Unit 1

Application of Pre-formulation Considerations in Dosage Form Development and Impact on Stability

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Pre-formulation studies are critical in the pharmaceutical development process as they provide essential information about the physical, chemical, and mechanical properties of a drug substance. This data is used to design and develop stable, effective, and manufacturable dosage forms. Here, we discuss the application of pre-formulation considerations in the development of solid, liquid oral, and … Read more

Biopharmaceutics Classification System (BCS)

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The Biopharmaceutics Classification System (BCS) is a scientific framework for classifying drugs based on their solubility and permeability. This system helps predict the drug absorption and bioavailability, which are critical factors in drug development and regulatory approval processes. BCS Classification The BCS classifies drugs into four categories: 1. Class I: High Solubility, High Permeability    … Read more

Chemical Properties of Drug Substances

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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. Hydrolysis – Definition: Hydrolysis is a chemical reaction in which water reacts with … Read more

Physicochemical Characteristics of Drug Substances

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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 … Read more

Study of Physicochemical Characteristics of Drug Substances

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 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

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 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 … Read more

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