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Stability evaluation of an extemporaneously compounded carbimazole oral suspension
Author(s) -
Song Yunmei,
Lwin Ei Mon Phyo,
Ellis David,
Turner Sean,
Williams Desmond,
Garg Sanjay
Publication year - 2020
Publication title -
journal of pharmacy practice and research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.222
H-Index - 22
eISSN - 2055-2335
pISSN - 1445-937X
DOI - 10.1002/jppr.1631
Subject(s) - carbimazole , medicine , suspension (topology) , chromatography , chemical stability , anesthesia , chemistry , mathematics , organic chemistry , disease , homotopy , graves' disease , pure mathematics
Abstract Aims To examine the physical, chemical and microbiological stability characteristics of an extemporaneously compounded carbimazole 2 mg/mL oral suspension. Methods and Results To determine the chemical stability of carbimazole in oral suspension, an analytical method was developed with high‐performance liquid chromatography (HPLC) that achieved a good resolution of the analysis. The physical and chemical stability studies of the drug were conducted at four different storage conditions: 4°C, 25°C, 4°C in‐use (to simulate a patient daily use condition), and 7 days at 4°C and 3 days at 25°C (to simulate a condition in which a patient does not return the medication back into the refrigerator after use). The microbiological test was performed on the “4°C in‐use” storage condition. The preparations were found to be physically and microbiologically stable since there were no significant changes in colour, odour, dispersion and microbial contamination tests. Regarding chemical stability, samples stored at 4°C and 25°C maintained more than 90% drug recovery limit for up to 3 weeks and 3 days, respectively. There were no significant changes in pH value for up to 6 weeks. Conclusion A shelf life of up to 19 days at 4°C, based on the 95% lower confidence interval (CI) of the data obtained, and 2 days at room temperature can be recommended for carbimazole oral suspension.