Page 12 - FAR 222 Laboratory Manual V2 2019

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

Exercise 1.2
Pilocarpine HCl 1 %
Buffer at pH 7.0
sig. iii gtt. ocul. h.d. × 3/7
Option 1:
100 mL 30 mL ∆ T/°C E1% NaCl Eqv
Pilocarpine HCl 1 % 1 g 0.3 g 0.138 0.138/0.576= 1×0.24 =
(0.5% pH 3.8- 0.240 0.24%
5.2)
Benzalkonium 0.01 % 50 mL 15 mL - - -
chloride (0.02% (0.02%
stock) stock)

For 30 Total NaCl 0.24%
mL, NaCl eqv=
eqv =
0.072 g
Borate buffer: 1L 100 mL 30 mL
pH 7.2
Boric acid 11.66 g 1.16 g 0.348 g
Borax 1.15 g 0.115g 0.0345 g
NaCl 2.7 g 0.27 g 0.081 g Amt of NaCl needed = 0.081-0.072 =
0.009 g (9 mg)
Distilled water qs ad 100 mL 30 mL -
100 mL

100 mL 30 mL
Pilocarpine HCl (0.5% pH 3.8- 1 % 1 g 0.3 g
5.2)
Benzalkonium chloride 0.01 % 50 mL (0.02% stock) 15 mL (0.02% stock)
Boric acid 11.66 g 1.16 g 0.348 g
Borax 1.15 g 0.115g 0.0345 g*
NaCl 2.7 g 0.27 g 9 mg *

Distilled water qs ad 100 mL 100 mL 30 mL
*MWQ

METHOD
1. Weigh materials (solid).
2. Prepare dilution for ingredients* with MWQ <200 mg.
3. Mix all solutions.
4. Measure benzalkonium Cl 15 mL.
5. Add 15 mL benzalkonium Cl to the solution and mix well.
6. Add boric acid (dissolve in hot d.water) to the solution and stir until dissolve.
7. Add water to 30 mL and mix well
8. Filter solution using sintered glass filter no 3.
9. Check particles using Allen viewer
10. Transfer 10 mL solution into eye drops bottle and close the bottle
11. Sterilise the preparation by Method B (aseptic filtration) or C (heating with bactericide at 98
– 100 °C for 30 min)

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