TY  -  JOUR
AU  -  Cappelletto, Paola Cristina
AU  -  Sorio, Daniela
AU  -  Tavella, Alicia
AU  -  Cappellazzo, Linda
T1  -  Niaprazine oral formulation: stability analysis by a high-performance liquid chromatography (HPLC)
PY  -  2025
Y1  -  2025-01-01
DO  -  10.1721/4489.44892
JO  -  Giornale Italiano di Farmacia Clinica
JA  -  GIFAC
VL  -  39
IS  -  1
SP  -  3
EP  -  6
PB  -  Il Pensiero Scientifico Editore
SN  -  1120-3749
Y2  -  2026/04/25
UR  -  http://dx.doi.org/10.1721/4489.44892
N2  -  Summary. Background. Niaprazine is a phenylpiperazine derivative utilized for treatment of sleep disorders in adults and children of age six months and older. Succeeding recent shortages of niaprazine (declared by the regulatory agency – AIFA – in 2022), a galenic preparation of the drug has been set up in Italy, mostly amongst pediatric patients. The syrup formulation provides better compliance compared with capsules and therefore greater efficacy for this patient setting. Objective of this study is to evaluate the stability of niaprazine prepared as a galenic syrup in our laboratory in relation to its directed end-of-use date. Material and methods. Three different batches (one bottle for each batch) of the formula were analyzed using high-performance liquid chromatography (HPLC) at 5 different time points. Results. A limited reduction in niaprazine concentration over time was detected (in acceptable range of +/- 10% of the initial concentration as required). Conclusions. Further investigations are needed to identify potential causes of degradation of the active ingredient, in order to obtain a galenic formula with increased stability.
ER  -