Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Patent
1995-09-19
1998-03-31
Azpuru, Carlos A.
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
623 16, A61F 202
Patent
active
057335648
DESCRIPTION:
BRIEF SUMMARY
BACKGROUND OF THE INVENTION
This invention relates to the use of bisphosphonates for the treatment of endo-osteal materials including implants to be used in surgery before their introduction into the human body. The invention concerns particularly the addition of a certain amount of a bisphosphonate to the sterile preservation medium for the endo-osteal materials.
In recent years intensive studies have been made on artificial endo-osteal materials, especially implants, to be introduced in the human body such as artificial joints, fixation plates in skeleton, hips and dental implants. Substantial efforts have been made with respect to materials which give high mechanical strength as well as good biological affinity.
Surgical techniques involving the use of endo-osteal prostheses including implants (screw implants, blade implants, pin implants etc) into bone tissue are extensively used in orthopaedic and dental surgery as a result of the progress made in somatological engineering.
Endo-osteal prostheses can roughly be divided into two groups: those comprising a metallic substrate on the one hand and ceramics and glass-ceramics (bioceramics) on the other hand. Metallic prostheses possess excellent strength properties but rather poor biocompatibility. Titanium and its alloys are the most frequently used metallic prostheses in both orthopaedic and dental surgery. In order to enhance the osseointegration and bone bonding process the metallic substrate is normally plasma-spray coated e.g. with apatite or hydroxyapatite to promote the bone bonding process. As examples of endo-osteal orthopaedic prostheses can mentioned Tricon-M and Allopro knee prostheses, Ortholoc tibial prosthesis and Monk, DF-80 and Authopor hip prostheses. Among the frequently used metal substrate implants in the dental field can be mentioned pure titanium implants (Nobelpharma, Swede-Vent.RTM., IMZ). Among coated metallic substrate implant can be mentioned Bonefit.RTM., a titanium substrate with titanium plasma coating; Steri-Oss.RTM., a hydroxyapatite-coated metal alloy substrate and Calcitec, a hydroxyapatite coated titanium substrate. The ceramic implants are e.g. based on polycristalline aluminium oxide, Al.sub.2 O.sub.3 (Frialit). Glass-ceramics and bioceramics include various compositions of glasses, ceramics and glass-ceramics having ability to bond to bone.
Endo-osteal materials to be introduced in the human body must be preserved strictly under sterile conditions before use. The preservation can take place under dry conditions or in a sterile solution. All the dental implants used are packed in sterile glass syringes. These syringes are either empty or contain physiologic saline solution. Dental implants are normally packaged in small ampouls in some milliliters of sterile sodium chloride solution. The hip prostheses are packed in sterile containers, all parts in their separate containers without any liquid.
The preservation of the prostheses and implants before their use is not just a problem relating to sterility. It is known that the biocompability of an implant is highly associated with the surface property of the material. It is therefore of great importance that the surface layer is carefully controlled and specified at the atomic level. Two implants initially manufactured from the same material can acquire completely different bioactivity properties depending on how the material is treated. Sterilization can for example vary between two similar implants and thus result in totally different biocompability for the two similar implants. The problem relating to the risk of contamination of the surface of the implant resulting in inactivation of the implant surface has been realized, and suggestions to overcome the problem have been made. U.S. Pat. No. 4,712,681 describes a method of packaging artifical implants in sterile and contamination-free manner according to which the implant is packaged in an inner capsule made of the same material as the implant itself. U.S. Pat. No. 4,763,788 suggests a rather similar solution of the con
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Chemical Abstract vol. 78, No. 25, Jun. 25, 1973 Jung, A. et al. abstract No. 155727, Calcif. Tissue Res. 1973 11 (4) 269-80.
Azpuru Carlos A.
Leiras Oy
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