Unlocking the Microstructure of Inhalation Blends using X-ray Microscopy

Parmesh Gajjar; Hrishikesh Bale; Timothy Burnett; Xizhong Chen; James A. Elliot; Herminso Villarraga Gomez; Robert B. Hammond; Hien Nguyen; Kevin J. Roberts; Ioanna Danai Styliari; Benjamin Tordoff; Philip Withers; Darragh Murnane

Unlocking the Microstructure of Inhalation Blends using X-ray Microscopy

Parmesh Gajjar, Hrishikesh Bale, Timothy Burnett, Xizhong Chen, James A. Elliot, Herminso Villarraga Gomez, Robert B. Hammond, Hien Nguyen, Kevin J. Roberts, Ioanna Danai Styliari, Benjamin Tordoff, Philip Withers, Darragh Murnane

Research output: Chapter in Book/Report/Conference proceeding › Conference contribution

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Abstract

Microstructural equivalence (Q3) for dry powder inhalers (DPIs) is complex because it involves both pre- and post-aerosolization powders and can be inﬂuenced by the DPI device and the patient’s aerosolization eﬃciency. In this paper, we show how advanced 3D X-ray microscopy (XRM, also known as X-ray computed tomography) techniques can provide unique microstructural insights into pre-aerosolized inhalation powders. Nano-scale XRM is used to detect diﬀerences within individual lactose particles and agglomerates, including voids and intra-agglomerate size distributions. Micro-scale XRM is used to visualize and quantify lactose ﬁnes (<12 mm) within a powder bed. XRM is also used to discriminate between excipient and terbutaline sulphate particles in an inhalation blend. These advanced XRM techniques could provide valuable microstructural information to help address Q3 equivalence during bioequivalence determination in inhalation drug products.

Original language	English
Title of host publication	Respiratory Drug Delivery 2020
Publisher	Respiratory Drug Delivery, RDD
Pages	101-112
Number of pages	12
Volume	1
Publication status	Published - 26 Apr 2020

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© Respiratory Drug Delivery 2020. Reproduced with permission from Respiratory Drug Delivery 2020, Virginia Commonwealth University and RDD Online.
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Gajjar, P., Bale, H., Burnett, T., Chen, X., Elliot, J. A., Gomez, H. V., Hammond, R. B., Nguyen, H., Roberts, K. J., Styliari, I. D., Tordoff, B., Withers, P., & Murnane, D. (2020). Unlocking the Microstructure of Inhalation Blends using X-ray Microscopy. In Respiratory Drug Delivery 2020 (Vol. 1, pp. 101-112). Respiratory Drug Delivery, RDD. https://www.rddonline.com/rdd/article.php?ArticleID=2656

@inproceedings{2b65462691b34e9b9e46b86f345046e2,

title = "Unlocking the Microstructure of Inhalation Blends using X-ray Microscopy",

abstract = "Microstructural equivalence (Q3) for dry powder inhalers (DPIs) is complex because it involves both pre- and post-aerosolization powders and can be inﬂuenced by the DPI device and the patient{\textquoteright}s aerosolization eﬃciency. In this paper, we show how advanced 3D X-ray microscopy (XRM, also known as X-ray computed tomography) techniques can provide unique microstructural insights into pre-aerosolized inhalation powders. Nano-scale XRM is used to detect diﬀerences within individual lactose particles and agglomerates, including voids and intra-agglomerate size distributions. Micro-scale XRM is used to visualize and quantify lactose ﬁnes (<12 mm) within a powder bed. XRM is also used to discriminate between excipient and terbutaline sulphate particles in an inhalation blend. These advanced XRM techniques could provide valuable microstructural information to help address Q3 equivalence during bioequivalence determination in inhalation drug products.",

author = "Parmesh Gajjar and Hrishikesh Bale and Timothy Burnett and Xizhong Chen and Elliot, {James A.} and Gomez, {Herminso Villarraga} and Hammond, {Robert B.} and Hien Nguyen and Roberts, {Kevin J.} and Styliari, {Ioanna Danai} and Benjamin Tordoff and Philip Withers and Darragh Murnane",

note = "{\textcopyright} Respiratory Drug Delivery 2020. Reproduced with permission from Respiratory Drug Delivery 2020, Virginia Commonwealth University and RDD Online.",

year = "2020",

month = apr,

day = "26",

language = "English",

volume = "1",

pages = "101--112",

booktitle = "Respiratory Drug Delivery 2020",

publisher = "Respiratory Drug Delivery, RDD",

}

Gajjar, P, Bale, H, Burnett, T, Chen, X, Elliot, JA, Gomez, HV, Hammond, RB, Nguyen, H, Roberts, KJ, Styliari, ID, Tordoff, B, Withers, P & Murnane, D 2020, Unlocking the Microstructure of Inhalation Blends using X-ray Microscopy. in Respiratory Drug Delivery 2020. vol. 1, Respiratory Drug Delivery, RDD, pp. 101-112. <https://www.rddonline.com/rdd/article.php?ArticleID=2656>

TY - GEN

T1 - Unlocking the Microstructure of Inhalation Blends using X-ray Microscopy

AU - Gajjar, Parmesh

AU - Bale, Hrishikesh

AU - Burnett, Timothy

AU - Chen, Xizhong

AU - Elliot, James A.

AU - Gomez, Herminso Villarraga

AU - Hammond, Robert B.

AU - Nguyen, Hien

AU - Roberts, Kevin J.

AU - Styliari, Ioanna Danai

AU - Tordoff, Benjamin

AU - Withers, Philip

AU - Murnane, Darragh

N1 - © Respiratory Drug Delivery 2020. Reproduced with permission from Respiratory Drug Delivery 2020, Virginia Commonwealth University and RDD Online.

PY - 2020/4/26

Y1 - 2020/4/26

N2 - Microstructural equivalence (Q3) for dry powder inhalers (DPIs) is complex because it involves both pre- and post-aerosolization powders and can be inﬂuenced by the DPI device and the patient’s aerosolization eﬃciency. In this paper, we show how advanced 3D X-ray microscopy (XRM, also known as X-ray computed tomography) techniques can provide unique microstructural insights into pre-aerosolized inhalation powders. Nano-scale XRM is used to detect diﬀerences within individual lactose particles and agglomerates, including voids and intra-agglomerate size distributions. Micro-scale XRM is used to visualize and quantify lactose ﬁnes (<12 mm) within a powder bed. XRM is also used to discriminate between excipient and terbutaline sulphate particles in an inhalation blend. These advanced XRM techniques could provide valuable microstructural information to help address Q3 equivalence during bioequivalence determination in inhalation drug products.

AB - Microstructural equivalence (Q3) for dry powder inhalers (DPIs) is complex because it involves both pre- and post-aerosolization powders and can be inﬂuenced by the DPI device and the patient’s aerosolization eﬃciency. In this paper, we show how advanced 3D X-ray microscopy (XRM, also known as X-ray computed tomography) techniques can provide unique microstructural insights into pre-aerosolized inhalation powders. Nano-scale XRM is used to detect diﬀerences within individual lactose particles and agglomerates, including voids and intra-agglomerate size distributions. Micro-scale XRM is used to visualize and quantify lactose ﬁnes (<12 mm) within a powder bed. XRM is also used to discriminate between excipient and terbutaline sulphate particles in an inhalation blend. These advanced XRM techniques could provide valuable microstructural information to help address Q3 equivalence during bioequivalence determination in inhalation drug products.

M3 - Conference contribution

VL - 1

SP - 101

EP - 112

BT - Respiratory Drug Delivery 2020

PB - Respiratory Drug Delivery, RDD

ER -

Unlocking the Microstructure of Inhalation Blends using X-ray Microscopy

Abstract

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