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…
21 CFR Part 11 is the FDA regulation for electronic records and electronic signatures. It establishes the criteria under which electronic records and signatures are considered trustworthy, reliable, and equivalent to paper records and handwritten signatures. Key Requirements of 21 CFR Part 11 Electronic Records Electronic Signatures System Validation Security Controls Who Needs to Comply?…
Authoring a high-quality CMC (Chemistry, Manufacturing & Controls) dossier is crucial for regulatory approval. However, many submissions face delays due to avoidable mistakes. Here are some common pitfalls and how to avoid them: Inconsistent Data Across Sections Lack of Justification for Critical Parameters Poorly Structured or Redundant Content Incomplete Stability Data Failure to Address Regional…
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