Powder flow and compounding of capsules_Deferred
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Royal Melbourne Institute of Technology *
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BUSM 3194
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Date
Dec 6, 2023
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Practical – 2 (Deferred)
Powder flow and capsule
compounding
PHAR1016 – Essential Medicine Formulations
Semester 2, 2022
Declaration:
1.
This work is my/our original work and no part of it has been copied from any other student’s
work or from any other source except where due acknowledgement is made.
2.
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collaboration has been authorised by the lecturer/teacher concerned.
3.
I give permission for this work to be reproduced, communicated, compared and archived for
the purpose of detecting plagiarism.
4.
I give permission for a copy of my marked work to be retained by the school for review and
comparison, including review by external examiners.
5.
I understand that plagiarism is the presentation of the work, idea or creation of another
person as though it is my/our own. It is a form of cheating and is a very serious academic
offence that may lead to exclusion from the University. Plagiarised material can be drawn
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6.
I understand that plagiarism includes the act of assisting or allowing another person to
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Student Name
ID: S ……………………
Signature
Date: …… / …… / 2022
Session
Tuesday (8:30 – 10:30 am)
Tuesday (10:30 – 12:30 pm)
Tuesday (1:30 – 3:30 pm)
Tuesday (3:30 – 5:30 pm)
© Pharmacy Discipline - SHBS – STEM College – RMIT University
RMIT Classification: Trusted
Safety in the laboratory
It is important that you review the Laboratory induction videos which are uploaded in Canvas
before you come to the laboratory. In these videos, you will learn about the principles of safe
working in the laboratory, the dress code, the precautions and how you should behave in different
situations. Each practical session will begin with a safety briefing which will discuss the specific
safety issues related to the practical class. Attending the safety briefing is a condition to complete
the class.
What to bring with you?
-
A copy of this report
-
Lab coat
-
Safety glasses
-
Wear appropriate footwear (fully enclosed).
-
RMIT highly recommends the use of masks while indoors to reduce the transmission of
COVID-19.
Learning outcomes
By the end of this practical, students should be able to:
1.
Measure the angle of repose for powders.
2.
Measure the bulk density of powders.
3.
Classify the powder flowability through the angle of repose method and Carr’s
index.
4.
Calculate the amount of diluent and capsules needed for a prescription of capsule
formulation
5.
Demonstrate understanding of extemporaneous compounding of capsules
6.
Write the working formula for extemporaneously compounded product.
7.
Justify the selection of appropriate capsule size
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Introduction
Capsules are considered the most versatile of all dosage forms. Capsules are relatively easy to
manufacture and commonly used to compound amended formulations by compounding
pharmacist.
Pre-lab activities
:
-
Watch lab induction videos in Canvas
-
Review lecture notes on powder module (Part 1)
-
Review lecture notes on capsules module (Part 1)
-
Read the relevant pages in chapter 12 of Aulton’s Pharmaceutics (5
th
Edition)
-
Review APF information on extemporaneous compounding (formulary – capsules)
Experiment Design
The practical is divided into three parts. You will be assigned into a group after the safety briefing.
Every group will be required to complete the three experiments to collect the data. In the first
experiment, each group will measure the angle of repose of different materials using the fixed
height cone method. In the second experiment, students will measure the bulk density of different
materials. In the third part, students will complete the working formula for a prescription of calcium
carbonate capsules and compound the prescription.
The report includes additional question linking
the data collected to the theory covered. Report must be completed individually and submitted
online by the due date (See the assignment tab in Canvas).
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Part 1 — Angle of repose
Equipment:
-
Holder
-
Funnel
-
Funnel holder
-
A4 coloured paper
-
Balance brush
-
Spatula or scoop
-
Ruler
-
Pen/pencil
Materials:
-
Calcium carbonate
-
Lactose monohydrate
Procedure:
1.
Ensure the funnel is attached to the holder at a fixed height (3 cm) and is above the centre
of the coloured A4 paper.
2.
Using the spatula/scoop, gradually and gently add first compound in the funnel. The
compound will start to form a cone shape on the paper.
3.
Continue adding the material until the tip of the powder cone reaches the bottom tip of the
funnel.
4.
Using a pen/pencil circle the cone base on the paper. Ensure that your plotted circle covers
most of the powder cone base (roughly not less than 90% of compound at the base).
5.
Record the diameter and the height of the cone formed.
6.
Transfer the powder from the paper to an empty open-mouth jar.
7.
Repeat steps 1-6 three times.
8.
Repeat steps 1-7 for the second compound.
Question 1.1:
The diameter and the height of the cone formed for each compound was recorded in
Table 1
(below). Calculate the average diameter (± SD) for each compound. [4 marks]
Table 1:
Diameter of the powder cone resulted from the angle of repose for calcium carbonate and
lactose monohydrate
Material
Diameter of the cone base (cm)
Replicate #1
Replicate #2
Replicate #3
Average ± SD
Calcium carbonate
4.8
4.9
5.1
Lactose monohydrate
5.9
6.2
5.8
Question 1.2:
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Showing your working, calculate the Angle of repose for each compound and classify its powder
flowability based on your measurements. [6 marks]
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Part 2 — Bulk density
Equipment:
-
Electronic balance or top pan balance
-
Weighing boats
-
100 mL or 50 mL graduate cylinder
-
Balance brush
-
Spatula or scoop
Materials:
-
Calcium carbonate
-
Lactose monohydrate
Procedure:
Using a 100 mL graduated cylinder and a top pan balance, measure the bulk density for each
compound.
Question 2.1:
Using a 100- or 50-mL graduated cylinder and an electronic balance, the volume of about 30 g of
each material was measured and recorded in
Table 2
(below). Calculate average bulk density (±
SD) for each compound. [4 marks]
Table 2:
Volume of about 30 g samples of calcium carbonate and lactose monohydrate
Material
Weight
(g)
Volume (mL)
Replicate #1
Volume (mL)
Replicate #2
Volume (mL)
Replicate #3
Calcium carbonate
30.08
32.0
33.5
31.8
Lactose monohydrate
29.65
48.0
49.0
47.6
Question 2.2:
Describe the method used to determine the bulk density in simple clear steps. [5 marks]
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Question 2.3:
Given that the tapped density for calcium carbonate and lactose monohydrate is 1.2 g/mL and 1.0
g/mL respectively, classify the powder flowability for each compound by calculating the Carr’s
index. [6 marks]
Question 2.4:
Good powder flowability is important for many pharmaceutical applications. Discuss importance of
powder flow for the filling of capsules in the large-scale manufacture of hard capsules. Your answer
should include strategies used to improve powder flowability. [10 marks] (Maximum 300 words)
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Part 3 — Compounding of calcium carbonate capsules
Calcium carbonate assists in strengthening bones, treating osteoporosis and preventing
calcium deficiency. You are required to compound the following prescription:
Rx
Calcium carbonate ………………. 550 mg
Lactose monohydrate ………………... q.s.
Use capsule size 00
Use: Three times daily for 5 days
Equipment:
-
Electronic balance
-
Spatula
-
Weighing boats
-
Glass mortar and pestle
-
Capsules size 00
-
Balance brush
Materials:
-
Calcium carbonate (Sigma-Aldrich, Batch #, 0009 7669, expiry: 12/2023
-
Lactose monohydrate (PCCA, Batch # 5634 2338, expiry: 03/2024)
Procedure:
1.
Weigh 5 empty capsules
2.
Fill the capsule shell separately with the drug and diluent and record the weights of each (3
replicates)
3.
Calculate the total amounts needed to compound 20 capsules
4.
Weigh each compound using a weighing boat
5.
Transfer into a glass mortar and pestle and mix using doubling up method
6.
Fill the capsules with the required amount by scooping the capsule body into the powder
mixture
7.
Close the capsule and clean capsules using a brush
8.
Estimate the drug dose in a sample of 5 capsules.
9.
Dispense compounded capsules into a jar.
Question 3.1:
The weight of the empty capsules was recorded in
Table 3
(below). Calculate the average weight
of the empty capsules. [2 marks]
Table 3:
Weight of empty capsules size 00
Capsule #
Total weight (mg)
1
110.4560
2
112.6622
3
111.1228
4
114.5220
5
118.4665
Average ± SD
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Question 3.2:
The weight of the filled capsules with either calcium carbonated or lactose monohydrate was
recored in
Table 4
(below). Showing your work, calculate the total amount of active ingredient and
lactose needed to compound 20 capsules. [8 marks]
Table 4:
Weight of empty capsules size 00
Capsule #
Capsule filled with CaCO
3
(g)
Capsule filled with lactose
monohydrate (g)
1
0.9334
0.7550
2
0.9655
0.7461
3
0.9855
0.7216
Average ± SD
Question 3.3:
complete the working formula in
Table 5
(below) as you compound the capsules. [10 marks]
Note:
Use your demonstrator initials to complete the column “Checked by” without referring to the
demonstrator or other student.
Table 5:
Working formula for the extemporaneous compounding of calcium carbonate
Ingredient
Manufacturer
Batch
number
Expiry
date
Required
weight
Actual
weight
Measured
by
Checked
by
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Question 3.4:
The weight of a sample of 5 compounded capsules was recorded in
Table 6
(below).
Calculate the
estimated weight of CaCO3 in each capsule and provide explanation of your calculation. [10 marks]
Table 5:
Estimated dose of calcium carbonate in a sample of capsules
Capsule #
Total weight (g)
Estimated calcium carbonate dose (mg)
1
0.9905
2
0.9877
3
0.9521
4
0.8792
5
0.9233
Average ± SD
Working out calculation:
Question 3.5:
Write the method used for compounding the capsules. Ensuer that you provide specific, step by
step instructions of compounding this product. Your answer should include the equipment and
glassware used and the explanation for each step. [10 marks]
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Question 3.6:
Your calculation of the required amount of lactose used the manual filling of capsule by the drug
and the diluent separately. Comment on how your calculations are compared with the APF25 Table
for the recommended hard capsule sizes and the filling weights given your measured bulk density
for the two compounds (
calcium carbonate
and lactose monohydrate) in
Part 2
(Ref. APF 25th
edition – page 61). [10 marks]
Question 3.7:
Size 00 was selected for compounding this prescription. Using the results in
Part 2
and what you
have learnt about capsule sizes and their filling weights, discuss the justification of this selection.
[10 marks]
Question 3.8:
Classify whether the filling of capsules used in the practical was dependent or independent. Justify
your answer by explaining the difference between
both types of filling. [5 marks]
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