RespiCell<sup>TM</sup>: An Innovative Dissolution Apparatus for Inhaled Products

To overcome some of the shortfalls of the types of dissolution testing currently used for pulmonary products, a new custom-built dissolution apparatus has been developed. For inhalation products, the main in vitro characterisation required by pharmacopoeias is the deposition of the active pharmaceut...

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Main Authors: Fabio Sonvico, Veronica Chierici, Giada Varacca, Eride Quarta, Davide D’Angelo, Ben Forbes, Francesca Buttini
Format: Article
Language:English
Published: MDPI AG 2021-09-01
Series:Pharmaceutics
Subjects:
Online Access:https://www.mdpi.com/1999-4923/13/10/1541
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author Fabio Sonvico
Veronica Chierici
Giada Varacca
Eride Quarta
Davide D’Angelo
Ben Forbes
Francesca Buttini
author_facet Fabio Sonvico
Veronica Chierici
Giada Varacca
Eride Quarta
Davide D’Angelo
Ben Forbes
Francesca Buttini
author_sort Fabio Sonvico
collection DOAJ
description To overcome some of the shortfalls of the types of dissolution testing currently used for pulmonary products, a new custom-built dissolution apparatus has been developed. For inhalation products, the main in vitro characterisation required by pharmacopoeias is the deposition of the active pharmaceutical ingredient in an impactor to estimate the dose delivered to the target site, i.e., the lung. Hence, the collection of the respirable dose (<5 µm) also appears to be an essential requirement for the study of the dissolution rate of particles, because it results as being a relevant parameter for the pharmacological action of the powder. In this sense, dissolution studies could become a complementary test to the routine testing of inhaled formulation delivered dose and aerodynamic performance, providing a set of data significant for product quality, efficacy and/or equivalence. In order to achieve the above-mentioned objectives, an innovative dissolution apparatus (RespiCell™) suitable for the dissolution of the respirable fraction of API deposited on the filter of a fast screening impactor (FSI) (but also of the entire formulation if desirable) was designed at the University of Parma and tested. The purpose of the present work was to use the RespiCell dissolution apparatus to compare and discriminate the dissolution behaviour after aerosolisation of various APIs characterised by different physico-chemical properties (hydrophilic/lipophilic) and formulation strategies (excipients, mixing technology).
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spelling doaj.art-f89a7164f69844e39bc12116aa26a7912023-11-22T19:37:12ZengMDPI AGPharmaceutics1999-49232021-09-011310154110.3390/pharmaceutics13101541RespiCell<sup>TM</sup>: An Innovative Dissolution Apparatus for Inhaled ProductsFabio Sonvico0Veronica Chierici1Giada Varacca2Eride Quarta3Davide D’Angelo4Ben Forbes5Francesca Buttini6Department of Food and Drug, University of Parma, Parco Area Delle Scienze 27/A, 43124 Parma, ItalyInterdepartmental Center for Innovation in Health Products, Biopharmanet Tec, University of Parma, Parco Area Delle Scienze 27/A, 43124 Parma, ItalyDepartment of Food and Drug, University of Parma, Parco Area Delle Scienze 27/A, 43124 Parma, ItalyDepartment of Food and Drug, University of Parma, Parco Area Delle Scienze 27/A, 43124 Parma, ItalyDepartment of Food and Drug, University of Parma, Parco Area Delle Scienze 27/A, 43124 Parma, ItalyInstitute of Pharmaceutical Science, King’s College London, 150 Stamford Street, London SE1 9NH, UKDepartment of Food and Drug, University of Parma, Parco Area Delle Scienze 27/A, 43124 Parma, ItalyTo overcome some of the shortfalls of the types of dissolution testing currently used for pulmonary products, a new custom-built dissolution apparatus has been developed. For inhalation products, the main in vitro characterisation required by pharmacopoeias is the deposition of the active pharmaceutical ingredient in an impactor to estimate the dose delivered to the target site, i.e., the lung. Hence, the collection of the respirable dose (<5 µm) also appears to be an essential requirement for the study of the dissolution rate of particles, because it results as being a relevant parameter for the pharmacological action of the powder. In this sense, dissolution studies could become a complementary test to the routine testing of inhaled formulation delivered dose and aerodynamic performance, providing a set of data significant for product quality, efficacy and/or equivalence. In order to achieve the above-mentioned objectives, an innovative dissolution apparatus (RespiCell™) suitable for the dissolution of the respirable fraction of API deposited on the filter of a fast screening impactor (FSI) (but also of the entire formulation if desirable) was designed at the University of Parma and tested. The purpose of the present work was to use the RespiCell dissolution apparatus to compare and discriminate the dissolution behaviour after aerosolisation of various APIs characterised by different physico-chemical properties (hydrophilic/lipophilic) and formulation strategies (excipients, mixing technology).https://www.mdpi.com/1999-4923/13/10/1541RespiCelldissolutionrespirable fractionpulmonary drug deliveryvertical cell diffusiondry powder inhaler
spellingShingle Fabio Sonvico
Veronica Chierici
Giada Varacca
Eride Quarta
Davide D’Angelo
Ben Forbes
Francesca Buttini
RespiCell<sup>TM</sup>: An Innovative Dissolution Apparatus for Inhaled Products
Pharmaceutics
RespiCell
dissolution
respirable fraction
pulmonary drug delivery
vertical cell diffusion
dry powder inhaler
title RespiCell<sup>TM</sup>: An Innovative Dissolution Apparatus for Inhaled Products
title_full RespiCell<sup>TM</sup>: An Innovative Dissolution Apparatus for Inhaled Products
title_fullStr RespiCell<sup>TM</sup>: An Innovative Dissolution Apparatus for Inhaled Products
title_full_unstemmed RespiCell<sup>TM</sup>: An Innovative Dissolution Apparatus for Inhaled Products
title_short RespiCell<sup>TM</sup>: An Innovative Dissolution Apparatus for Inhaled Products
title_sort respicell sup tm sup an innovative dissolution apparatus for inhaled products
topic RespiCell
dissolution
respirable fraction
pulmonary drug delivery
vertical cell diffusion
dry powder inhaler
url https://www.mdpi.com/1999-4923/13/10/1541
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