Physical-chemical Stability of the Extemporaneous Paracetamol Oral Suspension in Puccini Base

Int J Pharm Compd. 2024 Mar-Apr;28(2):151-155.

Abstract

This study describes a new method for the preparation of extemporaneous paracetamol-based suspensions for pediatric and adult patients. This method allows the preparation of extemporaneous suspensions up to concentrations of 50 mg/mL by using a liquid base, named "Puccini". A high-pressure liquid chromatographic method was developed and validated for the determination of chemical stability of paracetamol when the formulations were stored at 4°C and 25°C. The chemical stability of the active pharmaceutical ingredient in the base was demonstrated for more than 90 days. Visual analyses of the formulations showed a phenomenon of precipitation at both storage temperatures, but the simple agitation of the formulations before its use re-established the formation of homogeneous suspensions.

MeSH terms

  • Acetaminophen*
  • Administration, Oral
  • Adult
  • Child
  • Chromatography, High Pressure Liquid
  • Drug Compounding
  • Drug Stability
  • Drug Storage
  • Humans
  • Suspensions

Substances

  • Acetaminophen
  • Suspensions