Division of Food Technology
SOP 2003.00 1(5)
Standard Operating Procedure
SOP-2003.00
Instructions for seminars
Author
Date
................................................................
........................
Marie Wahlgren
QA-Approval
Date
................................................................
........................
Aniko Wolf
Distribution: all students in the course pharmaceutical technology
Division of Food Technology
SOP 2003.00 2(5)
Purpose
The purpose of this SOP is to describe the exercise don during the seminars in the
course pharmaceutical technology.
Responsibility
The teacher in pharmaceutical technology is responsible for this SOP.
The students in this course are responsible to follow these instructions.
Scope
The exercise in the course is described in this SOP.
Introduction
The exercise will be done during the seminars. Students that cannot be present might
do the exercise individual and turn them in to the teacher for correction. Seminars are
not mandatory but will be part of what are tested during the exam.
Division of Food Technology
SOP 2003.00 3(5)
Pharmacokinetics
Table 1 contains pharmacokinetic data from a clinical trail. The data is from one
single patient who was given 1 ml i.v. solution of 10 mg/ml and after a wash out
period where given one tablet containing 50 mg of the active substance. Use a onecompartment model to evaluate the data and answer the following questions
• What is the bioavailability of the tablets?
• What is the half-life of the substance in the body?
• Calculate the volume that the substance seems to be diluted in according to
this model. What does the value indicate?
• How long will it take for the drug formulation too reaches steady state if the
patient takes one tablet a day?
• What will be the steady state concentration if the patient takes one, two or
three tablets a day?
• Discuss what the difference would be to use a two-compartment model?
Table 1 Blood concentration of active substance
time (min)
10
30
60
120
180
240
300
360
420
480
540
600
660
720
780
840
900
C i.v g/L
1.19E-04
1.15E-04
1.10E-04
1.01E-04
9.29E-05
8.52E-05
7.81E-05
7.16E-05
6.57E-05
6.02E-05
5.52E-05
5.07E-05
4.65E-05
4.26E-05
3.91E-05
3.58E-05
3.28E-05
C tablet g/L
1.29E-05
3.52E-05
6.14E-05
9.43E-05
1.10E-04
1.15E-04
1.15E-04
1.11E-04
1.05E-04
9.85E-05
9.16E-05
8.48E-05
7.83E-05
7.21E-05
6.63E-05
6.09E-05
5.60E-05
Division of Food Technology
SOP 2003.00 4(5)
Shelf-life
Describe the Shelf-life study that you need to do too verify a major change in the
production for the existing drug product that is assigned to you. Write a study plan
following in SOP Instructions for handling and writing of reports and plans.
In early phase of development a company are using accelerated testing to evaluate
different possible dissintegrants for a tablet. In doing this they mix the active
substance with three different excipients explotab, starch and yy. They use a study
where they test the mixture at 20, 30, 40, 50 and 60 °C. The result from the study is
given below. Discuss the data. What models can be used to estimate shelf-life?
Estimate the shelf-life for 25 and 40 °C for the three set of dissintegrants.
Table 1: Stability test of substance X and different dissintegrants
Time (days)
20,0
1
2
3
4
8
10
12
16
100,0
100,0
100,0
100,0
99,9
99,9
99,9
99,9
1
2
3
4
8
10
12
16
99,8
99,7
99,5
99,3
98,7
98,3
98,0
97,4
Temperature (°C)
30,0
40,0
Starch
100,0
99,9
99,9
99,7
99,9
99,6
99,9
99,5
99,8
99,0
99,7
98,7
99,7
98,5
99,5
97,9
99,7
99,4
99,1
98,8
97,7
97,1
96,5
95,3
Expolotab
99,5
99,0
98,4
97,9
95,9
94,8
93,8
91,7
50,0
60,0
99,4
98,8
98,3
97,7
95,4
94,2
93,1
90,8
97,4
94,8
92,2
89,7
79,3
74,1
69,0
58,6
99,1
98,2
97,3
96,3
92,7
90,9
89,0
85,4
98,4
96,8
95,1
93,5
87,1
83,8
80,6
74,1
99,7
99,4
99,1
98,7
97,5
96,9
96,2
95,0
99,3
98,6
97,9
97,2
94,4
93,0
91,6
88,8
XX
1
2
3
4
8
10
12
16
100,0
99,9
99,9
99,9
99,8
99,7
99,7
99,5
99,9
99,9
99,8
99,7
99,5
99,4
99,2
99,0
99,9
99,7
99,6
99,4
98,9
98,6
98,3
97,7
Division of Food Technology
Review History
Rev 00: New
SOP 2003.00 5(5)