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Parenteral Definition

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Route of drug administration into the body other than through the gastrointestinal tract; designating a drug to be injected

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Enteral Definition

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Route of administration that involves absorption of the drug through the gastrointestinal tract (oral route)

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Parenteral Routes of Administration

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Intravenous; Intramuscular; Subcutaneous; Intradermal

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Methods of parenteral administration

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Injection; Infusion

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Injection Definition

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Process of administering a solution into the body, usually with a syringe and a hollow needle which is pierced through the skin to a sufficient depth for the material to be administered into the body

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Infusion Definition

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Process of administering a solution intravenously through an infusion set that includes a container containing the solution and tubing connecting the container to a catheter or a nedle in the patient's vein

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Administration Devices

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Syringes; IV administration Set; Needles; Catheter

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Needle Components (definitions)

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Lumen: hollow part of the needle; Bevel: slanted end of the needle; Shaft: needle's outer portion

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Needle designations (definition)

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Length: measured in inches from the juncture of the hub and the shaft to tip of point; Gauge: used to designate the size of the lumen

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Components of IV administration set

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Plastic spike; Drip chamber; Polyvinyl chloride tubing; Flow regulator; Injection Port; Connector

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Plastic Spike (IV administration)

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Pierce the closure seal on the IV container

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Drip Chamber (IV administration)

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Trip air and permit adjustment of flow rate

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Flow Regulator (IV administration)

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Control the rate at which the IV fluid infuses

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Injection Port (IV administration)

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Place where medication other than those in the current IV bag can be injected

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Connector (IV administration)

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Connect IV administration set to a venipuncture device

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Catheter definition

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Consists of hollow needle connected to a length of tubing through which medication, saline, or blood may flow

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Butterfly needle

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Rigid needle catheter may produce infiltration more frequently than flexible one; Often used for short-term therapy or for one time IV push

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Intravenous Route

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Primary use is to provide a rapid and immediate drug action; This route is also used for fluid, electrolyte, and nutrient supplement

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Injection Sites and Volume of IV route

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Can be injected into the veins of the arms and hands (basilic and cephalic veins on the back of the hand and dorsal forearm); Maximum volume is 3L/day for adults

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Intravenous Subdivisions

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IV bolus; Intermittent infusion; Continuous infusion

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IV Bolus (Definition and when to use)

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Drug solution is injected directly into vein via a syringe and needle or catheter within a short period of time, and toxicity may occur; Used in emergency situations when immediate action is required

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Intermittent Infusion (Definition and When to Use)

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Drug is diluted in an intermediate volume of parenteral fluid and is infused over a period of time; Safer form of drug administration than bolus; provides less consistent drug plasma level than continuous infusion

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Continuous Infusion Definition

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Drug is added to a large volume parenteral fluid and the solution is then slowly and continuously administered into a vein

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Continuous Infusion Advantages

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Allows fluid and drug therapy to be administered simultaneously; Provides an excellent control of drug plasma level; Problems associated with drug toxicity and irritation are minimized

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Continuous Infusion Disadvantages

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Unstable drugs cannot be administered due to extended run times; Cannot be used in fluid-restricted patients; Cannot be used to admix poorly soluble drugs in water-miscible drugs

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Intramuscular Route Definition and Injection Sites

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Injection made deep into the layers of muscle; Injects into Gluteus Maximus, Deltoid, and vastus lateralis

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Intramuscular Route Considerations

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The needles used are generally 0.5 to 1.5 inches long and 19-23 gauge size; Point of injection should be as far as possible from major nerves to avoid neural damage; Result in lower but more sustained blood concentrations

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Subcutaneous Route Definition and Injection Sites

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Administered beneath the surface between the dermis and the muscle; Injected into the upper arm, anterior surface of the thigh, lower portion of the abdomen, and the upper back

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Subcutaneous Route Considerations

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Needles are generally 3/8 to 1 inch in length and 24 to 27 in gauge size; Injection sites must be rotated; Absorption may be slower than IM administration; 2mL max volume

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Intradermal Route Definition, Site and Max Volume

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Involves injections just beneath the epidermis, within dermal or skin layer; Anterior surface or skin layer; Volume limited to 0.1 mL

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Intradermal Route Considerations

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Onset action and rate of absorption of medication are slow; Agents for intradermal route include diagnostic determinations, desensitization, and immunization

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Benefits of Oral Drugs

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Less expensive; Patient convenience and comfort; Retrievable, if necessary

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Benefits of Parenteral

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Rapid onset of action; Administrable to nonresponsive patients; administrable directly to site of action; Better absorption

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Requirements for Parenteral Products

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Sterile; Pyrogen Limited; Free from extraneous insoluble materials

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Sterility Definition

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Absence of life or the absolute freedom of living organism

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Aseptic Definition

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Free from contamination caused by harmful bacteria, viruses, or other microorganisms

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Sepsis Definition

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A potentially fatal whole-body inflammation caused by severe infection

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Pyrogen (bacterial endotoxin)

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Substance, typically produced by a bacterium, that produces fever and hypotension when introduced or released into the blood; Might originate from the microbes that get destroyed during sterilization

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Particulate Matters

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Any foreign particles, such as glass, fibers, precipitates and any floating material

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Forms of Parenteral Products

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Solutions; Lyophilized solids; Emulsions; Suspensions

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Official Types of inections

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Injections; For injection; Injectable emulsion; Injectable suspension; For Injectable suspension

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For injectable suspension (official types)

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Dry solid that, upon addition of suitable vehicle, yields preparation conforming in all respects to the requirements for injectable suspension; Due to inherent long term physical instability of suspensions, parenteral suspensions dosage forms are formulated as dry powder

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Injectable Suspensions (official types)

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Liquid preparations of solid suspended in a suitable liquid medium; Used if drug is insoluble or unstable in water

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Injectable Emulsion (Official Types)

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Liquid preparations of drug substances dissolved or dispersed in a suitable emulsion medium; Drugs that are oily or insoluble in an aqueous medium

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For Injection (Official Types)

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Dry Solids that, upon addition of suitable vehicles; Solids include drugs that are not stable in liquid media and are reconstituted with an appropriate vehicle

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Injections (Official Types)

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Liquid Preparations that are drug substances or solutions; The solution is the fastest acting form, good for immediate action

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Components of Parenteral Formulations

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Vehicles; Buffering Agents; Preservatives; Antioxidants; Chelating Agents; Tonicity Agents

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Vehicles Definition

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The medium in which formulation is prepared; Water is most commonly used for parenteral

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Types of Vehicles

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Water for injection; Sterile Water for injection; Bacteriostatic water for injection; Sodium chloride injection; Bacteriostatic Sodium Chloride injection

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Water For injection Vehicle

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Pyrogen free, purified water, contains no more than 1mg/100mL of trace elements; Prepared by distillation or reverse osmosis and should be used within 24 hours; Does not need to be sterilized, but final product must be terminally sterilized

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Sterile Water for Injection

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May contain slightly more than 1mg/100mL of solids because of the leaching of solids from the glass container during sterilization; Stored in single-dose containers not larger than 1 L; Commonly used as a vehicle for dry powder products

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Bacteriostatic water for injection

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Sterile water that contains one or more antimicrobial agents; Packed in prefilled syringes or in vial containing not more than 30mL of water; The container label must state names and proportions perservatives; Not used in large volume injectables due to toxicity; Must be labeled "Not for use in Neonates"

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Sodium Chloride Injections

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Sterile isotonic solution of sodium chloride in water for injection; Often used as a vehicle in preparing parenteral solutions and suspensions; Used as a catheter or IV line flush

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Bacteriostatic Sodium Chloride injection

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Sterile isotonic solution of sodium chloride in water which contains antimicrobial agents; Packed in containers smaller than 30 mL; Often used as a vehicle in preparing parenteral solutions and as catheter or IV flush line

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Types of Isotonic Solutions

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5% dextrose injection; Ringer's Injection

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5% Dextrose injection

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Isotonic with blood and uses as a water source and vehicle

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Ringer's Injection Definition

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Sterile Solution of sodium chloride, potassium chloride, and calcium chloride in water; Used as a vehicle for other drugs or alone as an electrolyte replenisher and plasma volume expander

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Hypotonic Solutions Usage

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Used to dilute excess serum electrolytes as in hyperglycemia; Should monitor patients closely

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Hypertonic Solution Usage

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Used to correct electrolytes imbalance, as in losses from excess vomiting and diarrhea; Monitor patients for fluid overload

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Main reasons for using non-aqueous vehicles

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Limited water solubility of the drug; Susceptibility to hydrolysis

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Water immiscible non-aqueous vehicles

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Fixed oils (corn, sesame, cottonseed, peanut oils); Ethyl oleate; Isopropyl Myristate; Benzyl Benzoate

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Water Miscible non-aqueous vehicles

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Propylene glycol; Glycerol; Ethyl alcohol; Polyethylene glycol

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Requirements for Non-aqueous vehicles

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Non-toxic in the amounts administered; nonirritating; non-sensitizing; it must not exert pharmacological activity

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Considerations for Non-aqueous Vehicles

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Physical and Chemical stability at various pH level; Viscosity; Fluidity; Boiling point; Constant purity or ease of purification

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Fixed-Oils (Non-aqueous vehicles)

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Never be administered IV, mostly IM; USP restricts oils for parenteral use which do not remain clear when cooled; They must not contain mineral oil or paraffin, as these are not absorbed by body tissue; Be labeled by oil, in case of patient allergic reactions

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Co-Solvents (Non-aqueous vehicles)

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Concentration of co-solvent used should be sufficient to render the drug soluble within the formulation but should not be irritant or toxic to the patient; The formulation should not be diluted with water or precipitation may occur

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Antimicrobial Preservatives (USP requirement)

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One or more suitable antimicrobial preservatives must be added to parenteral products that are packaged in multiple dose containers regardless of the method of sterilization unless otherwise directed in the individual monograph or Injection's active ingredients are themselves bacteriostatic

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Contraindications of antimicrobial preservatives

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Neonates; Parenteral products with volume greater than 30 mL

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When is it not necessary to add a preservatives

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The preparation will be used immediately; No water is present; the pH of the medium is either 9

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Properties of the ideal antimicrobial preservatives

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Effective at a low, nontoxic concentration against a wide variety of organisms; Chemically stable under normal conditions of use; Soluble at the required concentration; Compatible with a wide variety of drugs and excipients; nontoxic and non-sensitizing; Free from objectionable odor, taste, color or stinging

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Buffer agents are used to adjust and maintain the ____ if solutions in order to increase ____; ___; and _____

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pH; drug stability; solubility; absorption

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pH above 10 can cause _______, while pH under 3 induces _______

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tissue necrosis; severe pain

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Acceptable range of parenteral products (IV preparations range; and other routes)

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3 to 10.5; 4 to 9

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Commonly used beffers in parenteral products

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Acetate; citrate; Phosphate

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Requirements for Buffering Agents

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Ingredients of buffer to adjust pH must be nontoxic; Agents should be nonirritating at the needed concentration; Agents must be in sterile form or must be rendered sterile

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Antioxidants Definition

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Substances added to dosage forms to protect them from oxidative degradation

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True Antioxidants (examples)

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Have lower oxidation potential than the drugs and are preferentially oxidized (Butylated hydroxyanisole (BHA), Butylated hydroxytoluene (BHT), sodium formaldehyde sulfoxylate (SFS), and Tocopherol)

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Reducing Agents (Antioxidants) (examples)

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Reduced a drug or exipient that has been oxidized (Ascorbic acid, Sodium bisulfate)

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Chelating Agents Definition

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Compounds that can form complexes with metal ions and inactivate their catalytic activity in the oxidative process

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Tonicity Agents (examples and function)

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Dextrose, sodium chloride, or potassium chloride; commonly used to achieve isotonicity in a parenteral formulation

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Methods of sterilization

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Dry heat sterilization; Steam sterilization; filtration; gas sterilization; radiation

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Sterility assured by three processes

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Use of sterile starting materials and process equipment; Use of aseptic techniques in drug product manufacturer; Sterilization of post manufacture, preferably in final sealed containers

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Dry Heat sterilization

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Conducted at 150 to 170 degrees Celsius; Applies to thermostable powders, Fixed oils and glassware

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Disadvantages of Dry Heat sterilization

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Can not be used with materials that heat sensitive; Non-uniform heat distribution; It requires higher temperature and longer exposure time

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Steam Sterilization

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Carried out in an autoclave, which is airtight jacketed chamber designed to maintain a high pressure of saturated hot steam (120 degree Celsius); Applies to materials that can withstand 120 degrees Celsius and are penetrated by moisture

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Advantages of Steam Sterilization

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Microorganisms are destroyed at lower temperatures with moisture; Heat exchange by steam is more rapid than by dry heat

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Disadvantages of Steam Sterilization

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Cannot be used with materials that heat and moisture sensitive and are not penetrated by moisture (oils and fats)

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Filtration (sterilization)

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Depends on the physical removal of microorganisms by absorption on the filter medium or by sieving mechanism; Applies to thermoliable solutions of low viscosity

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Advantages of Filtration

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Simplicity and convenience; Ability to sterilize thermoliable materials

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Disadvantages of Filtration

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Macromolecules such as proteins may be damaged by filtration; Some filters absorb drugs; Time consuming for large volume solution

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Micro-filtration Removes these substances

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Bacteria; fungi; bacteriophages; parasites

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Ultra-filtration Removes these substances

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Viruses

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Nano-filtration Removes these substances

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Organic compounds in the molecular weight range of 300-1000 Da

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Reverse Osmosis Removes these substances

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Virtually all viruses, bacteria, pyrogens, organic molecules, and 90-99% of all ions

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Gas Sterilization

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Accomplished by exposure to gas that kills microorganisms; Applies to thermoliable powders, instruments, plastic syringes, needles, catheters

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Advantages of Gas Sterilization

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Ability to sterilize thermoliable and moisture-sensitive materials

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Disadvantages of Gas Sterilization

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Some drugs lose potency

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Radiation Sterilization

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Accomplished by IV light or high-energy ionizing radiation such as gamma rays; Applies to thermoliable drugs such as penicillin, streptomycin, thiamine, riboflavin

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Disadvantages of Radiation Sterilization

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Highly specialized equipment required; Some materials sensitive to irradiation

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Parenteral Dosage Form Types

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Large Volume Parenteral; Small volume parenteral

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Large Volume Parenteral

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Single-dose injection that is intended for intravenous use and is packaged in containers labeled as containing more than 100 mL

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Small Volume Parenteral

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Onjection packaged in containers labeled as containing 100mL or less

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Advantages of Plastic bag Large volume Parenteral

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Do not break; Weigh less; Take up less storage space

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Disadvantages of Plastic Bag Large volume parenteral

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Some drugs adsorb to the plastic; Some solutions leach a plasticizer out the plastic

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Advantages of Glass Bottle Large Volume Parenteral

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Administer drugs that are incompatible with plastic bags

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Large Volume Parenteral Uses

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Maintenance Therapy(Used for fluid and electrolyte balance); Replacement Therapy (Used for replacements of fluid and electrolytes); Drug Vehicle (administering other drugs)

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Admixtures

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The preparations of intravenous admixture involves the addition of one or more drugs to large volume sterile fluids such as sodium chloride injection, dextrose injection, and TPN fluid

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Drug incompatibilities Definition

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Refers to interactions between two or more substances which lead to changes in chemical, physical, therapeutic properties of the pharmaceutical dosage form

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Physical Incompatibility

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Interaction between two or more substances which lead to change in solubility, precipitation, color, odor, viscosity, and morphology

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Causes of Physical Incompatibility

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pH effect; Dilution of mixed solvent systems; Cation-anion interactions

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Cation-anion Interactions

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Precipitation is likely when oppositely charged, organic drug ions that contain aromatic rings are combined in relatively strong concentration

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Chemical Incompatibility Definition

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Decomposition of drug substance resulting from combination of parenteral dosage forms

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