Introduction Routes of administration of parenteral dosage form Types of parenteral preparation General requirements for parenteral dosage form Formulation of parenteral preparations Containers and closures used Processing of parenteral preparations Evaluation of parenteral preparations Labeling and packaging Production facilities Preparation of iv fluids and admixtures Sterlity testing Particulate matter monitoring Faculty seal packaging

1. By
QURAISHI INSHRAH FATEMA

2. STERILE DOSAGE FORM
 CONTENT
 Introduction
 Routes of administration of parenteral dosage form
 Types of parenteral preparation
 General requirements for parenteral dosage form
 Formulation of parenteral preparations
 Containers and closures used
 Processing of parenteral preparations
 Evaluation of parenteral preparations
 Labeling and packaging
 Production facilities
 Preparation of iv fluids and admixtures
 Sterlity testing
 Particulate matter monitoring
 Faculty seal packaging

3. INTRODUCTION
 Parenteral preparation are the preparation that are given by
other than orally. - Injections and transfusion fluids are
come under the parental preparation. - Injections should
be sterile, isotonic, and free from the foreign particles,
such as dust, fibers etc.
 Injections are the sterile solution and suspension of drug
in aqueous or oily vehicle meant for introduction in to the
body by means of an injectable needle under or through
one or more layer of skin or mucous membrane.

4.  Advantages of Parenteral Preparation: -
 The drug which are can not be administered by oral route, can
administered by this route.
 - The patient who are vomiting or suffering form unconscious
condition, can not able to take the drugs by orally, can
administered by this route.
 - The drug action is quick and rapid - Drug action can be
prolonged by modifying the formulation
 - Transfusion fluid are also contain nutritive like glucose and
electrolytes.
.

5.  Disadvantages: -
 The trained person is required to administer the drug
 - Injection causes the pain at the side of injection
 - The administration of drug from wrong route of
injection may very dangerous.
 - The chances of sensitivity reaction or allergic
reaction of the drug by an individual

6. Route of Administration:
 Intradermal Injection (IC)
 - Hypodermis Injection (SC)
 - Intramuscular Injection (IM)
 - Intravenous Injection (IV)
 - Intra Arterial Injection
 - Intracardiac Injection
 - Intrathecal Injection (surrounding to spinal cord)
 Intracisternal Injection (between first & second cervical vertebrae) for
withdrawing cerebrospinal fluid
 - Peridural Injection (inner aspect of vertebra)
 - Intra-articular Injection (in bones joint)
 - Intracerebral Injection (Cerebrum

7. GENERAL REQUIREMENTS FOR
PREPARATION OF PARENTERALS
 PP required careful consideration of the following requirement:
 - Stability
 - Sterility
 - Free from Pyrogen
 - Free from foreign particles
 - Isotonicity
 - Specific Gravity
 - Chemical Purity

8. Formulation of Parenteral
Preparation
 - The formulation of parental preparation is the careful
need of planning, through knowledge of the medicament
and adjuvant to be used
 Following formulating agents are used in the preparation
of parental such as
1-Vehicle
2-Adjuvant - Solubilising Agents - Stabilizers - Buffering
Agents - Antibacterial Agents - Chelating Agents -
Suspending, Emulsifying and wetting agents - Tonicity
Agents

9. Container and Closuers
 The glass and plastic containers are generally used for
dispensing of parental preparation. - The pharmacopeia
required the following conditions for a container and closure to
be used for parental preparation:
 Following three types glasses are used:
 - Borosilicate Glass or Natural Glass( TYPE 1)
 - Soda lime silicate Glass with hydrolytic resistance(type2)
 - Soda lime Glass with only moderate hydrolytic
resistance.(type3)

10. Processing of Parenteral Product
Following steps are involved in the processing of parental
products:
 Cleansing of Container, closer and equipment
 Collection of Material
 Preparation of parental product
 Filtration
 Filling the preparation in final container
 Sealing of Container
 Sterilization
 Evaluation of parental preparation
 Labeling and packing

11. Evaluation of Parenteral
Preparation
 Sterility Test
 Clarity Test
 Leakage Test
 Pyrogen Test
 Assay

12. Labeling and packing
The label should state:
- Name of Preparation
 Quantity of the preparation
 Mfg. license No.
 Batch no.
 Date of manufacture
 Date of Expiry
 Storage Condition
 Retail Prize
 Manufacturers address

13. Production Facilities
The manufacture of Parenteral preparation require special
precautions' and facilities in order to maintain sterility and
freedom from particulate matter.
The production area can be divided in to five sections such as:
 Clean Up area
 Preparation area
 Aseptic area
 Quarantine area
 Finishing and packing area

14. Preparation of Intravenous Fluids
 - Dextrose Injection IP – These are available in conc. of 5, 10,
25 and 50 % w/v/ solution.
 Nacl and Dextrose Injection IP: It contain Nacl from 0.11 to
0.9 % and dextrose from 2.5 to 25 % - Nacl Injection IP
 : It contain 0.9 % Nacl, is also called as normal saline solution.
 Sodium Lactose Injection: It contain 1.75 % to 1.95 % w/v of
sodium lactose. Used as electrolyte replenisher

15. IV admixture
 An IV admixture is the preparation of a pharmaceutical
mixture of two or more drugs into a large bag or bottle of IV
fluid.
 This is always done under the direction of a doctor,
controlled/performed by a trained pharmacists
 This is to be sure that no one is accidentally overdosed, or
given the wrong medications. I/V admixtures

16. Total parenteral nutrition
 Parenteral nutrition is the feeding of nutritional products to a
person intravenously, bypassing the usual process of eating and
digestion. The products are made by pharmaceutical
compounding companies
Purposes
 To provide nutrients required for the normal metabolism,
tissue maintenance, repair and energy demands.
 To bypass the GI tract for patients who are unable to take food
orally.

17. Dialysis fluids
 Dialysis is the process by which substances are
separated from one another due to their difference in
diffusibility through membranes , the fluids used in
dialysis are known as dialysis fluids
 Types
 Haemodialysis
 Intraperitoneal dialysis

18. Sterility testing
 Sterility Testing: • Are done to detect if viable forms of
micro-organisms are present or not on or in the
pharmaceutical preparations
 STEPS INVOLVED IN STERILITY TESTING
 1. Selection of the sample size
 . 2. Selection of the quantity of the product.
 3. Method of testing.
 4. Observation and Results

19. Particulate matter monitoring
 Particulate matter is defined as unwanted mobile
insoluble matter other than gas bubbles present in
product
 Sources
 Intrinsic contamination
 Extrinsic contamination

20. Methods for monitoring Particulate
matter contamination
 Visual method
 Coulter counter method
 Filtration method
 Light blockage method

21. Significance of Particulate matter
monitoring
 The presence of particulate matter may lead to
septicemia , blockage of small blood vessel cappileries
 Its presence creates doubt about quality of product

22. Pyrogen testing
 The test involves measurement of the rise in body temperature
of rabbits following the IV injection of a sterile solution into
ear vein of rabbit.
 Dose not exceeding 10 ml per kg injected intravenously
within a period of not more than 10 min
 Test animals: Use healthy, adult rabbits of either sex, preferably
of the same variety.
 • Recording of temperature: Clinical thermometer

23. PROCEDURE
 • Inject the solution under examination slowly into the marginal
veins of the ear of each rabbit over a period not exceeding 4
min.
 Record the temperature of each animal at half- hourly intervals
for 3 hours after injection.
 The difference between the initial temperature and the
maximum temperature which is the highest temperature
recorded for a rabbit is taken to be its response.

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