Sterile Dosage Forms and Technology

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Learning Outcomes
Sterile Dosage Forms
01
and calculation

02 Preformulation

03 Formulation

Sterility Test and

04
pyrogenetic test
 Class Rules
Time Evaluation
1 SKS Theory : 50/45 minutes Mid exam : 35%
2 SKS Practice : 2 x 160/145 minutes Final exam : 35%
200 minutes practice lab Task + soft skill (include quiz) : 30%
120/90 minutes yaitu pre dan post practice
UP I : 30%
Late maximum : 10 minutes? UP II : 35%
UP III : 35%
No eat and snacking, No SLEEP!
Keep the camera ON during class Final score : ((NT X SKS) + (NP X SKS))/Total SKS
Drink is allowed

Keep the class comfortable for everyone

Pro active!!
 References
Armstrong, N.A., and James, K.C., 1996, Pharmaceutical Experimental Design and
Interpretation. Taylor and Francis, Bristol.

Aulton,M.E., 1988, The Science of Dosageform Design, Churchil Livingstone, Edinburgh.

Avis, K.E., Lachman, L, and Lieberbamn, H.A., 2000, Pharmaceutical Dosageform :

Parenteral, Tablet, Disperse System, vol I, II, III, Marcel dekker Inc., New York.

Banker, G.S. and Rhodes, C.T. 2002, Modern Pharmaceutics, 3rd. Ed., MNarcel-Dekker Inc.,
New York.

Gennaro A.R, 2013, Remington : :The Sience and Practice of Pharmacy, 22nd Ed., Mack
Publ. Co., Pensylvania.

Lachman, 1986, The Theory and Practice of Industrial Pharmacy, 2nd, Ed., Lea & Febiger,
Philadelphia.
Sterile dosage Forms
Q Q
Sterile? Sterilization? Dosage form of sterile

Q product?

How to make sterile dosage

Q
Q forms?

Administration?
Why should be sterile?

Q
How to make sure the
sterility?
Q
Production facility?
 Sterile Products
01 Sterile 02 Why? 03 So, why?? 04 What?
Free of viable Injected through the skin
As first line of body - Starting material
microorganism or mucous membranes
defense - Production facility
into internal body
compartments - Manufacturing
Absolute condition process
(Relative - Person
connotation and
probability) of a total
destruction or
elimination of all
living microorganism
REMEMBER SAL!
06 Administration 05 How?
- Biovalaibility Sterilization ?
- Fast effect
- Targeted
Sterile
Dosage Forms Administration
Dosage - Small volume injection - Intravenous
Water or non water based - Intraspinal

Forms Oil
Suspension
Reconstitution powder
-
-
-
Intramuscular
Subcutaneous
Intradermal
- Ophthalmic preparation
- Large volume injection
Water based

- Semisolid
Ointment
Cream
Gel

- Eye drops

- Solid
Pellets
Implantation tablet
 Administration route
Intravascular Nonvascular injection

Absorption, passive diffusion

Absorption affected by :
Isotonic
1. PSD
2. Blood supply
3. Movement of tissue
4. Physicochemical properties
Has lipophilic and hydrophilic properties (Why?) 5. Dosage forms

Solution Solution
Suspension (particle size?, %) Suspension 5%
Emulsion
ACHTUNG!! Blockage of fine capillaries
 Nonvascular
Intramuscular, Intracutaneous Intraspinal
Subcutaneous

Solution
Suspension Less than 0.2 mL tissue
10 mL or less
Emulsion volume
Solid pellets

Intramuscular < 2 mL Absorption slow  lack of Absorption?

Subcutaneous < 1 mL blood vessels

Hypertonic for rapid Example? Example?

absorption
 Ophthalmic preparation
Location Dosage forms (conventional) Dosage form (new)

External surfaces (topical) Solution Gel

Inside (intraocular) Suspension Gel forming solution

Adjacent (periocular) Ointment Ocular inserts

Intravitreal injection

Implants
Specification
Example Text :
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Sterility Tonicity
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− Calculation
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Template will your Time,
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molds and viruses. The gram or filtration procedure? MoneyHealthy
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human body : -0.52ºC
negative bacteria produce the most
potent pyrogenic substance as 2. Sodium
Example Text : chloride equivalent
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Leakage test that is beautifully
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of NaCl that
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 Calculation of tonicity
1 2

3
 Thermal
Physical
Non
Thermal
Sterilization
technique
Gas
sterilization
Chemical
Surface
disinfection
Conclusion