Abstract Herbal drugs hold significant therapeutic potential but face formulation challenges limiting clinical use; solid dispersion (SD) based formulations address this by embedding herbal actives in polymer carriers via spray drying, yielding stable, uniformly dispersed particles with enhanced bioavailability. This study presents a standardized, reproducible protocol for SD development from a single herb, drawing from ICH, FDA, and WHO guidelines. The workflow spans herb authentication, extraction and marker identification, spray-dried formulation with defined Critical Process Parameters, and multi-faceted characterization including particle size distribution, X-ray diffraction, Differential Scanning Calorimetry, Thermogravimetric analysis, and infrared spectroscopy targeting Critical Quality Attributes like particle size, drug loading, encapsulation efficiency, dissolution, and stability. Employing a Quality by Design framework with QTPP, risk assessment, control strategy, and validation across three independent batches with acceptance criteria. The protocol emphasizes polymeric carriers for improved dissolution, rigorous testing, DoE, and preliminary biological screening as prerequisites for scale-up and clinical translation. This science-based approach ensures reproducibility, regulatory compliance, and progress toward clinical applicability.
Pruthi et al. (Thu,) studied this question.
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