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6/29/2017
`
`Tiny patch 'dots' pharmaceutical iandscape | Packaging World
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`
`ARTICLE | DECEMBER 31,1999
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`Noven Pharmaceuticals employs a new cartoner to help introduce an estrogen replacement
`therapy patch sold to pharmacies and merchandised free as physician samples.
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` 
`
`By Jim Butschli, Features Editor
`It's not unusual to see people use transdermal patches to stop
`smoking or to relieve angina. However, this "through-the-skin"
`dosing option is not as well-known for helping women cope
`with menopausal symptoms, though such estrogen
`replacement therapy (ERT) patches have been available since
`the 1970s. With last May's launch of Vive lie-Dot™, Noven
`Pharmaceuticals hopes to change that.
`
`FILEDIN: Machinery > Inspection > Checkweighers
`
`Print Email Share
`
`w v*
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`I to-
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`H.
`
`Noven uses a makeup "compacf'-shaped folding carton,
`printed with usage instructions and feminine color schemes to
`not only make the package more appealing to women, but also to ensure that product application and usage is
`understandable.
`
`MYLAN - EXHIBIT 102 j
`/12
`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
`

`

`6/29/2017
`Tiny patch 'dots' pharmaceutical landscape | Packaging World
`A cartoner from R.A. Jones (Cincinnati, OH) is equipped with a Videojet 270i ink-jet printer from newly renamed
`Marconi Data Systems (Wood Dale, IL), that prints Lot and expiration date codes onto carton end flaps.
`
`These inner cartons are then manually loaded into one of two different outer folding cartons. One carton is used
`for sales to pharmacies where the product is sold by prescription only. Another carton is used to ship samples to
`physicians who can offer Vivelle-Dot to appropriate patients. Both the outer and inner folding cartons come from
`Vista Color (Miami, FL).
`
`Vivelle-Dot is manufactured and packaged at Noven Pharmaceuticals' Miami, FL, facility, an FDA-approved facility
`that follows cGMP guidelines. Noven and Novartis Pharmaceuticals Corp. of East Hanover, NJ, formed a joint
`venture, Novogyne Pharmaceuticals, to market Vivelle-Dot and other women's health products.
`
`Producing pouches
`
`That material is rewound and slit into 6"- or 8"-W rolls to accommodate downstream packaging equipment. Rolls
`are wrapped in film and foil to prevent debris from contacting the product as pallet loads of it are moved by forklift
`to the warehouse. The rolls are threaded through one of three horizontal die-cutting and pouching machines that
`have been running since the late '80s.
`
`The machines package a postage-stamp-sized patch between an upper and lower film web supplied by RJR
`Packaging (Winston-Salem, NC). The adhesive-lamination for both rolls consists of 26# paper/4# low-density
`polyethylene/0.0055 aluminum foil/11# LDPE. The material is heat-sealed on four sides, with cuts made between
`seal areas to create individual pouches. A lot and expiration date (two years from the blending date) are debossed
`into the seal area of the pouch.
`
`Pouches are then conveyed past a checkweigher. Before they're loaded into corrugated cases, quality assurance
`personnel inspect representative samples to confirm compliance to pouched product integrity. Once approved,
`pallet loads of case-packed pouches are brought to what's called a "cartoning suite," where individual pouches are
`automatically cartoned on the R.A. Jones machine.
`
`Bought in '98
`
`"We acquired the machine in 1998," says Huda Midani, Noven's project manager of operations. "It did not replace
`another machine. Instead, it was purchased to handle another hormone therapy patch. We also use it for the
`Vivelle-Dot product line. We run about 60n cartons a day on it," she notes, "at speeds of 100 to 120 per minute.
`The machine has done very well for us."
`
`Midani says, "When we were looking for a cartoner, we had choices, but we looked for a company with an excellent
`track record and the best available product."
`
`The product is made by Noven's Dot-Matrix™ technology, a process that blends adhesives with estradiol, the
`synthetic form of the estrogen hormone that's used to counter symptoms such as hot flashes and night sweats.
`That solution is blended, then coated onto a film release liner. Solvents from the adhesive are removed during the
`process, leaving behind a plasma-like substance rather than a liquid. The adhesive side of the product is then
`laminated to a coextruded plastic backing.
`
`
`
 
     
      
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 !
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`  
   
`"
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   " 

`
`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
` 
`
`2/12
`
`

`

`6/29/2017
`Tiny patch 'dots' pharmaceutical landscape | Packaging World
`The ink-jet coder on the cartoner prints Lot and expiration date onto an end flap of the individual folding carton
`(IFC). From Vista Color, the CIS, 18-pt SBS carton is offset-printed in three colors plus varnish.
`
`Different configurations
`
`For physician samples, the cartoner loads two patches/carton. "That's one week's supply," says Natalie Rajcoomar,
`product manager, marketing and sales. For pharmacies, eight patches (one month's worth) are packed into the IFC.
`
`"We use the same carton for either two patches or eight for different reasons," Midani explains. "When the
`physician or nurse gives the carton with two patches to the patient, we want to familiarize the consumer with the
`package that she would receive from the pharmacy.
`
`"We also want her to know that when she opens the main carton flap she'll see the compliance 'calendar' that's
`printed on the inside flap," she continues. "This calendar has check boxes that list two days of the week, such as
`Sun/Wed, so that the woman checks the date she first applied the patch, say on a Sunday, and can see that she'll
`need to remove that patch and replace it with a new one on Wednesday."
`
`Using the same IFC for both markets has advantages for Noven that go beyond familiarizing users with the package
`and assisting them with compliance issues. "From a packaging perspective, we wanted to keep our changeovers on
`the Jones machine to a minimum," Midani says. "If we maintain a package size that's consistent, it requires fewer
`machine adjustments. That results in greater operating efficiencies and less downtime."
`
`After the machine erects the carton and tucks in the end flaps of one carton side, it loads the pouches into the
`carton. A friction feeder from Longford Equipment (Scarborough, Ontario, Canada) dispenses two printed, folded
`and glued paper inserts into the IFC. Then the R.A. Jones machine closes the end flaps. One insert is a physician's
`insert that carries information such as the product's chemical name; the other provides product information such as
`application instructions for the end user. Both inserts are required by FDA.
`
`
`
 
     
      
`  
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`´¹ƒN‘€ƒN}~ƒN€{ŽƒN{‚}wyNw‚Nƒ}~ƒ‚N}xwN‰{}~ƒ€Nw‚NƒŠ~}Nw‚N|ƒ‚ƒy}N‚ƒ{€wy€„µN¤|{yNƒ÷‰z{y€”N´¹~ƒyN}~ƒ
`‰~›€{yNw‚Ny‘‚€ƒNŠ“ƒ€N}~ƒN{‚}wyNx}~N}xwN‰{}~ƒ€N}wN}~ƒN‰{}ƒy}„NxƒNx{y}N}wN{Žz{‚ýƒN}~ƒNwy€‘Žƒ‚Nx}~N}~ƒ
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`
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`}~ƒNówyƒ€NŽ{~yƒN}wN{NŽyŽ‘Ž„µN¤|{yN€{›€”N´ŸNxƒNŽ{y}{yN{N‰{{ŠƒN€ýƒN}~{}²€Nwy€€}ƒy}„N}N‚ƒõ‘‚ƒ€Nƒxƒ‚
`Ž{~yƒN{|‘€}Žƒy}€”Nž~{}N‚ƒ€‘z}€NyNŠ‚ƒ{}ƒ‚Nw‰ƒ‚{}yŠNƒúƒyƒ€N{y|Nzƒ€€N|wxy}Žƒ”µ
`
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`ùw‚N}~ƒN‰~›€{yN€{Ž‰zƒ‚„N}~ƒN´|€‰z{›N‰{ƒ‚µN{‚‚ƒ€N}~ƒNwzw‚‘zN‰‘‚‰zƒNŠ‚{‰~€N{y|N~wz|€Nú“ƒNŸù €”NœN€Ž‰zƒ‚
`x~}ƒˆ{y|ˆ’z‘ƒNŠ‚{‰~€N€~ƒŽƒN€N‘€ƒ|Nw‚N}~ƒN‰~{‚Ž{›N´}‚{|ƒN‰{ƒ‚„µNx~~N~wz|€N}~‚ƒƒNŸù €”
`´ž~ƒ‚ƒ²€NŽw‚ƒNwN{NŽ{‚ƒ}yŠN€}‚{}ƒŠ›NyN{‰‰ƒ{zyŠN}wN}~ƒN‰~›€{y€N’ƒ{‘€ƒNxƒN~{“ƒN}wNwy“yƒN}~ƒŽN}~{}Nw‘‚
`‰‚w|‘}N€N}~ƒN’ƒ€}„µN€{›€N¤|{y”N¥ƒ€|ƒ€N‘€yŠNŽw‚ƒNwzw‚‘zNŠ‚{‰~€„N}~ƒN|€‰z{›N‰{ƒ‚Nyz‘|ƒ€N{N´‰w‰ˆ‘‰µNø{‰
`}~{}Nwz|€N‘‰N{y|N}‘€Ny}wN}~ƒN{‚}wyN’ƒ~y|N}~ƒN}~‚ƒƒNŸù €”N¾ƒ}N‘‰„N}~ƒN{‚}wyN}{ƒ€NwyN{N‚ƒ}{zˆzƒN{‰‰ƒ{‚{yƒ
`}~{}NŽ{ƒ€N}N{yN{‰‰ƒ{zyŠN{||}wyN}wN}~ƒN‰~›€{y²€Nwúƒ”Nž~{}Nƒ›ƒN{‰‰ƒ{zN€N‘yyƒƒ€€{‚›NyN‰~{‚Ž{ƒ€”
`
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` 
`
`Carton challenges
`
`Opening the carton's top flap reveals a perforated paper section that is part of the IFC. This panel includes patient
`instructions and is pulled open to provide access to the pouched packets in the carton.
`
`"This part of the carton was challenging from a design standpoint," says Midani. "We wanted the perforations to be
`strong enough to avoid collapse under minimal stress, but the perforations couldn't be so rigid that pulling them
`open as instructed would rip the carton's side panels. There was a considerable amount of stress analysis done
`until we got it just right. It's a unique package that we refer to as a straight-tuck, compact-style carton."
`
`Outer carton differences
`
`While the pouch and IFC are the same for both Vivelle-Dot target markets, they use different outer folding cartons.
`For the physician sampler, the "display packer" carries the colorful purple graphics and holds five IFCs. A simpler
`white-and-blue graphics scheme is used for the pharmacy "trade packer," which holds three IFCs.
`
`"There's more of a marketing strategy in appealing to the physicians because we have to convince them that our
`product is the best," says Midani. Besides using more colorful graphics, the display packer includes a "pop-up" flap
`that folds up and tucks into the carton behind the three IFCs. Set up, the carton takes on a retail-like appearance
`that makes it an appealing addition to the physician's office. That eye appeal is unnecessary in pharmacies.
`
`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
`3/12
`
`

`

`6/29/2017
`Tiny patch 'dots' pharmaceutical landscape | Packaging World
`Both of these outer cartons are again supplied by Vista Color. Like the IPCs, the trade packer consists of CIS, 18-pt
`SBS, offset-printed in three colors plus varnish. (The display packer is 20-pt SBS.) The purple color on the IPC and
`physician display box "looks feminine and differentiates it from our previous Vivelle® patch, which came in a larger
`teal-colored carton," says Rajcoomar. She points out that the new Vivelle-Dot is 66% smaller than the size of the
`Vivelle patch.
`
`
`
 
     
      
`  
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`Labeler in Action @ Pack Expo
`2015
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`Uses less material
`
`The patch size has many positive implications for Novogyne, its customers and product users. Por example, on the
`Vivelle-Dot with 0.05 milligram/day dosage (there are four strength varieties), the patch measures 5 cm2 as
`compared to 14.5 cm2 on the Vivelle version. Delivering the same dosage in a smaller patch was possible because
`of the Dot-Matrix manufacturing technology. The smaller patch is more comfortable to wear, less obtrusive and is
`exceptionally adherent.
`
`A smaller patch also means the pouch can be smaller. Por the 0.05-mg dose, the Vivelle-Dot pouch measures 2
`Vi"x2 Vi" as compared to 2 7/8"x2 7/8" for the Vivelle patch. With larger dosages, the package size difference
`increases. Similar package size reductions come from the IPC, outer folding cartons and corrugated shippers used
`for Vivelle-Dot. Midani estimates packaging material savings of 58% with Vivelle-Dot compared with materials
`necessary to package Vivelle.
`
`"Transdermals are dispensed at pharmacies in their original packaging, therefore, our packaging is designed with
`product integrity and protection number one, and number two to appeal to our female target market," says Midani.
`
`She says that "since its launch, Vivelle-Dot has gained five percent in new market share. Although it's difficult to
`assess how much of this success is due to packaging, the packaging design is serving us well. Our field reps are
`delighted at presenting these packages to their physician customers. The reps have received great feedback and
`pharmacies are pleased to display the product because it takes up less shelf space than does Vivelle."
`
`In a hurry? Request more info via Web-based reader service by clicking on company
`name.
`Or you can jump right to their Web site if it's listed.
`
`BROWSE 46 VIDEOS FROM VIDEOJET TECHNOLOGIES INC.
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`<
`
`Holiday Greetings from
`Videojet!
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`>? O  O   A
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`Videojet Case Coding in Action
`@ Pack Expo 2015
`
`Companies in this article:
`
`SUPPLIERS: » Videojet Technologies Inc.
`
`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
` 
`
`4/12
`
`

`

`  
`
`6/29/2017
`
`
`

    
   
`
`Tiny patch 'dots' pharmaceutical iandscape | Packaging World
`
`» Oystar Jones
`» Longford International LTD
`» RJR Packaging, a div. of RJ. Reynolds Tobacco Co.
`» Marconi Data Systems
`
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`https://www.packworld.com/article/machinery/lnspection/checkwelghers/tiny-patch-dots-pharmaceutlcal-landscape
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`  
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`6/29/2017
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`Packaging news and trends
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`Package design/development
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`Contract Packaging
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`Packaging Line engineering
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`Tiny patch 'dots' pharmaceutical iandscape | Packaging World
`
`( SUBSCRIBE )
`
`LEADERS
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`
`KIN PACKAGING
`Looking for Leading suppliers?
`Mouse over to see these companies;
`
`INSPECT/VISION/TESTING/CHECKWEIGH
`
`[f All-Fill Inc.
`
`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
` 
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`6/12
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`

`

`  
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`6/29/2017
`
`Tiny patch 'dots' pharmaceutical iandscape | Packaging World
`
`d? Anritsu Infivis Inc.
`[f Cognex Corporation
`[f Fortress Technology
`[f Heat and Control, Inc.
`d? Keyence Corp. of Americ...
`[f Leibinger
`[f Matrox Imaging
`[f Mettler Toledo
`c Thermo Fisher Scientifi...
`[P WIPOTEC-OCS, Inc.
`:Z Yamato Corporation
`
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`
`FORM/FILiySEAL - HORIZONTAL (POUCHES OR BAGS)
`
`[f All Packaging Machinery
`[f BPI Equipment
`d? Bradman Lake Inc.
`[P Duravant
`:Z Formost Fuji Corporatio...
`[f GGA Packaging, Division...
`[? Harpak-ULMA Packaging,...
`dP MASSMAN Automation Desi...
`dP Sleek Wrapper
`[f Weighpack Systems Inc.
`
`CARTONING
`
`d? Aagard Group, LLC
`ADCO Manufacturing
`dP BluePrint Automation
`[f Bosch Packaging Technol...
`dp Bradman Lake Inc.
`dP CAMA Group
`dP Delkor Systems, Inc.
`
`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
` 
`
`7/12
`
`

`

`  
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`6/29/2017
`
`Tiny patch 'dots' pharmaceutical iandscape | Packaging World
`
`d? Douglas Machine Inc.
`[f Econocorp Inc.
`[f EOL Solutions
`[f Exair Corporation
`d? Graco Inc.
`[f Graphic Packaging Intl.
`Kliklok-Woodman
`MG America
`S1 Molins Langen
`dP Nordson Corporation
`d? Nuspark Inc.
`[f Optima Machinery Corp.
`d? PMI Cartoning
`[f Propack Processing and...
`[f Serpa Packaging Solutio...
`dp Somic America, Inc.
`dP Triangle Package Machin...
`dP WestRock
`
`
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`CONTAINER HANDLING/FEEDING/UNSCRAMBLING
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`dP Baldor Electric Company
`dP CSS International
`dP CTM Labeling Systems, I...
`dP DAK Americas
`dP Eriez Magnetics
`dP Garvey Corporation
`dP Graphic Packaging Intl.
`@ LANGGUTH America Ltd.
`dP Material Transfer...
`dP Morrison Container Hand...
`dP Nalbach Engineering Co.
`dP National Bulk Equipment...
`
`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
`\ 
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`8/12
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`

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`  
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`6/29/2017
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`Tiny patch 'dots' pharmaceutical iandscape | Packaging World
`
`$ New England Machinery,...
`[? PFLow Industries Inc.
`& PHD, Inc.
`d? Regal Power Transmissio...
`[f Ryson International, In...
`[? Shibuya Hoppmann Corpor...
`[f Simplimatic
`[f Spee-Dee Packaging Mach...
`
`CARTONS AND BOXES
`
`d? Bennett
`$ Fibre Box Association
`[? Graphic Packaging Intl.
`® HLP Klearfold
`[f Iconotech
`^ Paperworks Industries
`Redimark
`^ Transparent Container C...
`Uline
`Wexxar/BEL
`[f WS Packaging Group, Inc...
`
`FLEXIBLE PACKAGING
`
`® ACPO
`^ Automated Packaging Sys...
`^ Bemis Company, Inc.
`[f1 Charter NEX Films
`Constantia Flexibles Gm...
`[f Coveris
`[f CP Flexible Packaging S...
`[f Fres-co System USA
`[f Glenroy Inc.
`
`
`

    
   
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`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
` 
`
`9/12
`
`

`

`Tiny patch 'dots' pharmaceutical iandscape | Packaging World
`
`d? MASSMAN Automation Desi...
`[f Overnight Labels, Inc.
`[f Phoenix Closures
`[f Printpack Inc.
`0 STA LLC
`
`
`

    
   
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`‹–W5¨
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`–cefemlcnn
`VIDEO
`
`  
`
`6/29/2017
`
`PLASTICS/RESINS
`
`^ DAK Americas
`[f King Plastic Corporatio...
`[f Leibinger
`
`•
`
`

`_cbccqimosem`˜emefbojktL
`
`» Velveeta now in 'mini blocks'
`
`720p
`
`
`
`1:37
`
`5WWMDDG_aWY5b
`
`SEE ALL VIDEOS »
`
`
 !
 !    
`  
   
`"
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   " 

`
`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
` 
`
`10/12
`
`

`

`  
`
`6/29/2017
`
`
`
 
     
      
`
`Tiny patch 'dots' pharmaceutical landscape | Packaging World
`
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`https://www.packworld.com/article/machinery/inspection/checkweighers/tiny-patch-dots-pharmaceutical-landscape
`
` 
`
`11/12
`
`

`

`  
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`6/29/2017
`
`
`

    
   
`
`Tiny patch 'dots' pharmaceutical landscape | Packaging World
`
`Packaging World @packagingworld
`
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`
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