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…
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…
Changing the API source requires evaluating its impact on safety, efficacy, stability, and manufacturability. Below are the key factors to assess: Physicochemical Properties Dissolution & Bioavailability Stability Considerations Regulatory & Compliance Manufacturing & Process Impact In-vivo Considerations Risk Assessment & Final Decision Conclusion API source changes demand scientific, regulatory, and process evaluations to prevent any…
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