Design and physicochemical stability studies of paediatric oral formulations of sildenafil

• Published in: International journal of pharmaceutics
• Main Authors: Provenza Bernal, Nora, Calpena Campmany, Ana Cristina, Mallandrich Miret, Mireia, Halbaut, Lyda, Clares Naveros, Beatriz
• Format: Journal Article
• Language: English
• Published: Elsevier B.V 11-11-2013
• Subjects: Administració de medicaments; Administration of drugs; Drug stability; Estabilitat dels medicaments; Farmacologia pediàtrica; Medicació oral; Oral medication; Pediatric pharmacology
• ISSN: 0378-5173

Abstract 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.