A Comprehensive Study About Natural vs Synthetic Super Disintegrant used in the Development of Rizatriptan Benzoate Oral Flash Films
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2026
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| author | Bose Babu Nargana*, Bommedi Durgadevi, Dunabayina Vaishnavi, Devera Jithendra, Garagaparthi Dhanuj Kumar, Golly Harsha Vardhan, Sarella Chandana |
| author_facet | Bose Babu Nargana*, Bommedi Durgadevi, Dunabayina Vaishnavi, Devera Jithendra, Garagaparthi Dhanuj Kumar, Golly Harsha Vardhan, Sarella Chandana |
| contents | <p class="MsoNormal"><span>Fast dissolving films (FDFs) are an advanced oral solid dosage form designed to rapidly disintegrate in the oral cavity with minimal saliva, improving onset of action and patient compliance, especially in geriatric and paediatric populations. Rizatriptan benzoate, a serotonin 5 HT1B/1D receptor agonist used in acute migraine, has an oral bioavailability of about 45–47% due to extensive first pass metabolism, making it a suitable candidate for oral fast dissolving systems. In this work, oral fast dissolving films of rizatriptan benzoate were formulated by solvent casting using HPMC E50 as film forming polymer, propylene glycol as plasticizer, aspartame as sweetener, and either sodium starch glycolate (SSG, synthetic superdisintegrant) or isabgol (natural superdisintegrant). Ten formulations were prepared in each group. The drug–excipient compatibility was evaluated by FTIR and DSC, which indicated no significant interaction between rizatriptan benzoate and the selected excipients. Prepared films were characterized for thickness, weight variation, folding endurance, surface pH, percentage moisture absorption, percentage moisture loss, disintegration time, drug content, mechanical properties, and in vitro drug release in pH 6.8 phosphate buffer. Among natural formulations, batch FN9 showed the shortest disintegration time (10 s) and highest drug release (99.39% at 5 min), while synthetic formulations showed comparatively slower disintegration and dissolution under identical conditions. Overall, isabgol based films demonstrated superior disintegration and drug release behaviour compared with SSG based films, suggesting that natural superdisintegrants can effectively replace synthetic ones in rizatriptan benzoate fast dissolving films to achieve rapid onset of antimigraine action</span></p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_20085372 |
| institution | Zenodo |
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| publishDate | 2026 |
| publisher | Zenodo |
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| spellingShingle | A Comprehensive Study About Natural vs Synthetic Super Disintegrant used in the Development of Rizatriptan Benzoate Oral Flash Films Bose Babu Nargana*, Bommedi Durgadevi, Dunabayina Vaishnavi, Devera Jithendra, Garagaparthi Dhanuj Kumar, Golly Harsha Vardhan, Sarella Chandana Rizatriptan benzoate, fast dissolving films, sodium starch glycolate, isabgol, HPMC E50, natural superdisintegrant, synthetic superdisintegrant. <p class="MsoNormal"><span>Fast dissolving films (FDFs) are an advanced oral solid dosage form designed to rapidly disintegrate in the oral cavity with minimal saliva, improving onset of action and patient compliance, especially in geriatric and paediatric populations. Rizatriptan benzoate, a serotonin 5 HT1B/1D receptor agonist used in acute migraine, has an oral bioavailability of about 45–47% due to extensive first pass metabolism, making it a suitable candidate for oral fast dissolving systems. In this work, oral fast dissolving films of rizatriptan benzoate were formulated by solvent casting using HPMC E50 as film forming polymer, propylene glycol as plasticizer, aspartame as sweetener, and either sodium starch glycolate (SSG, synthetic superdisintegrant) or isabgol (natural superdisintegrant). Ten formulations were prepared in each group. The drug–excipient compatibility was evaluated by FTIR and DSC, which indicated no significant interaction between rizatriptan benzoate and the selected excipients. Prepared films were characterized for thickness, weight variation, folding endurance, surface pH, percentage moisture absorption, percentage moisture loss, disintegration time, drug content, mechanical properties, and in vitro drug release in pH 6.8 phosphate buffer. Among natural formulations, batch FN9 showed the shortest disintegration time (10 s) and highest drug release (99.39% at 5 min), while synthetic formulations showed comparatively slower disintegration and dissolution under identical conditions. Overall, isabgol based films demonstrated superior disintegration and drug release behaviour compared with SSG based films, suggesting that natural superdisintegrants can effectively replace synthetic ones in rizatriptan benzoate fast dissolving films to achieve rapid onset of antimigraine action</span></p> |
| title | A Comprehensive Study About Natural vs Synthetic Super Disintegrant used in the Development of Rizatriptan Benzoate Oral Flash Films |
| topic | Rizatriptan benzoate, fast dissolving films, sodium starch glycolate, isabgol, HPMC E50, natural superdisintegrant, synthetic superdisintegrant. |
| url | https://doi.org/10.5281/zenodo.20085372 |