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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Medicine

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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. No part of this work has been written for me/us by any other person except where such 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 cited. 6. I understand that plagiarism includes the act of assisting or allowing another person to plagiarise or to copy my work. 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 CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 2 of 11 RMIT Classification: Trusted
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). CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 3 of 11 RMIT Classification: Trusted
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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: CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 4 of 11 RMIT Classification: Trusted
Showing your working, calculate the Angle of repose for each compound and classify its powder flowability based on your measurements. [6 marks] CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 5 of 11 RMIT Classification: Trusted
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] CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 6 of 11 RMIT Classification: Trusted
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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) CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 7 of 11 RMIT Classification: Trusted
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 CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 8 of 11 RMIT Classification: Trusted
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 CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 9 of 11 RMIT Classification: Trusted
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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] CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 10 of 11 RMIT Classification: Trusted
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] CHEM1290/Pharmacy//SHBS/STEM/RMIT Page 11 of 11 RMIT Classification: Trusted