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Title: Development, physical-chemical stability and release studies of four alcohol-free spironolactone suspensions for use in pediatrics
Author: Provenza Bernal, Nora
Calpena Campmany, Ana Cristina
Mallandrich Miret, Mireia
Ruiz Martínez, Mª Adolfina
Clares Naveros, Beatriz
Keywords: Medicació oral
Suspensions (Química)
Estabilitat dels medicaments
Sistemes d'alliberament de medicaments
Farmacologia pediàtrica
Oral medication
Suspensions (Chemistry)
Drug stability
Drug delivery systems
Pediatric pharmacology
Issue Date: Feb-2014
Publisher: Dissolution Technologies Inc.
Abstract: Dissolution studies have become of great significance because, in most cases, drug dissolution is the rate-limiting step in the absorption process. As occurs with solid oral dosage forms, heterogeneous disperse systems (suspensions) could also have some problems with their in vitro dissolution. The objective of this study was to evaluate influence of the excipients on the release of spironolactone from four alcohol free suspensions (pharmaceutical compounding) of spironolactone 5 mg/mL suitable for pediatric use. Also the comparison of the physical and chemical stability of the suspensions stored at 4, 25 and 40 ºC over a 60- day period has been studied. Rheological behavior, particle size, a prediction of long-term physical stability, pH and assay of spironolactone by HPLC were assessed at prefixed times. The dissolution profile of each suspension was determined and compared with that of the commercial tablets. A microbiological study of the best formula was also performed. Chemically, the four spironolactone suspensions were stable for 60 days stored at three temperatures; Suspension IV had optimum pH values and the highest recovery percentage. In terms of physical stability, sedimentation occurred in Suspension IV and flotation of spironolactone in Suspensions I, II and III. Suspension III had the highest viscosity and the slowest drug release. Suspension IV was also microbiologically stable for 60 days. In conclusion, Suspension IV had the best properties and the least suitable form was Suspension III, as its high viscosity made it difficult to achieve homogeneous redispersion, and it had the slowest dissolution profile.
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It is part of: Dissolution Technologies, 2014, vol. 21, num. 1, p. 19-30
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ISSN: 1521-298X
Appears in Collections:Articles publicats en revistes (Farmàcia, Tecnologia Farmacèutica i Fisicoquímica)

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