Extemporaneous reconstitution

The aggregation of metrizamide in solution further reduced its osmolality to about 485 mOsm kg at 300 mgl mL [ 1 ]. Unfortunately, this agent could not be sterilized by autoclaving and, consequently, had to be lyophilized and reconstituted extemporaneously. In the mid-1970s, stable nonionic compounds such as iopamidol or iohexol superseded metrizamide. Further improvement was reached by stabilization of the hydrophilic sphere against external disruption, as shown with iobitridol [2]. 

I. Extemporaneous sterile and non-sterile preparations Examples of this kind of preparations are Aseptic handling, i.e. uncomplicated operations with sterile medicines in closed containers after which they get a very short usage period, reconstitution of sterile and non-sterile authorised medicines and extemporaneous non-sterile preparations from raw materials. 

The underlying principles for premises for non-sterile stock preparations should be used for extemporaneous preparations as well. Preparation activities in a community pharmacy usually are confined to reconstitution, aseptic handling, manipulation of licensed medical products and non-sterile preparation firom raw materials. The avoidance of crossing process lines in small-scale situations is a... 

Preparations differ in size and complexity. The scale may range from a tailor-made preparation for one patient to a (semi-)industrial production for thousands of patients. The complexity may range from the reconstitution of an authorised medicine to complex preparations from active substances and excipients. In this chapter we focus mainly on stock preparatiOTis. The principles described are equally applicable to simpler preparations such as extemporaneous preparations and even for reconstitution [4]. However, the extent of quality control and validation should be justified by risk assessment [5, 6 and Chap. 21]. 

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