Term
| water for injection (WFI) |
|
Definition
-prepared from drinking water (standard set by EPA)
-purified by distillation or equivalent process
-contains no additives
-not sterile
-pyrogen free
-not used for injection
-used to prepare parenteral products |
|
|
Term
| sterile water for injection (SWFI) |
|
Definition
-prepared from WFI
-sterilized and suitably packaged (single dose containers up to 1L)
-contains no antimicrobials or other added substance
-used for reconstitution or other added substance
-used for reconstitution and dilution
-not for injection DIRECTLY |
|
|
Term
| bacteriostatic water for injection |
|
Definition
-prepared from WFI
-contains one or more antimicrobial agents
-sterilized and suitably packaged (pre filled syringes for single dose and less than 30ml vials for multidose)
-used for reconstitution and dilution (only for small volume injections less than 5ml, multidose)
-USP labeling requirement (names and proportions of microbials, NOT FOR USE IN NEWBORNS) |
|
|
Term
|
Definition
-WFI
-SWFI
-bacteriostactic WFI
-purified water
-pure steam
-sterile purified water
-sterile water for inhalation
-sterile water for irrigation
-last 3 not for parenteral injection b/c different requirement for pyrogens and particulates |
|
|
Term
| sodium chloride injection |
|
Definition
-sterile solution of NaCL in WFI
-isotonic is 0.9%, normal saline
-contains 95-105% labeled amount of NaCl
-contains no microbial agents
-used for reconstitution, dilution, flushing catheters and IV lines, fluid/electrolytes |
|
|
Term
| bacteriostatic sodium for injection |
|
Definition
-isotonic 0.9% NaCl
-contains one or more antimicrobial agents
-prefilled syringes/vials (<30ml)
-used for reconstitution/dilution (only for small volume injections less than 5ml, multidose)
-used as a flush for catheters and IV lines
-USP labeling requirement (names and proportions of antimicrobials, NOT FOR USE IN NEWBORNS) |
|
|
Term
|
Definition
-a sterile solution of dextrose in WFI
-5% solution isotonic, D5W
-contains 95-105% labeled amount of dextrose
-contains no antimicrobial agents
-used for reconstitution/dilution, fluid and nutrient |
|
|
Term
|
Definition
-contains Nacl, KCl, and CaCl2 in SWFI
-concentrations similar to those of body fluids
-used as a vehicle and for fluid /electrolyte replenishment |
|
|
Term
| lactated ringer's for injection |
|
Definition
-different quantities of NaCl, KCl, CaCl2
-contains sodium lactate
-used for fluid electrolyte replenishment and as a systemic alkalizer |
|
|
Term
|
Definition
-vegetable oils (mostly IM)
-glycerin
-propylene glycol
-PEG
-alcohol
-others (ethyl oleate, isopropyl myristate, dimethyl acetamide |
|
|
Term
|
Definition
-preservatives
-solubilizing agents
-stabilizers
-buffers
-tonicity
-inert gases (nitrogen)
-no colorants |
|
|
Term
|
Definition
-purpose?
-targets broad spectrum
-MOA-common properties of microbes
-dosage forms requiring-multi dose sterile products, non sterile solutions, suspensions, emulsions, and semi solids
-some dosage forms are self preserving (oleaginous, sugar) |
|
|
Term
| commonly used preservatives |
|
Definition
-benzoic acid (an its Na salt), benzyl alcohol (not for neonates), parabens
-phenols
-quaternary ammonium salts (ionic and hydrophobic interaction)
-mercurials (thimerosal) |
|
|
Term
| preservative selection criteria |
|
Definition
-compatibility with API, formulation (solvent, pH, polymer)
-packaging and devices
-efficacy and spectrum of activity
-safety |
|
|
Term
|
Definition
-pH modifiers (buffers, compatibility with blood pH)
-solvents (alcohol, glycerin, propylene glycol, PEG)
-surfactants-ionic (phospholipids), nonionic (POLYSORBATES ex. Tween)
-complexing agents (ex. cyclodextrins) |
|
|
Term
|
Definition
-antioxidants
-pH modifiers
-chelating agents
-cryoprotectants and lyoprotectants
-inert gases |
|
|
Term
| water soluble antioxidant |
|
Definition
|
|
Term
| lipid soluble antioxidant |
|
Definition
|
|
Term
|
Definition
-EDTA and citric acid (buffer too)
-can enhance efficacy of other preservatives |
|
|
Term
|
Definition
-ampules, vials, bottles
-clear and colorless amber
-must allow inspection for particulate matter
-type I class-most commonly used |
|
|
Term
|
Definition
-containers (vials/bags) and transferring devices
-PVC-most commonly used |
|
|
Term
| plastic container advantages |
|
Definition
-non breakable
-light weight
-collapsible, no venting needed |
|
|
Term
| plastic container disadvantages |
|
Definition
-clarity
-leachables (plastic can dissolve in liquid)
-drug can absorb onto plastic (most notable for low concentration)
-permeable to gases (water vapor and oxygen, overwrap)
-may not withstand heat sterilization (special cycles or use ethylene oxide) |
|
|
Term
| packaging single dose containers |
|
Definition
-prefilled syringes
-ampules
-vials, bottles, and bags |
|
|
Term
| packaging multi dose containers |
|
Definition
-multi-dose vials, less than 30ml
-must contain antimicrobials |
|
|
Term
| packaging small volume parenterals |
|
Definition
-single dose or multi dose
-therapeutic products
-solvents for reconstitution/dilution |
|
|
Term
|
Definition
-single dose
-replenish body fluid/electrolytes and provide nutrition
-slow infusion
-nutrients and drugs are often incorporated (compatibility is imperative, Handbook of Injectable Drugs) |
|
|
Term
|
Definition
-for only a few days (water dextrose sodium potassium)
-more than 3-5 days (higher caloric intake)
-for weeks or longer (total peripheral nutrition, macronutrients, compatibility issues) |
|
|
Term
|
Definition
|
|
Term
|
Definition
|
|
Term
|
Definition
|
|
