2.Pharmaceutical packaging and labelling-1.ppt

Pharmaceutical packaging

1. PHARMACEUTICAL
Packaging
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2. Packaging
•Packaging can be defined as an economical means of
providing presentation, protection, identification
information, containment, convenience and
compliance for a product during storage, carriage,
display and until the product is consumed.
• Packaging must provide protection against climatic
conditions biological, physical and chemical hazards
and must be economical.
• The package must ensure adequate stability of the
product throughout the shelf life.
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3. Types
•The primary packaging consist of those
packaging components which have a direct
contact with the product (i.e. bottle, cap, cap
liner, label etc).
•The main functions of the primary package are
to contain and to restrict any chemical, climatic
or biological or occasionally mechanical hazards
that may cause or lead to product deterioration.
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4. Secondary packaging
•Packaging external to the primary package is
known as the secondary packaging.
• The secondary packaging mainly provides the
additional physical protection necessary to
endure the safe warehousing and for refill
packaging.
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5. 6-5
Types of primary and secondary packaging material
Material  Type  Example
of use 
Glass  Primary 
Metric
medical bottle, ampoule,
vial 
Plastic  Primary 
Ampoule,
vial, infusion fluid
container,
dropper bottle  
  Secondary 
Wrapper
to contain primary
pack 
Cardboard  Secondary  Box
to contain primary pack
Paper  Secondary 
Labels,
patient information
leaflet

6. PHARMACEUTICAL
LABELING
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7. Package forms
•The wide variety of pharmaceutical solids,
liquids, and gasses are packaged in a wide
variety of packages. Some of the common
primary packages are:
•Blister packs
•Bottles
•1. Glass bottle
•2. Plastic bottle
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8. Raw materials Final product
•What Is missing??What Is missing??
•It is complete but
with lost
identity…………
processing

9. LABEL!!!

10. Contents
• What is Label?
•Need of a label
•Manufacturer label
•Legal requirements
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11. LABEL
“ Label means a display of written, printed or
graphic matter upon immediate container or the
wrapper of a drug package”
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12. NEED OF A DRUG
LABEL

13. Manufacturer label
•A label which contain drug information for the
use of medical practitioners, pharmacists, or
nurses supplied by the manufacturer, packer, or
distributor of the drug
(FDA)

14. LEGAL REQUIRMENTS OF A
MANUFACTURER LABEL
1.The name of preparation
2.Strength and dosage form.
3. Quantity.
4.Instructions for the use.
5.Precautions & warnings.
6.Registration number.
7.Batch number.
8.Manufacturing & Expiry date .
9.Price
10.The name and address of pharmaceutical industry

15. NAME OF THE PREPARATION
Generic name:
According to drug labeling and packaging rules
1986:
“ International non-proprietary name means the
name of a drug as recommended by WHO or
may be notified by the federal govt. in the
official gazette”
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16. Brand Name:

▫Brand name which is used to market the drug
▫Property of drug company
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17. STRENGTH
•It is amount of active drug per unit dose.
•Example: amoxicillin 250mg capsules and
amoxicillin 500mg capsules.
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18. SPECIFICATION
•U.S.P
•B.P

19. DOSAGE FORM
•Dosage form of the medicine should be
mentioned on the label. e.g.,
•Different dosage forms of Amoxicillin

20. QUANTITY
Quantity /volume present per a packaging unitQuantity /volume present per a packaging unit

The container hold 20 tablets and each tablet
has a dosage strength of 500 mg per tablet.

21. INSTRUCTIONS

22. Shake well before use:

Necessary on all disperse systems:
•Emulsions
•Suspensions

23. Warning!!!!!
DO NOT SHAKE THE PATIENT,
SHAKE THE BOTTLE WELL BEFORE USE …….
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24. Storage conditions
Store in a cool place:

25. Protect from light:
•Necessary for light sensitive preparations.
•Light resistive containers should be used.

26. Keep out of the reach of children
•All dispensed medicines should carry this
information on label

27. For external use only:

28. Inflammable:
If the preparation contain 50% or more alcohol
or any other inflammable solvent, the label
should contain word inflammable

29. Not to be taken:
•Liquid preparation that are not administered by mouth
•For nasal drops, enemas and nasal sprays
•Unit dosage forms e.g., pessaries and rectal
suppositories
•Help to administer drugs safely
•Types of warnings
• If hypersensitivity to a drug
▫For controlled substances
▫About combining with other drugs or products

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30. Registration number
•“A number given to a specific drug when it is
registered according to specific rules by
registration board set up by federal government”

31. Batch number
•Acc. to drug act 1976
•“A designation printed on label of a drug that
identifies the batch and permits the production
history of the batch including all stages of
manufacturer and control to be traced and are
viewed”

32. Manufacturing date
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33. Expiry date
•Accorrding to drug act 1976 S 3
•“Date stated on the label of a drug after which a
drug is not expected to retain its claimed
efficacy, safety, quantity, or potency or after
which it is no permissible to sell the drug”
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34. Liscense number
•Biological products are approved for marketing
under the provisions of the Public Health Service
(PHS) Act. The Act requires a firm who
manufactures a biologic for sale in interstate
commerce to hold a license for the product

35. Manufacturer information
•Name
•Adress
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36. Price
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37. Barcodes
•“It is an optical machine readable representation
of data, which shows data about the object to
which it attaches”
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38. SPECIAL INSTRUCTIONS
•Shake before use
•Do not exceed the prescribed dose
•Directions for use
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39. Interactions
•Certain drugs may have serious reactions if eat
with particular food or drugs,e.g:
a)Amine containing foods (tyrosine) with
monoamine oxidase inhibitors.(hypertension
crises)
b)Tetracycline with milk

40. REFERENCES:
1.Mannual of drug laws 2014
2.Dispensing for pharmaceutical students pharmacy
by S.J Carter
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