Assignment 3 (Oral PK) 2024 (1)

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PHRM-535 Dr. Kaushal Assignment-3 Pharmacokinetics of Oral Absorption Bioavailability and Bioequivalence Student Name: __________________________________________________________ Submission Due Date: 9 th February’2024 Maximum Points: 120 Read all the questions very carefully. Go over the data given to you and check all the units before you solve the problem. Proper units must accompany all the answers. As in real life, some information may be superfluous, redundant and sometimes ambiguous. You are expected to show all your calculations and circle all your final answers for each of the questions. You can also use excel or any other program to generate the final graphs instead of manually plotting the graphs. In case you are using the computer generated graphs, make sure you copy and paste the respective graphs on the space provided for each question or you can attach the properly labelled graph paper separately. Depending upon your personal font size you may need more or less space provided to you for each question. Feel free to make adjustments to the space in the document or to show work on the back of the page. 1

1. The following plasma concentration data were obtained after oral administration of a 400 mg of a new sulfonamide to a human subject Time (hrs) Plasma conc. (mg/L) 1 2.5 2 3.4 3 3.4 4 3.1 5 2.7 6 2.4 8 1.6 10 1.1 12 0.75 16 0.35 a. Calculate K, K a and t 1/2 b. Find FK a D 0 V ( K a − K ) (intercept) from the graph. c. Calculate C max and t max. 2

2. A 500 mg dose of a new drug was administered orally in the form of a compressed tablet and intravenously as a rapid injection, the dosage forms being given a week apart. Blood samples were collected and assayed from the five healthy adults who participated in the study. The following experimental data was obtained. Mean Blood Levels (µg/mL) Time (hr) IV Oral 0.5 29.50 2.68 0.75 25.50 7.50 1 22.50 14.75 1.5 17.50 17.50 2.5 10 14.50 4 4.7 6.84 5 - 3.90 6 - 2.34 Assume a one compartment linear model. a. Calculate K a , and V d . b. Calculate K from both IV and oral data. Which of these two K values would be more accurate and why? c. Calculate renal clearance (Cl) of this drug. d. Is there any lag time? If so, explain and calculate. 3

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3. Use the data given to you in question 2 for the following: a. Calculate the AUC 0-4 for both the routes. b. Calculate the oral bioavailability (F) of this drug. Use AUC 0-∞ to calculate this. 4

4. Two different formulations of erythromycin, product A (SK-Erythromycin) and product B (Erythromycin) were administered to the same volunteer in a crossover study. The dose was 250 mg in tablet form, and an interval of 1 week separated each administration. The serum levels observed as a function of time are tabulated below. Time (hrs) Serum Erythromycin Levels (μg/mL) Product A Product B 0 0.00 0.00 1.0 0.17 0.21 2.0 0.52 1.18 3.0 0.66 0.53 6.0 0.16 0.15 8.0 0.09 0.07 The t 1/2 for erythromycin in this volunteer was 2.0 hours. a. Plot the data on the same sheet and determine the bioavailability of product A relative to that of product B, i.e, F A /F B. (Hint: Use AUC (0-8h) to calculate F for both the products) b. By looking at the linear plots can you tell which of the 2 formulations has a larger absorption rate constant? c. How does K a affect C max and t max ? 5

5. A single oral dose (100 mg) of an antibiotic was given to an adult male patient (43 years, 72 kg). From the literature, the pharmacokinetics of this drug fits a one- compartment open model. The equation which best fits the pharmacokinetics of the drug is C p = 45 µg / ml × ( e − 0.17 t − e − 1.5 t ) The first-order rate constants are in hours -1 . From the equation above, calculate (a) T max (b) C p.max (c) t 1/2 for the drug in this patient. 6

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6. A study was done by Darwish et al 2013 to assess the absolute and relative bioavailabilities and transmucosal and gastrointestinal absorbency of fentanyl buccal tablet (FBT) and oral transmucosal fentanyl citrate (OTFC). In a randomized crossover design, 26 healthy subjects received FBT 400 μg (transmucosal), FBT 800 μg (oral), OTFC 800 μg (transmucosal), and fentanyl 400 μg (intravenous). The data in the Table below represents the average findings of AUCs in plasma concentration taken from these 26 subjects. Study Drug AUC (ng-h/mL) FBT Transmucosal 400 μg 6.48 FBT Oral 800 μg 6.60 OTFC 800 μg 9.58 Fentanyl IV 400 μg 10.29 a. What is the absolute bioavailability of fentanyl from oral tablet and transmucosal tablet? b. Calculate the relative bioavailability of FBT oral as compared to FBT transmucosal and OTFC. 7

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