Question 4 Consider the following tablet formulation for a new drug Y (hydrophobic drug) per tablet which was manufactur

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Question 4
Consider the following tablet formulation for a new drug Y
(hydrophobic drug) per tablet which was manufactured by dry
granulation:
Drug Y ……………………………………........... 250 mg
Microcrystalline cellulose ………….………. 90 mg
PVP …………………………………...........……….. 30 mg
Sodium starch glycolate ……………..……… 18 mg
Sodium lauryl sulfate ………………...…..…….. 6 mg
Lactose …………………………….….........……. 106 mg
A. Describe TWO possible reasons for the need to granulate the
drug-excipients mixtures as dry rather than wet granules. [2
marks]
B. Describe TWO possible conditions for compressing the
drug-excipients mixtures directly without granulation. [2
marks]
C. During the initial run, samples from the tablets were tested
for hardness and disintegration and found to be too hard and took
more than 30 minutes to disintegrate completely. Suggest two
formulation strategies to overcome this problem. [2 marks]
D. During the initial run, samples from the tablets were tested
visually and some tablets showed sticking and picking. Describe
each term, the causes and how to avoid these defects. [4 marks]
E. Explain why tablets have slow onset of action compared to
powdered dosage form by explaining the different stages for the
drug in immediate release tablets before it is available at the
site of action. [4 marks]
F. We are to design the drug in this tablet for extended release
and tablets need to be film coated. Explaining your selection,
outline TWO examples of suitable polymers and their relative
properties for an efficient coating. You will need to refer to the
handbook of pharmaceutical excipients for the actual properties of
the selected polymers. [4 marks]