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Disintegrable oral filmsRelated Patent Categories: Drug, Bio-affecting And Body Treating Compositions, Chewing Gum TypeDisintegrable oral films description/claimsThe Patent Description & Claims data below is from USPTO Patent Application 20070202057, Disintegrable oral films. Brief Patent Description - Full Patent Description - Patent Application Claims
[0001] This application claims the benefit of U.S. Provisional Application No. 60/774,592, filed Feb. 17, 2006. [0002] The present invention relates to disintegrable oral films for the delivery and release of an active agent into the oral cavity. According to certain embodiments, the invention relates to a slow disintegrating oral film containing a nicotine active for delivery and release into the oral cavity. The slow disintegrating oral film maximizes the absorption of the nicotine active through the oral mucosa to alleviate cravings for nicotine. BACKGROUND [0003] Smoking of tobacco products, such as cigarettes, cigars, and pipe tobacco, presents serious health risks to the tobacco user. Additionally, the use of smoke-less tobacco products, such as chewing tobacco (both short and broad leaf tobacco) and snuff, can also result in serious health risks to the user. [0004] While the serious health risks associated with the use of tobacco products are well documented and widely publicized, many habitual users are unable to quit using the tobacco products. The inability to quit using tobacco products can be primarily attributed to the fact that the user has developed a dependence on the nicotine that is present in the tobacco products. The dependence on nicotine manifests itself as nicotine cravings. Accordingly, a nicotine addicted tobacco user must continually use tobacco products to replenish the amount of nicotine in the blood, thereby satisfying the nicotine craving. [0005] In order to successfully quit using tobacco products, the nicotine addicted tobacco user must overcome the nicotine cravings, thereby diminishing the desire to use tobacco products. Certain nicotine replacement therapies have been developed to assist the habitual tobacco user to quit using tobacco products. These nicotine replacement therapies attempt to temporarily replace some of the nicotine in the blood that is lost when a habitual user quits using tobacco products. [0006] Nicotine replacement therapies have been developed and are provided in a variety of product forms. Such nicotine replacement products include, for example, nicotine containing gums, nicotine containing inhalers, nicotine containing transdermal patches, nicotine containing lozenges, and nicotine containing lollipops. Nicotine containing gums, lozenges and patches have enjoyed substantial commercial success. [0007] One commercially available nicotine containing gum product is available under the trademark NICORETTE. The nicotine containing gums are generally supplied as individual pieces of chewable gum. The user removes an individual piece of the nicotine containing gum from the package and places it into the oral cavity. While the user is chewing the gum, nicotine is released from the gum and is absorbed by the oral mucosa. The nicotine containing gums, however, must be used at regular intervals in order to maintain steady levels of nicotine in the blood. [0008] Nicotine containing gums may be used to relieve acute cravings experienced by a tobacco user that is attempting to quit smoking or smoke-less tobacco product use. For example, a single piece of gum may be self-administered by an individual in response to an acute nicotine craving. Such use of the nicotine gum typically results in an increase in blood nicotine levels to counteract the nicotine cravings. The tobacco user must repeatedly self-administer nicotine containing gums to maintain steady nicotine levels in the blood. [0009] Commercially available nicotine containing transdermal patches include, for example, NICODERM, NICOTROL, and HABITROL. The nicotine transdermal patches are generally supplied as a patch having an adhesive backing covered by a release liner to protect the adhesive. The user of the patch removes the release liner from the patch to expose the adhesive backing. The adhesive backing is then applied to a suitable location on the dermis of the user, thereby adhering the patch to the user. Over time, nicotine is released from the patch and diffuses through the dermis and into the blood. The nicotine containing transdermal patches are useful for maintaining relatively steady blood level concentrations over time by providing the user with a substantially continuous infusion of nicotine while the patch is being worn. [0010] Nicotine containing lozenges may be utilized in a similar manner as nicotine containing gums to provide relief from acute nicotine cravings. Commercially available nicotine containing lozenges include, for example, those lozenges sold under the trademarks COMMITS, STOPPERS, NIQUITIN, and NICOTINELLS. Similar to the nicotine containing gums, a tobacco user, instead of choosing to use a tobacco product, may self-administer a nicotine containing lozenge to alleviate a nicotine craving. [0011] While commercially available nicotine replacement products provide some level of alleviation of both steady and acute tobacco cravings, there is still an ongoing need to provide more effective craving relief and to assist the tobacco user in quitting use of the tobacco products. [0012] Films for delivering a pharmacologically or cosmetically active agent via the oral cavity have been developed. The films generally comprise water soluble films that disintegrate in the oral cavity and release the active agent that is incorporated the film. Nicotine has been incorporated into water soluble films, which upon disintegration of the film, releases nicotine into the oral cavity. The prior art has focused on water soluble thin films for achieving rapid disintegration or dissolution in the oral cavity, in order to alleviate acute nicotine cravings. For these rapidly disintegrating films, studies estimate that systemic absorption of the nicotine active is merely 25% of the total amount of the nicotine active initially present in the oral film dosage unit. This low level of absorption of the nicotine active through the oral mucosa can be directly attributed to the rapid disintegration of the oral film, which does not permit sufficient time for mucosal permeation. Thus, the vast majority of the nicotine active present in the oral film is simply swallowed. [0013] The prior art nicotine containing oral films, however, do not address the difficulty associated with maximizing absorption of the nicotine active through the oral mucosa. Thus, there remains a need in the art for a slower disintegrating oral film that disintegrates at a rate that maximizes the absorption of the nicotine active through the oral mucosa, which thereby effectively delivers a dose of nicotine active to a user in a sufficient amount to reduce or eliminate nicotine cravings associated with the cessation of tobacco usage. SUMMARY [0014] An oral film for delivering and releasing an active agent into the oral cavity is provided. The composition of the oral film provides a mucoadhesive film having a delayed or slow disintegration and release of active agent from the film. The rate of disintegration of the film and release of the active agent from the film within the conditions of the oral cavity maximizes the absorption of the active agent through the oral mucosa. [0015] According to certain embodiments, said oral film comprises at least about 45 weight percent of at least one water soluble film forming polymer, based on the weight of the dry film, and an active agent. [0016] According to other embodiments, the oral film comprises a mixture of a polyalkylene oxide and a cellulose polymer, wherein the ratio of said polyalkylene oxide to said cellulose polymer present in said film is about 1:2 to about 1:5, and an active agent. [0017] According to further embodiments, the oral film comprises at least one water soluble film forming polymer and an active agent, wherein said oral film maintains at least partial integrity and active agent release capability after in vitro exposure to artificial human saliva solution for at least 15 minutes. [0018] A method for preparing a slow disintegrating oral film from at least one water soluble film forming polymer and an active agent is provided. [0019] According to certain embodiments, the method for preparing a slow disintegrating oral film comprises mixing together at least one water soluble film forming polymer, an active agent and a solvent to form a mixture; and forming a film from the mixture, wherein said film comprises at least 45 weight percent of said at least one water soluble film forming polymer, based on the total weight of the dry film. [0020] According to other embodiments, the method for preparing a slow disintegrating oral film comprises mixing together at least one polyalkylene oxide polymer, at least one cellulose polymer, and an active agent to form a mixture; and forming a film from the mixture, wherein the ratio of said polyalkylene oxide polymer to said cellulose polymer present in said dry film is about 1:2 to about 1:5 (wt/wt). [0021] According to further embodiments, the method for preparing a slow disintegrating oral film comprises mixing together at least one water soluble film forming polymer and an active agent to form a mixture; and forming a film from the mixture, wherein said oral film maintains at least partial integrity and active agent release capability after in vitro exposure to artificial human saliva solution for at least 15 minutes. [0022] A method of using a slow disintegrating oral film to administer an effective amount of an active agent to the oral cavity is further provided. Continue reading about Disintegrable oral films... Full patent description for Disintegrable oral films Brief Patent Description - Full Patent Description - Patent Application Claims Click on the above for other options relating to this Disintegrable oral films patent application. ###  How KEYWORD MONITOR works... a FREE service from FreshPatents1. Sign up (takes 30 seconds). 2. Fill in the keywords to be monitored. 3. Each week you receive an email with patent applications related to your keywords. Start now! - Receive info on patent apps like Disintegrable oral films or other areas of interest. ### Previous Patent Application: Pharmaceutical formulations for dry powder inhalers comprising a low-dosage strength active ingredient Next Patent Application: Oral composition for improving mouth environment Industry Class: Drug, bio-affecting and body treating compositions ### FreshPatents.com Support Thank you for viewing the Disintegrable oral films patent info. IP-related news and info Results in 0.13721 seconds Other interesting Feshpatents.com categories: Daimler Chrysler , DirecTV , Exxonmobil Chemical Company , Goodyear , Intel , Kyocera Wireless , 174 |
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