PRESENTED BY:Anum YousafAtia Gulzar

Ayesha ArshadFatima Muhammad

Kainat ZahraNida Javaid

Nosheen Rehman

PRESENTED TO:Dr. Sobia

DATE OF PRESENTATIONAPRIL 27TH, 2015

• IntroductionHistoryWhy parenteral?Necessary condition

of parenteral• Methods of preparation• Quality control• Packaging• Types of parenteral

products• Routes of

administration• advantages/

disadvantages• conclusion

Introduction:

The administration of drugs into the

patient by injection under one or more

layer of the skin or mucous membrane.

The term parenteral is derived from two Greek words:

PARA (OUTSIDE)ENTERON

(INTESTINE)

It donate the route of administration

other than oral route.

Definition of parenterals:

Parenterals are those preparations intended for injection through the skin or other external boundary tissue, rather than through the alimentary canal, so that the active substances they contain are administered using gravity or force directly into a blood vessel, organ, or tissue.

History:

1657: first recorded injection in animals- Sir Christopher Wren

1855: first subcutaneous injection of drugs using hypodermic needles - Dr. Alexander wood

1920:proof of microbial growth resulting in infections

- Dr. Florence Seibert

1926: inclusion in the national formulary

1931: commercial intravenous solution(Baxter)

1946:organization of parenteral drug association

1965:development of total parenteral nutrition

Necessities of parenteral preparations:

• Sterility (must)

• Free from pyrogen (must)

• Free from particulate matter

• Clarity (must)

• Stability (must)

Isotonicity (should)

Solvents and vehicles used must meet special purity and other standard

Do not use coloring agents

Must be prepared under aseptic conditions

Specific and high quality packaging

MANUFACTURING PROCESS:

• A suitable test method for the preservative properties of the formulation are provided under Efficacy of antimicrobial preservation.

• Methods designed to ensure sterility and to avoid the introduction of contaminants and the growth of micro-organisms follow the method of sterilization.

• Water used in the manufacture of parenteral preparations complies with the requirements of water for injections

• The design and maintenance of the equipment and the method of manufacture must be such as to ensure the stability of the active substance and of the final product and sterility of the injection.

PARENTERAL PREPARATIONS

DEFINITION:Parenteral preparations are sterile preparations which may consist of one or more active ingredients intended for administration by injection, infusion or implantation into the body.

REQUIRED EXCIPIENTS: • Solvents• substances to enhance solubility • suspending agents• buffering agents• substances to make the preparation isotonic with blood

and • stabilizers or antimicrobial preservatives

TESTS• Parenterals are tested for particulate

contamination: sub-visible particles.

• For preparations for human use, solutions for infusion or solutions for injection supplied in containers with a nominal content of more than 100 ml comply with the test.

• Sterility. Parenteral preparations comply with the test for sterility.

STORAGEStore in a sterile, airtight, tamper-proof container.

LABELLINGThe label states :— the name and concentration of any added antimicrobial preservative,— where applicable, that the solution is to be used in conjunction with a final filter,— where applicable, that the preparation is free from bacterial endotoxins or that it is apyrogenic.

Precautions:• The manufacturing process should

meet the requirements of good manufacturing practices (GMP)

• The addition of excipients is kept to a minimum.

• When excipients are used they do not adversely affect the stability, bioavailability, safety or efficacy of the active ingredient(s), or cause toxicity or undue local irritation.

• There must be no incompatibility between any of the components.

• Sterilization may be omitted, provided that the preparation is subject to terminal sterilization. 

Quality control

• “In a pharmaceutical organization, the quality control deals with testing, sampling, specification and documentation- a procedure which ensures that all tests are actually carried out prior to release of material for sale or use”.

Quality tests

there are 4 types of quality tests.• Sterility tests• Pyrogen tests• Leaker test• Particulate

matter testing

Sterility test• Sterility is the most

important test.• Sterility means the removal

of micro-organisms.• It is essential test for the

parenteral.• There are two methods for

sterility.Direct transfer methodMembrane filtration

method

Direct transfer method

It is a traditional sterility test method which involves a direct transfer. This method is simple in theory but difficult in practice involving inoculation of require volume of a sample in two test tube containing a culture medium that is FTM,SCDM.

• Membrane filtration method:

• this method is basically involve filtration of a sample through membrane filters of porosity 0.22 micron and diameter 47mm.

Pyrogen test• Pyrogen are product of

metabolism in micro organism .• Gm-ve bacteria produce more

potent pyrogen.• When these are injected in to the

body then they cause ache and fever(rise in body temperature) with in one hour.

• Two types of test are present Rabbit testLAL test

Leakage test• The leakage test is

intended to detect the incompletely sealed ampoules.

• Any crack may be present at the base and the seal of the ampule due to the improper handling.

• The crack is usually detected by the negative pressure produced due to the crack in ampule in a vacuumed chamber

• Vials and bottles are not subjected to this test.

Particulate matter testing

• Particulate matter is primary concern in parenteral products given by i.v route, all parenteral product should be free from insoluble particles.

• In this all containers are visually inspected.

• It is done by holding the ampule by its neck against highly illuminated screens

• White screen for detection of black and black for white particles

• A method utilizing the video image projection could detect a moving particle with out destruction of product unit.

Parenteral Preparations and other sterile products must be packaged in a way that :

Maintains product sterility until the time of use .

Prevents contamination of contents during opening .

packaging

A . Types of containers There are five types of containers:

1 . Ampules,-the oldest type of Parenteral product containers, are made entirely of glass.

-Single use only.

Disadvantages .Because glass particles may become dislodged during ampule opening, the product must be filtered before it administered

2. Vials:-are glass or plastic containers closed with a rubber stopper and sealed with an aluminum crimp.

Vials have several advantages over ampoules.a. Vials can be designed to hold multiple doses.b. The drug product is easier to remove from vials than from ampules. c. Vials eliminate the risk of glass particle contamination during opening.

• b. However, Vials also have certain disadvantages

a. The rubber stopper can become cored, causing a small bit of rubber to enter the solution.

b. Multiple withdrawals (as with multiple-dose vials) can result in microbial

contamination.

3. Some drugs come in vials that may be attached to an diluents containing bag for reconstitution and administration (ADD-Vantage by abbott) .

a. The ADD-Vantage Vial is screwed into the top of an ADD- Vantage diluent bag, and the rubber diaphragm is dislodged from the vial, allowing the diluent solution to dissolve the drug.

b. The reconstituted ADD-Vantage vial and IV bag are ready for administration when hung.

4. Prefilled syringes:

Prefilled syringes and cartridges are designed for maximum convenience .

Drugs administration in an emergency

b. Prefilled cartridges Are ready-to-use

parenteral packages that offer improved sterility and accuracy.

They consist of a plastic cartridges holder and prefilled medication cartridge with a needle attached.

The medication is premixed and premeasured E.g. Enoxaparin .

5. Infusion solutions.

Are divided into two categories:

Small-volume parenterals(SVPs), Those having a volume less than 100 mL.

large-volume parenterals(LVPs), Those having a volume of 100 mL or greater. Infusion solution are used for the intermittent or continuous infusion of fluids or drugs .

B. Packing materials

Out of the two types of packaging materials used, one is glass

1. Glass, The original Parenteral packaging material, has superior clarity,

Compared to plastic, glass less frequently interacts with the preparation it contains.

2. Plastic polymers used for parenteral packages include polyvinylchloride (PVC) and polyolefin.

a. PVC is flexible and non rigid.

b. Polyolefin is semi rigid; it can be stored upright.

c. Plastic has several advantages over glass, including durability, easier storage and disposal.

Parenterals are classified into two main types:

1. Small Volume Parenterals(SVP),

2. Large Volume Parenterals(LVP).

3. Powder parenterals

Classification of parenterals

Small Volume Parenterals

They include ampules of 1ml, 2ml, 3ml up to 30 ml and vials of 1 ml up to 30 ml.

They are administered by various routes.

The most widely used small volume parenterals are various insulin preparations used for treatment of Diabetes Mellitus.

EXAMPLES:

-DIGOXIN solutions are administered intravenously and are used as cardiotonics.

Procaine Penicillin G- used for treatment of bacterial infections.

• : LVP are Parenterals designed to provide Fluids, Calories, Electrolytes or a combination of these.

• Volume 101-1000mL

• IV infusion technique is “Venoclysis”.

• They provide nutrition.

• Used in cases where there is loss of water, vomiting and diarrhea or when the patient cannot consume oral nutrition for long periods.

Large volume parenterals

Examples of lvp’s

1. Electrolytes:

• Sodium chloride solutions.• Potassium chloride

solutions

2. non –electrolytes:

• Dextrol solutions.• Mannitol solutions.

Powder parenterals

• Dry powders available in market are soluble in water or any other sterile solvent for injection prior to use.

• They are suitable for certain formulations which degrade by hydrolysis.

• For example:• Penicillin, ampycillin,

amoxycillin etc.

Routes of administration

Intravenous is a term that

means “into the vein”.

The needle is introduce in

vein near the elbow,

wrist, or on the back of

the hand. Different sites

can be used if necessary.

1) Intravenous

2) intramuscular

Intramuscular (IM)

injections are made

into the striated

muscle fibers that

are under the

subcutaneous layer

of the skin.

Needles used for

the injections are

generally 1 inch to

1.5 inches long.

It can be used for both short term and very long term therapies.The injection of a drug or the implantation of a device beneath the surface of the skin is made in

1. loose interstitial tissues of the upper arm

2. the anterior surface of the thigh

3. lower portion of the abdomen.

3) Subcutaneous

Advantages

As compared to other dosage forms, parenteral administration offers some selective advantages. 1. An immediate physiological response can be achieved if necessary.

2. It provides a direct route for achieving the drug effect within the body.

3. Modification of the formulation can however slow down the onset and prolong the action. This may also be achieved by the change in the route of injection.

4. When food cannot be taken by mouth, total nutritional requirement can be supplied by the parenteral route.

5. Low drug concentration

6. Low toxicity as compared to solid dosage form

7. Most suitable route for those drugs which are degraded or erratically or unreliably absorbed when administered orally

8. Most suitable if the patient is unconscious, difficult to swallow drug etc.

9. No chance of missing dose.

Disadvantages

The main disadvantages of parenteral products are:

1. Requirement of aseptic technique in production, compounding and handling of product

2. Requirement of trained personnel for administration

3. Real or psychological pain associated with the injection

4. Highly risky if any mistake at happens any point

5. High cost as compared to solid dosage form

6. It is difficult to reverse its physiological effect

CONCLUSION

The parenteral route of administration is the most effective route for the delivery of active pharmaceutical substances specially when drugs cannot be taken orally.

Parenteral administration of drugs usually provides an alternative route for the drugs that are highly hydrophobic as these drugs cannot pass through cell membranes.

Thankyou!!