What is pharmaceutical compatibility?

What is pharmaceutical compatibility?

Pharmaceutical incompatibilities are generally referred to as changes in the physical, chemical and/or therapeutic properties of a dosage form resulting from the interaction of the API with excipients or other components of the drug product [25].

What is excipient compatibility?

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 can drug excipients incompatibilities be identified?

Drug-excipient interactions can be identified by comparing DTA curves obtained from the test sample with those of inert reference. Incompatibilities are indicated by the appearance of one or more new DTA peaks or the disappearance of one or more DTA peaks corresponding to those of the components of the test sample.

What is the ratio of drug excipients taken for in compatibility study?

It is better to use 1:1 or 1:0.5 (Drug to Excipient) ratio to check the compatibity studies and then as per design exposed to different accelerated conditions.

What are pharmaceutical incompatibilities?

Abstract. 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.

How do you measure incompatibility?

 Incompatibilities are physically identified by  Visual observation for color or physical form changes,  Spectroscopic and calorimetric methods, and  Chemically quantified by analytical assays for drug content and impurities. ii.

What are the roles of excipients?

The intended function of an excipient is to act as the carrier (vehicle or basis) or as a component of the carrier of the active substance(s) and, in so doing, to contribute to product attributes such as stability, biopharmaceutical profile, appearance and patient acceptability and to the ease with which the product …

Which technique is employed in drug excipient compatibility screening?

The evaluation of drug-excipient compatibility is therefore an essential aspect of any preformulation study. The two commonly employed compatibility screening techniques are isothermal stress testing of binary drug-excipient mixtures and thermal analysis using either DSC or differential thermal analysis (DTA).

Which type of capsule are used to fill ophthalmic ointments?

Gelatin capsules
Manufacturing materials. Gelatin capsules, informally called gel caps or gelcaps, are composed of gelatin manufactured from the collagen of animal skin or bone.

What are the remedies of pharmaceutical incompatibilities?

These precipitates are found in diffusible in nature which results in physical incompatibility.  Remedy: – Use of suspending agents is necessary to suspend the precipitated chalk particles.  Generally 2% W/V of compound tragacanth powder is recommended as suspending agent.

How do you do a compatibility study?

Typically, a drug substance/excipient compatibility study is performed with binary mixtures which are prepared in the presence/absence of added water, stored at accelerated conditions, and then analyzed by stability-indicated methodology, such as HPLC.

What are the results of a compatibility study?

Stability studies at different conditions were also performed. Compatibility study results indicate that drug product was compatible with the product contact materials. Thermal cycling and photostabilty data indicates that there was no significant degradation in the formulation.

How is an excipient used in a compatibility study?

In a typical drug-excipient compatibility study, a solution, suspension, or solid mixture of drug substance and excipient is placed in the calorimeter and the thermal activity (heat gained or evolved) at a constant temperature is monitored. The thermal activity observed is assumed to be proportional to the rate…

How are physical interactions used in drug compatibility studies?

Physical interactions may result in changes in dosage uniformity, colour, odour, flow properties, solubility, sedimentation rate, dissolution rate etc. Incompatibilities are assessed by physically observing the test samples. Physical interactions can be either beneficial or detrimental to the product performance depending on its application.