Research Article
In Vitro-In Vivo Correlation Evaluation of Generic Alfuzosin Modified Release Tablets
Table 1
Composition of different scale up formulation and respective batch size.
| | Ingredients |
*Spec | Placebo batch | Pivotal batch | Commercial production batch | | Mg/tablets | Kg/batch | Mg/tablets | Kg/Batch | Mg/tablets | Kg/batch |
| | Intragranular | | | | | | | | | Alfuzosin HCl | | | | 10.000 | 0.5 | 10.000 | 1.300 | | Lactose monohydrate | NF | 106.000 | 5.026* | 106.000 | 5.3 | 106.000 | 13.780 | | Mono- and dig1ycerides (Imwitor 900) | NF | 100.000 | 4.334 | 100.000 | 5.0 | 100.000 | 13.000 | | Extragranular | | | | | | | | | Colloidal silicon dioxide (Aerosil 200) | NF | 4.500 | 0.196 | 4.500 | 0.225 | 4.500 | 0.585 | | Magnesium stearate | NF | 2.500 | 0.108 | 2.500 | 0.125 | 2.500 | 0.325 | | Talc (Luzenac) | USP | 2.000 | 0.086 | 2.000 | 0.10 | 2.000 | 0.260 |
| | Total | | 215.000 | 9.750 | 225.000 | 11.25 | 225.000 | 29.250 |
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*Specification.
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