The potential physical and chemical interactions between drugs and excipients can affect the dosage form's chemical, physical, and therapeutic properties, and stability. Drug excipient compatibility studies are an important part of understanding the role of inactive ingredients (excipients) in product quality and its performance. Our mechanistic understanding of the drug substance and its impurities, excipients degradation pathway, and potential processing conditions help select the right excipients for the compatibility study.
Our approach for drug excipient characterization
Our drug excipient compatibility studies are designed based on the:
- Intended route of administration
- Potential formulation choices and delivery system
- Test substance characteristics
- Excipient preferences
- Marketing preferences
Drug excipient compatibility (binary or ternary) studies are carried out at accelerated temperature and humidity conditions for an extended period using the drug alone and excipient alone as a control, applicable where additional moisture is incorporated to study the impact of humidity on drug stability.
Generally, our drug excipient compatibility studies are assessed through HPLC analysis of binary mixtures of excipient and drug substance at a 1:1 ratio in the solid state. Study samples will be stored at 25 °C/60 % RH and 40 °C/75 % RH in both open and closed containers for one month. Common excipients functioning as fillers, disintegrants, polymers, flavors, stabilizers, and lubricants are evaluated in the excipient compatibility study.
Quality parameters studied
Critical quality parameters like assay and degradation products shall be analyzed at the initial stage and after one month of incubation of long-term and accelerated stability conditions. An incompatibility with the active ingredient is indicated by a loss in assay or the detection of degradation products.
Why Aurigene Pharmaceutical Services?
Experience with various characterization techniques
USFDA -inspected labs with advanced instrumentation
Understanding of various regulatory and Pharmacopeial requirements
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