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Long Term Stability Evaluation of Prostacyclin Released from Biomedical Device through Turbiscan Lab Expert
Christian Celia, Marcello Locatelli, Felisa Cilurzo
1Department of Pharmacy, University "G. d'Annunzio" of Chieti - Pescara, Via dei Vestini 31, 66100 Chieti, Italy. l.dimarzio@unich.it.
Insights
Prostacyclin, like Iloprost, treats vascular disease but has drawbacks. This study assessed Iloprost stability in elastomeric pumps for improved home therapy, finding it a viable alternative to infusions.
Area of Science:
- Biomedical Engineering
- Pharmaceutical Sciences
- Vascular Medicine
Background:
- Prostacyclins, including Iloprost, are first-line treatments for vascular diseases and inflammation.
- Current intravenous Iloprost administration causes adverse reactions and reduces patient compliance.
- Biomedical devices like elastomeric pumps offer a potential solution for improved Iloprost delivery.
Purpose of the Study:
- To evaluate the long-term stability of Iloprost isotonic solution in elastomeric pumps.
- To assess the suitability of elastomeric pumps for home therapy in peripheral arterial disease patients.
- To investigate the physical-chemical properties and release profile of Iloprost from these devices.
Main Methods:
- Utilized Turbiscan technology to predict long-term stability of Iloprost solutions.
- Measured backscattering and transmission variations of dispersed particulates.
- Evaluated physical-chemical property changes and Iloprost release profiles from the biomedical device.
Main Results:
- The study investigated the long-term stability of Iloprost in solution-loaded elastomeric pumps.
- Turbiscan technology was employed to assess physical-chemical properties and particulate behavior.
- The release profile of Iloprost from the device was also evaluated.
Conclusions:
- Elastomeric pumps show promise for stable, long-term Iloprost delivery in home therapy.
- This approach could mitigate side effects and improve patient compliance for peripheral arterial disease treatment.
- Further research may validate elastomeric pumps as a safe and effective alternative to intravenous infusions.
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.
