DYSPHAGIA: DAILY CONCERNS AND INNOVATIVE FORMULATIVE APPROACHES

Dysphagia, defined as solids and liquids swallowing incapability, is a diffuse condition in elderly. It is also directly correlated to the difficulty about the solid oral dosage forms (SODFs) deglutition. This consideration justifies the need of compounding SODFs whenever the drug exists as SODFs [1]. Pravastatin sodium (PraNa), a hydrophilic statin, is hugely prescribed in cardiovascular diseases. PraNa is available just as tablet, therefore, nurses compound it to allow administration to dysphagic patients as liquid form via feeding tubes. Currently, nurses crush tablets in a mortar and disperse the powder in a proper vehicle (e.g., water). The focus of this work was to tune a microbiologically and chemically stable aqueous formulation of PraNa to administer via feeding tube. Commercial tablets of PraNa (Pensa Spa) instead of the drug in powder form were used to match the needs of a hospital pharmacy. Immediate-release (IR) tablets were dispersed in a preserved 8.4% NaHCO3 aqueous solution and the drug concentration was 4mg/ml. Chemical stability of PraNa solution till 60 days, was analyzed through HPLC-DAD to estimate the concentrations of PraNa. To evaluate microbiological stability, sowings onto two different culture media were carried out [2]. Moreover, evaluations about the performance of the formulation delivered in the tube were carried out to determine the real drug amount assumed by the patient. The results demonstrated that PraNa was stable overtime; in fact, constant concentrations of the drug were detected. Microbiological results showed no microbial growth in both culture media. Finally, although compounding of the original tablets was applied to obtained liquid form of PraNa, patients were correctly treated after enteral administration of the drug. The limits reported in the Italian Pharmacopoeia XII edition about drug content uniformity for SODFs were respected before and after the enteral tube administration. Concluding, IR tablets employed in this work may be compounded to arrange a stable liquid form to administer via feeding tube.