Granulation is a critical process in tablet formulation that involves the aggregation of powder particles to form larger, multi-particle entities called granules. This process enhances the flow properties, compressibility, and content uniformity of the powder blend, making it easier to handle and process into tablets. There are two primary methods …
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Formulation of Tablets
Tablets are the most common and widely used dosage form for oral administration of drugs. They are solid, unit-dose forms that are easy to handle, transport, and administer. The formulation of tablets involves several critical steps to ensure their efficacy, stability, and patient compliance. This note provides an in-depth exploration …
Excipients in Pharmaceutical Formulations
Definition of Excipients Excipients are inactive substances formulated alongside the active pharmaceutical ingredient (API) of a medication. They serve a variety of roles that are critical to the creation, stability, and functionality of the final pharmaceutical product. While excipients do not exert therapeutic effects themselves, they are essential for the …
Tablets: Introduction, Ideal Characteristics, and Classification
Introduction Tablets are solid dosage forms containing one or more active pharmaceutical ingredients (APIs) along with suitable excipients, which are compacted or molded into various shapes and sizes. They are among the most common and convenient forms of medication delivery due to their simplicity, ease of administration, accurate dosage, portability, …
Application of Pre-formulation Considerations in Dosage Form Development and Impact on Stability
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 …
Biopharmaceutics Classification System (BCS)
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: …
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. Hydrolysis – Definition: Hydrolysis is a chemical reaction …
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 …
