Chemical Properties of Drug Substances

Screenshot 2024 07 29 101238 Chemical Properties of Drug Substances

Understanding the chemical properties of drug substances is critical for predicting their stability, compatibility, and overall behavior during formulation, storage, and administration. Here, we detail key chemical processes including hydrolysis, oxidation, reduction, racemization, and polymerization, along with their significance in pharmaceutical development.  1. Hydrolysis Hydrolysis is a chemical reaction in which water reacts with a … Read more

Physicochemical Characteristics of Drug Substances

Screenshot 2024 07 28 153510 Physicochemical Characteristics of Drug Substances

1. 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 (crystals containing solvent molecules), and co-crystals (crystals composed of … Read more

Study of Physicochemical Characteristics of Drug Substances

Screenshot 2024 07 28 152700 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 products. Key Physicochemical Characteristics 1. … Read more

Pre-formulation Studies: Introduction, Goals, and Objectives

Screenshot 2024 07 28 152415 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 information about the drug substance that … Read more