about the parenteral preparations in pharmacy

1. SMALLAND LARGE VOLUMES
PARENTERAL PREPARATIONS
SEMINAR
FOR THE SUBJECT
PHARMACEUTICAL MANUFACTURING TECHNOLOGY (MQA204T)
SUBMITTED TO
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GUIDED BY:-
MRS. ESHA SHAH
M.PHARM
KRISHNA SCHOOL OF
PHARMACY
PRESENTED BY:-
VINIT NAI
M.PHARM.,SEM-2
PHARMACEUTICAL
QUALITY ASSURANCE
EN NO:-2203315010
Vadodara-Mumbai National Highway 8, Vadodara,
Gujarat 391240

2. CONTENT:-
 Introduction
 General requirements for Parenterals
 Advantages and disadvantages
 Classification
 SVP
 LVP
 Comparison
 Manufacturing process of Parenterals
 Formulation aspect
 Containers
 Evaluation of parenteral preparations
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3. INTRODUCTION:-
PARENTERALS:-
The term derived from Greek word ‛Para’ outside &
‛Enterone’ intestine.
Parenterals are sterile solutions or suspension of drug in
aqueous or oily vehicle.
Parenteral drugs are administered directly in to the veins,
muscles or under the skin, or more specialized tissues such
as spinal cord.
Term parenteral used for any drug/fluid whose delivery
doesn’t utilize the alimentary canal for entering in to the
body tissues
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4. GENERAL REQUIREMENTS
FOR PARENTERAL DOSAGE FORMS:-
Stability
Sterility
Free from pyrogens & toxins
Free from foreign particles
Isotonic
Chemical purity
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5. PARENTERAL ROUTS:-
The term parenteral literally means to avoid the gut
(gastrointestinal tract) and refers to any route of administration
outside of or beside the alimentary tract.
Thus, parenteral are injectable drugs that enter the body directly
and are not required to be absorbed in the gastrointestinal tract
before they show their effect.
Parenteral routes of administration usually have a more rapid
onset of action than other routes of administration.
1. Intravenous 6. Intracardiac
2. Intramuscular 7. Intrathecal
3. Subcutaneous 8.Intracerebral
4. intradermal
5. Intra-arterial
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6. ADVANTAGES:-
Use full for patients who cannot take drugs orally
Rapid onset of action
Useful for emergency situations
Avoid first pass metabolism
Can inject drug directly in to a tissue (target drug delivery)
Useful for delivering fluids, electrolytes, or nutrients
(TPN)
Can be done in hospitals, ambulatory infusion centers and
home health care centers
Complete bioavailability.
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7. DISADVANTAGES:-
pain on injection
Difficult to reverse an administered drug’s effect.
Sensitivity or allergic reaction at the site of injection.
Requires strict control of sterility & non- pyrogenicity
than other formulation.
Trained person is required.
Require specialized equipment, devices, and techniques to
prepare and administer drugs.
More expensive and costly to produce.
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8. CLASSIFICATION:-
Based on volume they are classified into two types:-
Small volume Parenterals (SVP’s)
Large volume Parenterals (LVP’s)
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9. SMALL VOLUME PARENTERALS(SVP’S):-
The volume is generally less than or equal to 100ml.
They are supplied in single or multiple doses.
They are used to dispense most of the drugs.
Examples: Ampoules, Vials, etc
TYPES OF SMALL VOLUMES PARENTERAL
1. Solution
2. Suspension
3. Emulsion
4. Dry Powders
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10. SOLUTIONS:-
Typically used for delivering medications at a controlled
infusion rate
Most commonly solutions of 5% dextrose normal, 45%
normal saline.
Dextrose contributes glucose to meet energy needs and
saline contributes sodium, an electrolyte that maintains
fluid balance and cellular functions.
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11. SUSPENSIONS:-
They should be sterile, pyrogen free, stable,
re‐suspendable, syringeable, injectable, isotonic &
non‐irritating.
They are usually administered by either subcutaneous
(S.C.) or intramuscular (I.M.) route.
These suspensions usually contain between 0.5% and
5.0% solids & should have particle size less than 5
micrometer for I.M. or S.C. administration.
Certain antibiotic preparations (For example procaine,
Penicillin G) may contain up to 30% solids
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12. INJECTABLE EMULSIONS:-
An emulsion is a heterogenous dispersion of one
immiscible liquid in another.
This inherently unstable system is made possible through
the use of an emulsifying agent, which prevent
coalescence of the dispersed droplet.
Parenteral emulsion are rare because it is necessary (and
difficult) to achieve stable droplet of less than 1 micron to
prevent emboli in blood vessels and it is not usually
necessary to achieve an emulsion for drug administration.
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13. LARGE VOLUME PARENTERALS(LVP’S):-
These are supplied for single dose having more than 100
ml.
These are delivered through IV route.
These generally provide electrolytes, nutrition to the body.
Examples: normal saline
TYPES OF LARGE VOLUME PARENTERALS:-
Hyper alimentation solutions
Cardioplegic Solutions
Peritoneal Dialysis solution
Irrigating solutions
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14. HYPERALIMENTATION SOLUTION:-
 Administration of large amount of nutrients to patients who unable
to take food orally.
 Formulation: mix. Of dextrose, amino acids , lipids, electrolytes, &
vitamins. TOTAL PARENTERAL NUTRITION
 Def. : A method of feeding patients by infusing a mixture of all
necessary nutrients into the circulatory system, thus bypassing the
GIT.
CONTENT SOURCES
1.Calories Dextrose
2.Nitrogen Crystalline amino acids
3.Electrolytes Na, K, Cl, Po4
4.Vitamins Water soluble and fat soluble
5.elements Traces of Zn, Cu, Mn,Cr
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15. CARDIOPLEGIC SOLUTIONS:-
LVP are used in heart surgery to prevent injury to
myocardium during reperfusion, as well as to maintain
bloodless operating field.
Maintains the diastolic arrest.
Administered in cold form.
Slightly alkaline to compensate metabolic acidosis,
Hypertonic
USE:-To minimize reperfusion injury resulting from tissue
edema.
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16. PERITONEAL DIALYSIS SOLUTION:-
Infused continuously into abdominal cavity, bathing
peritoneum & are then continuously withdrawn.
USE:-
Removal of toxic substances from body.
To aid & accelerate excretion normal.
To treat acute renal insufficiency.
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17. IRRIGATING SOLUTIONS:-
 To irrigate ,flush, & aid in cleaning body activities &
wounds.
Certain iv solution ( normal saline ) may be used as
irrigating solution , but solution designed as irrigating
solution should not be used parenterally.
Use-: treatment of serious wounds infused in to blood
stream.
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18. OVERVIEW OF MANUFACTURING
PROCESS OF PARENTERALS
Planning & scheduling
Equipment &
facility
Documentati
on &personal
Manufacturing
Bulk analysis
Aseptic filling
Visual inspection
Q.C. Testing
Sterilization
Material
management -
Raw material &
API -Packaging
material
Labeling & packing Finishing
Warehousing
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19. COMPARISON:-
PARAMETERS SVP LVP
Volume <=100ml 101-1000ml
Route IV,IM,SC IV
Dosage unit Single or multiple Multiple
Preservatives Used Used
buffer Used In composition
Isotonicity Must Must
pyrogenicity Must Must
Formulations Solution,
emulsion,
suspension
Solution,
o/w emulsion
Uses As therapeutic agent,
As diagnostic agent
As nutrition,
detoxification, aid
during surgery
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20. PRODUCTION FACILITIES:-
Clean up area
Production area
Aseptic area
Quarantine area
Finishing and packaging area
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21. FORMULATION ASPECT:-
Therapeutic agents.(API)
 ex: Insulin, Antibiotics, Vaccines, Antipyretics, Analgesics,
Dextrose, Nacl, Electrolytes.
Vehicles.
1) Water. Ex :WFI, BWFI, SWFI.
2) Aqueous vehicles. E.g.: Ethyl alcohol, Propylene Glycol.
3) Non-aqueous vehicles. E.g: Fixed oils (corn oil, peanut oil,
cotton seed oil.)
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22. ADDED SUBSTANCES(ADDITIVES):-
 1)Antimicrobials.
 E.g.: Phenyl mercuric acetate - 0.01%, Thiomersal - 0.01%, Benzothenium
chloride - 0.01%, Phenol and cresol - 0.5%.
 2) Anti oxidants. E.g.: Sodium bisulfide. ascorbic acid – 0.02- 0.1%, Thiourea
- 0.005%.
 3) Buffering agents. E.g.: Citric acid, sodium citrate.
 4)Bulking agents. E.g.: lactose – 0.14-0.5% mannitol – 0.4 – 2.5%
 5)Chelating agents:-Disodium edetate – 0.003 - 0.05 % Tetra sodium edetate –
0.01 %
 6) Protectants. E.g.: sucrose, lactose (2-5%)
 7) Solubilizing agents. E.g.: Tweens & polysorbates.
 8) Tonicity adjusting agents. E.g.: sodium sulfate – 1.1%, sorbitol – 2%
 9) Surfactants. E.g.: polyethylene- 0.1 -0.5% sorbitan monooleate-0.05-0.25%
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23. CONTAINERS:-
1.glass:-
Type :1 Highly Resistant Borosilicate Glass
Type II: Treated Soda lime Glass
Type III: Regular Soda Lime Glass
Type IV: N.P (Non-parenteral) Glass
Type 4 is not used for parenteral packaging, others all are
used for parenteral packaging.
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24. PLASTIC:-
 Plastic containers are used but they face following problems
 Permeation
 Sorption
 Leaching
 Softening
3.Rubber:-
 To provide closure for multiple dose vials, IV fluid bottles, plugs for
disposable syringes and bulbs for ophthalmic pipettes, rubber is the
material of choice. Problems associated with rubber closures are
 Incompatibility
 Chemical instability
 Physical instability
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25. EVALUATION OF PARENTERAL
PREPARATIONS:-
The finished parenteral products are subjected to
following tests in order to maintain quality controls:
A)Sterility test
B)Clarity test
C) Leakage test
D) Pyrogen test
E) Assay
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26. REFERENCE
Lachman/Lieberman’s “The Theory and Practice Of
Industrial Pharmacy” Fourth Edition 2013, Edited by:
Roop K Khar, SP Vyas, Farhan J Ahmad, Gaurav K Jain,
CBS Publishers and Distributors Pvt Ltd, New Delhi.
Modern Pharmaceutics Fourth Edition, Revised and
Expanded, Edited By G.S.Banker & C.T.Rhodes, Marcel
Dekker pg387-389
https://www.slideshare.net/InnocentSutnga/large-and-
small-volume-parenterals-preparations
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27. Thank you
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