Optimizing Azathioprine Preformulation and Exploring its Interactions with Excipients

Abstract

Preformulation studies investigate the physical and chemical properties of a drug substance, alone and in combination with other excipients. The goal of these studies is to develop a safe, effective, and stable dosage form. Preformulation studies are initiated once a new molecule is seeded. They focus on the concepts of physicochemical properties, which are vital for any new drug molecule and/or proteins/peptides. These properties affect the therapeutic efficacy and the development process of their specific dosage form. The stage of development known as preformulation is when the physicochemical qualities are defined by a set of parameters. Among these are characteristics of solid states such crystal form, water sorption behaviour, surface property, particle size and shape, other mechanical properties, solubility, dissolution behaviour, stability, partition coefficient, and ionisation constant. Drugs are almost always given a compounded property rather than being delivered as a pure chemical ingredient. These can range from quite easy fixes to intricate medication delivery schemes. through the incorporation of suitable excipients or additives into the formulations to offer legitimate and specific medicinal actions. Achieving a consistent, therapeutic response to a drug incorporated in a formulation that can be manufactured on a wide scale with repeatable results is the main goal of dosage form design. The main goal of designing a dosage form is to provide a medicine incorporated in a formulation with a predictable, therapeutic response that can be manufactured on a wide scale with consistent product quality. Preformulation studies are typically used to characterize and determine the stability of the medicinal ingredient. Since stability testing is the main method used to determine when pharmaceutical products should be put into clinical trials and under what storage conditions, it is imperative that the stability profile of any novel component be determined before moving further with product development. Throughout the course of the drug product's lifecycle, stability studies are essential to establishing and guaranteeing its safety, efficacy, and quality. stability information for the drug substance are used to determine optimal storage and packaging conditions for bulk lots of the material. Studies are designed to degrade the solid drug substance and appropriate solutions, allowing the determination of the degradation profile.