This document discusses parenteral formulations, including definitions, advantages, disadvantages, and classifications. It provides details on the preparation of small volume parenterals and large volume parenterals, including vehicles, buffers, preservatives, and other excipients used. It also covers the stability considerations for parenteral formulations and factors that influence syringeability, injectability, clogging, drainage, resuspendibility, and sedimentation of suspensions.

1. Presented by-
ROHIT
R.K.S.D. College of Pharmacy,
Kaithal(Hry)
M.Pharma (Pharmaceutics)

2. •Definition
•Advantages
•Disadvantages
•Classification
•Preparation of Small Volume Parenteral and Large Volume
Parenteral
•Stability of Small Volume Parenteral and Large Volume
Parenteral

3. • The term derived from Greek word ‛Para’ outside &
‛Enterone’ intestine.
• Parenteral are sterile solutions or suspension of in
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.

4. • Useful 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.
• Can be done in hospitals, ambulatory infusion centers and
home health care centers.
• Complete bioavailability.

5. • 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 formulations.
• Trained person is required.
• Require specialized equipment, devices, and techniques
to prepare and administer drugs.
• More expensive and costly to produce.

6. 1.Small Volume Parenterals (SVP)
2. Large Volume Parenterals (LVP)

7. • An injection that is packed in containers
labeled as containing 100 ml or less are called
as small volume parenterals.
LVP
LVP are parenterals designed to provide :-
• Fluid
• Calories (dextrose solution )
• Electrolytes
• Combenation of these
• Volume (101- 1000 ml)

8. 1.HYPERALIMENTATION SOLUTIONS
2. CARDIOLPAGIC SOLUTIONS
3. PERITONIAL DIALYSIS SOLUTION
4. IRRIGATING SOLUTIONS

9. 1. Suspensions
2. Emulsions
3. Solution
4. Dry powder

10. AQUEOUS VEHICLE :-
WATER FOR INJECTION (WFI) USP :-
• Highly purified water used as a vehicle for injective
preparations which will be subsequently sterilized.
• USP requirement include not 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.

11. • This type of water used for making parenteral
solutions prepared under aseptic conditions and not
terminally sterilized.
• Need to meet USP sterility test.
• It can contain an added bacteriostatic agent when
in containers of 30 ml or less.

12. • SWFI containing one or more suitable bacteriostatic
agent.
• Multiple – dose containers not exceeding 30 ml.
• They are permitted to contain higher levels of solid than
WFI because of possible leaching.
• Used for washing wounds , surgical incisions, or body
tissues.

13. • The number of solvents that are miscible with water has
been used as a portion of a vehicle.
• Primarily to affect solubility of drugs and to reduce
hydrolysis.
Example:
Ethyl alcohol,
Liquid propylene glycol
Glycerine
Ethyl alcohol used in the case of cardiac glycoside.

14. • Fixed oils (vegetable origin, liquid, and rancid resistance
unsaturated, free fatty acid contents).
• Peanut oil
• Corn oil
• Cotton seed oil
• Sesame oils
• Ethyl oleate
• Isopropyl myristate

15. ANTIBACTERIAL AGENTS
• These are added in multiple dose containers.
• To prevent microorganism growth
• Limitted concenteration of agents are used.
EXAMPLES-
Phenyl mercuric nitrate and thiomersol 0.01%.
Chloride & benzalkonium chloride 0.01%.
Phenol & cresol 0.05%
Chlorobutanol 0.05%

16. •Added to maintain pH.
•To stabilize a solution from chemical degradation.
•EXAMPLE-
Citrate and acetate buffer
Sodium benzoate and benzoic acid
Sodium tartarate and tartaric acid
Phosphate buffer

17. •To protect the formulation from oxidation.
•Two types-
1 Reducing agents
EXAMPLE-
Ascorbic acid
Sodium bisulfite 0.01%
Thiourea
2Blocking agents
EXAMPLE-
Tocopherol

18. • Solubilise the active ingredient
•EXAMPLES-
Polyoxythylene sorbitan monooleate
Sorbiton monooleate

19. •Need isotonic solution to avoid destruction of red blood
cells,irritation, and tissue damage.
•More important for large volumes, rapidly administered
,and extravascular injections.
•Reduces the pain on injection.
•EXAMPLES-
Sorbiton monooleate
NaCl and KCl
Dextrose solution

20. •To remove trace elements that catalyse oxidative
degeneration.
EXAMPLE-
Ethelene diamine tetra acetic acid 26

21. • Improve solubility
•Prevent potential for hydrolysis
EMULSIFYING AGENTS
•Lecithin
• Polysorbate 80

22. • For freeze dried preparations(solids)
•EXAMPLES-
Mannitol
Lactose ,sucrose
Dextran .
SUSPENDING AGENTS
EXAMPLES-
CMC,
Methyl cellulose, Gelatin

23. 1.Syringeability
2.Injectability
3.Cloging or Blockage
4.Drainage
5. Resuspendibilty
6.Sedimentation
7.Product Package Interaction
8.Compatibility with diluents

24. Syringeability describes the ability of the suspensions to pass
easily through hypodermic needle on transfer from the prior
to injection. It includes characteristics such as the ease of
withdraw clogging and foaming tendencies and accuracy of
dose measurements. Increase in the viscosity, density, particle
size and concentration of solids in suspension hinders the
syringeability of suspension. A suitable test is to ensure that
the entire suspension passes through a 25‐gauge needle of
internal 0.3 mm.

25. Injectability refers to the performance of suspension
during injection and includes factors such as pressure
or force required for injection. Evenness of flow
,aspiration qualities, and freedom from clogging. The
syringeability and injectability of suspension are
closely related to the viscosity and particle
characteristics of the suspension.

26. Clogging or blockage or syringe needles while administrating a
suspension may occur because of a single large particle or an aggregate
that blocks the lumen of the needle or because of a
bridging effect of the particles. It is advisable to avoid particles
greater than one‐third of the internal diameter of the needle to
prevent clogging. Clogging, if observed at or near the needle end, is
usually caused by restrictions to flow from the suspension and may
involve combination of factors such as vehicle, wetting of particles,
particle size. Shape and distribution viscosity, and flow
characteristics of the suspension.

27. Drainage refers to the ability of the suspension to
break cleanly away from the inner walls of the primary
container‐closure system and is another characteristic
of a well‐formulated characteristic of a
well‐formulated parenteral suspension. Silicone
coating of container, vials, and plugs with dimethicone
can improve the drainage of slightly over flocculated
systems as well as good suspensions.

28. Resuspendibility describes the ability of the suspension to
uniformly disperse with minimal shaking after it has stood for
some time. Qualitatively, light transmittance through the upper
solution in a cylinder after it has been spun for about 2 minutes
at 75 rpm can be used to detect the redispersion properties of
the system. Resuspendibility becomes a problem for suspension
that forms cakes on standing due to the deflocculated particles.
Caking describes a process by which the particles undergo growth
and fusion to form a nondispersable mass.