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PubMed1996

In vitro evaluation of polymeric matrix and porous biodegradable reservoir devices for slow-release drug delivery.

BACKGROUND AND OBJECTIVE: Biodegradable polymeric devices were evaluated in vitro for intravitreal drug delivery. MATERIALS AND METHODS: The matrix (short-term drug delivery) and the porous (longer-term drug delivery) reservoir devices were made from polycaprolactone of two molecular weights (30,000 and 56,000). Matrix devices were loaded with 5-fluorouracil or ganciclovir. Porous reservoirs were loaded with 5-fluorouracil, ganciclovir, 5-carboxyfluorescein, or foscarnet. The release was monitored in phosphate-buffered solution using ultraviolet spectrophotometry. RESULTS: Release from the matrix devices was characterized by an initial burst, followed by a nonlinear release. The porous reservoirs demonstrated zero order linear release of drugs, sustained up to 250 days in this experiment. CONCLUSIONS: The matrix device is capable of sustained release over several months; the porous reservoir can deliver drugs for over 1 year. Further studies are needed to evaluate in vivo biodegradation behavior and toxicity of drugs used for sustained release.

Antiviral Agents↗

PubMedDate not supplied

A review of material properties of biodegradable and bioresorbable polymers and devices for GTR and GBR applications.

Use of bioresorbable and biodegradable materials for guided tissue and guided bone regeneration is under intense investigation and is being tested in clinical trials. This study presents a basic overview of material properties of bioresorbable and biodegradable polymers and devices for guided tissue and guided bone regeneration treatment. Collagens and aliphatic polyesters, such as poly(glycolic acid), poly(lactic acid), and poly(epsilon-caprolactone), are discussed, as well as biocompatibility, mechanical properties, and sterilization.

Biocompatible Materials↗

PubMed1996

Cranial bone grafting: biodegradable versus titanium fixation in a rabbit model.

Rigid internal fixation with miniplates and screws has enabled reconstructive surgeons to position bony segments precisely. Unfortunately, our present systems have been associated with a potential adverse effect on ultimate craniofacial growth and development. Also, they may be palpable, necessitating secondary procedures for removal of the hardware. We have been involved in an ongoing study evaluating the efficacy of a commercially developed biodegradable system. In this study, we compared biodegradable lag screw fixation with traditional titanium screw fixation in full-thickness, membranous bone grafts harvested from the zygomatic arches to the snout in a rabbit model. The results were compared with standard hematoxylin and eosin stains and laser densometry. Although this study adds further credence to the resorption of bone grafts, those secured with the polyglycolic acid screws demonstrated significantly less resorption than those maintained in position by traditional methods.

Animals↗

PubMed1997

Microencapsulation of antigens using biodegradable polyesters: facts and phantasies.

New vaccination approaches and new delivery systems have been subject of intensive research activities recently. Controlled release vaccine delivery systems depend on the microencapsulation of antigens into biodegradable polymers, yielding small spherical polymeric particles, in the size range of 1-100 microns. By manipulating the micromorphology of the microparticles and degradation properties of the polymer either continuous or pulsatile release patterns can be adjusted. As biodegradable polymers mainly copolymers of lactic- and glycolic acid have been utilized, since these materials are known to be biocompatible and non-toxic. Apart from modulation of antigen release, an improvement of the adjuvant effect and an increase of in vitro (shelf-life) and in vivo stability of the antigen are issues of general interest with respect to parenteral vaccine delivery systems. Using different microparticles that release antigens in a pulsatile pattern at predetermined timepoints one hopes to induce protective immunity by a single administration of the vaccine delivery system. Using tetanus toxoid (TT) as a model antigen we have examined the stability during preparation, in vitro release and storage of TT microparticles. TT is a complex protein mixture sensitive to changes in pH conditions (pH < 5) and to thermal stress. TT microparticles can be prepared by a W/O/W double emulsion technique with satisfactory encapsulation efficiencies in good yields. In accordance with other investigators we observe an adjuvant effect of TT microspheres in mice upon sc administration leading to a long-lasting antibody response. In challenge experiments we could demonstrate a protective effect. The issue of an ideal release pattern remains open, since a boosting of the antibody titers during the bioerosion of the TT microspheres was not observed, possibly due to desactivation of TT in the degrading microspheres.

Animals↗

PubMed1995

Guided tissue regeneration using a biodegradable barrier membrane for new attachment: a clinical, histologic, and histometric study in dogs.

Although nonbiodegradable barrier membranes have proven partially successful in achieving regeneration of lost periodontium through the principles of guided tissue regeneration, their use requires a second surgical procedure for their removal. The results of a study, in which a biodegradable collagen membrane was used to treat dehiscence defects in dogs, are presented. The membrane was an effective barrier to the downgrowth of gingival epithelium during the early stages of healing and tended to increase the regeneration of new cementum and connective tissue attachment. It was also biocompatible and biodegradable.

Analysis of Variance↗

PubMed1999

Poly(ethylene glycol)-modified ligninase enhances pentachlorophenol biodegradation in water-solvent mixtures

Polychlorinated hydrocarbons are prevalent environmental contaminants whose rates of biodegradation are limited by their minimal solubilities in aqueous solutions where the biological reactions take place. In this study, ligninase (LiP) from Phanerochaete chrysosporium was modified by poly(ethylene glycol) to enhance its activity and stability for the biodegradation of pentachlorophenol (PCP) in the presence of acetonitrile (MeCN), a water-miscible solvent. The modified enzyme retained 100% of its activity in aqueous solutions and showed enhanced tolerance against the organic solvent. The activity of the modified enzyme was found to be over twice that of the native enzyme in the presence of 10% (v/v) MeCN. The solubility of PCP was enhanced significantly by the addition of MeCN to aqueous solutions, such that it was over 10-fold more soluble in the presence of 15% (v/v) MeCN than in pure aqueous buffer solution (from 0.06 to 0.65 mM). Capitalizing on the enhanced substrate solubility and the increased activity of the modified enzyme, the catalytic efficiency of the modified LiP in solutions containing 15% MeCN was over 11-fold higher than that of the native enzyme in buffer solutions (pH 4.2) in unoptimized reactor systems (from 44 to 480 mol PCP/mol LiP.h). Continued research both in the use of organic solvents to increase the availability of recalcitrant contaminants and in the modification of enzymes to enhance their activity and stability in such solvents promises to dramatically affect our ability to remediate contaminated sites. Published by John Wiley & Sons.

Journal Article↗

PubMed1996

Light-microscopic and electron-microscopic evaluation of short-term nerve regeneration using a biodegradable poly(DL-lactide-epsilon-caprolacton) nerve guide.

The aim of this study was to evaluate short-term peripheral nerve regeneration across a 10-mm. gap, using a biodegradable poly(DL-lactide-epsilon-caprolacton) nerve guide, with an internal diameter of 1.5 mm and a wall thickness of 0.30 mm. To do so, we evaluated regenerating nerves using light microscopy, transmission electron microscopy and morphometric analysis after implantation of 12-mm nerve guides in the sciatic nerve of the rat. Evaluation times ranged from 3-10 weeks. Three weeks after reconstruction, myelinated nerve fibers could be observed in the distal nerve stump. Ten weeks after reconstruction, the regenerating nerves already resembled normal nerves. In conclusion, we show that poly(DL-lactide-epsilon-caprolacton) nerve guides can be successfully applied in the reconstruction of severed nerves in the rat model. Furthermore, we have observed the fastest nerve regeneration described thus far, after reconstruction using a biodegradable nerve guide.

Animals↗

PubMed1997

Role of oxygen in biodegradation of poly(etherurethane urea) elastomers.

It is generally accepted that biodegradation of poly(etheruethane urea) (PEUU) involves oxidation of the polyether segments on the surface where leukocytes are adhered. The influence of dissolved oxygen, which is known to control oxidation of polymers in more traditional environments, was explored in this study. Specimens treated in vitro with hydrogen peroxide-cobalt chloride for 12 days exhibited a brittle, degraded surface layer about 10 microm thick. Attenuated total reflectance-Fourier transform infrared spectroscopy of the surface revealed that the ether absorbance at 1110 cm(-1) gradually decreased with in vitro treatment time to 30% of its initial value after 12 days. In contrast, 6 days in vitro followed by 6 days in air produced a decrease to 12% of the initial volume. Therefore, removing a specimen from the in vitro solution after 6 days and exposing it to air for the remainder of the 12 days actually resulted in more oxidation than leaving it in the in vitro solution for the entire 12 days. These results suggest that PEUU degrades by an autooxidation mechanism sustained by oxygen. By successfully modeling the depth of the surface degraded layer with a diffusion-reaction model, it was demonstrated that PEUU biodegradation is controlled by diffusion of oxygen into the polymer.

Biocompatible Materials↗

PubMed1997

Long-term engraftment of hepatocytes transplanted on biodegradable polymer sponges.

Hepatocyte transplantation may provide an alternative to orthotopic liver transplantation to treat liver failure. However, suitable systems to transplant hepatocytes and promote long-term engraftment must be developed. In this study, highly porous, biodegradable sponges were fabricated from poly (L-lactic acid) (PLA), and poly (DL-lacticco-glycolic acid) (PLGA), and utilized to transplant hepatocytes into the mesentery of three groups of Lewis rats. The portal vein was shunted to the inferior vena cava in one group of rats (PCS). The second group of animals received a PCS and a 70% hepatectomy on the day of sponge-hepatocyte implantation (PCS + HEP), and the control group (CON) received no surgical stimulation. The sponges were vascularized by ingrowth of fibrovascular tissue over the first 7 days in vivo. Approximately 95-99% of the implanted hepatocytes (determined utilizing computer-assisted image analysis) died in all three experimental groups during this time. The number of engrafted hepatocytes in the CON group further decreased over the next 7 days to 1.3 +/- 1.1% of the original cell number. However, the number of engrafted hepatocytes in the PCS and PCS + HEP increased over this time to 6 +/- 1% and 5 +/- 2%, respectively. The number of engrafted hepatocytes in the PCS group continued to increase over the next 2.5 months to a value of 26 +/- 12% of the initial cell number, and a large number of engrafted hepatocytes was still present at 6 months. These results indicate that stable new tissues can be engineered by transplanting hepatocytes on biodegradable sponges into heterotopic locations if appropriate stimulation is provided.

Animals↗

PubMed2000

Two parameters account for the flocculated growth of microbes in biodegradation assays.

Microbes in activated sludge tanks mostly occur in flocs rather than in cell suspensions. Flocculation results in a limited supply of substrate to the bacteria inside the flocs, which reduces the biodegradation rate of organic compounds by several orders of magnitude. This article presents a simple two-parameter extension of growth models for cell suspensions to account for the ensuing reduction of the degradation rate. The additional parameters represent floc size at division and diffusion length. The biomass of small flocs initially increases exponentially at a rate equal to that of cell suspensions. After this first phase, the growth rate gradually decreases and finally the radius becomes a linear function of time. At this time flocs are large and have a kernel of dead biomass. This kernel arises when the substrate concentration decreases below the threshold level at which cells are just able to pay their maintenance costs. We deduce an explicit approximative expression for the interdivision time of flocs, and thereby for the growth of flocculated microbial biomass at constant substrate concentrations. The model reveals that the effect of stirring on degradation rates occurs through a reduction of the floc size at division. The results can be applied in realistic biodegradation quantifications in activated sludge tanks as long as substrate concentrations change slowly.

Bioreactors↗

PubMed2001

Biodegradable polymeric scaffolds for musculoskeletal tissue engineering.

Biodegradable scaffolds have played an important role in a number of tissue engineering attempts over the past decade. The goal of this review article is to provide a brief overview of some of the important issues related to scaffolds fabricated from synthetic biodegradable polymers. Various types of such materials are available; some are commercialized and others are still in the laboratories. The properties of the most common of these polymers are discussed here. A variety of fabrication techniques were developed to fashion polymeric materials into porous scaffolds, and a selection of these is presented. The very important issue of scaffold architecture, including the topic of porosity and permeability, is discussed. Other areas such as cell growth on scaffolds, surface modification, scaffold mechanics, and the release of growths factors are also reviewed. A summary outlining the common themes in scaffold-related science that are found in the literature is presented.

Animals↗

PubMed2001

Biodegradable polymer/hydroxyapatite composites: surface analysis and initial attachment of human osteoblasts.

Biodegradable polymer/hydroxyapatite (HA) composites have potential application as bone graft substitutes. Thin films of polymer/HA composites were produced, and the initial attachment of primary human osteoblasts (HOBs) was assessed to investigate the biocompatibility of the materials. Poly(epsilon-caprolactone) (PCL) and poly(L-lactic acid) (PLA) were used as matrix materials for two types of HA particles, 50-microm sintered and submicron nonsintered. Using ESEM, cell morphology on the surfaces of samples was investigated after 90 min, 4 h, and 24 h of cell culture. Cell activity and viability were assessed after 24 h of cell culture using Alamar blue and DNA assays. Surface morphology of the polymer/HA composites and HA exposure were investigated using ESEM and EDXA, respectively. ESEM enabled investigation of both cell and material surface morphology in the hydrated condition. Combined with EDXA it permitted chemical and visual examination of the composite. Differences in HA exposure were observed on the different composite surfaces that affected the morphology of attached cells. In the first 4 h of cell culture, the cells were spread to a higher degree on exposed HA regions of the composites and on PLA than they were on PCL. After 24 h the cells were spread equally on all the samples. The cell activity after 24 h was significantly higher on the polymer/HA composites than on the polymer films. There was no significant difference in the activity of the cells on the various composite materials. However, cells on PCL showed higher activity compared to those on PLA. A polymer surface exhibiting "point exposure" of HA appeared to provide a novel and favorable substrate for primary cell attachment. The cell morphology and activity results indicate a favorable cell/material interaction and suggest that PLA and PCL and their composites with HA may be candidate materials for the reconstruction of bony tissue. Further investigations regarding long-term biomaterial/cell interactions and the effects of acidic degradation products from the biodegradable polymers are required to confirm their utility.

Bone Substitutes↗

PubMed2001

Limited adhesion of biodegradable microspheres to E- and P-selectin under flow.

In a variety of disease settings the expression of the endothelial selectins E- and P-selectin appears to be increased. This feature makes these molecules attractive targets around which to design directed drug-delivery schemes. One possible approach for achieving such delivery is to use polymeric biodegradable microspheres bearing a humanized monoclonal antibody (MAb) for E- and P-selectin, MAb HuEP5C7.g2. Perhaps the simplest technique for "coupling" HuEP5C7.g2 to the microspheres is via nonspecific adsorption. Previous studies suggest, however, that the adsorption of proteins onto microspheres fabricated in the presence of a stabilizer such as poly(vinyl alcohol) (PVA) is limited. It is unclear to what extent this limited level of adsorbed HuEP5C7.g2 would be able to support adhesion to E- and P-selectin under flow conditions. To explore this issue, we prepared microspheres from the biodegradable polymer, poly(epsilon-caprolactone) (PCL), using a single emulsion process and PVA as a stabilizer. We then incubated the PCL microspheres with HuEP5C7.g2 and studied the adhesion of the resulting HuEP5C7.g2 microspheres to E- and P-selectin under in vitro flow conditions. We found that the HuEP5C7.g2 PCL microspheres exhibit specific adhesion to Chinese hamster ovary cells stably expressing P-selectin (CHO-P) and 4-h IL-1beta-activated human umbilical vein endothelial cells (HUVEC). In contrast, HuEP5C7.g2 PCL microspheres exhibit little adhesion to parental CHO cells or unactivated HUVEC. The attachment efficiency to the selectin substrates was quite low, with appreciable attachment occurring only at low shear (0.3 dyn/cm(2)). Other supporting data strongly suggest that the limited attachment efficiency is due to a low level of HuEP5C7.g2 adsorbed to the PCL microspheres. Although the attachment was limited, a significant percentage of the HuEP5C7.g2 PCL microspheres were able to remain adherent at relatively high shear (8 dyn/cm(2)). Combined, our data suggest that HuEP5C7.g2 PCL microspheres exhibit selective limited adhesion to cellular substrate expressing E- and P-selectin.

Adsorption↗

PubMed2007

Encapsulation of proteins in biodegradable polymeric microparticles using electrospray in the Taylor cone-jet mode.

Solvent extraction (or evaporation from a W(1)/O/W(2)-dispersion), coacervation, and spray drying methods are commonly employed to encapsulate protein drugs in polymeric microparticles for sustained delivery applications. To overcome the limitations of these methods, a novel electrospray method was developed to encapsulate a model protein drug-bovine serum albumin (BSA) in biodegradable polymeric microparticles and examine the feasibility of the process in not denaturing the protein. Microparticles of approximately 20 microm diameter with corrugated surfaces and smooth surfaces were observed by scanning electron microscope. Confocal laser scanning microscope images showed that BSA was distributed evenly in microparticles. Sodium dodecyl sulfate-polyacrylamide gel electrophoresis (SDS-PAGE) was employed to investigate the protein integrity of BSA released from the polymer matrix after 38 days. No protein degradation was observed during the 38 days release. The secondary structure of released BSA was characterized by Fourier transform infrared (FTIR) and circular dichroism (CD), which suggested that the released BSA was almost identical to native BSA. The encapsulation efficiency could reach 76% by adjusting the amount of the additive Pluronic F127 and processing parameters. The release profile could be tailored by the fabrication process and the sustained release of BSA could endure for more than 1 month. More than 80% of the bioactivity of BSA (evaluated by BSA ELISA kit) could be maintained after releasing from polymer matrix. Findings of the present study demonstrate that this novel electrospray method is a promising approach to encapsulate bioactive materials such as proteins, enzymes, antibiotics, and DNA fragments in biodegradable polymeric particles.

Absorbable Implants↗

PubMed2002

Liquid acrylate-endcapped biodegradable poly(epsilon-caprolactone-co-trimethylene carbonate). I. Preparation and visible light-induced photocuring characteristics.

Photocurable liquid biodegradable copolymers were prepared by ring-opening copolymerization of epsilon-caprolactone (CL) and trimethylene carbonate (TMC) in the presence of a multifunctional hydroxyl group-bearing substance (di-, tri-, and tetra-functional alcohol and poly(ethylene glycol) (PEG) and its four-branched derivative) as an initiator and subsequent endcapping with acryloyl chloride at their hydroxyl terminals. These multifunctional, viscous liquid copolymers (molecular weights; approximately 2 x 10(3) to 7 x 10(3) g/mol) were converted to crosslinked solids by visible-light irradiation in the presence of camphorquinone as an initiator. The photocuring rate of these copolymers was enhanced by both higher functionality and lower molecule weight of the copolymers used. The photocuring rate depended on the amount of reducing agent (methacrylic acid 2-dimethylaminoethyl ester). Upon immersion in a phosphate buffer solution (pH 7.4), hydrolysis occurred preferentially on the surface except for photocured PEG-based copolymers that were degraded faster via both surface erosion and bulk degradation than low molecular weight alcohols-based copolymers. Cylindrical photocured constructs prepared by photoirradiation to the whole body in a mold filled with the liquid copolymer was demonstrated as an example of shape fabrication of biodegradable biomedical devices.

Acrylates↗

PubMed2001

Biodegradable poly(D,L-lactide) coating of implants for continuous release of growth factors.

Local application of growth factors like insulin like growth factor-I (IGF-I) and transforming growth factor-beta 1 (TGF-beta1) from a biodegradable thin layer of poly(D,L-lactide) (PDLLA) coated implants could stimulate fracture healing. A new "cold coating technique" for metallic implants was established to produce a biodegradable coating with a high mechanical stability that provides a continuous release of incorporated growth factors. The properties of this bioactive coating were investigated in vitro and in vivo. Scanning electron microscope analysis revealed a coating thickness of in average 14.8 microm on titanium and 10.7 microm on steel wires. Intramedullary implantation and extraction experiments depicted a loss of PDLLA coating from titanium and steel implants of less than 5%. After explantation of the implants, the coating displayed a complete and regular layer without any defects of PDLLA uncovering the metallic surface. Smear tests demonstrate that the coating can be performed under sterile conditions. The PDLLA depicted a reduction of about 8% within 6 weeks in vitro and in vivo. The growth factors were incorporated in a stable form and demonstrated a loss of stability of less than 3% within 42 days and less than 5% within one year. In an elution experiment, 54% IGF-I and 48% TGF-beta1 were released within the first 48 h. After 42 days, 76% of IGF-I and 71% of TGF-beta1 were detected in the elution fluid by ELISA. Comparable results were obtained in the in vivo experiments after 42 days.

Animals↗

PubMed1991

A laboratory model to quantitate the resistance of collagen vascular grafts to biodegradation.

Recent reports have shown that despite extensive preclinical testing, vascular grafts of biological origin undergo severe biodegradation and aneurysm formation after two or more years of implantation in man. The purpose of this study was to develop a laboratory model to quantitate and correlate the stability of crosslinked collagen grafts in vitro and in vivo. This resistance to biodegradation was assessed by measuring changes in suture pullout force and sample weight in response to controlled digestion with bacterial collagenase, in 0.5-cm-long cylindrical graft segments (chemically processed bovine carotid artery and human umbilical cord vein) that were implanted in the rat subcutis for 2 to 12 weeks. Scar tissue was removed from the explants by brief enzymatic digestion, a process that was inhibited when graft segments had become infected. Changes in dry weight were more consistent than were changes in wet weight; drying the graft segments had no effect on their degradation in vivo or in vitro. Intact cylindrical rings suffered somewhat less damage than did opened, flattened cylinders. Graft degradation increased markedly with implantation time, and was detected after only 3 weeks. We conclude that the rat subcutis model, when combined with controlled enzymatic digestion, first to remove scar tissue and then to challenge structural integrity, provides an accelerated assay by which to predict the stability of collagen vascular grafts.

Animals↗

PubMed1995

Preparation of a macroporous biodegradable polylactide implant for neuronal transplantation.

This article reports the production of a surgical implant meeting several specific requirements such as biocompatibility, biodegradability, macroporosity, and flexibility. Porosity was controlled by an original method consisting of the aggregation of calibrated poly-D,L-lactide microparticles. The size of the interstices between the aggregated microspheres was in a direct relationship to the microsphere diameter. A first approach was based on coating the microspheres with poly(vinyl alcohol) followed by chemically crosslinking the coating layers that were in mutual contact. This method was disregarded because of the acute cytotoxicity of glutaraldehyde used as the crosslinking agent, the absence of macroporosity, and the complete lack of flexibility. A physical technique of aggregation was then tested, which relied on the plasticization of poly-D,L-lactide microspheres with triethylcitrate to the point where microspheres strongly adhered to each other when they were in contact. This method has proved to be straightforward and definitely superior to the chemical approach, particularly with respect to cytotoxicity, control of macroporosity, and flexibility. A polymer support was thus successfully which was biodegradable, macroporous( interconnected pores of 10-100 microns in diameter), and flexible. This potential medical device is presently being used for neuronal transplantation in the central nervous system.

Animals↗