Injection Infusion Powder for injection Concentrated solution for injection Implants,Parenteral (GK, para enteron, beside the intestine) dosage forms differ from all other drug dosage forms,because they are injected directly into body tissue through the primary protective system of the human body,the skin,and mucous membrane.

1. PARENTERAL
PRODUCTS

2. Parenteral (GK, para enteron, beside the intestine) dosage forms differ from all other drug dosage
forms,because they are injected directly into body tissue through the primary protective system of the human
body,the skin,and mucous membrane.
CHARACTERISTICS
●
All products must be sterile.
●
All products must be free from pyrogenic
contamination.
●
Product should be isotonic,although strictness of
isotonicity depends on the route of administration.
●
IV infusion must be isotonic.
ADVANTAGES
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Use for patient who can not drugs orally.
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Rapid onset of action.
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Useful for emergency situations.
●
Providing sustained drug delivery,avoid first pass
metabolism.
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Can inject drug directly into a tissue.
DISADVANTAGES
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Pain on injection.
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Difficult to reverse an administered drug effect
●
Trained persons is required.
●
Required specialized equipment,devices,and
techniques to prepare administer drugs .MORE
expensive and costly to produce.
DEFINITION

3. ROUTE OF ADMINISTRATION
●
Inta venous
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Intra muscular
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Subcutaneous
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Intra dermal
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Intra arterial
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Intra cardiac
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Intra cerebral
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Intra thecal
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Intra cisternal
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Peridural
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Intra articular
PRE FORMULATION FACTORS
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Colour
●
Molecular structure and weight.
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Particle size and shape.
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Thermal analytical profile.
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Solubility .
●
Ionisation constant.
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Partition coefficient.

4. GENERAL REQUIREMENTS
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Stability
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Sterility
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Free from pyrogens
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Free from foreign particles
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Isotonicity
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Specific gravity
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Chemical purity
VEHICLES
1.AquoUs vehicle
-Water for injection
-Bacteriostatic water for
injection
-Sterile water for
injection (SWFI)
2.Non-aquous vehicle

5. TYPES OF PARENTERAL PRODUCTS
●
Injection
●
Infusion
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Powder for injection
●
Concentrated solution for injection
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Implants
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Injectable emulsion
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Injectable suspension
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Oily injection
-According to dose
1.Single dose preparation
2.Multi dose preaparation
-According to volume
1.Large volume parenterals
2.Small volume parenterals
ADDITIVES
●
Antimicrobial agent
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Buffer agent
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Anti oxidants
1.True anti oxidants
2.Reducing agent
3.Anti oxidant synergists
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Tonicity modifiers
●
Suspending agents
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Emulsifying agents
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Chelating agents
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Solubilizing agen

6. PRODUCTION OF PARENTERAL PRODUCTS
Production of parenteral product is different
from production of other Pharmaceutical
preaparations.The guidelines regarding the entry
of micro- organisms and impurities are more
stingent as compared to non sterile dosage forms.
The general procedure for manufacture of
parenteral products :
1.Preparation of soluton
2.Sterilisation
3.Processing of sterile products
4.Termination sterilisation
5.Sterilisation by filtration
6.Aseptic preparation.
7.Filling packaging and labelling
ISOTONICITY
For a solution to be termed as isotonic (equal
tone) it must have the same osmotic pressure as
that of specific body fluids( blood plasma or any
specific fluid)
Examples of tonicity modifiers -sodium
chloride,potassium chloride, dextrose
mannitol,sorbitol.
SIGNIFICANCE OF ISOTONICITY

7. WATER FOR INJECTION(WFI)
Procedure for production of WFI
1.Compression distillation
2.Multiple effect still
3.Reverse osmosis
LARGE VOLUME PARENTERALS (LVP)
TYPES: 1.Hyper alimentation solution
2.Cardiolplagic solution
3.Peritonial dialysis solutions
4.Irrigating solution
SMALL VOLUME PARENTERALS (SVP)
TYPES: 1.Solution
2.suspention
3.Emulsion
4.Dry powder
PRODUCTION FACILITIES AND
CONTROL
Area in parenteral processing
1. Clean up section
2. Compounding section
3. Aseptic section
4.Quarantine section
5.Packing and labelling section
Requirement for design of asceptic
area :
1. Site of premises
2.Size of premises
3.Windows
4. Doors
5. Floors, walls, bench tops

8. TYPES OF LAMINAR FLOW
SYSTEM
1.Vertical flow system
2.Horizontal flow system
3.Wall to floor flow system
SOURCES OF CONTAMINATION
1.Atmospheric contamination
2.Fluid contamination
3.Transfer contamination
TESTING OF CONTAMINATION
Glass :
1.Powder glass test
2.Water attack test
Plastic :
1.Leakage test
2.Water vapour permeation
test

9. ●
Lime soda glass
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Borosilicate glass
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Neutral glass
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Neutral tubing for ampules
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Lead free glass
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Sulphured containers
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Silicon treated containers
Thermo plastic
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Polyethylene
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HDP
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PCV
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PMMA
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Polypropyline
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PTFE
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Polyamide
Thermoseting plastic
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Phenol formaldehyde
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Urea formaldehyde
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Melamine formaldehyde
SINGLE DOSE INJECTION OF
SMALL VOLUMES
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Ampoules
●
Cartridges
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Injection units
SINGLE DOSE INJECTION OF
LARGE VOLUME
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British standard transfusion bottle
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Other containers
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Disposable plastic glass syringes
MULTIPLE DOSE INJECTIONS
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Rubber capped vial
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Clinbritic bottle
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Antibiotic vial
CONTAINERS
Glass Plastic
CLOSURES
1.Natural rubber
2.Synthetic rubber
TYPE OF INJECTION CONTAINERS

10. FORMULATION OF INJECTION
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Vehicles
●
Additives
1.Solubilizing agent
2.Stabilizers
3.Buffering agents
4.Antibacterial agent
5.Chelating agent
6.Suspending/emulsifying agent
7.Tonicity factors
STERILE POWDERS
Methods of preparing a sterile product
1.Sterile recrystallisation
2.Lyophilization
3.Spray drying
PROCESSING
There are 4 stages in the complete
drying process
1.Pretreatment
2.Freezing
3.Primary drying
4.Secondary drying

11. thank you..