Excipients Testing
What are Pharmaceutical excipients testing?
Excipients are pharmacologically inactive materials from different origins (biological or biotech products, minerals, chemical synthesis-based, etc.) Excipients are used in most drug products, and their quality, manufacturing processes and test methods are vital to the production of safe and effective therapies.
How are pharmaceutical excipients classified?
They are classified by the functions they perform in a pharmaceutical dosage form. Principal excipient classifications (functions) are the following:
- Binders
- Disintegrants
- Fillers (diluents)
- Lubricants
- Glidants (flow enhancers)
- Compression aids
- Colors
- Sweeteners
- Pharmaceutical Water
- Preservatives
- Propellant
- Suspending/dispersing agents
- Film formers/coatings
- Flavors
- Suspending or viscosity agent
- Printing inks
- pH Modifier
- Antioxidants
Why do we need to test for the analyte?
The most important function of any excipient is to ensure the safety and efficacy of the medicine throughout the formulation, the storage period, and during and after its administration. Excipients are no longer considered inert substances because they can interact with the API, lowering their titer. They also can generate undesirable impurities or alter the absorption, distribution, metabolism and excretion (ADME) that ultimately, reduce the bioavailability of the API. They are assessed as functional and essential substances added to a modern pharmaceutical formulation. These problems may be overcome by adopting and carefully adhering to good manufacturing practices (GMPs) and quality control similar to those for active principles.
What is the regulatory requirement in India?
- All excipient manufacturer sites and products require approval by Indian FDA. A licence is required to manufacture/stock and sell or distribute the excipient.
- As per Indian regulatory agencies the application for drug approval needs to list the excipients used in the drug preparations.
- Manufacturer is required to comply with IP, if a compendial monograph exists. In case of No IP claim by manufacturer then it is the user’s responsibility to ensure the excipient compliance to IP monograph.
- In absence of an IP monograph compliance to another international Compendia such as USP/EP/BP/JP etc. is acceptable, if the excipient is listed as such in the drug approval application.