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ABSTRACT
| Title |
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Palatability Evaluation Study Of Oral Disintegrating Tablets by Human Volunteers |
| Authors |
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Venkata Ramana Reddy S, Sathyanarayana Dondeti, Manavalan R, Sreekanth J |
| Keywords |
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Amberlite, Direct compression, Lyophilization, Oral disintegrating tablets (ODTs), Palatability evaluation study, Risperidone. |
| Issue Date |
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September 2010 |
| Abstract |
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The aim of the present investigation was to develop a suitable palatability evaluation study by human volunteers for oral disintegrating tablets (ODT). For this study insoluble and bitter drug like risperidone was selected to evaluate the palatability study efficiency. Palatability study design and procedure developed in healthy male human volunteers and same study design applied for risperidone ODT tablets. Total ten healthy male human volunteers (Age of volunteers in between 25 – 30 years) selected for this palatability evaluation study. For evaluation of the patient’s observation, both positive and negative controls also added in palatability evaluation study. Always positive control should get first rank and negative control should get last rank, then only palatability evaluation by the volunteers should be correct. Taste masking agents, taste enhancers and flavors ware used to develop the ODT formulation of risperidone. ODT of risperidone were prepared using different process like lyophilzation and compressed tablets technique. Amberlite was used a taste masking agent. All the formulation showed low weight variation, less disintegration time (less than 30 seconds) and rapid in vitro dissolution. The results revealed that the tablets containing for both the methods had a good palatability for the patients. The optimized formulations showed good palatability by human volunteers, less disintegration time (<30seconds) and release profile with maximum drug being released at all time intervals. It was concluded that risperidone ODT’s with improved taste masking and dissolution could be prepared by both lyophilization and compressed tablet technique with suitable taste masking agent like amberlite. The present study demonstrated to suitability of palatability study design by human volunteers and potentials for rapid disintegration in oral cavity with out water, improved taste masking and patient compliance. |
| Page(s) |
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326-346 |
| ISSN |
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0975-9492 |
| Source |
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Vol. 1, No.8 |
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