Practical, regulatory and clinical considerations for development of inhalation drug products
The formulation and device collectively constitute an inhalation drug product. Development of inhaled drugs must consider the compatibility between formulation and device in order to achieve the intended pharmaceutical performance and usability of the product to improve patient compliance with treat...
| Main Authors: | , , , |
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| Format: | Article |
| Language: | English |
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Elsevier
2015-12-01
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| Series: | Asian Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | http://www.sciencedirect.com/science/article/pii/S1818087615000690 |
| _version_ | 1828928385822228480 |
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| author | Shuguang Hou Jiangyue Wu Xu Li Hong Shu |
| author_facet | Shuguang Hou Jiangyue Wu Xu Li Hong Shu |
| author_sort | Shuguang Hou |
| collection | DOAJ |
| description | The formulation and device collectively constitute an inhalation drug product. Development of inhaled drugs must consider the compatibility between formulation and device in order to achieve the intended pharmaceutical performance and usability of the product to improve patient compliance with treatment instruction. From the points of formulation, device and patient use, this article summarizes the inhalation drugs, including pressurized metered dose inhaler (pMDI), dry powder inhaler (DPI), and nebulizer that are currently available in the US and UK markets. It also discusses the practical considerations for the development of inhalers and provides an update on the corresponding regulations of the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency). |
| first_indexed | 2024-12-14T00:04:06Z |
| format | Article |
| id | doaj.art-35f2f3590f60446e8dea4d8e71711b60 |
| institution | Directory Open Access Journal |
| issn | 1818-0876 |
| language | English |
| last_indexed | 2024-12-14T00:04:06Z |
| publishDate | 2015-12-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Asian Journal of Pharmaceutical Sciences |
| spelling | doaj.art-35f2f3590f60446e8dea4d8e71711b602022-12-21T23:26:09ZengElsevierAsian Journal of Pharmaceutical Sciences1818-08762015-12-0110649050010.1016/j.ajps.2015.08.008Practical, regulatory and clinical considerations for development of inhalation drug productsShuguang HouJiangyue WuXu LiHong ShuThe formulation and device collectively constitute an inhalation drug product. Development of inhaled drugs must consider the compatibility between formulation and device in order to achieve the intended pharmaceutical performance and usability of the product to improve patient compliance with treatment instruction. From the points of formulation, device and patient use, this article summarizes the inhalation drugs, including pressurized metered dose inhaler (pMDI), dry powder inhaler (DPI), and nebulizer that are currently available in the US and UK markets. It also discusses the practical considerations for the development of inhalers and provides an update on the corresponding regulations of the FDA (U.S. Food and Drug Administration) and the EMA (European Medicines Agency).http://www.sciencedirect.com/science/article/pii/S1818087615000690Pressurized metered dose inhaler (pMDI)Dry powder inhaler (DPI)NebulizerFormulationDeviceClinical application |
| spellingShingle | Shuguang Hou Jiangyue Wu Xu Li Hong Shu Practical, regulatory and clinical considerations for development of inhalation drug products Asian Journal of Pharmaceutical Sciences Pressurized metered dose inhaler (pMDI) Dry powder inhaler (DPI) Nebulizer Formulation Device Clinical application |
| title | Practical, regulatory and clinical considerations for development of inhalation drug products |
| title_full | Practical, regulatory and clinical considerations for development of inhalation drug products |
| title_fullStr | Practical, regulatory and clinical considerations for development of inhalation drug products |
| title_full_unstemmed | Practical, regulatory and clinical considerations for development of inhalation drug products |
| title_short | Practical, regulatory and clinical considerations for development of inhalation drug products |
| title_sort | practical regulatory and clinical considerations for development of inhalation drug products |
| topic | Pressurized metered dose inhaler (pMDI) Dry powder inhaler (DPI) Nebulizer Formulation Device Clinical application |
| url | http://www.sciencedirect.com/science/article/pii/S1818087615000690 |
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