Intravenous solutions, particulate matter

Embolism is another possible complication of the IV route. Particulate matter may be introduced if a drug intended for intravenous use precipitates for some reason, or if a particular suspension intended for IM or SC use is inadvertently given into a vein. Hemolysis or agglutination of erythrocytes may be caused by injection of hypotonic/hypertonic solutions, or by more specific mechanisms (Gray, 1978). 

Therefore, admixture studies are performed on parenteral drugs with commonly used intravenous diluents. Studies are performed by preparing admixtures of the drug product with various diluents in an appropriate type of flexible intravenous bag. Initial samples are taken for analysis before the bags are stored in temperature-controlled stability chambers. Subsequent samples may be pulled at 6-, 12-, 24-, 48-, and 72-h time points. The analytical tests commonly performed include visual appearance, pH, and HPLC assay. Degradation products are not commonly tested unless the method has been previously evaluated for specificity and stability-indicating ability with a particular intravenous diluent. This is necessary because there may be differences in the stability profile of the product in its original formulation compared to the admixture solution. Formation of any particulate matter is detected by visual... 

PN solutions should be administered with an infusion pump to ensure consistent and controlled delivery of the solution. The intravenous administration line may include an in-line filter at a point prior to connection to the catheter. A 0.22-micron filter is recommended for use with CAA-dextrose solutions to remove particulate matter, air, and any microorganisms that may be present in the solution from prior manipulations of the admixture or the administration line. Because the average size of IVLE particles is approximately 0.5 micron, IVLEs administered separately from the CAA-dextrose solution must be piggybacked into the PN line at a site beyond the in-line fllter. Routine use of in-line filters (>0.22 micron) with TNA solutions is controversial. However, the FDA recommends use of a 1.2-micron filter, which may be effective in preventing catheter occlusion due to precipitates or lipid aggregates. This filter size is also reported to remove Candida albicans. 

Visual evaluations are used to describe the physical state - that is, the appearance of crystalline or amorphous materials (DS) and lyophilisate or solutions (DP). A DP that is to be administered intravenously must be free of any particles, and a specific investigation of particulate matter is also performed by a special visual inspection. 

Tc-CEA-Scan injection is a clear, colorless solution suitable for intravenous injection, used as a single dose (740-1100 MBq resp., 20-30 mCi). The total volume is 2 ml. The pH of the injection solution is 5.0-7.0. The injection solution should be inspected visually for particulate matter and discoloration. If either is present, the product should be discarded (Immunomedics Europe 2000). 

The filling of products to be terminally sterilised should be carried out in an appropriate environment for control of viable and non-viable airborne particulate matter. Extra precautions in the form of contained work stations and/or laminar air flow protection may be necessary when solutions intended for intravenous use are filled into wide-necked containers. 

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... 

Fluid redistributes between prone and supine imaging (Fig. 14.19). Polyethylene glycol electrolyte solution bowel preparation typically results in more retained colonic fluid, compared to other bowel preparation regimens, but leaves less particulate stool matter in the colon. Fluid can also be seen in 3D endoluminal images (Fig. 14.20). When there is excessive fluid, intravenous contrast can be used to enhance submerged lesions. 

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