High molecular weight polymers and copolymers of BHMDO for...

Synthetic resins or natural rubbers -- part of the class 520 ser – Synthetic resins – From phenol – phenol ether – or inorganic phenolate

Reexamination Certificate

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Reexamination Certificate

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06300458

ABSTRACT:

INTRODUCTION
The present invention relates to new high molecular weight polymers and copolymers of 5,5-bis(hydroxymethyl)-1,3-dioxan-2-one (herein referred to as “BHMDO”) and to methods of making and using those polymers and copolymers in a number of biomedical applications including drug delivery systems and tissue engineering.
BACKGROUND OF THE INVENTION
The present invention relates to novel polymers having a wide range of biodegradability, biocompatibility, solubility, and physical morphology (e.g., crystalline, All amorphous, rubbery, or rigid). These unique polymers are synthesized from polycarbonates and polyiminocarbonates of carbohydrates, or analogous hydroxyl-containing, biocompatible moieties, such as pentaerythritol (“PE”) or glycerin (“GLC”).
BRIEF SUMMARY OF THE INVENTION
The present invention relates to high weight average molecular weight (>5,000) polymers and copolymers of 5,5-bis (bydroxymethyl) 1,3-dioxan-2-one (hereinafter referred to as “BHMDO”) and processes for manufacturing these polymers and copolymers. These polymers are biocompatible and useful for a variety of biomedical applications. The homopolymer is unique compared to current biomedical polymers. It is crystalline and has a high melting point (ca 160-190° C.) which provides excellent mechanical properties. At the same time, they are hydrophilic and swellable by water (ca 100% at 37° C.), thereby enhancing biodegradability. The hydroxyl groups permit easy modification, an important advantage over non-hydrophilic biopolymers. For example, in the treatment of cancer, pain relief, or other therapy, one can chemically bond a drug by an appropriate hydroxyl group reaction to form a hydrolytically labile bond or with a small peptide link cleavable by body enzymes along with a chemically bonded polysaccharide or protein to target the desired cell with the appropriate drug. The hydroxyl groups provide hydrogen bonding with carbohydrate polymers, including nucleic acids, and proteins, which also facilitate direction of these polymers, as is or modified, to specific cites for therapeutic purposes. Properties can be varied widely via copolymers (generally from about 1% up to about 99% BHMDO) to change properties and permit diverse biomedical applications.
Accordingly, a principal object of the present invention is to provide new and improved hydroxyl functional polymers for facilitating the delivery and dissemination of medically useful drugs to the human system.
Another object of the present invention is to provide new high molecular weight polymers and copolymers of 5,5-bis(hydroxymethyl) 1,3-dioxan-2-one (“BHMDO”) and methods of making such polymers.
A further object of the present invention is to employ new polymers and copolymers of BHMDO to provide a new and highly effective courier for delivery of therapeutic compounds to target sites.
These and still further objects as shall hereinafter appear are readily fulfilled by the present invention in a remarkably unexpected manner as will be readily discerned from the following detailed description of an exemplary embodiment.


REFERENCES:
patent: 753704 (1995-02-01), None

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