Form of sorption where there is diffusion and retention of a drug molecule within the matrix of the container or administration set material.6
A measure of the volume or weight of an ingredient to determine that the correct quantities of nutrients, electrolytes, or other components are delivered.3
Form of sorption where there is a weak and reversible interaction between a drug in solution and the container surface that causes the drug to bind to the surface of the container or administration set.
Process by which dispersed droplets come together but do not fuse. May be redispersed with gentle agitation.
Mixing to evenly disperse a drug or solution.
Antibiotic lock technique (ALT):
Instillation of a high concentration of antibiotic, usually at least 1000-times higher than the pathogen minimum inhibitory concentration, as a means to penetrate or disrupt biofilms and eradicate or prevent the growth of bacteria in a central venous catheter.
The date, or the hour and date, beyond which the preparation must not be used and must be discarded. The beyond-use date or BUD is determined from the date/time that preparation of the CSP is initiated. The BUD is not intended to limit the time during which the CSP is administered (e.g., infused).1
Central venous access device (CVAD):
A central venous access device (CVAD) is a catheter whose tip terminates in the lower segment of the superior vena cava. CVADs may be utilized for administration of any type of infusion therapy. The large diameter and high flow of blood permits administration of medications with high osmolality, concentration and/or viscosity, parenteral nutrition, chemotherapy, blood products, and medications with vesicant properties.
Seal on a sterile container that prevents leakage, tampering, or entry of contaminants. A closure is part of a container.3
The fusion of droplets leading to a decreased number of droplets and an increase in droplet size.
A drug product manufactured in large quantities intended for commercial sale.
Compounded sterile preparation (CSP):
A preparation intended to be sterile that is created by combining, admixing, diluting, pooling, reconstituting, repackaging, or otherwise altering a drug product or bulk drug substance.1
A detailed record that provides specific compounding instructions, describes how the CSP was prepared, and documents the entire process. Compounding records are specific to each compounding event.
Amount of active ingredient in a volume of solution (e.g., mg/mL).
That which holds the preparation and is or may be in direct contact with the preparation. The closure is part of the container.3
Coalescence of an emulsion continues to a point of complete separation and an oily layer is seen at the top.
Formation of a layer of aggregates at the emulsion surface.
Chemical and physical changes of a drug during storage resulting in modified pharmacological outcomes, altering the therapeutic or toxic profile.
Ingredient in a compounded sterile preparation that lacks pharmacologic activity but is necessary for the dissolution of drug(s) to be administered parenterally.
The process of dissolving one substance into another. A dissolution test measures the amount of drug that goes into solution over time.
Containers made of materials obtained by vulcanization (cross-linking) polymerization, polyaddition, or polycondensation of macromolecular organic substances (elastomers). Formulations contain natural or synthetic elastomers and inorganic and organic additives to aid or control vulcanization, impart physical and chemical properties or color, or stabilize the container formulation.2
A dosage form consisting of a two-phase system composed of at least two immiscible liquids, one of which is dispersed as droplets with the other liquid, generally stabilized with one or more emulsifying agents.5
Oil-in-water mixture requiring an emulsifying agent to disperse the oil phase into the aqueous phase.
Loss of water through the container material.
Date that identifies the time during which a conventionally manufactured drug product, active ingredient, or added substance can be expected to meet the requirements of a compendial monograph, if one exists, or maintain expected quality provided it is kept under the specified storage conditions. Expiration dates are assigned by manufacturers and are not the same as beyond-use dates (BUDs).1
The maximum time period in which 90% or greater of a labeled active ingredient is measurable in the solution and container specified, under the stated storage conditions. An exception applies to coagulation factors, which are considered stable when at least 80% of the factor activity is retained.
The prediction or estimation of a variable beyond the given data set by observing its relation with other variables in the existing data set.
Process by which dispersed droplets come together, but do not fuse, and may be redispersed with gentle agitation.
The chemical process of drug degradation by water. For aqueous solutions, pH, presence of acids or bases, drug concentration, and temperature are all factors that could affect the rate of hydrolysis.
Chemically inactive, and does not contain additives or other compounds that may potentially migrate into the finished preparation.
A fluid given parenterally for a therapeutic purpose.
Components of the plastic formulation (such as from a container) migrate into the infusate, contaminating the drug solution.
The ability of a compound to dissolve in lipid-containing solutions.
The final step in intravenous therapy administration when the vascular access device (VAD) will remain in place for future therapy to prevent occlusion or infection of a catheter between uses.
Master formulation record:
A detailed record that provides specific compounding instructions and describes how the CSP was prepared. Master formulation records should contain sufficient detail to be used on their own without additional verbal explanation.
Introduction of infectious material into a sterile solution.
Midline catheters measure 38 inches with the tip terminating in veins located between the elbow and shoulder. Midline catheter duration of therapy is typically 1 to 4 weeks. This type of catheter is an alternative to PICCs for certain indications, and intravenous solutions appropriate for administration into the peripheral vasculature.
The measure of particles of solute per kilogram of solvent (mOsm/kg), and contributes to the osmotic pressure of a solution.
The measure of particles of solute per liter of solution (mOsm/L), and contributes to the osmotic pressure of a solution.
Addition of a sufficient amount of excess solution to allow for water vapor transmission losses out of the container over the shelf life of the product, and to account for the variation in the amount of solution dispensed by compounding or administration devices. USP <1151>, Pharmaceutical Dosage Forms, recommends an excess volume of 2% of the labeled container size for mobile liquids.5
The chemical process of drug degradation by oxygen. Factors that affect the rate of oxidation include the presence of oxygen, light, heavy metal ions, temperature, pH, and the presence of other drugs or chemicals that act as oxidizing agents.
Intravenous administration of nutrition, which may include protein, carbohydrates, fats, minerals, electrolytes, and vitamins.
Peripheral catheters are usually 1 to 1.5 inches in length with the tip terminating in a peripheral vein. This type of catheter should not be used for continuous infusions of vesicants, parenteral nutrition, or infusates > 900 mOsm/L. The anticipated duration of therapy is generally less than 6 days.
Peripherally inserted central catheter (PICC):
A peripherally inserted central catheter (PICC) is a type of non-tunneled CVAD that is inserted in the antecubital space into the basilic, brachial, or cephalic veins and advanced within the blood vessel to achieve central placement.
Loss of container contents by allowing vapor, water, or drug molecules to migrate through the wall of the container.
Peroxidation of lipids occurs as a free radical-mediated chain of reactions that results in an oxidative degradation of lipid emulsions.
Component added to a plastic material to make it softer and more flexible.
Reaction upon mixing of drugs or solutions resulting in insoluble particulates that may be observed as crystals, haziness, or turbidity.
A commercially manufactured sterile drug or nutrient that has been evaluated for safety and efficacy by the US Food and Drug Administration (FDA). Products are accompanied by full prescribing information, which is commonly known as the FDA-approved manufacturer’s labeling or product package insert.
Commercially manufactured product that does not require additional compounding prior to administration.
The process of adding a diluent to a conventionally manufactured product to prepare a sterile solution or suspension.1
Occurs from differences of fluid velocity in moving liquids between the solution and the surface, such as a solution going through syringes and administration sets. It may promote interfacial reactions for solid-liquid (adsorption, leaching), gas-liquid (air-bubble entrapment), and oil-water (silicon lubricants).
Drug loss from a solution intended to be administered by adsorption to the surface or absorption into the matrix of the container material, administration set, or filter.3
The extent to which a product or preparation retains physical and chemical properties and characteristics within specified limits throughout its expiration or BUD.1
Standard operating procedure (SOP):
Written procedures describing operations, testing, sampling, interpretation of results, and corrective actions that relate to the operations that are taking place.4
Occurs when a temperature reading is outside the recommended range for the medication as defined in the manufacturer’s package insert.
Cloudiness or haziness of a solution caused by large numbers of individual particles.
Vascular access device (VAD):
Vascular access devices are flexible catheters inserted into a vein to deliver infusion therapy.
Specialized point-of-care activated devices and bags that allow for the connection of a vial of medication to a small volume infusion container.
Immediately after compounding, and as a condition of release, each CSP unit, where possible, should be inspected against a lighted white or black background or both for evidence of visible particulates or other foreign matter. Prerelease inspection also includes container-closure integrity and any other apparent visual defect. When CSPs are not distributed promptly after preparation, a pre-distribution inspection is conducted to ensure that a CSP with defects, such as precipitation, cloudiness, and leakage, which may develop between the time of release and the time of distribution, is not released.