Transcript Injectable Solutions

Injectable Solutions
Dr. Basavaraj K. Nanjwade
M. Pharm., Ph. D
Department of Pharmaceutics
Faculty of Pharmacy
Omer Al-Mukhtar University
Tobruk, Libya.
E-Mail: [email protected]
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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CONTENTS
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Definition
Advantages
Disadvantages
Routes of administration
General requirements for Injectable
Formulation of Injectable
Containers and Closures
Processing of Injectable
Evaluation of Injectable
Labeling and packaging
Production facilities
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Definition
• Injections are the sterile solutions or suspensions of
drugs in aqueous or oily vehicle meant for
introduction into the body by means of an injectable
needle under or through one or more layers of the
skin or mucous membrane.
• Injections should be sterile, isotonic and free from
foreign particles, such as dust, fibres etc.
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Advantages
1. Onset of action is quick
2. The drugs which cannot be administered by oral route, can
be administered by this route.
3. The patients who are vomiting or unconscious can not take
drug by oral route. In such cases the drug can be
administered by this route.
4. The drug action can be prolonged by modifying the
formulation
5. Transfusion fluids containing nutritives like gulcose and
electrolytes such as sodium chloride can be given by this
route.
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Disadvantages
1. Injection causes pain at the site of injection.
2. The trained persons are required to administer the
drugs.
3. The administration of a drug through wrong route of
injection may prove to be fatal.
4. It is difficult to save a patient when over dose is
given.
5. There are chances of sensitivity reaction or allergic
reaction of a drug by an individual. These reactions
are sometimes very fatal and lead to death.
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Routes of administration
• The various routes of administration of parenteral preparations are as
follows:
1. Intradermal (intracutaneous) injections
2. Hypodermis (subcutaneous) injections
3. Intramuscular injections
4. Intravenous injections
5. Intra-arterial injections
6. Intracardic injections
7. Intrathecal injections
8. Intracisternal injections
9. Peridural injections
10. Intr-articular injections
11. Intracerebral injections
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Routes of administration
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Types of Injectables
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Perenteral preparations can be classified as follows:-
1. Solutions or emulsions of medicaments suitable for
injections
2. Sterile solids
3. Sterile suspensions
4. Transfusion fluids
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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General requirements for
Injectable
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The formulation of parenteral products involves
careful consideration of the following requirements:Stability
Sterility
Free from pyrogens
Free from foreing particles
Isotonicity
Specific gravity
Chemical purity
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Formulation of Injectable
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The formulation of Injectable need carfeful planning, thorough knowledge of the
medicaments and adjuvants to be used.
The excess use of adjuvants in Injectable should be avoided as some of these may
interfere with the drug.
In the preparation of Injectable, the following substances are added to make a stable
preparation:Vehicles
Adjuvant
Solubilising agents
Stabilizers
Buffering agents
Antibacterial agents
Chelating agents
Suspending, emulsifying and wetting agents
Tonicity factors
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Containers and Closures
• The containers used for Injectable are either made
from glass or plastic material.
• The pharmacopoeia requires the following conditions
for a container and closure to be used for parenteral
preparations:
1. It should not yield foreign substances to the product.
2. It should be sufficient transparent to allow visual
inspection of the content in it.
3. It should not have any adverse effect on the product.
4. It should prevent diffusion in or across the walls.
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Types of glass containers
1. Type I glass: It is also called borosilicate glass or neutral
glass. It offers a high hydrolytic resistance due to its chemical
composition. It can withstand autoclaving and weathering.
2. Type II glass: It is a soda-lime-silicate glass with high
hydrolytic resistance as a result of treatment with moist
sulphur dioxide at high temperature. The container made
from this glass are suitable for most acidic and neutral
aqueous preparations
3. Type III glass: It is a soda-lime-silicate glass with only
moderate hydrolytic resistance. The containers made from
this glass are generally suitable for non-aqueous preparations
and powders for reconstitution immediately prior to
administration.
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Processing of Injectable
• The following steps are involved in the processing of parenteral
preparations:1. Cleaning of containers, closures and equipment
2. Collection of materials
3. Preparation of parenteral products
4. Filtration
5. Filling the preparation in final containers
6. Sealing the containers
7. Sterilization
8. Evaluation of parenteral preparations
9. Labelling and packaging
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Evaluation of Injectable
• The finished parenteral products are subjected to the
following test, in order to maintain quality control:1.
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Sterility test
Clarity test
Leakage test
Pyrogen test
Assay
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Labeling
• After evaluation of the parenteral preparation, the ampoules, vials
and transfusion bottles are properly labelled and packed.
• The label should state:1. Name of the preparation
2. Quantity of the preparation
3. Mfg. Lic. No.
4. Batch No.
5. Date of manufacture
6. Date of expiry
7. Storage conditions
8. Retail price
9. Manufacture’s address
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Packaging
• Parenteral packaging includes ampoules, rubber stoppered
vials and bottles, plastic bags and bottles, glass and plastic
syringes, and syringe-vial combinations.
• Glass containers have traditionally achieved widespread
acceptability for parenteral products because of their
relative inertness.
• In recent years, hospital preference for unit-dose and
clinical convenience has resulted in an increase in products
packaged in disposable syringes and the development of
polyvinylchloride, polyester, and polyolefin plastic
containers for IV fluids.
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Packaging
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Production facilities
• The manufacture of parenteral preparation requires
special precautions and facilities in order to maintain
sterility and freedom from particulate matter.
• The production area where sterile parenteral preparations
are manufactured can be divided into five sections:1. Clean-up area
2. Preparation area
3. Aseptic area
4. Quarantine area
5. Finishing and packaging area
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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Flow chart of parenteral
products preparation
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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THANK YOU
e-mail: [email protected]
2014/06/07
Faculty of Pharmacy, Omer Al-Mukhtar University,
Tobruk, Libya.
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