Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh Conditions
Cefdinir (CEF) is classified as a third-generation cephalosporin within class IV of the Biopharmaceutical Classification System (BCS). Cefdinir has low solubility and permeability, which may reduce oral bioavailability. The aim of this research was the preparation of cefdinir ternary solid di...
Saved in:
| Main Authors: | , , , |
|---|---|
| Format: | Article |
| Language: | English |
| Published: |
College of Pharmacy / Mustansiriyah University
2025-01-01
|
| Series: | Al-Mustansiriyah Journal of Pharmaceutical Sciences |
| Subjects: | |
| Online Access: | https://ajps.uomustansiriyah.edu.iq/index.php/AJPS/article/view/1106 |
| Tags: |
Add Tag
No Tags, Be the first to tag this record!
|
| _version_ | 1832587628997771264 |
|---|---|
| author | Naamaa A. Naama Ghaidaa S. Hameed Dalya Basil Hanna Zainab H. Mahdi |
| author_facet | Naamaa A. Naama Ghaidaa S. Hameed Dalya Basil Hanna Zainab H. Mahdi |
| author_sort | Naamaa A. Naama |
| collection | DOAJ |
| description |
Cefdinir (CEF) is classified as a third-generation cephalosporin within class IV of the Biopharmaceutical Classification System (BCS). Cefdinir has low solubility and permeability, which may reduce oral bioavailability.
The aim of this research was the preparation of cefdinir ternary solid dispersion in order to enhance its solubility. Then, after evaluating this ternary SD, investigate its stability under harsh conditions. In addition, formulation and evaluation of CEF ternary SD as capsule dosage form. The ternary SD is prepared by the solvent evaporation method using CEF, curcumin, and polyvinylpyrrolidone k30 in a weight ratio of 1:1:1. The ternary SD is subject to evaluation using Differential Scanning Calorimetry (DSC), Powder X-ray Diffractometry (PXRD), and Fourier Transform Infrared Spectroscopy (FTIR), saturated solubility, release, antibacterial activity, and a two months stability study under conditions of 40 ºC and 75% relative humidity. Then, six different capsule formulas were prepared using different excipients; each formula contained 300 mg of CEF. The capsule formulas were subjected to pre-formulation and capsule evaluation tests, which included weight variation, drug content, disintegration time, and In-vitro dissolution tests. The selected optimum capsule formula was subjected to further antibacterial activity test. Evaluation of ternary SD showed that, the system is totally amorphous with enhanced dissolution, saturated solubility, and antibacterial activity compared to pure CEF. Stability studies showed that, ternary SD remains amorphous after two months. Compared to commercial capsules (Sefarin® 300 mg) and other formulas, the F6 formula released 90% of CEF in 30 min. Antibacterial activity test results showed that the F6 formula was active against Staphylococcus aureus and Proteus vulgaris bacterial isolate. This research concludes that CEF solubility, antibacterial activity enhancement, and stability insurance could be obtained by preparing CEF ternary SD. All the ternary SD prepared capsule formulas showed enhancements in release compared to commercial capsules.
|
| format | Article |
| id | doaj-art-2d5b01607c5b48498bcf0ef63d0637c0 |
| institution | Kabale University |
| issn | 1815-0993 2959-183X |
| language | English |
| publishDate | 2025-01-01 |
| publisher | College of Pharmacy / Mustansiriyah University |
| record_format | Article |
| series | Al-Mustansiriyah Journal of Pharmaceutical Sciences |
| spelling | doaj-art-2d5b01607c5b48498bcf0ef63d0637c02025-01-24T13:47:28ZengCollege of Pharmacy / Mustansiriyah UniversityAl-Mustansiriyah Journal of Pharmaceutical Sciences1815-09932959-183X2025-01-0125110.32947/ajps.v25i1.1106Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh ConditionsNaamaa A. Naama 0Ghaidaa S. Hameed1Dalya Basil Hanna 2Zainab H. Mahdi3Department of Pharmaceutics, College of Pharmacy, Mustansiriyah University, Baghdad, IraqDepartment of Pharmaceutics, College of Pharmacy, Mustansiriyah University, Baghdad, IraqDepartment of Clinical Laboratory Sciences, College of Pharmacy, Mustansiriyah University, Baghdad, IraqDepartment of pharmaceutics, College of Pharmacy, Applied science private university, Amman, Jordan Cefdinir (CEF) is classified as a third-generation cephalosporin within class IV of the Biopharmaceutical Classification System (BCS). Cefdinir has low solubility and permeability, which may reduce oral bioavailability. The aim of this research was the preparation of cefdinir ternary solid dispersion in order to enhance its solubility. Then, after evaluating this ternary SD, investigate its stability under harsh conditions. In addition, formulation and evaluation of CEF ternary SD as capsule dosage form. The ternary SD is prepared by the solvent evaporation method using CEF, curcumin, and polyvinylpyrrolidone k30 in a weight ratio of 1:1:1. The ternary SD is subject to evaluation using Differential Scanning Calorimetry (DSC), Powder X-ray Diffractometry (PXRD), and Fourier Transform Infrared Spectroscopy (FTIR), saturated solubility, release, antibacterial activity, and a two months stability study under conditions of 40 ºC and 75% relative humidity. Then, six different capsule formulas were prepared using different excipients; each formula contained 300 mg of CEF. The capsule formulas were subjected to pre-formulation and capsule evaluation tests, which included weight variation, drug content, disintegration time, and In-vitro dissolution tests. The selected optimum capsule formula was subjected to further antibacterial activity test. Evaluation of ternary SD showed that, the system is totally amorphous with enhanced dissolution, saturated solubility, and antibacterial activity compared to pure CEF. Stability studies showed that, ternary SD remains amorphous after two months. Compared to commercial capsules (Sefarin® 300 mg) and other formulas, the F6 formula released 90% of CEF in 30 min. Antibacterial activity test results showed that the F6 formula was active against Staphylococcus aureus and Proteus vulgaris bacterial isolate. This research concludes that CEF solubility, antibacterial activity enhancement, and stability insurance could be obtained by preparing CEF ternary SD. All the ternary SD prepared capsule formulas showed enhancements in release compared to commercial capsules. https://ajps.uomustansiriyah.edu.iq/index.php/AJPS/article/view/1106CefdinirTernary solid dispersionPolyvinylpyrrolidone k30StabilityCapsule |
| spellingShingle | Naamaa A. Naama Ghaidaa S. Hameed Dalya Basil Hanna Zainab H. Mahdi Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh Conditions Al-Mustansiriyah Journal of Pharmaceutical Sciences Cefdinir Ternary solid dispersion Polyvinylpyrrolidone k30 Stability Capsule |
| title | Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh Conditions |
| title_full | Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh Conditions |
| title_fullStr | Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh Conditions |
| title_full_unstemmed | Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh Conditions |
| title_short | Formulation of Cefdinir Ternary Solid Dispersion and Stability Study under Harsh Conditions |
| title_sort | formulation of cefdinir ternary solid dispersion and stability study under harsh conditions |
| topic | Cefdinir Ternary solid dispersion Polyvinylpyrrolidone k30 Stability Capsule |
| url | https://ajps.uomustansiriyah.edu.iq/index.php/AJPS/article/view/1106 |
| work_keys_str_mv | AT naamaaanaama formulationofcefdinirternarysoliddispersionandstabilitystudyunderharshconditions AT ghaidaashameed formulationofcefdinirternarysoliddispersionandstabilitystudyunderharshconditions AT dalyabasilhanna formulationofcefdinirternarysoliddispersionandstabilitystudyunderharshconditions AT zainabhmahdi formulationofcefdinirternarysoliddispersionandstabilitystudyunderharshconditions |