Large volume parenteral

To support the institutional pharmacist in preparing IV admixtures (which typically involves adding one or more drugs to large-volume parenteral fluids), equipment manufacturers have designed laminar flow units, electromechanical compounding units, transfer devices, and filters specifically adaptable to a variety of hospital programs. 

Large-volume parenterals 101 and larger Venoclysis Solutions and some emulsions Nearly all drug classes (see... 

III. SPECIALIZED LARGE-VOLUME PARENTERAL AND STERILE SOLUTIONS... 

Large-volume parenterals designed to provide fluid (water), calories (dextrose solutions), electrolytes (saline solutions), or combinations of these materials have been described. Several other specialized LVP and sterile solutions are also used in medicine and will be described here, even though two product classes (peritoneal dialysis and irrigating solutions) are not parenteral products. 

Large-volume parenterals (LVPs) and small-volume parenterals (SVPs) containing no antimicrobial agent should be terminally sterilized. It is common practice to include an antimicrobial agent in SVPs that cannot be terminally sterilized or are intended for multiple-dose use. The general exceptions are products that pass the USP Antimicrobial Preservative Effectiveness Test [1] because of the antimicrobial activity of the active... 

USP Type II can be used for products that remain below pH 7.0 for their shelf life. The suitability of Type II for small volume parenterals should be evaluated for unbuffered solutions on a case-by-case basis. Type II containers are frequently found to be suitable for a variety of large-volume parenterals due to the less stringent requirements imposed by their lower surface-to-volume ratios. 

Many of these reactions are related to the quantity of excipient found in a dosage form. Benzyl alcohol benzalkonium chloride, propylene glycol, lactose, and polysorbates are all associated with dose-related toxic reactions [52-54], Large-volume parenterals containing 1.5% benzyl alcohol as a preservative have caused metabolic acidosis, cardiovascular collapse, and death in low birth weight premature neonates and infants. The cumulative dose of benzyl alcohol ranged from 99 to 234 mg/kg per day in these patients [55,56], Dose-related adverse effects to excipients are of particular concern in the preterm, low birth weight infant because... 

Device that uses drug concentrates to prepare large volume parenterals. 

Wearly, M. and Baker, B. (1977). Utilization of the limulus amebocyte lysage test for pyrogen testing of large-volume parenterals, administration sets and medical devices. Bull. Parenter. Drug Assoc. 31 127-133. 

The calories represented by large volume parenterals and TPN products may be calculated in three steps as follows ... 

Large-volume parenterals Appearance, color, clarity, particulate matter, pH, volume and extractables (when plastic containers are used), sterility, pyrogenicity, and closure integrity... 

Cost-prohibitive factors associated with the very large volume of some large-volume parenterals required for animals, and... 

IV Do not administer undiluted potassium - Potassium preparations must be diluted with suitable large volume parenteral solutions, mixed well and given by slow IV infusion. 

The review and approval of production and control records by the quality control unit shall extend to those records not directly related to the manufacture, processing, packing, or holding of a specihc batch of large volume parenteral dmg product but which have a bearing on the quality of batches being produced. Such indirectly related records shall include ... 

Mannermaa, J. P, Raisanen, J., Hyvonen-Dabek, M., Spring, E., and Yliruusi, J. (1994), Use of proton-induced X-ray emission (PIXE) analysis in the evaluation of large volume parenteral rubber stoppers, Int. J. Pharm., 103,125-129. 

FVP Large volume parenterals WSP Water sterilization process... 

FDA. FDA s proposed current good manufacturing practices (GMP) for regs. for large volume parenterals (LVP). Fed Reg (June 1, 1976). Preliminary Concept Paper of Sterile Drug Products Produced by Aseptic Processing, draft paper, Sept. 27, 2002. 

Another example would be for the case of products administered by injection. Compare the difference in the total amount of contaminant a patient would absorb for an injectable given as a single 2-cc injection daily in contrast to the amount received if the contaminated product is a large-volume parenteral (e.g., dextrose solution) that could be administered in amounts as large as 12 L (12,000 cc) per day. 

Validation in the pharmaceutical industry was the result of the septicemia outbreak traced back to large-volume parenteral (LVP) manufacturing practices... 

FDA. Current Good Manufacturing Practices—Large Volume Parenterals (proposed). Title 21, Part 212. June 1,1976. 

Large Volume Parenterals (LVP) Similar evaluations as described for SVPs should be conducted. In addition, if plastic containers are used, volume and extractables data should be evaluated. Another important parameter to consider, if applicable, is the maintenance of adequate preservative levels over the expiration dating period. 

In addition to their use in large-volume parenterals and IV sets, thermoplastic polymers have also recently found utility as packaging materials for ophthalmic solutions and some small-volume parenterals [43], However, there are many potential issues with using these polymers as primary packaging components that are not major concerns with traditional glass container closure systems, including [44] ... 

A packaging component means any single part of a container closure system. Typical components are containers (e.g., ampules, vials, bottles), container liners (e.g., tube liners), closures (e.g., screw caps, stoppers), closure liners, stopper overseals, container inner seals, administration ports [e.g., on large-volume parenterals (LVPs)], overwraps, administration accessories, and container labels [4],... 

Spectrex ILI-1000 Particle Counter combines the Prototron with a Particle Profile Attachment (multichannel analyzer). The instrument has been used [118] for examining volcanic ash. AC Fine Dust was used for calibration in eight 5 pm steps, which indicated that accurate data was obtained for sizes above 2 pm. It has also been shown to correlate well with the more tedious filtration and counting method for large volume parenteral liquids [119]. Although semi-transparent containers or liquids reduce the amount of transmitted light flux, the instrument gives valid data for particulates in oil [120]. 

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