Design and physicochemical stability studies of paediatric oral formulations of sildenafil.
Personalized medicine is a challenging research area in paediatric treatments. Elaborating new paediatric formulations when no commercial forms are available is a common practice in pharmacy laboratories; among these, oral liquid formulations are the most common. But due to the lack of specialized equipment, frequently studies to assure the efficiency and safety of the final medicine cannot be carried out. Thus the purpose of this work was the development, characterization and stability evaluation of two oral formulations of sildenafil for the treatment of neonatal persistent pulmonary hypertension. After the establishment of a standard operating procedure (SOP) and elaboration, the physicochemical stability parameters appearance, pH, particle size, rheological behaviour and drug content of formulations were evaluated at three different temperatures for 90 days. Equally, prediction of long term stability, as well as, microbiological stability was performed. Formulations resulted in a suspension and a solution slightly coloured exhibiting fruity odour. Formulation I (suspension) exhibited the best physicochemical properties including Newtonian behaviour and uniformity of API content above 90% to assure an exact dosification process.
Department of Biopharmacy and Pharmaceutical Technology, School of Pharmacy, University of Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain.
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Provenza
Department of Biopharmacy and Pharmaceutical Technology, School of Pharmacy, University of Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain.
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Calpena
Department of Biopharmacy and Pharmaceutical Technology, School of Pharmacy, University of Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain.
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Mallandrich
Department of Biopharmacy and Pharmaceutical Technology, School of Pharmacy, University of Barcelona, Av. Joan XXIII s/n, 08028 Barcelona, Spain.
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Halbaut
Department of Pharmaceutical Technology, School of Pharmacy, University of Granada, Campus of Cartuja street s/n, 18071 Granada, Spain. Electronic address: beatrizclares@ugr.es.
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Clares
D000284:Administration, Oral; D002626:Chemistry, Pharmaceutical; D002648:Child; D004355:Drug Stability; D006801:Humans; D006863:Hydrogen-Ion Concentration; D010316:Particle Size; D019999:Pharmaceutical Solutions; D058986:Phosphodiesterase 5 Inhibitors / Q000737:chemistry*; D010879:Piperazines / Q000737:chemistry*; D011687:Purines / Q000737:chemistry; D000068677:Sildenafil Citrate; D013450:Sulfones / Q000737:chemistry*; D013535:Suspensions; D014783:Viscosity
D019999:Pharmaceutical Solutions; D058986:Phosphodiesterase 5 Inhibitors; D010879:Piperazines; D011687:Purines; D013450:Sulfones; D013535:Suspensions; D000068677:Sildenafil Citrate
Drug administration; Paediatric; Sildenafil oral formulations; Stability