Excipient Compatibility Testing

Drug-Excipient compatibility studies are the first step in dosage form development and represent an important phase in the preformulation stage of the development of all dosage forms. Pharmaceutical excipients are crucial for drug delivery in the body. Generally, an excipient has no medicinal properties, and its standard purpose is to streamline the manufacture of the drug product and ultimately facilitate physiological absorption of the drug. Excipients might contribute to the lubricity, flowability, disintegration and taste of the drug and may confer some form of antimicrobial function to the drug. So, selecting appropriate excipient to support the design of your pharmaceutical formulation is an important step in the drug manufacturing process. Although excipients are pharmacologically inert, the potential physical and chemical interactions between drugs and excipients can affect the chemical, physical, therapeutical properties and stability of the dosage form.^[1] Therefore, drug excipients compatibility testing has the following important roles: it maximizes the stability of a dosage form; it bridges drug discovery and development; it is essential investigational new drug submission (IND); it helps to avoid surprise problems during formulation processes.

As a leading global pharmaceutical analysis services company, Alfa Chemistry provides excipient compatibility testing and other preformulation analysis services. Alfa Chemistry is the perfect partner for bringing expertise, flexibility, and reliability to your pharmaceutical formulation project.

Alfa Chemistry's drug excipients compatibility testings mainly focus on:

• Physical drug-excipient interactions: Physical interactions are very common in dosage form and are difficult to detect. Physical interactions involve changes in dissolution rate, solubility, sedimentation rate etc.

• Chemical drug-excipient interactions: Active pharmaceutical ingredients and excipients react with each other to form unstable compounds. Generally, chemical interactions have a deleterious effect on the formulation, so such kind of interactions must be avoided.

• Physiological/Biopharmaceutical drug-excipient interactions: These are the interactions observed after administration of medication. Interaction of the medicine with body fluids influences the rate of absorption.

Alfa Chemistry's instrument platforms:

Our advantages:

Contact us now!

Reference

• Patel, P., Ahir, K., Patel, V., Manani, L., & Patel, C. (2015). Drug-Excipient compatibility studies: First step for dosage form development. The Pharma Innovation, 4(5, Part A), 14.