Teknologi Sediaan Steril

Sediaan Parenteral
M. Ilham Tomagola, S. Farm., M.Si., Apt.
Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar
 Indikasi
Rute pemberian Keuntungan dan
Pendahuluan penggunaan
injeksi Kekurangan sediaan parenteral

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar
 The word is derived from the Greek words
and , meaning outside of intestine and
is used for those dosage forms administered by
routes other than the oral route.

The parenteral route of administration

is generally adopted for medicaments
that cannot be given orally, either
because of patient intolerance (for
example nausea in patient undergoing
chemotherapy), or because of
instability, therapeutic inactivity or
 Applied to preparations administered by injection poor absorption via the enteral route
through one or more layers of skin tissue.
 may produce a localized response (local
anesthetics, injections of corticosteroid), or an
extremely rapid general response by direct
systemic administration
Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar
 Sterility and Freedom
from particulate matter

The form administered

parenterally are also
pyrogen free
Parenteral

For drug products, Stability becomes

an additional consideration

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar
 Intravenous injection are administered directly into a prominent vein,
normally in the forearm. They are usually aqueous solutions, but may also
be oil in water emulsions in which the droplet size is carefully controlled.
Water in oil emulsion and suspensions must not be given by this route.

Intramuscular injection are administered into a muscle mass. A common site is the deltoid muscle of the
upper arm. Absorption is relatively rapid following administration via intramuscular route in comparison to
the subcutaneous route, but intramuscular administration will not mediate the rapid response that is
possible via intravena route.

Subcutaneous injection are administered into the loose tissue immediately below the dermis
layer of the skin. The most popular sites for subcutaneous injection are the arm an thigh.
Absorpsion after subcutaneous administration is slower than that following intramuscular
administration.

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar

 Intraarterial injection are
similar to intravenous injection
except that the drug is
administered directly into an
artery rather than vein.
Intradermal injection are
injected into skin between the
epidermis and the dermis. This
route is also referred to as the
intracutaneous route.

Intracardiac injection are aqueous Intraarticular injection are

solutions injected directly into either the aqueous solutions or suspensions
cardiac muscle or a ventricle. They are that are injected into the synovial
used in emergency treatment only. fluid in a joint cavity.

Intraspinal injection are also aqueous solutions injected into particular

areas of the spinal column. Intraspinal injections are further sub-divided
according to the area of spinal cord into which the injection is given.
These are intrathecal or subarachnoid, intracisternal and epidural or
peridural injection.

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar

 The most common are Subconjunctival injection, which are administered beneath Tenon’s capsul,
close to the eye but not into it. Intracameral injection are administered into the anterior chamber,
Intravitreous injection into vitreous humour, and Retrobulbar injection into the posterior segment of
the globe

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar

 Intraarterial Intraarticular injection
injection
Intraspinal injection

There are several other sites available for the administration of injectable
products. These include the peritoneum (intraperitoneal), the amniotic fluid
(intra-amniotic), the lymph (intra-lymphatic), the ureter (ureteral) and the
pleural cavity (Intrapleural). This list is not exhaustive.

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar
 The disadvantages of parenteral
products are predominately
Generally, parenterally associated with safety issues
administered drugs are related to infection and
advantageous because they thrombosis, tissue damage
can provide rapid and reliable and/or pain upon injection and
drug systemic effects, long- the use requirements for
term delivery and targeted specific equipment, devices and
delivery. technique.

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar

 Advantages
Useful for patients who cannot take drug orally
Useful for drugs that require a rapid onset of action
(primarily intravenous administration)
Useful for emergency situation
Useful for providing sustained drug delivery (implant,
intramuscular depot injection)
Can be used for self-delivery of drug (subcutaneous)
Useful for drugs that are inactived in the GI tract or
susceptible to first-pass metabolism by the liver
Useful for injection of drug directly into a tissue
(targeted drug delivered)
Useful for delivering fluids, electrolytes or nutrient
(TPN for patient)
Useful for providing precise drug delivery by IV
injection or infusion utilizing pharmacokinetic
techniques
Can be done in hospital, ambulatory infusion centers
and in home health care
Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar
Disadvantages
More expensive and costly to produce
Potential for infection at site of injection
Potential for sepsis
Potential for thrombophlebitis
Potential for fluid overload
Potential for air embolism
Potential for extravasation
Physichological distress by patient
Require specialized equipment, devices and techniques
to prepare and administrater drug
Potential for pain upon injection
Potential for tissue damage upon injection
Risk of needlestick injuries and exposure to blood-
borne pathogenis by health care worker
Increased morbidity associated with long-term vascular
access devices disposal of needles, syringes and other
infusion devices requires special consideration
Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar
 Medicaments that cannot given orally, either because of patient intolerance (for
example nausea in patients undergoing chemotherapy) or because instability,
therapeutic inactivity or poor absorption via the enteral route.
 Injection are often preferred for use in emergency therapy because they can
produce an extremely rapid and effective response.
 In the unconscious patient, parenteral administration is the only safe and
effective means of administering medicaments
 Parenteral therapy also gives the physician control of the drug regimen, since the
patient must return for continued treatment in most cases, thus aiding
compliance in patients who cannot be relied upon to take oral medication

Program Studi Sarjana Farmasi,Fakultas Farmasi, Universitas Muslim Indonesia, Makassar

 Sekian
dan
Terima Kasih