The role of capsule aperture size on the dispersion of carrier-based formulation at different air flowrates

Patricia Tang; Maziar Kakhi; Ahmed Albariqi; Srinivas Ravindra Babu Behara; Ross Walenga; Runyu Yang; Hak-Kim Chan

doi:10.1016/j.ijpharm.2023.123152

The role of capsule aperture size on the dispersion of carrier-based formulation at different air flowrates

Int J Pharm. 2023 Jul 25:642:123152. doi: 10.1016/j.ijpharm.2023.123152. Epub 2023 Jun 18.

Authors

Patricia Tang¹, Maziar Kakhi², Ahmed Albariqi¹, Srinivas Ravindra Babu Behara³, Ross Walenga⁴, Runyu Yang⁵, Hak-Kim Chan⁶

Affiliations

¹ Sydney Pharmacy School, The University of Sydney, Sydney, New South Wales, Australia.
² Division of Product Quality Research, Office of Testing and Research, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
³ Division of Immediate and Modified Release Products III, Office of Lifecycle Drug Products, Office of Pharmaceutical Quality, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
⁴ Division of Quantitative Methods and Modeling, Office of Research and Standards, Office of Generic Drugs, Center for Drug Evaluation and Research, US Food and Drug Administration, Silver Spring, MD, USA.
⁵ School of Materials Science and Engineering, The University of New South Wales, Sydney, New South Wales, Australia.
⁶ Sydney Pharmacy School, The University of Sydney, Sydney, New South Wales, Australia. Electronic address: kim.chan@sydney.edu.au.

PMID: 37339687
DOI: 10.1016/j.ijpharm.2023.123152

Abstract

The effect of capsule aperture size on the aerosol performance of lactose blend formulation was studied using Foradil® (containing 12 μg of formoterol fumarate (FF¹) and 24 mg of lactose) dispersed with a powder inhaler Aerolizer® at increasing air flowrates. Apertures sizes of 0.4, 1.0, 1.5, 2.5, and 4.0 mm were introduced at the opposite ends of the capsule. The formulation was dispersed into a Next Generation Impactor (NGI) at 30, 60 and 90 L/min, with the fine particle fractions (FPF_rec and FPF_em) measured by chemical assay of FF and lactose using high-performance liquid chromatography. Particle size distribution (PSD) of FF particles dispersed in wet media was also characterized by laser diffraction. FPF_rec showed a stronger dependency on the flowrate than the capsule aperture size. The most efficient dispersion was achieved at 90 L/min. At a given flowrate, FPF_em remained broadly constant across different aperture sizes. The laser diffraction studies demonstrated the presence of large agglomerates.

Keywords: Aerosol; Capsule aperture; Carrier-based formulation; Dry powder inhaler; Foradil; Powder.

MeSH terms

Administration, Inhalation
Aerosols / chemistry
Dry Powder Inhalers
Formoterol Fumarate
Lactose* / chemistry
Nebulizers and Vaporizers*
Particle Size
Powders

Substances

Lactose
Aerosols
Formoterol Fumarate
Powders