Sterile

Preparations
Pharmaceutics I

apt. Niken N. Widyakusuma, M.Sc.

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Definition

Sterile preparations
Therapeutic preparations which free from
micro-organisms: either its vegetative or
generative form (spores), either pathogen
or nonpathogenic

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Examples of
Injection (Injectiones)
Sterile
Preparations
Infusion iv (infundabilia)

Implant/susuk (pellets)

Vaccina and Immunosera

Eye ointment/ eye drops

(Oculenta and guttae 3
ophthalmicae)
Injection
Sediaan steril berupa larutan, emulsi,
suspensi atau serbuk yang harus dilarutkan
atau disuspensikan lebih dahulu sebelum
digunakan, disuntikkan dengan cara
merobek jaringan ke dalam kulit atau
melalui kulit atau selaput lendir.
(FI III)

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Injection Route

• Intracutaneous (ic) /intradermal

• Subcutaneous (sc)
• Intramuscular (i.m)
• Intravenous (iv)
• Intraarterial (i.a)
• intraperitoneal (i.p)
• Intrathecal/intraspinal
• Intraarticular
• Intrapleural
• Intracardial
• subconjunctiva

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 • Drug solutionInsulin injection
• Drug without solvent Ampicillin
Sodium Sterile
• Drug+excipient, without solvent
Amphotericin B For injection
• Without solvent, form suspension
Triamcinolone Acetonide
Suspension Sterile
Type of injection • With solvent, form suspension
preparation Ampicillin Sterile For Suspension

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Advantages and Disadvantages Injection
• Work very fast
• Bioavailability almost perfect
• Can be given to patients who
cannot receive medication by
mouth
• Used for drug which can
damage digestive tract when
given orally
• Need help from trained
professionals to administer
• Not practical, need syringe
• Invasive painful
• After injected, no one can
control the effect what if
patient has allergy/side effect
• Relatively more expensive
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Ideal condition Material addition
•clear • antioxidant: Na metabisulfite
•No color change • preservative: chlorbutanol
•isohydric • solubilizer: surfactant
•isotonic • buffer : buffer phosphate
•Sterile

Solvent
• Aqua p.i
• Olea p.i

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 Vials
Multiple dose
container (50-100 ml)

Containers

Ampoule
Single dose container
(1-10ml)

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Intravenous infusion

Sediaan steril berupa larutan atau emulsi,

bebas pirogen dan sedapat mungkin
isotonus terhadap darah, disuntikkan
langsung ke dalam vena dalam volume
relatif banyak.
(FI III)

Special injection because it is

administered/given slowly for big
volume of liquid (500 ml)

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Advantages and Disadvantages Infusion Intravenous

• Need help from trained

professionals
• Not practical
• Invasive painful

• For basic nutrition, repair

electrolyte balance
• Replacing body fluid, ex.
infusion dextrose and NaCl
• Help to diagnosis
• Drug substance carrier

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Ideal condition Receptacle
•Clear solution • Receptacle dose single
•Free particle • Example bottle infusion or
•Isohydric receptacle plastic500 ml
•Isotonic

If it is an emulsion infusion:
•The external/continuous phase should be water (O/W)
•Diameter phase is no more than 5 µm
•Still homogeneous, even after shaken

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Implant
Implan atau pelet adalah sediaan dengan
massa padat steril berukuran kecil, berisi
obat dengan kemurnian tinggi (dengan atau
tanpa eksipien), dimaksudkan untuk
ditanam di dalam tubuh (biasanya
subkutan).
(FI III)

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Advantages and Disadvantages Implant

• Need help of trained

professionals
• Not comfortable
• High effectivity • Still need to remove-reinstall in
• Increase adherence periodic time
• if patient experience side effect,
implant can be removed
• Used for drug which required
consistent dose in a (very) long
time

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Vaccine
Sediaan yg mengandung zat antigenik yg
mampu menimbulkan kekebalan aktif dan
khas pada manusia
(FI IV)

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Immunity
Antigen vs Antibody

Active Passive
Immunity immunity

Natural Artificial Natural Artificial

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 Frozen Dried Basil Calmette-
Examples of Guérin Vaccine

vaccine
Vaccinum Typhoidia

Vaccinum Cholerae

Vaccinum Polyomyelitidis
per Orale

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• Temperature 2 - 8º C
• protected from light Product
• Should not be frozen description

• Amount per ml
Storage • Name and bacteriocidal concentration
added
• Date expired

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Immunosera
Sediaan cair atau sediaan kering beku yang
mengandung imunoglobulin khas yang
diperoleh secara pemurnian serum hewan
yang telah dikebalkan.
(FI IV)

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• Immunosera tied the same germs/virus/antigen with the antigen used in
its production process
• Making method: Healthy animals is immunized with toxin/toxoid, venom
(snake), suspension of microorganism, or other suitable antigens
• Toxin= poison= product from bacteria
• Toxoid= Modification and detoxification from toxin, using heat and
chemical in such way that the antigent remains but less toxic

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•in an opaque/light-protected
container
Tagging
•If it is a multiple dose, suitable
preservative must be added
•Store in temperature 2-8 C
•Avoid freezing • The minimum amount (units per ml)
• Dose
• Date expired
• Storage condition
Container And Storage • Reconstitution volume (for dry powder)
• Excipient
• The species name as the source of
immunoserum

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 Immunoserum Botulinicum
Example (Antitoxinbotulinum)

Immunosera
Immunoserum
Tetanicum (Tetanus
Antitoxin)

Immunoserum
Diphthericum (Antitoxin
Diphtheria)

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Oculenta
Salep yang digunakan pada mata.
(FI IV)

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Requirements of Eye Ointment
• Not irritating
• Enable drug diffusion in eye fluid
• Maintain drug activity under appropriate storage
• Must contain appropriate material prevent growth/destroy microbes
• Free of rough particles
• Meets the requirements of Leakage & Metal Particles in the eye ointment test.
• Not using cera/ other material with high melt point

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 Tagging
•In a sterile tube
•protected from light
• Must state: eye ointment
•Store in cool temperature

ReceptacleAndStorage

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Eye drops
sediaan steril yang berupa larutan atau
suspensi yang digunakan dengan cara
meneteskan obat pada selaput lendir mata
disekitar kelopak mata dari bola mata.
(FI III)

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Ideal condition Container
•Sterile • Glass/plastic
•Isohydric • Tightly closed
•Isotonic • vol. 10 ml, equipped with dropper
• All containers must clean before
used (or sterilized if needed)

Tagging
“Cant be used > 1month after
opened”

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Thank
you

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