| Autor: |
Irshad, Asma, Yousuf, Rabia Ismail, Shoaib, Muhammad Harris, Qazi, Faaiza, Saleem, Muhammad Talha, Siddiqui, Fahad, Ahmed, Farrukh Rafiq, Rehman, Rauf-ur-, Jabeen, Sabahat, Farooqi, Sadaf, Khan, Momina Zarish, Masood, Rida |
| Zdroj: |
Journal of Drug Delivery Science and Technology; January 2023, Vol. 79 Issue: 1 |
| Abstrakt: |
The objective of the study was to develop a QbD based orodispersible Nitazoxanide 200 mg tablets its in-silicoPBPK modeling. The central composite design was applied to study the effect of four different superdisintegrant i.e., starch and cellulose based (sodium starch glycolate, pre-gelatinized starch, croscarmellose sodium), and crospovidone with microcrystalline cellulose as independent variables on disintegration time and % drug release. The Heckel analysis was applied to determine the compression behavior of the formulations which revealed a yield pressure in the range of ∼119 MPa–∼138 MPa. Moreover, the hardness of the tablets increased with the compression force and was largely independent of the disintegration time (<3 min for a maximum pressure of ∼138 MPa) owing to the role of superdisintrgrants in the formulations. The quality attributes suggest that the formulations containing microcrystalline cellulose (11–15%) with sodium starch glycolate (8%), pregelatinized starch (7.185%), croscarmellose sodium (2.755%), and crospovidone (5%) at the maximum desirability (0.799–0.902) exhibited minimum disintegration time and maximum % drug release. Their dissolution data (pH 1.2) were applied to predict the pediatric plasma profile of the active metabolite Tizoxanide by PBPK modeling. The QbD-based approach was successfully applied in designing Nitazoxanide 200 mg orodispersible tablets. |
| Databáze: |
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