Stability of Frusemide Tablets Repackaged in Dose Administration Aids
نویسندگان
چکیده
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 oC) 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
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