1 / 140

A Novel Topical Transdermal Delivery System

A Novel Topical Transdermal Delivery System. Mark S. Nestor, M.D., Ph.D. Director Center for Clinical and Cosmetic Research Aventura Florida. Topical Drug and Cosmetic Delivery. The skin is a formidable barrier against environmental assaults as well as topical drug delivery

elia
Download Presentation

A Novel Topical Transdermal Delivery System

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  1. A Novel Topical Transdermal Delivery System Mark S. Nestor, M.D., Ph.D. Director Center for Clinical and Cosmetic Research Aventura Florida

  2. Topical Drug and Cosmetic Delivery • The skin is a formidable barrier against environmental assaults as well as topical drug delivery • A variety of active compounds have significant activity in the skin, subcutaneous tissue or muscle but cannot adequately permeate the intact skin • Diseases such as acne, psoriasis, rosacea, and melasma as well as cutaneous aesthetic enhancement could dramatically benefit from our ability to better transport active compounds to target tissue • Solutions to a 100+ billion dollar market • Ionic Nano Particle Technology (InParT) is a novel and unique passive delivery system that can be utilized to assist the transport of a variety of active compounds to target sites in the skin and beyond

  3. InParT Drug Delivery SystemIonic Nano Particle Technology I • Novel, commercially viable trans dermal non-invasive drug delivery technology that enables delivery and absorption of active compounds through the stratum corneum and throughout the skin and sub cutaneous tissue without any cutaneous toxicity

  4. InParT Drug Delivery SystemIonic Nano Particle Technology II • Nano particles are made from combinations of micelles (surfactants and protein solubilizers), coated with lipid molecules • Nano paticles size; less than 1-10 nano meters smaller than the skin pores • Nano Particles Physically entraps active without any changes in the chemical composition • Stabilizes the actives: shelf stable at room temperature for extended period of time without refrigeration) • Uses all FDA approved ingredients

  5. InParT Drug Delivery SystemIonic Nano Particle Technology III • INParT technology is highly adaptable to most high molecular weight drugs, proteins, peptides and insoluble hydrophobic molecules • Capable of delivering more than one therapeutic agent at a time • Offers high market value by featuring maximum functionality at minimum system complexity and cost • The technology is easily scalable to any size without any complex new equipments need (no capital expenditure, commercially viable)

  6. SEM-Photograph- 250x SEM-Photograph- 1000x

  7. InParT Drug Delivery SystemClinical Investigation • Topical Hyaluronic Acid • Topical Lidocaine • Acne • Benzoyl Peroxide (BP) • Topical Botulinum Neurotoxin Type A (BoNTA) • Rhytids • Hyperhidrosis • Future Developments and Partnerships

  8. Topical Hyaluronic Acid (HA)

  9. InParT Drug Delivery SystemTopical Hyaluronic Acid (HA) HA crosslinked or non crosslinked difficult to adequately penetrate the stratum corneum If adequate penetration can be achieved topical cross linked HA can significantly improve fine lines as well as skin texture • Painless application • Companion treatment to injectablecrosslinked HA • Topical cosmecutical

  10. Topical Hyaluronic Acid (HA) Clinical Model The stabilized cream is applied topically onto the skin containing crosslinked (non crosslinked) HA The nano-spheres helps penetrate the skin layers with the aid of absorption enhancers and releases the HA into the deep layers of the skin HA incorporated into the dermis (rapid aesthetic benefit) and induces long term collagen synthesis

  11. A Double Blind Vehicle Controlled Trial to Investigate the efficacy and tolerance of Transdermal CL1 (Restylane) versus non-CL1 (Non Crossed Linked HA) in the appearance of photodamaged skin

  12. Topical Hyaluronic Acid (HA)Clinical Trial I 100 subjects 2 sites: Women 35 – 65 with moderate to severe photodamage: 40 CL1 (crosslinked HA – Restylane), 40 NCL1 (Non crossed linked HA), 20 Vehicle 2 US sites Subjects and investigators blinded 2 week wash out, 12 week trail (evaluations 2,6 and 12 weeks), 4 week post treatment (washout) Apply twice a day clean face .

  13. Topical Hyaluronic Acid (HA)Clinical Trial II Visia camera system Objective evaluations • Goldman-Rao” photographic scale in 5 grades • Evaluation of skin roughness, skin hydration, skin radiance, smoothing effect, overall efficacy and tolerance Subjective Questionnaires : • Product Qualities • Subjective improvement .

  14. Topical Hyaluronic Acid (HA)Clinical Trial - Washout Evaluation of sustained effect of topical HA Patient discontinued all Topicals at day 90 and were evaluated for sustained effects at day 120 Visia photographs Clinical evaluations .

  15. Trial Data

  16. Blinded Investigator Assessments

  17. Clinical Evaluation: Skin Roughness CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  18. Clinical Evaluation: Skin Roughness CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  19. Clinical Evaluation: Skin Hydration CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  20. Clinical Evaluation: Skin Hydration CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  21. Clinical Evaluation: Skin Elasticity CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  22. Clinical Evaluation: Skin Elasticity CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  23. Clinical Evaluation: Skin Radiance CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  24. Clinical Evaluation: Skin Radiance CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  25. Clinical Evaluation: Smoothing Effect CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  26. Clinical Evaluation: Smoothing Effect CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  27. Clinical Evaluation: Overall Efficacy CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  28. Clinical Evaluation: Overall Efficacy CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  29. Clinical Evaluation: Tolerance CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  30. Blinded Subjective Assessments

  31. Subjective Evaluation: Wrinkle Improvement CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  32. Subjective Evaluation: Elasticity and Tightness CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  33. Subjective Evaluation: Elasticity and Tightness CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  34. Subjective Evaluation: Texture Improvement CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  35. Subjective Evaluation: Texture Improvement CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  36. Subjective Evaluation: Skin Hydration Improvement CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  37. Subjective Evaluation: Skin Hydration Improvement CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  38. Subjective Evaluation: Global Appearance Improvement CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  39. Subjective Evaluation: Global Appearance Improvement CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  40. Subjective Evaluation: Overall Efficacy CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  41. Subjective Evaluation: Overall Efficacy CL1: Crosslinked HA (Restylane) NCL1: Non Crosslinked HA Control: Nano Technology Vehicle

  42. Product Qualities

  43. Assessment of ProductSmell

  44. Assessment of ProductColor

  45. Assessment of ProductTexture

  46. Assessment of ProductEasiness of Application

  47. Assessment of ProductPenetration

  48. Assessment of ProductOverallQualities of the Cream

  49. Topical Hyaluronic Acid (HA) 90 Day Results Summary I • Blinded Investigator evaluations showed highly statistically significant improvement using the topical crosslinked HA (Restylane) over time and vs the non cross linked and vehicle in Skin Roughness, Hydration, Elasticity, Radiance, Smoothing Effect and Overall Efficacy. Most dramatic differences with Smoothing Effect and Overall Efficacy • Blinded subjective evaluations showed highly statistically significant improvement using the topical crosslinked HA (Restylane) over time and vs the non cross linked and vehicle in, Hydration, Elasticity and tightness, Texture improvement,, Global Appearance Improvement and Overall Efficacy .

More Related