¹Department of Pharmaceutical Technology, Hamidiye Faculty of Pharmacy, University of Health Sciences Türkiye, Tıbbiye St., No:38, Üsküdar, İstanbul, Türkiye
²SFA R&D Private Health Services, Teknopark Blv, No:1 3A Z01, Teknopark Istanbul, Pendik, Istanbul, Türkiye
³Süleyman Demirel University, Faculty of Pharmacy, Department of Pharmaceutical Technology, Türkiye DOI : 10.29228/jrp.2024.00 Individuals deficient in melatonin are more prone to experiencing difficulties with sleep. The creation of an orally disintegrating tablet formulation of melatonin (MT) would enable a rapid and efficacious response to the population's needs. This formulation is suitable for all individuals, including the elderly and children, and is also preferred due to its pleasant taste. The text in question discusses the role of pyridoxine (PY) as a vital coenzyme involved in a number of physiological processes within the human body. The text emphasises the necessity of obtaining pyridoxine (PY) from external sources, given that the body is incapable of producing it autonomously. Moreover, the text delineates the formulation of a tablet containing both MT and PY, which is designed for convenient use and enhanced efficacy. Moreover, the text delineates the exhaustive testing regimen, which encompasses weight deviation, friability, disintegration time, moisture content, diameter and height measurements, and hardness tests, to ensure the physical stability of the manufactured tablets. The aforementioned tests demonstrated that the tablet satisfied the criteria set forth in the European Pharmacopoeia. The results of the physical tests conducted on the tablet containing MT and PY demonstrated that the values obtained were within the desired range and in accordance with the standards set forth in the European Pharmacopoeia. The mean hardness of the manufactured tablets was determined to be within the range of 27 ± 3.2 to 35 ± 1.5 Newton. In the friability test, the efficiency ratio was calculated to be 99.793. It is a widely accepted principle that the diameter and thickness of tablets should be 1/4. The results demonstrate that all ODTs exhibit this characteristic. The tablets were found to possess both hardness and friability, which ensures that the tablet remains stable and reduces losses to a minimum. The mean diameter of the tablets was found to be 7.08 ± 0.01 mm, with a mean height of 2.50 ± 0.01 mm. Furthermore, the mean diameter was determined to be 6.97 ± 0.01 mm, with a mean height of 3.21 ± 0.01 mm. The standardisation of the tablets was successfully accomplished. The disintegration test yielded an average disintegration time of between 20 and 28 seconds for the tablets in the oral cavity, which was deemed optimal. In conclusion, the text suggests that further evaluation through in vivo and in vitro tests could be conducted to further develop the formulation. Keywords : Melatonin; pyridoxine (vitamin B6); orodispersible tablet; formulation; physical analysis