Application of void forming index (VFI): Detection of the effect of physical properties of dry powder inhaler formulations on powder cohesion
[Display omitted] Dry powder inhaler (DPI) is an attractive alternative for non-invasive drug administration and can make the use of critical biopharmaceutical formulations more convenient for patients. Inhalation of biopharmaceutical formulations can provide targeted delivery to the lungs as well a...
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| Published in | International journal of pharmaceutics Vol. 588; p. 119766 |
|---|---|
| Main Authors | , , |
| Format | Journal Article |
| Language | English |
| Published |
Elsevier B.V
15.10.2020
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| Subjects | |
| Online Access | Get full text |
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| Abstract | [Display omitted]
Dry powder inhaler (DPI) is an attractive alternative for non-invasive drug administration and can make the use of critical biopharmaceutical formulations more convenient for patients. Inhalation of biopharmaceutical formulations can provide targeted delivery to the lungs as well as systemic delivery. Generally, biopharmaceutical DPI formulations consist of highly cohesive powders that tend to agglomerate. For successful delivery to the lungs, the detection of powder cohesiveness and its effect on the performance of the formulations is mandatory. Herein, the effects of the physical properties of mannitol on the cohesiveness of DPI formulations were investigated. The powder cohesion was detected using the void forming index (VFI) measured by inverse gas chromatography (iGC) at 4 h (VFI4h), which was defined as the pressure drop ratio of 4 h purged sample to that of the initial sample. VFI4h was found to correlate well with the cohesiveness of DPI formulations. The amount of investigated samples required for VFI measurement was less than that required for conventional measurements. VFI showed a good relationship between the cohesiveness of DPI formulations and the physical properties of mannitol. Thus, VFI can be a reliable standard index to evaluate the cohesiveness of DPI formulations. |
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| AbstractList | [Display omitted]
Dry powder inhaler (DPI) is an attractive alternative for non-invasive drug administration and can make the use of critical biopharmaceutical formulations more convenient for patients. Inhalation of biopharmaceutical formulations can provide targeted delivery to the lungs as well as systemic delivery. Generally, biopharmaceutical DPI formulations consist of highly cohesive powders that tend to agglomerate. For successful delivery to the lungs, the detection of powder cohesiveness and its effect on the performance of the formulations is mandatory. Herein, the effects of the physical properties of mannitol on the cohesiveness of DPI formulations were investigated. The powder cohesion was detected using the void forming index (VFI) measured by inverse gas chromatography (iGC) at 4 h (VFI4h), which was defined as the pressure drop ratio of 4 h purged sample to that of the initial sample. VFI4h was found to correlate well with the cohesiveness of DPI formulations. The amount of investigated samples required for VFI measurement was less than that required for conventional measurements. VFI showed a good relationship between the cohesiveness of DPI formulations and the physical properties of mannitol. Thus, VFI can be a reliable standard index to evaluate the cohesiveness of DPI formulations. |
| ArticleNumber | 119766 |
| Author | Ando, Shuichi Yonemochi, Etsuo Maruyama, Sunao |
| Author_xml | – sequence: 1 givenname: Sunao orcidid: 0000-0003-2794-9825 surname: Maruyama fullname: Maruyama, Sunao email: maruyama.sunao.yp@daiichisankyo.co.jp organization: Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo 140-8710, Japan – sequence: 2 givenname: Shuichi surname: Ando fullname: Ando, Shuichi organization: Formulation Technology Research Laboratories, Daiichi Sankyo Co., Ltd., 1-2-58, Hiromachi, Shinagawa-ku, Tokyo 140-8710, Japan – sequence: 3 givenname: Etsuo orcidid: 0000-0001-5255-5129 surname: Yonemochi fullname: Yonemochi, Etsuo email: e-yonemochi@hoshi.ac.jp organization: Department of Physical Chemistry, School of Pharmacy and Pharmaceutical Sciences, Hoshi University, 2-4-41, Ebara, Shinagawa-ku, Tokyo 142-8501, Japan |
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Pharm. doi: 10.1016/j.ijpharm.2016.06.059 contributor: fullname: Capece – year: 2018 ident: 10.1016/j.ijpharm.2020.119766_b0020 contributor: fullname: Council of Europe – volume: 547 start-page: 489 year: 2018 ident: 10.1016/j.ijpharm.2020.119766_b0010 article-title: Formulation techniques for high dose dry powders publication-title: Int. J. Pharm. doi: 10.1016/j.ijpharm.2018.05.036 contributor: fullname: Brunaugh – volume: 549 start-page: 58 year: 2018 ident: 10.1016/j.ijpharm.2020.119766_b0040 article-title: Dosing considerations for inhaled biologics publication-title: Int. J. Pharm. doi: 10.1016/j.ijpharm.2018.07.054 contributor: fullname: Ferrati – volume: 10 start-page: 252 year: 2018 ident: 10.1016/j.ijpharm.2020.119766_b0025 article-title: Moisture-resistant co-spray-dried netilmicin with L-leucine as dry powder inhalation for the treatment of respiratory infections publication-title: Pharmaceutics doi: 10.3390/pharmaceutics10040252 contributor: fullname: Cui – volume: 306 start-page: 41 year: 2005 ident: 10.1016/j.ijpharm.2020.119766_b0035 article-title: Micro-mechanical properties of drying material bridges of pharmaceutical excipients publication-title: Int. J. Pharm. doi: 10.1016/j.ijpharm.2005.08.028 contributor: fullname: Farber – volume: 57 start-page: 495 year: 2004 ident: 10.1016/j.ijpharm.2020.119766_b0095 article-title: Functionality testing of inhalation grade lactose publication-title: Eur. J. Pharm. Biopharm. doi: 10.1016/j.ejpb.2003.12.003 contributor: fullname: Steckel – volume: 447 start-page: 251 year: 2013 ident: 10.1016/j.ijpharm.2020.119766_b0030 article-title: Inhaled proteins: challenges and perspectives publication-title: Int. J. Pharm. doi: 10.1016/j.ijpharm.2013.02.031 contributor: fullname: Depreter – volume: 42 start-page: 150 issue: 1 year: 2016 ident: 10.1016/j.ijpharm.2020.119766_b0070 article-title: Inhaled PYY(3–36) dry-powder formulation for appetite suppression publication-title: Drug Dev. Ind. Pharm. doi: 10.3109/03639045.2015.1036067 contributor: fullname: Philip |
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| Title | Application of void forming index (VFI): Detection of the effect of physical properties of dry powder inhaler formulations on powder cohesion |
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