Describe some of the issues related to large volume parenteral solutions. Describe some of the issues related to small volume parenteral solutions. Discuss the equipment and facilities related to sterile preparations. Review the procedures related to sterile compounding. Discuss the procedure related to proper aseptic technique. Review quality control procedures related to sterile preparations. There are no barriers like skin ormuscle to absorb the drug first, which allow the most rapid onset of action. Intravenous Administration Intravenous administration of drugs has advantages over other routes of administrationbecause it provides the fastest route to the bloodstream.So, radiation has become yet another way to sterilize devices and medications (Adsorption)~MOA: micro organisms adhere to the filter~Method: solution is processed through a filter to remove micro organisms.Aseptic technique must be used~Examples: heat sensitive products. Must be in solution~must use chemical (solution) that doesn't destroy filter ~Range: 0.0025 to 14 microns~To remove pyrogens use ultrafiltration: 0.001 to 0.01 microns~to remove bacteria: 0.22 microns (hospitals mostly)~To clarify (remove glass): 5 microns~to filter blood: 170 microns~others to filter lipids (3 in 1=specialized filter, more expensive), alcohols, etc~filters are easy to use and cheap~alcohol destroys filters, so has special filters ~USP requirements: if making a batch product, USP spells out testing required for each type of sterilization method. A spore) to test a statistical random sample of the batch~QA must show that the product is sterile, non pyrogenic, and of the potency required~These would be high risk compounded sterile products~~If sterilizing a single (not a batch) product, sterility must still be proven~innoculate a sample of product onto a growth media OR filter product and culture filter~Turbid=cloud (something growing) fever producing organic substances arising from microbial contamination of lipopolysaccharides from the microbe's outer cell wall and/or endotoxins.The medicinal part of the willow tree is the inner bark.It is on the WHO Model List of Essential Medicines, the most important medications needed in a basic health system.This handbook is the first to cover all aspects of stability testing in pharmaceutical development.Written by a group of international experts, the book presents a scientific understanding of regulations and balances methodologies and best practices.
The second type of administration is an IV infusion.~Sterility is the absence of viable microorganisms.~Sterilization (destruction) is (1) process or method by which all viable forms of microorganisms are removed or destroyed and (2) the method used is determined by the nature of the product Sterilization using STEAM~MOA: hot moisture coagulates cellular protein at a lower temperature due to use of pressure~Methods: time, temperature, pressure, and steam (ex) 15lbs pressure, 121 degrees C, for 20-60 mins~Used for: solutions, glassware, surgical dressings, instruments, tubing (items that can be penetrated by water vapor)!!! Sterilization using Dry Heat~MOA: dehydrates the cell, then a slow burn oxidizes the cell~Method: 250 degrees C (higher than autoclave) for at least 2 hours~Examples: glassware, instruments, dry chemicals (powders), oils, glycerin, petrolatum.!! (chemicals)~MOA: interferes with cell metabolism~Method: gas must permeate entire product (50-60 degrees C, 60% humidity, 4-16 hours).Uses ethylene oxide or propylene oxide gas.~Examples: catheters, needles, plastics, medications (like antibiotics); things that would be destroyed by high heat (newer)~MOA: gamma radiations or electron beam~Safety concerns: ethylene oxide use has been questioned and more heat sensitive devises have been developed.Nearly all parenterals packaged in glass use this type of glass~Quality Assurance: USP standards~Coloring (more expensive): if a medication in solution is light sensitive, it is stored in Type Ii amber colored glass Additives~Plasticizers: improve softness/flexibility~Stabilizers: retard/prevent degradation due to heat or light.Improves shelf life.~Anti Oxidants: a special type of stabilizer used to retard oxidation (crusty). Overview of Sterile Compounding and the Role of the C. Since the inner lining of a vein is relativelyinsensitive to pain, drugs that can be irritating if given by another route can be givenintravenously as a slow rate without causing pain.