Study of formulation of pharmaceutical solution form of paracetamol in the pediatric clinical practice

Med Arh. 2012;66(1):5-8. doi: 10.5455/medarh.2012.66.5-8.

Abstract

AIM of the study was selection of 2 different formulations of paracetamol of 2.5% (125 mg/5 mL) in the Pediatric practice. Paracetamol is widely used in the form of the syrup, with usual percentage of acting ingredient of 125 mg/5 mL.

Material and methods: Both samples of the paracetamol syrup were monitored each day regarding organoleptic features (potential changes in color, smell, transparency, crystallization, etc.), whilst in monthly intervals (1 month, 2 months, 3 months, 4 months and 5 months) content of the paracetamol was analyzed, with the spectrophotometric method (HPLC).

Results and discussion: Content of the paracetamol in both syrup formulations has not incurred any change even after a period of 6 months of storage, which showed that these two formulations are appropriate ones. From six different formulations of the paracetamol syrup in percentage of 2.5% (125 mg/5 ml) as more appropriate are: fifth formulation which can be considered, without no doubt, as most appropriate one because of its relatively low cost, an stabilized pH, a quite likeable taste and as such also consequently acceptable in the pediatric practice. In some cases, mainly during the winter, the crystallization of the paracetamol in the lid, walls and bottom of the bottle was ascertained also.

Conclusion: Syrup of paracetamol 2.5% (125 mg/5 mL) as per the formulation 5 experimented by our side can be recommended as most appropriate to be produced in industrial conditions for purposes of pediatric practice.

MeSH terms

  • Acetaminophen / chemistry*
  • Analgesics, Non-Narcotic / chemistry*
  • Antipyretics / chemistry*
  • Chemistry, Pharmaceutical
  • Child
  • Humans
  • Pharmaceutical Solutions / chemistry

Substances

  • Analgesics, Non-Narcotic
  • Antipyretics
  • Pharmaceutical Solutions
  • Acetaminophen