Impact of Extractables and Leachables on Drug Stability and Shelf Life
Extractables and leachables (E&Ls) are substances that migrate from packaging materials into pharmaceutical products. They can significantly influence drug stability and shelf life. Extractables are substances that can potentially migrate from packaging materials into the product under simulated conditions, while leachables are those that have actually migrated.
The presence of E&Ls in pharmaceutical products can lead to various adverse effects. They can interact with the active pharmaceutical ingredient (API), altering its stability and efficacy. Additionally, E&Ls can cause toxicity, allergic reactions, or other undesirable health outcomes. Moreover, they can compromise the product's appearance, taste, or odor, affecting patient acceptability.
The type and quantity of E&Ls that migrate into a product depend on several factors, including the nature of the packaging material, the drug formulation, storage conditions, and the duration of exposure. For instance, plastic packaging materials can release plasticizers, monomers, and oligomers, while rubber stoppers may leach antioxidants or sulfur-containing compounds.
To ensure drug safety and efficacy, it is crucial to minimize the migration of E&Ls into pharmaceutical products. This can be achieved through careful selection of packaging materials, optimization of manufacturing processes, and implementation of effective quality control measures. Risk assessment and testing are also essential to identify potential E&Ls and evaluate their impact on drug stability.
Visit our website to know more: https://www.leadventgrp.com/events/global-extractables-leachables-forum/details
For more information and group participation, contact us: [email protected]
Leadvent Group - Industry Leading Events for Business Leaders!
www.leadventgrp.com| [email protected]
