Design and physicochemical stability studies of paediatric oral formulations of sildenafil

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.

First Development, Optimization, and Stability Control of a Pediatric Oral Atenolol Formulation

“…The microbial count was considered to be the average number of the colony forming units (cfu) found in agar. Liquid oral formulations would meet the microbial requirements if the total aerobic microbial count was less than 10 2 cfu/mL, the total combined yeast/mold countless than 10 1 cfu/mL, and confirmed the absence of Escherichia coli (31).…”

Paediatric Medicines: Formulation Considerations

“…Although there is lack of studies on the quality and stability of extemporaneous preparations, some authors have developed stability studies with simple formulations for some drugs frequently administered off-label and unlicensed, such as sildena il [15,16], metformin [17], clonidine [18], propafenone [19]. Moreover the bioavailability of extemporaneous preparations is not studied, however it is well known that the bioavailability of the drug is modi ied when a dosage form is extemporaneously compounded [11,20].…”

Development of reconstitutable suspensions containing diclofenac sodium-loaded microspheres for pediatric delivery

“…This is the typical behaviour of pseudoplastic fluids. It could be probably due to the presence of xanthan gum in suspension formulation the shearing action on the long chain molecule of xanthan gum (Provenza et al, 2014).…”