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…
While dissolution testing is a primary tool for predicting bioequivalence, several other in vitro methods contribute critical insights, especially for BCS Class II/IV drugs or complex formulations. Below is a list 1. Solubility Studies 2. Permeability Assays 3. Precipitation Kinetics and Supersaturation Studies 4. Dynamic Gastrointestinal Simulation Models 5. In Vitro Lipolysis 6. IVIVC 7….
A Frequently Overlooked Yet Crucial Step in Generic Drug Development. When a formulation is finalized and development stability data is already generated, teams often wonder: Q: āIf we manufacture a fresh batch for the pivotal bioequivalence (BE) study, do we need to place it on stability again?ā Answer: YES. Absolutely. Even if: The pivotal BE…
Viscosity plays a particularly critical roleāespecially when the goal is to demonstrate bioequivalence (BE) with a Reference Listed Drug Key functions of viscosity in suspensions: Bioequivalence Considerations BE studies are conducted to ensure that the rate and extent of drug absorption from a generic product are comparable to that of the RLD. For BCS Class…
