In generic drug development, the materials you source dictate everything downstreamâfrom formulation consistency and regulatory approval to long-term commercial viability. âYour sourcing strategy is not just a procurement exerciseâit’s a regulatory foundation.â Hereâs what a smart, compliant, and inspection-ready sourcing strategy looks like: 1. Use Only Commercial-Grade Raw Materials Why it matters? Using research-grade or…
In generic drug development, every excipient decision mattersânot just for performance, but for regulatory approval. One of the most underrated tools we have is the FDA Inactive Ingredient Database (IID). The IID isnât just a list. Itâs a strategic database that gives you regulatory confidence while selecting excipients. It contains excipients that are already approved…
In pharmaceutical development, understanding your Critical Quality Attributes (CQAs) is not just regulatory jargon â itâs the foundation of Quality by Design (QbD). According to ICH Q8(R2), a CQA is any physical, chemical, biological, or microbiological characteristic that must be controlled within an appropriate range to ensure the desired product quality. These attributes have a…
Once regulatory direction is clear, the next step is formulation developmentâthe heart of generic product success. But remember, formulation is not just about blending ingredients. Itâs a strategic and scientific process. The goal is not only to match the innovator product (RLD), but to ensure your formulation is bioequivalent, manufacturable, stable, and regulatory compliant. Hereâs…
Optimizing API particle size is pivotal for tablets and capsulesâimpacting flow, compressibility, content uniformity and ultimately, drug performance. Start with the APIâs 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…
Adjusting polymer content in a sustained-release dosage form requires a systematic approach to maintain the desired drug release profile while ensuring manufacturability and regulatory compliance. Role of the Polymer in Drug Release Control Polymers in sustained-release formulations act as matrix formers, coating agents, or swelling/erosion regulators. For example, HPMC, Ethylcellulose (EC), and Polyethylene Oxide (PEO)…
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