Quality Evaluation of Humidified Magnesium Oxide Tablet Formulations with Respect to Disintegration Time Prolongation
In the present study, we conducted a detailed evaluation of the effects of humidification on the quality of five types of commercial magnesium oxide (MgO) tablet formulations. When near-IR spectroscopy was performed, a peak derived from the first overtone of the stretching vibration of the hydroxyl group was observed at approximately 7200 cm−1 in a humidified MgO tablet formulation. To visually evaluate the effect of this humidification, a mapping image was created using microscopic IR spectroscopy. In the IR spectrum, a peak derived from the stretching vibration of the hydroxyl group appears at approximately 3700 cm−1, so we created a mapping image using the absorbance ratio of 3700 and 3400 cm−1 as an index. In the mapping image of humidified MgO tablet formulations, many areas had a higher absorbance ratio than the dried tablet formulations.
From these results, it is qualitatively confirmed that the MgO was changed to magnesium hydroxide (Mg(OH)2) by humidification. Although these results were observed in the four types of MgO tablet formulations, only one type of tablet formulation was less affected by humidification. In addition, although most tablet formulations tended to prolong disintegration time due to humidification, there was almost no effect of humidification on the disintegration time in one type of tablet formulation, which had little change in the above evaluation. Thus, in most commercial MgO tablet formulations, humidification prolongs the disintegration time, and Mg(OH)2 significantly contributes to this factor.
Materials
Microcrystalline cellulose (CEOLUS® UF-702, MCC) and L-hydroxypropyl cellulose (LH-21, L-HPC) were purchased from Asahi Kasei Chemicals (Tokyo, Japan) and Shin-Etsu Chemical (Tokyo, Japan), respectively. Croscarmellose sodium (Ac-Di-Sol®, Cr-CMC-Na) was purchased from FMC Health and Nutrition (Philadelphia, United States). Carmellose calcium (E.C. G-505®, CMC-Ca) were purchased from Gotoku Chemical (Tokyo, Japan). Crospovidone (Polyplasdone™ XL-10, CP) was purchased from Ashland (Covington, United States).
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Yoshihisa Yamamoto, Kosuke Ohgi, Yoshinori Onuki, Toshiro Fukami and Tatsuo Koided, Quality Evaluation of Humidified Magnesium Oxide Tablet Formulations with Respect to Disintegration Time Prolongation, Chem. Pharm. Bull. 165–174, Volume 71, 2023, ISSN: 1347-5223
https://doi.org/10.1248/cpb.c22-00798