DEPARTMENT OF TECHNICAL EDUCATION ANDRA PRADESH

Name of the Staff Designation : Y.Venkat Reddy : Sr. Lecturer

Branch
Institute Subject Subject Code Topic Sub topic Duration Teaching Aid

: Packaging Technology
: J.N.G.P.Ramanthapur,Hyd : Drug & Pharmaceutical Packaging : PKG.503 : Introduction to Drug Packaging : Basic concept of Drug & its terminology : 100 minutes : PPT, Animations & Photographs
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Objectives
Up on the completion of the topic the student will able to understand
The Concept of Drug and its related Terminology

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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.

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VIAL
A container designed for containing parenteral drug for multiple dosages closed by a rubber cork and sealed by Aluminum products.

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

The shell is composed of a single

sealed enclosure, or two halves that fit together and which are sometimes sealed with a band.

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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 high concentrations 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 protecting the public health by assuring the safety, efficacy, and security 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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FDA Statute 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 public

distribution.

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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 in pharmaceutical research, development, manufacture and testing. Pharmacopoeia standards are compliance requirements, that is, they provide the means for an independent judgment as to the overall quality of an article and apply throughout the shelf-life of a product.
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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 Physicians of 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.
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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 line of 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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Quiz
1. What does Drug Packaging Do?

a) Stores the drug

b) Delivers the Drug c) Protects the Drug d) All of the above

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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 above

e) a and b of above
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Frequently asked Questions

1. 2. 3. 4. Define the terms i) Drug ii) Drug packaging Define the terms i) Ampoule ii) Vial Define the terms i) Capsule ii) Caplet Elaborate the following terms

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

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