What is drug-excipient compatibility?
Drug-excipient compatibility study is very much
important stage of formulation development of drug product in combination of
excipients. It’s significant phase of pre-formulation study. Drug product not
only contains active pharmaceutical ingredient (API) but it’s combination of
different forms of excipients. it’s important to study the physical and
chemical interaction between API and excipient. Generally, for excipient
compatibility study combination of binary mix in ratio of 1:1 is assessed. In
some instances, to check the extreme interaction and complications, multiple excipient
mixture in presence of API were appraised.
Importance of excipients and it’s
compatibility with API:
Selection of appropriate excipients could be done
by performing the drug excipient compatibility study. It supports to prevent
the expected last-minute complications throughout the process of formulation
development.
Role of excipients is important in formulations
development of active ingredient into effective drug product. Excipients
enhance the essential quality of the drug product such as exact required
dosage, stability, solubility, performance, acceptability, quality, absorption
of the drug in vivo, safety and efficacy. As per regulatory requirements
drug-excipient compatibility study require to predict probable degradation
pathways of the drug product. This study supports to recognize the selection of
appropriate excipients and helps to understand the interaction between drug and
excipients and the storage condition of the product.
Interaction of drug-excipients:
Drug-excipient compatibility complications obtain
from the direct reactions amongst API and excipients or by the presence of
responsible impurities in the excipients. Interaction between excipient and the
presence of sensitive functional group of API results into incompatibility of drug-excipients
compatibility study. Degradation of drug in presence of excipients lead to
formation of impurities and to identify these impurities need complete
understanding of the reaction and sufficient analytical details. Analytical
characterization data helps to understand the possible degradation pathway of
API.
Following are the some of the typical process of
drug-excipient compatibility which may impact the drug product stability in
presence of excipient.
Physical interactions,
Chemical interactions,
Physiological interactions,
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