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Preformulation analysis is to study the physicochemical properties of drug candidates before drug development. The information obtained through preformulation analysis can help us to screen out the appropriate drug substance form (salt or crystal), the best dosage form (tablets, capsules or injections), and provide important information for formula design for the subsequent development of stable and safe dosage forms with good bioavailability.
Alfa Chemistry's state-of-the-art preformulation analysis laboratory has the capacity of conducting physicochemical characterization of new and existing drug molecules and finished dosage forms to guide the development of complex dosage forms. To support the robust product development, a high-quality data report is generated by our extensive experienced scientific staff. Equipped with advanced analytical instruments and technical expertise, scientists from Alfa Chemistry can provide customers with fully integrated services, including:
Different crystal forms of the same drug may have significant differences in appearance, solubility, melting point, dissolution, bioavailability, etc., thereby affecting drug stability, bioavailability and efficacy. The phenomenon of drug polymorphism is one of the important factors affecting the quality and clinical efficacy of the drug, so it is essential for the detection of crystallinity.
Water absorption by pharmaceutical substances or excipients can influence the chemical stability and physical properties of the preformulation such as the agglomeration, the decline of fluidity, the deliquescence and the change of the crystal type, and result in the change of color, content and components. As post-hygroscopic preformulation are more easily oxidized, hydrolyzed and mildew, the shape, appearance, stability, availability, safety and other external and internal factors of the drug can be affected by the hygroscopicity of preformulation, therefore it is crucially important to study the hygroscopicity of the preformulation.
In preformulation analysis, particle characterization analysis is also necessary. Some physical and chemical properties of the drug are affected by the particle size distribution, including drug dissolution rate, bioavailability, texture, color, stability, etc. Particle size, shape, and surface area parameters affect particle velocity, interfacial chemistry, and fluidity in the media, and thus affect the pharmacological efficacy.
Suitable vehicles are extremely critical to the intrinsic properties of drug formulation such as API's release, absorption, distribution and (local) tolerance. Therefore, an ideal vehicle for drug substances testing during preformulation exact negligible impact on any biological activity of active ingredients and has no risk of inducing any toxicity that would mask or confound the effects of the API of interest.