How do you test for drug-excipient compatibility studies?
Infrared (IR), near-infrared (NIR) and Raman spectroscopy are the most commonly used non-thermal techniques for the screening of drug-excipient compatibility. These techniques provide a unique fingerprint to the API and the excipients based on their physical and chemical attributes.
What is API excipient compatibility?
Preformulation is a crucial phase in drug development in which the physicochemical profiling of active pharmaceutical ingredients (APIs) and excipients is determined and prototype formulations made.
How do you choose excipients for formulation?
Excipients can be selected according to the characteristics of the dosage form and the needs of the route of drug administration. The excipients used should not have an adverse interaction with the main drug, and should not affect the content determination of the preparation and the inspection of related substances.
What is an example of an excipient?
Examples include gelatin, cellulose, cellulose derivatives, polyvinylpyrrolidone, starch, sucrose and polyethylene glycol.
What are the types of incompatibilities?
The types are: 1. Therapeutic (Pharmacological) Incompatibility 2. Chemical Incompatibility 3. Physical Incompatibility.
What is the significance of studying drug excipient interaction in Preformulation?
Study of drug-excipient compatibility is an important phase in the pre-formulation stage of drug development. The potential interactions between drugs and excipients have effects on the chemical, physical, bioavailability and stability of the dosage form.
What is the full form of IST which is used in drug excipient interaction studies?
Isothermal stress testing (IST) The conditions used in IST provide an environment that accelerates the drug/excipients reactions.
What are the important considerations in the choice of excipients *?
In the selection of excipients, it is also important to consider potential interactions with charged drug substances. Such interactions can result in incomplete recovery of the drug from the formulation, which can lead to assay irregularities or, worse, reduce the bioavailability of the drug.
What are the importance of pharmaceutical excipients?
Pharmaceutical excipients are substances that are included in a pharmaceutical dosage form not for their direct therapeutic action, but to aid the manufacturing process, to protect, support or enhance stability, or for bioavailability or patient acceptability.
What are the types of excipients?
On the basis of their functions, excipients can be categorized as binders, cosolvents, fillers, disintegrates, lubricants, surfactants, emulsifying agents, suspending agents, antimicrobials, preservatives, etc. (Table 12.1).
What is the purpose of excipient?
Generally, an excipient has no medicinal properties. Its standard purpose is to streamline the manufacture of the drug product and ultimately facilitate physiological absorption of the drug. Excipients might aid in lubricity, flowability, disintegration, taste and may confer some form of antimicrobial function.
What are the three major types of incompatibilities?