E-DRUG: RFI: frusemide oral liquid from injection (or tablet?)(3)
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Dear Evans:
the following article has a furosemide oral preparations.
Stability of Furosemide in Extemporaneously Prepared Oral Solutions
Chedsada Noppawinyoowong1 Janya Srisangchun1 Chuleekorn Sirisangtragul2
Jomjai Sujja-areevath3 Aroonsri Primpree 3Chulaporn Limwattananon2
1Pharmaceutical Manufacturing Unit, Srinagarind Hospital, Faculty of Medicine, and the Departments of 2Clinical Pharmacy and 3Pharmaceutical Technology , Faculty of Pharmacy, Khon Kaen University, Thailand
Background: A number of pharmaceutical dosage forms that are not commercially available, especially oral liquid forms must be made in the hospital's pharmaceutical-manufacturing unit. Preparations can be prepared from pure drug powder or from commercially available dosage forms (i.e. tablets, capsules, or injection). Before finally deciding on a formulation and assigning an expiry date, the appropriateness of an in-house oral mixture must be tested for its stability and compatibility.
Objective: To compare the stability of refrigerated (4°C) and room temperature (30°C) furosemide oral solutions (1 mg/ml) in various pHs (7.5, 8.5 and 9.5).
Design: An experimental study
Setting: Faculties of Medicine and Pharmaceutical Sciences, Khon Kaen University, Thailand
Subjects: Furosemide oral solutions (1 mg/ml) at pHs 7.5, 8.5 and 9.5 were prepared by mixing furosemide injection (20mg/2ml) with a vehicle comprising glycerin 21%, sorbitol 60%, sodium benzoate 0.12%, and distilled water. The pH was adjusted using diluted NaOH. The solutions were then stored in amber glass bottles at 4°C and 30°C.
Outcome Measurement: On days 0, 7, 14, 21, 28 and 42, a sample from each bottle was inspected for change in color, precipitate and pH. Each sample was analyzed for the remaining furosemide by high performance liquid chromatography and expressed as a percentage of original composition.
Results: No precipitate or color change was observed in any of the samples. The pH of all samples decreased significantly (p<0.05). By day 42, the concentration of furosemide in each of the oral solutions was greater than 90% (lower limit of the 95% CI).
Conclusions: The furosemide oral solutions (1 mg/ml) made from injections and a vehicle (comprising glycerin 21%, sorbitol 60%, sodium benzoate 0.12% and distilled water) pHs 7.5 to 9.5, stored in amber glass bottles at either 4oC or 30°C, were physically and chemically stable for 42 days. Change of pH had no effect on the stability of the mixture.
Source: http://ae.md.kku.ac.th/thai/abstract/poster/stability_of_furosemide_in_extem.htm
Daniel Domosbian, pharmacist
Drug Information Center
Colegio de Farmacéuticos de la Provincia de Bs. As.
calle 5 nº 966
(1900) La Plata
Bs. As.
Argentina