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.