preparation and stability Large and small volume parental – physiological and formulation consideration, Manufacturing and evaluation.

1. Large and Small
Volume Parenteral
By Gajanan Sormare

2. Contents-
• INTRODUCTION
• CLASSIFICATION OF
PARENTERALS
• LARGE VOLUME PARENTERALS
• SMALL VOLUME PARENTERALS
• PREPARATION OF PARENTERALS
• FORMULATION
CONSIDERATION

3. INTRODUCTION
• Parenteral means para enteron, beside the gut
or beside the intestine
• A Parenteral dosage form can be defined as a
sterile drug product, which is presented in the
form of solution, suspension, emulsion, or
reconstituted lyophilized powder, suitable for
administration by injection into the body.
• Parenteral dosage forms differ from all other
drug dosage forms, because they are injected
directly into body tissue through the primary
protective systems of the human body, the skin,
and mucous membranes.

4. Ideal characteristics of
parenterals
• Sterile
• Free from visible particulate
matter
• Isotonic
• Chemically and physically stable
• Free from pyrogen
• Compatible

6. ROUTES OF ADMINISTRATION
Intravenous (IV)- into a
vein, usually a large
proximal vein
Intramuscular (IM)- into a
muscle, usually the gluteal
(buttocks), vastus lateralis
(lateral thigh) or deltoid
(upper arm) muscles
Subcutaneous (SC)- into
the subcutaneous tissue, a
layer of fat located below
the dermis
Intradermal (ID)- into the
dermal layer of the skin
Intra-arterial (IA)- into an
accessible artery
Intrathecal (IT) or Intra-
cisternal- into the
cerebrospinal fluid

7. ROUTES OF ADMINISTRATION
Intradural- within the
dural membrane
surrounding the spinal
cord
Extradural- outside the
dural membrane and
within the spinal caudal
canals
Intracardiac (IC)- into
the muscles of the
heart
Intraperitonial (IP)- into
the peritonial cavity
Intra-articular- into the
synovial fuild (joints)
Intra-mammary- into
the mammary glands of
breast

8. Routes of
parenteral
administration

9. CLASSIFICATION OF
PARENTERALS
It is classified into two:
• SMALL VOLUME PARENTERALS
• LARGE VOLUME PARENTERALS

10. Difference
between svp
and lvp -

11. LARGE VOLUME
PARENTERALS

12. LARGE VOLUME PARENTERALS
• A single-dose injection that is intended for intravenous use.
• 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

13. PRIMARY USES OF LVP:
To provide nutrients when oral administration is not possible.
To maintain acid base balance in the body.
To act as a plasma expander.
To provide water, electrolyte, and simple carbohydrates required for
the body.

14. SMALL VOLUME PARENTERALS

15. SMALL VOLUME PARENTERALS
• Injected by a syringe.
• Less than 100 ml.
• Most routes are used.
• Could be made hypertonic.
• Could be pyrogenic.
•

16. PRIMARY USES OF SVP
• Therapeutic injections
• Ophthalmic products
• Diagnostic agents
• Allergenic extracts

17. FORMULATION OF PARENTERALS

18. FORMULATION OF PARENTERALS

19. ACTIVE DRUG:
A thorough evaluation of properties of the active drug or
drugs is essential in developing a stable and safe parenteral dosage
form.
VEHICLE:
Aqueous vehicle
Non aqueous vehicle

20. PRESERVATIVES:
Required to prevent microorganism growth.
Eg: Phenyl mercuric nitrate , thiomersal – 0.01%
Benzethonium chloride, benzalkonium chloride – 0.5%
Phenol, cresol – 0.5%
BUFFERS:
Add to maintain pH.
Results in stability.
Eg: citrate buffer, acetate buffer, phosphate buffer.

21. ANTIOXIDANTS:
Protects from oxidation.
Eg: Ascorbic acid (0.02 – 0.1%)
Tocopherols (0.05 – 0.75%)
TONICITY AGENTS:
Reduce the pain at the injection site.
Added at the last stage of production.
Eg: Nacl, Kcl, Dextrose, Mannitol.
SURFACTANTS:
Used sometimes to enhance the solubility.
Eg: sorbitan monooleate, polyoxy ethylene sorbitan
monooleate.

22. CHELATING AGENTS:
Used to bind in non- ionisable form, trace amount of heavy
metals.
Eg: Trisodium or calcium disodium salt of EDTA.
INERT GASES:
Used to displace oxygen from a solution and reduce
possibility of oxidation.
Eg: Nitrogen ( gentamycin sulfate injection)
Carbon dioxide (sodium bicarbonate injection)