Chloromphenicol formulation :

Chloramphenicol Ophthalmic Solution

(3%)
1. Formulation
Chloramphenicol ......................................3.0 g
Kollidon 25 [1] ........................................15.0 g
Preservative ...............................................q.s.
Water ............................................add 100.0 g
2. Manufacturing
Dissolve the preservative in hot water, cool, dissolve Kollidon 25, add
chloramphenicol and stir until a clear solution is obtained.
3. Properties
Clear colourless solution having a low viscosity.
4. Remark
To prevent of discolouration of Kollidon in the solution during storage 0.2
to 0.5 % of cysteine could be added as antioxidant.
BASF Pharma Ingredients Generic Drug Formulations 2005
6

Chloramphenicol Palmitate Oral or Topical

Emulsion
(2.5% = 250 mg/10 ml)
1. Formulation
I. Chloramphenicol palmitate........................2.5 g
Lutrol E 400 [1].........................................4.0 g
Cremophor RH 40 [1] ...............................4.0 g
II. Sucrose, crystalline ................................40.0 g

Water.....................................................40.0 g
III. Water................................................ad 100 ml
2. Manufacturing
Mix components I at 70C to obtain a clear solution. Cool to 40 C and
add this solution slowly to the well stirred solution II. Fill up with III to
100 ml.
3. Properties
White, homogeneous emulsion without foam formation

Chloramphenicol Palmitate Oral or Topical

Emulsion
(5.0% = 500 mg/10 ml)
1. Formulation
I. Chloramphenicol palmitate...........................5 g
Lutrol E400 [1] ............................................6 g
Cremophor RH 40 [1] ..................................4 g
II. Sucrose, crystalline ...................................40 g
Preservative ...............................................q.s.
Water........................................................45 g
2. Manufacturing
Mix components I at 70C to obtain a clear solution and cool to about
40 C. Add the warm solution II slowly to the well stirred solution I.
3. Properties
White, milky emulsion
4. Physical Stability
After 3 weeks at room temperature and at 45 C no change of appearance and viscosity was
observed.