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Development and Stability Control of Pediatric Oral Tizanidine Hydrochloride Formulations for Hospital Use

Caren Gobetti1, Maria Eduarda Balsan2, Márcio Vinícius Ayres3

  • 1Pharmaceutical Sciences Graduate Program, College of Pharmacy, Federal University of Rio Grande do Sul (UFRGS), Av. Ipiranga, 2752. Laboratory 402, Santana, Porto Alegre, RS, 90610-000, Brazil. carengobetti@hotmail.com.

AAPS Pharmscitech
|July 31, 2020
PubMed

Insights

New tizanidine hydrochloride liquid formulations were developed for patients with swallowing difficulties. These stable formulations are suitable for hospital use for up to 70 days under various storage conditions.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Formulation Development

Background:

  • Tizanidine hydrochloride, a muscle relaxant for spasticity, is typically available in solid dosage forms.
  • Existing formulations pose challenges for pediatric and adult patients with dysphagia (swallowing impairment).
  • There is a need for stable, orally administered liquid formulations of tizanidine hydrochloride.

Purpose of the Study:

  • To develop and optimize stable oral liquid formulations of tizanidine hydrochloride.
  • To evaluate the physicochemical and microbiological stability of these new formulations.
  • To establish appropriate storage conditions and shelf-life for clinical application.

Main Methods:

  • Development of 30 liquid formulations using syrup and sodium carboxymethyl cellulose vehicles.
  • Validation of a stability-indicating high-performance liquid chromatography (HPLC) method.
  • Stability testing under various conditions (room temperature, refrigeration, 40°C) in different containers.
  • Evaluation of physicochemical properties and microbiological counts.

Main Results:

  • Two optimal tizanidine hydrochloride liquid formulations were selected for stability testing.
  • Formulations demonstrated physicochemical and microbiological stability for 70 days across tested storage conditions.
  • All evaluated parameters remained within recommended specifications throughout the study period.

Conclusions:

  • Developed tizanidine hydrochloride liquid formulations are stable and suitable for hospital use.
  • The formulations offer a viable alternative for patients unable to take solid oral dosage forms.
  • Results provide a reliable reference for storage and handling in clinical settings, particularly for vulnerable populations.

Keywords:
Box-Behnken designliquid formulationspediatricphysicochemical and microbiological stabilitytizanidine hydrochloride

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