Stent based drug delivery system
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Shenkar Plastics ENG.DEP. SUPERVISORS: Professor Hanna Dodiuk Eng. Tehila Efrat PowerPoint PPT Presentation


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Stent based drug delivery system Joint program Allium medical – AorTech. Shenkar Plastics ENG.DEP. SUPERVISORS: Professor Hanna Dodiuk Eng. Tehila Efrat Presented by Inbar Freiberg. Release of Dexamethasone from Polyurethane Silicone Copolymers ( Elast-Eon  s ) coated stents,

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Shenkar Plastics ENG.DEP. SUPERVISORS: Professor Hanna Dodiuk Eng. Tehila Efrat

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Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

Stent based drug delivery system

Joint program

Allium medical – AorTech

Shenkar Plastics ENG.DEP.

SUPERVISORS:

Professor Hanna Dodiuk

Eng. Tehila Efrat

Presented by Inbar Freiberg


Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

Release of Dexamethasone

from Polyurethane Silicone Copolymers (Elast-Eons)coated stents,

as a therapy for Prostatitis.

Release

Dexamethasone

Polyurethane Silicone Copolymers (Elast-Eons)

stents

Prostatitis


Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

INTRODUCTION- control drug delivery

  • Drug/medical device combination products, represent an emerging new trend in implantable therapeutics.

  • Controlled drug delivery occurs when a polymer, whether natural or synthetic, is combined with a drug or other active agent in such a way that the active agent is released from the material in a predesigned manner.

 With traditional tablets or injections the level rises after each administration of the drug and then decreases until the next administration

 In controlled drug delivery systems the drug level In the blood remaining constant, between the desired maximum and minimum, for an extended period of time .

Reproduced from Ref. [1]

Introduction

Methodology

Results

Discussion

Conclusions

Objectives


Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

Normal prostate

Infected prostate maycause

pain with urination

Introduction: Prostatitis

An inflammation of the prostate

  • 1.Chronic Prostatitis/chronic Pelvic Pain Syndrome (CP / CPPS):

    • 1a.Inflammatory - presence of white blood cells in semen

    • 1b.Non-inflammatory- absence of white blood cells in semen

  • 2.Asymptomatic inflammatory prostatitis.

  • www.towerurology.com/handler.cfm?event=pract

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Introduction: Stent

    “If interventional medicine, using the body's circulatory systemas a "highway" to deliver therapy, worked with devices,it could also work with medicines......”[13]

    www.jnjgateway.com

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Introduction: Elast-Eon

    Excellent

    Excellent

    mechanical performanceand fatigue resistance

    Biocompatibility

    and

    biostability

    Silicon

    Polyurethane

    Poor long-term biostability, biocompatibility.

    Poor mechanical performance and fatigue resistance.

    Biostable Biocompatible

    Fatigue Resistant

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Introduction: Elast-Eon - Structure Materials

    Polyurethane

    Silicon

    AAA

    CCC

    DDD

    BBB

    Polyurethane Silicone Copolymers (Elast-Eons)

    Hard Segment

    Soft Segment

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Introduction: Elast-Eon

    2A

    652

    545

    48% hard

    40% hard

    45% hard

    52% soft

    60% soft

    55% soft

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Introduction: Dexamethaone

    Dexamethasone

    Dexamethasone acetate

    http://gxwonder.com/Pictures/Dexamethasone.jpg

    www.chemblink.com/structures/1177-87-3.gif

    The use of these two kinds of dexamethasone is to examine if there are differences in the way of the releasing regime.

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Dexamethasone has

    hydrophobic and lipophilic character not soluble in water

    ALLIUM Ltd. decided

     to continue with the project without the Dexamethasone

     claiming that the release will be in negligibleamount

    Results

    Discussion

    Conclusions

    Recommendations

    Work Process

    Introduction


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Dexamethasone-water soluble

    Cyclodextrin

    • 2-hydroxypropyl - beta-cyclodextrin is a

    • water-soluble oligosaccharide. It can be used to dissolve lipophilic drugs,

    • such as Dexamethasone, in aqueous solutions.[36]

    • Dexamethasone-water soluble composed of 6% of Dexamethasone and 94% of 2-hydroxypropyl-beta-cyclodextrin

    2-hydroxypropyl-beta-cyclodextrin

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    OBJECTIVES

    • This work is aimed, to characterize and to find the drug release profile (Quantity) of Dexamethasone in PBS ( Phosphate buffered saline ) solution, from Polyurethane Silicone Copolymers (Elast-Eons).

    Notes:

    • PBS solution simulates human urine controlled at 37°C.

    • The copolymers are intended to coat stents, as a therapy for Prostatitis (inflammation in the prostate).

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Methodology

    • Three types of Polyurethane Silicone Copolymers (Elast-Eons) were prepared ( 2A, 545, 652)

      Each type consist of drug in various concentrations:

    • Dexamethasone (30%,40% and 50%)

    • Dexamethasone-water soluble (50%)

    Samples for Tests

    Temprature Control

    UV-Visible Absorption

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Tests Methods

    • DMTA - dynamic mechanical thermal analysis

    • Is used to determine the influence of drug concentration in the film, on the mechanical properties of the film. Hence, achieve the optimal mechanical properties.

    • UV - Visible Absorption

    • Is used to evaluate the amount of the eluted drug into the PBS solution.

    UV - Visible Absorption equipment in preparation step

    .

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Results – DMTA Results

    • The storage modulus decreases at 37°C from 0.58 x108 (Pa) for the film without drug,

      to 0.4 x108 Pa for the film with the drug ;

      Total decreases of 31%.

    The graphs present the change in the storage modulus as a function of temperature for EE2A

    EE2A without Dexamethasone

    EE2A-40% Dexamethasone

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Results - UV Visible Absorption

    Total released percents of Dexamethasone (%) Eluted from Elast-Eon Films after 11 weeks

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Results - UV Visible Absorption

    • Dexamethasone has hydrophobic

    • and lipophilic characters, which makes

    • it hard to release from any polymer

    • Matrix in aqueous solutions.

    • The hydrophobic Dexamethasone tends to interact with the hydrophobic soft segment (silicon).

    • The free volume of the soft segment (silicon) contributes to the drug

      ability to be released more easily.

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Results - UV Visible Absorption

    Total released percent of Dexamethasone water soluble Eluted from Elast-Eon Films, after 3 weeks

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Results - UV Visible Absorption

    • Dexamethasone-water soluble composed of 6% of Dexamethasone and 94% of 2-hydroxypropyl-beta-cyclodextrin, which is highly hydrophilic. This compound enables Dexamethasone to dissolve betterin the PBS solution.

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Results - UV Visible Absorption

    Comparison between the release of Dexamethasone and Dexamethasone - water soluble from E2A-50% after 21 days

    The release amount of Dexamethasone- water soluble

    is approximately greater ten (10) times more

    compared to the release amount of Dexamethasone!

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives

    Work Process


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Conclusions

    • mechanical performance correlates with drug addition to matrix. Less drug in the matrix give higher mechanical performance.

    • The higher the percent of the soft segment, greater amount of the drug will be released.

    • The higher the drug concentration in the Elast-Eon films, greater amount of the drug will be released.

    • Drug with hydrophilic character will produce more release than drug with hydrophobic character

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Thank you for your attention!


    Shenkar plastics eng dep supervisors professor hanna dodiuk eng tehila efrat

    Results - Visual Quality Results

    • Dexamethasone and Dexamethasone acetateare hydrophobic and lipophilic materials.

    • "lipophilic" and "hydrophobic" are not synonymous, as can be seen with silicones, which are “hydrophobic “ but not “lipophilic” [35].

    • According to the results, Dexamethasone acetate have much lower lipophilic character compared with Dexamethasone.

    • 30%dex-A, 2A at 40 min at 45ºC and 70ºC for 15 min.

    50% dex 2A, 40 min at 45ºC and 70ºC for 15 min.

    Introduction

    Methodology

    Results

    Discussion

    Conclusions

    Objectives


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