Biopharmaceutics

Formulation Development Strategy for BCS Class IV Molecules
For a Class IV drug (low solubility and low permeability) in the Biopharmaceutics Classification System (BCS), formulation development needs a strategic approach to address these limitations. Here’s how this information can be leveraged: Enhancing Solubility: Solubility-Enhancing Techniques: Use solubilizers, surfactants, or co-solvents in the formulation to improve the drug’s solubility. ... Read More

Formulation Development Strategy for BCS Class III Molecules
For BCS Class 3 drugs, which are characterized by high solubility but low permeability, the primary formulation approach focuses on enhancing their permeability to improve bioavailability. Here are strategies tailored to different dosage forms: Oral Solid Dosage Forms Permeation Enhancers: Adding permeation enhancers like surfactants, bile salts, or certain excipients ... Read More

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