RT Journal Article
SR Electronic
T1 Chemical and microbiological stability studies of an aqueous solution of pravastatin sodium salt for drug therapy of the dysphagic patients
JF European Journal of Hospital Pharmacy
JO Eur J Hosp Pharm
FD British Medical Journal Publishing Group
SP 288
OP 293
DO 10.1136/ejhpharm-2015-000781
VO 23
IS 5
A1 Bonacucina, Giulia
A1 Logrippo, Serena
A1 Cespi, Marco
A1 Ganzetti, Roberta
A1 Casettari, Luca
A1 Sestili, Matteo
A1 Perinelli, Diego Romano
A1 Ricciutelli, Massimo
A1 Marziali, Antonella
A1 Polidori, Carlo
A1 Palmieri, Giovanni Filippo
YR 2016
UL http://ejhp.bmj.com/content/23/5/288.abstract
AB Objective This study is aimed to improve dysphagic patient compliance under therapy with cholesterol-lowering drugs. Patients suffering severe dysphagia, who do not feed independently, receive enteral nutrition through feeding tube and they need alternative oral route also for the administration of pharmacological therapy. This research deals with the development and stability (chemical and microbiological) of an aqueous solution of pravastatin sodium salt that will be administered orally directly in the feeding tube starting from commercial tablets. Tablets formulation is the only pharmaceutical dosage form available on the market for this type of drug.Methods Pravastatin sodium salt tablets are dissolved in a preserved sodium bicarbonate solution at the final concentration of 4 mg/mL. Samples are stored in two different conditions until 60 days. The samples are prepared for high-performance liquid chromatography analysis coupled to a diode array detector (HPLC-DAD), microbiological analysis and pH measurements.Results The chemical stability of the solution performed with HPLC-DAD analysis shows peaks’ overlapping, which are characteristic of pravastatin, and correspondence of the concentration of the active ingredient in the solution. The detected values are analysed by one-way analysis of variance showing no statistically significant differences. Microbiological analyses proved that there is not microbial growth. By considering the dilution factor applied, it was possible to express the result as <10 CFU/mL in the two different culture media.Conclusion This study demonstrated the possibility to reformulate pravastatin tablets as liquid pharmaceutical formulation for enteral administration with the aim of improving drug therapy in dysphagic patients.