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Effect of USP Induction Ports, Glass Sampling Apparatus, and Inhaler Device Resistance on Aerodynamic Patterns of Fluticasone Propionate–Loaded Engineered Mannitol Microparticles

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Abstract

The present investigation is to study the effect of two different induction ports (IP), i.e., USP IP and USP-modified IP equipped with andersen cascade impactor on in vitro aerodynamic performance along with the impact of USP-modified glass sampling apparatus on delivered dose uniformity of fluticasone propionate (FP) dry powder inhaler (DPI). FP DPI was fabricated by spray drying technique using engineered mannitol microparticles (EMP) with different force controlling agents, i.e., leucine and magnesium stearate. Additionally, commercially available two DPI inhaler devices namely Handihaler® and Breezhaler® were used to aerosolize the FP blends. Spherical smooth surface of EMP showed good powder flow properties and acceptable percentage content uniformity (> 95%). Amounts of FP deposited in cascade assembly using USP-modified IP with the Breezhaler® device was significantly higher (1.32-fold) as compared with the Handihaler® device. Moreover, USP-modified IP showed better deposition as compared with USP IP. Additionally, both inhaler devices showed a satisfactory delivered dose (> 105%) for FP using modified glass sampling apparatus at a flow rate of 60 L/min for 2 s. It was interesting to note that not only formulation properties but also IP geometry and device resistance have significant impact on DPI deposition pattern. This study is a first detailed account of aerodynamic performance of FP using USP-modified IP and USP-modified glass sampling apparatus. Thus, it can be of potential importance for both the academic and industry perspective.

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Acknowledgments

The authors would like to acknowledge the Tuberculosis Association of India for short-term research assistance. The authors would like to acknowledge Bharati Vidyapeeth (Deemed to be University), Poona College of Pharmacy, Pune 38, Maharashtra, India, for ACI facility and Central Instrumentation Facility, Savitribai Phule Pune University, Pune 411007, for technical support during the FESEM analysis.

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Authors and Affiliations

  1. Department of Quality Assurance, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, 411038, India

    Piyush Mehta

  2. Department of Pharmaceutics, Poona College of Pharmacy, Bharati Vidyapeeth (Deemed to be University), Pune, Maharashtra, 411038, India

    C. Bothiraja & Atmaram Pawar

  3. Bharati Vidyapeeth Bhavan, Bharati Vidyapeeth (Deemed to be University), LBS Road, Pune, Maharashtra, 411030, India

    Shivajirao Kadam

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  1. Piyush Mehta
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Correspondence to Atmaram Pawar.

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Mehta, P., Bothiraja, C., Kadam, S. et al. Effect of USP Induction Ports, Glass Sampling Apparatus, and Inhaler Device Resistance on Aerodynamic Patterns of Fluticasone Propionate–Loaded Engineered Mannitol Microparticles. AAPS PharmSciTech 20, 197 (2019). https://doi.org/10.1208/s12249-019-1409-9

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