Extemporaneous preparation of paediatric oral formulations with sildenafil citrate

The paediatric population is composed of several very diferent subgroups, each with its own specifc characteristics. For this reason, children cannot be considered “small adults”. The development of formulations suitable for children is a complex process, as it must consider the physiological changes that occur during childhood and the impact they have on the absorption of drugs. Sildenafl citrate is a drug with a narrow therapeutic index used in paediatrics to treat pulmonary hypertension. In the present work, technological approaches for extemporaneous preparation of paediatric oral forms containing sildenafl citrate for personalized therapy in children were studied. Te prepared formulations were tested for physical and microbiological stability, in-use stability, and determination of active substance content. All tested oral formulations remained unchanged in terms of appearance during the entire period of stability monitoring at the selected storage conditions – room temperature 25 °C ± 5 °C and in a refrigerator at 5 °C ± 2 °C. Te established
pH values suggest that the formulations remained chemically stable during the stability study. Te content of sildenafl citrate in all prepared oral formulations remained above 95% w/v. Te microbiological quality of the prepared compositions was confrmed. Rational strategies for preparation of extemporaneous formulations were proposed based on the analysis of experimental data.

Materials

Sucrose was purchased from Zaharni Zavodi (Gorna Oryahovitsa, Bulgaria). Fructose, crystalline was purchased from Omnia (Adana, Turkey). Methylcellulose, 4000 CP, Nipagin, E218 and magnesium stearate wer purchased from Sigma-Aldrich (Schnelldorf, Germany). Prosolv SMCC HD 90, Vivasol and Vivapur type101 were purchased from JRS Pharma (Rosenberg, Germany). Wheat starch was obtained from Roquette Pharma (Lille, France), Kollidon K25 was obtained from BASF (Hannover, Germany), talc was obtained from Brenntag (Amsterdam, Netherlands).

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Dimitrov M, Georgieva D, Petkova V (2023) Extemporaneous preparation of paediatric oral formulations with sildenafl citrate. Pharmacia 70(4): 1047–1055.
https://doi.org/10.3897/pharmacia.70.e111611

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