Combined Effect of Synthetic and Natural Polymers in Preparation of Cetirizine Hydrochloride Oral Disintegrating Tablets: Optimization by Central Composite Design

Table 2

Composition of preliminary trial batch with individual disintegrant and their evaluation parameters.

Ingredients (mg)
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
Other	12	12	12	12	12	12	12	12
Aspartame	4	4	4	4	4	4	4	4
Evaluation
Parameters
DT (sec)
(%)	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%; HRM: 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.
excipients used were magnesium stearate, 2 mg (1%); aerosil, 2 mg (1%); talc, 2 mg (1%); and flavour, 6 mg (3%).