Abstract. Purpose: In this article we studied the effect of the packaging material on the liquid stability of interferon alpha 2b (rhIFN-a2b). Methods: The compatibility of this cytokine with type I borosilicate glass ampoules was evaluated by ELISA and RP-HPLC, at 4ºC and after heat sealing. Additionally, the influence of protein concentration (3 and 10 MIU/ml), buffer species (sodium phosphate, sodium citrate and sodium citrate-phosphate) and additives (polysorbate 80 and EDTA Na2 x 2H2O) were studied in samples with and without contact with chlorobutyl stoppers by RP-HPLC. Results: The compatibility of this cytokine in sodium phosphate buffer, with type I borosilicate glass ampoules showed a significant adsorption at the lowest concentration. This influence was eliminated with a polysorbate 80/benzyl alcohol-based vehicle.

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Diabetes is the fourth leading cause of death worldwide and accounts for $286 billion in annual healthcare costs. Globally, 194 million people suffer from diabetes and this number is rising rapidly. For these patients, a regular regimen of pills or injectable insulin is necessary to control blood-glucose levels and to minimize the chance of disabling and potentially deadly complications such as blindness, kidney failure, nerve damage, heart disease, and limb loss.

Although patient compliance problems have been receiving attention for at least a decade, many medications are still dispensed in bottles that contain a supply intended to last days or weeks and require considerable effort on the part of the patient or caregiver to keep track of the dosing schedule. As a result, when it comes to consistently taking the right dose at the right time for the duration of a prescription, many consumers don't do a very good job.

The failures add up to millions of dollars in unnecessary healthcare costs and lost work time, as well as nursing home admissions and patient illnesses and death. Packaging designed to help patients follow proper dosage regimens could reduce or even eliminate many noncompliance problems.

Compliance packaging is especially important for regimens that require frequent doses, multiple medications, or titrated doses. But it also can help patients remember simple regimens such as once-a-week doses.

The unit-dose bar coding rule requires integration of bar code technology, printing, quality control, data collection and transmission, and recordkeeping.

We are now less than a year aw ay from the April 24, 2006, de adline that requ i res bar coded labels on approx i m a tely 153,500 packaging units of prescription and over- t h e - counter (OTC) dru gs dispen s ed in hospitals. Drug products approved for use after the ru l e’s April 24, 2004, ef fective date must be bar coded within 60 days of approval. FDA’s final rule requires a linear bar code repre senting the produ ct’s nati onal drug code (NDC ) to be placed on the immed i a te container label and the outer wra pper that appe a rs on most pre s c ri pti on and certain OTC dru gs com m on ly used in hospitals, or abo ut 75% of OTC produ ct s .

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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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

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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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.”

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).

From a packaging perspective, the
themes of the 2001 Interphex show
held in March in Philadelphia were
easier operation, quicker changeover,
and product security. Nearly all categories
of equipment, containers, and materials
were well represented among the
approximately 900 exhibitors spread across
240,000 ft2 of floor space.
Flexible packaging
Bags used for the delivery of parenteral nutrition,
antibiotics, and specialty drugs andfilm is extruded as a tube in a controlled
environment so only Class 100 filtered air
touches the inside product-contact surface,
which then is protected throughout
packaging, distribution, and use on the
form–fill–seal equipment (M312 film, Cryovac
North America, Duncan, SC).

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BR> Advances in the HPLC Column Packing Design
 
Even though HPLC column technology is considered to be somewhat mature, new developments continue. Improvements in packing-material design, bonded-phase chemistry, column construction and formats have occurred. Users now have a better understanding of the advantages and limitations of silicabased materials and do not attempt to use them under conditions that may shorten their lifetime or decrease their performance. In addition, new phases have extended operating pH ranges (high and low) providing more versatility. In this article, I will update developments in packing morphology and particle design. Instead of trying to cover the entire domain of HPLC column development, I will focus on a few key areas.
 
Improvements in Porous Packings:
 
Porous packings have been in favour throughout the history of HPLC.