Table 3.

Quality Target Product Profile and Identification of Critical Quality Attributes

Quality Attributes of Drug Product	Target		Is It CQAs?	Justification
Dosage form	Modified release Oral formulation		Yes	Modified dosage form Have minimum fluctuation in bioavailability.
Administration Route	Oral		Yes	Oral route of administration is preferred.
Dosage design	Tablets		Yes	It was objective to formulate Fixed dose matrix tablet.
Physical Characteristics of Tablets	Appearance	–	No	Appearance is not critical factor only meant for patient acceptability.
	Friability	< 1%	Yes	Friability is critical factor as affecting s release of drug.
	Thickness (mm)		Yes	For packaging tablet thickness is a critical factor.
	Hardness (Kp)		Yes	Hardness is critical factor as affecting tablet disintegration and, dissolution rate.
	% Yield		Yes	% Yield should be maximum and formulation factor affects % yield it is critical factor.