Table 2.
Composition of preliminary trial batch with individual disintegrant and their evaluation parameters.
| Ingredients (mg) | F A1 | F A2 | F A3 | F A4 | F A5 | F A6 | F A7 | F A8 |
|---|---|---|---|---|---|---|---|---|
| CTZ | 10 | 10 | 10 | 10 | 10 | 10 | 10 | 10 |
| CCS | 5 | 10 | 15 | 20 | — | — | — | — |
| (2.5%) | (5%) | (7.5%) | (10%) | |||||
| HRM | — | — | — | — | 10 | 20 | 30 | 40 |
| (5%) | (10%) | (15%) | (20%) | |||||
| Pearlitol SD 200 | 149 | 144 | 139 | 134 | 144 | 134 | 124 | 114 |
| Sorbitol | 20 | 20 | 20 | 20 | 20 | 20 | 20 | 20 |
| Otherexcipients∗ | 12 | 12 | 12 | 12 | 12 | 12 | 12 | 12 |
| Aspartame | 4 | 4 | 4 | 4 | 4 | 4 | 4 | 4 |
|
| ||||||||
| Evaluation | ||||||||
| Parameters | ||||||||
|
| ||||||||
| DT (sec) | 31 ± 2 | 18 ± 2.2 | 25 ± 1.3 | 28 ± 2.3 | 39 ± 0.33 | 28 ± 0.12 | 36 ± 0.23 | 49 ± 0.32 |
| F (%) | 0.93 | 0.91 | 1.11 | 1.34 | 0.49 | 0.31 | 0.79 | 0.87 |
| Wetting time (sec) | 27 | 16 | 24 | 22 | 36 | 25 | 33 | 47 |
| DR at 25 min | 98.24 | 98.99 | 98.72 | 97.47 | 93.32 | 98.32 | 89.45 | 87.33 |
Net tablet weight: 200 mg; batch size: 50 CTZ ODTs.
Note. The amount of all the ingredients was calculated on the basis of net weight of one tablet (200 mg). For the preliminary trial batch four varied concentrations of CCS and HRM (ΔCCS: 2.5%–10%; ΔHRM: 5%–20%) were trialed for desired tablet properties. D-sorbitol (10%) and aspartame (2%) as sweetening agent were used to mask the inherent bitter taste of cetirizine hydrochloride in all the trial formulations.
∗Other excipients used were magnesium stearate, 2 mg (1%); aerosil, 2 mg (1%); talc, 2 mg (1%); and flavour, 6 mg (3%).