Stable clozapine suspension formulation
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Abstract
A physicochemically stable aqueous composition including clozapine suspension.
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Citations
45 Claims
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1-26. -26. (canceled)
- 27. A physicochemically stable aqueous composition comprising clozapine in suspension.
- 39. A method for preparing a physicochemically stable aqueous composition including clozapine in suspension, the method comprising the step of controlling the pH of the formulation between about 6 and about 11.
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42. A method of producing a physicochemically stable aqueous composition comprising clozapine in suspension comprising the following steps:
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(a) stirring the clozapine with about three quarters of the propylene glycol ascribed to the batch;
(b) addition of the buffer salt (and optionally sweetening agents) dissolved in about half the volume of water ascribed to the batch with constant stirring;
(c) adjusting the pH value with the base component of the buffer with mixing;
(d) addition of the preservatives dissolved in the remaining propylene glycol;
(e) slow addition of the suspending agent with continuous stirring until the mixture thickens; and
,(f) further diluting the suspension with water to the desired end-volume. - View Dependent Claims (44)
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43. A method for producing a physicochemically stable aqueous composition comprising clozapine in suspension comprising the following steps:
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(a) stirring the clozapine with about three quarters of the glycerine ascribed to the batch;
(b) addition of the buffer salt (and optionally sweetening agents) dissolved in about half the volume of water ascribed to the batch with constant stirring;
(c) adjusting the pH value with the base component of the buffer with mixing;
(d) addition of the preservatives dissolved in a small volume of water;
(e) slow addition of the suspending agent wetted with the remaining glycerine with continuous stirring until the mixture thickens; and
,(f) further diluting the suspension with water to the desired end-volume. - View Dependent Claims (45)
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Specification