Sunday , November 27 2022

Formulation of Paracetamol Suspension

Formulation of paracetamol suspension seems very easy to formulate. But a pharmacist make it less complicated after encountering numerous practical problems associated with formulation of paracetamol suspension in R&D and production unit. Unlike powder for suspension, paracetamol suspensions are marketed as ready suspension form for direct administration not require to reconstitution. Formulation of paracetamol suspension is essential due to water insolubility nature of Paracetamol and to make a stable, riskless drug dosage form to get an antipyretic and analgesic effect. If you want to know about the method & procedure for formulation of suspension as well as excipients for suspension click the link.

Formulation of a common pharmaceutical suspension

All paracetamol suspensions contain paracetamol BP or Acetaminophen USP with some common excipients such as suspending agents, viscosity modifiers, wetting agents,  co-solvent, solvents,  preservatives, flavoring agents, coloring agents, sweetening agents, and humectants etc. Excipients may vary from formula to formula. A formula of paracetamol suspension of Rosemont Pharmaceuticals Limited contains paracetamol with xanthan gum (as suspending agents), methyl hydroxybenzoate & propyl hydroxybenzoate (as preservative), sorbitol solution 70% (as humectant), mango flavor (as flavoring agents), sucrose (as sweetening agents), propylene glycol (as co-solvent), and purified water (as solvent) [1]. For paracetamol suspension (sugar free) you have to avoid using of sugar and you may use or increase the amount of artificial sweetening agents. Generally as flavoring agents in the formulation of paracetamol suspension, cherry, banana, mango, strawberry, and raspberry are used.

Formula of Paracetamol Suspension 

This formula of paracetamol suspension is for 120 mg per 5 ml but you may increase the amount of paracetamol API and make the formulation for higher strength of paracetamol. The following formula is stable and has a good shelf-life.

Name of raw materials Functions Quantity/ 100 ml
Paracetamol BP (Acetaminophen USP) API 2.40 gm

(for 120 mg/5 ml)

Microcrystalline Cellulose & Carboxy Methylcellulose Sodium (Avicel RC 591) Suspending Agent 0.20 gm
Carboxymethyl Cellulose Sodium Suspending Agent 0.04 gm
Xanthan Gum Suspending Agent 0.20 gm
Sucrose (Sugar) Sweetening Agent 60.00 gm
Glycerol BP (Glycerin USP) Humectant 10.00 gm
Non Crystallizing Liquid Sorbitol Humectant 10.00 gm
Sodium Benzoate Preservative 0.10 gm
Methyl Hydroxybenzoate BP (Methyl Paraben USP) Preservative 0.15 gm
Propyl Hydroxybenzoate BP (Propyl Paraben USP) Preservative 0.02 gm
Butyl Hydroxybenzoate  BP (Butyl Paraben USP) Preservative 0.02 gm
Saccharin Sodium Sweetener 0.10 gm
Sodium Lauryl Sulphate Surfactant 0.04 gm
Mango flavor Liquid Flavoring Agent 0.25 gm
Allura Red AC Colorant 0.001 gm
Simethicone Emulsion USP SME 300 (30% Aqueous) Anti-foaming Agent 0.040 gm
Purified Water Solvent QS to 100 ml

 Label claim of this paracetamol suspension: Each 5ml spoonful contains Paracetamol 120 mg.

Warning: This Formula of Paracetamol Suspension is only for oral use.

If you need more formulation of paracetamol suspension visit this patent from the link: WO2003082243A1

Preparation of Paracetamol Suspension (Procedure)

Note that: this procedure is made for laboratory and commercial production of paracetamol suspension or Acetaminophen suspension.

1. Before formulation of paracetamol suspension, check and ensure all of the necessary API, excipients are available as well as all apparatus and other accessories are clean and dry.

2. Dispense all the raw materials as per formula of paracetamol suspension (given above).

3. Place following materials into a stainless steel vessel and mix for 30 – 50 minutes to dissolve. After mixing, rise the temperature of sugar syrup at 55°C and maintain this temperature.

  • Purified Water
  • Sucrose (sugar) (a portion)
  • Sodium Benzoate

4. Take the following material into a S.S. container and bring the temperature up to 85°C.

  • Glycerol (Glycerin) (1/3 of total amount of glycerin)

5. Dissolve the following materials into step-4 and after that add the mixture to step- 3 and again mix for 10 minutes.

  • Methyl Paraben
  • Propyl Paraben
  • Butyl Paraben

6. Add the following material into the same SS  vessel of step 3 and mix for 5 minutes.

  • Liquid Sorbitol

7. Cool down the temperature between 30°C – 40°C then add the following one after another into the SS vessel of step 3 and mix with stirrer for 60 mins.

  • Xanthan Gum
  • Microcrystalline Cellulose & Carboxy Methylcellulose Sodium (Avicel RC 591)
  • Carboxy Methyl Cellulose Sodium

8. Homogenize the above step-7 by a homogenizer for 60 minutes.

9. Place the following material into S.S vessel and mix for 30 minutes and transfer into SS Vessel of step 3. Remember that, finally Paracetamol dispersion must rinse by purified water.

  • Glycerin
  • Paracetamol

10. Dissolve the following material into a small SS vessel and transfer to the same SS Vessel of step-3 by mix  for 15 minutes.

  • Sodium Lauryl Sulphate
  • Saccharin Sodium
  • Purified Water

11. Take the following materials into a S.S vessel and dissolve and then transfer to the same SS vessel of step-3 by passing through a # 60 mesh screen and mix with stirrer for 10 minutes.

  • Mango flavor Liquid
  • Allura Red AC
  • Purified Water (Temperature 40°C-50°C)

12. Mix the following material into a small SS vessel and transfer to the same SS Vessel of step-3.

  • Simethicone Emulsion (30% Aqueous)
  • Purified Water

13. Settle down the preparation for 20 minutes and Add sufficient Purified Water to adjust the volume to final volume of the batch. Mix the bulk suspension with propeller for 60 minutes.

14. Check the following parameters of the sample of bulk paracetamol suspension.

In-process Parameters for this Formulated of paracetamol suspension

Parameters Specification
General Identification A light red colored, mango flavored suspension, free from any visible particles.
Weight per ml 1.20 – 1.25 g/ml
pH 4.50 – 6.90
Viscosity 800 cps – 1600 cps
Assay 95.0 to 105.0% of the stated amount
Microbial test As per aqueous preparations for oral use; USP <1111>

15. After checking the above parameters within specification this formulation of paracetamol suspension are ready to packing within bottles.

paracetamol-suspension

Storage condition: As per BP, paracetamol oral suspension should be protected from light [2].

Keywords: Paracetamol suspension, Acetaminophen suspension, Formulation of paracetamol suspension, Preparation of Paracetamol Suspension, Formulation of Acetaminophen suspension, Formula of paracetamol suspension. Paracetamol Infant Suspension, Junior Paracetamol suspension.

Usually appearance of paracetamol suspension is generally white to off-white color without coloring agents. Paracetamol suspension is indicated for fever and for the treatment of mild to moderate pain including headache, neuralgia, inflammatory pain, migraine, colic pain, osteoarthritic pain, post-operative pain, toothache, period pains, post vaccination pain, sore throat, other aches, pains of colds and flu.

So, write a comment if you have any queries about formulation of paracetamol suspension. I think formulation of paracetamol suspension is an easy task to you now. You may find all necessaries information to evaluate this paracetamol suspension in various pharmacopeia such as BP, USP, Ph. Eur, JP, IP, ChP etc.

References

  1. Paracetamol 120mg/5ml Oral Suspension, EMC, link: https://www.medicines.org.uk/emc/product/6693/smpc#
  2. British Pharmacopoeia Commission. British Pharmacopoeia 2021. London: TSO; 2021.

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