advantages of liposome based delivery system
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Advantages of liposome-based delivery system. Boost efficiency of ocular drug delivery Delivery of hydrophilic or lipophilic drugs Delivery of DNA/peptide/protein Liposome encapsulation may reduce ocular irritation. Criteria set forth by Lippomix. Within ocular pH range (6.8-7.6) Isotonic

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advantages of liposome based delivery system
Advantages of liposome-based delivery system
  • Boost efficiency of ocular drug delivery
  • Delivery of hydrophilic or lipophilic drugs
  • Delivery of DNA/peptide/protein
  • Liposome encapsulation may reduce ocular irritation
criteria set forth by lippomix
Criteria set forth by Lippomix
  • Within ocular pH range (6.8-7.6)
  • Isotonic
  • Stable over the long term
    • Projection of Commercial Shelf Life
  • Pharmaceutically Elegant
formulation development
Formulation development
  • Formulation prototypes (44)

-Buffered (24)

-Unbuffered (20)

  • Formulations which meet criteria (11)
  • Short term stability data (1 month @ RT)
  • Summary
  • Conclusions
formulation prototypes
Unbuffered Formulations

0.9% NaCl

Phosphatidylcholine (PC)

Diclofenac

Benzalkonium or Benzethonium chloride

Buffered Formulations

Boric acid, pH 7.2

Phosphatidylcholine (PC)

Diclofenac

Benzalkonium or Benzethonium chloride

Formulation prototypes
liposomal formulation placebo
Liposomal formulation (placebo)
  • 0.1% (w/v) PC
  • 0.9% (w/v) NaCl
anti microbial agents
Benzethonium chloride

FDA approved for ophthalmic use

Does not contain mercury

Maximum concentration of 0.01% (w/v)

Benzalkonium chloride

Commonly used, FDA approved preservative for multiple-use ophthalmic products

Does not contain mercury

Maximum concentration of 0.013% (w/v)

Anti-microbial agents
ph stability unbuffered formulations
pH Stability- Unbuffered formulations
  • No change in pH over a period of 30 days
  • pH of all six samples was between 6.5-7.0
particle size stability unbuffered formulations
Particle size stability: Unbuffered formulations
  • No change in sample containing 0.3% PC and 0.1% diclofenac up to 20 days.
  • Five formulations increase in size after processing, but remain constant in size up to 20 days.
ph stability buffered formulations
pH Stability: Buffered Formulations
  • No change in pH over a 20 day period.
  • pH of all five formulations ranges from 7.2-7.3.
particle size stability buffered formulations
Particle size stability: Buffered Formulations
  • During cooling of sample, all formulations shifted to a size ~3 m.
  • Microscopic estimates put the liposomes between 1-5 m.
  • The larger-sized particles appear to maintain their size over the short term.
  • Once a sample equilibrates, there is no change in particle size.
summary of findings
Summary of findings
  • Formulations may be made buffered (boric acid) or unbuffered (NaCl).
  • PC concentrations within 0.05-0.3% (w/v) produce formulations with greatest clarity.
  • Diclofenac may be added at 0.02-0.1%.
  • Benzethonium chloride at 0.01% is the more suitable anti-microbial agent, with regard to formulation clarity.
  • pH of recommended formulations is constant over the short term (~30 days).
  • Most formulations shift to a larger particle size after processing, but remain stable once equilibrated.
formulation criteria
Formulation Criteria
  • Formulation clarity
  • Free of ethanol/organic solvents
  • Ability to include an anti-microbial agent
  • Within ocular pH range (6.8-7.6)
  • Isotonic
  • Stable over the long term (1 month to date)
    • Projection of Commercial Shelf Life
  • Pharmaceutically Elegant
conclusion
Conclusion
  • We can produce several liposome-based ophthalmic formulations of diclofenac.
  • All formulations are sterile, contain an anti-microbial agent, no organic solvents, and are within ocular pH and tonicity.
  • Furthermore, these formulations are stable with respect to clarity and pH .
future developments
Future developments

Additional product opportunities:

  • Hydrophilic drugs
  • Lipophilic drugs
  • DNA/Proteins/Peptides
  • Other disease states (glaucoma, seasonal allergic or bacterial conjunctivitis, dry eye, etc…)
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