Chapter 5: Oral Suspensions

Formulating a poorly soluble active pharmaceutical ingredient into an oral suspension is a common practice for different therapeutic indications and is one of the preferred routes of administration in paediatric and geriatric patients, as well as patients that are unable to swallow oral solid dosage forms. The aim of this chapter is to provide guidance on the formulation and manufacture of oral suspensions, in order to achieve the desired quality target product profile. The chapter firstly provides an understanding of the links between key ingredients and finished product attributes that are driving safety, efficacy and acceptance of oral suspensions. An overview of the manufacturing equipment and typical processing conditions is provided together with a description of the key ingredients and their recommended concentration range. Common challenges in the formulation and manufacture of oral suspensions are also discussed and potential solutions proposed.