Medicilon has extensive experience of performing stability studies on active pharmaceutical ingredients, early prototype formulations and finished dosage forms. Stability testing is performed according to FDA-ICH guidelines, client approved protocols and standard operating procedures. Stability test services include:
ICH Conforming Stability Studies
Forced Degradation Studies
In-Use Studies (IV bags, Infusion Pumps, etc.)
Stability studies are a critical part of the drug development process and are essential for drug product marketing approval.
Stability studies are conducted at all phases of the drug development cycle for different purposes with the ultimate goal of having a stable product on the market. During development, stability studies are conducted to support the formulation development and safety and efficacy claims of investigational new drugs. At registration, they are conducted to ascertain the quality and shelf-life of the drug product in their intended packaging configuration. After approval, the stability studies are conducted to ensure the quality of production and to support site or other changes to the product.
ICH Stability Testing
Stability testing and a well-designed ICH-compliant stability program are critical elements of a rigorous drug formulation and development plan. Our facility is equipped with state-of-the-art temperature and humidity controlled and monitored chambers for accelerated and long-term stability testing. Medicilon’s pharmaceutical stability programs operate under ICH guidelines, supplemented by custom programs that are designed as needed. Our comprehensive physical characterization and analytic capabilities complement our stability testing, providing our clients with a single source for a complete stability solution.
Preclinical studies include standard stability studies to assess shelf life, but also utilize special studies to study the drug and its degradation characteristics. The drug substance characterization and stability is usually determined as part of pre-formulation studies. Studies are designed to degrade the solid drug substance and appropriate solutions, allowing the determination of the degradation profile. The drug substance is usually challenged under a variety of accelerated environmental conditions to evaluate its intrinsic stability and degradation profile.
HPLC is the predominant tool used to analyze the drug substance and the impurities,particularly for small molecules. Frequently, the same HPLC method may be used for drug substance and drug product, although different sample preparation methods would normally be required. Often the assay and impurity testing can be performed using a single HPLC method. However, the assay and purity determinations may also be separate methods. At least in the U.S., full validation of the analytical method is not required until the end of Phase 2 clinical trials, but the establishment of specificity, linearity and limit of quantification (for impurities) is important at the earliest stages, since verification of stability hinges on a suitable method for separating impurities from the active ingredient and at least quantifying the impurities relative to the drug substance.
Stress studies at elevated temperature for several weeks may be performed to assess thermal stability. Provided the degradation mechanism is the same at the different temperatures used, kinetic or statistical models can be used to determine the rate of degradation at other temperatures. The solid stability should also be performed in the presence and absence of water vapor to assess the dependence of stability on humidity.
Degradation studies should also be performed in solution. The solvent used for the solution testing will depend on the solubility of the drug substance and should include water, if the drug substance is water-soluble. Other solutions or solvent systems may be evaluated depending on the anticipated formulation or the synthetic process. A series of buffered solutions in the pH range 2-9 are useful in assessing the impact of solution pH on the degradation. Photostability should also be evaluated. A xenon light source can be used as a stress condition. Alternatively, one can use an accelerated version of either Options 1 or 2 as described in the ICH guideline for determination of photostability. Oxidation of the drug substance under accelerated conditions may also be performed to establish oxidation products that could be formed and sensitivity to oxidative attack.
Early drug product stability studies are designed to help establish a suitable formulation for delivery of the drug substance. Compatibility studies of the drug substance with excipients should be performed to eliminate excipients that are not compatible with the drug substance.
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