Question: Please answer it ASAP Your company want to develop a sustained release oral formulation of an already marketed API. The table below report data for

Please answer it ASAP

Your company want to develop a sustained release oral formulation of an already marketed API. The table below report data for an iv-bolus administration, an oral solution of the API, the already marketed tablet and two candidate new formulations administered to the same subject (BGS, 33 years old, 78 kg).

Table 1 Data provided

Iv-bolus

Oral solution

Marketed tablet

Sustained-release Tablet A

Sustained-release Tablet B

Dose (mg)

100

200

300

300

300

AUC (mg/L/hr)

365

625

855

893

932

AUMC (mg/L/hr2)

3160.173

5687.5

8379

8947.86

10438.4

From the data provided in Table 1, calculate the following:

Units

Iv-bolus

Oral solution

Marketed tablet

Sustained-release

Tablet A

Sustained-release Tablet B

Absolute F

Relative F (to oral solution)

MRT

MAT

MDT

Half-life

ka

Based on your calculations, what formulation (Tablet A or Tablet B) appears more promising as a sustained release product?

Write a short report according to the provided guidelines.

Step by Step Solution

There are 3 Steps involved in it

1 Expert Approved Answer
Step: 1 Unlock blur-text-image
Question Has Been Solved by an Expert!

Get step-by-step solutions from verified subject matter experts

Step: 2 Unlock
Step: 3 Unlock

Students Have Also Explored These Related Accounting Questions!