Shelf life parenteral preparations

Furthermore, the drafted guide suggests that the level of end-product testing for those products will depend on the associated risk connected to the scale of operation, shelf life of the product, frequency of preparation, as well as type of product (parenterals, orals) and type of facility where the product has been prepared. 

Emulsifying agents are used both to promote emulsification at the time of manufacture and to control stability during a shelf life that can very from days for extemporaneously prepared emulsions to months or years for commercial preparations. In practice, combinations of emulsifiers rather than single agents are used. The emulsifier also influences the in vivo fate of lipid parenteral emulsions by its influence on the surface properties of the droplets and on the droplet size distributions. For convenience, most pharmacy texts classify emulsifiers into three groups i) surface active agents ii) natural (macromolecular) polymers and hi) finely divided solids. 

Preservatives are added to various dosage forms and cosmetic preparations to prevent microbial contamination. In parenteral and ophthalmic preparations, preservatives arc used to maintain. sterility in the event of accidental contamination during use. An ideal prc.scrvative would be effective at low concentrations against all possible microorganisms, be nontoxic and compatible with other constituents of the preparation, and be stable for the. shelf life of the preparation. The ideal pre.servative dues not exi.st. but there is quite a bit of experience with some of them. In srnne ca.ses. combinations of preservative agents arc used to approximate a mixture of ideal features. 

Copper occurs in many foods particularly good sources are liver, kidney, shellfish, nuts, raisins, and dried legumes. Copper deficiency due to diet is rare except in malnutrition and in children with chronic diarrhea. It occurs in total parenteral nutrition with fluids low in copper, particularly following intestinal resection and in patients who receive large amounts of zinc to improve wound healing or for management of sickle cell anemia. Copper is often removed from prepared foods to increase their shelf life. 

The shelf life of reconstituted parenterals prepared in the hospital pharmacy is to be determined by the responsible pharmacist (see Sect. 22.6). When Ucensed injection fluids are reconstituted and prepared for individual patients the shelf life is determined by evaluation of the physico-chemical stability and risk of microbiological contamination. Shelf life depends from a microbiological viewpoint on the risks associated with aseptic preparation and the results of validation studies performed under the pharmacy s specified aseptic preparation cmiditions (see Sect. 31.3.6). 

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