Parenteral administration filters

As SLN are of particular interest for parenteral administration, sterility of the formulations is an important issue. The common method for the sterilization of aqueous systems is autoclaving. Sterilization is also possible by filtration of the formulation through a 0.2 f/m membrane filter. However, this method is less safe and can only be applied for solutions or colloidal dispersions with appropriately small particles. ... 

A. The usual formulation is as a 10% (100-mg/mL) or 20% (200-mg/mL) solution, supplied as an inhaled mucolytic agent (Mucomyst, Mucosil, or generic). This form is available through most hospital phannacies or respiratory therapy departments. This preparation is not FDA approved for parenteral use. In rare circumstances v en intravenous administration of this preparation is required, dilute the dose to a 3-4% solution (In D5W), use a micropore (0.22-micron) filter, and give the dose over 45-60 minutes. 

Studies on the problem of particulate matter and micro-organisms contaminating parenteral products continue to be of considerable interest for clinicians, hospital pharmacists and the pharmaceutical industry. In the USA about 10 million patients receive intravenous therapy each year. In order to reduce and prevent complications connected with i.v. infusions, much work has already been done as regards the manufacture of solutions, but especially with respect to the actual administration to the patient (1 ). Micropore filters (also called final filters or inline filters ) with a pore size of 0.45 imi or less, have proved their usefulne in removing particles and most... 

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