Graded Assignment Declaration

Coursework

The context of the written assignment should make reference to the information given in the following question.

Question 1

Straits Pharmaceuticals is currently manufacturing Drug A and B to be marketed in Europe. Listed below in Table 1 and Table 2 are the physicochemical properties of Drugs A and B.

Table 1: Physicochemical Properties of Drug A
Physical State Powder
Dose 300mg; 3 times a day
Colour White
Taste Bitter
Melting Point 60°C
Solubility in water Poor solubility
Hausner Ratio 1.10
Carr’s Index 12%
Angle of Repose 25°
Half-life 4 hours

Stability Analysis Degrades when exposed to UV light

Table 1: Physicochemical Properties of Drug A

Table 2: Physicochemical Properties of Drug B
Physical State Powder
Molecular Weight 420 Da
Dose 80mg; 2 times a day
Colour White
Taste Bitter
Melting Point 50°C
Solubility in water Soluble in water
pKa 7.35
Half-life 4 hours
Stability Analysis Unstable in aqueous environment for more than 3 hours

Table 2: Physicochemical Properties of Drug B

a) As part of the formulation team at Straits Pharmaceutical, you are tasked to propose TWO suitable dosage forms each for Drugs A and B based on the information provided in Tables 1 and 2. Justify your choices and explain how the selected dosage forms help to impart stability to the drug.

b) Discuss the importance of biopharmaceutical and therapeutic factors in dosage form design. Include in your answer at least two biopharmaceutical and two therapeutic factors you have to consider to successfully formulate the selected dosage forms in part (a).

c) From the list of excipients provided in Annex A, select the excipients to formulate each of your chosen dosage forms in part (a). Justify your choice of excipients used in the formulation.