Quality by Design (QbD) Assisted Fabrication of Fast Dissolving Buccal Film for Clonidine Hydrochloride: Exploring the Quality Attributes

Table 2

Quality target product profile (QTPP) earmarked for fast dissolving buccal film of CLH.

QTPP	Target	Justification
Dosage form	Buccal Film	Pharmaceutical requirement; equivalence same dosage form.
Route of administration	Buccal Cavity	Recommended route for delivery of Clonidine HCl to enhance drug dissolution and bypass the first pass metabolism.
Dosage strength	0.2 mg	Unit dose of Clonidine HCl incorporated into a single formulation of FDBF
Dosage Type	Fast dissolving buccal film (FDBF)	Faster onset of action leading to enhanced therapeutic effect.
Packaging	Polyethylene strip	Pharmaceutical requirement equivalence same packaging
Stability	At least 90 days at room temperature	To maintain therapeutic potential of the drug during stipulated storage period
Alternative routes of administration	None	No other method of administration.