Page 3 - Extemp Marking Scheme

FAR 222/3 Dosage Form II Extemporaneous Exercise – Marking Scheme 2019 – 2020

Exercise 2.5 B

SCHOOL OF PHARMACEUTICAL SCIENCES
UNIVERSITI SAINS MALAYSIA
11800 USM, PENANG, MALAYSIA
Tel: 04-6532211 Fax: 04-6570017

NAME: DATE:
ADDRESS: AGE: SEX:

Amethocaine Eye-drops B.P.C. 1973

sig. v gtt. pro.ocul. dext. lat. d.d. × 1/12
G.Eiffel
G. Eiffel MD

Questions:
1. Complete a pharmaceutical production document for this formulation and prepare the
formulation accordingly. (25 marks)

2. Based on your formula, is this eye drops isotonic and acceptable? Explain your answer with
calculation using ONLY sodium chloride equivalent method. (5 marks)

NAME OF BATCH
PRODUCT NO. DATE
TARE
FORMULA – 3M QUANTITY CHECKED MEASURED CHECKED
BY
BY
USED
BY
Amethocaine hydrochloride 0.3 g 0.5M
Na metabisulphite 0.03 g* 0.5M
3 mL
PMN (0.02% 0.5M
stock)
NaCl 0.2 g 1M
qs ad
Distilled water 0.5M
30 mL

Size 30 mL
CONTAINER -3M Type Eye drops amber bottle FILTRATION Sintered glass filter Grade
(1M ea) -1M 3 (15 – 40 µm)
Closure type Glass dropper with a
rubber teat
Waterbath (heating
Equipment used Autoclave Aseptic filtration
with a bactericide)
Duration 15 min 30 min -
STERILISATION
-3M (1M ea) Laminar flow hood -
Condition 121-123°C, 1.05 1M
(temperature, kgf/cm 99-100°C Swinnex filter holder
2
pressure etc) with a 0.22 µm
membrane filter -1M

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