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That the Tout Untuk Ta in an Area Maria Mai Mari Chanthi THATTHE TOUT UNTUK TAUS IN20170304150A1 AN AREA MARIA MAI MARI CHANTHI ( 19) United States (12 ) Patent Application Publication ( 10) Pub . No. : US 2017/ 0304150 A1 Gumudavelli et al. ( 43 ) Pub . Date: Oct. 26 , 2017 ( 54 ) STABLE PACKAGING SYSTEM FOR A61K 31/ 22 ( 2006 . 01 ) MOISTURE AND OXYGEN SENSITIVE B01J 20 / 10 (2006 .01 ) PHARMACEUTICAL DOSAGE FORMS A61K 47 / 02 ( 2006 .01 ) B65D 81 / 26 (2006 .01 ) ( 71) Applicant: Ascent Pharmaceuticals , Inc ., B65D 75 / 36 ( 2006 .01 ) Hauppauge , NY (US ) (52 ) U . S . CI. CPC . .. .. .. A61 ) 1 /035 (2013 .01 ) ; B650 81/ 268 ( 72 ) Inventors : Sridhar Gumudavelli, Hauppauge, NY ( 2013 .01 ) ; B650 81/ 264 ( 2013 .01 ) ; B650 (US ) ; Sudhakar Vidiyala , Hauppauge , 75 / 368 ( 2013 .01 ) ; A61K 31/ 22 ( 2013 .01 ) ; NY (US ) ; Madhava Reddy , B01J 20 / 103 ( 2013 .01 ) ; A61K 47 /02 Hauppauge , NY (US ) ( 2013 .01 ) ; A61K 31 /352 (2013 .01 ) ; B01J ( 21 ) Appl. No. : 15 /490 ,216 2220 / 66 (2013 .01 ) (22 ) Filed : Apr. 18 , 2017 (57 ) ABSTRACT Related U . S . Application Data The invention describes a blister packaging system , and method of making the system , capable of establishing and (60 ) Provisional application No . 62/ 324 ,472 , filed on Apr. maintaining arid and anaerobic conditions for packaging 19 , 2016 . pharmaceutical products that are sensitive to oxygen and /or moisture . The blister packaging system encompasses , for Publication Classification example , a scaffold of several interconnected cavities (51 ) Int . Cl. intended for product and one or more reservoirs comprising A61 ) 1 /03 ( 2006 .01 ) an oxygen scavenger and /or a desiccant. Furthermore , the B650 81 / 26 ( 2006 . 01) concentration of the components is maintained at a level that A61K 31 /352 ( 2006 .01 ) prevents establishment of equilibrium conditions. Channel Drug Product Cavity Drug product Patent Application Publication Oct. 26 , 2017 US 2017 / 0304150 A1 Figure 1 Channel Drug Product Cavity * ** * Drug product Desiccant / Scavenger US 2017 /0304150 A1 Oct. 26 , 2017 STABLE PACKAGING SYSTEM FOR invention provides a package wherein the oxygen scavenger MOISTURE AND OXYGEN SENSITIVE is selected from the group consisting of organic , inorganic , PHARMACEUTICAL DOSAGE FORMS metallic , non -metallic , and enzymatic in nature . The inven tion provides a package where in the desiccants is selected [ 0001] This application claims the benefit of U . S . Provi from the group consisting of organic desiccants , inorganic sional Application Ser . No. 62 /324 , 472 , filed Apr. 19, 2016 , desiccants , uncoated polymers , coated adsorbent polymers , the entirety of which is incorporated herein by reference . and combinations thereof . The invention provides a package wherein the frangible lidding has moisture barrier proper BACKGROUND OF THE INVENTION ties . [0002 ] The present invention describes a blister packaging [0007 ] The invention provides a blister package for an system , and method of making the system , capable of oxygen and / or moisture sensitive pharmaceutical product establishing and maintaining arid and anaerobic conditions comprising: ( i) a shaped film comprising : ( A ) a plurality of for packaging pharmaceutical products that are sensitive to cavities configured to each hold a single unit dose of the oxygen and /or moisture . The blister packaging system pharmaceutical product , and ( B ) at least one airflow channel , encompasses, for example , a scaffold of several intercon and ( C ) at least one reservoir ; wherein the at least one nected cavities intended for product and one or more reser airflow channel connects each of the plurality of cavities to voirs comprising an oxygen scavenger and / or a desiccant . the at least one reservoir ; ( ii ) a frangible lidding sealed to the Furthermore , the concentration of the components is main shaped film so that the unit dose is substantially confined tained at a level that prevents establishment of equilibrium between said frangible lidding and said at least one cavity ; conditions . ( iii ) an absorbent confined between the reservoir and the [0003 ] All references cited herein are incorporated herein frangible lidding ; ( iii ) optionally a backing film ; and ( iv ) by reference in their entireties . single unit doses of an oxygen and/ or moisture sensitive pharmaceutical product confined between the cavities and BRIEF SUMMARY OF THE INVENTION the frangible lidding . The invention provides a package [ 0004 ] The invention provides a packaging system for a wherein the absorbent comprises a desiccant and an oxygen pharmaceutical product that is sensitive to oxygen and / or absorber, wherein the desiccant is selected from the group moisture comprising : a blister pack comprising: (i ) a blister consisting of silica gel , clay desiccants , calcium sulfate , sheet comprising of an array of interconnected cavities calcium chloride, calcium oxide , zeolite , activated alumina , connected through channels that allows the exchange of air activated charcoal, and combinations thereof, and the oxy between them ; (ii ) wherein one ormore of the cavities serve gen absorber is selected from the group consisting of iron as a reservoirs holding an oxygen scavenger and / or a des oxidase , glucose oxidase , sodium sulfate , potassium chlo iccant at concentrations high enough to provide higher ride , ammonium chloride , ammonium sulfate , calcium chlo equilibration time for oxygen and / or moisture ; ( iii ) further ride , sodium phosphate , calcium phosphate , magnesium wherein one or more of the cavities comprise at least one chloride , and combinations thereof. pharmaceutical product that is sensitive to oxygen and / or [0008 ] The invention provides a package wherein the moisture ; and ( iii ) a frangible lidding sealed to the sheet absorbent comprises a moisture sensitive color indicator to protecting the product in the cavity . The invention provides indicate when the desiccant is no longer operable. The a package wherein the pharmaceutical product contains an invention provides a package wherein the cavities are inter active that comprises at least one amine as a part of chemical connected by airflow channels . The invention provides a groups . The invention provides a package , where in the package wherein the pharmaceutical product is selected pharmaceutical products is an active that is selected from the from the group consisting of morphine , hydromorphone , group consisting of cannabinoids, drobinol, dronabinol, promethazine , dopamine , epinephrine , norepinephrine , 8 - tetrahydrocannabinol, cannabidiol, and combinations esterified estrogen , ephedrine , pseudoephedrine , acetamino thereof. phen , ibuprofen , danofloxacin , erythromycin , penicillin , [ 0005 ] The invention provides a package, wherein the cyclosporine , methyldopate , cetirizine, diltiazem , vera pharmaceutical product is selected from the group consisting pamil , mexiletine , chlorothiazide , carbamazepine , selegi of statins , lovastatin , simvastatin , fluvastatin , atorvastatin , line , oxybutynin , vitamin A , vitamin B , vitamin C , L - cys pitavastatin , and combinations thereof. The invention pro teine, L - tryptophan , and combinations thereof. The vides a package , wherein the pharmaceutical product is invention provides a package wherein the shaped film com selected from the group consisting ofmorphine , hydromor prises polyvinyl chloride , polyvinylidene chloride , polycar phone , promethazine , dopamine , epinephrine , norepineph bonate , polyester , copolyester , acrylonitrile , low density rine, esterified estrogen , ephedrine , pseudoephedrine , acet polyethylene , polypropylene , or a combination thereof . The aminophen , ibuprofen , danofloxacin , erythromycin , invention provides a package wherein an active pharmaceu penicillin , cyclosporine, methyldopate , cetirizine , diltiazem , tical ingredient in the pharmaceutical product is an active verapamil , mexiletine , chlorothiazide , carbamazepine , sele that is selected from the group consisting of cannabinoids , giline, oxybutynin , vitamin A , vitamin B , vitamin C , L -cys drobinol, dronabinol, d - tetrahydrocannabinol, cannabidiol, teine , L - tryptophan , and combinations thereof. statins, lovastatin , simvastatin , fluvastatin , atorvastatin , [ 0006 ] The invention provides a package wherein the pitavastatin , and combinations thereof. blister sheet that has light and moisture protectant proper ties . The invention provides a package wherein the blister BRIEF DESCRIPTION OF SEVERAL VIEWS OF sheet is made ofmaterials selected from the group consisting THE DRAWINGS of polyvinylchloride , polyvinylidene chloride , polycarbon [ 0009 ] The invention will be described in conjunction with ate , polyester, copolyester , acrylonitrile , low density poly - the following drawings in which like reference numerals ethylene, polypropylene , and combinations thereof. The designate like elements and wherein : US 2017 /0304150 A1 Oct. 26 , 2017 [ 0010 ] FIG . 1 shows an orthogonal view of an example of subject is an elderly human . In another embodiment, the the blister pack component of the packaging system . subject is a human adult . In another embodiment, the subject is a human child . In yet another embodiment, the subject is DETAILED DESCRIPTION OF THE a human infant . INVENTION [ 0016 ] As used herein , the phrase " pharmaceutically [ 0011 ] The present invention describes a blister packaging acceptable ” means approved by a regulatory agency of the system capable of establishing and maintaining arid and
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