The document summarizes information about parenteral products presented by Ankit Raj from Amity University Haryana. It defines parenteral products as those meant for injection and discusses large volume parenteral (LVP) and small volume parenteral (SVP) formulations. It covers the preparation, formulation considerations, manufacturing, and evaluation of parenteral products, including sterility testing, particulate testing, and pyrogen testing.

1. AMITY INSTITUES OF PHARMACY
PRESENTATION ON TOPIC
PARENTRAL PRODUCT
NAME : ANKIT RAJ
M .PHARMA
[1 SEM.]
AMITY UNIVERSITY ,HARYANA

2. CONTENT
 INTRODUCTION
 DEFINATION AND PREPARATION OF LVP & SVP
 FORMULATION CONSIDERATION
 PHYSIOLOGICAL CONSIDERATION
 MANUFACTURING
 EVALUATION

3. INTRODUCTION
Parenteral refers injectable route of administration. It derived from Greek words Para
(Outside) and enteron (Intestine). So it is a route of administration other than the oral
route. This route of administration bypasses the alimentary canal Pyrogens, fever-
producing substances, primarily lipopolysaccharide product of metabolism of
microorganism; they may be soluble, insoluble, or colloid.
Routes of Parenteral Administration
• Intravenous injections and infusions
• Subcutaneous injections
• Intramuscular injections
• Intradermal injections
• Intra-arterial injections
• Intraspinal injections

4. LARGE VOLUME PARENTRAL [LVP]
A single-dose injection that is intended for intravenous use and is
packaged in containers labeled as containing more than 100 mL.
CHARACTERSTICS OF LVP
➢ Packaged in glass bottles or in large volume flexible containers.
➢ May contain greater than 100 mL to greater than 1 or 2 L
➢ Sterile
➢ Pyrogen-Free
➢ Essentially free of particulate matter
➢ No anti-microbial agents
➢ Isotonicity

5. SMALL VOLUME PARENTRAL [SVP]
• 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. 2. Suspension
3. 3. Emulsion
4. 4. Dry Powders

6. PREPARATION OF LVP & SVP
1. Aqueous vehicle :
WATER FOR INJECTION [WFI]
 Highly purified water used as a vehicle foe injective preparation
which will be subsquently sterilized.
 Usp requirement include more than 10 parts per million of total
solids.
 Ph of 5.0 – 7.0
 Wfi may be prepared by either distillation or reverse osmosis.

7. BACTERIOSTATIC WATER FOR INJECTION
 This type of water used for making parental solution prepared under aspetic
condition and not terminally sterilized
 need to meet USP sterlity test .
 it can contain an added bacterial static agent to when it container of 30 mill
or less.
WATER MISCIBLE VEHICLES
 the number of solvent that are miscible with the water has been used as a
portion of vehicles.
 primarily to effect solubility of drugs and to reduce hydrolysis

8. 2. Non-aqueous vehicles
 Fixed oil [vegetable origin, liquid and Rancid resistance
unsaturated, free fatty acid content]
 peanut oil
 corn oil
 cotton seed oil
 sesame oil
 ethyl oleate

9. 3.Others addidative
 Anti bacterial agentes e.g. phenyl mercuric nitrate and thiomersol
0.01%, phenol & cresol 0.05%, chlorobutanol 0.05%.
 Buffers e.g. citrate and acetate buffer, phosphate buffer , sodium
tartarate and tartaric acid.
 Antioxidant e.g. ascorbic acid , thiourea etc.
 Surfactant e.g. polyoxythylene sorbitan monooleate.
 Tonocity agent e.g. sorbiton monooleate, sod. Chloride etc

10. FORMULATION CONSIDERATION OF PARENTRALS
 In the preparation of parenteral products, the following substances are added
to make a stable preparation:
 The active drug
 Vehicles
 Aqueous vehicle (e.g.water for injection, water for inj. free from CO2)
 Non-aqueous vehicle (e.g. Ethyl alcohol, propylene glycol, almond oil)
 Solubilizing agents (e.g. Tweens & polysorbates)
 Stabilizers & antioxidants (e.g. thiourea, ascorbic acid, tocopherol)
 Buffering agents (e.g. citric acid, sodium citrate)
 Antibacterial agents (e.g. benzyl alcohol, metacresol, phenol) / Chelating
agents (e.g. EDTA)
 Suspending, emulsifying & wetting agents (e.g. MC, CMC)

11. PHYSIOLOGICAL CONSIDERATION OF PARENTRALS
• PH = The pH of the preparation should be close to the physiological
pH.[7.4]
• BUFFER = important for parentral dosage form because due to alteration of
pH in formulation . E.g. potassium phosphate, tartaric acid etc.
• TONICITY = All parentral product should be isotonic, due to risk of
hemolysis. Tonicity adjustment agent such as gelatin, mannitol, sorbitol etc.
• STABILIZER = To prevent the degradation of drug substances.
• All products must be free from pyrogenic contamination.
• Injectable solutions must be free from visible particulate matter
• All products must be sterile.

12. MANUFACTURING
• 1. Cleaning of containers, closures & equipments :Thoroughly cleaned with
detergents with tap water → distilled water →finally rinsed with water for
injection. • Rubber closures are washed with o.5% sodium pyrophosphate in
water.
• 2. Collection of materials: All raw material of preparation should be collect from
warehouse after accurate weighed. water for injection should be pyrogens free.
• 3. Preparation of parenteral products: The parenteral preparation must be
prepared in aseptic conditions. • The ingredients are accurately weighed
separately and dissolved in vehicle as per method of preparation to be followed.

13. 4. Filtration : The parenteral preparation must be filtered by bacteria proof
filter such as filter candle, membrane filter
5. Filling the preparation in final container : The filling operation is carried out
under strict aseptic precautions .
6. Sealing the container : Sealing should be done immediate after filling in
aseptic environment.
7. Sterilization: For thermostable substances the parenteral products are
sterilized by autoclaving method at different temperature & pressure.
• Heat sensitive or moisture sensitive material are sterilized by exposure to
ethylene oxide or propylene oxide gas .
8. Evaluation of the parenteral preparation: Sterility testing, Clarity test,
Leakage test, Pyrogen testing and Assay.

15. EVALUATION
 Sterility testing
 Clarity test (Particulate matter monitoring)
 Leakage test (Faulty seal packaging)
 Pyrogen testing
 i. Rabbit test
 ii. LAL test

16. STERILITY TEST
• Sterility is defines as freedom from the presence of viable microorganism.
• Sterility test is define as microbiological test applied to sterile product to
show are the product manufactured and processed under specification guided
by cGMP.
• Sterility test is destructive test thus,it is impossible to test every item for
sterility.

17. PARTICULATE TEST
 Particulate matter refers to the extraneous, mobile, undissolved particles,
other than gas bubbles, unintentionally present in the solutions.
 2 methods are used:
 Method A-Light Obscuration Particle Count Test
 Method B-Microscopic particle count test
LEAKER TEST
• Leaker test for ampoules is intended to detect incompletely sealed ampoules so
that they can be discarded in order to maintain sterile condition of the
medicines.
• Tip seals are more likely to be incompletely closed than pull seals.
• Open capillaries or cracks at the point of seal result in LEAKERS.

18. PYROGEN TEST
 The test involves measurement of the rise in body temperature of rabbits
following the IV injection of a sterile solution into ear vein of rabbit.
 Dose not exceeding 10 ml per kg injected intravenously within a period of
not more than 10 mins.
 Test animals: Use healthy, adult rabbits of either sex, preferably of the same
variety.
 Recording of temperature: Clinical thermometer, thermistor.
 Carry out the test using a group of 3 rabbits.
 Preparation of the sample: Dissolve the substance in,or dilute with, pyrogen
free saline solution.

19. thank you