SlideShare a Scribd company logo
1 of 107
A Novel Topical Transdermal Delivery System Mark S. Nestor, M.D., Ph.D. Pankaj Modi, Ph.D, M.D.
[object Object],[object Object],[object Object],[object Object],Disclosure
Topical Drug Delivery ,[object Object],[object Object],[object Object],[object Object]
InParT Drug Delivery System Ionic Nano Particle Technology I ,[object Object]
InParT Drug Delivery System Ionic Nano Particle Technology II ,[object Object],[object Object],[object Object],[object Object],[object Object]
InParT Drug Delivery System Ionic Nano Particle Technology III ,[object Object],[object Object],[object Object],[object Object]
SEM-Photograph- 250x  SEM-Photograph- 1000x
InParT Drug Delivery System Clinical Investigation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
NTL4: The Next Generation Topical Anesthetic Optimized 4% Topical Lidocaine in a Unique Nano Technology Delivery System Results of Clinical Trials Comparing NTL4 to LMX4   Protocols N °   10025 10025.1 Center for Clinical and Cosmetic Research (CCCR), Aventura, Florida Mark S. Nestor, M.D., Ph.D.
[object Object],[object Object],[object Object],[object Object],[object Object],Disclosure
[object Object],[object Object],[object Object],[object Object],[object Object],Introduction Yentzer BA et al.: Utilization of Topical Anesthetics By Dermatologists in the US. Cosmetic Derm 22, 238 2009.
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Topical Anesthetics Yentzer BA et al.: Utilization of Topical Anesthetics By Dermatologists in the US. Cosmetic Derm 22, 238 2009.
Topical Drug Delivery ,[object Object],[object Object],[object Object],[object Object],[object Object]
[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],NTL4
CCCR Protocol 10025 ,[object Object]
Study Design: Protocol 10025 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],AE, adverse event.
Results Summary: Protocol 10025 ,[object Object],[object Object],[object Object],[object Object],[object Object]
Results Summary: Protocol 10025 ,[object Object],[object Object]
CCCR Protocol 10025.1 ,[object Object]
Study Design: Protocol 10025.1 ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],AE, adverse event.
Results Summary I: Protocol 10025.1 ,[object Object]
Results Summary II: Protocol 10025.1 ,[object Object],[object Object],[object Object]
Results Summary III: Protocol 10025.1 ,[object Object],[object Object]
Efficacy Results: Subjective VAS  Early Onset (5 Minutes) (N=6) N=6   N=6   N=6 p=0.045   p=0.309  p=0.643   d=0.61 (Large)   d=0.27 (Small) X Axis: Time After Injection Y Axis: VAS Scale
Subjective Level of Pain  Early Onset (5 Minutes) (N=6) P=0.079 LMX4 NTL4 Product_Randomization 4 3 2 1 0 Count Moderate Pain Mild Pain Minimal Pain No Pain Subject_Level_of_Pain Bar Chart
Subject Satisfaction Data: Overall Preference  Early Onset (5 Minutes) (N=6)   P=0.02 Preference Rates: NTL4 = 83% (5/6) LMX4 = 16% (1/6) No Preference = 0% (0/8)
Blinded Investigator’s Evaluation of Pain Early Onset (5 Minutes) (N=6) P=0.076 LMX4 NTL4 Product_Randomization 4 3 2 1 0 Count Mild Pain Minimal Pain No Pain Subject_Level_of_Pain Bar Chart
VAS Comparison: Onset Immediate Post Injection N=30   N=6   N=8   N=6 p=0.044   p=0.004   p=0.068   p=0.045   d=0.98 (Large) X Axis: Duration of Application Y Axis: VAS Scale
Results Combined Trials
Results Summary Combined Trials ,[object Object],[object Object]
Discussion I ,[object Object],[object Object],[object Object]
Discussion II ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Topical Hyaluronic Acid (HA)
InParT Drug Delivery System Topical Hyaluronic Acid (HA) ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Topical Hyaluronic Acid (HA)  Clinical Model  ,[object Object],[object Object],[object Object]
[object Object],[object Object]
Topical Hyaluronic Acid (HA) Clinical Trial ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],.
Clinical Evaluation: Skin Roughness
Clinical Evaluation: Skin Hydration
Clinical Evaluation: Skin Elasticity
Clinical Evaluation: Skin Radiance
Clinical Evaluation: Smoothing Effect
Clinical Evaluation: Overall Efficacy
Subjective Evaluation: Elasticity and Tightness
Subjective Evaluation: Texture Improvement
Subjective Evaluation: Skin Hydration Improvement
Subjective Evaluation: Global Appearance Improvement
Subjective Evaluation: Overall Efficacy
49
 
 
33 BEFORE 33
 
 
 
 
 
 
 
 
 
Topical Hyaluronic Acid (HA) Clinical Trial - Washout ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],.
Clinical Evaluation: Skin Roughness
Clinical Evaluation: Skin Hydration
Clinical Evaluation: Skin Elasticity
Clinical Evaluation: Skin Radiance
Clinical Evaluation: Smoothing Effect
Clinical Evaluation: Overall Efficacy
Topical BP Combination Acne
InParT Drug Delivery System Topical BP: Acne I ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Topical BP: Acne  Clinical Model ,[object Object],[object Object],[object Object],[object Object]
Topical BP: Acne  Pilot Clinical Study ,[object Object],[object Object]
Topical BP: Acne  Pilot Clinical Study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Topical BP: Acne  Pilot Clinical Study ,[object Object],[object Object],[object Object]
Topical BP: Acne  Pilot Clinical Study ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Topical BP: Acne  Pilot Clinical Study ,[object Object],[object Object],[object Object],[object Object]
 
Clinical Photographs Baseline 4 weeks
Clinical Photographs Baseline 6 weeks
Clinical Photographs Baseline  3 weeks  6 weeks
Clinical Photographs Baseline  3 weeks  6 weeks
Topical Botulinum Neurotoxin Aesthetic
InParT Drug Delivery System Clinical Investigation ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
InParT Drug Delivery System Topical BoNTA: Aesthetics ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
Topical BoNTA: Aesthetics Clinical Model ,[object Object],[object Object],[object Object]
Topical BoNTA: Aesthetics Pilot Clinical Study I ,[object Object],[object Object],[object Object],[object Object],Chajchir I, Modi P, Chajchir A:  Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
Topical BoNTA: Aesthetics Pilot Clinical Study II ,[object Object],[object Object],[object Object],[object Object],Chajchir I, Modi P, Chajchir A:  Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
Topical BoNTA: Aesthetics Pilot Clinical Study III ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Chajchir I, Modi P, Chajchir A:  Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
Topical BoNTA: Aesthetics Pilot Clinical Study IV ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Chajchir I, Modi P, Chajchir A:  Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
Topical BoNTA: Aesthetics Pilot Clinical Study V ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Chajchir I, Modi P, Chajchir A:  Novel Topical BoNTA (CosmeTox, Toxin Type A) Cream Used to Treat Hyperfunctional Wrinkles of the Face Mouth and Neck. Aesth Plast Surg 2007
Topical BoNTA: Aesthetics Secondary Pilot Clinical Study ,[object Object]
Topical BoNTA: Aesthetics Secondary Pilot Clinical Study ,[object Object],[object Object],[object Object]
Topical BoNTA: Aesthetics Secondary Pilot Clinical Study ,[object Object],[object Object],[object Object]
Topical BoNTA: Aesthetics Secondary Pilot Clinical Study ,[object Object],[object Object],[object Object]
Topical Toxin  Before After 10 days
Topical Toxin  Before After 10 days
Topical Toxin  Before After 10 days
Topical Toxin  Before After 10 days
Topical Botulinum Neurotoxin Hyperhidrosis
InParT Drug Delivery System Topical BoNTA: Hyperhidrosis ,[object Object],[object Object],[object Object],[object Object],[object Object]
Topical BoNTA: Hyperhidrosis Clinical Model ,[object Object],[object Object],[object Object]
Topical BoNTA: Hyperhidrosis Pilot Clinical Study I ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],Rogelio J, Morales O:  HYPERHIDROSIS TREATMENT WITH TOPIC BOTULIN TOXIN TYPE A GEL Submitted .
Topical BoNTA: Hyperhidrosis Pilot Clinical Study II ,[object Object],[object Object],[object Object],Rogelio J, Morales O:  HYPERHIDROSIS TREATMENT WITH TOPIC BOTULIN TOXIN TYPE A GEL Submitted .
Hyperhidrosis; Before and After ( at week 16)
Hyperhidrosis; Before and After ( at week 16)
InParT Drug Delivery System Future Applications ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]
InParT Drug Delivery System Opportunities ,[object Object],[object Object],[object Object],[object Object],[object Object],[object Object],[object Object]

More Related Content

What's hot

Transdermal drug delivery
Transdermal drug deliveryTransdermal drug delivery
Transdermal drug delivery
Arya Soman
 
transdermal drug delivery system
transdermal drug delivery systemtransdermal drug delivery system
transdermal drug delivery system
Biva Biscuity
 
Transdemal dds : a review
Transdemal dds : a reviewTransdemal dds : a review
Transdemal dds : a review
Adhikari Natraj
 
Transdermal Drug Delivery System
Transdermal Drug Delivery SystemTransdermal Drug Delivery System
Transdermal Drug Delivery System
optimpharma
 
Transdermal drug delivery system
Transdermal drug delivery systemTransdermal drug delivery system
Transdermal drug delivery system
ravipharmabwm
 
Transdermal drug delivery system (2)
Transdermal drug delivery system (2)Transdermal drug delivery system (2)
Transdermal drug delivery system (2)
Sonam Gandhi
 

What's hot (20)

Transdermal drug delivery
Transdermal drug deliveryTransdermal drug delivery
Transdermal drug delivery
 
Tdds
TddsTdds
Tdds
 
11 seminar on transdermal drug delivery system copy
11 seminar on transdermal drug delivery system   copy11 seminar on transdermal drug delivery system   copy
11 seminar on transdermal drug delivery system copy
 
Approaches for the Development of TDDS & Physical Approaches for Permeation E...
Approaches for the Development of TDDS & Physical Approaches for Permeation E...Approaches for the Development of TDDS & Physical Approaches for Permeation E...
Approaches for the Development of TDDS & Physical Approaches for Permeation E...
 
Transdermal Drug Delivery Systems
Transdermal Drug Delivery SystemsTransdermal Drug Delivery Systems
Transdermal Drug Delivery Systems
 
transdermal drug delivery system
transdermal drug delivery systemtransdermal drug delivery system
transdermal drug delivery system
 
Transdermal drug delivery system
Transdermal drug delivery systemTransdermal drug delivery system
Transdermal drug delivery system
 
Transdemal dds : a review
Transdemal dds : a reviewTransdemal dds : a review
Transdemal dds : a review
 
Introduction of Transdermal Drug Delivery System (TDDS)
Introduction of Transdermal Drug Delivery System (TDDS)Introduction of Transdermal Drug Delivery System (TDDS)
Introduction of Transdermal Drug Delivery System (TDDS)
 
TDDS by Nitin Sonar
TDDS by Nitin SonarTDDS by Nitin Sonar
TDDS by Nitin Sonar
 
TRANSDERMAL DRUG DELIVERY SYSTEMS
TRANSDERMAL DRUG DELIVERY SYSTEMSTRANSDERMAL DRUG DELIVERY SYSTEMS
TRANSDERMAL DRUG DELIVERY SYSTEMS
 
Transdermal Drug Delivery System
Transdermal Drug Delivery SystemTransdermal Drug Delivery System
Transdermal Drug Delivery System
 
Preparation and Evaluation of Metformin Transdermal Patches
Preparation and Evaluation of Metformin Transdermal PatchesPreparation and Evaluation of Metformin Transdermal Patches
Preparation and Evaluation of Metformin Transdermal Patches
 
Transdermal drug delivery system
Transdermal drug delivery systemTransdermal drug delivery system
Transdermal drug delivery system
 
New drug delivery system
New drug delivery systemNew drug delivery system
New drug delivery system
 
TDDS
TDDS TDDS
TDDS
 
Transdermal drug delivery system (2)
Transdermal drug delivery system (2)Transdermal drug delivery system (2)
Transdermal drug delivery system (2)
 
Transdermal drug delivery system by MANSOORI MOHAMMAD SHOAIB.
Transdermal drug delivery system by  MANSOORI MOHAMMAD SHOAIB. Transdermal drug delivery system by  MANSOORI MOHAMMAD SHOAIB.
Transdermal drug delivery system by MANSOORI MOHAMMAD SHOAIB.
 
Tdds by rahul shirode
Tdds by rahul shirodeTdds by rahul shirode
Tdds by rahul shirode
 
TDDS ppt by Oly
TDDS ppt by OlyTDDS ppt by Oly
TDDS ppt by Oly
 

Similar to Transdermal Corp (PPT)

Lidocaine Comparison Trial Full
Lidocaine Comparison Trial FullLidocaine Comparison Trial Full
Lidocaine Comparison Trial Full
Pankaj Modi
 
EVALUATION AND RECENT TECHNIQUES OF TRANSDERMAL DRUG DELIVERY SYSTEM”.pptx
EVALUATION AND RECENT TECHNIQUES OF TRANSDERMAL DRUG DELIVERY SYSTEM”.pptxEVALUATION AND RECENT TECHNIQUES OF TRANSDERMAL DRUG DELIVERY SYSTEM”.pptx
EVALUATION AND RECENT TECHNIQUES OF TRANSDERMAL DRUG DELIVERY SYSTEM”.pptx
RahulBGole
 

Similar to Transdermal Corp (PPT) (20)

Lidocaine Comparison Trial Full
Lidocaine Comparison Trial FullLidocaine Comparison Trial Full
Lidocaine Comparison Trial Full
 
local drug delivery in periodontics
local drug delivery in periodonticslocal drug delivery in periodontics
local drug delivery in periodontics
 
Transdermal drug delivery system
Transdermal drug delivery systemTransdermal drug delivery system
Transdermal drug delivery system
 
Microneedles
MicroneedlesMicroneedles
Microneedles
 
Topical Skin Preparation Formulation
Topical Skin Preparation FormulationTopical Skin Preparation Formulation
Topical Skin Preparation Formulation
 
Recent Advances in local Anaesthesia in dentistry
Recent Advances in local Anaesthesia in dentistryRecent Advances in local Anaesthesia in dentistry
Recent Advances in local Anaesthesia in dentistry
 
transdermal drug delivery systems.ppt
transdermal drug delivery systems.ppttransdermal drug delivery systems.ppt
transdermal drug delivery systems.ppt
 
TRANSDERMAL DRUG DELIVERY SYSTEM
TRANSDERMAL DRUG DELIVERY SYSTEMTRANSDERMAL DRUG DELIVERY SYSTEM
TRANSDERMAL DRUG DELIVERY SYSTEM
 
Transdermal patches by Shagufta Nisar
Transdermal patches by Shagufta NisarTransdermal patches by Shagufta Nisar
Transdermal patches by Shagufta Nisar
 
Transdermal Drug Delivery System.pptx
Transdermal Drug Delivery System.pptxTransdermal Drug Delivery System.pptx
Transdermal Drug Delivery System.pptx
 
Transdermal Drug Delivery System
Transdermal Drug Delivery SystemTransdermal Drug Delivery System
Transdermal Drug Delivery System
 
Advances in Transdermal drug delivery system by Kailash vilegave
Advances in Transdermal drug delivery system by Kailash vilegave Advances in Transdermal drug delivery system by Kailash vilegave
Advances in Transdermal drug delivery system by Kailash vilegave
 
Penetration enhancer with their examples
Penetration enhancer with their examplesPenetration enhancer with their examples
Penetration enhancer with their examples
 
Trasndermal Drug Delivery System
Trasndermal Drug Delivery SystemTrasndermal Drug Delivery System
Trasndermal Drug Delivery System
 
Innovative Medical Devices: Developing Multidisciplinary Safety & Efficacy Te...
Innovative Medical Devices: Developing Multidisciplinary Safety & Efficacy Te...Innovative Medical Devices: Developing Multidisciplinary Safety & Efficacy Te...
Innovative Medical Devices: Developing Multidisciplinary Safety & Efficacy Te...
 
Local drug delivery
Local drug deliveryLocal drug delivery
Local drug delivery
 
Nano Technology by moun
Nano Technology by mounNano Technology by moun
Nano Technology by moun
 
Recent advances in Local anesthesia
Recent advances in Local anesthesiaRecent advances in Local anesthesia
Recent advances in Local anesthesia
 
Trans Dermal Drug Delivery System Prasad Katare 02
Trans Dermal Drug Delivery System  Prasad Katare 02 Trans Dermal Drug Delivery System  Prasad Katare 02
Trans Dermal Drug Delivery System Prasad Katare 02
 
EVALUATION AND RECENT TECHNIQUES OF TRANSDERMAL DRUG DELIVERY SYSTEM”.pptx
EVALUATION AND RECENT TECHNIQUES OF TRANSDERMAL DRUG DELIVERY SYSTEM”.pptxEVALUATION AND RECENT TECHNIQUES OF TRANSDERMAL DRUG DELIVERY SYSTEM”.pptx
EVALUATION AND RECENT TECHNIQUES OF TRANSDERMAL DRUG DELIVERY SYSTEM”.pptx
 

Transdermal Corp (PPT)

Editor's Notes

  1. RLX 085-rev 6.6.08 bh jb.ppt