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 refe
rs 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 preparati
ons 2. Ophthalmic preparations - for the eye 3. Otic preparations - for the ear
4. Nasal preparations - for the nose & throat 5. Irrigating solutions - for wash
ing wounds or abraded mucous membrane Parenteral Routes of Administration 1. Int
ra-articular joints 2. Intraspinal spinal column 3. Intra-arterial arteries 4. I
ntravenous veins 5. Intradermal shin 6. Intrasynovial joint fluid 7. Intrathecal
spinal fluid 8. Intracardiac heart 9. Intramuscular muscles 10. Subcutaneous un
der the skin
Physician's assistant Nurse Parenterals are administered at: Hospitals Clinics Ext
ended 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 f
or solution for injection Botulinum toxin Brand name: Myobloc Generic name: Botu
linum 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: M
ay 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 dru
g administered, it cannot be retrieved. In the case of adverse reaction to the d
rug, for instance, the drug cannot be easily removed from the circulation. Preca
utions: Strict aseptic precautions must be taken at all times to avoid risk of i
nfection. The syringes and needles used must be sterilized and to the point of e
ntrance 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 ex
pressed 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. Ex
ample: Metoprolol (beta blocker) 3 bolus injections of 5 mg each at about 2 minu
te intervals oral dosing (100 mg/day) NOTE: Not only are the injectable solution
s sterile, syringes, needles must also be disinfected to reduce the chance of ca
rrying bacteria
Parenterals are administered by: Physician
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A backflow of blood into the administration set or syringe indicates proper plac
ement of the needle in the vein Intravenous drugs ordinarily must be aqueous sol
ution They must mix with the circulating blood and not precipitate from solution
. Such an event can lead to pulmonary micropillary occlusion and blockage of blo
od flow.
4. 5.
6. 7. 8. 9.

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 pa
tients requiring parenteral nutrition for extended period, usually more than 5 d
ays. The product contains up to: 30% soybean oil emulsified with eggyolk phospho
lipids in a vehicle of glycerin in water injection
Example: WalkMed PCA Ability to provide constant and uniform analgesia Can preve
nt pharmacokinetics and pharmacodynamic differences between patients from interf
ering with the effectiveness of analgesia Also permits patients to medicate them
selves when there is breakthrough pain Minimizes various side effects PCA device
s can be used for IV, SC or epidural administration These devices are either, de
mand dosing (fixed dose of drug is injected intermittently) or constant-rate inf
usion plus demand dosing
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 b
lood 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 blo
t 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 referr
ed to as an Embolism. Example: Automated IV delivery system - Self administratio
n analgesics Advantages: 1. Patient Controlled Analgesia (PCA) used to control p
ain 2. Allows greater degree of ambulation and independence 3. Typical PCA conta
ins analgesic drug, syringe and programmable electromechanical unit, which might
be compact enough to be worn on a belt or carried in a pocket
Intramuscular (IM) Intramuscular injections of drugs provide effects that are le
ss rapid, but generally of greater duration than those obtained from intravenous
administration IM are performed deep into the skeletal muscles. The point of in
jection should be as far as possible from major nerves and blood vessels. Injuri
es to patients from IM injection usually are related to the point at which the n
eedle entered and where the medication was deposited. Such injuries include: 1.
Paralysis resulting from neural damage 2. Abscesses 3. Cysts 4. Embolism 5. Hema
toma 6. Sloughing of the skin 7. Scar formation Adult upper outer quadrant of th
e gluteus maximus Infants gluteal area is small, composed primarily fats not musc
le, 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 inc
hes 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 displac
ed laterally, then needle inserted and syringe aspirated, and injection performe
d slowly & smoothly. The needle is then withdrawn and the skin release. This cre
ates 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 (V
alium) by sealing in the lower muscle Subcutaneous Route (SC)
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May be utilized for the injection of small amounts of medication or of drugs ben
eath 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 wi
ll 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 lengt
h between 5-16 to 5-8 inch. Upon insertion, if blood appears in the syringe, a n
ew site should be selected. Irritating drugs and those in thick suspension may p
roduce induration, sloughing, or abscess and may be painful. Such preparations a
re not suitable for subcutaneous injection

Intradermal Route Substances may be effectively injected into the corium, the mo
re vascular layer of the skin just beneath the epidermis. These substances inclu
de: diagnostic determinations, desensitization, or immunization. Usual site: ant
erior 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 i
njection is made when the bevel just disappears into the corium. Volume: Usually
about 0.1 mL Specialized Access Devices that provide continued access and reduc
e pain associated with administration (Repeated injections over time) Several ca
theters of central venous are used for a variety of parenteral medications. Exam
ple: cancer chemotherapy, long term antibiotic, therapy,TPN solutions The use of
indwelling plastic catheters reduces the need for multiple punctures during int
ravenous therapy. Composed of polyvinyl chloride Teflon Polyethylene these should
be radiopaque to ensure that they are visible on radiographs. Usually, these mu
st be removed within 48 hours after insertion.
The choice of catheter depends on several factors 1. Length of time of the infus
ion 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. Cathet
er inside needle Official Types of Injections 1. Drug Injection Liquid preparati
ons that are drug substances or solutions thereof Ex.: Insulin Injection, USP 2.
Drug for Injection Dry solids that, upon the addition of suitable vehicles, yie
ld solutions conforming in all respects to the requirement for Injections Ex.: C
efamandole Sodium for Injection 3. Drug Injectable Emulsion Liquid preparations
of drug substances dissolved or dispersed in a suitable emulsion medium Ex.: Pro
pofol 4. Drug Injectable Suspension Liquid preparations of solids suspended in a
suitable liquid medium Ex.: Methylprednisolone Acetate Suspension 5. Drug Injec
table Suspension Dry solids that, upon the preparations conforming in all respec
ts to the requirements for Injectable Suspensions Ex.: Imipenem, Cilastatin for
Injection Suspension, USP a. b. c. INSULIN INJECTION, USP PROPOFOL METHYLPREDNIS
OLONE 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 a
dministration If the drug is unstable in water, the solvent may be replaced in p
art or totally by a solvent in which the drug is insoluble If the drug is insolu
ble in water, an injection may be prepared as an aqueous suspension or as soluti
on in a suitable nonaqueous solvent, such as a vegetable oil If an aqueous solut
ion is desired, a water soluble salt form of the insoluble drug is frequently pr
epared Aqueous or blood miscible solutions may be injected directly into the blo
od stream Blood immiscible liquids, such asoleaginous injections and suspensions
can interrupt the normal flow of blood, and their use is generally restricted t
o other than intravenous administration Often times long action is desired to re
duce the frequency of injections.
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These long acting injections are called respiratory or depot preparations Follow
ing differences with other preparations 1. Solvents or vehicles used must meet s
pecial purity and other standards assuring their safety by injection 2. The use
of added substances, as buffers, stabilizers, and antimicrobial preservatives, f
all under specific guidelines of use and are restricted in certain parenteral pr
oducts. The use coloring agents is strictly prohibited. 3. Parenteral products a
re always sterilized and meet sterility standards and must be pyrogen free. 4. P
arenteral solutions must meet compendial standard for particulate matter. 5. Par
enteral products are packaged in special hermetic containers of specific and hig
hly quality. 6. Each container of an injection is filled to a volume in slight e
xcess of the labeled size or volume to be withdrawn. This overfill permits the eas
e of withdrawal and administration of the labeled volumes 7. Parenteral products
must be prepared in environmentally controlled areas, under strict sanitation s
tandards, and by personnel especially trained and clothed to maintain the sanita
tion 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. Spe
cific powders intended for solution or suspension immediately prior to injection
are frequently packaged as lyophilized or freezedried powders to permit ease of
solution or suspension upon the addition of the solvent or vehicle. Solvents an
d 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 st
erilized, 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
singledose containers of not greater than IL size as water for Injection, it mus
t be pyrogen free and may not contain an anti-microbial agent or other added sub
stance.
4.
5.
6.
7.
Bacteriostatic Water for Injection, USP is sterile water for injection containin
g one or more suitable antimicrobial agents. it is packaged in pre-filled syring
es 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 toxicit
y of the bacteriostat. Sodium Chloride Injection, USP a sterile isotonic solutio
n of sodium chloride in Water for Injection. It contains no anti-microbial agent
s Bacteriostatic Sodium Chloride Injection is a sterile isotonic solution of sod
ium chloride in Water for Injection. It contains one or more suitable antimicrob
ial agents which must be specified in the label. Sodium chloride concentration i
s 0.9% to render isotonic solution. It is also used to flush a catheter or IV li
ne to maintain its patency.. Not for Use in Newborns. Ringer's Injection, USP is a s
terile solution of sodium chloride, potassium chloride, and calcium chloride in
water for injection. It is used as electrolyte replenisher and a systemic alkali
zer. Lactated R = Na lactate
Characteristics Of Components used in Compounding 1. Therapeutically effective w
hen used as the active ingredients 2. Provide maximum safety 3. Function efficie
ntly (when used as excipient) 4. Free from contamination 5. Physically and chemi
cally stable even after thermal sterilization 6. Produce little or no tissue irr
itation 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 activ
ity of the medicinal agent Other Considerations Of Selecting Nonaqueous Solvents
1. Physical and chemical stability 2. Its viscosity (syringeability) and its fl
uidity 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 dur
ing heat sterilization
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Constant purity or ease of purification & standardization Examples of Nonaqueous
Solvents 1. Fixed vegetable oils 2. Glycerin 3. Polyethylene glycols 4. Propyle
ne glycol 5. Ethyl oleate 6. Isopropyl myristate 7. Methylacetamide 8. Alcohol N
onaqueous 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 purif
ied by distillation or by reverse osmosis stored in tight container with tempera
ture below or above the range of microbial growth must be pyrogen free Added Sub
stances Additives are essential for almost every product to enhance its stabilit
y. They must exhibit the following characteristics: 1. Perform its function thro
ughout 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 c
omponents of the formulation 5. Must not interfere with: a. Therapeutic efficacy
b. Assay of the active therapeutic compound Such substances include: 1. Solubil
izers 2. Chelating agents 3. Anti-microbial agents 4. Hydrolysis Inhibitors 5. A
ntioxidants 6. Buffers 7. Tonicity contributors 8. Antifoaming agents Antifungal
/Antibacterial must be present in adequate concentration at the time of use to p
revent the multiplication of microorganism. Ex.: agents containing mercury and t
he cationic, surface active compounds - 0.01%; for agents like chlorobutanol, cr
esol, and phenol - 0.5%
6.
Antioxidants Oxidation is one of the pathways of degradation which can be accele
rated during thermal sterilization. To protect a therapeutic agent susceptible t
o this reaction, antioxidants are required. Ex.: Sulfur dioxide - 0.2% Classific
ation of Antioxidants used in Sterile products: 1. Reducing agents - antioxidant
s which functions by being preferentially oxidized Ex.: ascorbic acid, sodium bi
sulfate, metabisulfite, thiourea, sodium formaldehyde, sulfoxylate 2. Blocking a
gents - antioxidants which block an oxidative chain reaction in which they are n
ot usually consumed Ex.: ascorbic acid esters, butyl hydroxytoluene (BHT), tocop
herols 3. Synergists - compounds increase the effectiveness of antioxidants, par
ticularly those blocking oxidative reactions Ex.: ascorbic acid, citraconic acid
, phosphoric acid, citric acid, tartaric acid 4. Chelating agents - those that c
omplex 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 possib
ility of oxidative changes in the formulation Buffers

added to maintain the required pH for many products; a change in pH may cause si
gnificant alterations in the rate of degradation reactions. Changes in pH may oc
cur during storage as a result of: 1. Dissolving of glass constituents in the pr
oduct 2. Release of constituents from rubber closures or plastic components in c
ontact 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. Reacti
ons within the product The principal buffer systems used to stabilize pH are the
1. Acetates 2. Citrates 3. Phosphates Tonicity Contributors Compounds contribut
ing to the isotonicity of a product reduce the pain of injection in areas with n
erve endings Buffers may serve as tonicity contributors as well as as stabilizer
s for the___?___
Containers Containers for sterile products are made of glass or plastic. Glass i
s still preferred for injectable products. Glass is composed principally of the:
silicon dioxide tetrahedron
A. Uy | Page 5 of 14

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 - treat
ed soda-lime glass 3. Type III - soda lime glass 4. NP (nonparenteral) - general
purpose sodalime 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 an
d elastic enough to permit entry and withdrawal of a hypodermic needle without l
oss of the integrity of the sealed container. Accessories used in conjunction wi
th 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 el
imination of microbial life The choice of the most effective sterilization proce
dure is dependent on: 1. Compatibility of the process with the preparation; (ste
rilization process must not have significant adverse effect upon the preparation
) 2. The successful validation of the process (the parameters must prove to be l
ethal to the most resistant spores of microorganism normally encountered) 5 gene
ral 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. Ther
mal Method i. Microorganisms are killed by heat by what is thought to be coagula
tion of the protein of a living cell. The lethal effectiveness of heat is depend
ent on: The degree of heat The exposure period The moisture present ii. Steam st
erilization is conducted in an autoclave and employs steam under pressure iii. T
he 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. D
ry-Heat Sterilization usually carried out in sterilizing ovens specifically desi
gned for this purpose. The ovens may be heated either gas or electricity and gen
erally thermostatically controlled. It is conducted at temperatures of 1600C to
1700C for periods not less than 2 hours. B. Nonthermal Methods i. Ultraviolet li
ght is commonly employed to aid in the reduction of airborne contamination and t
o attempt to sterilize surfaces within the processing environment. The germicida
l light produced by mercury vapor lamps is emitted at a wavelength of 2537 Angst
rom units (253.7 millimicrons) The lethal mechanism of UV light works when this
energy is absorbed by orbital electrons within the molecules of the microorganis
ms or of their essential metabolites causing excitation and alteration of activi
ty. 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 velociti
es and energies (cathode rays, beta rays). Ionizing radiations destroy
A. Uy | Page 6 of 14
microorganisms by stopping reproduction as a result of lethal mutations. iii. Fi
ltration This is a nonthermal method for the sterilization of select solutions b
y removing microorganisms from the solution while permitting the passage of all
the desired components of the solution and imparting no undesirable components f
rom the filter. They are available in pore sizes from 14 to 0.025 um. The size o
f the smallest particle visible to the naked eye is about 40 um, a red blood cel
l 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 o
xide believed to exert its lethal effect upon microorganisms by alkylating essen
tial metabolites, affecting particularly the reproductive process. Ethylene diox
ide sterilization is the acceptable practical method for sterilizing plastic. Ot
her gases used are beta propiolactone, formaldehyde & sulfur dioxide B. Surface
Disinfection Disinfectants do not sterilize a surface. However, as adjuncts to t
horoughly cleaning of surfaces, disinfectants properly used may be expected to p
rovide an aseptic condition of the surfaces involved Validation of Sterility Reg
ardless of the method of sterilization employed, Pharmacutical preparations must
undergo sterility tests to confirm the absence of microorganisms. A biologic in
dicator is characterized preparation of specific microorganisms resistant to a p
articular sterilization process 2 main forms 1. Spores are added to a carrier, a
s a strip of filter paper, packaged to maintain physical integrity while allowin
g the sterilization effect. 2. The spores are added to representative units of t
he product being sterilized, with sterilization assessed based on these samples
In moist heat (steam) - Bacillus stearothermophilus In dry heat - Bacillus subti
lis In ionizing radiation - Bacillus pumilus, stearothermophilus, subtilis Pyrog
ens 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 polys
accharide but may be a protein.
2 Official Tests for Detecting and Measuring Pyrogens 1. Bacterial Endotoxins Te
st Using Limulus Amebocyte Lysate (LAL) which has been obtained from aqueous ext
racts of the circulating amebocytes of the horseshoe crab, Limulus polyphemus, a
nd which has been prepared & characterized for use as an LAL reagent for gel-clo
t formation The procedure include incubation for a preselected time of reacting
endotoxins and control solutions with LAL Reagent and reading of the spectrophot
ometer light absorbance at suitable wavelength 2. Pyrogen Test The test involves
measuring the rise in temperature of rabbits following the intravenous injectio
n of a test solution and is designed for products that can be tolerated by the t
est 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 temp
erature 0.60C or more above its respective control temperature, and if the sum o
f the 3 individual maximum temperature rises does not exceed 1.400 C, the produc
t meets the requirements for the absence of pyrogens. Depyrogenation Method are
as follows: 1. Adequate washing with detergent treatment followed by dry heat st
erilization 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 contamina
tion results from fermentation. PRODUCTION of a sterile preparation consists of
the following steps: 1. Compounding Processing of sterile preparations follow no
rmal manufacturing procedures which must be done in aseptic condition. All equip
ment 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. Ster
ilization by filtration is achieved when
A. Uy | Page 7 of 14
viable microorganisms and spores of approximately 0.3 microns are removed. Membr
anes with porosity ratings of 0.22 or 0.45 microns are usually specified for ste
rile filtration. 3. Filling Bulk preparations are subdivided into unit dose cont
ainers during filling. This process forces a measured volume of the preparation
through the orifices of a delivery tube designed to enter the constricted openin
g of a container by means of gravity, vacuum or with the aid of a pressure pump.
Sealing Sealing will retain the contents of a sterile product and will assure a
tamper-proof presentation Sterilization
3. 4. 5. 6. 7. 8. 9. 10. 11.
Erythromycin Lactobionate for Injection Oxytetracycline Hydrochloride Injection
Nafcillin Sodium for Injection Hydrocortisone Sodium Succinate for Injection Cyc
lophosphamide for Injection Hyaluronidase for Injection Mitomycin for Injection
Penicillin G Potassium for Injection Vinblastine Sulfate for Injection
4.
5.
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 heati
ng 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 bat
h (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 duri
ng washing and 100% inspection that follows after. Examples of Sterile Drugs pre
pared and packaged without the presence of phamaceutical additives as buffers, p
reservatives, stabilizers, tonicity agents, and other substances 1. Sterile Ampi
cillin Sodium 2. Sterile Ceftazidime Sodium 3. Sterile Kanamycin Sulfate 4. Ster
ile Penicillin G Banzathine 5. Sterile Tobramycin Sulfate 6. Sterile Ceftizoxime
Sodium 7. Sterile Cefuroxime Sodium 8. Sterile Nafcillin Sodium 9. Sterile Stre
ptomycin Sulfate Examples of Sterile Drugs prepared and packaged with the presen
ce of phamaceutical additives as buffers, preservatives, stabilizers, tonicity a
gents, and other substances 1. Cephradine for Injection 2. Dactinomycin for Inje
ction
Containers 1. Mix-O-Vial - that incorporates the cover as part of the plunger. On
ce 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 exam
ple of readyto-mix sterile IV product designed for intermittent IV administratio
n of potent drugs that do not have long term stability in solution. Two componen
ts: a. A flexible plastic IV container partially filled with diluents b. Glass v
ial of powdered or liquid drug The vials containing the medication and the piggy
backs (50-250 mL of Dextrose 5% in Water Injection) or Normal Saline Solution ar
e specially designed to be used together. The ADD-Vantage System can be used wit
hin 30 days from the date that the diluent container was removed from the overwr
ap. 3. Monovial Safety Guard This is new system integrated device (drug transfer
mechanism) with a protective shield surrounding the attached transfer needle. T
he reconstitution and transfer of the drug into an infusion bag is accomplished
safely, quickly, and necessitates fewer materials. The needle is inserted into t
he 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 se
veral 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 f
or injections, including closures, must not interact physically and chemically w
ith the preparation Single-dose container - A single dose container is a hermeti
c container holding a quantity of sterile drug intended for parenteral administr
ation as a single dose, and which when opened cannot be re-sealed with assurance
that sterility has been maintained.
A. Uy | Page 8 of 14
-
-
Multiple-dose container - A multiple-dose container is a hermetic container that
permits withdrawal of successive portions of thecontents without changing the s
trengths, quality, or purity of the remaining portion. Note: Recall type I,II,II
I containers
The Labels on containers of parenteral products must state: 1. The name of the p
reparation 2. For liquid preparation, the percentage content of the drug or amou
nt of the drug; for dry preparation - the amount of the active ingredient presen
t and the volume of liquid to be added to the dry preparation to prepare a solut
ion or suspensions. 3. The route of administration 4. Statement of storage condi
tions and expiration 5. The name of the manufacturer and distributor 6. The iden
tifying 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 person
nel who are exposed to these ovens, especially those with cardiac pacemakers. 3.
The possible leaching of rubbers material when the rubber material on the conta
iner is exposed to microwave heating. 4. A possible explosion that may result fr
om the increase in internal pressure as a result of placing a closed or sealed c
ontainer into the microwave oven. 5. Developing protocols to ensure that the fin
al solution temperature does not exceed room temperature Examples of some Inject
ions Usually Package and Administered in Small Volume 1. Butorphanol Tartrate In
jection - Narcotic AgonistAntagonist Analgesic 2. Chlorpromazine HCl Injection -
Antipsychotic drug with antiemtic 3. Cimetidine HCl Injection - Histamine H2 an
tagonist 4. Dalteparin Sodium Injection- Prophylaxis against deep vein thrombosi
s 5. Dexamethasone Sodium Phosphate Injection Glucocorticoids 6. Digoxin Injecti
on Cardiotonic 7. Dihydroergotamine Mesylate Injection - Alphaadrenergic blockin
g agent 8. Diphenhydramine HCl Injection - An ethanolamine, non selective antihi
stamine 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 Fum
arate Injection - An antiarrhythmic drug 14. Iron Dextran Injection- Hematinic a
gent
15. Isoproterenol HCl Injection - Adrenergic (bronchodilator) 16. Ketorolac Trom
ethamine Injection - NSAID 17. Lidocaine HCl Injection - Cardiac depressant as a
n antiarrhythmic 18. Magnesium Sulfate Injection Anticonvulsant/Electrolyte 19.
Meperidine HCl Injection - Narcotic analgesic 20. Metoclopramide Monohydrochlori
de InjectionGastrointestinal stimulant 21. Midazolam HCl - Short acting benzodia
zepine CNS depressant 22. Morphine Sulfate injection - Narcotic analgesic 23. Na
loxone HCl Injection - Narcotic antagonist 24. Nalbuphine HCl Injection - Narcot
ic Agonist-Antagonist Analgesic 25. Oxytocin Injection- Oxytoxic 26. Phenytoin S
odium Injection - Anticonvulsant 27. Phytonadione Injection - Vitamin K (prothro
mbogenic) 28. Procaine Penicillin G Injection - Anti-infective 29. Prochlorperaz
ine 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. Verapami
l HCl Injection - Calcium channel blocking agent INSULIN 1. Insulin Injection (r
egular) Insulin Injection is a sterile aqueous solution of insulin. It is prepar
ed from beef or pork pancreas or both or through biosynthetic means (Human Insul
in). 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, Phe
nol or Cresol (0.1 to 0.25%) Storage: Cold place, preferably the refrigerator 2.
Human Insulin It is produced by utilizing a special nondiseaseforming laborator
y 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 actio
n (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 ac
tion (slightly less than 24 hours) than regular insulin 3. Lispro Insulin Soluti
on Insulin solution consists of Zinc-insulin lispro crystals dissolved in a clea
r aqueous fluid. It is created when the amino acids at positions 28 and 29 on th
e Insulin B-chain are reversed
A. Uy | Page 9 of 14
4.
5.
6.
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 h
ours) Lispro insulin are administered fifteen minutes before meals has decreased
the risk of hypoglycemic episodes and improve postprandial glucose excursions w
hen compared to conventional regular insulin. Storage: Refrigerator; room temper
ature - 28 days Note: If accidentally frozen, it should not be used Isophane Ins
ulin Suspension (NPH Insulin) Is a sterile suspension, in an aqueous vehicle buf
fered with dibasic sodium phosphate to between pH 7.1 and 7.4, of insulin prepar
ed 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, an
d protamine. Protamine is prepared from the sperm or the mature testes of fish b
elonging to the genus Oncorhynchus. Expiration date: 24 months Dosage: dosage ra
nge subcutaneously is 10 to 80 USP Units NPH used in some product names stands f
or Neutral Protamine Hagedorn; the pH is 7.2 and developed by Hagedorn. The term is
ophane is based on the Greek: iso and phane, meaning equal and appearance and refers
to equivalent balance between the protamine and insulin. Isophane Insulin Suspen
sion and Insulin Injection A premixed formulation of of isophane insulin suspens
ion and Insulin injection. 2 Formulations: A. Humulin 70/30 - combination that c
onsists of 70% isophane insulin suspension and 30% insulin injection B. Humulin
50/50 - combination that consists of 50% isophane insulin suspension and 50% ins
ulin injection They contain zinc of 0.01 to 0.04 mg/100 units. Neutral in pH and
phosphate buffered Preservatives: m-cresol and phenol Insulin Zinc Suspension m
odified by the addition of zinc chloride so that the suspended particles consist
s 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 p
reservatives Expiration: 24 months after the immediate container was filled. Sto
rage: Refrigerator with freezing being avoided
7.
Extended Insulin Zinc Suspension Is a sterile suspension of zinc insulin crystal
s in an aqueous medium buffered to between pH 7.2 and 7.5 with sodium acetate. P
resent also are 0.7% sodium chloride for tonicity & 0.1% methylparaben as preser
vatives Dosage: The usual dosage range is 10 to 80 USP Units Expiration: 24 mont
hs after the immediate container was filled 8. Prompt Insulin Zinc Suspension Th
e 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 amor
phous 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 pu
mps allow the patients to achieve and maintain blood glucose at nearnormal level
s 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 microco
mputers to regulate the flow of insulin from a syringe attached to a catheter (u
sually 18 gauge) connected to a 27 to 28 gauge needle inserted in the patient. T
he insulin may be delivered SubQ, IV, IP Patients who used infusion pumps for th
e continuous subcutaneous administration of insulin may develop hard nodules at
the site of injection 10. Humalog Mix Manufactured premix insulin consisting lis
pro and neutral protamine lispro (NPL) in afixed ratio Humalol Mix 50/50 consist
s 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 es
timated that these premixed combinations are used by more than 40% of diabetes p
atients 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-acti
ng insulin It is created when the amino acids at position 21a of human insulin a
re placed by glycine and 2 arginines are added to the C terminus of the B chain
A. Uy | Page 10 of 14
Types of Insulin: Approximate effect/action * Characteristics Onset 5 - 30 mins
1 - 2 hrs Peak Duration
Short/Fast-Acting (clear)
1 - 3 hrs 4 - 12 hrs 2 - 12 hrs 8 - 24 hrs
4 - 8 hrs 16 - 24 hrs 16 - 24 hrs 28 - 36 hrs
Intermediate-Acting (milky) Premixed (Short & Intermediate) Long-Acting (milky)
Ins ulin Activity Prof iles and Comp at ib ility Insulin Preparat ions mixed w i
th Rapid acting Insulin I nj (reg ular) Insulin Z inc Lispro Ins ulin Sol'n Interm
ediate Isophane Insulin Suspension (NPH) Insulin Zinc Suspension(lente) 1to 2.5
Long acting PZI (Protamine Zinc Insulin) Extended Insulin Zinc Isophane Ins ulin
Suspensio n Premixed 50% and Insulin Inj 50% insulin Isophane Ins ulin Susp. 70
% and Insulin Inj, 30% 0.5 4 to 8 4 to 8 1 to 1.5 1 to 1.5 Onset (hr)
1/2 hr
4 hrs
Peak (hr)
Duration (hr) Compatible
0.5 to 1 8 to 12 5 to 10 12 to 16 0.25 0.5 to 1.5 4 to 12 7 to 15 14 to 24 10 to
30 6 to 8 24 24 36 >36
all Lente
Prompt
Suspension(semilente) Ultralente, NPH regular regular, semilente regular regular
, semilente
2 to 12
18 to 24
regular, NPH
Examples of Some Injections Administered in Large Volume by IV t hat may be Admi
nistered in Volumes of 1 Liter or More, Alone, or With Other Drugs Added Injecti
on Usual Content Category/Comments
Amino Acid Injection 3.5,5,5.5,7,8.5,10% crystalline amino Fluid /Nutrient reple
nishe r acids with or without varying concentrations of electrolytes or glycerin
Dextrose Injection,USP 2.5,5,10,20% dextrose, other strengths Fluid/Nutrient re
plenishe r Dextrose and sodium Dextrose varying from 2.5 to 10% and F luid/Nutri
ent/Electrolyte chloride Injection,USP sodium chloride from 0.11 (19 mEq Na) ele
ctrolyte to 0.9% (154 m Eq sodium) Mannitol Injection, USP 5,10,15,20 and 25% ma
nnitol f unction determinatio ns; diuret ic. Fluid/Nut rient Ringers' Injection, U
SP 147 mEq sodium, 4 mEq potassium calcium, and 156 mEq chloride/ liter Diagnost
ic aid in renal
Fluid/electrolyte
Lactated Ringer's 2.7 mEq calcium, 4 mEq potassium, Systemic alkalinizer; Injectio
n, USP 130 mEq sodium and 28 mEq f luid and electro lyte lactate per liter repl
enisher Sodium Chloride USP vehicle 0.9% sodium Chloride Fluid and electrolyte I
njection, replenisher, isotonic

Large Volume Parenterals (LVPs) These solutions are usually administered by IV i

nfusion to replenish body fluids, electrolytes, or to provide nutrition. They ar
e 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, ele
ctrolytes, 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 gastroi
ntestinal patients, and anorexic patients 2. Utilized as Replacement therapy in
patients who have suffered a heavy loss of fluid and electrolytes. Replacement T
herapy given to the patient in which there is heavy loss of water and electrolyt
es, as in severe diarrhea or vomiting, greater than usual amounts of these mater
ials may be initially administered and maintenance therapy provided. Patients wi
th Crohn's disease, AIDS, burn patients, or those experiencing trauma are candidat
es for replacement therapy. Water Requirement The daily water requirement is tha
t 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 muscl
e 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 ene
mas, trauma (such as severe burns), uncontrolled diarrhea, diseases of intestina
l tract, surgical operations and others Low potassium levels - Hypokalemia, can
lead to death Symptoms of potassium loss :weak pulse, faint heart sounds, fallin
g blood pressures & generalized weakness Excess potassium is not good either : H
yperkalemia can cause kidney failure
A. Uy | Page 11 of 14
*
Symptoms : diarrhea, irritability, muscle cramps, and pain 2. Sodium is vital to
maintain normal extracellular fluids. Average daily intake of sodium: 135 to 17
0 mEq (8 to 10 g of Sodium chloride) Sodium loss/deficit: 3 to 5 g sodium chlori
de (51 to 85 mEq of sodium) is administered daily Symptoms: excessive sweating,
fatigue, muscle weakness, convulsions Symptoms (excess): Dry, sticky mucous memb
ranes, flushed skin, elevated body temperature, lack of tears, and thirst 3. Chl
oride the principal anion of the extracellular fluid usually paired with sodium.
Chloride is also important for muscle contraction, balancing the fluid levels i
nside and outside the cells & maintaining the acid-base balance of the extracell
ular fluid. Caloric Requirements : Basic caloric requirements may be estimated b
y 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 gluc
ose reduces this loss by half. Generally patients requiring parenteral fluids ar
e 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 feedin
g of protein solutions containing high concentration of dextrose (approximately
20%), electrolytes, vitamins, and sometimes insulin.

Niacin 40 mg Vitamin B2 3.6 to 4.93 mg Vitamin B1 3 to 3.35 mg Vitamin B6 4 to

.86 mg Pantothenic Acid 15 mg Folic Acid 400 mcg Vitamin B12 5 mcg Biotin 60 m
Amino Acids: Essential Amino Acids 1. L - Isoleucine..590 mg 2. L - Leucine .770 m
Lysine acetate..870 mg (free base.620 mg) 4. L - Methionine 450 mg 5. L - Threon
- Tryptophan 130 mg 7. L - Valine .560 mg 8. L - Phenylalanine ..480 mg Noness
ds 1. L - Alanine ..600 mg 2. L - Arginine .810 mg 3. L - Histidine .240 mg 4.
L - Serine .500 mg 6. Aminoacetic acid 1.19 g
Enteral Nutrition Enteral nutrition products may be administered orally, via nas
ogastric 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 formul
a diets may be monomeric or oligomeric (amino acids or peptides and simple carbo
hydrates) or polymeric (more complex protein and carbohydrates sources. Ex.: Pro
tein - 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-r
ate 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. Chorpro
mazine HCl 2. Insulin 3. Promethazine HCl 4. Trifluoperazine HCl 5. Thioridazine
HCl 6. Diazepam 7. Promazine HCl
Components of Parenteral Nutrition Solutions Electrolytes 1. Sodium. 25 mEq 2. Potas
sium ... 20 mEq 3. Magnesium ..5 mEq 4. Calcium .5 mEq 5. Chloride .. 30 mEq 6. Ace
mEq 7. Phosphate ..18 mM Vitamins Vitamin A 3300 I.U. Vitamin D 200 I.U. Vitamin
10 I.U. Vitamin C 100 mg
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8. 9.
Thiopental sodium Warfarin sodium

Another Example: Nitroglycerin should always be prepared in glass containers, an

d is adsorbed (40 to 80% of total dose) to polyvinylchloride (PVC), a plastic co
mmonly used in administration components and some infusion containers, therefore
, it should be packaged with special non-PVC tubing to avoid loss <5% of the dru
g into the tubing during administration. Selected Infusion Devices Used in Paren
teral Nutrition Support 1. Volumetric Infusion Pumps - AVI 2000 #200: Flo-Gard 8
100; IMED 2. Multiple-rate Programmable Pumps CADD-TPN 3. Volumetric Infusion Pu
mps - Provider one; Quest 521 Intelligent 4. Multiple-solution Programmable Pump
s - Gemini PC 2; Life Care 5000 Plum;Omni-Flow 4000 5. Others- Breeze Lifecare 17
5, 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 f
rom their containers while they are being manipulated. Basic Steps in handling Ch
emotherapeutic Agents 1. Utilizing vertical laminar flow hoods (or bacteriologic
al gloves boxes) for the preparation and reconstitution of cytotoxic drugs. 2. W
earing protective gloves and mask during product preparation 3. Handling and dis
posing of cytotoxic drugs centrally utilizing specially designed waste container
s and incineration. 4. Periodic monitoring of personnel involved with handling a
dmixtures of cytotoxic drugs (CBC, blood chemistry screen, differential cell cou
nt) 5. Informing personnel handling cytotoxic drugs that a potential risk to the
ir health exists. 6. Instituting specialized labeling of containers to ensure pr
oper handling and disposal of the cytotoxic agent. Other Injectable Products Pel
lets or Implants are sterile, small, usually cylindrical-shaped solid objects ab
out 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 relea
se 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.: (d
esoxycorticosterone, estradiol, testosterone) given other routes are release slo
wly into general circulation Pellets were formulated with no binders, diluents,
or excipients, to permit total dissolution and absorption of the pellets. Ex.: L
evonorgestrel
Levonorgestrel Implants These are a set of six flexible, closed capsules of a di
methylsiloxane/methylvinylsiloxane copolymer, each containing 36 mg of the proge
stin levonorgestrel These are found in an insertion fit to facilitate surgical s
ubdermal implantation through a 2 mm incision in the mid-portion of the upper ar
m about 8 to 10 cm above the elbow crease. These are implanted in a fan like pat
tern, 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. Irriga
tion and Dialysis Solutions Solutions for irrigation of body tissues and dor dia
lysis resemble parenteral solutions in that they are subject to the same stringe
nt standards. These solutions are not injected into the vein, but employed outsi
de of the circulatory system. Irrigation Solutions Irrigation solutions are inte
nded to bathe or wash wounds, surgical incisions, or body tissues. Ex.: 1. Aceti
c 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 de
bris away while maintaining suitable conditions for the tissue. 2. Neomycin and
Polymixin B Sulfate Solution for Irrigation, USP - Employed as a topical antibac
terial 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 s
olution is sterile and pyrogen free. 4. Sodium Chloride Irrigation, USP - This s
olution is employed topically to wash wounds and into body cavities where absorp
tion into the blood is not likely. The solution also employed rectally as an ene
ma for simple evacuation and also for colonic flush. 5. Sterile Water for Irriga
tion, USP - The label designations for irrigation only and not for injection must ap
pear prominently on the label. The water must not contain any antimicrobial or o
ther added agent.
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Dialysis Solutions May be defined as a process whereby substances may be separat
ed from one another in solution by taking advantage of their differing diffusibi
lity through membranes Peritoneal Dialysis Solutions allowed to flow into the pe
ritoneal cavity, are used to remove toxic substances normally excreted by the ki
dney 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 memb
rane bathed in an electrolyte solution. Following the dialysis, the blood is ret
urned to the body circulation through a vein.
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