C-15 Parenterals
C-15 Parenterals
C-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 6. Intrasynovial
–joints –joint fluid
2. Intraspinal 7. Intrathecal
–spinal column –spinal fluid
3. Intra-arterial 8. Intracardiac
–arteries –heart
4. Intravenous 9. Intramuscular
–veins –muscles
5. Intradermal 10. Subcutaneous
–shin –under the skin
ROUTES
PARENTERALS
Injections- (1874) Earliest injectible drug:
Mophine solution
Preparation intended to be administered
parenterally
Sterility is important because they are placed in
direct contact with internal body tissues or fluids,
Sterile
Pyrogen- free
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
complex)
Form: Powder for solution for injection
Botulinum toxin
Example:
Metoprolol (beta blocker)
– 3 bolus injections of 5 mg each
at about 2-minute intervals;
– oral dosing (100 mg/day)
Intravenous Route (IV)
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 Route (IV)
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
INTRAVENOUS
Different lengths of needles
Intravenous Route (IV)
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
Injections
Blood immiscible liquids, such as
oleaginous 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.
Following differences with other
preparations
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 specially trained and clothed to maintained 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 and
• 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
I L size.
• as water for Injection, it must be pyrogen free and may
not contain an anti-microbial agent or other added
substance.
Solvents and Vehicles for Injections
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”.
Example: 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 anti-
microbial agents
Solvents and Vehicles for Injections
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
BACTERIOSTATIC
WATER SODIUM
CHLORIDE
INJECTION, USP;
POTASSIUM
CHLORIDE
SODIUM CHLORIDE
INJECTION, USP
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.
conducted at temperatures of 1600C to
1700C for periods not less than 2 hours.
B. Nonthermal Methods
1. 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.
2 MAIN DIVISIONS OF STERILIZATION
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
unit 2 mL
Single-dose
vials
BUTORPHANOL
TARTRATE
INJECTION
8 fl oz
8 mL
Multi-dose
TAGAMET vials
300 mg/2 mL
Product Classification: RX
Manufacturer: SMITHKLINE
LANOXIN
BEECHAM PHARM
FUROSEMIDE
INJECTION
SODIUM
BICARBONATE
INJECTION
>>>IRON
DEXTRAN
INJECTION
LIDOCAINE<<
HCL
INJECTION
MIDAZOLAM HCL
INJECTION>>>>
>>PROCAINE
PENICILLIN G
INJECTION
>>NALBUPHIN
HCL
INJECTION
MAGNESIUM SULFATE
PHYTONADIONE
Examples of some Injections Usually
Package and Administered in Small Volume
Am ino Acid Inje ct ion 3 .5,5 ,5 .5 ,7,8 .5 ,1 0 % cryst a lline am ino Flu id / Nut rie nt re ple nishe r
acid s wit h or wit hou t varyin g
conce nt rat ions of e le ct ro lyt e s or g lyce r in
De xt rose Inje ct ion,USP 2.5 ,5 ,1 0 ,2 0% de xt rose , ot he r st re ngt hs Flu id/ Nut rie nt re ple nishe r
De xt rose and sod iu m Dex t rose var ying f rom 2 .5 t o 1 0% and Flu id/ Nut rie nt / Ele ct rolyt e
chlor ide Inje ct ion,USP sodiu m chlo ride f rom 0 .11 (1 9 mEq Na) e le c t ro ly t e
t o 0.9 %(1 5 4 mEq so d ium)
Mannit o l In je c t io n, US P 5,10,15,20 and 25 % mann it o l Diag no s t ic aid in re na l
f unc t io n d e t e rminat io ns ;
d iu re t ic . Fluid / Nut rie nt
Ring e rs ’ In je c t io n, US P 1 47 mEq s od ium, 4 mEq p ot as s ium Fluid / e le c t ro ly t e
c alc iu m, and 1 56 mEq c hlo rid e / lit e r
Lac t at e d Ring e r’s 2.7 mEq c alc ium, 4 mEq p ot as s ium, Sy s t e mic alk alin iz e r; Inje c t io n,
US P 1 30 mEq s od ium a nd 2 8 mEq f luid and e le c t ro ly t e
lac t at e p e r lit e r re p le n is he r
So d ium Ch lo rid e 0 .9 %s o d ium Chlo rid e Fluid and e le c t ro ly t e Inje c t io n,
US P re p le n is he r, is o t o nic
ve h ic le
INSULIN INJECTION
SITES
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.
2. Utilized as Replacement therapy in
patients who have suffered a heavy
loss of fluid and electrolytes.
Maintenance Therapy
Is 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
Replacement Therapy
Is 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
Sodium loss/deficit:
3 to 5 g sodium chloride (51 to 85 mEq of sodium) is
administered daily
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 B1 – 3 to 3.35 mg
Vitamin D – 200 I.U. Vitamin B6 – 4 to 4.86 mg
Vitamin E – 10 I.U. Pantothenic Acid – 15 mg
Vitamin C – 100 mg Folic Acid – 400 mcg
Niacin – 40 mg Vitamin B12 – 5 mcg
Vitamin B2 – 3.6 to Biotin – 60 mcg
4.93
mg
Components of Parenteral Nutrition solutions
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
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.
Examples of Irrigation Solutions
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.