Drug – bio-affecting and body treating compositions – Preparations characterized by special physical form – Implant or insert
Reexamination Certificate
2002-07-19
2003-07-22
Page, Thurman K. (Department: 1621)
Drug, bio-affecting and body treating compositions
Preparations characterized by special physical form
Implant or insert
C424S434000, C424S400000, C424S719000, C424S721000
Reexamination Certificate
active
06596295
ABSTRACT:
The present invention relates to an aqueous solution that is administrable by perinodular injection or by inhalation and is usable for treating degenerative or autoimmune diseases and/or as an immunomodulatory agent.
The invention also relative to a method for preparing this solution.
This method is characterized in that:
in a first step, camphor is reacted with ammonium hydroxide;
in a second step, the product obtained in the first step is suspended in an aqueous solution of sodium chloride; and
in a third step, the pH of the liquid suspension obtained in the second step is neutralized with nitric acid to obtain the desired aqueous solution.
The aqueous solution according to the invention as obtained by the method described above, has been thoroughly tested and has proven to have pharmacological properties which make it efficient for the treatment of degenerative or autoimmune diseases and/or as an immunomodulatory agent.
Thus, it has been noticed that it mimicks human cytokines. Thus, it acts on monocytes to transform them into macrophages which, in turn, secrete two proinflammatory cytokines: interleukin 1 beta, 6, 8&agr; and a tumor necrosis factor TNF alpha. Depending on the mimicked cytokine family, monocytes are transformed into macrophages or block molecules which paralyse the immune system. In both cases, a stimulation of the immune system and an increase in the tumor necrosis factor, which is also classified among immunostimulating factors, occur. This factor is also known for the role it plays in host resistance against viral infections or others, and in tumor development.
Based on testings performed on animals, the solution according to the invention would be applicable in human therapeutics using 0.075 ml per pound of body weight for 21 days, that is to say a total of 10.5 ml per series, which corresponds to 0.5 ml per day for a person weighing 140 pounds. Administration can be done by perinodular injection or by inhalation with an ultrasonic nebulizer.
For a person of 140 to 190 pounds, the first series should be applied in a progressive way according to the following schedule:
1
st
day
0.1 ml injection
2
nd
day
0.2 ml injection
3
rd
day
0.3 ml injection
4
th
day
0.4 ml injection
5
th
day
0.5 ml injection
All the other injections should comprise the same volume (0.5 ml) of injected product.
The following series will use 0.5 ml at each injection for 21 days.
Cycles can be repeated if needed with an interruption of 2 days between each cycle.
The structure of the active principle present within the aqueous solution according to the invention has not been established with precision yet. As it stands out on the reaction diagram identified as
FIG. 1
in appendix, camphor reacts in a reversible way with ammoniac to produce a hemiaminal derivative. This hemiaminal derivative of camphor is itself prone to a number of possible reversible conversions in the presence of ammoniac and water, and has been impossible to identify by infrared spectrophotometry yet. However, the Applicant however thinks that it is the chloride of this hemiaminal derivative of camphor obtained in the second step of neutralization which is probably the active principle of the aqueous solution insofar as the structure of this derivative could effectively mimick the structure of &bgr; family cytokines which are known to act on monocytes and stimulate the production of IL-1 beta, 6, 8 and TNF alpha. The complete chemical name of the chloride derivative is the trimethyl-1,7,7 amino-2 hydroxy-2-bicyclo [1,2,2] heptane chloride.
The invention will be better understood upon reading what will follow in a practical example of synthesis and the detailed description of assays performed up to now by the Applicant.
REFERENCES:
patent: 385 148 (1932-12-01), None
patent: 97 05780 (1997-02-01), None
XP002167940, vol. 29, No. 3, 1896, pp. 2807-2808.
Darby & Darby
Joynes Robert M.
Page Thurman K.
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