This document discusses the manufacturing techniques of parenteral products. It begins with an introduction to parenterals and their advantages and disadvantages. It then discusses the types of parenterals including large volume parenterals (LVPs) and small volume parenterals (SVPs), and their formulations. The document provides details on the manufacturing processes of LVPs using blow fill and seal technology and of SVPs such as ampules. It compares LVPs and SVPs and concludes that the parenteral route is effective for delivering drugs that cannot be taken orally or that are highly hydrophobic.
3. CONTENT
Introduction
Advantages & Disadvantages
Types
Formulation
LVP
Manufactuing of LVP
SVP
Manufacturing of SVP
LVP VS SVP
Conclusion
4. OBJECTIVE
To get introduced with the Manufacturing technique
of Parenteral Preparations.
To get discussed about the process of Parenteral
Preparation Manufacturing
5. INTRODUCTION
Parenteral
Products
Greek word”
Para” outside
& “Enterone”
Intestine
Administered
directly in the
veins ,
muscles or
under the skin
Term parenteral
used for any
drugfluid whose
delivery doesn’t
utilize the
alimentary canal
Sterile
solutions or
suspension of
drugs in
aqueous or
oily vehicle
Ref:Avis E. Kennet,Liberman Herbert,Lachman Leon.Pharmaceutical Dosage
Forms:Parenterals,Volumes 1.2nd Edition.New Delhi,India:Taylor & Francis,1989p:346-348
6. Advantages Disadvantages
1.Quick onset 2.Wrong dose or overdose
can be fatal
2.Vomittng and unconscious
patients can take
2.Pain at side
3.Prolonged action modified
formulation (Depot)
3.Trained person required
4.Nutritive fluids can be given 4.Expensive
5.Drugs with poor absorbtion or
instability from GT
5.Necessity of aseptic
conditions in
production,compounding and
administration.
Ref:Avis E. Kennet,Liberman Herbert,Lachman Leon.Pharmaceutical Dosage
Forms:Parentrals,Volumes 1.2nd Edition.New Delhi,India:Taylor &
Francis,1989p:346-348
7. Classification of Parenteral Preparations :
Ref:Avis E. Kennet,Liberman Herbert,Lachman Leon.Pharmaceutical Dosage
Forms:Tablets,Volumes 1.2nd Edition.New Delhi,India:Taylor &
Francis,1989p:346-348
• Single dose units
• Infusion solution
• Multiple dose units
According to
Packaging dose
units
• Small volume
parenteral (SVP)
• Large volume
parenteral (LVP)
According to
volume
9. LARGE-VOLUME PARENTERALS
Lvp are Parenterals designed to provide
Most common LVP’s are 0.9% sodium chloride, dextrose 5% in water,
dextrose 5% in normal saline & LR solution.Volume 101-1000ml
(250ml,500ml & 1000ml mostly)
Ref: Allen V. Lloyd,Popovich G. Nicholas,Ansel C. Howard. Ansel's Pharmaceutical
Dosage Forms and Drug Delivery Systems.9th edition. Chicago,U.S.:Lippincott Williams &
Wilkins, 2011.Page No:470-473
Fluid
(Water)
Calories
(Dextrose
solution)
Electrolytes
(Saline
Solutin)
Combination
of these
10. MANUFACTURING OF LVP(SALINE)
BFS
(Blow Fill
and Sealed
Technology )
1.Parison
Extrusion
2..Contai
ner
Molding
3.Contain
er Filling
4.Contain
er
Sealing
BFS
Preservative
free single
dose
Asepctically
manufactured
sterile
product
NO human
intervention,a
utomated.
Ref: Allen V. Lloyd,Popovich G. Nicholas,Ansel C. Howard. Ansel's Pharmaceutical Dosage
Forms and Drug Delivery Systems.9th edition. Chicago,U.S.:Lippincott Williams & Wilkins,
2011.Page No:470-473
11.
12. SMALL VOLUME PARENTERALS
Volume less than 100ml
Usually range 1-30ml in
volume
Mostly given as multiple
dose
Types
Ampul
es
Dry
powder
Prefille
d
Syring
e
Vials
Ref: Allen V. Lloyd,Popovich G. Nicholas,Ansel C. Howard. Ansel's Pharmaceutical
Dosage Forms and Drug Delivery Systems.9th edition. Chicago,U.S.:Lippincott Williams &
Wilkins, 2011.Page No:470-473
13. MANUFACTURING OF SVP (AMPULES)
Ingrediants,Vehicles
Compounding of the
product & Filtration of
the solute
Processing
equipments &
cleaning
Container
Component
Cleaning
Sterilization
Filling Sealing
Packing
Product storage
Ref: Avis E. Kennet,Liberman Herbert,Lachman Leon.Pharmaceutical Dosage
Forms:Tablets,Volumes 1.2nd Edition.New Delhi,India:Taylor & Francis,1989p:344-346
15. LVP VS SVP
Parameters SVP LVP
Volume 100ml or less 101-1000ml
Routes IV, IM & SC IV-LVP & non IV-LVP
Dosage Unit Single or multiple Single
Preservative Used Not used
Buffers Used Not used
Formulation Solution,emulsion,sus
pension
Solution & o/w nutrient
emulsion
Isotonicity Not essential Must
Pyrogenicity Not essential Must
Use Therapeutic &
Diagonistic
Nutrition,detoxification
and during surgery
Ref:Jisna Sibastian.Prenteral preparations education blog[Internet]Published
in: Slideshare on Jul 1,2016 available at
https://www.slideshare.net/JisnaSebastian/parenteral-preparationsRef
16. CONCLUSION
Despite of aseptic
technique in
production,compou
nding and handling
of product this is
the most effective
route for the
delivery of active
pharmaceutical
substances
specially when
drugs cannot be
taken orally
Alternative route
for the drugs that
are highly
hydrophobic as
these drugs
cannot pass
through cell
memrane
