Standards and guidelines for biopolymers in tissue-engineered medical products: ASTM alginate and chitosan standard guides. American Society for Testing and Materials.

The American Society for Testing and Materials (ASTM) is making a concerted effort to establish standards and guidelines for the entire field of tissue-engineered medical products (TEMPS). Safety, consistency, and functionality of biomaterials used as matrices, scaffolds, and immobilizing agents in TEMPS are a concern. Therefore, the ASTM has established a number of task groups to produce standards and guidelines for such biomaterials. Alginate is a naturally occurring biomaterial used for immobilizing living cells to form an artificial organ, such as encapsulated pancreatic islets. In order to aid in successful clinical applications and to help expedite regulatory approval, the alginate used must be fully documented. The ASTM alginate guide gives information on selection of testing methodologies and safety criteria. Critical parameters such as monomer content, molecular weight, and viscosity, in addition to more general parameters, such as dry matter content, heavy metal content, bioburden, and endotoxin content are described in the ASTM document. In a like manner, the characterization parameters for chitosan, a bioadhesive polycationic polysaccharide, are described in a separate guide. For chitosan, the degree of deacetylation is of critical importance. Control of protein content and, hence, potential for hypersensitivity, endotoxin content, and total bioburden are important in chitosan preparations for TEMPS. Together these two guides represent part of the effort on behalf of the ASTM and other interested parties to ensure quality and standardization in TEMPS.

Chitosan as a nasal delivery system: the effect of chitosan solutions on in vitro and in vivo mucociliary transport rates in human turbinates and volunteers.

In these studies, we examined the effect on mucociliary transport rates (MTR) of various 0.25% (w/v) chitosan solutions applied to human nasal tissue both ex vivo and in vivo. In the first study a range of chitosans with different molecular weights were applied to freshly amputated human nasal turbinates, and their effect on MTR was recorded. The transient inhibitory effect on turbinate MTR that was found for most of the chitosan preparations showed a marked dependence on the volume of chitosan solution applied and the molecular weight of the chitosan tested. The higher the molecular weight of the chitosan and the more chitosan applied, the longer the original MTR was depressed. A small scale human trial, investigating the effect of chitosan glutamate, on saccharin clearance times, was also undertaken. The study showed that a once daily application of a 0.25% solution of the chitosan for 7 days had no effect on either saccharin clearance times or nasal histology as examined by light microscopy.

Metal recovery using chitosan.

Chitosan is a natural polycationic polymer which possesses valuable properties as a metal recovering and water purifying agent. Applications are waste water treatment for heavy metal and radio isotope removal and valuable metal recovery, potable water purification for reduction of unwanted metals, agriculture--controlled release of trace metals essential to plant growth, food--complex binding of iron in precooked food to reduce 'warmed-over flavour'. The interactions of metals with chitosan are complex, probably simultaneously dominated by adsorption, ion-exchange and chelation. To study this it is of utmost importance to work with well characterized chitosans. This has been a problem as available characterizing methodology is limited. Degree of polymerization and deacetylation and the distribution of acetyl groups along the polymer chain is of crucial importance for chitosan metal interacting characteristics. Making chemical derivatives is a way to alter the metal interacting characteristics of chitosan. Chitosan possesses general coagulant/flocculant characteristics towards bio-molecules and surfaces.