Pharmaceutical compositions containing new polymorphic forms of olanzapine and uses thereof
AssigneeU & I Pharmaceuticals Ltd.
InventorsYusuf K. Hamied, Rajendra N. Kankan, Dharmaraj R. Rao
Life of this patent
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Abstract
Pharmaceutical compositions containing Form III, Form IV, Form V olanzapine and/or pharmaceutically acceptable salts thereof. The pharmaceutical compositions are useful for the treatment of psychotic conditions, mild anxiety and gastrointestinal conditions. In particular, the compositions are useful for treating schizophrenia and related disorders, acute mania, Bipolar I Disorder, psychotic mood disorder and psychosis in patients with Alzheimer's disease.
Claims19
A pharmaceutical composition comprising as an active ingredient at least one solid olanzapine polymorph selected from Form III olanzapine, Form IV olanzapine, Form V olanzapine, and salts and mixtures thereof;
- and
- one or more pharmaceutically acceptable carriers, excipients or diluents;
- wherein Forms III, IV and V olanzapine are olanzapine polymorphs having typical x-ray powder diffraction patterns represented by the following interplanar spacings:
- FORM-III
- FORM-IV
- FORM IV
- d-spacing (Å)
- d-spacing (Å)
- d-spacing (Å)
- 10.3156
- 9.9487
- 10.5932
- 7.1713
- 8.5074
- 10.2170
- 6.5014
- 8.2103
- 9.9503
- 5.5165
- 4.8172
- 8.5259
- 4.8541
- 4.7114
- 7.1016
- 4.5578
- 4.6122
- 6.0731
- 4.4938
- 4.5282
- 5.2041
- 4.4536
- 4.2340
- 4.9856
- 4.2588
- 4.0901
- 4.8153
- 3.9898
- 3.7574
- 4.7514
- 3.7288
- 3.6989
- 4.5302
- 3.5626
- 4.4714
- 3.0262
- 4.2271
- 4.1307
- 3.9880
- 3.7763
- 3.7167
- 3.5315.
- and the composition is in the form of a suspension, emulsion, solid capsule, tablet, caplet, cachet, lozenge, troche, granular formulation or powdered formulation.
A pharmaceutical composition containing as an active ingredient at least one solid olanzapine polymorph selected from Form III olanzapine, Form IV olanzapine, Form V olanzapine, and salts and mixtures thereof;
- wherein Forms III, IV and V olanzapine are olanzapine polymorplis having typical x-ray powder diffraction patterns represented by the following interplanar spacings:
- FORM-III
- FORM-IV
- FORM-V
- d-spacing (Å)
- d-spacing (Å)
- d-spacing (Å)
- 10.3156
- 9.9487
- 10.5932
- 7.1713
- 8.5074
- 10.2170
- 6.5014
- 8.2103
- 9.9503
- 5.5165
- 4.8172
- 8.5259
- 4.8541
- 4.7114
- 7.1016
- 4.5578
- 4.6122
- 6.0731
- 4.4938
- 4.5282
- 5.2041
- 4.4536
- 4.2340
- 4.9856
- 4.2588
- 4.0901
- 4.8153
- 3.9898
- 3.7574
- 4.7514
- 3.7288
- 3.6989
- 4.5302
- 3.5626
- 4.4714
- 3.0262
- 4.2271
- 4.1307
- 3.9880
- 3.7763
- 3.7167
- 3.5315
- and the composition is in the form of a suspension, emulsion, solid capsule, tablet, caplet, cachet, lozenge, troche, granular formulation or powdered formulation.
A method of treating a patient having a psychotic condition or mild anxiety comprising administering a therapeutically effective amount of at least one olanzapine polymorph to said patient;
- wherein the at least one olanzapine polymorph is selected from Form III olanzapine, Form IV olanzapine, Form V olanzapine, and salts and mixtures thereof;
- and
- wherein Forms III, IV and V olanzapine are olanzapine polymorphs having typical x-ray powder diffraction patterns represented by the following interplanar spacings:
- FORM-III
- FORM-IV
- FORM IV
- d-spacing (Å)
- d-spacing (Å)
- d-spacing (Å)
- 10.3156
- 9.9487
- 10.5932
- 7.1713
- 8.5074
- 10.2170
- 6.5014
- 8.2103
- 9.9503
- 5.5165
- 4.8172
- 8.5259
- 4.8541
- 4.7114
- 7.1016
- 4.5578
- 4.6122
- 6.0731
- 4.4938
- 4.5282
- 5.2041
- 4.4536
- 4.2340
- 4.9856
- 4.2588
- 4.0901
- 4.8153
- 3.9898
- 3.7574
- 4.7514
- 3.7288
- 3.6989
- 4.5302
- 3.5626
- 4.4714
- 3.0262
- 4.2271
- 4.1307
- 3.9880
- 3.7763
- 3.7167
- 3.5315.
A method of treating a patient having a psychotic condition selected from schizophrenia and schizophreniform disorders, acute mania, Bipolar I Disorder, psychotic mood disorder and psychosis associated with Alzheimer's disease comprising administering a therapeutically effective amount of at least one olanzapine polymorph to said patient;
- wherein the at least one olanzapine polymorph is selected from Form III olanzapine, Form IV olanzapine, Form V olanzapine, and salts and mixtures thereof and
- wherein Forms III, IV and V olanzapine are olanzapine polymorphs having typical x-ray powder diffraction patterns represented by the following interplanar spacings:
- FORM-III
- FORM-IV
- FORM IV
- d-spacing (Å)
- d-spacing (Å)
- d-spacing (Å)
- 10.3156
- 9.9487
- 10.5932
- 7.1713
- 8.5074
- 10.2170
- 6.5014
- 8.2103
- 9.9503
- 5.5165
- 4.8172
- 8.5259
- 4.8541
- 4.7114
- 7.1016
- 4.5578
- 4.6122
- 6.0731
- 4.4938
- 4.5282
- 5.2041
- 4.4536
- 4.2340
- 4.9856
- 4.2588
- 4.0901
- 4.8153
- 3.9898
- 3.7574
- 4.7514
- 3.7288
- 3.6989
- 4.5302
- 3.5626
- 4.4714
- 3.0262
- 4.2271
- 4.1307
- 3.9880
- 3.7763
- 3.7167
- 3.5315.
Dependencies are inferred from the claim text.