Early decisions streamline pharmaceutical packaging efficiency.
Decisions on packaging protection for pharmaceutical formulations often come in the late stages of drug research and development, just prior to commercialization. As a result, drug manufacturers may fail to consider important stability profiles of certain formulations and be forced to make last-minute changes to packaging formats. As new pharmaceutical product formulations enter the market, traveling through various environments along the supply chain, it is more important than ever for companies to consider stability testing early on in the drug development process.
We had a chance to speak with Daniel Stagnaro, global market development, pharmaceutical and medical device films, Klöckner Pentaplast, about the benefits of accelerated stability testing. Stagnaro will discuss blister-based packaging solutions for liquid and semi-liquid dosage forms at the Innovation Stage at Pharma EXPO 2016 (McCormick Place, Chicago; Nov. 6-9).
Q: What are the benefits of doing drug stability testing in packaging early on in the drug commercialization process?
Stagnaro: Pharmaceutical companies often neglect to consider the specific environmental conditions for their drug formulations until late in the game. This can include shipping products through different climates with varying rates of humidity or taking into account drug degradation profiles that require specific packaging formats to extend shelf life, etc. As a result, companies often take a scattershot approach to packaging and then find they need to make last-minute changes. Our advice: don’t rush and plan early. With early planning, companies can save on material costs and improve productivity. Completing stability testing of product formulations as soon as possible allows for packaging decisions to be made more strategically. We are now able to do this testing on a “fast track.” It can efficiently narrow down purchasing choices early on in the process and avoid costly, last-minute changes prior to launching new products.
Q: Can you give some examples of cases in which early stability testing can lead to benefits and cost-savings?
Stagnaro: We have seen examples of extending product shelf life by 25 percent if the right packaging materials are chosen. In one case of a double capsule dose formulation, we compared blister packaging the capsules separately versus packaging them together. Our testing concluded that by packaging them together, we were able to extend the shelf life. In another case of a packaging format that included a pouch and a desiccant, our testing determined that a blister package without the desiccant would offer the same protection and stability. By removing the desiccant, we were able to increase productivity 44 percent and decrease material use by 23 percent. Companies also sometimes run the risk of “over-packaging,” which early testing can prevent. Companies may, for example, rush and decide to incorporate multiple protective barriers in their packaging, when they only need one, or only need added protection for certain market distributions. Strategic, early stability testing and modeling can steer companies in the right direction.
Q: In your opinion, when in the drug development process should companies do stability and degradation testing?
Stagnaro: Companies are sometimes surprised to learn how early in the process they can consider stability testing. We generally recommend testing before formulations are finalized, in Phase II or Phase III clinical testing. This is when companies consider dosage size and conduct excipient testing. At this relatively early stage, we can start modeling how formulations will behave under certain packaging and transportation conditions, even before the actual product is in hand. This is especially important for drug formulations that are particularly sensitive.
Q: Are there any drug industry or consumer trends that you think require a greater emphasis on early stability testing?
Stagnaro: Yes, there are new excipients and active pharmaceutical ingredients (APIs) being used that are particularly sensitive to moisture and other forms of degradation. One example is the increase in rapid release formulations that dissolve or melt in the mouth. We are seeing more of these formats in the market for consumers who have difficulty swallowing. Typically, these formats are more vulnerable to degradation and require extra protection. Early testing can help determine the packaging—including the machining and material—that will keep formulations protected and shelf-stable, cost-effectively.
Daniel Stagnaro will make his presentation, titled “Developing a Unique Blister-Based Solution to Package and Protect Liquid and Semi-Liquid Dosage Forms,” on Monday, Nov. 7, 2016, from 10:00 a.m. to 10:30 a.m. at the Innovation Stage Booth W-320 at McCormick Place. The Innovation Stage presents free, 30-minute supplier-led seminars. Sessions start on the hour on Monday and Tuesday from 10 a.m. to 3:30 p.m. and Wednesday from 10 a.m. to 11:30 a.m. (start to end times).
Pharma EXPO is co-produced by PMMI, The Association for Packaging and Processing Technologies, and the International Society for Pharmaceutical Engineering (ISPE). Pharma EXPO will be co-located with PACK EXPO International 2016. Together, the shows will feature more than 2,500 exhibitors and draw 50,000 attendees.
For more information, visit: www.pharmaexpo.com.
PMMI, The Association for Packaging and Processing Technologies, represents the voice of more than 750 North American manufacturers of equipment, components, and materials for processing and packaging. The PACK EXPO trade shows unite the world of processing and packaging to advance the industries they serve: PACK EXPO International, PACK EXPO Las Vegas, Pharma EXPO, PACK EXPO East, EXPO PACK México, EXPO PACK Guadalajara, and ProFood Tech, launching in April 2017. PMMI Media Group connects manufacturers to the latest solutions, trends and innovations in processing and packaging year-round through brands including Packaging World, Automation World, Healthcare Packaging, Contract Packaging, ProFood World, and Packaging + Processing OEM. PMMI Business Drivers assist members in pursuing operational excellence through workforce development initiatives, deliver actionable business intelligence on economic, market and industry trends to support members' growth strategies, and actively connect the supply chain throughout the year.