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Formulation design of oral pediatric Acetazolamide suspension: dose uniformity and physico-chemical stability study

Ana Santoveña1, Javier Suárez-González1, Cristina Martín-Rodríguez1

  • 1a Departamento de Ingeniería Química y Tecnología Farmacéutica, Facultad de Farmacia , Universidad de La Laguna , Tenerife , Spain.

Pharmaceutical Development and Technology
|April 26, 2016
PubMed

Insights

Acetazolamide (AZM) oral suspensions for pediatric use were formulated but failed dose uniformity tests. This indicates AZM requires more complex excipients or solid dosage forms for pediatric administration.

Area of Science:

  • Pharmaceutical Sciences
  • Pediatric Drug Formulation

Background:

  • Oral solutions/suspensions are common pediatric formulations due to lack of pediatric doses.
  • Formulation stability and dose accuracy depend on the active pharmaceutical ingredient's (API) properties.
  • Class IV APIs present formulation challenges in pediatric drug delivery.

Purpose of the Study:

  • To formulate Acetazolamide (AZM), a Class IV API, as an oral suspension for pediatric use.
  • To ensure the developed suspension meets quality, safety, and efficacy standards for pediatric administration.

Main Methods:

  • Utilized simple compounding procedures with minimal excipients suitable for children.
  • Conducted mass and content uniformity assays.
  • Performed physical and chemical stability studies.
  • Quantified API using Ultra-Performance Liquid Chromatography (UPLC).

Main Results:

  • Physico-chemical stability of the Acetazolamide (AZM) suspensions was confirmed.
  • The suspensions passed the European Pharmacopeia (EP) mass uniformity test.
  • The suspensions failed to meet the dose uniformity test requirements.

Conclusions:

  • Simple suspension formulations of Acetazolamide (AZM) do not ensure dose uniformity for pediatric administration.
  • Alternative formulations, such as those with complex excipient systems or solid dosage forms, are necessary for pediatric AZM.
  • Further research is needed to develop suitable pediatric dosage forms for AZM.
Abstract

Keywords:
AcetazolamideBCS class IVdose uniformitypediatric oral suspensionphysico-chemical stability

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