For multiple strengths, one well-designed bioequivalence study is often sufficient for both the UK and EU, provided the remaining strengths qualify for a biowaiver. The number of BE studies is determined by formulation proportionality, pharmacokinetic linearity, manufacturing process and comparative dissolutionānot merely by the number of strengths. For immediate-release tablets or capsules, the BE study…
A Practical Tool in Matrix-Based SR Product DevelopmentIn sustained-release (SR) oral dosage forms, drug release is often controlled by polymeric matricesāespecially 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…
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…
