Packaging of Cream and Ointment

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Packaging of Cream and Ointment

• Kausar Ahmad
• Kulliyyah of Pharmacy
• http//staff.iiu.edu.my/PHM4153

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Contents

• Packaging materials
• Types of packaging
• Filling
• Packaging requirements
• Packaging equipment

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Introduction

• Correct formulation, Correct packaging
• Container
• Closure
• Carton
• Box
• Labeling

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Packaging Suitability

• 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

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Packaging Materials

• Fabricated from
• Metals
• Plastics, rubber
• glass
• Any combination from the above

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Metals

• 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.

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A study on internal surfaces of Al tube

• 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

• Al tubes both unlined lined
• incompatible with extracts from plants e.g.
  chamomile, eucalyptus
• Al form numerous complexes why?
• Ag, Cu, Hg, Sn,
• epoxy resin incompatible with
• vegetable oils, resins, gums
• Exercise any other problem associated with Al?

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Polymers - plastics

• 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
• Name other polymers other than the above.

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Additives in Polymers

• Add other substances to improve stability,
  processing behaviour, or in-use performance.
• E.g. PVC
• need stabilizers, softeners?
• Vulnerable to oxidation
• Add antioxidants
• NN-di-b-naphthyl-p-phenylenediamine.
• 4-biphenylsalicylate (clear plastics organics
  absorber)
• These chemicals should not interact with product
• Q what is the problem with bottled water?

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Ideal Closures

• 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

• Some examples
• Push-on
• Bung
• Oldest known closures
• Screw-cap
• Fusion hermetic seal
• Give an application to each of the above. Other
  examples of closure?

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Filling of Cream Ointment

• 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
• accelerate oxidation
• produce bubbles
• interfere with pumping - right amount of product
  not delivered to the container)

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Containers for creams

• Wide-mouthed squat jars in HTAA?
• Collapsible metal problem?
• Flexible plastic tubes
• Reduce contamination, narrow orifice
• LIMIT suck-back- result in microbial
  contamination, oxidation,hydrolysis or
  dehydration
• Aluminum tubes

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Containers for ointments

• Screw-capped amber glass
• Plastic pots (but)
• Methyl salicylate incompatible with plastic
  containers
• Collapsible metal tubes (but)
• Tend to shed metal particles near their
  screw-threads

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Packaging in general
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PRIMARY PACKAGING

• Blister packaging, including "child resistant",
  "senior friendly".
• Aluminum/aluminum (cold formed blisters)
• pouch filling (powders, liquids, creams,
  capsules, tablets, softgels),
• "nitrogen flush" bottling (tablets, capsules,
  softgels)
• strip packaging (tablets, capsules, softgels)
• high volume commercial production
• stability testing
• clinical trials
• promotional samples

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SECONDARY PACKAGING

• Cartoning
• automated insertion of blisters and leaflets as
  well as bar code and 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

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Packaging and Labeling requirements

• 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.

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Unit dose packaging

• 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.

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Unit-dose multiblock packaging

• 2 to 30 containers in connected blocks
• volumes from 0,12 ml to approximately 50 ml.

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Child Resistant and Senior Friendly Blister Card
Packaging

• commercial and clinical trials packaging
• Slide pack
• To open, the patient must insert their index
  finger through an opening, pull the plastic
  trigger to the right to expose the foil, hold and
  press the blister to push medication through the
  foil and release the trigger - thus preventing
  access again.
• E-Z tear
• To access, the patient must remove a single dose
  at the perforation - which will tear at bubble
  blister only. Note the child resistant foil will
  not puncture.
• Rx barrier pack
• Blisters are protected by a PVC cover (barrier)
  to prevent child from biting individual cavities

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Packaging equipment - liquid filler

• Capacities
• range from 15ml up to 1 gallon
• with neck finishes
• of 28mm and larger

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Packaging Materials Inspection

• proof checking system
• for packaging materials and documentation
  inspection.
• utilizes CCD camera technology to capture images
  for quick comparison clearly showing any
  changes.

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AIR CONTROL SYSTEM

• positive pressure corridor with hepa terminal
  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.
• individual production rooms where temperature and
  relative humidity are monitored.

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COMPRESSED AIR SYSTEM

• oil free
• hydrocarbon free
• dessicant system (-40c dew point)
• to prevent air condensation inside packaging that
  can affect the quality of products when
  temperatures vary

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ELECTRONIC INSPECTION SYSTEM (WITH CAMERA)

• bottling line (integrity and presence)
• blister pack line (integrity and presence)
• cartoning line (pharma-code and bar-code
  inspection)

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References

• http//www.pharmaceuticalonline.com/
• http//www.ropack.com/cadre.html
• http//www.botlab.com/production.asp
• EL Pizzolitto, AC Pizzolitto GL Pozetti, Braz.
  J. Microbio. 324 (2001)