title: Effect of pharmaceutical excipients on the stability of trichlormethiazide tablets under humid conditions.
abstract: The stability of trichlormethiazide (TCM) and the drug in the nine products available on the market (the original tablet (B) and 8 generic tablets (G1-G8)) were investigated under humid conditions. TCM was non-hygroscopic and was not degraded under humid conditions. Drug degradation in aqueous ethanol was accelerated with increased water concentration, and the drug stability in buffer solution was improved with decreased pH. TCM decomposition was not detected in each unwrapped tablet at low relative humidity. However, rapid degradation was observed for products G1 and G2, while product B and G7 showed higher stability at high relative humidity. The stability of products G1 and G2 decreased with increasing humidity. The same results were observed for the tablets in press-through packages (PTP), but the degradation rate was much slower than tablets without PTP packages. These results suggested that the adsorbed moisture by excipients cause TCM degradation. Various pharmaceutical excipients are added to TCM tablets and these vary between different pharmaceutical companies. Intact drug and pharmaceutical excipients, including lactose, microcrystalline cellulose, corn starch, hydroxypropylcellulose (HPC), low substituted HPC (L-HPC), calcium stearate, and light anhydrous silicic acid, were mixed, and the sample mixtures were stored in humid conditions. It was found that the TCM content decreased significantly in a binary mixture of TCM/HPC 1 : 1.
authors: Department of Pharmaceutical Technology, Kobe Pharmaceutical University, Motoyama-kitamachi, Higashi-nada, Japan. teraoka@kobepharma-u.ac.jp
authors: Reiko
authors: R
authors: Teraoka
authors: Yuki
authors: Y
authors: Matsushima
authors: Isao
authors: I
authors: Sugimoto
authors: Kana
authors: K
authors: Inoue
authors: Shin-ya
authors: SY
authors: Morita
authors: Shuji
authors: S
authors: Kitagawa
mesh_terms: D000959:Antihypertensive Agents / Q000737:chemistry*; D004355:Drug Stability; D000431:Ethanol / Q000737:chemistry; D005079:Excipients / Q000737:chemistry* / Q000494:pharmacology; D006813:Humidity; D006863:Hydrogen-Ion Concentration; D008969:Molecular Sequence Data; D013607:Tablets; D014237:Trichlormethiazide / Q000737:chemistry*; D014867:Water / Q000737:chemistry; D017155:Wettability
chemical_list: D000959:Antihypertensive Agents; D005079:Excipients; D013607:Tablets; D014867:Water; D000431:Ethanol; D014237:Trichlormethiazide