It is well known that ethanol or propylene glycol or mixtures thereof are used as carriers for paracetamol in the common paracetamol syrups. But, Oral administered syrup for children should be free from alcohol. Another reason is the bad taste of propylene glycol, the taste of this solvent is difficult to mask.





FORMULATION of PARACETAMO SYRUP 2.5% (250 mg /10 ml)

Batch size 100.0 ml Paracetamol syrup

IngredientsWeightFunction
Part I

Paracetamol2.5 gActive ingredient
Polyethylene glycol 6000 (PEG  6000)10.0 gSolubilizer
Glycerin2.5 gDiluent and sweetener
D.M Water30.0 mlDiluent



Part II

Sucrose 30.0 gSweetening agent
D.M Water20.0 g Diluent
Sweetener0.220 gSweetener
Sodium Methyl paraben0.150 gPreservative
Sodium Propyl paraben0.030 gPreservative
Sodium Benzoate0.150 gPreservative
Citric acid monohydrate0.070 gpH modifier
Coloring agent2.50 mgColoring agent
Flavoring agent0.25 mlFlavoring agent



Physical property :
  • Appearance : Clear and transparent
  • pH : 5.90
Procedure and Manufacturing of Paracetamol Syrup :

Part I
1. Heat (PEG 6000)at 50Oc and add Paracetamol in it. Stir the solution for 30 minutes.
2. Heat Glycerin at 50oC and then add in step 1 solution ((PEG 6000)-+Paracetamol) under continues stirring. Stir the solution for 20 minutes. Transparent solution will be obtained
3. Heat water at 50oC and put it under continuous stirring
4. Add step 1 solution ((PEG 6000)+Paracetamol+Glycerin) slowly in to D.M. Water under continuous stirring. Transparent solution will be obtained

Part II
5. Weigh accurately sucrose. Add sucrose in hot (65oC) D.M Water under continuous stirring till it dissolved
6. Filter above solution through filter press. Keep filtrate under stirring
7. Add citric acid monohydrate, sodium methyl paraben, Sodium propyl paraben, Sweetener and Sodium benzoate in it with continuous stirring for 10 minutes.

Mixing of Part I and Part II
8. Slowly add part I in Part II under continuous stirring. Stir it till clear solution is obtained
9. Check pH above solution. If pH is not between 3.80-6.10 than add accordingly Citric acid solution to adjust pH
10. Add colour solution in above solution under stirring. Now, add flvor under continuous stirring
11. Make volume 100 ml by D.M. water if required
12. Clear transparent Paracetamol syrup is obtained

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