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

Author(s):  Lacassia Chiara, Spennacchio Antonio, Lopedota Angela Assunta, la Forgia Flavia Maria, Fontana Sergio, Denora Nunzio, Lopalco Antonio

Issue:  Mar/Apr 2024 - Volume 28, Number 2
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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.

Related Categories: PAIN MANAGEMENT, PEER-REVIEWED, STABILITIES, COMPATIBILITIES, DOSAGE FORMS/DRUG CARRIERS

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