Formulation Development
Solubility Enhancement Techniques for BCS Class II Molecules
For BCS Class II drugs, which have low solubility but high permeability, formulation efforts center on enhancing solubility to improve bioavailability. Here’s how we turn API properties into actionable formulation strategies: Solubility Improvement With BCS Class II drugs’ low solubility, enhancing solubility is key for bioavailability. Techniques include: Particle Size ... Read More
Formulation Development Strategy for BCS Class I Molecules
For BCS Class I drugs, with high solubility and high permeability, formulation strategies across various dosage forms are generally more straightforward than for other BCS classes. These drugs can dissolve and permeate easily, meaning that the focus is typically on optimizing stability, dosage form design, and patient compliance rather than ... Read More
Importance of Understanding the Biopharmaceutics Classification System
Guides Formulation Strategy: The BCS class helps in identifying the solubility and permeability characteristics of the drug. Drugs in different classes require distinct formulation approaches. For example, a poorly soluble drug (BCS Class II or IV) may need solubility enhancement techniques like solid dispersions or nano-formulations. Predicts Drug Absorption and ... Read More
Particle Size Distribution (PSD) Requirements for Different Dosage Forms
Immediate-Release Tablets Controlled-Release Tablets Oral Suspensions Inhalation Formulations Topical Creams/Ointments Injectables (Parenterals) Practical Steps for PSD Optimization Read also: Resource Person: Moinuddin Syed. Ph.D, PMP
Formulation of the Pharmaceutical Enzymes
Formulating enzymes products presents unique challenges in maintaining stability, activity, and functionality. Here are the key areas to consider: Enzyme Stability Enzyme Activity Formulation Compatibility Preparation and Mixing Compression (for Tablets) Storage Stability Regulatory and Quality Assurance Successfully formulating enzyme products involves strategic formulation, strict process controls, and comprehensive testing ... Read More
Drug Excipient Compatibility Study During QbD
To perform Drug-Excipient Compatbility (DEC) study 4 types of samples are required to be preprared: All these samples are packed in flint glass vial or amber color vial (if API is light sensitive) with and without sealing & exposed for a particular time period i.e. 1 Day, 3 Days, 7 ... Read More
Design of Experiments (DOE) in Drug Formulation Development
In pharmaceutical industry, the Design of Experiments (DOE) stands as a pivotal tool, systematically guiding the exploration and optimization of critical processes. By efficiently analyzing multiple factors and their interactions, DOE empowers the industry to enhance product quality, ensure consistency, and meet stringent regulatory requirements. Its strategic application contributes to ... Read More
Excipients in Pharmaceutical Applications
Pharmaceutical excipients are used in virtually all drug products and are essential for drug product manufacturing and performance. Thus, the successful manufacture of a robust product requires the use of well-defined excipients and manufacturing processes that consistently yield a quality product. The intended end use of the excipient should be ... Read More
Literature Review in Pharmaceutical Product Development
The literature review is an important part of pharmaceutical product development demonstrating literature based knowledge and understanding of the target drug product. The objective of this study is to find out the development and manufacturing feasibility of the product. A list of information to be collected during literature review are ... Read More
How to Increase Solubility of Drug?
The solubility of drug molecule is one of the most challenging aspect in formulation development. It is crucial to ensure the right concentration of a drug gets into the bloodstream so the bioavailability of the drug causes the desired pharmacological response. Therefore, using a variety of techniques to improve solubility ... Read More