Novel Fluticasone Propionate and Salmeterol Fixed-Dose Combination Nano-Encapsulated Particles Using Polyamide Based on L-Lysine
One of the key challenges in developing a dry powder inhaler (DPI) of an inhalable potent fixed-dose combination (FDC) is the ability of the formulation to generate an effective and reproducible aerosol able to reach the lower parts of the lungs. Herein, a one-step approach is presented to expedite...
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| Format: | Article |
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MDPI AG
2022-03-01
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| Series: | Pharmaceuticals |
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| Online Access: | https://www.mdpi.com/1424-8247/15/3/321 |
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| author | Mohammad H. Alyami Eman Zmaily Dahmash Dalia Khalil Ali Hamad S. Alyami Hussien AbdulKarim Samar A. Alsudir |
| author_facet | Mohammad H. Alyami Eman Zmaily Dahmash Dalia Khalil Ali Hamad S. Alyami Hussien AbdulKarim Samar A. Alsudir |
| author_sort | Mohammad H. Alyami |
| collection | DOAJ |
| description | One of the key challenges in developing a dry powder inhaler (DPI) of an inhalable potent fixed-dose combination (FDC) is the ability of the formulation to generate an effective and reproducible aerosol able to reach the lower parts of the lungs. Herein, a one-step approach is presented to expedite the synthesis of nanoaggregates made from a biocompatible and biodegradable polyamide based on L-lysine amino acid employing market-leading active pharmaceutical ingredients (fluticasone propionate (FP) and salmeterol xinafoate (SAL)) for the management of asthma. The nanoaggregates were synthesized using interfacial polycondensation that produced nanocapsules with an average particle size of 226.7 ± 35.3 nm and zeta potential of −30.6 ± 4.2 mV. Differential scanning calorimetric analysis and x-ray diffraction, as well as scanning electron microscopy of the produced FDC, revealed the ability of the produced nanocapsules to encapsulate the two actives and display the best aerodynamic performance. The FDC nanocapsules displayed 88.5% and 98.5% of the emitted dose for FP and SAL, respectively. The fine particle fraction of the nominated dose was superior to the marketed product (Seretide Diskus<sup>®</sup>, Brentford, United Kingdom). The in-vitro release study showed an extended drug release profile. Our findings suggest that nanoaggregates using polyamides based on L-lysine and interfacial polycondensation can serve as a good platform for pulmonary drug delivery of FDC systems. |
| first_indexed | 2024-03-09T13:01:14Z |
| format | Article |
| id | doaj.art-d7c3da47ff5f4a869408090f0c67bf7a |
| institution | Directory Open Access Journal |
| issn | 1424-8247 |
| language | English |
| last_indexed | 2024-03-09T13:01:14Z |
| publishDate | 2022-03-01 |
| publisher | MDPI AG |
| record_format | Article |
| series | Pharmaceuticals |
| spelling | doaj.art-d7c3da47ff5f4a869408090f0c67bf7a2023-11-30T21:54:29ZengMDPI AGPharmaceuticals1424-82472022-03-0115332110.3390/ph15030321Novel Fluticasone Propionate and Salmeterol Fixed-Dose Combination Nano-Encapsulated Particles Using Polyamide Based on L-LysineMohammad H. Alyami0Eman Zmaily Dahmash1Dalia Khalil Ali2Hamad S. Alyami3Hussien AbdulKarim4Samar A. Alsudir5Department of Pharmaceutics, College of Pharmacy, Najran University, Najran 55461, Saudi ArabiaDepartment of Applied Pharmaceutical Sciences and Clinical Pharmacy, Faculty of Pharmacy, Isra University, Amman 11622, JordanDepartment of Physiotherapy, Faculty of Allied Medical Sciences, Isra University, Amman 11622, JordanDepartment of Pharmaceutics, College of Pharmacy, Najran University, Najran 55461, Saudi ArabiaDepartment of Applied Pharmaceutical Sciences and Clinical Pharmacy, Faculty of Pharmacy, Isra University, Amman 11622, JordanNational Center of Biotechnology, Life Science and Environmental Research Institute, King Abdulaziz City for Science and Technology, Riyadh 11442, Saudi ArabiaOne of the key challenges in developing a dry powder inhaler (DPI) of an inhalable potent fixed-dose combination (FDC) is the ability of the formulation to generate an effective and reproducible aerosol able to reach the lower parts of the lungs. Herein, a one-step approach is presented to expedite the synthesis of nanoaggregates made from a biocompatible and biodegradable polyamide based on L-lysine amino acid employing market-leading active pharmaceutical ingredients (fluticasone propionate (FP) and salmeterol xinafoate (SAL)) for the management of asthma. The nanoaggregates were synthesized using interfacial polycondensation that produced nanocapsules with an average particle size of 226.7 ± 35.3 nm and zeta potential of −30.6 ± 4.2 mV. Differential scanning calorimetric analysis and x-ray diffraction, as well as scanning electron microscopy of the produced FDC, revealed the ability of the produced nanocapsules to encapsulate the two actives and display the best aerodynamic performance. The FDC nanocapsules displayed 88.5% and 98.5% of the emitted dose for FP and SAL, respectively. The fine particle fraction of the nominated dose was superior to the marketed product (Seretide Diskus<sup>®</sup>, Brentford, United Kingdom). The in-vitro release study showed an extended drug release profile. Our findings suggest that nanoaggregates using polyamides based on L-lysine and interfacial polycondensation can serve as a good platform for pulmonary drug delivery of FDC systems.https://www.mdpi.com/1424-8247/15/3/321fluticasone propionatesalmeterol xinafoatepolyamiderespiratory drug deliveryL-lysinenanocapsules |
| spellingShingle | Mohammad H. Alyami Eman Zmaily Dahmash Dalia Khalil Ali Hamad S. Alyami Hussien AbdulKarim Samar A. Alsudir Novel Fluticasone Propionate and Salmeterol Fixed-Dose Combination Nano-Encapsulated Particles Using Polyamide Based on L-Lysine Pharmaceuticals fluticasone propionate salmeterol xinafoate polyamide respiratory drug delivery L-lysine nanocapsules |
| title | Novel Fluticasone Propionate and Salmeterol Fixed-Dose Combination Nano-Encapsulated Particles Using Polyamide Based on L-Lysine |
| title_full | Novel Fluticasone Propionate and Salmeterol Fixed-Dose Combination Nano-Encapsulated Particles Using Polyamide Based on L-Lysine |
| title_fullStr | Novel Fluticasone Propionate and Salmeterol Fixed-Dose Combination Nano-Encapsulated Particles Using Polyamide Based on L-Lysine |
| title_full_unstemmed | Novel Fluticasone Propionate and Salmeterol Fixed-Dose Combination Nano-Encapsulated Particles Using Polyamide Based on L-Lysine |
| title_short | Novel Fluticasone Propionate and Salmeterol Fixed-Dose Combination Nano-Encapsulated Particles Using Polyamide Based on L-Lysine |
| title_sort | novel fluticasone propionate and salmeterol fixed dose combination nano encapsulated particles using polyamide based on l lysine |
| topic | fluticasone propionate salmeterol xinafoate polyamide respiratory drug delivery L-lysine nanocapsules |
| url | https://www.mdpi.com/1424-8247/15/3/321 |
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