Pharmaceutical Packaging Articles

Protecting a product from temperature abuse is gaining importance as the number of biopharmaceutical formulations grows and regulators look for proof of product stability throughout the distribution process. In the absence of cold chain management standards, the Parenteral Drug Association’s Pharmaceutical Cold Chain Discussion Group (PDA–PCCDG, Bethesda, MD) has released a draft guidance, “Medicinal Cold Chain Guideline.” The purpose of the document is to “provide guidance … on the essential principles and practices of transporting temperature-sensitive medicinal products through the transportation environment. Comments were due to PDA by 15 January 2004.

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Ablizzard that dumped several inches of snow on New York City on 15 March 2004, the first day of this year’s Interphex show, couldn’t slow traffic on the exhibit floor.Hot topics at the show included unit-dose bar coding, counterfeiting prevention, reproduction of reduced space symbology (RSS) bar codes, radio frequency identification (RFID), and, as always, quality control.

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In an industry as complex and regulated as pharmaceutical, locating the right packaging
information is sometimes a bigger challenge than designing, sourcing, filling, or labeling the
package. The good news is that the maturing of the Internet has made it much easier to find upto- date information on virtually any packagingrelated topic.
The first place to start, particularly for matters relating to regulations, guidelines, and current

FDA announced its intention to require bar codes on prescription (Rx) and over-the-counter (OTC) drugs and certain biological products used in hospitals more than one year ago. The final rule was published on 26 February 2004 (www.fda.gov/ OHRMS/DOCKETS/98fr/04-4249.htm). Yet drug makers and their suppliers seem to be largely in the dark about the regulation’s requirements. In fact, at the Interphex show in New York City in March, misinformation about the requirements of the final regulation was rampant.

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Packaging machines for new or existing lines are easier to operate and change over than they ever were before. Today’s packaging machines also accommodate a greater variety of heights, diameters, finishes, or dosage regimen counts. These benefits are mainly a result of the replacement of mechanical parts such as gears, shafts, and cams with electronic components such as servo motors and drives. Fully electronic motion control allows each function to be servo-controlled so that product and format changes can be executed at the touch of a button and manual adjustments can be minimized. “All servo machines allow operation across a virtually infinite set of parameters,” says John Kirk, vice-president of sales, liquid packaging, and pharmaceutical operations at Robert Bosch Packaging Technology, Inc. (Minneapolis, MN)

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When designing a package for a new pharmaceutical product, attention to detail is imperative, and there are many details to consider. The sequence of events is important also. If a step is overlooked or out of order, expenses can escalate dramatically, and there could be a delay to market with attendant losses of sales and market share. As the packaging design process proceeds, design reviews should be conducted periodically to ensure the credibility of performance criteria, physical safety, compatibility, barrier demands, and manufacturability. The reviews can also resolve documentation issues such as assembly drawings, manufacturing
instructions

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Enhanced blister packaging that adds a paperboard or plastic component to standard formed film–lidstock blisters is familiar in hospital settings and clinical trials. Such structures, which can provide a unit dose, help ensure patient compliance, or make a package more childresistant (CR), are used for a growing number of physician samples and animal healthcare products. Converting packaging to this format for prescription and over-thecounter (OTC)  Pharmaceuticals could benefit consumers, caregivers, retailers, and drug maker. In fact, mass-merchandising giant “Wal-Mart (Bentonville, AR) has expressed interest,” reports Tom Grinnan, vicepresident of business development at MeadWestvaco Healthcare Packaging (Mebane, NC), “in ‘consumerized packaging’ that is well-branded, compliance enhanced, and easily handled by pharmacists.”

Oxidative degradation of drug substances in pharmaceutical formulations is well documented (1). Although exact mechanistic details about what promotes reactions between drug substances (RH in the schematic below) and molecular oxygen in pharmaceutical formulations is not understood fully, such reactions are generally thought to be in the category of  auto-oxidation processes as described

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Counterfeit medicines, products that are not made by the authorized manufacturer but are presented to the consumer as if they were, represent a significant problem to legitimate manufacturers in the pharmaceutical industry and a potential health threat to patients (1). Counterfeit products may be subpotent, contain no active ingredient, or even contain harmful substances. Examples of these hazards can be found all over the world. For instance, in 1995 dozens of children in Haiti and Nigeria died after taking counterfeit medicinal syrups that contained diethylene glycol, an industrial solvent (1). Counterfeit versions of Serostim and Nutropin, which are growth hormones, and Neupogen, a cancer drug, have been found in the United States (2). A substandard counterfeit growth hormone also has been found in Europe (3), and in Asia, one report cited an estimate that 90% of Viagra sold in Shanghai, China, was counterfeit (4).

Life is full of turning points. Sometimes we immediately recognizetheir significance; other times it’s only as we look back that we recognize a change in the course of events.In pharmaceutical packaging, several industry-altering episodes have occurred during the years, including passage of the Poison Prevention Packaging Act; the Tylenol tampering incident; the addition of  senior-friendly requirements to childresistant (CR) packaging requirements; the mandate for simpler over-the-counter (OTC) product labels; CGMP changes to minimize the chance of mislabeling; the phase-out of chlorofluorocarbon (CFC) propellants in inhalers; and the development of blister packaging, transdermal delivery systems, blow–fill–seal systems, and
barrier isolators.

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