This document is intended to cover stability testing of all oral liquid formulations including suspensions, emulsions, solutions and powders for reconstitution

Introduction

Oral liquid medicines are often prepared or sourced as unlicensed medicines (Specials) or extemporaneously prepared medicines; these are required to meet a special patient need in such circumstances as paediatrics, for those who cannot swallow tablets or where the dose required is not available in solid dosage forms, or for patients with naso-gastric feeding tubes in place.

These products are often ordered in small numbers and may not be well formulated in order to maximise stability or to meet the patient need.  Nevertheless they are critical medicines and need to be of a quality suitable to their usage and meet with specifications throughout their shelf life.

As well as chemical and microbiological stability issues there are also other factors to consider such as the stability of a suspension or emulsion and the ability to re-suspend following storage, including an assessment of the ability to continue to provide accurate dosages.

Attachments

Change history

  1. Attachment re-secured
  1. Published