To support NHS compounding units and purchasers to derive and assess stability data for pharmaceutical products (Specials and extemporaneously compounded).

Introduction

PN is unique in that, although it is a source of nutrients designed to support physiological processes it is also a Prescription Only Medicine made from licensed and sometimes unlicensed medicinal products.

PN is a complex mixture of components, and can contain over fifty separate chemical entities. The complexity of such admixtures requires careful consideration of factors that may affect stability, which include: overall admixture composition, mixing order of individual ingredients; mixing process (automated or manual / gravity fill); type of final container; quantity of air in the final container and/or dissolved within the final admixtures; and the quantity of air found in individual ingredients, exposure to light; temperature during storage; duration of storage. The inclusion of micro-nutrients (trace elements and vitamins) is almost always an essential part of PN admixtures but these can generate potentially hazardous by-products that need to be understood and their clinical importance determined.

To have a viable PN service there must be assurance that products will be assigned with an operationally and clinically relevant shelf life.

Attachments

Change history

  1. Attachment re-secured
  1. Published