This document discusses parenteral products, which are sterile preparations meant to be administered via injection. It covers preformulation factors like pH and solubility that must be considered, as well as common routes of administration like intravenous, intramuscular, and subcutaneous. The main types of parenterals described are powders for injection, colloidal solutions, injectable emulsions, suspensions, and infusion fluids. Key aspects of parenteral formulation include choosing appropriate solutes, vehicles like water and oils, and added substances like antimicrobials and buffers. General procedures for production include cleaning, preparation, sterilization, filling and packaging using containers like vials, ampoules and cartridges.

1. PARENTERAL
PRODUCTS
Submitted by -Palakdeep kaur
B Pharmacy(7th )

2. INTRODUCTION
• The parenterals derives from the greek words;
Para means outside
Enteron means intestine
• The administration of drugs through the patient by injection
under through one or more layers of skin or mucous
membrane.
• They are sterile, pyrogen – free preparations intended to be
administered parentrally.
• The term parentals refers to the injectable routes of
administration.

3. PREFORMULATION FACTORS
It is study about physical & chemical properties of drug substance
prior formulation is called as preformulation. These factors are :-
1. pH:- The pH should be neither acidic nor basic but should be
neutral.
2. Solubility:- The contents should be readily soluble.
3. pKa(dissociation constant)
4. Particle size
5. Oxidation & reduction
6. Compatibilities studies

4. ROUTES OF ADMINISTRATION
• Intra muscular (IM)
• Intra dermal (ID)
• Intravenous (IV)
• Subcutaneous/ hypodermic (SC)
• Intrarterial
• Intra cardiac
• Intra peritonial
• Intra spinal
• Intra synovial
• Intraplueral

5. TYPES OF PERENTERAL
 Powder for injection - Eg. Cefuroxime for injection
 Colloidal solution -Eg. Iron dextran
 Injectable emulsion -Eg. Propofol USP
 Injectable suspension -Eg. Methylprednisolone acetate
 Oily injections (solution)
 Infusion fluid

6. FORMULATION OF PARENTERAL
1. SOLUTES :- They should be free from microbial and
pyrogenic contamination.
2. ADDED SUBSTANCES :- Substances added to a product to
enhance its stability. They should not interfere with
therapeutic efficacy. They must be non-toxic in the quantity
administered to the patient. These includes :-
• Antimicrobial agents: They must be included in the
formulation packed in multiple dose vials and are included in
formulations to be sterilized by marginal process or made by
aseptic manipulation.
• Antioxidants: They are included to protect a therapeutic
agent susceptible to oxidation.

7. • Buffer: They are added to maintain a require pH for many
products.
• Suspending agents
• Emulsifying agents
• Cyroprotectant
3. VEHICLE
• Aqueous ( water for injection) :
•The most frequently used solvent in the large-scale manufacturer
of injections is Water for Injection, USP.
This water is purified by distillation or by reverse osmosis .Although
water for injection is not required to be sterile, it must be pyrogen-
free. Water for injection should be stored in tight containers at
temperatures below or above the range in which microbial growth
occurs. Naturally, the water should be collected in sterile and
pyrogen-free containers. Water for injection is intended to be used
within 24 hours following its collection. The containers are usually
glass or glass-lined.

8. • Non aqueous :The vehicle should be non- toxic, non- irritating
and sensitizing. The solvents physical and chemical properties
such as stability, viscosity, fluidity, boiling point, purity must be
considered.
Some of non aqueous vehicles are:-
1. Fixed vegetable oils
2. Polyethylene glycols
3. Propylene glycols
4. Alcohol
5. Arachis oil

9. GENERAL PROCEDURE
• Cleaning & washing of containers.
• Preparation of solution.
• Sterilization (filteration)
• Filling
• Packaging

10. CONTAINERS & CLOSURES
1. Plastic
• ampoules (single dose)
• vials (multiple dose)
• cartridges
• automatic injector
2. Rubber closures with aluminium caps
• Small volume parenterals
• Large volume parenterals
3. Glass

11. IMAGES

12. Thank you