TY - JOUR
T1 - Photostability studies on (±)-TRAmadol in a liquid formulation
AU - Suno, Manabu
AU - Ichihara, Hidenori
AU - Ishino, Takahiro
AU - Yamamoto, Kento
AU - Yoshizaki, Yuta
N1 - Funding Information:
This work was supported in part by the Japan Society for the Promotion of Science Grant-in-Aid for Scientific Research (C) Grant Number 25460213.
Publisher Copyright:
© 2014 Suno et al.; licensee BioMed Central.
PY - 2015/2/5
Y1 - 2015/2/5
N2 - Background: Tramadol ((±)-TRA) is recommended for the treatment of mild to moderate cancer pain by the World Health Organization. An oral liquid formulation of (±)-TRA is preferable for patients with a compromised swallowing function. However, the stability of (±)-TRA in aqueous solution has yet to be determined in a clinical setting. The aim of this study was to evaluate the photostability of (±)-TRA in aqueous solution in a clinical setting. Methods: We improved high performance liquid chromatography (HPLC) method for the enantiomeric separation of (±)-TRA, and then the (±)-TRA concentration was determined using HPLC method. We investigated the photodegradation of (±)-TRA in an aqueous solution irradiated with ultraviolet (UV) light: UV-A, UV-B, and UV-C. We also evaluated the stability of liquid formulations of (±)-TRA in a clinical setting by keeping (±)-TRA aqueous solution in normal dispensing bottles and in light-shading dispensing bottles under conditions of both sunlight and diffused light in a room. Samples were collected sequentially over time. Results: (±)-TRA in aqueous solution was degraded the most rapidly when irradiated with UV-C, but was not affected by irradiation with UV-A. No significant difference was observed in the photodegradation behavior of (+)-TRA and (-)-TRA with UV-A, UV-B, and UV-C irradiation. The residual percentages of (±)-TRA were 94.6-104.3% after 14 days in the presence of either sunlight or diffused light in a room, with or without protection from light. Conclusions: These results demonstrated the stability of (±)-TRA in aqueous solution to both sunlight and diffused light in a room. Therefore, liquid formulations of TRA are preserved at room temperature for up to 2 weeks, with or without protection from light. Our results provide additional treatment options with tramadol for pain control.
AB - Background: Tramadol ((±)-TRA) is recommended for the treatment of mild to moderate cancer pain by the World Health Organization. An oral liquid formulation of (±)-TRA is preferable for patients with a compromised swallowing function. However, the stability of (±)-TRA in aqueous solution has yet to be determined in a clinical setting. The aim of this study was to evaluate the photostability of (±)-TRA in aqueous solution in a clinical setting. Methods: We improved high performance liquid chromatography (HPLC) method for the enantiomeric separation of (±)-TRA, and then the (±)-TRA concentration was determined using HPLC method. We investigated the photodegradation of (±)-TRA in an aqueous solution irradiated with ultraviolet (UV) light: UV-A, UV-B, and UV-C. We also evaluated the stability of liquid formulations of (±)-TRA in a clinical setting by keeping (±)-TRA aqueous solution in normal dispensing bottles and in light-shading dispensing bottles under conditions of both sunlight and diffused light in a room. Samples were collected sequentially over time. Results: (±)-TRA in aqueous solution was degraded the most rapidly when irradiated with UV-C, but was not affected by irradiation with UV-A. No significant difference was observed in the photodegradation behavior of (+)-TRA and (-)-TRA with UV-A, UV-B, and UV-C irradiation. The residual percentages of (±)-TRA were 94.6-104.3% after 14 days in the presence of either sunlight or diffused light in a room, with or without protection from light. Conclusions: These results demonstrated the stability of (±)-TRA in aqueous solution to both sunlight and diffused light in a room. Therefore, liquid formulations of TRA are preserved at room temperature for up to 2 weeks, with or without protection from light. Our results provide additional treatment options with tramadol for pain control.
KW - Liquid formulation
KW - Photodegradation
KW - Photostability
KW - Tramadol
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U2 - 10.1186/s40780-014-0003-2
DO - 10.1186/s40780-014-0003-2
M3 - Article
AN - SCOPUS:85088417235
VL - 1
JO - Journal of Pharmaceutical Health Care and Sciences
JF - Journal of Pharmaceutical Health Care and Sciences
SN - 2055-0294
IS - 1
M1 - 5
ER -