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Pharmaceutical Blister Packaging, Part I

68 Pharmaceutical TechnologyNOVEMBER is one of the largest in-dustry sectors in the world, worth$280 billion. Consumer healthcarepackaging represents 4% ($ bil-lion) of the packaging industry. As drugmanufacturers approach the 21st century,they face a number of challenges thatpackaging can help them decade ago packaging often was anafterthought for many pharmaceuticalcompanies, viewed as merely the final stepin manufacturing. But now firms mustconsider packaging earlier during the de-velopment process. Pharmaceutical pack-aging is quickly becoming an essentialpart of the drug delivery system as wellas a core element of the marketing mix,through which manufacturers can dif-ferentiate their products from those oftheir competitors.

72 Pharmaceutical Technology NOVEMBER 2000 www.pharmaportal.com benefit is the role of blister packaging in compliance. As many as 30% of all pre-scriptions are not taken properly initially,

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Transcription of Pharmaceutical Blister Packaging, Part I

1 68 Pharmaceutical TechnologyNOVEMBER is one of the largest in-dustry sectors in the world, worth$280 billion. Consumer healthcarepackaging represents 4% ($ bil-lion) of the packaging industry. As drugmanufacturers approach the 21st century,they face a number of challenges thatpackaging can help them decade ago packaging often was anafterthought for many pharmaceuticalcompanies, viewed as merely the final stepin manufacturing. But now firms mustconsider packaging earlier during the de-velopment process. Pharmaceutical pack-aging is quickly becoming an essentialpart of the drug delivery system as wellas a core element of the marketing mix,through which manufacturers can dif-ferentiate their products from those oftheir competitors.

2 The demand for phar-maceutical packaging is increasing andwill continue to increase as companiesrely more on packaging and labeling asmedia to protect and promote their prod-ucts, increase patient compliance, andmeet new configuration ofblister basic types of pharma-ceutical Blister packages exist. In one va-riety the cavity is constructed of clear,thermoformed plastic, and the lid isformed of clear plastic or a combinationof plastic, paper, and/or foil. The othertype of package contains foil as an es-sential component of both webs, and itscavity is created by cold stretching. Fig-ure 1 shows the basic configuration of ablister the early 1960s, Karl Klein designedthe first machinery for producing push-through Blister packaging .

3 He did not ob-tain a patent for the design because theEuropean Pharmaceutical industry wasnot very interested in it that is, untilRon Pilchik is a principal atThe Techmark Group, 1040 North Kings Highway, Suite 707,Cherry Hill, NJ 08034-1921, tel. , fax , e-mail Blister packaging , Part IRationale and MaterialsRon PilchikEighty-five percent ofsolid drugs in Europe arepacked in blisters,compared with less than20% of those in theUnited States. However, Blister packaging isbecoming more acceptedin the United Statesasboth manufacturers andconsumers recognize itsbenefits. This articlediscusses the materialsused for Blister packagesand typical , TechnologyNOVEMBER birth control pill was formulated a fewyears later.

4 For this revolutionary productSchering (Berlin, Germany) chose blisterpackaging because it seemed to be themost appropriate way to package the pillfor effective the most important reason forintroducing Blister packaging technologywas to offer patients a clearly marked in-dividual dose, enabling them to checkwhether they had taken the prescribeddrugs on a given day. Moreover, the drugsthat were not taken remained in the ori-ginal package and were fully protectedagainst adverse external conditions. Thepatient could handle the Blister packagemore easily and could store it more con-veniently than conventional soon, manufacturers and pack-agers recognized other advantages of blis-ter packaging such as the prevention ofbroken glass bottles and reduced costs andhigher packaging speeds relative to otherpackaging materials.

5 Another importantbenefit became apparent later: It is easierto prove misuse with Blister packagingthan with conventional packaging . Thus, Blister packages effectively meet the de-mand for tamper-evident packaging . Allthese advantages explain why Blister pack-aging is used for approximately 85% ofsolid drugs in in Europe versus use in the situation is just the oppositein the United States, where virtually allover-the-counter and prescription drugsare packaged in bottles. For example, lessthan 20% of nonliquid pharmaceuticalproducts in the United States currently aresold in Blister has been a great deal of specula-tion about the causes for the difference inthe use of Blister packaging in the UnitedStates and Europe.

6 First, following WorldWar II, European packaging machinery(like almost everything else) lay in packagers in Europe started overfrom scratch, and when they did theychose Blister machinery over bottle equip-ment. Second, European regulations onchild-resistant closures are far less strin-gent than rules in the United third reason lies in the differencesamong health plans in the two areas. InEurope, most health plans limit the num-ber of units that can be prescribed at onetime to a 10- to 14-day supply. In theUnited States, however, insurers allow alonger supply period, typically 30 to 60days. The smaller European purchasequantity favors Blister packaging becauseit costs less to package small numbers ofitems in blisters than in bottles.

7 Finally,the European community has strongerenvironmental incentives to use blisterpackaging. For example, manufacturersare penalized for introducing excessivematerial into the system. The use of blis-ter packaging allows manufacturers to re-duce packages to a minimal use in the United is becoming more accepted inthe United States as Pharmaceutical manu-facturers and consumers recognize itsbenefits. Blister packs can help patientsfollow drug regimens, protect drugs overa long shelf life, and are portable. Advo-cates of Blister packaging in the UnitedStates cite five aspects in which blisterpackaging is better than integritylproduct protectionltamper evidencelreduced possibility of accidental misuse lpatient retail-level prepara-tion of prescription drugs in the UnitedStates is troubling.

8 Pharmacists or phar-maceutical technicians count pills in theuncontrolled atmosphere of the super-market and drug store, where many fac-tors can negatively affect sensitive drugsas they are transferred from container packaging helps retain productintegrity because drugs that are pre-packaged in blisters are shielded from adverse conditions. Furthermore, oppor-tunities for product contamination areminimal, and each dose is identified byproduct name, lot number, and expira-tion date. Therefore, Blister packaging ensures product integrity from the pro-ducer directly through distribution to packaging pro-tects pharmaceuticals in the home betterthan bottles do.

9 For example, most con-sumers store their medicines within themedicine cabinet in the bathroom. But thebathroom environment periodically isfilled with clouds of steam. As a result, itmay be no exaggeration to say that oncean opened bottle of pills has been storedunder these conditions, the unused pillswill never be the packaging , however, keeps eachtablet or capsule hermetically sealed inits own bubble. Drugs that are not takenremain in the original package and arefully protected against external condi-tions. A Blister protects a moisture-sensitive tablet right up to administra-tion. In contrast, the moisture in theheadspace of a multiple-unit bottle is re-placed each time the bottle is evidence is an-other strength of Blister packaging .

10 Thedosage units are individually sealed inconstructions of plastic, foil, and/orpaper. The package must be designed sothat one must tear the compartment toget at the product, and it must not bepossible to separate the backing materi-als from the Blister without leaving evi-dence. Once a bottle has been opened,whatever tamper-evident mechanism ithad is gone. With Blister packaging , how-ever, each tablet or capsule is individu-ally protected from tampering until use,so any form of tampering with a blisterpackage is immediately of accidental pack-aging also can be made child resistant,and several such designs currently are inuse.


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