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Production of Pharmaceuticals

Industrial insulin production uses genetically engineered E. coli expressing a proinsulin gene controlled by a tryptophan promoter and containing a methionine linker for later cleavage. The cells also carry ampicillin resistance for selective growth. Seed cultures are stored at −80 °C and production begins by thawing a small amount to inoculate starter cultures, which are progressively scaled to a 50,000-L bioreactor. In the bioreactor, E. coli grow in nutrient-rich media under sterile, tightly...

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Dry Powder and Nebulized Aerosol Inhalation of Pharmaceuticals Delivered to Mice Using a Nose-only Exposure System

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Simple and scalable method for peptide inhalable powder production.

Aurélie Schoubben¹, Paolo Blasi, Stefano Giovagnoli

¹Dipartimento di Chimica e Tecnologia del Farmaco, Università degli Studi di Perugia, Via del Liceo 1, 06123 Perugia, Italy. lululi@unipg.it

European Journal of Pharmaceutical Sciences : Official Journal of the European Federation for Pharmaceutical Sciences

|November 3, 2009

Summary

This study developed novel capreomycin formulations for tuberculosis inhalation therapy. Hydrophobic ion pairing and spray-drying created respirable powders and microparticles with increased drug content.

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Area of Science:

Pharmaceutical Sciences
Drug Delivery Systems
Pulmonary Therapeutics

Background:

Tuberculosis (TB) remains a significant global health challenge.
Inhalation therapy offers a targeted approach for TB treatment.
Capreomycin is a critical antibiotic for multidrug-resistant TB.

Purpose of the Study:

To develop capreomycin dry powder and PLGA microparticles for inhalation.
To enhance capreomycin's properties for pulmonary delivery.
To utilize scalable manufacturing methods.

Main Methods:

Hydrophobic ion pairing of capreomycin with oleate.
High-pressure homogenization for particle size reduction.
Spray-drying for powder and microparticle production.

Main Results:

Modified capreomycin (oleate) achieved increased drug content.
High-pressure homogenization yielded nano- and micro-sized particles.
Spray-dried PLGA microparticles showed high encapsulation efficiency (~90%) and suitable inhalation dimensions.
SEM confirmed particle morphology suitable for inhalation.

Conclusions:

Two distinct capreomycin formulations for pulmonary delivery were successfully created.
Hydrophobic ion pairing is an effective strategy to increase drug loading.
Developed formulations are promising for tuberculosis inhalation therapy.