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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MDPI AG
2021-09-01
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Series: | Pharmaceutics |
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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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format | Article |
id | doaj.art-f89a7164f69844e39bc12116aa26a791 |
institution | Directory Open Access Journal |
issn | 1999-4923 |
language | English |
last_indexed | 2024-03-10T06:17:46Z |
publishDate | 2021-09-01 |
publisher | MDPI AG |
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series | Pharmaceutics |
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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