Biodegradable Polymeric by 이흐완 히다얏
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Biodegradable Polymeric by 이흐완 히다얏






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Biodegradable Polymeric by 이흐완 히다얏 Biodegradable Polymeric by 이흐완 히다얏 Presentation Transcript

  • Biodegradable Polymeric Biomaterial Presented by: Ikhwan Hidayat ( 이흐완 히다얏 )
  • Contents
    • Introduction & Application
    • Poly ( α -esters)
      • Polyglycolide (PGA)
      • Polylactide (PLA)
      • Polycaprolactone
    • Other Polymers under Development
    • Biodegradation Mechanism
    • Packaging & Sterilization
    • Surface Modification for Biodegradable Polymer
  • Introduction
    • The current trend, Biodegradable are more favorable than biostable material for biomedical applications.
    • Important properties of a biodegradable polymer:
      • Appropriate mechanical properties.
      • Does not evoke inflame or toxic response.
      • Have acceptable shelf life.
      • Degradation time should match the healing.
      • Fully metabolized & Easily sterilized.
    • Classifications
      • Hydrolytically & Enzymatically degradable
  • Applications
    • Large Implants: Orthopedic fixation devices; bone screws , bone plates
    • Small implants: Sutures, Staples, Nano/Micro-sized drug delivery
    • Dental devices: as a void filler and as a guided-tissue-regeneration (GTR)
    • Multifilament meshes or porous structures for tissue engineering
    Figure 1. Biodegradable intravascular stent
  • Poly( α -esters)
    • Thermoplastic polymer with hydrolytically labile aliphatic ester linkages in their backbone.
      • Only short aliphatic chains can degrade over the time required for biomedical application
    • Good biocompatibility and controllable degradation profiles
    • Poly( α -esters) based on polylactide (PLA), polyglycolide (PGA), and polycaprolactone (PCL) have been extensively employed as biomaterials.
    Figure 2. Polyester based, meniscus repair devices
  • Polyglycolide (PGA)
    • Highly crystalline polymer
      • Excellent mechanical properties
    • Excellent fiber forming ability
      • Initially investigated for developing resorbable sutures
      • DEXON, approved 1960
    • In the body, PGA are broken down into glycine
      • Excreted or converted
    • Applications:
      • Scaffolding matrices for tissue regeneration
      • Bone Internal Fixation Devices (Biofix)
  • Polylactides (PLA)
    • Lactide is a chiral molecule
      • L-lactide (PLLA)
      • DL-lactide (PDLLA)
    • PLLA: slow degradation time, crystalline, good tensile strength, low elongation and high modulus
      • Load bearing applications
      • Scaffold for developing ligament replacement
    • Poly DL-lactide (PDLLA): amorphous, lower strength & higher elongation, rapid degradation time
      • Drug delivery system
  • Poly( ε -caprolactone) (PCL)
    • Semicrystalline polyester
      • Highly processible,
      • Low melting point (55-60 o C) &
      • Glass transition temperature (-60 o C)
    • Low tensile strength but extremely high elongation
    • Slow rate degradation, high permeability to many drugs and non-toxicity
      • Long-term drug/vaccine delivery devices
      • A copolymer of ε -caprolactone with glycolide, as a monofilament suture (Monacryl)
  • Other Polymers under Development
    • Low-cost biodegradable polyemer
      • Synthesis of polymers using microorganism
      • Polyhydroxybutyrate (PHB) & polyhydroxyvalerate (PHV), commercially available as a copolymer named Biopol
        • Require enzymes for biodegradation
        • Under consideration for several biomedical application
    • Synthetic poly(amino acids)
      • Wide occurrence in nature
      • High crystalline: difficult to process and slow degradation
      • Synthesizing “pseudo” poly(amino acids) using tyrosine derivative
  • Biodegradation Mechanism
      • Second phase
        • Enzymatic attack and metabolization of the fragments occur
        • Resulting in a rapid loss of polymer mass, this type of degradation is also called “ bulk erosion ”
    • Simple chemical hydrolysis of the hydrolytically unstable backbone
      • First phase
        • Water penetrates the bulk of the device, attacking the chemical bonds
        • Reduction in molecular weight &the physical properties
  • Biodegradation Mechanism
    • Surface Erosion
      • Polymer penetrates the device, slower than the rate of conversion of the polymer into water-soluble materials.
      • Results in the device thinning over time while maintaining its bulk integrity.
    • Related factors that resulting degradation:
      • Chemical Stability
      • The presence of catalyst, additives, impurities.
      • The geometry of the device
  • Packaging
    • Hydrolytically unstable
      • the presence of moisture can degrade the biodegradable polymers
    • The polymers are quickly packaged after manufacture
      • Double-bagged, under an inert atmosphere or vacuum
    • Final packaging
      • Placing the device in a moisture proof container
    • Sterilization
      • Biodegradable polymer is sterilized by gamma or E-beam irradiation or Ethylene Oxide (EtO) gas
      • Temperature and humidity should be considered
  • “ Biomimetic calcium phosphate coating on electrospun- poly( ε -caprolactone) scaffolds for bone tissue engineering”
    • PCL scaffolds with uniform fibrous structure were fabricated by electrospinning.
    • Before CaP coating, a plasma surface treatment was applied to clean and activate the PCL surface for calcium and phosphate ion grafting.
    • The treated PCL scaffolds were immersed in 10× simulated body fluid (SBF10) for varying time periods.
    By: F. Yang, J.G.C. Wolke, J.A. Jansen
    • The deposited calcium phosphate coatings improved the wettability of the electrospun PCL scaffold.
    • As the mineralized electrospun scaffold has a similar structure as the natural bone, it is expected to be a potential cell carrier in bone tissue engineering.
    • Scanning Electron Microscopy (SEM)
    • Gravimetric measurement
    • X-ray Diffraction
    • Energy Dispersive Spectroscopy
    • Water wettability test
  • Appendix a. Properties of common biodegradable polymers Polymer Melting Point (°C) Glass-Transition Temp (°C) Modulus (Gpa) a Degradation Time (months) b PGA 225—230 35—40 7.0 6 to 12 PLLA 173—178 60—65 2.7 >24 DLLA Amorphous 55—60 1.9 12 to 16 PCL 58—63 (—65)— (—60) 0.4 >24 PDO N/A (—10)— 0 1.5 6 to 12 PGA-TMC N/A N/A 2.4 6 to 12 85/15 DLPLG Amorphous 50—55 2.0 5 to 6 75/25 DLPLG Amorphous 50—55 2.0 4 to 5 65/35 DLPLG Amorphous 45—50 2.0 3 to 4 50/50 DLPLG Amorphous 45—50 2.0 1 to 2 a Tensile or flexural modulus. b Time to complete mass loss. Rate also depends on part geometry.
  • Appendix b. Commercial biodegradable medical products Application Trade Name Composition a Manufacturer   Dexon PGA Davis and Geck   Maxon PGA-TMC Davis and Geck   Vicryl PGA-LPLA Ethicon Sutures Monocryl PGA-PCL Ethicon   PDS PDO Ethicon   Polysorb PGA-LPLA U.S. Surgical   Biosyn PDO-PGA-TMC U.S. Surgical   PGA Suture PGA Lukens   Sysorb DLPLA Synos   Endofix PGA-TMC or LPLA Acufex   Arthrex LPLA Arthrex Interference screws Bioscrew LPLA Linvatec   Phusiline LPLA-DLPLA Phusis   Biologically Quiet PGA-DLPLA Instrument Makar Suture anchor Bio-Statak LPLA Zimmer   Suretac PGA-TMC Acufex Anastomosis clip Lactasorb LPLA Davis and Geck Anastomosis ring Valtrac PGA Davis and Geck Dental Drilac DLPLA THM Biomedical Angioplastic plug Angioseal PGA-DLPLA AHP Screw SmartScrew LPLA Bionx Pins and rods Biofix LPLA or PGA Bionx   Resor-Pin LPLA-DLPLA Geistlich Tack SmartTack LPLA Bionx Plates, mesh, screws LactoSorb PGA-LPLA Lorenz
  • 감사합니다
    • Thank you for your attention….
    • - Questions & Discussion -
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