Injectable Solutions

2014/06/07

Dr. Basavaraj K. Nanjwade

Department of Pharmaceutics Faculty of Pharmacy Omer Al-Mukhtar University Tobruk, Libya.

E-Mail: [email protected]

M. Pharm., Ph. D

Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

1

CONTENTS

• • • • • • • • • • • 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.

2

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.

3

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.

4

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.

5

Routes of administration

• 1.

2.

3.

The various routes of administration of parenteral preparations are as follows: Intradermal (intracutaneous) injections Hypodermis (subcutaneous) injections Intramuscular injections 4.

5.

6.

7.

Intravenous injections Intra-arterial injections Intracardic injections Intrathecal injections 8.

9.

Intracisternal injections Peridural injections 10. Intr-articular injections 11. Intracerebral injections 2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

6

Routes of administration

2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

7

Types of Injectables

• 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.

8

General requirements for Injectable

• The formulation of parenteral products involves careful consideration of the following requirements: 1. Stability 2. Sterility 3. Free from pyrogens 4. Free from foreing particles 5. Isotonicity 6. Specific gravity 7. Chemical purity 2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

9

Formulation of Injectable

• • • 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: 1.

2.

Vehicles Adjuvant (a) Solubilising agents (b) Stabilizers (c) Buffering agents (d) Antibacterial agents (e) Chelating agents (f) Suspending, emulsifying and wetting agents (g) Tonicity factors 2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

10

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.

11

Types of glass containers

1.

2.

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.

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.

12

Processing of Injectable

6.

7.

8.

9.

2.

3.

4.

5.

• 1.

The following steps are involved in the processing of parenteral preparations: Cleaning of containers, closures and equipment Collection of materials Preparation of parenteral products Filtration Filling the preparation in final containers Sealing the containers Sterilization Evaluation of parenteral preparations Labelling and packaging 2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

13

Evaluation of Injectable

• The finished parenteral products are subjected to the following test, in order to maintain quality control: 1. Sterility test 2. Clarity test 3. Leakage test 4. Pyrogen test 5. Assay 2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

14

Labeling

7.

8.

9.

3.

4.

5.

6.

• After evaluation of the parenteral preparation, the ampoules, vials and transfusion bottles are properly labelled and packed.

• 1.

The label should state:-

Name of the preparation 2.

Quantity of the preparation Mfg. Lic. No.

Batch No.

Date of manufacture Date of expiry Storage conditions Retail price Manufacture’s address 2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

15

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.

16

Packaging

2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

17

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.

18

Flow chart of parenteral products preparation

2014/06/07 Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

19

THANK YOU

e-mail: [email protected]

Faculty of Pharmacy, Omer Al-Mukhtar University, Tobruk, Libya.

2014/06/07 20