Assessment Task 1

Question 1:

A. Identify and discuss THREE major challenges associated with the extraction of Active Pharmaceutical Ingredient from oral dosage forms such as tablets and oral suspensions. Support your answer with suitable examples and appropriate references.

B. Discuss suitable approaches to overcome the THREE challenges you have mentioned above. Support your answer with suitable examples and appropriate references.

Question 2:

Identify and discuss THREE studies that have investigated the concentration of a fluoroquinolone.

Your answer should include the following:

i. THREE types of analytical techniques used for the determination of the fluoroquinolone in the studies identified above.
ii. Explain which ONE of the THREE above mentioned analytical techniques you would use for the concentration determination of the fluoroquinolone. Briefly discuss the reasoning behind your selection of a particular analytical technique.

Question 3:
A. What was the amount of ciprofloxacin you found in a tablet that was used to prepare 50 μg/ml of ciprofloxacin.
B. Briefly discuss the effects of pH on the solubility profile of ciprofloxacin. Support your answer with suitable examples and appropriate references.

Assessment Task 2

PART B:

1. Describe how you would set up the Y-site assembly to collect a sample containing amoxicillin, parenteral nutrition (PN) and lipid that could be used to investigate the chemical and physical incompatibility of amoxicillin, PN and lipid. In addition, using a suitable clinical example discuss - why administration of total parenteral nutrition (TPN - PN +lipid) and anidulafungin would be required to a patient using a Y-site assembly.

2. In week 2, you were provided with a sample containing amoxicillin, PN and lipid (Sample A). The concentrations of amoxicillin, PN and lipid were calculated based on the doses of amoxicillin (infused over a period of 30 minutes) and TPN (infused over a period of 24 hours) used in 0.5kg patients. The sample was then subjected to centrifugation. Visual analysis of the centrifuged sample revealed the presence of particles.

In week 4, a lipid free sample containing amoxicillin, PN and water was prepared (Sample B). The concentrations of amoxicillin and PN were calculated based on the doses of amoxicillin (infused over a period of 24 hours) and TPN (infused over a period of 24 hours) used in 0.5 kg patients. Microscopic and visual analyses of the sample did not show the signs of precipitation or particles.

Answer the following questions:
1. Why did sample A after centrifugation show the presence of particles.
2. Why the visual and microscopic analyses of sample B did not show the signs of particles?
3. In clinical practice, would it be appropriate to infuse amoxicillin over a period 24 hours (also referred to as continuous infusion)? Support your answer with a suitable example.
4. Which one of the two types of amoxicillin infusion (1- continuous and 2 - intermittent infusion; e.g. three times a day) has a better clinical efficacy? Support your answer using a suitable example.

3. Why is it important to evaluate the pH of an admixture (antibiotic-PN-lipid) collected at y-site? Support your answer with at least two clinically relevant examples.

4. Discuss three different clinically relevant examples of drug-drug incompatibility. Your answer should include mechanisms responsible for drug-drug incompatibility. Each mechanism of incompatibility should be different than each other. It is not necessary that the given examples should be of Y-site incompatibility only.

5. Discuss two different techniques that could be used to assess the compatibility of lipid that is present in Y-site admixture containing lipid and drug solution. In addition, briefly provide scientific reasoning behind which one of the two above mentioned techniques you would select/employ to assess the compatibility of lipid.