DRUG AND PHARMACEUCTICAL PACKAGING 1

8/12/2019 DRUG AND PHARMACEUCTICAL PACKAGING 1

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Name of the Staff : Y.Venkat Reddy

Designation : Sr. Lecturer

Branch : Packaging Technology

Institute : J.N.G.P.Ramanthapur,Hyd

Subject : Drug & Pharmaceutical Packaging

Subject Code : PKG.503

Topic : Introduction to Drug Packaging

Sub topic : Basic concept of Drug & its terminology

Duration : 100 minutes

Teaching Aid : PPT, Animations & Photographs

DEPARTMENT OF TECHNICAL EDUCATION

ANDRA PRADESH


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Up on the completion of the topic the student will able to

understand

The Concept of Drug and its related Terminology

Objectives


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INTRODUCTION TO DRUG PACKAGING

What does Drug Packaging Do?

Stores the drug


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Stores the drug


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What does Drug Packaging Do?Delivers the Drug


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What does Drug Packaging Do?

Manufactures the drug


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What does Drug Packaging do?

Protects the Drug


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Concept of Drug

The article intended for use in the diagnosis, cure,

treatment or prevention of disease in Man or other

Animals


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Definition: DRUG PACKAGING

An economical means of providing

protection ,

presentation,identification ,

information

and convenience for a pharmaceutical product from

moment of its production until it is used or administered.


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General aspects of Drug packaging

Better protection for a longer duration.

Sustain the quality with stability.

Preserving quality and lengthening shelf life.


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Creating brand awareness and expanding consumer

preferences.

Products are packaged to meet the criteria of safety,

convenience and attractiveness.


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National and International Guidelines

Code of Federal Regulations

United States Pharmacopoeia

British Pharmacopoeia

European Pharmacopoeia

Japanese Pharmacopoeia


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AMPULE

AMPULE: A container capable of

being hermetically sealed,

intended to hold sterile materials.
http://www.pharmaceutical-technology.com/contractors/packaging/kaisha/kaisha1.htmlhttp://www.pharmaceutical-technology.com/contractors/packaging/nuova/nuova4.html


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VIAL

A container designed for

containing parenteraldrug for multiple dosages

closed by a rubber cork

and sealed by Aluminum

products.
http://www.pharmaceutical-technology.com/contractors/packaging/nuova/nuova5.html


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CAPSULE

Capsule shells may be

made from gelatin, starch,

or cellulose, or other

suitable materials,

may be soft or hard,

and are filled with solid or

liquid ingredients that can

be poured or squeezed.
http://images.google.co.in/imgres?imgurl=www.urofoam.co.uk/images/medical/capsule.jpg&imgrefurl=http://www.urofoam.co.uk/uk/medical.htm&h=171&w=180&sz=6&tbnid=NOSi5hTB7W8J:&tbnh=91&tbnw=95&start=2&prev=/images%3Fq%3Dcapsule%26hl%3Den%26lr%3D%26ie%3DUTF-8


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The shell is composed of a single

sealed enclosure, or two halves

that fit together and which are

sometimes sealed with a band.

A solid oral dosage form consisting of a shell and a filling


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CAPLET

A tablet shaped like a capsule and coated with materials

to provide ease of swallowing.


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SYRUP

An oral solution containing highconcentrations of sucrose or

other sugars; the term has also

been used to include any other

liquid dosage form prepared in

a sweet and viscid vehicle,

including oral suspensions.


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U.. S.. Food and Drug Administration

Excerpt from the FDA Mission

Statement

the FDA is responsible for

protect ing the publ ic heal th

by assuring the safety, eff icacy, and

secur i ty of

human and veterinary drugs,

biological product, Medical devices


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Historical milestones of the FDA

1862- PRESIDENT LINCOLN appoints a chemist to serve in

the Bureau of Chemistry, the predecessor of the Food and

Drug Administration.

1820- Eleven physicians establish U.S. PHARMACOPEIA,

the first compendium of standard drugs for the United States.


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Contd.

1906- The original FOOD AND DRUGS ACT is passed

by Congress

1938- The FEDERAL FOOD, DRUG, AND COSMETIC

(FDC) ACT is passed by Congress

1949- FDA publishes GUIDANCE TO INDUSTRY for the

first time.


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FDA- Federal Drug Administration Act

In the United States, such packaging is controlled under

the Federal Food, Drug, and Cosmetic Act .

Also stipulates requirements for tamper-resistance and

child-resistance.


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FDAStatute protects consumers against :

adulterated and misbranded foods and drugs,

regulates food quality, food additives, and food

classifications,

approves all prescription and over-the-counter drugs before

they may be sold to the public, and

has the authority to pull food and drugs from publicdistribution.


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USP

About USPAn Overview

The United States Pharmacopoeia (USP) is the official

public standards-setting authority for all prescription and

over-the-counter medicines, dietary supplements, and other

healthcare products manufactured and sold in the United

States.


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USP's standards are also recognized and used in more

than 130 countries.

Product QualityStandards and Verification

Patient Safety

Healthcare Information


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BP-British Pharmacopoeia

British Pharmacopoeia (BP) is a collection of quality

standards for UK medicinal substances ,Published

annually.

It is used by individuals and organizations involved inpharmaceutical research, development, manufacture

and testing.

Pharmacopoeia standards are compliance requirements,

that is, they provide the means for an independentjudgment as to the overall quality of an article and apply

throughout the shelf-life of a product.
http://en.wikipedia.org/wiki/Pharmacopoeiahttp://en.wikipedia.org/wiki/United_Kingdomhttp://en.wikipedia.org/wiki/Medicinalhttp://en.wikipedia.org/wiki/Medicinalhttp://en.wikipedia.org/wiki/United_Kingdomhttp://en.wikipedia.org/wiki/Pharmacopoeia


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History

The regulation of medicinal products by officials in the United

Kingdom dates back to the reign of King Henry VIII (1491

1547).

The Royal College of Physiciansof London had the power to

inspect apothecaries products in the London area and to

destroy defective stock.

The first list of approved drugs with information on how they

should be prepared was the London Pharmacopoeia

published in 1618.
http://en.wikipedia.org/wiki/King_Henry_VIIIhttp://en.wikipedia.org/wiki/Royal_College_of_Physicianshttp://en.wikipedia.org/wiki/Royal_College_of_Physicianshttp://en.wikipedia.org/wiki/Royal_College_of_Physicianshttp://en.wikipedia.org/wiki/Royal_College_of_Physicianshttp://en.wikipedia.org/wiki/Royal_College_of_Physicianshttp://en.wikipedia.org/wiki/Royal_College_of_Physicianshttp://en.wikipedia.org/wiki/Royal_College_of_Physicianshttp://en.wikipedia.org/wiki/Royal_College_of_Physicianshttp://en.wikipedia.org/wiki/King_Henry_VIIIhttp://en.wikipedia.org/wiki/King_Henry_VIIIhttp://en.wikipedia.org/wiki/King_Henry_VIIIhttp://en.wikipedia.org/wiki/King_Henry_VIIIhttp://en.wikipedia.org/wiki/King_Henry_VIII


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DMF

Drug master file

It is maintained by FDA


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Parenteral Drug

Any drug intended for administration by

injection ,

subcutaneously or

intramuscularly or

intravenously


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Packaging is the

life lineof the

Pharma Products


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SUMMARY

A drug packaging can Stores the drug, Delivers the drug,

Protects the Drug, Manufactures the drug.

Ampoule is a single dose Injectable container, Vial is a

multi dosage container.


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FDA is Food and drugs administration

USP means United states pharmacopoeia

Tablet ,caplet, capsule ,syrup, parenterals are various

medications.


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1. What does Drug Packaging Do?

a) Stores the drug

b) Delivers the Drug

c) Protects the Drug

d) All of the above

Quiz


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Quiz

2. Food and Drug Administration will have control

on substances of

a) Only pharmaceutical products

b) Only food related products

c) Only cosmetic related products

d) d) all of the abovee) a and b of above


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Frequently asked Questions

1. Define the terms i) Drug ii) Drug packaging

2. Define the terms i) Ampoule ii) Vial

3. Define the terms i) Capsule ii) Caplet

4. Elaborate the following terms

i) FDA ii) DMF iii) USP iv) BP


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DRUG AND PHARMACEUCTICAL PACKAGING 1