Suspensions final_deferred 2022
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Royal Melbourne Institute of Technology *
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PTE192
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Medicine
Date
Dec 6, 2023
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Practical - 1
Suspensions: Compounding & Evaluation
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
from, and presented in, written, graphic and visual form, including electronic data and oral
presentations. Plagiarism occurs when the origin of the material used is not appropriately
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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)
RMIT Classification: Trusted
© Pharmacy Discipline - SHBS – STEM College – RMIT University
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. Learning outcomes
By the end of this practical, students should be able to:
1.
Demonstrate understanding of extemporaneous compounding of suspensions
2.
Write a method of preparation for extemporaneously compounded product. 3.
Explain the type of excipients used in pharmaceutical suspensions.
4.
Calculate the sedimentation volume ratio of a pharmaceutical suspension.
5.
Determine the effect of excipients on the stability of pharmaceutical suspensions.
CHEM1290/Pharmacy//SHBS/STEM/RMIT
Page 2 of 12
RMIT Classification: Trusted
Introduction
Pharmaceutical suspensions are liquid formulations where the active pharmaceutical ingredient
(API) does not dissolve in the vehicle and remains as solid particles. Hence the API is dispersed in
a liquid, which is often termed the continuous phase. Suspensions are not optically clear.
Suspensions can be categorised as colloidal suspension or coarse suspension depending on the
particle size. Although suspensions offer an approach to provide a liquid dosage form of an API
with poor aqueous solubility, it is challenging to ensure the stability of these formulations. Many
formulation excipients have the potential to affect the interaction between dispersed particles in a
suspension and the sedimentation behaviour. Therefore, the formulation needs to be considered
holistically and the effect of each excipient on the stability must be carefully considered. Pre-lab activities
:
-
Watch lab induction videos
-
Review lecture notes on suspensions
-
Review pre-lab video and practical notes
-
Read chapter 26 of Aulton’s Pharmaceutics (5
th
Edition)
-
Review APF24 information on extemporaneous compounding, pages 2 to 16
CHEM1290/Pharmacy//SHBS/STEM/RMIT
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Part 1 — Preparation of Trimethoprim suspension APF (individual activity)
Trimethoprim is an antibiotic indicated for the treatment of uncomplicated lower urinary tract
infections in adults and children. Commercially, this is available as a solid dosage form that is not
suitable for paediatric patients. Therefore, pharmacists are required to prepare a liquid formulation
of trimethoprim to meet patient clinical needs.
Table below outlines the excipients required to prepare Trimethoprim Mixture CF as per Australian
Pharmaceutical Formulary edition 24 (APF24) Table 1: Trimethoprim Mixture CF 10mg/mL
Ingredient
Original formula quantity
Trimethoprim
600 mg
Methylcellulose mucilage 2%
15 mL
Purified water, freshly boiled and cooled
15 mL
Compound hydroxybenzoate solution
0.5 mL
Syrup
To 60 mL
CHEM1290/Pharmacy//SHBS/STEM/RMIT
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RMIT Classification: Trusted
Activity 1:
Prepare 60mL of trimethoprim mixture APF (24
th
edition). Note: This is an individual activity and your demonstrators will guide you. 1.1: complete the first four columns of the working formula below as you prepare the mixture. (10 marks)
Working formula
Ingredient
Manufacturer
Batch number
Expiry date
Required
Actual
Measured
by
Checked by
CHEM1290/Pharmacy//SHBS/STEM/RMIT
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1.2: Write a suitable method for compounding of Trimethoprim mixture APF. Ensuer you provide specific, step by step instructions of compounding this product. (15 marks)
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1.3: Trimethoprim mixture APF can be prepared by either using commercially available
trimethoprim tablets or pure trimethoprim powder. Which of the 2 would you consider having better
physical stability. Provide a justification for your answer. (6 marks)
1.4: Explain the role of following excipients in trimethoprim mixture APF. (6 marks)
Methylcellulose mucilage –
Syrup –
Compound hydroxybenzoate - 1.5: Outline THREE cautionary advisory labels (CALs) you would include on the label for
trimethoprim mixture APF. Briefly explain the reasons for including each CAL. (3 marks)
CHEM1290/Pharmacy//SHBS/STEM/RMIT
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RMIT Classification: Trusted
1.6: Outline the solubility of trimethoprim in water and organic solvents. And discuss two other
strategies that may be used to prepare liquid dosage form of trimethoprim. (10 marks)
CHEM1290/Pharmacy//SHBS/STEM/RMIT
Page 8 of 12
RMIT Classification: Trusted
Part 2 — Evaluation of Calamine lotion APF (group activity)
Calamine lotion can be used to reduce skin itch due to sunburns, insect bites or other itchy
skin conditions. The ingredients used to prepare calamine lotion APF24 is given in the table below. Table 2: Calamine lotion APF
Ingredient
Original formula quantity
Calamine
15 g
Zinc oxide
5 g
Bentonite
3 g
Sodium citrate
500 mg
Liquefied phenol
0.5 mL
Glycerol
5 mL
Purified water, freshly boiled and cooled
To 100mL
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The following formulations of calamine lotion have been prepared for you to evaluate. Please work in the allocated groups to complete this activity.
Ingredient
Formulation
1
2
3
Calamine
7.5 g
7.5 g
7.5 g
Zinc oxide
2.5 g
2.5 g
2.5 g
Bentonite
1.5 g
Nil
1.5 g
Sodium citrate
250 mg
250 mg
Nil
Liquefied phenol
0.25 mL
0.25 mL
0.25 mL
Glycerol
2.5 mL
2.5 mL
2.5 mL
Purified water, freshly boiled
and cooled
To 50mL
To 50mL
To 50mL
1.
Determine the sedimentation volume ratio (SVR) for all formulations using the following
equation and record in the table provided. (15 marks)
SVR = sediment volume (mL)/ total volume (mL)
2.
Record (see table below) the visual appearance and clarity of the supernatant for each
formulation (5 marks)
3.
Record (see table below) ease of re-dispersion for each formulation as per classifications below
(5 marks): Easy - 2 inversions to re-suspend
Moderate - 3-5 inversions to re-suspend
Difficult - more than 5 inversions to re-suspend 4.
Comment on the nature of the sediment for each formulation (i.e. flocculated vs. deflocculated)
(see table below). (5 marks)
CHEM1290/Pharmacy//SHBS/STEM/RMIT
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RMIT Classification: Trusted
Observation
Formulation
1
2
3
SVR
Supernatant appearance
Ease of redispersion
Nature of sediment 5.
Discuss the use of bentonite and sodium citrate in the calamine lotion APF. Your answer should
detail the role of these two excipients and how the amount of each of these excipients can affect
the lotion properties. Include references for this discussion. (15 marks)
6.
Explain the role of following excipients in calamine lotion APF. (5 marks)
CHEM1290/Pharmacy//SHBS/STEM/RMIT
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a.
Liquefied phenol
b.
Glycerol
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