Formulation of Paracetamol Syrup

Manufacturing and Formulation of Paracetamol Syrup (Free  Alcohol) for Children 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 m ask.

FORMULATION of PARACETAMO SYRUP 2.5% (250 mg /10 ml) Batch size 100.0 ml Paracetamol syrup

Ingredients

Weight

Function

Part I

Paracetamol

2.5 g

Active ingredient

Polyethylene glycol 6000 (PEG 6000)

10.0 g

Solubilizer 

Glycerin

2.5 g

Diluent and sweetener 

D.M Water 

30.0 ml

Diluent

Part II

Sucrose

30.0 g

Sweetening agent

D.M Water 

20.0 g

Diluent

Sweetener 

0.220 g

Sweetener 

Sodium Methyl paraben

0.150 g

Preservative

Sodium Propyl paraben

0.030 g

Preservative

Sodium Benzoate

0.150 g

Preservative

Citric acid monohydrate

0.070 g

 pH modifier 

Coloring agent

2.50 mg

Coloring agent

Flavoring agent

0.25 ml

Flavoring 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