TY - JOUR
T1 - Determination of Hardness of a Pharmaceutical Oral Jelly by Using T2 Relaxation Behavior Measured by Time-Domain NMR
AU - Tsuji, Takahiro
AU - Kobayashi, Ryosuke
AU - Hayashi, Yoshihiro
AU - Kumada, Shungo
AU - Mizuguchi, Mineyuki
AU - Okada, Kotaro
AU - Onuki, Yoshinori
N1 - Publisher Copyright:
© 2022 The Pharmaceutical Society of Japan.
PY - 2022/8/1
Y1 - 2022/8/1
N2 - Hardness is a critical quality characteristic of pharmaceutical oral jelly. In this study, the hardness was determined by using the T2 relaxation curves measured by time-domain NMR. For sample preparation, kappa- and iota-carrageenans, and locust bean gum, were used as gel-forming agents. Ten test jellies with different gel-forming agent composition were prepared, and their hardness and T2 relaxation curves were measured by a texture analyzer and time-domain NMR (TD-NMR). A negative correlation between T2 relaxation time (T2) and hardness was observed; however, it was difficult to determine the hardness directly from the T2 value. That is probably because the T2 relaxation curve contains information about molecular states, not only of water but also of the solute, and T2 values calculated by single-exponential curve fitting only express one property of the test jelly. By considering this issue, partial least squares (PLS) regression analysis was performed on the T2 relaxation curves for hardness determination of the test jellies. According to the analysis, an accurate and reliable PLS model was created that enabled accurate assessment of the hardness of the test jellies. TD-NMR enables the measurement of samples nondestructively and rapidly with low cost, and so could be a promising method for evaluation of the hardness of pharmaceutical oral jellies.
AB - Hardness is a critical quality characteristic of pharmaceutical oral jelly. In this study, the hardness was determined by using the T2 relaxation curves measured by time-domain NMR. For sample preparation, kappa- and iota-carrageenans, and locust bean gum, were used as gel-forming agents. Ten test jellies with different gel-forming agent composition were prepared, and their hardness and T2 relaxation curves were measured by a texture analyzer and time-domain NMR (TD-NMR). A negative correlation between T2 relaxation time (T2) and hardness was observed; however, it was difficult to determine the hardness directly from the T2 value. That is probably because the T2 relaxation curve contains information about molecular states, not only of water but also of the solute, and T2 values calculated by single-exponential curve fitting only express one property of the test jelly. By considering this issue, partial least squares (PLS) regression analysis was performed on the T2 relaxation curves for hardness determination of the test jellies. According to the analysis, an accurate and reliable PLS model was created that enabled accurate assessment of the hardness of the test jellies. TD-NMR enables the measurement of samples nondestructively and rapidly with low cost, and so could be a promising method for evaluation of the hardness of pharmaceutical oral jellies.
KW - T2 relaxation time
KW - hardness
KW - oral jelly
KW - partial least squares regression
KW - time-domain NMR
UR - http://www.scopus.com/inward/record.url?scp=85135211621&partnerID=8YFLogxK
U2 - 10.1248/cpb.c22-00261
DO - 10.1248/cpb.c22-00261
M3 - 学術論文
C2 - 35908922
AN - SCOPUS:85135211621
SN - 0009-2363
VL - 70
SP - 558
EP - 565
JO - Chemical and Pharmaceutical Bulletin
JF - Chemical and Pharmaceutical Bulletin
IS - 8
ER -