C-15 parenterals

A. Uy | Page 1 of 14

Chapter 15: Parenterals

Parenteral

The term parenteral derived from the Greek words:

para (outside) and enteron, (intestine)

denotes routes of administration other than oral route

refers to the injectable routes administration

sterile

Parenteral Injections

pyrogen free preparations

intended to be administered parenterally.

Based on the route of administration, sterile products are

classified into:

1. Parenteral preparations

2. Ophthalmic preparations - for the eye

3. Otic preparations - for the ear

4. Nasal preparations - for the nose & throat

5. Irrigating solutions - for washing wounds or abraded

mucous membrane

Parenteral Routes of Administration

1. Intra-articular – joints

2. Intraspinal – spinal column

3. Intra-arterial – arteries

4. Intravenous – veins

5. Intradermal – shin

6. Intrasynovial – joint fluid

7. Intrathecal – spinal fluid

8. Intracardiac – heart

9. Intramuscular – muscles

10. Subcutaneous – under the skin

Parenterals are administered by:

Physician

Physician’s assistant

Nurse

Parenterals are administered at:

Hospitals

Clinics

Extended care facilities

Antirheumatic injectables

Brand Name: Enbrel

Generic name: Etanercept

Manufacture: Immunex

Form: Injectable

Recommended initial dose: 25mg (1 vial) twice a week injected

subcutaneously

Botulinum toxin

Brand name: Botox

Generic name: Clostridium botulinum ( type A neurotoxin

complex)

Form: Powder for solution for injection

Botulinum toxin

Brand name: Myobloc

Generic name: Botulinum toxin Type B

Form: Injection, solution [single-dose vial]: 5000 units/mL (0.5 mL, 1

mL, 2 mL) [contains albumin 0.05%]

Intravenous Route (IV)

Advantage:

May be a life-saving procedure because of the

placement of the drug directly into the circulation

and the prompt actions which ensues.

Disadvantage:

Once the drug administered, it cannot be

retrieved.

In the case of adverse reaction to the drug, for

instance, the drug cannot be easily removed from

the circulation.

Precautions:

Strict aseptic precautions must be taken at all

times to avoid risk of infection.

The syringes and needles used must be sterilized

and to the point of entrance must be disinfected

to reduce chance of carrying bacteria from the

skin into the blood via the needle

Flow Rates:

Generally, the flow rates of IV are expressed in

mL/hour,

Range from 42 to 150 mL/hour.

Lower rates are used for keep-open (KO, KVO)

Great care must be taken to prevent overdosing

or underdosing.

Example:

Metoprolol (beta blocker)

– 3 bolus injections of 5 mg each at about

2 minute intervals

– oral dosing (100 mg/day)

NOTE:

Not only are the injectable solutions sterile,

syringes, needles must also be disinfected to

reduce the chance of carrying bacteria


A backflow of blood into the administration set or

syringe indicates proper placement of the needle

in the vein

Intravenous drugs ordinarily must be aqueous

solution

They must mix with the circulating blood and not

precipitate from solution. Such an event can lead

to pulmonary micropillary occlusion and blockage

of blood flow.

Intravenous fat emulsions

Intralipid, 10,20,30%

Clintec

Liposyn 11,10, 20%

Abott Liposyn 111, 10,20,30%

as a source of calories and essential fatty acids for

patients requiring parenteral nutrition for extended

period, usually more than 5 days.

The product contains up to: 30% soybean oil

emulsified with eggyolk phospholipids in a vehicle

of glycerin in water injection

Different lengths of needles

Hazard of Intravenous Injection

The possibility of thrombus formation

– induced by the touching of the wall of the

vein by the catheter or needle.

Thrombus

– is a blood clot formed within the blood vessel

(or heart) due usually to a slowing of the

circulation or to an alteration of the blood or

vessel wall.

Once such a blot circulates, it becomes an Embolus

– carried by the blood stream until it lodges in a

blood vessel, obstructing it, and resulting in

blockage or occlusion referred to as an

Embolism.

Example: Automated IV delivery system - Self administration

analgesics

Advantages:

1. Patient Controlled Analgesia (PCA) used to control

pain

2. Allows greater degree of ambulation and

independence

3. Typical PCA contains analgesic drug, syringe and

programmable electromechanical unit, which might

be compact enough to be worn on a belt or carried in

a pocket

Example: WalkMed PCA

4. Ability to provide constant and uniform analgesia

5. Can prevent pharmacokinetics and

pharmacodynamic differences between patients from

interfering with the effectiveness of analgesia

6. Also permits patients to medicate themselves when

there is breakthrough pain

7. Minimizes various side effects

8. PCA devices can be used for IV, SC or epidural

administration

9. These devices are either, demand dosing (fixed dose of

drug is injected intermittently) or constant-rate infusion

plus demand dosing

Intramuscular (IM)

Intramuscular injections of drugs provide effects that

are less rapid, but generally of greater duration than

those obtained from intravenous administration

IM are performed deep into the skeletal muscles.

The point of injection should be as far as possible from

major nerves and blood vessels.

Injuries to patients from IM injection usually are related

to the point at which the needle entered and where

the medication was deposited.

Such injuries include:

1. Paralysis resulting from neural damage

2. Abscesses

3. Cysts

4. Embolism

5. Hematoma

6. Sloughing of the skin

7. Scar formation

Adult – upper outer quadrant of the gluteus

maximus

Infants– gluteal area is small, composed

primarily fats not muscle, so not

recommended

Infants and Young children – deltoid, muscles

of the upper arm or the midlateral muscles of

the thigh

Volume of Administration:

limited :

– 5 mL in the gluteal region

– 2 mL in the deltoid of the arm

Injection is 2 to 3 inches deep

20 to 22 gauge needle.

To avoid staining: it must be injected only into

the muscle mass of the upper outer quadrant

of the buttock.

The skin is displaced laterally, then needle inserted and

syringe aspirated, and injection performed slowly &

smoothly. The needle is then withdrawn and the skin

release. This creates a “Z” pattern that blocks

infiltration of medication into subcutaneous tissue.

The Z-Track Injection technique is useful for IM injections

of medications that stain upper tissue.

Examples:

Iron dextran injection –irritate tissues

Diazepam (Valium) – by sealing in the lower

muscle

Subcutaneous Route (SC)


May be utilized for

the injection of small amounts of medication

or

of drugs beneath the surface of the skin of the

1. upper arm

2. the anterior surface of the thigh, and the

3. lower portion of the abdomen.

The site of injection is usually rotated when injections

are frequently given, as with daily insulin injection.

The maximum amount of drug given SC is about 1.3 mL

Amounts greater than 2 mL will most likely cause painful

pressure

Syringes: up to 3 mL capacities

Utilizing needles: 24 to 26 gauges

SC insulin needles:

gauge between 25 to 30

needle length between 5-16 to 5-8 inch.

Upon insertion, if blood appears in the syringe, a new

site should be selected.

Irritating drugs and those in thick suspension may

produce

induration, sloughing, or abscess and may be

painful. Such preparations are not suitable for

subcutaneous injection

Intradermal Route

Substances may be effectively injected into the corium,

the more vascular layer of the skin just beneath the

epidermis.

These substances include:

diagnostic determinations, desensitization, or

immunization.

Usual site: anterior surface of the forearm.

Needle:

A short (3-8 inch) and narrow gauge (23 to

26).

is inserted horizontally into the skin with the

bevel facing upward. The injection is made

when the bevel just disappears into the

corium.

Volume: Usually about 0.1 mL

Specialized Access

Devices that provide continued access and reduce

pain associated with administration (Repeated

injections over time)

Several catheters of central venous are used for a

variety of parenteral medications.

Example: cancer chemotherapy, long term antibiotic,

therapy,TPN solutions

The use of indwelling plastic catheters reduces the

need for multiple punctures during intravenous therapy.

Composed of

polyvinyl chloride

Teflon

Polyethylene

these should be radiopaque to ensure that they are

visible on radiographs.

Usually, these must be removed within 48 hours after

insertion.

The choice of catheter depends on several factors

1. Length of time of the infusion

2. Purpose of the infusion

3. Condition and availability of the veins

Types of Catheter

1. Plain plastic

2. Catheter over needle or outside needle

3. Catheter inside needle

Official Types of Injections

1. Drug Injection

Liquid preparations that are drug

substances or solutions thereof

Ex.: Insulin Injection, USP

2. Drug for Injection

Dry solids that, upon the addition of

suitable vehicles, yield solutions

conforming in all respects to the

requirement for Injections

Ex.: Cefamandole Sodium for Injection

3. Drug Injectable Emulsion

Liquid preparations of drug substances

dissolved or dispersed in a suitable

emulsion medium

Ex.: Propofol

4. Drug Injectable Suspension

Liquid preparations of solids suspended in

a suitable liquid medium

Ex.: Methylprednisolone Acetate

Suspension

5. Drug Injectable Suspension

Dry solids that, upon the preparations

conforming in all respects to the

requirements for Injectable Suspensions

Ex.: Imipenem, Cilastatin for Injection

Suspension, USP

a. INSULIN INJECTION, USP

b. PROPOFOL

c. METHYLPREDNISOLONE ACETATE

SUSPENSION

Injections

Generally, if a drug is unstable in solution, it may be

prepared as a dry powder intended for reconstitution

with the proper solvent at the time of administration

If the drug is unstable in water, the solvent may be

replaced in part or totally by a solvent in which the

drug is insoluble

If the drug is insoluble in water, an injection may be

prepared as an aqueous suspension or as solution in a

suitable nonaqueous solvent, such as a vegetable oil

If an aqueous solution is desired, a water soluble salt

form of the insoluble drug is frequently prepared

Aqueous or blood miscible solutions may be injected

directly into the blood stream

Blood immiscible liquids, such asoleaginous injections

and suspensions can interrupt the normal flow of blood,

and their use is generally restricted to other than

intravenous administration

Often times long action is desired to reduce the

frequency of injections.


These long acting injections are called respiratory or

depot preparations

Following differences with other preparations

1. Solvents or vehicles used must meet special

purity and other standards assuring their safety

by injection

2. The use of added substances, as buffers,

stabilizers, and antimicrobial preservatives, fall

under specific guidelines of use and are

restricted in certain parenteral products. The

use coloring agents is strictly prohibited.

3. Parenteral products are always sterilized and

meet sterility standards and must be pyrogen

free.

4. Parenteral solutions must meet compendial

standard for particulate matter.

5. Parenteral products are packaged in special

hermetic containers of specific and highly

quality.

6. Each container of an injection is filled to a

volume in slight excess of the labeled “size” or

volume to be withdrawn. This overfill permits

the ease of withdrawal and administration of

the labeled volumes

7. Parenteral products must be prepared in

environmentally controlled areas, under strict

sanitation standards, and by personnel

especially trained and clothed to maintain

the sanitation standards.

8. There are restrictions over the volume of

injection permitted in multiple-dose containers

and also a limitation over the types of

containers (single-dose or multiple- dose)

which may be used for certain Injections.

9. Specific powders intended for solution or

suspension immediately prior to injection are

frequently packaged as lyophilized or freeze-

dried powders to permit ease of solution or

suspension upon the addition of the solvent or

vehicle.

Solvents and Vehicles for Injections

1. Water for Injection, USP

This water is purified by distillation or

by reverse osmosis.

Water for Injection is not required to

be sterilized, it must be pyrogen free.

2. Purified water, USP

may not contain other substances

meets standard for the presence of

total solids

3. Sterile Water for Injection, USP

is water for injection which has been

sterilized and packaged in single-

dose containers of not greater than

IL size

as water for Injection, it must be

pyrogen free and may not contain

an anti-microbial agent or other

added substance.

4. Bacteriostatic Water for Injection, USP

is sterile water for injection

containing one or more suitable anti-

microbial agents.

it is packaged in pre-filled syringes or

in vials containing not more than 30

mL of the water. Label must state,

“Not for Use in Newborns”.

Ex.: benzyl alcohol - not good for

neonates and the toxicity of the

bacteriostat.

5. Sodium Chloride Injection, USP

a sterile isotonic solution of sodium

chloride in Water for Injection.

It contains no antimicrobial agents

6. Bacteriostatic Sodium Chloride Injection

is a sterile isotonic solution of sodium

chloride in Water for Injection. It

contains one or more suitable

antimicrobial agents which must be

specified in the label.

Sodium chloride concentration is

0.9% to render isotonic solution. It is

also used to flush a catheter or IV

line to maintain its patency.. “Not for

Use in Newborns”.

7. Ringer’s Injection, USP

is a sterile solution of sodium chloride,

potassium chloride, and calcium

chloride in water for injection.

It is used as electrolyte replenisher

and a systemic alkalizer.

Lactated R = Na lactate

Characteristics Of Components used in Compounding

1. Therapeutically effective when used as the active

ingredients

2. Provide maximum safety

3. Function efficiently (when used as excipient)

4. Free from contamination

5. Physically and chemically stable even after thermal

sterilization

6. Produce little or no tissue irritation at site of

administration

Nonaqueous Vehicles Selected Vehicles must be:

1. Nonirritating

2. Non toxic in the amounts administered

3. Nonsensitizing

4. It must not exert a pharmacologic activity

5. May not adversely affect the activity of the medicinal

agent

Other Considerations Of Selecting Nonaqueous Solvents

1. Physical and chemical stability

2. Its viscosity (syringeability) and its fluidity

3. Its boiling point (it should be high to permit heat

sterilization)

4. Its miscibility with body fluids

5. Its low vapor pressure to avoid problems during heat

sterilization


6. Constant purity or ease of purification &

standardization

Examples of Nonaqueous Solvents

1. Fixed vegetable oils

2. Glycerin

3. Polyethylene glycols

4. Propylene glycol

5. Ethyl oleate

6. Isopropyl myristate

7. Methylacetamide

8. Alcohol

Nonaqueous Vehicles…

Examples of Fixed Oils Commonly Used in Injections

1. Corn Oil

2. Cottonseed seed Oil

3. Peanut Oil

4. Sesame Oil

5. Castor Oil and Olive Oil (occasion)

SOLVENTS AND VEHICLE FOR INJECTIONS

Water for Injection

solvent

purified by distillation or by reverse osmosis

stored in tight container with temperature below or

above the range of microbial growth

must be pyrogen free

Added Substances

Additives are essential for almost every product to

enhance its stability. They must exhibit the following

characteristics:

1. Perform its function throughout the useful life of

the product

2. Must be non-toxic and non-irritating

3. Must not exert any adverse effect on the product

4. Must be compatible in all components of the

formulation

5. Must not interfere with:

a. Therapeutic efficacy

b. Assay of the active therapeutic

compound

Such substances include:

1. Solubilizers

2. Chelating agents

3. Anti-microbial agents

4. Hydrolysis Inhibitors

5. Antioxidants

6. Buffers

7. Tonicity contributors

8. Antifoaming agents

Antifungal/Antibacterial

must be present in adequate concentration at the time

of use to prevent the multiplication of microorganism.

Ex.: agents containing mercury and the cationic,

surface active compounds - 0.01%; for agents like

chlorobutanol, cresol, and phenol - 0.5%

Antioxidants

Oxidation is one of the pathways of degradation which

can be accelerated during thermal sterilization.

To protect a therapeutic agent susceptible to this

reaction, antioxidants are required.

Ex.: Sulfur dioxide - 0.2%

Classification of Antioxidants used in Sterile products:

1. Reducing agents - antioxidants which functions

by being preferentially oxidized

Ex.: ascorbic acid, sodium bisulfate,

metabisulfite, thiourea, sodium formaldehyde,

sulfoxylate

2. Blocking agents - antioxidants which block an

oxidative chain reaction in which they are not

usually consumed

Ex.: ascorbic acid esters, butyl hydroxytoluene

(BHT), tocopherols

3. Synergists - compounds increase the

effectiveness of antioxidants, particularly those

blocking oxidative reactions

Ex.: ascorbic acid, citraconic acid,

phosphoric acid, citric acid, tartaric acid

4. Chelating agents - those that complex with

catalysts which otherwise would accelerate the

oxidative reaction

Ex.: ethylenediaminetetraacetic acid salts

5. Inert gases like nitrogen and carbon dioxide

have been used to displace oxygen from a

solution and reduce the possibility of oxidative

changes in the formulation

Buffers

added to maintain the required pH for many products;

a change in pH may cause significant alterations in the

rate of degradation reactions.

Changes in pH may occur during storage as a result of:

1. Dissolving of glass constituents in the product

2. Release of constituents from rubber closures or

plastic components in contact with the product

3. Dissolving of gases and vapors from the air

space in the container or by diffusion through

the rubber or plastic component.

4. Reactions within the product

The principal buffer systems used to stabilize pH are the

1. Acetates

2. Citrates

3. Phosphates

Tonicity Contributors

Compounds contributing to the isotonicity of a

product reduce the pain of injection in areas

with nerve endings

Buffers may serve as tonicity contributors as well

as as stabilizers for the___?___

Containers

Containers for sterile products are made of glass or

plastic.

Glass is still preferred for injectable products.

Glass is composed principally of the:

silicon dioxide tetrahedron


modified physicochemically by such oxides as

those of sodium, potassium, calcium,

magnesium, aluminum, boron and iron.

Two general types of glass

1. soda-lime

2. borosilicate

Based on its chemical resistance, glass compounds are

classified into 4 types:

1. Type I - highly resistant borosilicate glass

2. Type II - treated soda-lime glass

3. Type III - soda lime glass

4. NP (nonparenteral) - general purpose soda-

lime glass

***Glass containers like ampule cartridges and vials

may be manufactured from glass tubings or blow

molding.

Rubber closures are used to seal the openings of

catridges, vials and bottles, providing a material soft

and elastic enough to permit entry and withdrawal of a

hypodermic needle without loss of the integrity of the

sealed container. Accessories used in conjunction with

closures are aluminum caps with or without flif-off seals.

Examples of Some Injections in Oil

METHODS OF STERILIZATION

Sterilization

defined as the complete destruction or elimination of

microbial life

The choice of the most effective sterilization procedure

is dependent on:

1. Compatibility of the process with the

preparation; (sterilization process must not have

significant adverse effect upon the preparation)

2. The successful validation of the process (the

parameters must prove to be lethal to the most

resistant spores of microorganism normally

encountered)

5 general methods:

1. Steam distillation

2. Dry-heat sterilization

3. Sterilization by filtration

4. Gas sterilization

5. Sterilization by ionizing radiation

2 MAIN DIVISIONS OF STERILIZATION

1. Physical Processes of Sterilization

A. Thermal Method

i. Microorganisms are killed by heat

by what is thought to be

coagulation of the protein of a

living cell. The lethal

effectiveness of heat is

dependent on:

The degree of heat

The exposure period

The moisture present

ii. Steam sterilization is conducted

in an autoclave and employs

steam under pressure

iii. The usual steam pressures, the

temperatures obtainable under

these pressures, and the

approximate length of time

required after the system reaches

the indicated temperatures are

as follows:

10 pounds pressure

(115.50C), for 30 min.

15 pounds pressure

(121.50C), for 20 min.

20 pounds pressure

(126.50C), for 15 min.

iv. Dry-Heat Sterilization usually

carried out in sterilizing ovens

specifically designed for this

purpose. The ovens may be

heated either gas or electricity

and generally thermostatically

controlled. It is conducted at

temperatures of 1600C to 1700C

for periods not less than 2 hours.

B. Nonthermal Methods

i. Ultraviolet light

- is commonly employed to aid in the

reduction of airborne contamination and

to attempt to sterilize surfaces within the

processing environment. The germicidal

light produced by mercury vapor lamps is

emitted at a wavelength of 2537

Angstrom units (253.7 millimicrons)

- The lethal mechanism of UV light works

when this energy is absorbed by orbital

electrons within the molecules of the

microorganisms or of their essential

metabolites causing excitation and

alteration of activity. Thus the organism

dies or is unable to reproduce.

ii. Ionizing Radiations - are highly

radiations emitted from

radioactive isotopes such as

cobalt-60 (gamma rays) or

produced by mechanical

acceleration of electrons to very

high velocities and energies

(cathode rays, beta rays).

Ionizing radiations destroy


microorganisms by stopping

reproduction as a result of lethal

mutations.

iii. Filtration

- This is a nonthermal method for the

sterilization of select solutions by

removing microorganisms from the

solution while permitting the passage of

all the desired components of the

solution and imparting no undesirable

components from the filter.

- They are available in pore sizes from 14 to

0.025 um.

- The size of the smallest particle visible to

the naked eye is about 40 um, a red

blood cell is about 6.5 um, the smallest

bacteria, about 0.2 um, and a polio virus,

about 0.025 um

2. Chemical Processes of Sterilization

A. Gas Sterilization

– Ethylene oxide believed to exert

its lethal effect upon

microorganisms by alkylating

essential metabolites, affecting

particularly the reproductive

process. Ethylene dioxide

sterilization is the acceptable

practical method for sterilizing

plastic. Other gases used are

beta propiolactone,

formaldehyde & sulfur dioxide

B. Surface Disinfection

– Disinfectants do not sterilize a

surface. However, as adjuncts

to thoroughly cleaning of

surfaces, disinfectants properly

used may be expected to

provide an aseptic condition of

the surfaces involved

Validation of Sterility

Regardless of the method of sterilization employed,

Pharmacutical preparations must undergo sterility tests

to confirm the absence of microorganisms.

A biologic indicator is characterized preparation of

specific microorganisms resistant to a particular

sterilization process

2 main forms

1. Spores are added to a carrier, as a strip of filter paper,

packaged to maintain physical integrity while allowing the

sterilization effect.

2. The spores are added to representative units of the product

being sterilized, with sterilization assessed based on these

samples

In moist heat (steam) - Bacillus stearothermophilus

In dry heat - Bacillus subtilis

In ionizing radiation - Bacillus pumilus, stearothermophilus, subtilis

Pyrogens and Pyrogen Testing

Pyrogens are fever producing organic substances

arising from microbial contamination and responsible

for many of the febrile reactions which occur in

patients following injections.

Are lipid substances associated with a carrier molecule

which is usually a polysaccharide but may be a protein.

2 Official Tests for Detecting and Measuring Pyrogens

1. Bacterial Endotoxins Test

– Using Limulus Amebocyte Lysate (LAL) which

has been obtained from aqueous extracts of

the circulating amebocytes of the horseshoe

crab, Limulus polyphemus, and which has

been prepared & characterized for use as an

LAL reagent for gel-clot formation

– The procedure include incubation for a

preselected time of reacting endotoxins and

control solutions with LAL Reagent and

reading of the spectrophotometer light

absorbance at suitable wavelength

2. Pyrogen Test

– The test involves measuring the rise in

temperature of rabbits following the

intravenous injection of a test solution and is

designed for products that can be tolerated

by the test rabbit in a dose not to exceed 10

mL per Kg injected intravenously within a

period of not more than 10 minutes

– If no rabbit shows an individual rise in

temperature 0.60C or more above its

respective control temperature, and if the

sum of the 3 individual maximum temperature

rises does not exceed 1.400 C, the product

meets the requirements for the absence of

pyrogens.

Depyrogenation Method are as follows:

1. Adequate washing with detergent treatment followed

by dry heat sterilization is recommended for glasswares

and equipment. Optimum temperature is 2500C for 45

minutes.

2. Distillation is the most reliable method of eliminating

pyrogens from water. Pyrogenic substances are not

volatile and thus will remain in the distilland.

3. Removal of pyrogens by select adsorbents has limited

use because of the concurrent phenomenon of

adsorption of solute ions of molecules. It is of interest in

the production of antibiotics where heavy pyrogen

contamination results from fermentation.

PRODUCTION of a sterile preparation

consists of the following steps:

1. Compounding

- Processing of sterile preparations follow

normal manufacturing procedures which

must be done in aseptic condition. All

equipment and materials used whenever

possible must be sterile

2. Filtration

- Membrane filters are used for clarification

when a highly polished solution is desired.

The process removes particulates matter

down to at least 3 microns in size.

Sterilization by filtration is achieved when


viable microorganisms and spores of

approximately 0.3 microns are removed.

Membranes with porosity ratings of 0.22

or 0.45 microns are usually specified for

sterile filtration.

3. Filling

- Bulk preparations are subdivided into unit

dose containers during filling. This process

forces a measured volume of the

preparation through the orifices of a

delivery tube designed to enter the

constricted opening of a container by

means of gravity, vacuum or with the aid

of a pressure pump.

4. Sealing

- Sealing will retain the contents of a sterile

product and will assure a tamper-proof

presentation

5. Sterilization

Containers

should be sealed in an aseptic area adjacent to the

filling machine. Ampuls are sealed by heating with a

high temperature gas-oxygen flame to form

1. Tip-seals: those made by melting sufficient

glass at the tip of the ampul neck to form a

bead of glass and close the opening

2. Pull-seals: those made by heating the neck of

a rotating ampul below the lip, then pulling

away the tip to form a small, twisted capillary

just prior to being melted closed.

A leakers test

is a useful method for evaluating the efficiency of the

sealing process.

the test consists of immersing completely the sterile

sealed ampuls in an aqueous dye bath (0.5 to 1.0% of

methylene blue) within a vacuum chamber.

ss negative pressure of 27 inches Hg or more is created,

a tiny drop of dye solution can penetrate an opening

of an incompletely sealed ampul.

the colored ampuls are sorted out during washing and

100% inspection that follows after.

Examples of Sterile Drugs prepared and packaged without the

presence of phamaceutical additives as buffers, preservatives,

stabilizers, tonicity agents, and other substances

1. Sterile Ampicillin Sodium

2. Sterile Ceftazidime Sodium

3. Sterile Kanamycin Sulfate

4. Sterile Penicillin G Banzathine

5. Sterile Tobramycin Sulfate

6. Sterile Ceftizoxime Sodium

7. Sterile Cefuroxime Sodium

8. Sterile Nafcillin Sodium

9. Sterile Streptomycin Sulfate

Examples of Sterile Drugs prepared and packaged with the

presence of phamaceutical additives as buffers, preservatives,

stabilizers, tonicity agents, and other substances

1. Cephradine for Injection

2. Dactinomycin for Injection

3. Erythromycin Lactobionate for Injection

4. Oxytetracycline Hydrochloride Injection

5. Nafcillin Sodium for Injection

6. Hydrocortisone Sodium Succinate for Injection

7. Cyclophosphamide for Injection

8. Hyaluronidase for Injection

9. Mitomycin for Injection

10. Penicillin G Potassium for Injection

11. Vinblastine Sulfate for Injection

Containers…

1. Mix-O-Vial - that incorporates the cover as part of the

plunger. Once mixed, the small circle of plastic that

covers the injection site is removed. This reduces the

touch contamination

2. Add-Vantage System IVPH - is other example of ready-

to-mix sterile IV product designed for intermittent IV

administration of potent drugs that do not have long

term stability in solution. Two components:

a. A flexible plastic IV container partially filled

with diluents

b. Glass vial of powdered or liquid drug

The vials containing the medication and the

piggybacks (50-250 mL of Dextrose 5% in Water

Injection) or Normal Saline Solution are specially

designed to be used together.

The ADD-Vantage System can be used within 30

days from the date that the diluent container was

removed from the overwrap.

3. Monovial Safety Guard

- This is new system integrated device

(drug transfer mechanism) with a

protective shield surrounding the

attached transfer needle. The

reconstitution and transfer of the drug

into an infusion bag is accomplished

safely, quickly, and necessitates fewer

materials. The needle is inserted into the

port of the infusion bag and then the

transfer set is pushed down toward the

vial until a “Click” is heard. With Monovial

upright, the infusion bag is squeeze

several times to transfer liquid into the

Monovial. The Monovial is then shaken to

reconstitute the drug. It is then inverted,

the minibag is squeezed and release to

transfer the drug back into the infusion

bag. This process is repeated until the

vial is empty

- Packaging, Labeling, and Storage of

Injections - Containers for injections,

including closures, must not interact

physically and chemically with the

preparation

- Single-dose container - A single dose

container is a hermetic container holding

a quantity of sterile drug intended for

parenteral administration as a single

dose, and which when opened cannot

be re-sealed with assurance that sterility

has been maintained.


- Multiple-dose container - A multiple-dose

container is a hermetic container that

permits withdrawal of successive portions

of thecontents without changing the

strengths, quality, or purity of the

remaining portion.

- Note: Recall type I,II,III containers

The Labels on containers of parenteral products must state:

1. The name of the preparation

2. For liquid preparation, the percentage content of the

drug or amount of the drug; for dry preparation - the

amount of the active ingredient present and the

volume of liquid to be added to the dry preparation to

prepare a solution or suspensions.

3. The route of administration

4. Statement of storage conditions and expiration

5. The name of the manufacturer and distributor

6. The identifying lot number

General Precautions required with the use of microwave ovens

for thawing frozen premixed products include

1. Being aware that the possibility of radiation leakage

does exist. However, manufacturers of microwave

ovens are required by law to comply with federal

standards

2. Safeguarding pharmacy personnel who are exposed to

these ovens, especially those with cardiac

pacemakers.

3. The possible leaching of rubbers material when the

rubber material on the container is exposed to

microwave heating.

4. A possible explosion that may result from the increase in

internal pressure as a result of placing a closed or

sealed container into the microwave oven.

5. Developing protocols to ensure that the final solution

temperature does not exceed room temperature

Examples of some Injections Usually Package and Administered

in Small Volume

1. Butorphanol Tartrate Injection - Narcotic Agonist-

Antagonist Analgesic

2. Chlorpromazine HCl Injection - Antipsychotic drug with

antiemtic

3. Cimetidine HCl Injection - Histamine H2 antagonist

4. Dalteparin Sodium Injection- Prophylaxis against deep

vein thrombosis

5. Dexamethasone Sodium Phosphate Injection -

Glucocorticoids

6. Digoxin Injection – Cardiotonic

7. Dihydroergotamine Mesylate Injection - Alpha-

adrenergic blocking agent

8. Diphenhydramine HCl Injection - An ethanolamine, non

selective antihistamine

9. Furosemide Injection - Loop diuretic

10. Granisetron HCl Injection - Prevention of nausea &

vomiting

11. Heparin Sodium Injection - Anticoagulant (IV or SubQ)

12. Hydromorphone HCl Injection - Narcotic analgesic

13. Ibutilide Fumarate Injection - An antiarrhythmic drug

14. Iron Dextran Injection- Hematinic agent

15. Isoproterenol HCl Injection - Adrenergic

(bronchodilator)

16. Ketorolac Tromethamine Injection - NSAID

17. Lidocaine HCl Injection - Cardiac depressant as an

antiarrhythmic

18. Magnesium Sulfate Injection -

Anticonvulsant/Electrolyte

19. Meperidine HCl Injection - Narcotic analgesic

20. Metoclopramide Monohydrochloride Injection-

Gastrointestinal stimulant

21. Midazolam HCl - Short acting benzodiazepine CNS

depressant

22. Morphine Sulfate injection - Narcotic analgesic

23. Naloxone HCl Injection - Narcotic antagonist

24. Nalbuphine HCl Injection - Narcotic Agonist-Antagonist

Analgesic

25. Oxytocin Injection- Oxytoxic

26. Phenytoin Sodium Injection - Anticonvulsant

27. Phytonadione Injection - Vitamin K (prothrombogenic)

28. Procaine Penicillin G Injection - Anti-infective

29. Prochlorperazine Edisylate Injection - Antidopaminergic

30. Propranolol HCl Injection - Beta adrenergic receptor

blocking agent

31. Sodium Bicarbonate Injection- Electrolyte

32. Sumatriptan Succinate injection - treat acute migraine

attacks

33. Verapamil HCl Injection - Calcium channel blocking

agent

INSULIN

1. Insulin Injection (regular)

Insulin Injection is a sterile aqueous solution of

insulin. It is prepared from beef or pork pancreas

or both or through biosynthetic means (Human

Insulin). With apH of 2.8 to 3.5. Insulin Injection is

prepared to contain 100 or 500 USP Insulin Units in

each mL.

Expiration: Not to be later than 24 months

after the date of distribution.

Preservative: Glycerin (1.4 to 1.8) for stability,

Phenol or Cresol (0.1 to 0.25%)

Storage: Cold place, preferably the

refrigerator

2. Human Insulin

It is produced by utilizing a special nondisease-

forming laboratory strain of Escherichia coli and

recombinant DNA technology.

Two formulations:

A. Neutral Regular Human Insulin (Humulin R) -

consists of Zinc-insulin crystals in solution. It has

a rapid onset of action and relatively short

duration of action (6 to 8 hours)

B. NPH Human Insulin (Humulin N) - is a turbid

preparation that is intermediate acting, with a

slower onset of action and longer duration of

action (slightly less than 24 hours) than regular

insulin

3. Lispro Insulin Solution

Insulin solution consists of Zinc-insulin lispro

crystals dissolved in a clear aqueous fluid. It is

created when the amino acids at positions 28

and 29 on the Insulin B-chain are reversed


Compared to regular insulin, however, peak

serum levels of lispro insulin occur earlier,

(within 0.5 to 1.5 hours) are higher, and are

shorter acting ( 6 to 8 hours)

Lispro insulin are administered fifteen minutes

before meals has decreased the risk of

hypoglycemic episodes and improve

postprandial glucose excursions when

compared to conventional regular insulin.

Storage: Refrigerator; room temperature - 28

days

Note: If accidentally frozen, it should not be

used

4. Isophane Insulin Suspension (NPH Insulin)

Is a sterile suspension, in an aqueous vehicle

buffered with dibasic sodium phosphate to

between pH 7.1 and 7.4, of insulin prepared

from zinc-insulin crystals modified by the

addition of protamine so that the solid phase

of the suspension consists of crystals

composed of insulin, zinc, and protamine.

Protamine is prepared from the sperm or the

mature testes of fish belonging to the genus

Oncorhynchus.

Expiration date: 24 months

Dosage: dosage range subcutaneously is 10

to 80 USP Units

NPH used in some product names stands for

“Neutral Protamine Hagedorn”; the pH is 7.2

and developed by Hagedorn. The term

“isophane” is based on the Greek: iso and

phane, meaning “equal” and “appearance”

and refers to equivalent balance between

the protamine and insulin.

5. Isophane Insulin Suspension and Insulin Injection

A premixed formulation of of isophane insulin

suspension and Insulin injection.

2 Formulations:

A. Humulin 70/30 - combination that

consists of 70% isophane insulin

suspension and 30% insulin injection

B. Humulin 50/50 - combination that

consists of 50% isophane insulin

suspension and 50% insulin injection

They contain zinc of 0.01 to 0.04 mg/100 units.

Neutral in pH and phosphate buffered

Preservatives: m-cresol and phenol

6. Insulin Zinc Suspension

modified by the addition of zinc chloride so

that the suspended particles consists of a

mixture of crystalline and amorphous insulin

in a ratio of approximately 7 parts of crystals

to 3 parts of amorphous material.

Buffered to pH 7.2 to 7.5 with sodium acetate:

0.7% sodium chloride for tonicity; 0.10%

methylparaben as preservatives

Expiration: 24 months after the immediate

container was filled.

Storage: Refrigerator with freezing being

avoided

7. Extended Insulin Zinc Suspension

Is a sterile suspension of zinc insulin crystals in

an aqueous medium buffered to between pH

7.2 and 7.5 with sodium acetate.

Present also are 0.7% sodium chloride for

tonicity & 0.1% methylparaben as

preservatives

Dosage: The usual dosage range is 10 to 80

USP Units

Expiration: 24 months after the immediate

container was filled

8. Prompt Insulin Zinc Suspension

The sterile suspension of insulin in Prompt Insulin

Zinc Suspension is modified by the addition of

Zinc chloride so that the solid phase of the

suspension is amorphous

The suspension is available in 100 USP Insulin

Units per mL in vials of 10 mL

Expiration: not more 24 months

9. Insulin Infusion Pumps

Insulin infusion pumps allow the patients to

achieve and maintain blood glucose at near-

normal levels on a constant basis.

The main objective of pump therapy is the

strict control of the blood glucose level

between 70 to 140 mg/dL

These systems utilize microcomputers to

regulate the flow of insulin from a syringe

attached to a catheter (usually 18 gauge)

connected to a 27 to 28 gauge needle

inserted in the patient.

The insulin may be delivered SubQ, IV, IP

Patients who used infusion pumps for the

continuous subcutaneous administration of

insulin may develop hard nodules at the site

of injection

10. Humalog Mix

Manufactured premix insulin consisting lispro

and neutral protamine lispro (NPL) in afixed

ratio

Humalol Mix 50/50 consists of 50% insulin NPL

suspension and 50% insulin lispro injection

Humalog Mix 75/25 contains 75% insulin NPL

suspension and 25% insulin lispro injection

It is estimated that these premixed

combinations are used by more than 40% of

diabetes patients who inject insulin twice daily

11. Insulin Glargine

It is a long acting (up to 24 hours) basal insulin

preparation intended for once daily

subcutaneous administration at bedtime in

the treatment of type 1 diabetes mellitus in

adult and children

In can be used by adults with type 2 diabetes

who require long-acting insulin

It is created when the amino acids at position

21a of human insulin are placed by glycine

and 2 arginines are added to the C terminus

of the B chain


Insulin Activity Prof iles and Compat ibility

Insulin Preparat ions Onset (hr) Peak (hr) Duration (hr) Compatible

mixed with

Rapid acting

Insulin Inj (regular) 0.5 to 1 8 to 12 all Lente Prompt

Insulin Z inc 1 to 1.5 5 to 10 12 to 16

Suspension(semilente)

Lispro Insulin Sol’n 0.25 0.5 to 1.5 6 to 8 Ultralente, NPH

Intermediate

Isophane Insulin 1 to 1.5 4 to 12 24 regular

Suspension (NPH)

Insulin Zinc Suspension(lente) 1to 2.5 7 to 15 24 regular, semilente

Long acting

PZI (Protamine Zinc Insulin) 4 to 8 14 to 24 36 regular

Extended Insulin Zinc 4 to 8 10 to 30 >36 regular, semilente

Isophane Insulin Suspension

Premixed 50% and Insulin Inj 50%

insulin Isophane Insulin Susp. 0.5 2 to 12 18 to 24 regular, NPH

70% and Insulin Inj, 30%

Examples of Some Injections Administered in Large Volume by IV that may be Administered

in Volumes of 1 Liter or More, Alone, or With Other Drugs Added

Injection Usual Content Category/Comments

Amino Acid Injection 3.5,5,5.5,7,8.5,10% crystalline amino Fluid /Nutrient replenisher

acids with or without varying

concentrations of electrolytes or glycerin

Dextrose Injection,USP 2.5,5,10,20% dextrose, other strengths Fluid/Nutrient replenisher

Dextrose and sodium Dextrose varying from 2.5 to 10% and Fluid/Nutrient/Electrolyte

chloride Injection,USP sodium chloride from 0.11 (19 mEq Na) electrolyte

to 0.9% (154 mEq sodium)

Mannitol Injection, USP 5,10,15,20 and 25% mannitol Diagnostic aid in renal

function determinations;

diuret ic. Fluid/Nut rient

Ringers’ Injection, USP 147 mEq sodium, 4 mEq potassium Fluid/electrolyte

calcium, and 156 mEq chloride/ liter

Lactated Ringer’s 2.7 mEq calcium, 4 mEq potassium, Systemic alkalinizer; Injection,

USP 130 mEq sodium and 28 mEq f luid and electro lyte

lactate per liter replenisher

Sodium Chloride 0.9% sodium Chloride Fluid and electrolyte Injection,

USP replenisher, isotonic

vehicle

Types of Insulin: Approximate effect/action *

Large Volume Parenterals (LVPs)

These solutions are usually administered by IV infusion to

replenish body fluids, electrolytes, or to provide

nutrition. They are usually administered in volumes of

100 mL to liter amounts and more per day by slow

intravenous infusion with or without controlled-rate

infusion systems

USES:

1. Employed as Maintenance therapy for the

patient entering or recovering from surgery, or for

the patient who is unconscious and unable to

obtain fluids, electrolytes, and nutrition orally.

Maintenance Therapy

– given to the patient being

maintained on parenteral fluids only

several days, simple solutions

providing adequate amounts of

water, dextrose and small amounts

sodium and potassium generally

suffice.

– Total Nutrient Admixtures also may

be given (TNA) include all substrate

necessary for nutritional support (

carbohydrates, protein, fat,

electrolytes, trace elements and

others).

– These admixtures are very useful for

patients undergoing chemotherapy,

and for gastrointestinal patients, and

anorexic patients

2. Utilized as Replacement therapy in patients who

have suffered a heavy loss of fluid and

electrolytes.

Replacement Therapy

– given to the patient in which there is

heavy loss of water and electrolytes, as in

severe diarrhea or vomiting, greater than

usual amounts of these materials may be

initially administered and maintenance

therapy provided. Patients with Crohn’s

disease, AIDS, burn patients, or those

experiencing trauma are candidates for

replacement therapy.

Water Requirement

– The daily water requirement is that

amount needed to replace normal and

expected losses. Normal requirement

adult -25 to 40 mL/kg of body weight or

an average of about 2,000 mL per square

meter of body surface area

– Estimate guidelines in normal daily

requirement for water

1. <10 kg: 100 mL/kg/day

2. 10-20kg: 1000 mL plus 50 mL/kg/day

for weight over 10 kg

3. >20 kg to maximum of 80 kg: 1500

mL Plus 20 mL/kg/day for weight

over 20 kg

Electrolyte Requirement

1. Potassium

important for cardiac and skeletal

muscle function. The usual daily intake

is about 100 mEq and the usual daily

loss is about 40 mEq

Potassium can be lost through:

excessive perspiration, repeated enemas,

trauma (such as severe burns), uncontrolled

diarrhea, diseases of intestinal tract, surgical

operations and others

Low potassium levels - Hypokalemia,

can lead to death

Symptoms of potassium loss :weak

pulse, faint heart sounds, falling blood

pressures & generalized weakness

Excess potassium is not good either :

Hyperkalemia can cause kidney

failure

Characteristics Onset Peak Duration

Short/Fast-Acting (clear) 5 - 30

mins 1 - 3 hrs 4 - 8 hrs

Intermediate-Acting (milky) 1 - 2 hrs 4 - 12

hrs

16 - 24

hrs

Premixed (Short &

Intermediate) 1/2 hr

2 - 12

hrs

16 - 24

hrs

Long-Acting (milky) 4 hrs 8 - 24

hrs

28 - 36

hrs


Symptoms : diarrhea, irritability, muscle

cramps, and pain

2. Sodium

is vital to maintain normal extracellular

fluids.

Average daily intake of sodium:

135 to 170 mEq (8 to 10 g of Sodium

chloride)

Sodium loss/deficit: 3 to 5 g sodium

chloride (51 to 85 mEq of sodium) is

administered daily

Symptoms: excessive sweating,

fatigue, muscle weakness, convulsions

Symptoms (excess): Dry, sticky mucous

membranes, flushed skin, elevated

body temperature, lack of tears, and

thirst

3. Chloride

the principal anion of the extracellular

fluid usually paired with sodium.

Chloride is also important for muscle

contraction, balancing the fluid levels

inside and outside the cells &

maintaining the acid-base balance of

the extracellular fluid.

Caloric Requirements :

– Basic caloric requirements

may be estimated by body

weight; in the fasting state,

the average daily loss of

body proteins is

approximately 80g/day for

a 70 kg man.

– Daily ingestion of at least

100 g of glucose reduces

this loss by half.

– Generally patients requiring

parenteral fluids are given

5% dextrose to reduce

caloric deficit

* Parenteral hyperalimentation

This is the infusion of large amounts of basic nutrients

sufficient to achieve active tissue synthesis and growth.

It is employed with a long term intravenous feeding of

protein solutions containing high concentration of

dextrose (approximately 20%), electrolytes, vitamins,

and sometimes insulin.

Components of Parenteral Nutrition Solutions

Electrolytes

1. Sodium…………. 25 mEq

2. Potassium ……... 20 mEq

3. Magnesium ……..5 mEq

4. Calcium …….……5 mEq

5. Chloride ……….. 30 mEq

6. Acetate …..…… 25 mEq

7. Phosphate ……..18 mM

Vitamins

Vitamin A – 3300 I.U.

Vitamin D – 200 I.U.

Vitamin E – 10 I.U.

Vitamin C – 100 mg

Niacin – 40 mg

Vitamin B2 – 3.6 to 4.93 mg

Vitamin B1 – 3 to 3.35 mg

Vitamin B6 – 4 to 4.86 mg

Pantothenic Acid – 15 mg

Folic Acid – 400 mcg

Vitamin B12 – 5 mcg

Biotin – 60 mcg

Amino Acids: Essential Amino Acids

1. L - Isoleucine……………..590 mg

2. L - Leucine ……………….770 mg

3. L - Lysine acetate………..870 mg

(free base…………….620 mg)

4. L - Methionine ……………450 mg

5. L - Threonine ……………..340 mg

6. L - Tryptophan ……………130 mg

7. L - Valine ………………….560 mg

8. L - Phenylalanine ………..480 mg

Nonessential Amino Acids

1. L - Alanine ……………..600 mg

2. L - Arginine …………….810 mg

3. L - Histidine …………….240 mg

4. L - Proline ………………950 mg

5. L - Serine ……………….500 mg

6. Aminoacetic acid ………1.19 g

Enteral Nutrition

Enteral nutrition products may be administered orally,

via nasogastric tube, via feeding gastronomy, or via

needle-catheter jejunostomy.

These products are formulated to contain vitamins,

minerals, carbohydrates, proteins, fats and caloric

requirements to meet specific needs of the patient.

The formula diets may be monomeric or oligomeric

(amino acids or peptides and simple carbohydrates) or

polymeric (more complex protein and carbohydrates

sources.

Ex.:

Protein - ProMod Powder, Propac Powder

Carbohydrates - Moducal Powder

Fat - Lipomul Liquid

Fewer calories- Ensure HN, Sustacal, & Osmolite HN

Intravenous Infusion Devices

Advances in infusion technology and computer

technology have resulted in devices with extremely

sophisticated drug-delivery capabilities

Ex.: Multiple-rate programming, pump or controller

operation)

Special Considerations Associated with Parenteral Therapy

Adsorption Of Drugs - Some drugs are adsorbed onto

the inner lining of IV containers and tubing or

administration sets.

Ex.:

1. Chorpromazine HCl

2. Insulin

3. Promethazine HCl

4. Trifluoperazine HCl

5. Thioridazine HCl

6. Diazepam

7. Promazine HCl


8. Thiopental sodium

9. Warfarin sodium

Another Example:

Nitroglycerin

should always be prepared in glass containers, and is

adsorbed (40 to 80% of total dose) to polyvinylchloride

(PVC), a plastic commonly used in administration

components and some infusion containers, therefore, it

should be packaged with special non-PVC tubing to

avoid loss <5% of the drug into the tubing during

administration.

Selected Infusion Devices Used in Parenteral Nutrition Support

1. Volumetric Infusion Pumps - AVI 2000 #200: Flo-Gard

8100; IMED

2. Multiple-rate Programmable Pumps – CADD-TPN

3. Volumetric Infusion Pumps - Provider one; Quest 521

Intelligent

4. Multiple-solution Programmable Pumps - Gemini PC –2;

Life Care 5000 Plum;Omni-Flow 4000

5. Others- Breeze Lifecare 175, Coleague 3, Horozon Nxt,

Sabratek 600

NOTE: All these devices have their own features like: safety

alarm, flow rate error, alarm for air in line, door open, low

battery, occlusion, malfunction, invalid rates and others

Handling/Disposal of Chemotherapeuticc Agents for Cancer

In theory, “correct and perfect preparation and

handling techniques will prevent drug particles or

droplets from escaping from their containers while they

are being manipulated”.

Basic Steps in handling Chemotherapeutic Agents

1. Utilizing vertical laminar flow hoods (or

bacteriological gloves boxes) for the

preparation and reconstitution of cytotoxic

drugs.

2. Wearing protective gloves and mask during

product preparation

3. Handling and disposing of cytotoxic drugs

centrally utilizing specially designed waste

containers and incineration.

4. Periodic monitoring of personnel involved with

handling admixtures of cytotoxic drugs (CBC,

blood chemistry screen, differential cell count)

5. Informing personnel handling cytotoxic drugs

that a potential risk to their health exists.

6. Instituting specialized labeling of containers to

ensure proper handling and disposal of the

cytotoxic agent.

Other Injectable Products

Pellets or Implants

are sterile, small, usually cylindrical-shaped solid objects

about 3.2 mm in diameter and 8 mm in length,

prepared by compression and intended to be

implanted subcutaneously for the purpose of providing

the continuous release of medication over prolonged

period of time

The pellets - implanted under the skin (thigh or

abdomen) with special injector or by surgical incision -

used for potent hormones.

The implanted pellets, which might contain 100 times

the amount of drug.

Ex.: (desoxycorticosterone, estradiol, testosterone)

given other routes are release slowly into general

circulation

Pellets were formulated with no binders, diluents, or

excipients, to permit total dissolution and absorption of

the pellets.

Ex.: Levonorgestrel

Levonorgestrel Implants

These are a set of six flexible, closed capsules of a

dimethylsiloxane/methylvinylsiloxane copolymer, each

containing 36 mg of the progestin levonorgestrel

These are found in an insertion fit to facilitate surgical

subdermal implantation through a 2 mm incision in the

mid-portion of the upper arm about 8 to 10 cm above

the elbow crease.

These are implanted in a fan like pattern, about 150

apart, for a total of 750. Removal after the end of the

5th year.

The dose of levonergestrel is about 85 mcg/day by 9

months and to about 35 mcg/day by 18 months, with a

further decline thereafter to about 30 mcg/day.

Irrigation and Dialysis Solutions

Solutions for irrigation of body tissues and dor dialysis

resemble parenteral solutions in that they are subject to

the same stringent standards.

These solutions are not injected into the vein, but

employed outside of the circulatory system.

Irrigation Solutions

Irrigation solutions are intended to bathe or wash

wounds, surgical incisions, or body tissues.

Ex.:

1. Acetic acid Irrigation, USP - This solution is

employed topically to the bladder as a 0.25%

solution for irrigation. It is administered to wash

blood and surgical debris away while

maintaining suitable conditions for the tissue.

2. Neomycin and Polymixin B Sulfate Solution for

Irrigation, USP - Employed as a topical

antibacterial in the continuous irrigation of the

bladder.

3. Ringer’s Irrigation, USP - It is used topically as an

irrigation and must be labeled “not for

injection”. The solution is sterile and pyrogen

free.

4. Sodium Chloride Irrigation, USP - This solution is

employed topically to wash wounds and into

body cavities where absorption into the blood is

not likely. The solution also employed rectally as

an enema for simple evacuation and also for

colonic flush.

5. Sterile Water for Irrigation, USP - The label

designations “for irrigation only” and “not for

injection” must appear prominently on the label.

The water must not contain any antimicrobial or

other added agent.


Dialysis Solutions

May be defined as a process whereby substances may

be separated from one another in solution by taking

advantage of their differing diffusibility through

membranes

Peritoneal Dialysis

Solutions allowed to flow into the peritoneal cavity, are

used to remove toxic substances normally excreted by

the kidney

The solutions are made to be hypertonic (with dextrose)

to plasma to avoid absorption of water from the dialysis

solution into the circulation

Hemodialysis

Is employed to remove toxins from the blood. In this

method, the arterial blood is shunted through a

polyethylene catheter through an artificial dialyzing

membrane bathed in an electrolyte solution. Following

the dialysis, the blood is returned to the body

circulation through a vein.

Documents

C-15 parenterals