Table of Contents
What is drug-excipient compatibility study?
The drug-excipient compatibility studies are carried out with an intent to identify, quantify and predict potential interactions (physical or chemical) along with the impact of these interactions on the manufacturability, quality and performance of the final drug product.
What is the ratio of drug excipients taken for in compatibility study?
Generally, for excipient compatibility study combination of binary mix in ratio of 1:1 is assessed.
Why is it important to study compatibility among formulation components?
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.
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 are compatibility studies?
Excipient compatibility studies are conducted with the primary goal of selecting dosage form components that are compatible with the drug. Methodically-conducted experiments also provide additional information on the stability profile of the drug, and identify degradation products and mechanisms.
What is significance of studying drug excipients interaction in Preformulation?
Studies of drug-excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. The potential physical and chemical interactions between drugs and excipients can affect the chemical, physical, therapeutical properties and stability of the dosage form.
What are different methods of drug excipient interaction?
Various advanced analytical techniques like thermal methods (TG, DTA, DSC, Thermomicroscopy, Isothermal microcalorimetry, Isothermal Titration Calorimetry, High sensitivity DSC), Isothermal stress testing, Optical microscopy, XRD, IR, NMR and chromatography can detect potential drug excipient incompatibilities.
What is pharmaceutical incompatibility?
Pharmaceutical incompatibility is a combination of ingredients in which, because of the interaction of medicinal substances between themselves or with excipients, their physical and chemical properties change and thus the stability and effect of the medicine.
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 ideal properties of excipients?
Ideally, an excipient is pharmacologically inactive, non-toxic, and does not interact with the active ingredients or other excipients.
What is drug excipient interactions?
Excipients can initiate, propagate or participate in chemical or physical interactions with an active substance, possibly leading to compromised quality or performance of the medication.
Which one of the following technique is most suitable for identification of drug excipient interaction?
Differential scanning calorimetry (DSC) is one of the well-developed techniques used in detection of incompatibilities in drug/ drug and drug/excipient interactions.
What are the 3 forms of incompatibility?
Incompatibility is defined as a change resulting and an undesirable product is formed, which may affect the safety, efficacy, appearance and stability of the pharmaceutical product. It is of three types. It includes physical, chemical and therapeutic incompatibilities.
What is the classification of excipients?
The excipients are classified in their capacity to impact metabolization and efflux mechanisms. First class would include excipients with low risk of interference with intestinal metabolization and efflux mechanisms.
What are ideal properties of excipients?
What is the importance of drug excipient compatibility study?
☻Importance of Drug Excipient Compatibility Study:- Stability of the dosage form can be maximized. Any physical or chemical interaction between drug and excipient can affect bioavailability and stability of drug. It helps to avoid the surprise problems.
What are the different approaches to design excipient compatibility studies?
In this article, we studied three different approaches to design excipient compatibility studies, using three different scenarios: a completely randomized experiment, a split-plot experiment and a strip-plot experiment. We compare designs proposed by Refs. [9], [16] to D- and I-optimal designs.
How to assess the stability of drug and excipients?
In order to obtain rapid stability assessment of drug and excipients, drug stability is investigated under the stress condition according to standard protocol and/or existing knowledge on potential degradation pathway or incompatibilities. 3.1 a. Physical drug-excipient interactions 3.2 b. Chemical drug-excipient interactions 4.1 1.
What are process variables in excipient compatibility studies?
In an excipient compatibility study, the factors defining the storage conditions should be regarded as process variables. Depending on how they are performed, mixture-process variable experiments may involve different kinds of grouping. When analyzing the results, the grouping structure should be accounted for.