| University | University of Sunderland (UoS) |
| Subject | Biopharmaceutical |
- (a) List the following solid forms of a particular drug in terms of their increasing aqueous solubility: solvated crystals, amorphous form, desolvated crystals. In terms of their structures, explain how the difference in solubility arises between these three different forms.
(b) What information must a drug company have before it can file an investigational new drug application?
(c) Briefly outline the drug development process. Include in your answer definitions of Phase I, Phase II, and Phase III trials. - You have been asked to develop a tablet formulation for a newly developed cholesterol-lowering agent. It has low solubility in water and starts to decompose when exposed to moisture. It is also found to decompose in the presence of stearate-based compounds. In order for the drug to have the desired bioavailability, it has to be milled to a mean particle size of 15 pm. The drug powder does not flow very well and is also poorly compactable. Excipients available for you to use are listed below.
- Polyvinylpyrrolidone
- Pre-gelatinized starch
- Talcum powder
- Magnesium stearate
- Fumed silicon dioxide
- Sodium lauryl sulfate
- Starch
- Methylcellulose
- Microcrystalline cellulose
- Calcium hydrogen phosphate
(a) From the list of available excipients suggest a suitable formulation and outline the manufacturing process to prepare tablets containing 100 mg of the active. Remember to provide a justification for your choice of ingredients.
(b) Suggest a suitable capsule formulation that will maximize the bioavailability of the active.
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