Exploration of Medicine

S. No.	QTPP	Target	Justification
1	Dosage form	Lipid based formulation	Selection of NLC, which is lipid based enhances the oral bioavailability of lipid soluble, BCS class II drugs
2	Dosage shape	Spherical	High surface area, high rate of drug release
3	Dosage type	Controlled release	Low dosing frequency
4	Dosage strength	X (mg)	Required dose to be incorporated in formulation to provide therapeutic benefit
5	Pharmacokinetics	C_max, AUC	High AUC and C_max are required to achieve higher plasma drug concentration and thus higher oral bioavailability
6	Route of administration	Oral	Good patient compliance, non-invasive
7	Container and closure	Air-tight amber color bottle	To protect drug degradation from light and moisture
8	Stability	At least 12 months at room temperature	To maintain the therapeutic activity of the drug during the storage period

S. No.

QTPP

Target

Justification

Dosage form

Lipid based formulation

Selection of NLC, which is lipid based enhances the oral bioavailability of lipid soluble, BCS class II drugs

Dosage shape

Spherical

High surface area, high rate of drug release

Dosage type

Controlled release

Low dosing frequency

Dosage strength

X (mg)

Required dose to be incorporated in formulation to provide therapeutic benefit

Pharmacokinetics

C_max, AUC

High AUC and C_max are required to achieve higher plasma drug concentration and thus higher oral bioavailability

Route of administration

Oral

Good patient compliance, non-invasive

Container and closure

Air-tight amber color bottle

To protect drug degradation from light and moisture

Stability

At least 12 months at room temperature

To maintain the therapeutic activity of the drug during the storage period