Fast Disintegrating Combination Tablet of Taste Masked Levocetrizine Dihydrochloride and Montelukast Sodium: Formulation Design, Development, and Characterization

Table 17

Stability study data for optimized formulation K4 and K5.

Formulation batch	Parameters evaluated	Time interval (months)
		0		1		2		3
K4	Hardness (kg/cm^2)	3.1 ± 0.47		3.2 ± 0.38		3.1 ± 0.24		3.3 ± 0.42
	Friability (%)	0.49 ± 0.089		0.51 ± 0.072		0.43 ± 0.091		0.39 ± 0.103
	Dispersion time (sec)	20.37 ± 0.16		19.78 ± 0.21		19.64 ± 0.39		21.31 ± 0.25
	Drug content (%)	L	M	L	M	L	M	L	M
		97.6	93.2	96.3	94.7	96.9	93.6	98.2	92.5
	Disintegration time (sec)	18 ± 0.12		20 ± 0.16		18 ± 0.07		19 ± 0.21
K5	Hardness (kg/cm^2)	3.3 ± 0.52		3.2 ± 0.41		3.1 ± 0.62		3.3 ± 0.57
	Friability (%)	0.58 ± 0.076		0.63 ± 0.069		0.48 ± 0.062		0.51 ± 0.092
	Dispersion time (sec)	23.69 ± 0.89		22.54 ± 0.73		22.79 ± 0.83		21.39 ± 51
	Drug content (%)	L	M	L	M	L	M	L	M
		98.2	94.3	96.7	94.9	97.4	93.5	98.3	95.1
	Disintegration time (sec)	20 ± 0.06		21 ± 0.15		21 ± 0.11		19 ± 0.18

L: Levocetrizine dihydrochloride; M: Montelukast sodium.