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( N Am Am Pm Vpm 17 16 US 20090202635A1 (19) United States (12) Patent Application Publication (10) Pub. No.: US 2009/0202635 A1 Scott (43) Pub. Date: Aug. 13, 2009 (54) DELIVERY SYSTEM, APPLICATION, AND Publication Classification METHOD (51) Int. Cl. (76) Inventor: Stephen Michael Scott, Tampa, FL A6IR 9/12 (2006.01) (US) A69/20 (2006.01) Correspondence Address: STEPHEN M. SCOTT (52) U.S. Cl. ............................ 424/468; 424/464; 424/45 515 BOSPHORUS AVE TAMPA, FL 33606 (US) (21) Appl. No.: 12/361,863 (57) ABSTRACT (22) Filed: Jan. 29, 2009 A sequenced biologically compatible delivery system, appli cation, and method is provided, which increases therapeutic Related U.S. Application Data care of animals by conveniently and effectively Supplying (60) Provisional application No. 61/027,265, filed on Feb. meticulous administration plans requiring sequential admin 8, 2008. istration of varying biologically active agents. 14 15 1 O 16 22 ( N AM AM PM VPM 17 16 88: SH: 8 21 2O 9 Patent Application Publication Aug. 13, 2009 Sheet 1 of 10 US 2009/0202635 A1 ( N AM AM PM VPM II 88: 888 21 2 O 9 Patent Application Publication Aug. 13, 2009 Sheet 2 of 10 US 2009/0202635 A1 F.G. 2A FIG. 2C-2G 30.3 32 3334 3. |Niles (III OOOOOOOss 'eofooooo.OOOOOOO 4 O 36 3. Coolooloo 38 37 3 O FIG. 2B 3. FIG. IIC Patent Application Publication Aug. 13, 2009 Sheet 3 of 10 US 2009/0202635 A1 FIG. 38 37 43 30 FIG. 2G Patent Application Publication Aug. 13, 2009 Sheet 4 of 10 US 2009/0202635 A1 FIG. 3 C FIG 3D 31 36 33 , FIG 3E FIG 3F in3 O 42 FIG. 3 G 3 O 43 ur. 3 O 44 3. Patent Application Publication Aug. 13, 2009 Sheet 5 of 10 US 2009/0202635 A1 FIG. 4A 53 F.G. 4B 6 O 62 63 54 FIG. 4B 6 53 3 53 EY My Patent Application Publication Aug. 13, 2009 Sheet 6 of 10 US 2009/0202635 A1 FIG. 5A 70 71 72 73 74 75 (1 YZZY(64 WOOO of OO --T I I Patent Application Publication Aug. 13, 2009 Sheet 7 of 10 US 2009/0202635 A1 FIG. 7A Patent Application Publication Aug. 13, 2009 Sheet 8 of 10 US 2009/0202635 A1 FIG. 8A 136 1.37 41 Patent Application Publication Aug. 13, 2009 Sheet 9 of 10 US 2009/0202635 A1 FIG. 9A FIG. 9C 152 153 154 151. 15 O N () () ( FIG 9D Patent Application Publication Aug. 13, 2009 Sheet 10 of 10 US 2009/0202635 A1 FIG 1 O 61 1.65 164 US 2009/0202635 A1 Aug. 13, 2009 DELIVERY SYSTEM, APPLICATION, AND 0010. In addition, there is a delay between the time of oral METHOD administration and the time that the therapeutic effect begins, and this delay is often substantial. Where rapid turnover of BACKGROUND OF THE PRESENT INVENTION users is essential Substantial delays are unacceptable. 0001 Administration plans for medications or other 0011. Another problem with administration by swallow agents for those with special therapeutic requirements require ing is variation of the active agents in the bloodstream from an improved delivery system, application, and method for user to user. This variation depends on the action of the meticulous administration plans to assist users in proper stomach, the Small and the large intestines, the effects of the therapeutic care, and to provide for monitoring of therapeutic secretions of these organs, the pH within these organs, and care and track compliance with the meticulous administration finally the rate of absorption into the bloodstream. plans. It is well documented that various groups of users do 0012. In addition, administrations are often for use with an not follow administration plans, including the elderly, the average user. The result may be underdosing or overdosing infirm, children, and those who are otherwise alert, but are a particular user. pre-occupied. The meticulous administration plan must be followed precisely because user errors can prevent efficacy 0013. In addition, administration by swallowing routes and create health risks. active agents into the bloodstream via a first pass through the 0002 Manythin edible films may be used to deliver medi liver. More than sixty percent of most biologically active caments or other agents to a target bodily cavity or area as it agents (and essentially one hundred percent of certain bio has been known to administer biologically active agents in an logically active agents) are removed by the liver during this edible film vehicle. first pass. 0003 U.S. Pat. Nos. 7,132,113, 7,067,116, 7,025,983, 0014. The result is that swallowing is impractical for many 5,948,430, 5,700,478, 5,411,945, 5,047,244, 4,900,552, biologically active agents as the above described factors can 4,876,092 describe films allowing the release of a biologi prevent or reduce efficacy. cally active agent. 0015. As an alternative, injection is frequently used, 0004 Similarly, WO 99/17753, WO 98/26780, WO allowing the biologically active agent to become rapidly dis 98/20862, WO 98/26763, EPO 200508 B1, EP0381 194 B1, tributed to various portions of the user's body before exposure CA 1263. 312, DE 2449 865.5, DE 3630 603, EPO 219 762, to the liver. Injections are comparatively inconvenient, pain EP0452466 B1 disclose films that release biologically active ful, and costly. agents that are incorporated in the product. 0016. Alternatively, administration through the buccal 0005. These disclosures are deficient in several respects mucosa of the cheek pouch or by Sublingual administration is when considered in meticulous administration plans. First, suggested, for example U.S. Pat. No. 4,671,953. Administra they are limited in the quantity of actives that can be delivered tion of therapeutic agents through the mucosal tissues of the by the relatively thin cross-section practical in production and mouth, pharynx, and esophagus offers advantages. The bio consumption of thin films. Second, they provide only a single logically active agent is not exposed to the gastric and intes composition of any active agent. Finally, they provide no tinal digestive juices. In addition, the biologically active effective monitoring means for users or monitors to track agents bypass the liver and are not immediately initially compliance. metabolized and inactivated. 0006. These preparations and methods also do not allow for sequential administration of differentformulations of bio 0017. Another problem is user errors. Improper adminis logically active agents from a common biologically compat tration of prescriptions occurs in about 30% to 50% of all ible carrier. They propose mono-product, homogenous deliv users. (See Libow et al.) In addition, 50% of acute care users ery carriers that fail to provide a wide variety of biologically do not comply with their administration plan. (See Parkinet active agents from a common biologically compatible carrier. al.) Further, administration errors often produce illness. (See Further their innate geometries allow only for relatively low Seidl et al.) Finally, elderly users revealed 2.3 serious errors administration amounts of a single composition of active per user among 25%, while about 59% overall error in their agent. administrations. (See Schwartz et al.) 0007. Therefor, these prior administrative forms known in 0018 Packages which are used to improve user compli the art fail to provide for sequential administration of differ ance with administration plans have been previously dis ent formulations of biologically active agents from a common closed. biologically compatible carrier, and cannot provide adequate (0019 U.S. Pat. No. 6,951,353 proposes an administration amounts of active agent in all cases. management system that includes a card or overlay with 0008 Another problem is solid administration forms. Oral raised tabs that are pressed down after a pill is taken. U.S. Pat. administration by Swallowing Solid forms is a prevalent No. 5,261,702 proposes a system that includes a chart. U.S. method of administration. Oral administration is often pre Pat. No. 4,815,767 is illustrative of a chart system for use in ferred because it is convenient, comfortable, painless, and assisting a user in tracking an administrations plan. simple to accomplish for many users. 0020 Examples of blister packages for organizing admin 0009. However, administration by Swallowing suffers istrations are set forth in U.S. Pat. Nos. 7,000,769, 6,375,956, from several disadvantages. One disadvantage is that pediat 3,905,479.; 3,912,082; 3,924,747; 3,835,995; 3,912,081; ric and geriatric users frequently have difficulty Swallowing 3,924,746; 3,809,220; 3,809,221; 3,811,564; 3,872,970; pills and other solid forms. Such users find swallowing liquid 3,899,080; 3,921,805; and 3,941,248. administrations inconvenient. Swallowing often requires flu 0021. Similarly, WO 01/07012, WO 98/22072, Great Brit ids and increases gastric Volume, increasing the incidence of ain Patent No. 2 228 922 disclose examples of blister pack nausea and Vomiting. ageS. US 2009/0202635 A1 Aug. 13, 2009 0022 U.S. Pat. Nos. 5,788,974, 5,695,063, 5,624,036, 0031 Despite the existence of homogeneous films, mono 5,358,118, 5,325,968, 5,310,060, 4,958,736, 4,889,236, product, and multi-product blister packs in the prior art, there 4.295.567 disclose other packages for organizing administra is need for new compositions, applications, and methods for tions. making them. 0023 These proposals include combining various biologi 0032. Thus, there is a need for delivery a system for bio cally active agents, various dosage forms, and various admin logically active agents, and applications therefor, and meth ods therefor, that do not suffer from the foregoing disadvan istrations in various packaging.
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