PARENTERALS

Presented By: Jyoti Singh

(Pharmaceutical Mgt)

Parenterals, UIAMS, Panjab University 1

 TABLE OF CONTENT
• Introduction to Parenteral
• Routes of Administration
• Types of Parenteral
• Classification of Depot Formulation
• Formulation of Parenteral
• Advantages & Disadvantages For
Parenteral
• Conclusion
• References

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Parenterals, UIAMS, Panjab University
 PARENTERALS?
The term parenteral is derived from Greek word
para: beside
enteron: intestine (i.e. beside the intestine)

They are sterile products intended for

administration by injection, infusion or
implantation into the body.

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Parenterals, UIAMS, Panjab University
 WHY PARENTERALS?
1) Rapid action
2) Oral route can not be used
3) Not effective except as injection
4) For drugs those get inactivated in GIT if given
orally.
5) New drugs require to maintain potency &
specificity sodium that they are given by
parenteral.
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 DESIRABLE CHARACTERISTICS OF AN
IDEAL PARENTERAL DRUG CARRIER

• Versatility in that carrier can deliver a variety of agents.

• High capacity to carry a sufficient quantity of drug per unit carrier

to release therapeutic concentration to the target site without
excessively loading host with the carrier.

• Restricting drug distribution to the desired target tissue.

• Uniform distribution within the capillary vasculature of the target

tissue.

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 DESIRABLE CHARACTERISTICS OF AN
IDEAL PARENTERAL DRUG CARRIER
(Contd)
• Affording drug ready access to the parenchyma of target
tissue.

• Restricting drug activity at the target site over a prolonged

period.

• Protecting drug from inactivation by plasma enzymes.

• Being biocompatible and minimally antigenic.

• Undergoing biologic degradation with prompt elimination and

minimal toxicity of the breakdown products.

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 ROUTES OF ADMINISTRATION
Intradermal (I.D)

Subcutaneous (S.C)

Intramuscular
(I.M)
Intravenous (I.V)

Intra-arterial
Intra-cardiac
Intra-articular
(joint)
Intrasynovial (joint fluid
area)
Intraspinal, Intrathecal
(spinal fluid)

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Fig. Routes of Parenteral administration
Numbers on needles indicate size or gauge of needle.
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They are five main types of Parenteral Preparations

Injection

Powder
Infusion for
Injection

Conc. Sol
for Implants
Injections

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Parenterals, UIAMS, Panjab University
 INJECTION
Sterile Solutions, emulsions or
suspensions.

Prepared by dissolving,
emulsifying or suspending the
active ingredient(s) and any added
substances in Water for Injection or
in a suitable non aqueous vehicle, or
in a mixture of the two if they are
miscible.

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 INFUSION
Sterile aqueous solutions or
emulsions with water as the
continuous phase.

They are isotonic with blood and

do not contain any added anti
microbial preservatives.

Intravenous Infusions that are

emulsions do not show any
evidence of phase separation.

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Parenterals, UIAMS, Panjab University
 POWDER FOR INJECTION
Sterile, solid substances(including
freeze-dried materials) which are
distributed in their final.

When shaken with the prescribed

volume of the appropriate sterile
liquid, rapidly, form clear and
practically particle- free solutions or
uniform suspensions.

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 CONCENTRATED SOLUTION
FOR INJECTION

Sterile solutions that

are intended to be
administered by
injection or by
intravenous infusion
only after dilution with
a suitable liquid.

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 IMPLANT
Sterile solid preparations of
size and shape suitable for
implantation into body tissues
so as to release the active
ingredient over an extended
period of time.

They are normally presented

individually in sterile
containers.

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Parenterals, UIAMS, Panjab University
 TYPES OF PARENTERAL
Small Volume Parenteral Large Volume Parenteral
Primary uses of SVP Primary Uses of LVP
• Therapeutic injections • Basic Nutrition
• Ophthalmic products • Restoration of
Electrolyte balance
• Diagnostic agents • Fluid replacement
• Allergenic extracts • Blood and blood
products
• Drug carriers

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 CLASSIFICATION OF
DEPOT FORMULATION

• Dissolution-Controlled Depot Formulation

• Adsorption Type Depot Formulation

• Encapsulation Type Depot Formulation

• Esterification Type Depot Formulation

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 ADSORPTION TYPE DEPOT
FORMULATION
• Formed by binding of drug molecules to adsorbents.

• Only unbound(free species) of drug is available for

absorption. As soon as free drug molecules are
absorbed a fraction of bound drug is released to
maintain equilibrium.

• E.g. Vaccines in which antigens are bound to highly

dispersed Al(OH)₃ gel to sustain release & prolong
duration of action of stimulation of antibody
formation & Protamine-Insulin complex

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 ENCAPSULATION-TYPE DEPOT
FORMULATION
• Formed by encapsulating drug solids within a
permeation barrier or dispersing drug particles in a
diffusion matrix.

• Release of drug molecule is controlled by rate of

permeation across permeation barrier & rate of
biodegradation of barrier macromolecules.

• Both permeation barrier & diffusion matrix are

fabricated from biodegradable or bio absorbable
macromolecules such as gelatin, dextran.

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 ESTERIFICATION-TYPE DEPOT
FORMULATION
• This type of preparation is produced by esterifying a
drug to form a bio convertible prodrug-type ester & then
formulating it in an injectable formulation.
• This chemical approach depends upon number of
enzyme (esterase) present at the injection site.
• e.g. nandrolone decanoate in oleaginous solution

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 FORMULATION OF PARENTERAL
Active/Therapeutic Ingredient
• Insulin
• Antibiotics
• Anticancer
• Steroids
• Vaccines
• Antipyretic
• Analgesics
• Anti- inflammatory
• LVP’s like Dextrose, NaCl or combination etc

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 FORMULATION OF PARENTERAL
VEHICLE
AQUEOUS VEHICLE NON-AQUEOUS VEHICLE

• Water For • Fixed oils

Injection(WFI) USP • Water-miscible
• Bacteriostatic Water vehicles
for Injection (BWFI)
• Sterile Water for
Injection USP

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Parenterals, UIAMS, Panjab University
 FORMULATION OF PARENTERAL
ADDITIVES
 Antibacterial Agents
 Buffers
 Surfactant
 Tonicity Agent
 Chelating Agent
 Inert Gases
 Suspending Agents
 Emulsifying Agents
 Flocculating Agents

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Parenterals, UIAMS, Panjab University 24
 IPQC TEST FOR
PARENTERALS

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 QUALITY CONTROL FOR PARENTERAL

 Sterility testing

 Pyrogenic test

 Clarity test

 Leakage test

 Isotonicity test

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 Advantages of Parenteral
• Quick onset of action

• Suitable for the drugs which are not administered by oral

route

• Useful for unconscious or vomiting patients

• Useful for patients who cannot take drugs orally

• Useful for emergency situations

• Duration of action can be prolonged by modifying formulation

• Can be done in hospitals, ambulatory infusion centers and

health care.

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 Disadvantages of Parenteral
• Pain on injection

• Difficult to reverse an administered drug’s effects

• Sensitivity or allergic reaction at the site of injection

• Requires strict control of sterility & non pyrogenicity

than other formulation

• Only trained person is required

• Require specialized equipment, devices, and techniques

to prepare and administer drugs

• More expensive and costly to produce

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