Extractable Studies
Extractables are chemicals or compounds that could be extracted, in the presence of solvent and heat, from the materials in a product’s packaging system, manufacturing system, or medical device. These materials will include any plastics (polymers), elastomers (rubber gaskets and seals), adhesives, glass, or metals that contact the product. Any extractables that pose a potential health risk to consumers, such as genotoxic or carcinogenic substances, need to be identified, quantified, and reviewed by a qualified toxicologist to ensure product safety.
We offer a range of extraction studies based on your regulatory needs and the materials in your packaging, system, or medical device. An initial risk assessment conducted by our team will inform the type of extraction study that is required, as it will detail the materials of construction, product interactions, and potential E&L risks.
Extraction studies are conducted in various ways, but they largely fall into two categories – Simulated and Traditional. All extraction studies use a minimum of 2 solvents for the extraction process. The resulting extractables are then analysed by liquid chromatography-mass spectrometry (LC-MS) and gas chromatography-mass spectrometry (GC-MS). Additional analytical techniques and instrumentation may be used dependant on the materials involved and the potential risks.
Simulated Studies
Simulated extraction studies use solvents that mimic the product. This produces a library of compounds that is most likely to reflect the actual compounds that might leach into the product over the duration of its shelf life.
Advantages: This method yields a smaller, more targeted number of compounds to identify and quantify, which typically results in a faster turnaround for the study and lower costs for the client.
Disadvantages: Not all possible compounds that could leach into the product will be detected, which could pose a potential risk. However, we can help our customers to assess the risk based on our years of experience with various types of packaging, products, and materials.
Use Case: A client’s oral liquid formulation contains only aqueous components, and the product is packaged in a high density polyethylene (HDPE) container. Following a risk assessment, it is determined that the potential for leaching is moderate. It is therefore deemed appropriate to perform a 2-solvent extraction with water and isopropyl alcohol on the container closure system (bottle, cap, foil seal, label, and adhesives).
Traditional Studies
Traditional extraction studies are designed to extract all possible compounds from a material. These studies typically use multiple solvents, and the extractions continue until no further compounds can be extracted from the samples (exhaustive extraction).
Advantages: This method yields a comprehensive library of potential leachables, reflecting the ‘worst case scenario’ for the product. This ensures a thorough evaluation of all potential risks.
Disadvantages: This method will produce many compounds that may not leach into the product under normal conditions, and could result in the need for an unnecessary and costly leachable study. Whilst this method is the safest option, it is not always necessary depending on the product and regulatory requirements. Our team can help you to determine the best option for your product.
Use Case: The client’s product is a metered dose inhaler with a drug formulation containing a non-polar propellant and ethanol. Following a risk assessment, it is determined that the risk of leaching is high. In this case, all of the components of the primary pack are exhaustively extracted using a three solvent system consisting of a polar, non-polar, and chlorinated solvent to ensure complete extraction.
Why choose Extractus?
We’ve been in your shoes! We have 45+ years combined experience in the pharmaceutical industry, working as E&L subject matter experts and outsourcing studies for some of the world’s largest pharmaceutical and consumer health companies. As such, we have a deep understanding of your needs, constraints, and regulatory requirements. We provide a fast, flexible, high quality, and solution-focused service to help you meet your targets on time, and within budget.