This document discusses parenteral dosage forms, which are medications administered via injection rather than orally. Parenteral routes include subcutaneous, intramuscular, intravenous, and intradermal. Parenteral dosage forms deliver the drug directly into tissues or blood, bypassing the gastrointestinal tract. They have advantages like rapid action, but also disadvantages like invasiveness and higher risk. Parenteral products are classified as large or small volume based on dosage size. Large volume parenterals provide nutrients, while small volume include injections and infusions. Preformulation studies evaluate factors like stability, toxicity, and polymorphism for parenteral drug development. Isotonicity is also important to prevent hemolysis when administered intravenously.

1. Parenteral Products
Unit -IV
B.Pharmacy 5th semester
Presented By
Miss Sudipta Roy
Designation: Associate Professor
B.Pharmacy & Master of Pharmacy
(Pharmaceutics)
Agra public pharmacy college Artoni

2.  To understand Parenteral dosage form. Firstly to
understand about different types of Parenteral routes
other than oral route.
 Parenteral dosage forms are given mostly to avoid fast
pass metabolism.
 It's a preferable dosage form for unconscious and
comma patient.
 There are different types of parenteral routes are -
subcutaneous route, intramuscular route, intravenous
route, intradermal route.

3.  Parenteral dosage forms refers to administration by injection
which takes the drug directly into tissue fluid or blood without
having to cross the intestinal mucosa.
 Advantage:
 Drug action is faster .
 It's a important route for emergencies and immediate drug
response.
 Gastric irritation and vomiting is avoided.
 Parenteral routes are favourable for unconscious, uncooperative
or vomiting patient.
 Liver is bypassed.
 There are no chances of interference by food or digestive juices.

4.  Disadvantages:
 The preparation has to be sterilized.
 It's costly dosage forms than others dosage forms.
 Technique is invasive and painful.
 In such cases , there is need of help by another person
for injection, for self injection is possible, eg. Insulin
by diabetics.
 Parenteral route is more risky than oral.

5.  Parenteral dosage forms are classified into two types on
basis of dosage volume.
 1) Large volume parenteral :An injection that is packed in
container labelled as containing 101ml - 1000ml . It is
used basically for single use to provide calories,
dielectrolytes fluid, preservatives are not used ,
administered through IV infusion technique.
 2) Small volume parenteral: An injection that is placed in
containers labelled as containing 100ml or less, used for
single or multiple use, drugs and preservatives are used,
administered through various parenteral routes.

6.  Large volume parenterals:
 1) Hyper Alimentation Solutions: Administration of
nutrients to patients. Eg. Mixture of dextrose, amino acids,
lipids, steroids etc.
 2) Cardioplegic Solution:
 It is used in heart surgery to prevent injury to myocardium .
 3) Irrigation Solution:
 To irrigate flush and aid body cavities and wounds. Eg.
Saline solution

7.  Small volume parenterals:
 Eg: Insulin injection administered during diabetes
mellitus.
 Injections: Injections are sterile, pyrogen free solutions or
dispersions(emulsions or suspensions) of one or more
active ingredients in a suitable vehicle.
 Single dose injection.
 Multidose Preparation.
 Intravenous infusion
 Powders for Injection
 Implants

8.  Preformulation factors:
 Preformulation study for Parenteral is an information
gathering process to ensure that all of the required
information is in place to begin the preformulation
development studies that saves the time and effort of
development scientist.
 Thermal stability: if the bulk drug is degrading in response
to high temperature.
 Oxidation Potential: if the drug is degraded when exposed
to oxygen.
 Light stability: if the drug is degraded in the presence of
light .

9.  Bulk drug preparation: if there are any residual
solvents present from the manufacturing process.
 Polymorph existence: if any other forms of bulk drugs
exist.
 Pka :- Acid association constant for small molecules .
 Isoelectric point: The isoelectric point for proteins.

11.  Isotonicity is important for parenteral preparations
because the possibility that the product may penetrate
red blood cells and cause hemolysis is greatly reduced
if the solution is isotonic with blood i.e., the cells
maintain their “tone”.

12.  Tonicity is a measure of the effective osmotic pressure
gradient; the water potential of two solutions
separated by a semipermeable cell membrane. In other
words, tonicity is the relative concentration of solutes
dissolved in solution which determine the direction
and extent of diffusion.

13.  Osmotic pressure is the minimum pressure which
needs to be applied to a solution to prevent the inward
flow of its pure solvent across a semipermeable
membrane. It is also defined as the measure of the
tendency of a solution to take in pure solvent by
osmosis .

34.  Thank you.