Sandoz coex bottle protects heart medication

A coextruded prescription pharmaceutical bottle in the works for six years was declared the winner of the Bernard M. Seid Best of Show Award in the annual competition of the National Assn. of Container Distributors. The two-layer bottle from O. Berk Co. (Union NJ) was just one of several packages that demonstrated how distributors help packagers by pushing the "envelope of technology" in container design. Many of the winners in some seven different product categories exhibit a wide range of distributor expertise in meeting the technical and marketing demands of product manufacturers. From a package that keeps microorganisms alive through innovative seals and closures to a package sourced entirely from overseas winning packages displayed the moxie of distributors. The coextruded two-layer high-density polyethylene bottle is used for Sandoz Pharma- ceuticals' Lescol Capsules a medication for heart patients. The East Hanover NJ company had previously used amber glass bottles for products that required stringent barriers to light and moisture. Although plastic containers might have been preferred packagers had been required to use glass bottles to achieve an appropriate expiration date for prescription drugs that were very sensitive to light and moisture. Finally with the help of O. Berk Sandoz found a multilayer plastic bottle from Silgan Plastics (Chesterfield MO) that provides the following features: * The new bottles pass a 0.0% (290-450 nm) light transmission specification said to be a great improvement over amber glass bottles. * An induction seal can be applied with a far better barrier than the pulp/poly liner available for glass bottles. * This coextruded plastic bottle is far less costly than the amber glass bottle it replaces. Even when adding the cost for the induction seal the savings in component costs is substantial. * As expected the shift to plastic bottles reduces to zero the credits that Sandoz must refund for glass bottles that are broken in transit. Long-term development Although coextruded bottles had already begun to make their mark for foods and other products they had rarely been considered for pharmaceutical bottles. "While I was touring Silgan's research laboratory I saw a sample of a coextruded multilayer bottle they had been experimenting with. Knowing that Sandoz had been looking for a plastic light-protecting bottle I gave a sample to our salesman on that account" Norb Gaelen chairman of O. Berk recalls. "Usually the simplest developments are the most difficult to see. When most packagers think of coextruded bottles they're thinking of gas or moisture barriers. No one had really given much thought to using coextrusion for a light barrier" points out Fred Renz Sandoz senior packaging development engineer. "So by breaking that paradigm we were able to move into a plastic bottle that gave us both the physical properties and chemical properties we need." Because the inside layer is the light-shielding black Sandoz tested to see if there was any contamination with any of their light-sensitive drugs Gaelen reports. "Sandoz did a lot of light sensitivity testing and they did a lot of drug testing studies. "They did long-term tests for light and long-term studies on shelf life for what was then an unapproved drug called Lescol. The major advantage that was revealed in their testing was the extended shelf life that the coextruded bottle provided" says Gaelen. "Normally a white high-density polyethylene bottle will average about seven-percent light transmission" Renz says. "With this bottle we've taken that rate down to 0.0 percent. It's quite an achievement." Building custom molds About three years ago Sandoz authorized the building of two sets of custom molds to produce the bottles in 60-cc and 175-cc sizes. Two years ago Silgan and O. Berk began to ship some production quantities of the bottles to Sandoz for packaging line trials and sample work. "We've standardized our packaging lines around a couple of bottle sizes" says Renz. "One is the 60-cc plastic bottle that is identical in size to a 1 3/8-ounce glass bottle. The other is the 175-cc plain white bottle. So we had these bottles sized to eliminate any changeovers on our packaging lines." Silgan produces the bottles at its Deep River CT plant. "We make these bottles on our proprietary coextrusion blow molding process that we call BDS for Blown Direct Screw" says Art Brown of Silgan. One reason the technology is proprietary is that it doesn't require tie layers that can introduce new chemicals that must be tested. Silgan uses an FDA-approved food-grade concentrated black colorant for light barrier he says. Although the bottle has been in development for several years it really was launched into the market when Lescol in this form finally received its approval in mid-'94. In production the square-shaped bottle is filled and receives a partial wraparound label. Its CR cap contains a glassine-based liner that is glued to the bottle mouth. Renz says that an induction-sealed liner will likely be used by the end of the year. A prefolded patient insert is applied to the back panel of the bottle. While this package has been approved and it meets Sandoz's requirements the packager is pushing for the same protection with added aesthetics. Although still in what Sandoz calls the "technology" department a three-layer bottle from Silgan traps the black light-barrier layer in between two layers of white. Although perhaps a few years away from becoming commercial Sandoz is working with Silgan on the selection of the colorant the let-down ratio and wall thicknesses to develop the tri-layer bottle at the same size and gram weight of the current bottles Renz reports. Having a white interior color would address the concerns that the pharmaceutical company has about patients who might find the black inner surface of the two-layer bottle somewhat objectionable. Cosmetics Gold: The winner was W. Braun Co. (Chicago IL) for Second Skin Satin products from Gryphon Development Inc. New York NY. These slender bottles of polyethylene terephthalate (PET) were designed to showcase the distinctive colors of the products marketed exclusively through Victoria's Secret lingerie shops located in major shopping malls. The judges liked the graceful shape of the bottle and recognized the difficulty in molding a bottle with such an unusual length-to-diameter ratio. Silver: Twin City Bottle (Minneapolis MN) won for The Thymes family of bath and shower gels. The Minneapolis-based packager restaged the packaging with a custom mold incorporating soft lines to fit the hand well. In-mold texturizing of the bottle surface added softness to the use of medium-density polyethylene for the bottle. The well-proportioned complementary dome screw cap combines with an orifice reducer to add richness and visual apeal. Twin City also does the screen printing. Bronze: Calpac Container a div. of Caliber Packaging (Cerritos CA) won for the Shower Gel container from Terranova Berkeley CA. This cylinder bottle of polyvinyl chloride was selected because the modern silhouette worked with overall packaging design. A special environmentally-friendly bottle "frosting" process added a new dimension to the clear bottle yet permitted the color of the product to be visible. A custom cap complemented the lines of the cylinder. Foods Silver: Bourassa Premium Glacial Water won for Richards Packaging (Mississauga Ont. Canada). The bottle for the Canadian Water Corp. Maple Ridge B.C. Canada is an intriguing polyvinyl chloride design. Sold exclusively to the Japanese market the square design allows optimum facings on store shelves while it subtly resembles a glacial ice chunk. Bronze: Beaverton Foods Beaverton OR wanted customers to be able to squeeze its bottles gently to dispense the product carefully. The amount and type of plastic used by Olshen's Bottle Supply Co. (Portland OR) was formulated to permit maximum pliability. The screen printing of the bottle body and coordinating closure color are consistent throughout a large product line. Household Chemicals Gold: Biosys Palo Alto CA won for its unusual container for Bio Flea Halt! from Caliber Packaging (Cerritos CA). The 24-oz container for powders is white high-density PE with a 63-mm neck finish for easy filling. The cylindrical container was a stock style that fit a new product launch with unpredictable quantities. Most critical was the closure that consisted of a breathable liner that allows the product's live organisms to live inside the container. This material transmitted sufficient oxygen yet was tight enough to prevent the microorganisms from escaping the container. Because the closure also needed to breathe the distributor suggested a mold modification to accommodate three holes in the closure top. Silver: Packaging West (Denver CO) won for Orange Glo a cleaner from Appel Co. Littleton CO. For the first time the company tried retail merchandising and chose a clear PVC oval sprayer bottle that allows the color of the product to show through. The trigger sprayer is molded to coordinate with the color of the screen printing. Bronze: Smith Container (Atlanta GA) won for an unusual product/package combo from Frit Industries Ozark AL for Pro-Sol plant food. This "no-mess no-measure" plant food includes dissolvable plant food packets that are packaged in compact easy to handle PVC containers. The size and shape of the package makes it attractive to the distribution points since it can be easily stacked or shelved for display to the consumer. Pet & Vet Products Gold: All-Pak Inc. (Bridgeville PA) won for Gravy Time Gourmet Gravy from the Grateful Pet Laboratories Richmond VA. To find a unique package that would dispense the product easily a slant handle F-style HDPE bottle from Container Mfg. (Middlesex NJ) includes a special color blend that yields a translucent brown. As the product is dispensed particles can cling to the inside of the container which would be unsightly. The bottle is finished with a dispensing closure from Polytop (Slatersville RI) that offers dispensing ease from virtually any position. Silver: Kaufman Container (Cleveland OH) won for Udder Cream from Redex Industries Salem OH. Three sizes (1/4- 2- and 12-oz jars) of polypropylene jars are decorated with Holstein color patches in two colors the same as the jar lids. Since Redex has adopted the new look sales have "skyrocketed." Bronze: Some five products in the Mela Miracle line won for Cincinnati Container Co. (Cincinnati OH) and maker G.C.G. Inc. Cincinnati OH. This group of packages was designed for products with organic/natural ingredients in a package style that was designed to be both striking and appealing. Drugs/Pharmaceuticals Gold: Packaging West (Denver CO) won for an Australian Tea Tree Oil of Espial Englewood CO. What made this project special is that the distributor sought a dispensing/delivery system that could be used with amber glass. None of these components could be found in the domestic market. So Packaging West found a German company that made a dropper fitment and another German company that made a glass bottle that would work with the dropper plug. A tamper-evident cap completes the package. Silver: Also to Packaging West for the Surfas product from Weaver & Co. Aurora CO. The customer wanted to package a thick gel to be used by health professionals administering Ultra Sound tests. But it wanted a package different from the traditional tube or cold-cream jar. The distributor suggested an LDPE cylinder bottle for its good squeezability. A wide-orifice dispensing cap often used for food products worked well with the product. The container was tinted to resemble the color of the gel product and the screened bottle decoration used exact registration. Bronze: Seaborne Inc Atlanta GA won for containers supplied by Northwestern Bottle Co. (St. Louis MO). The Essential Sea line of dietary supplements sold exclusively in amber glass in Japan needed a complementary package that denoted its upscale image. The private-mold HDPE bottle has embossed swirls that mimic the company's logo while it offers product recognition that says it's more than just another dietary supplement. Teal and gold screen printing with a metal-look closure keeps the product distinctive. The metal closure combines with a plastic jar to permit a lightweight package that cuts shipping costs. Industrial/Automotive Gold: Kaufman Container (Cleveland OH) won for an unusual squeeze bottle for U. S. Chemical's Icing a polyester finishing putty for auto body repair. The new white LDPE 22-oz bottle allows the consumer to knead and dispense the product easily. To ensure product compatibility the bottle is fluorinated to Level 5. A 38-400 white dispensing cap with a .500 orifice from Seaquist Dis-pensing (Cary IL) has a peg on the inside of the cap to keep the orifice from clogging. Bold graphics are screen printed in magenta and black. Silver: Kaufman also won for Malco Products' line of Presta products for the automotive aftermarket. The Barberton OH-based company chose black PVC ribbed oval bottles for the 8- and 32-oz sizes; a black 1-gal F-style PVC container is decorated with an attractive pressure-sensitive label. PVC was selected for product compatibility. The professional execution of a family of packages impressed the judges. Bronze: O. Berk won for the Accu-San container from Ulster Scientific New Paltz NY. This second-generation Tip-N-Measure container with two chambers is designed to be used by police or medical technicians to decontaminate blood at accident scenes or in hospital emergency rooms.