Plants of the genus Limonium gmelinii (L. gmelinii), recognized as an official pharmacopoeial raw material in Kazakhstan, show great potential for medical applications due to their accessibility and valuable biological properties. Developing new phytomedicines is challenging due to variable chemical composition from genetic, ecological, and seasonal factors. This study aimed to develop and validate a technology for gel formulations using phytosubstances (API) from L. gmelinii, following ICH Q8 guidelines. Results: Compatibility of excipients and APIs was confirmed through IR spectral analysis and visual evaluation. No physical changes were observed after 30 days of storing API solutions with excipients. All gel samples exhibited acceptable pH, transparency, homogeneity, and stability during phase separation tests. The 1.0% carbomer and the 10.0% propylene glycol concentration was found to be optimal based on release kinetics and rheological characteristics. Validation tests of lab batches showed Cp and Pp > 1.33, indicating high process capability, though Cpk and Ppk were negative. This issue is common with herbal preparations, which often have only lower specification limits and require more data collection for stability assessment. Gel containing 7.0% API showed the best anti-inflammatory effects in vivo on the formalin-induced paw edema model in mice, outperforming Diclofenac gel, while gel with 5.0% API had comparable effectiveness, demonstrating a dose-dependent anti-inflammatory effect, with higher efficacy observed in gels made from the aerial parts compared to the roots. Validation confirmed the process's compliance with international standards, controllability, and potential for successful scaling. Further monitoring and optimization are necessary to ensure stability and reproducibility when scaling up production. 

Dariya Kassymova is a PhD candidate at the Department of Chemistry and Technology of Organic Substances, Natural Compounds, and Polymers at al-Farabi Kazakh National University. Her research focuses on developing and validating technological schemes for obtaining substances from Limonium Mill plants and preparing plant-based gels. Dariya has interned at the University of Valencia, La Sapienza University of Rome, The National Center of Expertise of Medicines and Medical Devices, and Abdi Ibrahim Global Pharm. She has published more than 10 papers and abstracts in reputed journals and conference proceedings.