LH 11 (4)
LH 11 (4)
LH 11 (4)
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© Ramaiah University of Applied Sciences
Intended Learning Objectives
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• Discuss Contact lens as drug deliver device to the eye
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• Enlist the QC tests for ophthalmic dosage forms
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• Briefly explain packaging of eye drops
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Contact Lens
• Contact lenses are thin, and curved shape plastic disks which are designed
to cover the cornea
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• After application, contact lens adheres to the film of tears over the cornea
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due to the surface tension
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Contact Lens
Early Conventional
Hydrogel
(CH) CLs did not
1930 1965 provide adequate
Polymethyl Use of soft oxygen transmission
methacrylate contact lens to the cornea, resulting
(PMMA) was used as (SCL) in hypoxia related
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the first successful for ophthalmic complications
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contact lens (CL) drug delivery during overnight wear,
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material (Sedlacek) limiting their long term
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therapeutic
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potential
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1970,s 1960s
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• Limited mixing in the tear
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film between the lens and
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the cornea leads to a
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residence time of more than
30 minutes (Compared to tB
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• Increase in bioavailability
Materials For Contact Lens
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transmissibility
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• Poly HEMA - water content of about 38%
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• Methacrylic acid (MAA) with HEMA, soft contact lenses(SCLs) with
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different water contents, hardness, strength and oxygen
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permeabilities can be created
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Strategies/Techniques For Contact Lens Based Drug
Delivery System
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Soaking Method
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• Contact
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lenses have internal channels/cavity for
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receiving/accommodating the drug molecules
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• Drug loading depends on the water content, thickness of lenses, the
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Limitations
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penetrate the aqueous channels of contact lenses and remain on
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the surface only
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• Contact lenses have low affinity for most of the ophthalmic drugs
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Molecular Imprinting (MI)
Limitation
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physical performance of contact lens
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• The drug-loading capacity is limited by the template molecules and
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functional monomers, and the deformation (change in dimension)
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of contact lenses after release of drug was also noted
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– Identification Therapeutic efficacy
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• Compatibility
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– Assay
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Clarity
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– Impurities
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• Particulate matter
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• IPQC • Insoluble particulate matter
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• FPQC • Particle size
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• Uniformity of volume
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• Uniformity of content
• Uniformity of weight
• Bacterial endotoxin
• Sterility testing
Packaging of eye drops
• Ophthalmic liquids can be packaged in sterile glass bottles
with separate dropper or in plastic bottles with self-contained
dropper tips
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Glass bottle packaging
• Dropper bottle for eye drops are fitted with a cap , rubber teat
and dropper as the closure
• The bottles are used at a capacity of 10 ml or 20 ml
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• Glass containers are used in only a very few instances because of
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stability limitations
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• Type 1 glass vials with appropriate stoppers are used for
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ophthalmic products
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© Ramaiah University of Applied Sciences
Plastic packaging
• Currently all most all commercially available ophthalmic
products are packaged in plastic containers
• Advantages of plastic containers are ease of use, little breakage,
less spillage. This led to universal acceptance of plastic
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containers.
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• Plastic packaging components consists of bottle fitment and
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closure
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• It has multi-component single-drop dispenser. Eye drops must be
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sterilezed after filling into the containers and sealing, by
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one shot container which eliminates the need for any
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preservative and reduces the risk of infecting the eye during
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applications almost to zero
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• Single dose packs are available in which the solutions can
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be sterilised by autoclaving in air ballasted autoclaves these
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solutions can therefore be formulated without a
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preservative
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and to support the maintenance of sterility
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• Examples of preservatives are phenyl mercuric nitrate or acetate,
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chlorhexidine acetate or benzalkonium chloride
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Summary
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