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Protein deposition from dry powder inhalers: fine particle multiplets as performance modifiers
P Lucas1, K Anderson, J N Staniforth
1Department of Pharmacy and Pharmacology, University of Bath, Claverton Down, U.K.
Pharmaceutical Research
|May 20, 1998
Summary
Fine particle excipients enhance protein dry powder aerosol delivery. Adding fine particle lactose or polyethylene glycol improved protein fine particle fraction, suggesting redistribution of particles within the formulation.
Area of Science:
- Pharmaceutical Sciences
- Materials Science
Background:
- Dry powder aerosols are crucial for protein inhalation delivery.
- Optimizing formulation performance is key for effective drug delivery.
Purpose of the Study:
- To assess carrier-based dry powder aerosols for protein inhalation.
- To investigate the impact of fine particle excipients on formulation performance.
Main Methods:
- Bovine serum albumin (BSA) and maltodextrin were spray-dried into model protein particles.
- Aerosol formulations were created by mixing protein powders with lactose or modified lactoses containing fine particle lactose (FPL) or micronized polyethylene glycol 6000 (PEG).
- Inhalation performance was evaluated using a twin-stage impinger in Diskhaler and Rotahaler devices.
Main Results:
- Inclusion of FPL and micronized PEG 6000 improved the fine particle fraction of BSA-maltodextrin aerosols.
- A 5% FPL addition increased the protein fine particle fraction from 31.7% to 47.4% with the Diskhaler.
- Excipient addition altered powder properties but did not impact device emptying; performance improvements were independent of addition order.
Conclusions:
- Fine particle excipients effectively enhance carrier-based protein dry powder aerosol performance.
- Performance improvement is attributed to particle redistribution within the ternary mix, favoring fine particles.