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A novel formulation technique for metered dose inhaler (MDI) suspensions
Hartwig Steckel1, Sebastian Wehle
1Department of Pharmaceutics and Biopharmaceutics, Christian Albrecht University, Gutenbergstr. 76, 24118 Kiel, Germany. steckel@pharmazie.uni-kiel.de
International Journal of Pharmaceutics
|September 30, 2004
Summary
A novel formulation method creates stable budesonide micro-suspensions for metered dose inhalers (MDIs) using hydrofluoroalkane (HFA) propellants. This technique ensures consistent drug delivery, overcoming challenges with new HFA propellants.
Area of Science:
- Pharmaceutical Technology
- Drug Delivery Systems
- Pulmonary Medicine
Background:
- Metered dose inhalers (MDIs) are crucial for pulmonary drug delivery, particularly for anti-asthmatic medications.
- The transition from chlorofluorocarbon (CFC) to hydrofluoroalkane (HFA) propellants presented formulation challenges, including surfactant solubility and component compatibility.
- Existing HFA-based MDI formulations often require novel surfactants or co-solvents to maintain drug stability and delivery.
Purpose of the Study:
- To introduce a novel formulation approach for developing stable, HFA-based metered dose inhalers.
- To address the technical challenges associated with using HFA propellants in MDIs.
- To demonstrate the efficacy of an in situ precipitation method for creating budesonide micro-suspensions.
Main Methods:
- Development of a physically stable micro-suspension of budesonide using an in situ precipitation process.
- Utilizing a hydrophilic stabilizer within the propellant system to form a drug-excipient network structure.
- Conducting through-life dose uniformity testing and fine particle fraction analysis of the formulated MDIs.
Main Results:
- The novel in situ precipitation process successfully created physically stable budesonide micro-suspensions in HFA propellant.
- The formulated suspensions exhibited stable drug suspension for several weeks.
- Dose uniformity testing confirmed consistency within FDA draft guidance limits.
- Fine particle fraction analysis indicated formulation and hardware-dependent outcomes, allowing for optimization.
Conclusions:
- The developed in situ precipitation technique offers a viable method for creating stable HFA-based MDI formulations.
- This approach effectively overcomes the solubility and stability issues associated with HFA propellants.
- The flexibility of the technique allows for optimization of budesonide delivery through adjustments in formulation and aerosol hardware.