Bioresorbable Polymer Compounds for implantable devices - - PowerPoint PPT Presentation

bioresorbable polymer compounds
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Bioresorbable Polymer Compounds for implantable devices - - PowerPoint PPT Presentation

Bioresorbable Polymer Compounds for implantable devices Confidential Bioabsorbable Polymers Attributes Synthetic Inert to the body; biocompatible Hydrolytically unstable Absorbed in body and metabolized Conventional melt processing


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Bioresorbable Polymer Compounds

for implantable devices

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Bioabsorbable Polymers Attributes

Synthetic Inert to the body; biocompatible Hydrolytically unstable Absorbed in body and metabolized Conventional melt processing Sterilizable with gamma and ETO Range of physical and degradation properties Property modification: molecular weight; copolymerization

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Applications

Sutures Dental devices Orthopedic fixation Controlled drug delivery Tissue fixation Biodegradeable stents Bone and tissue engineering

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Bioabsorbable Polymers

PLA – polylactides PGA – polyglycolides PLGA – poly(lactide-co-glycolides) PCL - Polycaprolactone

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PolyGlycolides (PGA)

Highly crystalline

lower solubility in water

Absorbs quickly

loses strength within 1 month loses mass within 6 -12 months

Melt point: 225 – 230 C Glass transition: – 35 – 40 C High modulus

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PolyLactides (PLA)

PLLA

slow rate of absorption (>2 yrs) highly crystalline glass transition: 50 – 80 C melt point: 173 – 178 C high modulus (load bearing applications

PDLA

faster absorption rate than PLLA

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Poly(lactic-co-glycolic acid) (PLGA) Copolymer

Properties based on ratio of lactide to glycolide

Amorphous Glass Transition: 40 - 60C Very good solubility Degradation depends on ratio of above

50/50 ratio absorbs in about 2 months

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Polycaprolactone (PCL)

Low melting point: 60 C Glass transition temperature: -60C Often used as additive to improve processing & end use properties Slow degradation rate (>2yrs)

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Factors Affecting Biodegradation

Chemical structure & composition Molecular weight & distribution Morphology (amorphous/crystalline structure) Site of implantation Part shape and design Mechanism of hydrolysis (enzymes v. water) Processing & handling conditions

Annealing Sterilization process Storage history Drying Presence of additives

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Foster Experience

Range of Bioresorble Polymer Compounds Small Volume Manufacturing

1/2 lb sample 10+ lb production

Low/medium shear screw configurations Can hold tight tolerances Appropriate drying capabilities 2 plants environmentally controlled

Las Vegas, Nevada facility Putnam, CT

Packaging capabilities

metalized bags, poly bags, vacuum canning