Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability
The present study was aimed to formulate and evaluate fast dissolving oral film of Rosuvastatin calcium to improve its bioavailability in comparison to typical solid oral dosage forms. The drug was formulated as solid dispersion with hydrophilic polymers and assessed for different constraints such a...
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| Format: | Article |
| Language: | English |
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Elsevier
2023-01-01
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| Series: | Saudi Pharmaceutical Journal |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S1319016422002882 |
| _version_ | 1797954195337248768 |
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| author | Randa Mohammed Zaki Munerah Alfadhel Vidya DevanathaDesikan Seshadri Faisal Albagami Majed Alrobaian Salha M Tawati Musarrat Husain Warsi Alanood S. Almurshedi |
| author_facet | Randa Mohammed Zaki Munerah Alfadhel Vidya DevanathaDesikan Seshadri Faisal Albagami Majed Alrobaian Salha M Tawati Musarrat Husain Warsi Alanood S. Almurshedi |
| author_sort | Randa Mohammed Zaki |
| collection | DOAJ |
| description | The present study was aimed to formulate and evaluate fast dissolving oral film of Rosuvastatin calcium to improve its bioavailability in comparison to typical solid oral dosage forms. The drug was formulated as solid dispersion with hydrophilic polymers and assessed for different constraints such as drug content, saturated solubility, and drug-polymer interaction. Best formula was selected and prepared in the form of orodispersible film. The films were developed by solvent casting method and examined for weight variations, drug content, folding endurance, pH, swelling profile, disintegration time, and in vitro dissolution. Further pharmacokinetic study was also performed on rabbit and compared with that of the marketed oral formulation. The drug and the polymers were found to be compatible with each other by FTIR study. Maximum solubility was found at drug polymer ratio of 1:4 and that was 54.53 ± 2.05 µg/mL. The disintegration time of the developed film was observed to be 10 ± 2.01 s, while release of the Rosuvastatin from the film was found to be 99.06 ± 0.40 in 10 min. Stability study shown that developed film was stable for three months. Further pharmacokinetic study revealed that developed orodispersible film had enhance oral bioavailability as compared to marketed product (Crestor® tablets). Conclusively, the study backs the development of a viable ODF of Rosuvastatin with better bioavailability. |
| first_indexed | 2024-04-10T23:13:46Z |
| format | Article |
| id | doaj.art-d42dec94985842cfb9672de178bfad67 |
| institution | Directory Open Access Journal |
| issn | 1319-0164 |
| language | English |
| last_indexed | 2024-04-10T23:13:46Z |
| publishDate | 2023-01-01 |
| publisher | Elsevier |
| record_format | Article |
| series | Saudi Pharmaceutical Journal |
| spelling | doaj.art-d42dec94985842cfb9672de178bfad672023-01-13T04:15:49ZengElsevierSaudi Pharmaceutical Journal1319-01642023-01-01311135146Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailabilityRanda Mohammed Zaki0Munerah Alfadhel1Vidya DevanathaDesikan Seshadri2Faisal Albagami3Majed Alrobaian4Salha M Tawati5Musarrat Husain Warsi6Alanood S. Almurshedi7Department of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, P.O. Box 173, Al-Kharj 11942, Saudi Arabia; Department of Pharmaceutics and Industrial Pharmacy, Faculty of Pharmacy, Beni-Suef University, Beni-Suef 62514, EgyptDepartment of Pharmaceutics, College of Pharmacy, Prince Sattam Bin Abdulaziz University, P.O. Box 173, Al-Kharj 11942, Saudi Arabia; Corresponding author.Department of Pharmacology and Toxicology, College of Pharmacy, Prince Sattam Bin Abdulaziz University, P.O. Box 173, Al-Kharj 11942, Saudi ArabiaDepartment of Pharmacology and Toxicology, College of Pharmacy, Prince Sattam Bin Abdulaziz University, P.O. Box 173, Al-Kharj 11942, Saudi ArabiaDepartment of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaGlasgow International College, G1 5ES Glasgow, United Kingdom; Faculty of Pharmacy, University of Benghazi, P.O. Box 1308, Benghazi, LibyaDepartment of Pharmaceutics and Industrial Pharmacy, College of Pharmacy, Taif University, P.O. Box 11099, Taif 21944, Saudi ArabiaDepartment of Pharmaceutics, College of Pharmacy, King Saud University, P.O. Box: 2457, Riyadh 11451, Saudi ArabiaThe present study was aimed to formulate and evaluate fast dissolving oral film of Rosuvastatin calcium to improve its bioavailability in comparison to typical solid oral dosage forms. The drug was formulated as solid dispersion with hydrophilic polymers and assessed for different constraints such as drug content, saturated solubility, and drug-polymer interaction. Best formula was selected and prepared in the form of orodispersible film. The films were developed by solvent casting method and examined for weight variations, drug content, folding endurance, pH, swelling profile, disintegration time, and in vitro dissolution. Further pharmacokinetic study was also performed on rabbit and compared with that of the marketed oral formulation. The drug and the polymers were found to be compatible with each other by FTIR study. Maximum solubility was found at drug polymer ratio of 1:4 and that was 54.53 ± 2.05 µg/mL. The disintegration time of the developed film was observed to be 10 ± 2.01 s, while release of the Rosuvastatin from the film was found to be 99.06 ± 0.40 in 10 min. Stability study shown that developed film was stable for three months. Further pharmacokinetic study revealed that developed orodispersible film had enhance oral bioavailability as compared to marketed product (Crestor® tablets). Conclusively, the study backs the development of a viable ODF of Rosuvastatin with better bioavailability.http://www.sciencedirect.com/science/article/pii/S1319016422002882Orodispersible filmRosuvastatin calciumSolvent casting methodPharmacokinetics |
| spellingShingle | Randa Mohammed Zaki Munerah Alfadhel Vidya DevanathaDesikan Seshadri Faisal Albagami Majed Alrobaian Salha M Tawati Musarrat Husain Warsi Alanood S. Almurshedi Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability Saudi Pharmaceutical Journal Orodispersible film Rosuvastatin calcium Solvent casting method Pharmacokinetics |
| title | Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability |
| title_full | Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability |
| title_fullStr | Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability |
| title_full_unstemmed | Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability |
| title_short | Fabrication and characterization of orodispersible films loaded with solid dispersion to enhance Rosuvastatin calcium bioavailability |
| title_sort | fabrication and characterization of orodispersible films loaded with solid dispersion to enhance rosuvastatin calcium bioavailability |
| topic | Orodispersible film Rosuvastatin calcium Solvent casting method Pharmacokinetics |
| url | http://www.sciencedirect.com/science/article/pii/S1319016422002882 |
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