Abstract
Compounded oral preparations, made with use of manufactured products as sources of active pharmaceutical ingredients, are characterized by short beyond-use-dates due to their instability.Aim: The aim of this study is to investigate the physical, chemical and microbiological stability of compounded furosemide syrups within a 30 days period.Methods: Batches of 5 mg/ml compounded syrups, using furosemide substance and commercial tablets (two brands) as sources of active pharmaceutical ingredients, were stored in the dark at 5±3 °C and 23±2 °C and examined at days 0, 7, 15, 23, and 30 for changes in physical (pH, formation of colour, gas, odour and changes in viscosity), chemical and microbial stability. A stress test was conducted in order to distinguish signs of chemical instability using a stability-indicating thin-layer chromatographic method. Bacterial inoculation of these samples were examined for microbial stability based on the total aerobic microbial count (TAMC <100), the total combined yeasts/moulds count (TYMC <10) and absence of Escherichia coli.Results: Throughout the storage period the investigated syrups showed no extra spots on the chromatogram, no significant changes in pH, colour, odour, gas formation, viscosity. On day 30, the content (≥99.3%) of furosemide, total aerobic microbial count (< 102), total combined yeasts/moulds count (<101) in studied samples were within acceptable limits. Stressed samples showed presence of extra and diminished spots.Conclusions: Extemporaneous syrups of furosemide substance and dispersed furosemide tablets, stored in glass bottles in the dark at 5±3 °C and 23±2 °C, was found to be physically, chemically and microbiologically stable for at least 30 days
Highlights
The need for compounded preparations as a panacea for patient-specific dosing, logistical and therapeutical quagmires in pharmacotherapy is usually faced with the challenge of affirming their stability
Dispersed solid dosage forms are often used as active pharmaceutical
Formulation of the problem in a general way, the relevance of the theme and its connection with important scientific and practical issues Excipients from finished products in extemporal oral liquids alter the environment and properties of the dispersion medium and this may lead to microbiological, chemical or physical instability. These in turn are reflected in formation of unwanted products, degradation and change in potency or strength of active pharmaceuticalNo5(9)2017 ingredients (API)
Summary
The need for compounded preparations as a panacea for patient-specific dosing, logistical and therapeutical quagmires in pharmacotherapy is usually faced with the challenge of affirming their stability. No5(9)2017 ingredients (API) in compounding oral dosage forms for patients whose prescriptions contain doses different from available standard manufactured formulations [1, 2]. Excipients from finished products in extemporal oral liquids alter the environment and properties of the dispersion medium (pH, viscosity, etc) and this may lead to microbiological, chemical or physical instability. These in turn are reflected in formation of unwanted products, degradation and change in potency or strength of API. Due to these factors, certain limits on beyond-use-dates (BUDs) were introduced to manage potential risks from extemporaneous preparations with unknown stability data. Analysis of recent studies and publications in which a solution of the problem are described and to which the author refers
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