SEDIAAN

PARENTERAL
Disusun oleh:
Jihan Istiqomah
11171020000098

PROGRAM STUDI FARMASI
FAKULTAS ILMU KESEHATAN
UIN SYARIF HIDAYATULLAH
JAKARTA
 What is parenteral
preparation ?

 Parenteral preparation are those pharmaceutical product
that are given by other than oral routes.
 Transfusion fluids and injection are parenteral preparation.
Injection are the sterile  solution or suspension of drugs in
aqueous or oily vehicle meant for introduction into  the body
by means of an injectable needle under or through one or
more layers of the skin or mucous membrane.
 Injection  should be sterile, isotonic and free from foreign
particles, such as dust, fibres etc.

(Pharmamed, 2019)
 
 Injections are sterile, pyrogen limited, that is, bacterial endotoxin units
limit, preparations intended to be administered parenterally. The term
parenteral refers to the injectable routes of administration. It derives
from the Greek words para (outside) and enteron (intestine) and
denotes routes of administration other than the oral route.
 Pyrogens, or bacterial endotoxins, are organic metabolic products shed
from Gram-negative bacteria which can cause fever and hypotension
in patients when they are in excessive amounts in intravenous (IV)
injections.
 In general, the parenteral routes are used when rapid drug action is
desired, as in emergencies; when the patient is uncooperative,
unconscious, or unable to accept or tolerate oral medication; or when
the drug itself is ineffective by other routes. With the exception of
insulin injections, which are commonly self- administered by diabetics.
(Ansel, 2011)
 ADVANTAGES OF
PARENTERAL PREPARATION

1. Onset of action is quick.

2. The drugs which can not be administered bo oral route, can be

administered by oral route.

3. The patients who are vomiting or unconscious can not take drug by
oral route, in such cases the drug can be administered by this route.

4. The drug action can be prolongs by modifying the formulation.

5. Tranfusion fluids containing nutritives such as glucose and electrolytes

like sodium chloride can be given by this route.

(Pharmamed, 2019)
  
DISADVANTAGES OF
PARENTERAL PREPARATION

1. Injection causes pain at the site of injection.

2. The trained persons are required to administer the drugs.

3. The administration of a drug through wrong route of injection may

prove to be fatal.

4. It is difficult to save a patient when overdose is given.

5. There are chances of sensitivity reaction of allergic reaction of a drug by

an individual. These reactions are sometimes very fatal and lead to death.
(Pharmamed, 2019)
 Stabilit
y

Chemica Sterilit
l purity

GENERAL
REQUIREMENT
y

S FOR
PARENTERAL
DOSAGE
FORMS. Free
Specifi
from
c pyroge
gravity n
Free
Isotonicit from
y foreign
particles

(Pharmamed, 2019)
 ROUTES OF ADMINISTRATION
OF PARENTERAL PRODUCTS  

 Intradermal ( intracutaneous injection)
 Hypodermis ( subcutaneous ) injection l
 intramuscular injection Drugs may be injected into almost any organ
 Intravenous route or area of the body, including the joints
(intraarticular), joint fl uid area
 Intra- arterial injections- (intrasynovial), spinal column (intraspinal),
 Intracardiac injections- spinal fl uid (intrathecal), arteries (intra-
arterial), and in an emergency, even the heart
 Intracardiac injections- (intracardiac). However, most injections go
 intracisternal injection into a vein (intravenous, IV), into a muscle
(intramuscular, IM), into the skin (intradermal,
 peridural injections. ID; intracutaneous), or under the skin
 intra- articular injections (subcutaneous, SC; sub-Q, SQ; hypodermic,
hypo)
 intracerebral injections (Ansel, 2011)
(Pharmamed, 2019)


(Ansel, 2011)
 
Solutions or
emulsions of
medicaments suitable
for injections

Sterile solid
TYPES OF
PARENTERA
L SOLUTION
Sterile suspensions

Transfusion fluids

(Pharmamed, 2019)
 FORMULATIONS OF
PARENTERAL PREPARATIONS
1) Vehicles

2) Adjuvants Solubilizing agents

Stabilizers

Buffering agents

Antibacterial agents

Chelating agents

Suspending, emulsifying and wetting agents

Tonicity factors
(Pharmamed, 2019)
Although an aqueous vehicle is generally preferred for an injection, it may
be precluded by the limited water solubility of a medicinal substance or
its susceptibility to hydrolysis. When such physical or chemical factors
limit the use of a wholly aqueous vehicle, the pharmaceutical formulator
must turn to one or more non-aqueous vehicles.


Aquous
Vehicle
Non-aquous

Non-irritating,
nontoxic in the
amounts
administered, and not
sensitizing.

(Ansel, 2011)
 SOLVENTS AND VEHICLES
FOR INJECTIONS

AQUOUS
1. water for injection, USP.
The most frequently used solvent in the largescale manufacturer of
injections.
2. Sterile water for injection, USP.
is packaged in single-dose containers not larger than 1 L. As with
water for injection, it must be pyrogen free but does have an
allowable endotoxin level. This water is intended to be used as a
solvent, vehicle, or diluent for already sterilized and packaged
injectable medications.
3. Bacteriostatic water for injection, USP.
Is sterile water for injection containing one or more suitable
antimicrobial agents.
(Ansel, 2011)
 
4. Sodium chloride injection, USP.
is a sterile isotonic solution of sodium chloride in water for injection.
5. Bacteriostatic sodium chloride injection, USP.
is a sterile isotonic solution of sodium chloride in water for injection.
6. Ringer’s injection, USP.
is a sterile solution of sodium chloride, potassium chloride, and
calcium chloride in water for injection. The three agents are present in
concentrations similar to those of physiologic fl uids.
7. Lactated Ringer’s Injection, USP.
has different quantities of the three salts in Ringer’s injection, and it
contains sodium lactate. This injection is a fl uid and electrolyte
replenisher and a systemic alkalizer.

(Ansel, 2011)
 
NON-AQUOUS
Often used
1. fixed vegetable oils,
2. glycerin,
3. polyethylene glycols,
4. propylene glycol,
5. alcohol,
Less used
6. ethyl oleate,
7. isopropyl myristate,
8. dimethyl acetamide.
(Ansel, 2011)


(Ansel, 2011)
 (Pharmamed, 2019)

PROCESSING OF PARENTERAL
PREPARATIONS
Cleaning of
containers,

Sealing the
Sterilization
closure and container
equipments

Filling the Evaluation of

Collection of
preparation in parenteral
material
final container preparations

Preparation of
Labelling and
parenteral Filtration
packaging
products
 METHODS OF Steam sterilization is conducted in an autoclave and
STERILIZATION employs steam under pressure.


For substances that are not effectively sterilized by
Steam moist heat. Such substances include fi xed oils;
glycerin; various petroleum products, such as
petrolatum, liquid petrolatum (mineral oil), and
Dry heat paraffin; and various heat-stable powders, such as
zinc oxide.
Is used for heat-sensitive solutions.
Filtration Some heat-sensitive and moisture-sensitive materials
can be sterilized much better by exposure to ethylene
oxide or propylene oxide gas than by other means.
Gas These gases are highly fl ammable when mixed with
air but can be employed safely when properly diluted
with an inert gas such as carbon dioxide or a suitable
fluorinated hydrocarbon. Such mixtures are
Ionizing radiation commercially available.
Techniques are available for sterilization of some
types of pharmaceuticals by gamma rays and by
cathode rays.
(Ansel, 2011)
 (Ansel, 2011)
Sterilization by Filtration


 
Steam Sterilization Sterilization by ionizing radiation

Dry Heat Sterilization (Ansel, 2011; google search)

 REFERENCES

 Pharmamad. 2019. Sterile Dosage Form. Diakses dari:
https://www.pharmamad.com/sterile-dosage-form
/ pada 16 Maret 2020.
 Ansel, Howard C., Popovich, Nicholas G., Allen,
Loyd v. 2011. Pharmaceutical Dosages Forms and
Drug Delivery Systems.