Simplified process for sterilizing semi-solid to solid preparati

Chemical apparatus and process disinfecting – deodorizing – preser – Process disinfecting – preserving – deodorizing – or sterilizing – Using microwave energy

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422307, 25045511, A61L 212

Patent

active

052446280

DESCRIPTION:

BRIEF SUMMARY
BACKGROUND OF THE INVENTION

DE-OSS 32 29 540 and 37 16 302 relate to resorbable waxes for mechanically stanching blood on hard, body tissue, particularly on bones, which are characterized in that they consist of polyester oligomers of lower hydroxycarboxylic acids which are viscous to solid and wax-like at body temperature. Corresponding polyesters, oligomers of lactic acid and/or glycolic acid are described as particularly suitable. By virtue of their structure, these waxes can be degraded by the body's own metabolic mechanisms, the degradation rate being adjustable in known manner. The preferred waxes have average molecular weights in the range from about 200 to 1,500 and, more particularly, in the range from about 300 to 1,000.
Monofunctional and/or difunctional alcohols and/or carboxylic acids are used to regulate the average molecular weight, particular significance being attributed to glycerol as a polyfunctional alcohol. In another important embodiment, the resorbable materials are almost completely freed from free carboxyl groups. This may be done either by specific purification, as described for example in the publications cited above, or by salt formation at carboxyl groups which are still present in the reaction product or which have been specifically added, for example through free hydroxycarboxylic acids of the type mentioned.
Thus, earlier German patent applications P 38 25 211.2 (D 8293) and P 38 26 915.5 (D 8265) describe compositions based on oligomers of the described type which are characterized by a content of body-compatible salts of organic and/or inorganic acids, corresponding salts being formed by reaction of any free carboxyl groups still present in the oligomer wax and/or being homogeneously incorporated in the wax as added salts. In the second of these two earlier applications, this concept of body-compatible and resorbable oligomer compounds, particularly based on glycolic acid and/or lactic acid, is widened to the extent that at least partly resorbable bone substitutes and/or bone composites and auxiliaries for fixing prosthesis material in living bone tissue are described. The oligomers used for this purpose may have average molecular weights in a broader range of from about 200 to 10,000 g/mol and, more particularly, in the range from about 300 to 5,000 g/mol. Mixtures of oligomer resins containing ceramic materials in preferably homogeneous distribution are described as particularly suitable. These ceramic materials, which are present in particular in powder and/or granular form, may be resorbable or even non-resorbable in the body, particular significance being attributed to bioactive ceramic materials, above all based on calcium phosphate compounds. Suitable calcium phosphates are, for example, hydroxyl apatite and/or tricalcium phosphate.
The described oligomer compounds are produced by a polycondensation and/or polyaddition reaction carried out at elevated temperature, generally in the presence of small quantities of mildly acidic catalysts. The ceramic materials and/or salts optionally used are also normally incorporated at elevated temperature, generally via the melt phase of the organic resins.


DESCRIPTION OF THE INVENTION

For practical application in the field of surgery, the compositions in question generally have to lend themselves to portion-controlled packing and, at the same time, to complete sterilization. The problem addressed by the present invention was to satisfy these requirements as simply as possible for materials of the described type. The technical solution to this problem is based on the known principle of germ destruction by heating the material to be sterilized to sufficiently high temperatures. The teaching of the invention is crucially dependent upon the choice of the technical said with which temperature control is undertaken and managed for at least considerable periods of the sterilization process. The new teaching is based on the discovery that it is possible to heat the material to be sterilized to the necessary temperatures in a predeter

REFERENCES:
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patent: 4778656 (1988-10-01), Allen et al.
patent: 4801427 (1989-01-01), Jacob et al.
patent: 4818488 (1989-04-01), Jacob
patent: 4917586 (1990-04-01), Jacob
patent: 4931261 (1990-06-01), Jacob
patent: 4943417 (1990-07-01), Jacob

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