Transcript Packaging of Cream and Ointment

Packaging for Cream
1
KAUSAR AHMAD
KULLIYYAH OF PHARMACY
http://staff.iium.edu.my/akausar
PHM4153 Dosage Design 2 2011/12
Contents
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Packaging materials
Types of packaging
Packaging
requirements
PHM4153 Dosage Design 2 2011/12
Filling
Packaging equipment
Introduction
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• Container
• Closure
Correct packaging
• Carton
• Labeling
PHM4153 Dosage Design 2 2011/12
Packaging Suitability
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Ability to contain without loss by
spillage or permeation
Protection against environmental
hazards
Suit for the function of the product
Free from interaction between the
product and container
Cost
PHM4153 Dosage Design 2 2011/12
Primary Packaging
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Dosage form
Packaging
Solid
Bottles, Blisters, Sachets
Jars
Liquids
Bottles (glass & plastic)
Drops, Nasal Sprays
Metered dose pumps, Drinkable ampoules
Semi-solid
Tubes (metal, plastic, laminate)
Cans/jars, Applicators
Sticks, Al-cold blister (suppositories)
Suppository blister strips
Vials (glass & plastic)
Ampoules, Pre-filled syringes
Ophthalmic tubes (creams), Ophthalmic drops
Sterile
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Unit dose packaging
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 plastic tubes
 caps that snap off, twist off
and pierce to open.
 liquid, ointment.
 1 to 5 ml sizes
 can have reclosable or non-
reclosable caps.
PHM4153 Dosage Design 2 2011/12
Containers for creams
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Wide-mouthed squat jars
• HTAA?
Collapsible metal
• problem?
Flexible plastic tubes
• Reduce contamination, narrow orifice
• LIMIT: ‘suck-back’- may result in microbial contamination,
oxidation,hydrolysis or dehydration
Aluminum tubes
PHM4153 Dosage Design 2 2011/12
Packaging Materials
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Fabricated from:
• Metals
• Plastics, rubber
• Glass
• Any combination from the above
PHM4153 Dosage Design 2 2011/12
Packaging Materials Inspection
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proof checking system
for packaging materials and
documentation inspection.
utilizes CCD camera
technology to capture images
for quick comparison; clearly
showing any changes.
PHM4153 Dosage Design 2 2011/12
Metals
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Tin
• Metal resistant
• Tin-coated tubes
• Eye ointment tubes
Iron
• Fabrication of drums, screw caps
Aluminum
• Low atomic weight, very reactive.
• Widely used e.g. neomycin or HC cream packed in
Al tubes.
PHM4153 Dosage Design 2 2011/12
A study on internal surfaces of Al tube
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two types of internal surfaces
• unlined
• lined with epoxy resin
both surfaces porous
from SEM
• adherence of microorganisms (biofilm)
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Problems with Al tube
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Al tubes both unlined & lined
• incompatible with extracts from plants e.g. chamomile,
eucalyptus
Al form numerous complexes
• Why?
epoxy resin lining incompatible with
• vegetable oils, resins, gums
Exercise: any other problem associated with
aluminum?
PHM4153 Dosage Design 2 2011/12
Polymers - plastics
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High MW with good thermal and electrical insulators
Less rigid, but can be as strong as metals.
High degree of resistance to inorganic reagents but softened
or dissolved by organic solvents.
E.g. PTFE, PP, PC, PE
Q. Name other polymers other than the above.
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Additives in Polymers
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 Add other substances to improve stability, processing behaviour,
or in-use performance.

E.g. PVC
 need
stabilizers, softeners?
 Vulnerable to oxidation

Add antioxidants
 These chemicals should not interact with product
PHM4153 Dosage Design 2 2011/12
Ideal Closures
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 Seal the container to prevent loss of product and
ingress of gases or other substances
 Withstand sterilization process
 Prevent contamination by micro-organism
 Non-reactive
 Easily remove and replace the closure and reseal (best
reseal with glass fusion)
 Material?
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Basic types of closure
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Some examples
• Push-on
• Bung
• Oldest known closures
• Screw-cap
• Fusion – hermetic seal
Other examples of closure?
PHM4153 Dosage Design 2 2011/12
Filling of Cream
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Facilitated by warming the product to
reduce the viscosity.
• Careful to avoid: chemical degradation,
sedimentation of suspended solid if excessive
reduction in viscosity by heating.
Viscous product that contain
surfactants, prone to aeration & may:
• accelerate oxidation
• produce bubbles
• interfere with pumping - right amount of product
not delivered to the container)
PHM4153 Dosage Design 2 2011/12
Packaging equipment - liquid filler
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Capacities
range from 15ml up to 1 gallon
with neck finishes
of 28mm and larger
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SECONDARY PACKAGING
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Cartoning
automated insertion of
blisters & leaflets & bar code
& pharma-code inspection
(using electronic scanners
to inspect leaflets and
cartons)
Heat-sealed carton cards for
blisters (samples for
physicians and commercial
production)
labeling for "double-blind
study" or "open label study"
patient kit assembly for
clinical studies, (clinical
study sites) according to
specifications
PHM4153 Dosage Design 2 2011/12
Packaging and Labeling requirements
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accuracy
quality assurance for packaging and labeling
Packaging graphics and labels require consistency for branding
….even colour
need to meet local regulatory requirements.
correct language, technical terminology, dosage instructions,
cautions and warnings must be clear.
PHM4153 Dosage Design 2 2011/12
AIR CONTROL SYSTEM
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positive pressure corridor with hepa filter
positive pressure production rooms using
hepa terminal filter and 18" above ground air
return to create laminar air flow that ensures
99.997% air purity at 0.03 microns.
temperature and relative humidity are
monitored.
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COMPRESSED AIR SYSTEM
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 oil free
 hydrocarbon free
 dessicant system (-40°c dew point)

to prevent air condensation inside packaging that can
affect the quality of products when temperatures vary
PHM4153 Dosage Design 2 2011/12
ELECTRONIC INSPECTION SYSTEM
(WITH CAMERA)
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bottling line (integrity and
presence)
cartoning line (pharma-code
and bar-code inspection)
PHM4153 Dosage Design 2 2011/12
References
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http://www.pharmaceuticalonline.com/
http://www.ropack.com/cadre.html
http://www.botlab.com/production.asp
Pizzolitto, E. L., Pizzolitto, A. C. & Pozetti, G. L. (2001). Braz. J.
Microbio. 32:4
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