Forced degradation studies are more than a regulatory checkbox—they are a cornerstone of quality assurance, designed to reveal the intrinsic stability of a molecule and its behavior under stress. Yet, their potential is often underutilized due to common yet avoidable pitfalls. Key Insights into Frequent Challenges Inadequate Stress Conditions The art of forced degradation lies…
Regulatory excellence lies in the details. Minor oversights in stability and analytical sections can trigger major delays or rejections. exploring three critical but often missed pitfalls: Missing Microbial Limits Justification in Stability for Non-Sterile Products Even non-sterile formulations must maintain acceptable microbial limits throughout shelf life. Failing to include microbial testing data during stability studies…
A Drug Master File (DMF) is one of the essential documents submitted to regulatory authorities to support drug approvals. It contains detailed technical information about the Active Pharmaceutical Ingredient (API). Two Parts of API DMF Open Part (Applicant’s Part): Closed Part (Restricted Part): What is LOA? A Letter of Access (LOA) is a formal agreement…
The Critical Micelle Concentration (CMC) is the surfactant concentration at which micelles begin to form in solution. Above the CMC, these micelles encapsulate hydrophobic drug molecules, dramatically improving solubility and dissolution. For sodium lauryl sulfate (SLS), the CMC in pure water at 25 °C is approximately 8.2 mM . Practical Example: In ezetimibe tablets, introducing…
Optimizing API particle size is pivotal for tablets and capsules—impacting flow, compressibility, content uniformity and ultimately, drug performance. Start with the API’s BCS Class BCS II/IV (Poor Solubility) BCS III (High Solubility) Low-Dose APIs Class II Align Particle Size with Manufacturing Strategy Direct Compression Wet Granulation Roller Compaction Tailor Particles to the Dosage Form Immediate-Release…
One of the key lessons we learned in addressing biowaiver requests for non-RLD strengths until 2022 was a fundamental misinterpretation of FDA’s 5% allowance for rate-controlling polymers (RCPs). Initially, we assumed that as long as the total amount of RCPs remained unchanged, we could increase one polymer by 5% and simultaneously decrease another polymer by…
