FORMULATION, EVALUATION AND SOLID-STATE THERMOGRAPHIC CHARACTERIZATION OF CFC FREE BECLOMETASONE DIPROPIONATE PRESSURIZED METERED DOSE INHALATION
Keywords:
Beclometasone dipropionate, Pressurized Metered dose inhaler (pMDI), CFC, Hydrofluoro alkane, HFA 134a, HFA 227ea, HPLC, DSCAbstract
Objective: In view of the aim, the objective of the present work was to develop a solution based pulmonary drug delivery system containing Beclometasone dipropionate 250mcg using a Hydrofluoroalkane (HFA 134a and HFA 227ea), a non-chlorofluorocarbon, as propellant to be administered as pressurized metered dose inhalation (pMDI) for direct and targeted delivery of the drug to the lungs and to evaluate the effect of formulation variables on its efficacy and stability.
Methods: In the formulations, 0.015 % oleic acid and 14% of ethanol were used as surfactant and co-solvent respectively. To assure stability of the formulations various quality control tests were performed. Quantitative estimation was done by HPLC method, In-vitro drug deposition studies was carried out using Anderson cascade impactor and the particle characterization was done by using Twin impinge. Thermographic characterization was done by DSC.
Results: The formulation with HFA 227ea was found to be more stable than the formulation containing HFA 134a in three months study period. DF 316 valves with 50µl spraying capacity having pp actuator systems were found to encompass acceptable results for dosage test or pump delivery and leak test with better fine dose respirable fraction. DSC indicated solid-state property of a net respirable fraction and thermograhic characterization of the particle emitted from optimized formulations.
Conclusion: The formulation may be an attempt to develop pulmonary administrable product of Beclometasone dipropionate in form of pMDI using an eco-friendly chlorine-free propellant HFA 227ea as hydrofluoro alkanes were found to be the stable and robust for obtaining the desired attributes to meet the packaging requirements.
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References
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