By a News Reporter-Staff News Editor at Drug Week A patent application by the inventors Riis, Jennifer L. (Neenah, WI); Liu, Yuan (Neenah, WI); McMillan, Lyndsey A. (Neenah, WI); Osborn, Christopher L. (Germantown, WI); Jain, Rishabh (Appleton, WI), filed on February 10, 2015, was made available online on June 29, 2017, according to news reporting originating from Washington, D.C., by NewsRx correspondents (see also Patents).
This patent application has not been assigned to a company or institution.
The following quote was obtained by the news editors from the background information supplied by the inventors: "Pharmaceuticals such as the drugs fentanyl and nicotine are often administered through the use of transdermal patches which are applied to a patient's skin to permit drug delivery over time by absorption. Prior to application of a drug containing patch, the patch is packaged in a pouch which is designed to be opened to permit access to the patch by the patient or caregiver for application to a patient's skin. Suitable packaging for transdermal patches should contain the patch and its drug within the package while protecting the patch from contamination and deleterious effects from the external environment. Thus, articles such as a pouch may hold a transdermal patch to protect the patch and its drug contents from contact or exposure to unwanted materials such as microbes, insects, air, moisture, sunlight, etc. The container is typically sealed e.g. by a heat seal to provide a hermetic barrier.
"The materials used in constructing transdermal patch packaging and especially the patch contact package interior surface layer should resist migration of chemicals between the patch and the package materials. Such migration of the drug or patch components from the patch to the package structure is referred to as 'scalping'. A common material employed for transdermal patch package interior surface layers that prevents scalping is polyacrylonitrile which is often sold under the Barex.RTM. trademark by Ineos AG. While Barex.RTM. has superb antiscalping properties it is very expensive, poor tear properties that make pouch opening difficult, and has limited availability which creates supply chain risk because of its manufacture on only a single production reactor. Other polymers used in transdermal patch packaging as a surface contact layer include polyester. Polyester suffers from the disadvantage of being less resistant to scalping of certain chemicals than desired and its tear properties are also less than desired. Accordingly, there is a need for a more cost efficient packaging material for containing articles for collecting or administering a physiologically active substance such as transdermal drug delivery patches."
In addition to the background information obtained for this patent application, NewsRx journalists also obtained the inventors' summary information for this patent application: "This disclosure, among other things, relates to films for packaging products containing a pharmaceutical active agent. The films resist migration of chemicals, such as pharmacological active agents or excipients, between the product and the film. Thus, the films are anti-scalping films. In a packaged product, the anti-scalping layer can be in contact with the pharmaceutical active agent. As used herein, 'in contact with the pharmaceutical active agent,' in the context of a layer of a film, means that under typical storage conditions some portion of the active agent will contact the layer. The active agent may be in direct contact with the product contacting layer or may be in indirect contact with the layer. Indirect contact between the active agent and the product contacting layer can occur, for example, due to volatilization of the active agent or an active agent carrier within the package to cause the active agent, which is not stored in direct contact with the product contacting layer, to contact the layer. However, even if the active agent is not in contact with the sealing layer, it may be desirable for the sealing layer to be anti-scalping to provide assurance that if an active agent accidentally became exposed to the sealing layer, the sealing layer would not substantially scalp the active agent.
"The product contacting layers of the films described herein include at least 90 wt. % of an ethylene norbornene copolymer having a glass transition temperature in a range from 50.degree. C. to 138.degree. C. Layers having such properties were found to resist migration of nicotine and fentanyl. These results were unexpected because ethylene norbornene copolymers, like polyethylene, are polyolefins, and because polyethylene has been previously shown to have poor anti-scalping properties.
"Polymers are typically compared based on their polymer classification. Accordingly, because polyethylene was determined to be a poor choice for an anti-scalping film or layer, other polyolefins would be expected to be poor choices as well. These expectations were bolstered by the fact that cyclic olefin copolymers (COCs), such as ethylene norbornene copolymers, perform similarly to linear low density polyethylene with regard to d-limonene. See, for example, 2005 PLACE Conference, September 27-29, Las Vegas, Nev., slide show entitled 'TOPAS.RTM. Cyclic Olefin Copolymers in Food PackagingHigh Aroma Barrier Combined with Low Extractables, presented by Randy Jester, slide 10, available at http://www.slideshare.net/TopasAdvancedPolymers/aroma-barrier-web, which states, 'Scalping of d-Limonene by COC is similar to that of LLDPE, indicating that the solubility of d-Limonene in COC is similar to that of LLDPE.'. That is, COCs and linear low density polyethylene were determined to have poor anti-scalping performance with regard to d-limonene.
"Following the unexpectedly good anti-scalping properties COCs as described herein with regard to nicotine and fentanyl, the anti-scalping properties of COCs with regard to other active pharmaceutical agents were evaluated to identify whether COCs may be useful as anti-scalping films or layers for these other active agents and to attempt to identify whether certain parameters can be used to predict whether COCs would be effective anti-scalping layers.
"Without intending to be bound by theory, it is now believed that a combination of Hansen Solubility Parameter (HSP) of the pharmaceutical active agent and a film or layer comprising the ethylene norbornene copolymer and the glass transition temperature of the film or layer can be used to predict whether an ethylene norbornene copolymer film will have a suitable anti-scalping properties for a given pharmaceutical active agent.
"In various embodiments, the pharmaceutical active agent has a HSP for the film or layer of 0.5 or greater and has a glass transition temperature of 50.degree. C. or greater. The HSP is preferably 0.6 or greater, such as 0.7 or greater, 0.8 or greater, 0.9 or greater, or 1 or greater. Preferably, the glass transition temperature is 55.degree. C. or greater, such as 60.degree. C. or greater, or 65.degree. C. or greater. In various embodiments, the glass transition temperature is 138.degree. C. or less, such as 110.degree. C. or less.
"In some embodiments, the pharmaceutical active agent is selected from the group consisting of fentanyl, nicotine, lidocaine, estradiol, clonidine, ethinyl estradiol, oxybutynin, buprenorphine, granisitron, methylphenidate, and scopolamine.
"In some embodiments, a flexible, multilayer packaging film suitable for packaging an article for collecting or administering a physiologically active substance such as transdermal drug delivery patches, oral dissolvable thin strips, and disposable, microfluidic test cassettes is provided having: (a) an article contact layer having at least 90 wt. % of a norbornene ethylene copolymer and a glass transition temperature of from 65 to 110.degree. C.; (b) a poly olefin bulk layer; a first intermediate adhesive layer; (d) an oxygen barrier layer having an oxygen transmission rate of less than less than 0.01 cm3/100 inches2/24 hours at 1 atmosphere and 23.degree. C.; (e) a second intermediate adhesive layer; and (f) an exterior protective layer comprising a polymer selected from the group consisting of amorphous polyester, polyamide, polyolefin, nylon, polypropylene, or copolymers, or blends thereof; wherein said multilayer film has the following properties: a WVTR of less than 0.01 g/100 inches.sup.2 per 24 hours at Room Temperature (RT) (23.degree. C.) and 1 atmosphere; and a thickness of 10 mil or less."
URL and more information on this patent application, see: Riis, Jennifer L.; Liu, Yuan; McMillan, Lyndsey A.; Osborn, Christopher L.; Jain, Rishabh. Anti-Scalping Pharmaceutical Packaging Film. Filed February 10, 2015 and posted June 29, 2017. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO1&Sect2=HITOFF&d=PG01&p=1&u=%2Fnetahtml%2FPTO%2Fsrchnum.html&r=1&f=G&l=50&s1=%2220170174405%22.PGNR.&OS=DN/20170174405&RS=DN/20170174405
Keywords for this news article include: Biotechnology, Alkenes, Patents, Fentanyl, Polyenes, Hydrocarbons, Polyethylenes, Organic Chemicals, Drugs and Therapies, Narcotic Analgesics, Transdermal Delivery, Drug Delivery Systems, Central Nervous System Agents.
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