Drug – bio-affecting and body treating compositions – Designated organic active ingredient containing – Heterocyclic carbon compounds containing a hetero ring...
Patent
1997-11-25
2000-06-06
Henley, III, Raymond
Drug, bio-affecting and body treating compositions
Designated organic active ingredient containing
Heterocyclic carbon compounds containing a hetero ring...
A61K 31381
Patent
active
060719028
DESCRIPTION:
BRIEF SUMMARY
This invention provides a method for using 2-methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine, (hereinafter referred as "olanzapine"), for the treatment of excessive aggression.
Excessive agression can be a problem for institutionalized patients and may be associated with violent suicides. Extreme aggressiveness can be harmful to the individual prone to extreme aggressivenes, may be detrimental to relationships and family members interacting with the individual, and may complicate the management of patients or prisoners in the institutional setting.
Studies of animals and human beings suggest that 5-HT serves a critical role in aggression and impulsivity. Several human studies report a correlation between low cerebrospinal fluid 5-HIAA and violent suicides. Therefore, extreme aggression appears to be associated with abnormalities in 5-HT. Goodman and Gillman, The Parmacololgical Basis of Therapeutics, 257 (9th Ed. McGraw-Hill, New York, 1996). However, there is a need for new treatments that can manage extreme aggression in a safe and ethical manner.
It is known that olanzapine can provide antipsychotic activity and is currently undergoing investigation for this purpose. Olanzapine is a known compound and described in U.S. Pat. No. 5,229,382 as being useful for the treatment of schizophrenia, schizophreniform disorder, acute mania, mild anxiety states, and psychosis. U.S. Pat. No. 5,229,382 is herein incorporated by reference in its entirety. However, olanzapine was not known to be useful for the treatment of excessive aggression. Applicants have discovered that olanzapine can be useful for the treatment of extreme aggression. Olanzapine could address a long felt need for treatments which provides a favorable safety profile and effectively provides relief for the patient or individual suffering from extreme aggression.
The presently claimed invention provides a method for treating extreme aggression, comprising administering an effective amount of olanzapine or a pharmaceutically acceptable salt thereof to a patient in need of such treatment.
The present invention provides a method for treating excessive aggression in a mammal, wherein the mammal is not clinically diagnosed as suffering from a psychotic condition.
Olanzapine is of the formula ##STR1## or an acid addition salt thereof.
It is especially preferred that olanzapine will be the Form II olanzapine polymorph having a typical x-ray powder diffraction pattern as represented by the following interplanar spacings:
______________________________________ ______________________________________
10.2689
8.577
7.4721
7.125
6.1459
6.071
5.4849
5.2181
5.1251
4.9874
4.7665
4.7158
4.4787
4.3307
4.2294
4.141
3.9873
3.7206
3.5645
3.5366
3.3828
3.2516
3.134
3.0848
3.0638
3.0111
2.8739
2.8102
2.7217
2.6432
2.6007
______________________________________
A typical example of an x-ray diffraction pattern for Form II is as follows wherein d represents the interplanar spacing and I/I.sub.1 represents the typical relative intensities:
______________________________________ d I/I.sub.1
______________________________________
10.2689
100.00
8.577 7.96
7.4721 1.41
7.125 6.50
6.1459 3.12
6.071 5.12
5.4849 0.52
5.2181 6.86
5.1251 2.47
4.9874 7.41
4.7665 4.03
4.7158 6.80
4.4787 14.72
4.3307 1.48
4.2294 23.19
4.141 11.28
3.9873 9.01
3.7206 14.04
3.5645 2.27
3.5366 4.85
3.3828 3.47
3.2516 1.25
3.134 0.81
3.0848 0.45
3.0638 1.34
3.0111 3.51
2.8739 0.79
2.8102 1.47
2.7217 0.20
2.6432 1.26
2.6007 0.77
______________________________________
The x-ray diffraction patterns set out herein were obtained using a Siemens D5000 x-ray powder diffractometer having a copper K.sub..alpha. radiation source of wavelength, .lambda.=1.multidot.541 .ANG..
It is further preferred that the Form II olanzapine polymorph will be administered as the substantially pure Form II olan
REFERENCES:
patent: 4595535 (1986-06-01), Vlattas
patent: 5229382 (1993-07-01), Chakrabarti et al.
Beasley Jr. Charles M
Tran Pierre V
Eli Lilly and Company
Henley III Raymond
Jones Macharro Vorndran
Palmberg Arleen
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