Innovation Stage Presentation at Pharma EXPO Addresses Guidance and Equipment Options
It is well-known that light exposure can negatively impact certain active pharmaceutical ingredients (APIs) and reduce drug efficacy. For these ingredients, the pharmaceutical industry requires extensive shelf stability studies that focus on factors including natural and UV light exposure. Due to this issue, these drugs are packaged in the distinctive amber or opaque pill bottles with the “protect from light” warning labels. To ensure safety and effectiveness, pharmaceutical manufacturers must conduct photostability testing based on international testing guidelines, and this can have implications from labeling and packaging, to dispensation and shelf-life. However, the mandatory guidelines can be complicated and there are various testing options.
We had a chance to speak with Allen Zielnik, Senior Consultant for Atlas Material Testing Technology, LLC about the finer points of the photostability testing guidelines, as well as various testing options and trends in protective packaging. Zielnik will present at the Innovation Stage at Pharma EXPO (McCormick Place; Nov. 6–9).
Q: Can you explain the photostability guidelines for pharmaceutical products and what implications it has for the pharmaceutical industry?
A: The International Commission on Harmonization (ICH) established photostability testing guidelines in 1996. Section Q1B is a guideline mandating small molecule photostability testing and has become the globally accepted standard. Virtually all regulatory agencies require this test data to be submitted for new drug approval. Q1B sets minimum forced degradation test and confirmatory requirements using various light sources. Testing takes place in controlled chambers that replicate environmental conditions through exposure to light sources, including Xenon Arc lamps that simulate natural or glass filtered sunlight, as well as UV and visible fluorescent lights. Testing is done to determine whether or not light exposure results in unacceptable change in the pharmaceutical product, and, if so, what special packaging and/or labeling are needed. This is driving the need for specialized testing equipment and services, as well as protective packaging solutions.
Q: The Q1B guidelines can be complicated. What testing requirements should manufacturers pay particular attention to?
A: There are some parts of Q1B confirmatory testing that are unclear regarding procedure. Pharmaceutical manufacturers need to understand what is needed in order to meet minimum requirements. For example, ICH guidelines allow tests using non-equivalent light sources providing either an outdoor daytime sunlight or behind-glass filtered spectrum. Clearly, outdoor sunlight is the more severe of the two, so which lighting option should a manufacturer use during forced degradation testing? It is also important to remember that photostability testing is required for all parts of the life cycle. This means testing is mandatory for not only the active API drug substance, but the inert excipient ingredients as well, taking place in batch, full-production scale, and if a change in packaging or drug reformulation occurs. Manufacturers should know that this can be a complicated, time-extensive process.
Q: What role does photostability testing play in pharmaceutical production?
A: Photosensitive pharmaceutical ingredients that have degraded in the light can have a detrimental effect on how long or how well a drug works. This has a marked effect on the product testing and package design stages of product development. Manufacturers are understandably interested in testing to determine shelf-life under various conditions and specifying protective packaging that is not only compliant with regulations, but can safely extend product lifecycle. And in the end, they must assure the product remains safe and effective.
Q: Are there packaging trends that you see in which photostability testing may be an issue?
A: One major consumer trend is product visibility. This is especially true in the food & beverage and health & beauty industries. Everyone wants to see the product inside the package, requiring clear or transparent packaging. What was typically opaque for photostability protection now needs a window, creating new photodegradation challenges for manufacturers.
Allen Zielnik will make his presentation, entitled “Photostability Testing of Pharmaceuticals and Protective Packaging: An Insider's Guide to Your Testing Options,” on Tuesday, Nov. 8, 2016, from 11:00 a.m. to 11:30 a.m. at the Innovation Stage Booth W-320, McCormick Place Chicago. The Innovation Stage presents free, 30-minute supplier-led seminars every half hour—all day, every day while the show floor is open. Sessions start on the hour, every hour, on Monday and Tuesday from 10 a.m. to 3:30 p.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: http://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. We work to advance a variety of industries by connecting consumer goods companies with manufacturing solutions through the world class PACK EXPO portfolio of trade shows, leading trade media and a wide range of resources to empower our members. 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.