Introduction: Ursodeoxycholic acid (UDCA) is used to treat liver and biliary disorders, including neonatal jaundice. In neonatal practice, UDCA administered orally (10–30 mg/kg/day, divided doses) shortens phototherapy duration and reduces serum total bilirubin. A suspension dosage form may mask bitter taste, improve dissolution and bioavailability, and is not currently registered in Mongolia. To develop and evaluate suspension formulations of UDCA and to identify an optimal composition and manufacturing technology. Methods: UDCA drug substance was characterized according to the European Pharmacopoeia (EP 11.0). Five suspension formulations (A1–A5) were prepared using wet-milling (size-reduction) technology and appropriate excipients. Physical, chemical and microbiological quality attributes of the suspensions were assessed per the United States Pharmacopeia (USP 2021) and microbiological methods of the Pharmacopoeia of the Russian Federation (GOST 2018). Assays were performed by validated chromatographic methods; measurements were performed in triplicate (n=3).
The UDCA raw material met pharmacopeial specifications and was suitable for use. All five formulations were uniform and free of agglomerates by visual inspection. Formulation A5 met USP acceptance criteria for pH (4.5 ± 0.02), sedimentation volume (0.91 ± 0.20 mL), density (1.14 ± 0.005 g/cm3), viscosity (1583.5 ± 0.38 mPa·s), fill volume (150 ± 0 mL) and active substance content (96.6 ± 0.05%), and complied with microbiological limits. Other formulations failed one or more quality attributes (notably pH, assay or sedimentation). Conclusion The UDCA raw material complied with pharmacopeial quality standards. Among tested variants, formulation A5 satisfied critical quality attributes for a stable suspension and was identified as the optimal formulation with respect to composition and manufacturing process.

Introduction: Doxylamine succinate has an anticholinergic effect and is an antihistaminic active compound. Drugs containing this active compound relieve the symptoms of allergies, allergic rhinitis, and the common cold and treat short-term insomnia.
In Mongolia’s National Drug Registration list, five doxylamine succinate-based tablets are cataloged, and imported from France, Turkey, Slovenia, India, and South Korea. Doxylamine succinate tablets have not yet been introduced into production within domestic industries. Therefore, we have developed tablets featuring novel technology and standardization. Purpose: This study aims to investigate the research on technology and standardization of doxylamine succinate tablets and assess the viability of their introduction into domestic manufacturing. Methods: For the technological study, the main raw material was purchased from Apollo Healthcare Ltd. in China, and tablets of 5 versions were obtained by wet granulation compression method. Carr’s index and Hausner’s ratio of the granules were calculated according to the British pharmacopeia.
For the standardization study, we purchased standards from Sigmaaldrich® and determined physical, and chemical parameters by Mongolian National Pharmacopoeia (MNP) and United States Pharmacopoeia (USP). Results: Version 2’s Carr’s index was 8.15%, and Hausner’s ratio was 1.09, indicating that the tablet’s compressibility and flowability of granules are excellent. Moreover, version 3’s Carr’s index was 10.70%, and Hausner’s ratio was 1.12, which indicates the tablet’s compressibility and flowability of granules are good.
Both versions above met the requirements as appearance, friability, breaking force, weight variation limits, dissolution, and assay according to USP and MNP. Despite that, only version 3 conformed to disintegration for requirements outlined in the MNP. Conclusion The assay determination method has been validated following ICH guidelines and the quality attributes of the tablet have been specified. Based on the results obtained, version 3 of the experimental tablets is deemed feasible for introduction into production.