Injectable products total parenteral nutrition

Their use as an injectable warrants assurance of product sterility. Whereas the FDA-preferred heat-sterilization process is acceptable for total parenteral nutritional (TPN) emulsions, it could affect chemical as well as physical stability of emulsions containing therapeutic agents. Recently, data supporting the Liter sterilization of emulsions have been published. 

Physicochemical incompatibilities are of particular concern when parenteral administration is planned. For example, when calcium and phosphate ion concentrations are excessively high in a total parenteral nutrition (TPN) solution, precipitation will occur. Similarly, the simultaneous administration of antacids or products high in metal content may compromise the absorption of many drugs in the intestine, eg, tetracyclines. The package insert and the Handbook on Injectable Drugs (Trissel 2003) are good sources for this information. 

Oils such as safflower and soybean are used in total parenteral nutrition products, where they serve as a fat source and as carriers for fat-soluble vitamins. The U.S. Pharmacopeia (USP) requirement for injectable oils is as follows ... 

As stated previously, contaminated products injected directly into the bloodstream or instilled into the eye cause the most serious problems. Intrathecal and epidural injections are potentially hazardous procedures. In practice, epidural injections are frequently given through a bacterial filter. Injectable and ophthalmic solutions are often simple solutions and provide Gram-negative opportunist pathogens with sufficient nutrients to multiply during storage if contaminated, a bioburden of 106 CFU as well as the production of endotoxins should be expected. Total parenteral nutrition fluids, formulated for individual patients ... 

The most obviously recognized sterile pharmaceutical preparations are injections. These vary from very small volume antigenic products to large volume, total parenteral nutrition products. Other... 

Parenteral emulsions were first introduced to provide an IV source of essential fatty acids and calories. This has developed into the extensive and routine use of products such as Intraplipid, Lipofundin and Liposyn in total parenteral nutrition. There are relatively few commercially available emulsions containing active compounds the only example on the U.S. market is Diprivan Injectable Emulsion, the formulation of which is shown in Table 9.4. Diazepam is also available as an injectable emulsion on the UK market (Diazemuls ). For a more detailed discussion of the issues involved in developing parenteral emulsions, the reader is referred to Collins-Gold et al. (1990). 

---