Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies
<i>Silybum marianum</i> has been used for centuries by herbalists and physicians to treat different forms of liver diseases. It contains flavonoid, which has antioxidant, anti-inflammatory, antifibrotic and anticancer properties. The objective of this research was to develop a silymarin-...
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MDPI AG
2023-02-01
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| author | Divyambika Catakapatri Venugopal Reshma Devi Senthilnathan Saba Maanvizhi Yasasve Madhavan Sathasivasubramanian Sankarapandian Vijayalakshmi Ramshankar Mangathayaru Kalachaveedu |
| author_facet | Divyambika Catakapatri Venugopal Reshma Devi Senthilnathan Saba Maanvizhi Yasasve Madhavan Sathasivasubramanian Sankarapandian Vijayalakshmi Ramshankar Mangathayaru Kalachaveedu |
| author_sort | Divyambika Catakapatri Venugopal |
| collection | DOAJ |
| description | <i>Silybum marianum</i> has been used for centuries by herbalists and physicians to treat different forms of liver diseases. It contains flavonoid, which has antioxidant, anti-inflammatory, antifibrotic and anticancer properties. The objective of this research was to develop a silymarin-based mucoadhesive gel for prolonged release in oral mucosa and to evaluate the same by using <i>in vitro</i> drug release kinetic models and <i>ex vivo</i> methods for drug permeation using chicken buccal mucosa. The mucoadhesive gel was formulated in different trials by varying the concentration of silymarin and polymer. Out of 10 formulation trials, the F10 optimized trial was characterized for <i>in vitro</i> physicochemical parameters such as pH, homogeneity, viscosity, stability, drug content, <i>in vitro</i> drug release, <i>in vitro</i> antioxidant assay and <i>ex vivo</i> permeation study. Trial 10 was chosen as the best trial formulation among the other trials and was marked as an optimal trial. The physicochemical properties observed were pH to be 6.4 ± 0.01, the gel free of lumps, spreadability of 23.75 ± 0.03 and drug content of 32.77 ± 0.20 mg/g. It had no physiological changes such as color shift or fluid exudate segregation after 6 months of storage at room temperature. <i>In vitro</i> drug release established the presence of a non-fickian mechanism and demonstrated dose-dependent antioxidant activity. <i>Ex vivo</i> findings indicated 21.97 ± 0.18% release, proving that the gel can permeate through the oral mucosal membrane. Our future research will concentrate on expanding the therapeutic scope by developing the formulation trial F10 to a nanoformulation and conducting clinical trials for its potential use in various oral diseases. |
| first_indexed | 2024-03-11T08:47:49Z |
| format | Article |
| id | doaj.art-54b311de8a1b472084be163e6a1b1598 |
| institution | Directory Open Access Journal |
| issn | 2310-2861 |
| language | English |
| last_indexed | 2024-03-11T08:47:49Z |
| publishDate | 2023-02-01 |
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| series | Gels |
| spelling | doaj.art-54b311de8a1b472084be163e6a1b15982023-11-16T20:39:45ZengMDPI AGGels2310-28612023-02-019213910.3390/gels9020139Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral PathologiesDivyambika Catakapatri Venugopal0Reshma Devi Senthilnathan1Saba Maanvizhi2Yasasve Madhavan3Sathasivasubramanian Sankarapandian4Vijayalakshmi Ramshankar5Mangathayaru Kalachaveedu6Department of Oral Medicine and Radiology, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai 600116, IndiaDepartment of Pharmacognosy, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai 600116, IndiaDepartment of Pharmacognosy, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai 600116, IndiaDepartment of Oral Medicine and Radiology, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai 600116, IndiaDepartment of Oral Medicine and Radiology, Sri Ramachandra Institute of Higher Education and Research (DU), Porur, Chennai 600116, IndiaDepartment of Preventive Oncology (Research), Cancer Institute (WIA), Adyar, Chennai 600020, IndiaHerb and Food Division, Isha Arogya, Coimbatore 641010, India<i>Silybum marianum</i> has been used for centuries by herbalists and physicians to treat different forms of liver diseases. It contains flavonoid, which has antioxidant, anti-inflammatory, antifibrotic and anticancer properties. The objective of this research was to develop a silymarin-based mucoadhesive gel for prolonged release in oral mucosa and to evaluate the same by using <i>in vitro</i> drug release kinetic models and <i>ex vivo</i> methods for drug permeation using chicken buccal mucosa. The mucoadhesive gel was formulated in different trials by varying the concentration of silymarin and polymer. Out of 10 formulation trials, the F10 optimized trial was characterized for <i>in vitro</i> physicochemical parameters such as pH, homogeneity, viscosity, stability, drug content, <i>in vitro</i> drug release, <i>in vitro</i> antioxidant assay and <i>ex vivo</i> permeation study. Trial 10 was chosen as the best trial formulation among the other trials and was marked as an optimal trial. The physicochemical properties observed were pH to be 6.4 ± 0.01, the gel free of lumps, spreadability of 23.75 ± 0.03 and drug content of 32.77 ± 0.20 mg/g. It had no physiological changes such as color shift or fluid exudate segregation after 6 months of storage at room temperature. <i>In vitro</i> drug release established the presence of a non-fickian mechanism and demonstrated dose-dependent antioxidant activity. <i>Ex vivo</i> findings indicated 21.97 ± 0.18% release, proving that the gel can permeate through the oral mucosal membrane. Our future research will concentrate on expanding the therapeutic scope by developing the formulation trial F10 to a nanoformulation and conducting clinical trials for its potential use in various oral diseases.https://www.mdpi.com/2310-2861/9/2/139silymarinmucoadhesive geltopical formulationdrug releasebioavailability |
| spellingShingle | Divyambika Catakapatri Venugopal Reshma Devi Senthilnathan Saba Maanvizhi Yasasve Madhavan Sathasivasubramanian Sankarapandian Vijayalakshmi Ramshankar Mangathayaru Kalachaveedu Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies Gels silymarin mucoadhesive gel topical formulation drug release bioavailability |
| title | Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies |
| title_full | Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies |
| title_fullStr | Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies |
| title_full_unstemmed | Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies |
| title_short | Preparation and Characterization of Silymarin Gel: A Novel Topical Mucoadhesive Formulation for Potential Applicability in Oral Pathologies |
| title_sort | preparation and characterization of silymarin gel a novel topical mucoadhesive formulation for potential applicability in oral pathologies |
| topic | silymarin mucoadhesive gel topical formulation drug release bioavailability |
| url | https://www.mdpi.com/2310-2861/9/2/139 |
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