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Development of an extemporaneous oral liquid formulation of oxandrolone and its stability evaluation

Alka Garg1, Sanjay Garg, Richard Wong She

  • 1National Burn Centre, Middlemore Hospital, Auckland, New Zealand. garga@middlemore.co.nz

Burns : Journal of the International Society for Burn Injuries
|July 19, 2011
PubMed

Insights

A new stable, extemporaneous oral liquid formulation of oxandrolone was developed. This addresses the lack of suitable dosage forms, especially for pediatric patients requiring weight-based dosing.

Area of Science:

  • Pharmaceutical Sciences
  • Drug Formulation
  • Medicinal Chemistry

Background:

  • Oxandrolone is clinically valuable for muscle wasting conditions like severe burns.
  • Current oxandrolone dosage forms (tablets) are unsuitable for accurate weight-based dosing, particularly in children.
  • Limited guidance exists for extemporaneous oral liquid formulations of oxandrolone.

Purpose of the Study:

  • To develop and validate a stable, extemporaneous oral liquid formulation of oxandrolone.
  • To provide a practical alternative to existing tablet forms for accurate dosing.
  • To ensure the formulation is suitable for hospital and community pharmacy settings.

Main Methods:

  • Oxandrolone suspensions were prepared using New Zealand-available vehicles and ethanol.
  • High-Performance Liquid Chromatography (HPLC) and Liquid Chromatography-Mass Spectrometry (LC-MS) were used for assay method development.
  • Formulation stability was assessed according to International Conference on Harmonization (ICH) guidelines over 28 days.

Main Results:

  • A stable extemporaneous liquid formulation of oxandrolone was successfully developed.
  • The formulation utilizes crushed oxandrolone tablets dispersed in Simple Syrup BP or Orablend® vehicle.
  • Confirmed stability for 21 days under evaluation.

Conclusions:

  • A validated, stable oxandrolone oral liquid formulation is now available.
  • This formulation offers a practical solution for accurate oxandrolone dosing, especially for pediatric use.
  • The formulation can be readily prepared in pharmacy settings using accessible materials.

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