QUESTION 1
Data from individual patients in a crossover bioequivalence study comparing a test formulation to a reference formulation are listed in the table below. If the 90% confidence interval of the AUC ratio for this study when converted to natural log is -0.09691 to +0.09691, would the test formulation be considered bioequivalent to the reference formulation? Fill in the rest of the table to determine your answer.
Subject
|
Test AUC (ng/mL.h)
|
Ref AUC
(ng/mL.h)
|
Ln Test AUC
|
Ln Ref AUC
|
AUC ratio
LnTest-LnRef
|
1
|
2560
|
4020
|
|
|
|
2
|
118
|
211
|
|
|
|
3
|
905
|
572
|
|
|
|
4
|
764
|
815
|
|
|
|
5
|
729
|
715
|
|
|
|
6
|
2460
|
1940
|
|
|
|
7
|
3180
|
1750
|
|
|
|
8
|
2740
|
2720
|
|
|
|
9
|
3260
|
4670
|
|
|
|
10
|
1220
|
1930
|
|
|
|
11
|
2340
|
2240
|
|
|
|
12
|
1050
|
1010
|
|
|
|
QUESTION 2
Compare and contrast the different types of membrane transport (passive diffusion,facilitated diffusion,active transport,vesicular transport). Which is best for transport of pharmaceuticals?Why?
QUESTION 3
Drug UML040518is a promising new drug for the treatment of Alzheimer's disease. Recent preclinicalstudies indicate that it is aP-glycoproteinsubstrate.Why is it important for the pharmaceutical company developing the drug to know this? What are two potential strategies that can be used to deliver this drug to its target site following oral administration?
QUESTION 4
What is preformulation? Describe what the types of experiments that must be done at this stage for solid dosage forms are (solid state properties, partition coefficients & pKa, solubility, dissolution, polymorphism and stability). Explain the influence of each on the further development of the drug (i.e. why is it important to understand this information?)
QUESTION 5
Neurontin (gabapentin) tablets are supplied as elliptical film-coated tablets containing 600 mg and 800 mg of gabapentin. The inactive ingredients for the tablets are poloxamer 407, copolyvidonum, cornstarch, magnesium stearate, hydroxypropyl cellulose, talc, candelilla wax and purified water. What are each of the inactive ingredients (i.e. diluent, binder, etc.) and what is their most likely function(s) in this tables?
QUESTION 6
Describe the strengths and weaknesses of the various techniques for enhancing the solubility of drugs when preparing liquid dosage forms (i.e. chemical modification, co-solvents, micellar solubilization by surfactnts, complexation and self-emulsifying drug delivery systems).
QUESTION 7
What are three factors that must be taken into consideration when designing the delivery of a drug via an aerosol dosage form? As a formulator, how could you address these?
QUESTION 8
Three of the most important characteristics of semisolid dosage forms are the particle size of the drug, the rheological properties of the dosage form and the release of the drug from the dosage form. Explain the ways in which each of these might be evaluated or characterized.
QUESTION 9
Compare and contrast the use of nanoparticle and liposomal systems for enhanced drug delivery. What are the advantages and disadvantages of each?