Title:Long Term Stability Evaluation of Prostacyclin Released from Biomedical Device through Turbiscan Lab Expert
Volume: 11
Issue: 4
Author(s): Christian Celia, Marcello Locatelli, Felisa Cilurzo, Donato Cosco, Emanuela Gentile, Daniela Scalise, Maria Carafa, Cinzia Anna Ventura, Mathias Fleury, Christelle Tisserand, Renato. C Barbacane, Massimo Fresta, Luisa Di Marzio and Donatella Paolino
Affiliation:
Keywords:
Critical limb ischemia, disposable infusion pumps, endoprost, high performance liquid chromatography, prostacyclin,
Turbiscan technology.
Abstract: Therapeutic guidelines indicate prostacyclin as the first line of treatment in inflammation and vascular diseases.
Prostacyclins prevent formation of the platelet plug involved in primary hemostasis by inhibiting platelet activation and,
combined with thromboxane, are effective vasodilators in vascular damage.
Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease II guidelines indicates
prostacyclins; in particular, Iloprost, as the first therapeutic option for treating peripheral arterial disease. However, therapeutic
efficacy of Iloprost has witnessed several drawbacks that have occurred in patients receiving repeated weekly administration
of the drug by intravenous infusions. Adverse reactions arose under perfusion with Iloprost for 6 h and patient
compliance was drastically decreased. Biomedical devices could provide a suitable alternative to overcome these
drawbacks. In particular, elastomeric pumps, filled with Iloprost isotonic solution, could slowly release the drug, thus decreasing
its side effects, representing a valid alternative to hospitalization of patients affected by peripheral arterial disease.
However, the home therapy treatment of patients requires long-term stability of Iloprost in solution-loaded elastomeric
pumps.
The aim of this work was to investigate the long-term stability of Iloprost isotonic solution in biomedical devices using
Turbiscan technology. Turbiscan Lab Expert (L’Union, France) predicts the long-term stability of suspensions, emulsions
and colloidal formulations by measuring backscattering and transmission of particulates dispersed in solution. The formulations
were evaluated by measuring the variation of physical-chemical properties of colloids and suspensions as a function
of backscattering and transmission modifications. In addition, the release profile of Iloprost isotonic solution from the
biomedical device was evaluated.
