SEDIAAN STERIL

SEDIAAN STERIL

Sterilitas

Bebas dari
mikroorganisme
Pembagian Sediaan Steril
Pengemasan
Penggunaan
Bentuk fisik dari produk

Injeksi Single
Larutan
dose
Steril
unit Larutan diagnostik
Bentuk fisik dari produk
Infus Suspensi
MultipleSteril
dose Larutan dan salep mata

Penggunaan
Radiopharmaceutical
Cairan
Emulsi
volume
steril
besar Pelet steril

Zat padat kering Antikoagulan

Larutan irigasi Sediaan vaksin

Larutan dialisis
Sediaan Parenteral Berdasarkan Vol

Sediaan parenteral volume

besar (>100 ml)

Sediaan parenteral kecil

besar (≤ 100 ml)
 KARAKTERISTIK SEDIAAN STERIL
Persyaratan steril berlaku untuk semua
Wherever possible, parenteral products
STERIL
should be isotonic TONISITAS
sediaan parenteral, pengobatan mata dan alat
Pirogen merupakan bakteri endotoksin
kesehatan yang berkaitan dengan cara
yang dihasilkan
Hypertonic solutions
Kejernihan are preferable
atau tidak adanya bahanto pemberian tsb di pada kebanyakan
atas, bebas dari
hypotonic
partikelsolutions because
yang tampak of the risk
selalu bakteri gram negatif yang merupakan
mikroorganisme hidup merupakan jaminan
BEBAS PIROGEN
of hemolysis associated
dipertimbangkan with persyaratan
sebagai the latter. produkkeabsahan
terhadap
JERNIH
metabolikproses
dari pertumbuhan
sterilisasi yang
Auntuk
parenteral
Hypotonic product
formulations
produk should
can be be
parenteral. easily Obatmikroorganisme
digunakan
dalamdansediaan
pengemasan yangserta
larutanberupatehnik
cenderung
aseptik yang digunakan
lipopolisakarida merupakan air,jaminan
formulated
avoided by thewith
use aofpH close to often
excipients, menjadi kurang yang
stabillarut
daripada tahan
obat
STABIL
physiological,
sodium chloride,unless
to raisestability or
osmolarity. peniadaan mikroorganisme secara
panas,dapat menyebabkan respon
dalam bentuk kering. Pemilihan bahan
kontinyu.
solubility considerations preclude this. tambahan pH dan DAPAR
demam setelah penyuntikan,
membantu yang tidak
dalam peranannya
Often, the pH selected for the product dapat
pada dihancurkan denganfisika.
kestabilan secara proses
is a compromise between the pH of sterilisasi uap dan dengan filtrasi.
maximum stability, solubility, and
physiological acceptability.The target
pH for maximum physiological
acceptability is approximately pH 7.4
Persyaratan Steril

Sterilisasi
Sterilitas
Steril
Proses
Keadaan
baik
yang
steril
Sterilitas
Karakteristik
dariyang
penghancuran
vegetatif
hadir
yang
atau
pada
bebas
dibutuhkan
maupun
tingkat
dariatau
mikroorganisme
pada
objekkesterilan
spora,
eliminasi
atau sediaan
baik
sediaan
setelah
m.o
patogen
untuk
mencapai
dilakukan
maupun
suatu
proses
apatogen.
keadaan
sterilisasi
steril

Sterilisasi
 Persyaratan Produksi
Sediaan Steril
Personil yang bekerja pada bagian produk
steril, harus memiliki moral dan etika
profesional yang tinggi
Setiap personil mendapat latihan tentang
sediaan steril secara lengkap
Memiliki teknik spesialisasi untuk
memproduksi sediaan steril
Bahan yang digunakan harus bermutu
tinggi
Kestabilan dan kemanjuran produk harus
terjamin

Program quality control harus baik untuk

memastikan mutu produk dan memenuhi
keabsahan prosedur produksi.
 Introduction

PAR/PARA
Avoid
Parenteral is to avoid the intestine

ENTERON
The
intestine
 Sediaan Parenteral
Sediaan steril berupa larutan, emulsi, Larutan yang dimaksudkan
suspensi atau serbuk
Suatu yangyang
sediaan harusberupa
dilarutkan
larutan, emulsi suspensi atau
atau disuspensikan terlebih dahulu
untuk dimasukkan ke dalam
serbuk yang harus dilarutkan atau disuspensikan terlebih
sebelumdahulu
digunakan, yangdigunakan,
sebelum
tubuh dengan
disuntikkanyang disuntikkan dengan menggunakan
cara
dengan caramerobek
merobekjaringan
jaringankekedalam alat
dalamkulit atau suntik
melalui kulit atau
kulit atau melalui
selaputkulit atau
lendir selaput
untuk lendir kedalam tubuh dengan
dimasukkan
menggunakan alat suntik, dimana zat aktif dari sediaan
tersebut langsung ke dalam pembuluh darah, organ,
As those preparations intended
jaringan atau for injection
luka, sediaan tersebutthrough the skin or other external
harus memenuhi
persyaratan
boundary tissue, steril,pirogen,
rather than throughpartikulat atau kontaminan
the alimentary canal, so that the active
substances lainnya, dan paling
they contain utama mengandung
are administered usingbahan yang
gravity dapat directly into a
or force
blood vessel, organ, menghambat
tissue, orpertumbuhan mikroorganisme.
lesion. Parenteral products are prepared
scrupulously by methods designed to ensure that they meet pharmacopeial
requirements for sterility, pyrogens, particulate matter, and other
contaminants, and, where appropriate, contain inhibitors of growth of
microorganisms.
 History and Use of Parenterals
In the late 15th century Baxter produced the first
when a blood transfusion commercially prepared
from three young boys was intravenous solutions in 1913
given to Pope Innocent VIII,
In the mid 1960s, many hospitals
The 17th century introduced intravenous admixture
services.
In the mid-19th century.
 Morefor
Useful expensive
patientsand
whocostly
cannotto take
produce
drugs
orallyat site of injection
Potential for infection

Disadvantage Useful for drugs that require

Potential a rapid onset of
for sepsis
Advantages action (primarily intravenous administration)
s Potential for thrombophlebitis
Useful for emergency situations
Potential for fluid overload
Useful for providing sustained drug delivery
(implants, intramuscular
Psychological depot
distress injections)
by the patient

Advantages and Disadvantages of

Can be used for self-delivery of drugs
Require specialized equipment, devices, and
(subcutaneous)
techniques to prepare and administer drugs

Parenteral Formulations
Useful for drugs that are inactivated in the
Potential for pain upon injection
gastrointestinal tract or susceptible to first-
pass metabolism
Potential by the
for tissue liver upon injection
damage
Useful
Risk of for injectioninjuries
needlestick of drugsanddirectly into ato
exposure
tissue (targeted
blood-borne drug delivery)
pathogens by health care worker
Can be done
Increased in hospitals,
morbidity ambulatory
associated infusion
with long-term
centers,
vascularand in home
access health
devices careof
Disposal
needles,syringes, and other infusion devices
requires special consideration
 Routes of Parenteral
Administration
IV IM
SCIV
(Subcutaneous)
(Intramuscular)
(INTRAVENA) Extradural
This
Dueinvolves
This involves
to the Viscous
Faulty
subsequentformulations
injection
administration
administration
achieves dilutionintoare
atechnique
rapid
into of not
may generally
a muscle,
and
the the leadusually
injected
predictable
subcutaneous administered
to local
dosethe muscle
and
response.gluteal
tissue, the relative
a layer of
fat
IM
(buttocks),
insensitivity
located
muscles.
employed
vastus
below
Thefor
IM
ofthe
lateralis
venous
It ensures
musculature
dermis.
the administration
injections are
subcutaneously
walls damage.
(lateral
100%of thigh)
resides below
usually
veins, or
IV administration
deltoid (upper arm)
drug bioavailability.
of drugs
used
thethat
for
subcutaneous
would normally
controlled-release
may be
Intradural
tissue be
BothTherelarge-
is Typical
(which itselftoo
a(up
slower
to sites
500onset
liesirritating
beneath
ml) of
and
ofifthe
SC action
small-
injection and
(up
epidermisinclude
administered
sometimes
and
to 10
by other
the
ml)
the arms, legs and formulations.
volume
less
dermis).
routes.
total absorption
abdomen.of
formulations
infused
Care must
the10rate
nutrition,
SC
therapeuticmay
Theintovolume
administration.
be
the
agentsbe administered
vein at
when compared
ofAsinjection
before,
SC administration
mlinfusiontaken
in insulin.
of divided
drug ofregarding
doses. from
absorption
solutions
is small,
a controlled
the
the
intravenously.
isnature
rate
to the IV orLarge
usually
therate,
route
of
of1–3
ofe.g.
the total
IM routes

IC
ml or
formulation
choice
administration
of electrolytes/nutrients
volumes
forup
parenteral
this site: oily solutions
the
of
to
of are
directly
the
either
or aqueous
affects of
administration
parenteral formulation. If the administration issecond
performed tooIVquickly,
containing
the time
suspension
IM injection
an excessive
TheFormulations
volumeto
leading
the rate
results

of absorption
ID
or devoid
ofintherapeutic
of drugs.
relatively
taken forconcentration
the onset of action.
ofdrug-induced
injection
are usuallyis typically
of drugs
agents
rapid
of drugThe
solutions
shock. circa
exhibit slower
absorption,
at the
nature
or1emulsions IT
target
ml; however,
oforgan
drug absorption.
only to with respect to
may result,directly affects
the formulation
large-volume
(in which the size parenteral
administered by the IM route. Drug absorption from
of
solutions (electrolyte
the disperse phaseorisdextrose,
small, 1 lm). up to 1000 ml) may
Suspensions be infusedthat
(or solutions subcutaneously.
Thisprecipitate
based)
technique within
difficulty
solutions
toTraining
is termed
of
in accessing
disruption
administered
to increase
of blood
thehypodermoclysis
drugs.
is required a vein.
to the volume
the available
On someIA
aqueous solutions is greater than from aqueous suspension or non-aqueous (oil-
blood stream) must
toflow.
ensure
vein andatthat
thatoccasions
andnot
the dosage
the puncture
is only employed when
be administered
form is actually
hyaluronidase
of the vein
site by catalysing
there is
IV due
may be administered
theistemporary
avoided. breakdown
of the connective tissue at the site (hyaluronic acid).
 Routes of Parenteral
Administration
IAIC
IT(Intra-arterial)
(Intracardiac)
(Intrathecal)
Intradural and Extradural
ID (Intradermal)
This route
Route is used
involves
Injected to administer
injection
into anof therapeutic
the formulation
accessible agents
artery. directly
Intradural and extradural administration is
to
This the
is cerebrospinal
the
into the musclesinjection fluid
into
of the to
the ensure
dermal that
layer the
of
heart. spinal anaesthesia.the skin.
employed to achieve
appropriate concentration of drug is obtained at
Thissite
route requires specialist training to administer
this
Generally (e.g.
used for the
for astreatment
diagnostic of infection).
purposes, e.g. for
This route
Intradural
therapeutic isagents
normally
administration used
ifinvolveswhenever
injection
the artery there
of the
is missed, is athe
possible
diagnosis
cardiac to
therapeutic
damage ofadjacent
agent allergy
emergency. within and
thefor
Other
nerves the membrane
more
dural
may tuberculin
specialised
result. test.
routes
areDespite
surrounding employed
thebeing forathe
spinal cord.delivery
vascular site,ofabsorption
the therapeutic
is slow and
agent directly
Used tofrom
limited to
administerthe target site/region.
radiopaque media to visualise
this region.
organs, e.g. heart,
Extradural administration kidney.
involves injection of the
therapeutic agent Onlyoutside the duralmay
small volumes membrane and circa 0.1 ml.
be injected,
within the spinalIt is caudal
used tocanals.administer anticancer drugs to ensure
that the highest possible concentration of drug
reaches the target organ.
Terima kasih