Bromhexine Hydrochloride Syrup

Bill of Materials
Scale (mg/5 mL)
4.00
1000000
10.00
1.00
5000
151.50
2857000
10.00
0.70
q.s.

Item
1
2
3
4
5
6
7
8
9
10

Material Name
Bromhexine HCl
Glycerin (glycerol)
Benzoic acid
All fruits avor
Tartaric acid
Alcohol (ethanol 95%)
Sorbitol (70% solution)
Carboxymethylcellulose sodium (sodium CMC)
Sodium hydroxide pellets
Water, puried,

MANUFACTURING DIRECTIONS
1. Add 250.0 g of item 10 to a suitable stainless
steel manufacturing vessel and heat to 65 to
70C.
2. Add 20.0 g of item 2 in a separate stainless steel
container and mix item 8 using Ekato stirrer,
carefully avoiding lump formation.
3. Transfer the slurry to the manufacturing vessel
while continuing to mix to make a clear mucilage. Avoid air entrapment.
4. Cool down to 30C while mixing at slow speed.
5. Transfer the mucilage to container. Load 100.0
g of item 2 to the manufacturing vessel.
6. Add item 6 in a separate stainless steel container and dissolve item 3 using stirrer.
7. Add 60.0 g of item 2 to the container while
mixing at slow speed.
8. Add and dissolve item 1 to the container while
mixing at slow speed. Avoid splashing of the
solution. Check that bromhexine is dissolved
completely.
9. Add item 4 to the container and mix well.
Transfer the solution to the manufacturing vessel while mixing at high speed.
10. Rinse the container with 20.0 g of item 2 and
transfer the rinsing to the manufacturing vessel
while mixing.

2004 by CRC Press LLC

Quantity/L (g)
0.80
200.00
2.00
0.34
1.00
30.31
571.40
2.00
0.14
q.s. to 1 L

11. Rinse the container with 20.0 g of item 10 and

transfer the rinsing to the manufacturing vessel
while mixing. Add 15.0 g of item 10 in a separate stainless steel container and dissolve item
5 using stirrer and transfer to the manufacturing
vessel while mixing.
12. Check clarity of the solution in manufacturing
vessel. The solution must be clear without any
undissolved particles of the drug.
13. Add item 7 to the manufacturing vessel while
mixing at high speed.
14. Transfer the cooled mucilage of item 8 to the
manufacturing vessel used above while mixing
at slow speed.
15. Check and record the pH of the solution (limit
3.3 to 3.6).
16. Dissolve item 9 in 5.0 g of cooled item 10
(30C) in a separate stainless steel container.
17. Adjust the pH of the syrup in manufacturing
vessel using the sodium hydroxide solution.
Add sodium hydroxide solution in small portions at a time. Mix well and check the pH after
every addition. Adjust the pH to 3.5 (limit 3.3
to 3.6).
18. Make up the volume up to 1.0 L with item 10
and, nally, mix for 15 to 20 minutes at high
speed. Check and record the pH (limit 3.3 to
3.6). Filter the syrup at 1.5 bar. Recirculate.