Page 22 - Tutor Manual

FAR 222/3 Dosage Form II Semester 1/ 2019-2020

Exercise 3.1
Chloramphenicol Eye Drops B.P.C. 1973
sig. 2 gtt. pro ocul. tert. hor. × 2/12
Questions:
1. Which sterilisation method(s) is(are) recommended by B.P.C.?
2. Why is the autoclaving method not suitable?
3. Is this preparation isotonic with tears? Support your answer with calculation.
4. What is the storage condition this preparation? And why?

Eye Drops BPC page 689
100 mL 30 mL ∆Tf
Chloramphenicol 0.5 g 150 mg 0.06
PMN or PMA 0.002 g 3 mL (stock 0.02%w/v) 0.241
Borax 0.3 g 90 mg
Boric acid 1.5 g 450 mg 0.288
Distilled water qs ad 100 mL 30 mL

Answer: Refer to BPC page 687: Eye drops 2. Prepare 30 mL of eye drops preparation
sterilisation methods 3. Sterilisation : Use method C. Heating
1. Suitable sterilisation method for the with bactericide at 98 -100 °C for 30
preparation is method B or C minutes
Method B : Filtration method, transfer 4. Label the preparation
using aseptic technique Expiry date:
Method C : Heating with bactericide at • Sterilise by heat method, the expiry date
98 – 100 °C for 30 minutes 4 weeks after opening the container.
2. Autoclaving method is not used because • Sterilise by filtration, the expiry date 2
the preparation will degrade/decompose weeks after date of preparation
about 15 % if heated at 115 °C for 30 Label
minutes. Refer to Martindale Ed. 28
th
page 1137 10 mL
3. Isotonicity calculation using Freezing CHLORAMPHENICOL EYE DROPS BPC
point depression 0.5 %w/v
W = 0.52 –a Bactericide: PMN/A 0.002%w/v
TWO (2) drops to be applied to the both
b eyes every THREE (3) hours
W = 0.52 – {(0.06 X 0.5) + (0.241 X 0.3) Store in a cool place
0.288 Protect from light
= 0.52 – (0.03 + 0.0723) For external use only
0.288 Sterile until opened
= 0.52 – 0.1023 = 0.4177 = 1.45 %w/v Use with care to avoid contamination during
0.288 0.288 use
From calculation - Boric acid needed 1.45 Stored at room temperature
%w/v ≈ 1.5 %w/v Date of sterilisation:
Therefore, the solution is isotonic with tears Expiry date: 2 years; 4 weeks after opening
4. Storage: Refer to references : - BPC pg BN:
689 – 690
• When stored at a temperature of 2 – 8 Name of patient:
Date of dispensing:
°C the solution stable for 18 months
• When stored at a temperature not Keep out of Reach of Children
exceeding 25°C the solution stable for 4 SCHOOL OF PHARMACEUTICAL
months. SCIENCES,
METHOD USM, PENANG
1. Follow method suggested in BPC pg
689.

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