Pharmaceutical Packaging Articles

This year's INTERPHEX show, held April 24–26 at the Javits Center in New York, provided an opportunity to see new packaging materials, containers, and machines firsthand. In addition to the usual wide range of anticounterfeiting and quality-control solutions, this year's show emphasized barrier packaging and child resistance. On the machinery side, the theme was line efficiency.

Hallie Forcinio
A multitude of overt and covert tools help authenticate products and prevent counterfeits from reaching consumers. New tools include ink technology that allows color to reappear when rubbed or scratched. ("Secur" labels, Ad Tape & Label, Menomonee Falls, WI).

The market for biotherapeutics has grown significantly since the first biologic drug was launched over 50 years ago. More than 250 biologic molecules have been developed and launched since 1996, and today biologics account for nearly 30% of compounds in the drug-development pipeline.
Recently, research and development (R&D) resources have focused not only on new molecular entities but also on improvements to commercially available products. Reformulations now comprise nearly 50% of new drug application (NDA) approvals at the US Food and Drug Administration (FDA).2 At drug-delivery companies focusing on injectable therapeutics, over 50% of the molecules in the pipelines are biologics, with many projects focused on developing sustained-release formulations.3

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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This innovative method increases flexibility, saves money, and supports the Critical Path Initiative.

With the increasing number of patient-specific and genetically based medications being developed and the globalization of clinical trials, pharmaceutical and biotechnology companies are facing greater pressures to increase efficiencies in clinical trial material (CTM) management. In particular, there is growing demand on clinical supplies teams to minimize CTM repackaging or overage, shorten packaging and labeling timelines, have the flexibility to customize supplies, and reduce the overall costs associated with CTM management. Oftentimes, these demands are implicit even in situations where significant last-minute protocol changes that affect CTM have been made—including changes in number of patients, sites, locations, duration of treatment, and dose regimen.

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.

In 2003, the FDA announced a mass recall of the cholesterol-lowering drug Lipitor. The recall, triggered
by the discovery of counterfeits, affected more than 130,000 bottles.

While drug counterfeiting in the U.S. is still rare, the number of investigations are on the rise. According to the FDA, the number of counterfeit drug investigations has risen from an average of five per year in the 1990s to more than 20 per year since 2000.

Growing use of the Internet to purchase prescription drugs also complicates matters. “The biggest threat now to every pharmaceutical manufacturer is online buying of prescription products. How do you control that, make sure that the authentic product is being purchased, plus at the correct price?” asked Neil Sellars, director of product development and marketing for National Label Company in Lafayette Hill, PA. “Online purchasing brings everything to a whole new threshold.”

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.

Counterfeiting prevention has joined quality control as a top concern for pharmaceutical manufacturers. Both issues received a high level of attention at the recent Interphex and Interpack trade exhibitions. Product security and quality control were major themes of this year's Interphex trade show, held April 26–28 in New York City.

A variety of interesting packaging machinery innovations were featured at the event.Brand protection Counterfeiting and diversion have become top concerns for pharmaceutical manufacturers as counterfeiting technology becomes more sophisticated, the incidence of fake products increases, and organized crime and terrorists turn to counterfeit goods to generate cash flow. Most experts recommend layering protective technologies by selecting a combination of overt and covert techniques.

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 .

The appropriate barrier system should be selected using a logical, risk-based approach, with awareness of all the possible sources of contamination. Nothing can come of nothing, but the contamination of a drug can come from everything. Selecting the appropriate barrier system for protecting the product and/or the environment requires a logical approach while recognizing the various routes of possible contamination in the aseptic processing chain.he ultimate goal of pharmaceutical manufacturing is to satisfy the patient.We do this fairly well because we are all po ten tial pati en t s .