Sterile

Preparations
Pharmaceutics I

apt. Niken N. Widyakusuma, M.Sc.

1
Definition

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

2
Examples of Injection (Injectiones)
Sterile
Preparations
Loading…
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)

4
Injection Route

• Intracutaneous (ic) /intradermal

• Subcutaneous (sc)
• Intramuscular (i.m)
• Intravenous (iv)
• Intraarterial (i.a) Loading…
• intraperitoneal (i.p)
• Intrathecal/intraspinal
• Intraarticular
• Intrapleural
• Intracardial
• subconjunctiva
5
 • Drug solution Insulin injection
• Drug without solvent Ampicillin
Sodium Sterile
• Drug+excipient, without solvent
Amphotericin B For injection
• Without solvent, form suspension
Triamcinolone Acetonide
Type of injection Suspension Sterile
• With solvent, form suspension
preparation Ampicillin Sterile For Suspension

6
 Advantages and Disadvantages Injection

• Need help from trained

professionals to administer
• Not practical, need syringe
• Work very fast • Invasive painful
• Bioavailability almost perfect • After injected, no one can control
• Can be given to patients who the effect what if patient has
cannot receive medication by allergy/side effect
mouth • Relatively more expensive
• Used for drug which can damage
digestive tract when given orally

7
 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

8
 Vials
Multiple dose
container (50-100 ml)

Containers

Ampoule
Single dose container
(1-10ml)

9
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)

10
 Advantages and Disadvantages Infusion Intravenous

• Need help from trained

professionals
• Not practical
• Invasive painful

• For basic nutrition, repair

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

11
 Ideal condition Receptacle
• Clear solution • Receptacle dose single
• Free particle • Example bottle infusion or
• Isohydric receptacle plastic500 ml
• Isotonic

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

12
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)

13
 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

14
Vaccine
Sediaan yg mengandung zat antigenik yg
mampu menimbulkan kekebalan aktif dan
khas pada manusia
(FI IV)

15
Immunity
Antigen vs Antibody

Active Immunity Passive immunity

Natural Artificial Natural Artificial

16
 Frozen Dried Basil Calmette-
Guérin Vaccine
Examples of
vaccine
Vaccinum Typhoidia

Vaccinum Cholerae

Vaccinum Polyomyelitidis
per Orale

17
• Temperature 2 - 8º C
• protected from light Product
• Should not be frozen description

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

18
Immunosera
Sediaan cair atau sediaan kering beku yang
mengandung imunoglobulin khas yang
diperoleh secara pemurnian serum hewan
yang telah dikebalkan.
(FI IV)

19
• 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

20
• in an opaque/light-protected container
• If it is a multiple dose, suitable
Tagging
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

21
 Immunoserum Botulinicum
Example (Antitoxinbotulinum)

Immunosera
Immunoserum
Tetanicum (Tetanus
Antitoxin)

Immunoserum
Diphthericum (Antitoxin
Diphtheria)

22
Oculenta
Salep yang digunakan pada mata.
(FI IV)

23
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

24
 Tagging
• In a sterile tube
• protected from light
• Store in cool temperature • Must state: eye ointment

ReceptacleAndStorage

25
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)

26
 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”

27
Thank
you

28