSCHICHT CONSTRUCTION DE SUPPORT MULTISTRATIFIEE POUVANT ETRE ALVEOLEE ET INSCRIPTIBLE (84) Designated Contracting States: (72) Inventor: AUDETT, Jay Douglas AT BE BG CH CY CZ DE DK EE ES FI FR GB GR Mountain View, CA 94040 (US) HU IE IT LI LU MC NL PT RO SE SI SK TR (74) Representative: Williams, Paul Edwin et al (30) Priority: 30.08.2002 US 407126 P Ablett & Stebbing Caparo House (43) Date of publication of application: 101-103 Baker Street 01.06.2005 Bulletin 2005/22 London W1U 6FQ (GB) (73) Proprietor: ALZA Corporation (56) References cited: Mountain View, CA 94039-7210 (US) EP-A- 0 309 073 WO-A-92/16202 DE-A- 19 724 871 US-A- 5 906 830 Note: Within nine months of the publication of the mention of the grant of the European patent in the European Patent Bulletin, any person may give notice to the European Patent Office of opposition to that patent, in accordance with the Implementing Regulations. Notice of opposition shall not be deemed to have been filed until the opposition fee has been paid. (Art. 99(1) European Patent Convention). EP 1 534 508 B1 Printed by Jouve, 75001 PARIS (FR) 1 EP 1 534 508 B1 2 Description ously are directly laminated to a pressure sensitive ad- hesive to provide labels having good adhesion. However, Technical Field embossing microporous film after direct lamination to a pressure sensitive adhesive would be problematic. Em- [0001] The present invention relates to a multilaminate 5 bossing such microporous films would result in a poorly backing construction for a transdermal drug delivery sys- resolved image due to the slow intrusion of the adhesive tem. In particular, the invention relates to a system and into the opaque film layer. The slow adhesive flow into method for labeling a transdermal drug delivery system, the pores, accompanied by the crushing of the pores due wherein the outermost layer of the multilaminate backing to embossing would render the film transparent. Further, construction contains an embossable and writable ma- 10 the embossed image would be poorly resolved due to terial. adhesive flow into the pores. Background of the Invention Summary of the Invention [0002] The use of microporous materials, including 15 [0006] The present invention is directed to the afore- films, in label application for various packaging materials, mentioned needs in the art, and provides a multilaminate containers, stationary, blood bags, recording paper, backing construction for a transdermal system. In partic- bandages and the like has been described in great detail. ular, the invention relates to a system and method for The following patents U.S. Patent Nos. 6,255,552; labeling a transdermal drug delivery system, wherein the 6,162,858; 5,906,830; 5,871,829; 5,583,171; 5,507,525; 20 outermost layer of the multilaminate backing layer con- 5,484,603; 5,314,421; 4,751,087; 4,334,530 andtains an embossable and writeable material. 3,928,099 describe various ways of labeling packaging [0007] In one aspect, the invention provides a multil- materials, containers, stationary, blood bags and record- aminate backing construction comprising ing paper wherein sheet materials, e.g., microporous ma- terials, containing additives such as inorganic powder, 25 (a) an outer layer (2) comprising a breathable, em- printing inks,swellable agents, coloring agents, fillersetc. bossable and writable material, of porous, micropo- are used to create markings, e.g., etching, scoring, print- rous, microfibrullar, spun-bonded, spun laced, track ing, and writing, on the label. In general, these processes etched, rayon, wood-pulp, spun laced polyester, or require the use of high temperatures and/or the presence coated paper products and combinations thereof; of additives within the microporous film in order to display 30 (b) a tie layer (3), the tie layer disposed on the skin the markings on the surface. proximal surface of the outer layer; and D1, WO9216202 defines (fig. 1; cl.1-3, 13, pages 8 to 10) (c) a base layer (4) disposed on the skin proximal a percutaneous anaesthetic delivery system (transder- surface of the tie layer. mal patch) and comprises a skin conformable (outer) backing layer, an amethocaine (1)-bearing (base) mate- 35 Preferably, rial and an intermediate layer having little or no tendency to absorb the drug (1). (a) the outer layer is a microporous layer or a micro- [0003] Labeling or printing information on transdermal fibrullar layer; and systems has been a challenge. For example, use of print- ing inks, coloring agents, solvents and other additives 40 (b) the tie layer comprises a secondary drug-con- necessary for printing may adversely interact with the taining reservoir. active agents within the transdermal system. To address these concerns, transdermal systems have been labeled [0008] Preferably, the secondary drug-containing res- using a process not requiring the use of inks. The backing ervoir comprises a beneficial agent and the base layer layer of the transdermal system is labelled by a thermal 45 is a beneficial agent release rate controlling means. embossing process. The polyolefin face of the backing Preferably, the tie layer is multilaminate. The tie layer material is melted under pressure to reveal the label. may contain a secondary drug-containing reservoir. [0004] Notwithstanding some success, the existing [0009] In preferred aspects, the multilaminate backing technology for labeling transdermal systems has not construction of the invention comprises a base layer im- been entirely satisfactory. The additives in the backing 50 permeable to the drug within the drug reservoir or the tie layer and/or the adjacent layers can interact adversely layer, wherein the base layer comprises a material which with the active agents. Additionally the use of high tem- is insoluble in water, alcohol and organic solvents. The peratures to label the transdermal systems may degrade base layer may optionally be a multilaminate layer. In various components of the transdermal systems or cause certain embodiments, the base layer may be a drug re- adhesive flow beyond the perimeter of the backing.55 lease rate controlling means, e.g., a drug release rate These challenges would in turn affect the potency and controlling membrane. The base layer may comprise a stability of the transdermal systems. polymer such as polyolefin laminates (Dow Chemical, [0005] Further, the microporous films described previ- Midland, MI), acrylonitrile copolymer films (BAREX, BP 2 3 EP 1 534 508 B1 4 Chemicals, Koln, Germany), polyethylnapthalene (PEN), material, such as, ethyleneoctene copolymers such as polyethylene terephthalate (PET), PET modified with ad- ENGAGE 8407 (from Dupont-Dow Elastomers), ethyl- hesion improvement coatings such polyacrylates or pol- ene-vinyl acetate copolymer (EVA), low density polyeth- yesters, polyimide, polyurethane, polyethylene, metal- ylene (LDPE), medium density polyethylene (MDPE), lized films and glass coated films where these films can 5 non pressure sensitive formulation of styrenic block co- include ethylene copolymers such as ethylene-vinyl ac- polymer thermoplastic elastomers, and the like. In pre- etate copolymer (EVA), and combinations thereof. In pre- ferred embodiments, the tie layer is formed from ethyle- ferred embodiments, the base layer comprises polyester, neoctene copolymers, as described in greater detail be- such as PET, laminated to a polymer, such as poly- low. urethane, polyethylene, and ethylene copolymers. 10 [0013] The tie layer may comprise a secondary drug- [0010] In preferred embodiments, the base layer is containing reservoir. The secondary drug-containing res- comprised of a polymeric material selected from the ervoir may contain a beneficial agent or an antagonist group consisting of a polyester-polyolefin material such for the beneficial agent, wherein the antagonist is in a as Scotchpak 9735 (PET-PE laminate, 3M), Mediflex form that is not releasable through the base layer. The 1500 (PET-pigmented EVA laminate, Mylan Technolo- 15 skin distal surface of the drug reservoir is disposed on gies), Mediflex 1200 (PET-EVA laminate, Mylan Tech- the outer surface. The secondary drug- containing reser- nologies); Mediflex 1000 (a translucent polyolefin film, voir may be the same size as the other layers of the back- Mylan Technologies), Medifilm 500 series (EVA mem- ing construction or the secondary drug- containing reser- brane material, Mylan Technologies); polyethylenes voir may be inset from the edge of the die cut backing such as low density polyethylene (LDPE), medium den- 20 construction. sity polyethylene (MDPE), high density polyethylene [0014] In certain embodiments, the secondary drug- (HDPE), Kapton polyimide film, and other ethylene co- containing reservoir comprises the drug dispersed within polymer films such as EMA, or EBA copolymer films. a polymer, wherein the drug is substantially insoluble in [0011] The multilaminate backing construction of the the secondary drug- containing reservoir polymer. In cer- invention comprises an outer layer comprising an em- 25 tain embodiments, the drug is dispersed in a matrix com- bossable and writeable material. The outer surface can prising a material which substantially prevents release be scribed with a pen, and can be embossed by applying of the drug; or the drug is complexed with an ionic resin. pressure with an embossing roll before or after lamination In additional embodiments, the secondary drug- contain- of the multilaminate backing construction to a pressure ing reservoir comprises the drug in a multiparticulate sensitive adhesive.
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