Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Particulate form
Reexamination Certificate
2000-08-17
2003-08-05
Page, Thurman K. (Department: 1615)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Particulate form
C424S400000, C424S493000, C424S464000, C424S466000
Reexamination Certificate
active
06602523
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates in general to a composite material, and more particularly, to a composite material having a beneficial agent associated with another high surface area component. Such a composite material enables increased bioavailability and/or activity of the beneficial agent, and can be used in numerous applications, including topical, oral and/or systemic administration of a medicament, pharmaceutical agent, chemical agent, etc.
2. Background Art
Beneficial agents have been known in the art for years and are the subject of numerous patents, including U.S. Pat. No. 4,344,934, U.S. Pat. No. 4,517,179, and U.S. Pat. No. 5,641,515.
U.S. Pat. No. 4,344,934 discloses medical compositions comprising wetted mixtures of poorly soluble drugs with water soluble polymers which are useful in increasing bioavailability of associated drugs.
U.S. Pat. No. 4,517,179 discloses rapidly dissolving uniform compositions of low water solubility drugs formed from a dry mixture of the drug having a reduced particle size in combination with properly selected and sized excipients including microcrystalline cellulose, dibasic calcium phosphate, starches and a lubricant.
U.S. Pat. No. 5,641,515 discloses a controlled release pharmaceutical formulation comprising nanoparticles formed of a biodegradable polycyanoacrylate polymer in which insulin is entrapped.
While beneficial agents have become common in numerous applications, the efficiency of their administration remains problematic for several applications. In particular, numerous beneficial agents comprise molecules which are undesirably insoluble in an associated environment to the extent that they are not sufficiently bioavailable during a predetermined administration period. One way to increase the solubility of the beneficial agent is by configuring the beneficial agent into nanoparticles. However, in doing so these agents commonly aggregate, conglomerate, and/or coagulate. Upon aggregation, conglomeration, and/or coagulation, the effective surface area of the beneficial agent can be dramatically decreased. As a result, the beneficial agent is not effectively soluble, and, in turn, truly bioavailable, due to decreased surface area of the beneficial agent.
It is therefore an object of the present invention to associate a beneficial agent with a high surface area inert component or another high surface area beneficial agent to substantially maintain a predetermined effective high surface area of the beneficial agent to that of the high surface area inert component. When such an effective high surface area is maintained, the bioavailability and activity of the beneficial agent can be improved substantially.
These and other objects of the present invention will become apparent in light of the present specification, claims, and drawings.
SUMMARY OF THE INVENTION
The present invention is directed to a composite material suitable for external and/or internal association with a living body comprising: (1) a first component having a surface area greater than 10 M
2
/gm; and (2) a first beneficial agent associated with at least a portion of the surface of the first component.
In a preferred embodiment of the invention, the first component is fabricated from a material having an hardness greater than the hardness of the first beneficial agent.
Preferably, the first component comprises: (1) a diameter ranging from approximately 1 to approximately 100 nanometers; and (2) a substantially inert material. It is also contemplated that the inert first component be fabricated from either a hygroscopic or hydrated material.
In another preferred embodiment of the invention, the first component is fabricated from at least one material selected from the group consisting essentially of noble metals such as Ag, Pt, Rh, Au, etc., metal oxides, metal nitrides, metal carbides, metal phosphates, carbonaceous materials, ceramic materials, and mixtures thereof.
In yet another preferred embodiment of the invention, the first component is fabricated from at least one material selected from the group consisting essentially of zeolites, Ag
2
O, Ag, Au, Ta
2
O
5
, Al
2
O
3
, TiO
2
, C, SiO
2
, Bi
2
O
3
, ZnO and mixtures and compounds thereof. In such an embodiment, the first component may be fabricated from an antibacterial material. In an alternative embodiment of the present invention, the first component could be fabricated from hydrated ceramic materials.
In accordance with the present invention, the first beneficial agent is fabricated from at least one material selected from the group consisting essentially of a pharmaceutical agent, a medicament, a chemical agent, and mixtures thereof. The first beneficial agent may also be associated with an effervescent material.
Additionally, a second beneficial agent may be processed such that the composite is formed between the second beneficial agent and the first beneficial agent. In this embodiment, the first beneficial agent may be fabricated from a material having a hardness and surface area greater than the hardness and surface area of the second beneficial agent.
The present invention is also directed to a composite material suitable for external and/or internal association with a living body comprising: (1) a first beneficial agent having a high surface area; and (2) a second beneficial agent associated with at least a portion of the surface of the first beneficial agent.
In a preferred embodiment of the invention, a tertiary beneficial agent may also be associated with at least a portion of the surface of the second beneficial agent.
The present invention is also directed to a process for fabricating a composite material comprising the steps of: (1) providing a first component having a high surface area; (2) providing a first beneficial agent; and (3) associating the first beneficial agent with at least a portion of the surface of the first component.
The present invention is further directed to a process for fabricating a composite material, comprising the steps of: (1) providing a first beneficial agent having a surface area greater than 10 M
2
/gm; (2) providing a second beneficial agent; and (3) associating the second beneficial agent with at least a portion of the surface of the first beneficial agent.
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patent: 4517179 (1985-05-01), Raghunathan
patent: 5164186 (1992-11-01), Tsuru et al.
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patent: 5641515 (1997-06-01), Ramtoola
patent: 5879716 (1999-03-01), Katz et al.
patent: 5922299 (1999-07-01), Bruinsma et al.
patent: 6087353 (2000-07-01), Stewart et al.
patent: 6344271 (2002-02-01), Yadav et al.
patent: 6350470 (2002-02-01), Pather et al.
Factor Jody L.
Joynes Robert M.
Page Thurman K.
Technology Holding, LLC.
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