Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performance
The primary objective of the research effort is to establish efficient solid self-nanoemulsifying drug delivery systems (S-SNEDDS) for benidipine (BD) through the systematic application of a quality-by-design (QbD)-based paradigm. Utilizing Labrafil M 2125 CS, Kolliphor EL, and Transcutol P, the BD-...
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Taylor & Francis Group
2024-12-01
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| Series: | Drug Delivery |
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| Online Access: | https://www.tandfonline.com/doi/10.1080/10717544.2023.2288801 |
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| author | Sheetal S. Buddhadev Kevinkumar C. Garala Saisivam S Mohamed Rahamathulla Mohammed Muqtader Ahmed Syeda Ayesha Farhana Ismail Pasha |
| author_facet | Sheetal S. Buddhadev Kevinkumar C. Garala Saisivam S Mohamed Rahamathulla Mohammed Muqtader Ahmed Syeda Ayesha Farhana Ismail Pasha |
| author_sort | Sheetal S. Buddhadev |
| collection | DOAJ |
| description | The primary objective of the research effort is to establish efficient solid self-nanoemulsifying drug delivery systems (S-SNEDDS) for benidipine (BD) through the systematic application of a quality-by-design (QbD)-based paradigm. Utilizing Labrafil M 2125 CS, Kolliphor EL, and Transcutol P, the BD-S-SNEDDS were created. The central composite design was adopted to optimize numerous components. Zeta potential, drug concentration, resistance to dilution, pH, refractive index, viscosity, thermodynamic stability, and cloud point were further investigated in the most efficient formulation, BD14, which had a globule size of 156.20 ± 2.40 nm, PDI of 0.25, zeta potential of −17.36 ± 0.18 mV, self-emulsification time of 65.21 ± 1.95 s, % transmittance of 99.80 ± 0.70%, and drug release of 92.65 ± 1.70% at 15 min. S-SNEDDS were formulated using the adsorption process and investigated via Fourier transform infrared spectroscopy, Differential scanning calorimeter, Scanning electron microscopy, and powder X-ray diffraction. Optimized S-SNEDDS batch BD14 dramatically decreased blood pressure in rats in contrast to the pure drug and the commercial product, according to a pharmacodynamics investigation. Accelerated stability tests validated the product’s stability. Therefore, the development of oral S-SNEDDS of BD may be advantageous for raising BD's water solubility and expanding their releasing capabilities, thereby boosting oral absorption. |
| format | Article |
| id | doaj-art-4c3b6635d0654f1285b7f6b2f7fe34b2 |
| institution | OA Journals |
| issn | 1071-7544 1521-0464 |
| language | English |
| publishDate | 2024-12-01 |
| publisher | Taylor & Francis Group |
| record_format | Article |
| series | Drug Delivery |
| spelling | doaj-art-4c3b6635d0654f1285b7f6b2f7fe34b22025-08-20T02:30:28ZengTaylor & Francis GroupDrug Delivery1071-75441521-04642024-12-0131110.1080/10717544.2023.2288801Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performanceSheetal S. Buddhadev0Kevinkumar C. Garala1Saisivam S2Mohamed Rahamathulla3Mohammed Muqtader Ahmed4Syeda Ayesha Farhana5Ismail Pasha6School of Pharmaceutical Sciences, Atmiya University, Rajkot, IndiaSchool of Pharmaceutical Sciences, Atmiya University, Rajkot, IndiaN. R. Vekaria Institute of Pharmacy, Gujarat Technological University, Junagadh, IndiaDepartment of Pharmaceutics, College of Pharmacy, King Khalid University, Abha, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, Al-Kharj, Saudi ArabiaDepartment of Pharmaceutics, Unaizah College of Pharmacy, Qassim University, Unaizah, Saudi ArabiaDepartment of Pharmacology, Orotta College of Medicine and Health Sciences, Asmara University, Asmara, State of EritreaThe primary objective of the research effort is to establish efficient solid self-nanoemulsifying drug delivery systems (S-SNEDDS) for benidipine (BD) through the systematic application of a quality-by-design (QbD)-based paradigm. Utilizing Labrafil M 2125 CS, Kolliphor EL, and Transcutol P, the BD-S-SNEDDS were created. The central composite design was adopted to optimize numerous components. Zeta potential, drug concentration, resistance to dilution, pH, refractive index, viscosity, thermodynamic stability, and cloud point were further investigated in the most efficient formulation, BD14, which had a globule size of 156.20 ± 2.40 nm, PDI of 0.25, zeta potential of −17.36 ± 0.18 mV, self-emulsification time of 65.21 ± 1.95 s, % transmittance of 99.80 ± 0.70%, and drug release of 92.65 ± 1.70% at 15 min. S-SNEDDS were formulated using the adsorption process and investigated via Fourier transform infrared spectroscopy, Differential scanning calorimeter, Scanning electron microscopy, and powder X-ray diffraction. Optimized S-SNEDDS batch BD14 dramatically decreased blood pressure in rats in contrast to the pure drug and the commercial product, according to a pharmacodynamics investigation. Accelerated stability tests validated the product’s stability. Therefore, the development of oral S-SNEDDS of BD may be advantageous for raising BD's water solubility and expanding their releasing capabilities, thereby boosting oral absorption.https://www.tandfonline.com/doi/10.1080/10717544.2023.2288801Benidipinesolid self-nanoemulsifying drug delivery systemsS-SNEDDSternary phase diagramcentral composite designCCD |
| spellingShingle | Sheetal S. Buddhadev Kevinkumar C. Garala Saisivam S Mohamed Rahamathulla Mohammed Muqtader Ahmed Syeda Ayesha Farhana Ismail Pasha Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performance Drug Delivery Benidipine solid self-nanoemulsifying drug delivery systems S-SNEDDS ternary phase diagram central composite design CCD |
| title | Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performance |
| title_full | Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performance |
| title_fullStr | Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performance |
| title_full_unstemmed | Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performance |
| title_short | Quality by design aided self-nano emulsifying drug delivery systems development for the oral delivery of Benidipine: Improvement of biopharmaceutical performance |
| title_sort | quality by design aided self nano emulsifying drug delivery systems development for the oral delivery of benidipine improvement of biopharmaceutical performance |
| topic | Benidipine solid self-nanoemulsifying drug delivery systems S-SNEDDS ternary phase diagram central composite design CCD |
| url | https://www.tandfonline.com/doi/10.1080/10717544.2023.2288801 |
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