A Practical Tool in Matrix-Based SR Product DevelopmentIn sustained-release (SR) oral dosage forms, drug release is often controlled by polymeric matrices—especially hydrophilic polymers like HPMC or hydrophobic ones like ethyl cellulose. One critical but often underappreciated factor that governs the release kinetics is the viscosity of the hydrated matrix system. The gel layer viscosity plays…
In sustained-release (SR) or extended-release (ER) formulations, the relationship between Tmax, Cmax, and dissolution specification time points is critical to ensure the product delivers the drug at a controlled rate, maintaining therapeutic levels over an extended period. Unlike immediate-release formulations where the goal is rapid absorption and a quick Tmax, SR products are designed to…
What is IVIVC? BCS and IVIVC Feasibility Types of IVIVC Steps to Develop Level A IVIVC for SR Products Regulatory Validation Criteria If met, the IVIVC model can support biowaivers and post-approval changes without further clinical studies. Best Practices for Dissolution Testing in SR IVIVC Applications of IVIVC in SR Development Common Challenges in SR…
SR formulations are designed to release the drug gradually over an extended period, making their performance highly dependent on variable GI conditions such as pH, motility, and enzymes. Therefore, a single dissolution test is insufficient. 1. MMD Testing SR formulations must release consistently across the GI tract. Dissolution is evaluated at pH 1.2 (stomach), pH…
Adjusting polymer content in a sustained-release dosage form requires a systematic approach to maintain the desired drug release profile while ensuring manufacturability and regulatory compliance. Role of the Polymer in Drug Release Control Polymers in sustained-release formulations act as matrix formers, coating agents, or swelling/erosion regulators. For example, HPMC, Ethylcellulose (EC), and Polyethylene Oxide (PEO)…
