Application of instrumental evaluation of color for the pre-formulation and formulation of rabeprazole.
The aims of this study were to fast screen the compatibility of rabeprazole and excipients using a spectrocolorimeter and to examine the relationship between the color change value and drug contents/drug degradation products in solid dosage forms. The color change values of rabeprazole-excipient mixtures were measured using a spectrocolorimeter, with six tablet formulations compressed using a single-punch instrumental tablet press. The rabeprazole and degradation products contents in the tablets were analyzed using an HPLC method, with the color change values of the tablets measured using spectrocolorimetery for 4 weeks. These experiments indicated that the instrumental evaluation of color was a speedy, simple and useful tool in the determination of the interaction between the drug and excipients, as well as in the formulation of solid dosage forms. The relationships of the % reduced drug contents versus the color change value, and those of the % drug degradation products versus the color change value were exponentially increased in formulations containing zinc stearate. On stress testing, the color change value of rabeprazole was inconsistent with previous reports, as the degradation of rabeprazole can be greatly influenced by humidity as well as temperature. Consequently, these results highlight the potential of color formation in the application of pre-formulation and formulation of drugs.
Rhee
Yun-Seok
YS
College of Pharmacy, Sungkyunkwan University, Jangan-gu, Suwon, Gyeonggi-do 440-746, Republic of Korea.
Park
Chun-Woong
CW
Shin
Yoon-Sub
YS
Kam
Sung-Hoon
SH
Lee
Kyu-Hyun
KH
Park
Eun-Seok
ES
D053799:2-Pyridinylmethylsulfinylbenzimidazoles / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical; D002851:Chromatography, High Pressure Liquid; D003116:Color; D004355:Drug Stability; D005079:Excipients; D064750:Rabeprazole
D053799:2-Pyridinylmethylsulfinylbenzimidazoles; D005079:Excipients; D064750:Rabeprazole