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Insulin-micro- and nanoparticles for pulmonary delivery
Claudia Klingler1, Bernd W Müller, Hartwig Steckel
1Department of Pharmaceutics and Biopharmaceutics, Christian Albrecht University Kiel, Gutenbergstrasse 76, 24118 Kiel, Germany.
International Journal of Pharmaceutics
|May 19, 2009
Summary
Pulmonary insulin delivery via inhalation shows promise for diabetes treatment. Nano-precipitated insulin powders, when inhaled, demonstrate superior lung deposition compared to existing products.
Area of Science:
- Pharmaceutical Sciences
- Drug Delivery Systems
- Respiratory Medicine
Background:
- Pulmonary drug delivery offers a promising route for systemic delivery of peptides and proteins like insulin.
- Achieving systemic effects requires inhaled particles to reach the alveoli, necessitating a mass median diameter below 2 micrometers.
- Spray drying is a common method for producing dry powders with the desired particle size for inhalation.
Purpose of the Study:
- To evaluate a novel method of nano-precipitation of insulin prior to spray drying for inhalation.
- To compare the characteristics and aerodynamic performance of precipitated insulin powders with those produced from solution and a marketed product (Exubera).
- To assess the efficacy of precipitated insulin particles delivered via a standard capsule-based inhaler (Aerolizer).
Main Methods:
- Nano-precipitation of insulin using the solvent change method, followed by spray drying.
- Characterization of powder properties, including insulin yield, particle size, and aerodynamic performance.
- Comparison with insulin powder produced directly from solution and the Exubera product, using the Aerolizer device.
Main Results:
- Insulin yield during precipitation is significantly influenced by pH and the amount of non-solvent.
- Increasing non-solvent content reduces particle size after spray drying.
- Precipitated insulin particles exhibited superior aerodynamic performance, with a higher fraction below 2 micrometers, compared to spray-dried solutions.
- The Exubera device showed lower fine particle fractions and higher residue compared to the Aerolizer device.
Conclusions:
- Nano-precipitated insulin particles delivered via a standard capsule-based inhaler are in vitro effective, comparable to the marketed Exubera product.
- Optimized precipitated powders with increased fine particle fractions (< 2 micrometers) could enhance insulin delivery to the deeper lung.
- This approach may enable lower insulin doses for effective diabetes therapy.
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