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Stability of Frusemide Tablets Repackaged in Dose Administration Aids
Author(s) -
Bowen Luke,
Mangan Martina,
Haywood Alison,
Glass Beverley
Publication year - 2007
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/j.2055-2335.2007.tb00738.x
Subject(s) - medicine , chemical stability , dosage form , dissolution , active ingredient , pharmacology , chemistry , organic chemistry
Background Repackaging tablets into a dose administration aid (DAA) requires that the pharmacist consider the stability of the active pharmaceutical ingredient and the excipients of the drug product. Frusemide is susceptible to photodegradation and is commonly repackaged into DAAs. Aim To evaluate the stability (chemical and physical) of frusemide tablets repackaged into DAAs. Method Frusemide tablets repackaged into DAAs were evaluated for physicochemical stability over a period of 8 weeks at a controlled room temperature (25 ±2 °C) and other relevant in‐use conditions. In addition, photostability studies were performed according to the International Committee on Harmonisation (ICH) guidelines. Results Chemical stability was confirmed for all storage conditions, including the ICH light conditions, with the frusemide content within the British Pharmacopoeial range of 95 to 105%. Although the physical stability was confirmed by all tests (weight uniformity, hardness, friability, disintegration, dissolution), storage in a simulated pharmacy environment after one week and exposure to ICH light conditions resulted in a yellow colouration of the tablets. Conclusion Although the chemical and physical stability of frusemide was within acceptable limits during the study, the discolouration of the tablets from light exposure is unacceptable. It is recommended that DAAs are stored protected from light immediately after repackaging with frusemide tablets, and that patients are counselled to store the DAA in a cool dark place.