Physicochemical Characteristics of Drug Substances

Physical Form (Crystal & Amorphous) – Crystalline Form:   – Crystal Lattice Structure: Crystalline substances have a defined and repetitive arrangement of molecules. This structure is characterized by unit cells that repeat in three dimensions.   – Types of Crystals: Includes polymorphs (different crystal forms of the same compound), hydrates/solvates …

Study of Physicochemical Characteristics of Drug Substances

 Introduction The study of physicochemical characteristics of drug substances is essential in pharmaceutical development. It involves the comprehensive evaluation of physical and chemical properties of the Active Pharmaceutical Ingredient (API), which influences the drug’s formulation, stability, efficacy, and bioavailability. Understanding these characteristics is crucial for designing effective and stable pharmaceutical …

Pre-formulation Studies: Introduction, Goals, and Objectives

 Introduction to Pre-formulation Pre-formulation studies are a crucial part of the pharmaceutical development process. These studies involve the characterization of the physical, chemical, and mechanical properties of a drug substance (API – Active Pharmaceutical Ingredient) alone and in combination with excipients. The primary goal of pre-formulation is to generate useful …

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