Delayed release compositions
AssigneeAmneal Complex Products Research LLC
InventorsKanji Meghpara, Siva Ram Kiran Vaka, Dipen Desai, Navnit H. Shah
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Abstract
The present disclosure provides oral compositions providing delayed release of armodafinil/modafinil. The compositions of the disclosure provide a lag time that is independent of the presence or absence of food, type of food, pH, gastric emptying, gastric motility, and volume and viscosity of gastric fluid. The compositions of the disclosure can be programmed to provide a desired lag time, and release drug at a rhythm that matches the human circadian rhythm regulating sleep-wake cycle to optimize therapeutic outcome and minimize side effects.
Claims18
A delayed release composition comprising:
- a) a vertically compressed multilayer core comprising a placebo layer, an active layer, and a push layer, wherein:
- (i) the placebo layer comprises at least one polyethylene oxide polymer having a weight average molecular weight of from about 400,000 Da to about 900,000 Da,
- (ii) the active layer comprises an active agent comprising armodafinil or a pharmaceutically acceptable salt thereof, and at least one polyethylene oxide polymer having a weight average molecular weight of from about 100,000 Da to about 300,000 Da,
- (iii) the push layer comprises at least one polyethylene oxide polymer having a weight average molecular weight of greater than or equal to 1,000,000 Da;
- and
- b) a semipermeable membrane containing an orifice and surrounding the multilayer core, and
- wherein the layers in the multilayer core are placed in the following order:
- the placebo layer facing the orifice in the semipermeable membrane;
- the active layer;
- and the push layer facing away from the orifice.
A method for treating excessive sleep disorder in patients suffering from narcolepsy, obstructive sleep apnea, shift work sleep disorders, or idiopathic hypersomnia, the method comprising orally administering to the patient a delayed release composition comprising:
- a) a vertically compressed multilayer core comprising a placebo layer, an active layer, and a push layer, wherein:
- (i) the placebo layer comprises at least one polyethylene oxide polymer having a weight average molecular weight of from about 400,000 Da to about 900,000 Da,
- (ii) the active layer comprises an active agent comprising armodafinil or a pharmaceutically acceptable salt thereof, and at least one polyethylene oxide polymer having a weight average molecular weight of from about 100,000 Da to about 300,000 Da,
- (iii) the push layer comprises at least one polyethylene oxide polymer having a weight average molecular weight of greater than or equal to 1,000,000 Da;
- and
- b) a semipermeable membrane comprising an orifice and surrounding the multilayer core, and
- wherein the layers in the multilayer core are placed in the following order:
- the placebo layer facing the orifice in the semipermeable membrane;
- the active layer;
- and the push layer facing away from the orifice.
A method for treating excessive sleep disorder and improving early morning wakefulness in patients suffering from narcolepsy, obstructive sleep apnea, shift work sleep disorders, or idiopathic hypersomnia, the method comprising orally administering to the patient a delayed release composition comprising:
- a) a vertically compressed multilayer core comprising a placebo layer, an active layer, and a push layer, wherein:
- (i) the placebo layer comprises at least one polyethylene oxide polymer having a weight average molecular weight of from about 400,000 Da to about 900,000 Da,
- (ii) the active layer comprises an active agent comprising armodafinil or a pharmaceutically acceptable salt thereof, and at least one polyethylene oxide polymer having a weight average molecular weight of from about 100,000 Da to about 300,000 Da,
- (iii) the push layer comprises at least one polyethylene oxide polymer having a weight average molecular weight of greater than or equal to 1,000,000 Da, and b) a semipermeable membrane comprising an orifice and surrounding the multilayer core, and
- wherein the layers in the multilayer core are placed in the following order:
- the placebo layer facing the orifice in the semipermeable membrane;
- the active layer;
- and the push layer facing away from the orifice.
A method for making a delayed release composition comprising a multilayer core comprising a placebo layer comprising a placebo layer blend;
- an active layer comprising an active layer blend;
- and a push layer comprising a push layer blend;
- and a semipermeable membrane covering at least a portion of the multilayer core and comprising at least one orifice;
- the method comprising:
- (i) making a placebo layer blend comprising at least one polyethylene oxide polymer having a weight average molecular weight of from about 400,000 Da to about 900,000 Da;
- (ii) making an active layer blend comprising an active agent comprising armodafinil or a pharmaceutically acceptable salt thereof, and at least one polyethylene oxide polymer having a weight average molecular weight of from about 100,000 Da to about 300,000 Da;
- (iii) making a push layer blend comprising at least one polyethylene oxide polymer having a weight average molecular weight of greater than or equal to 1,000,000 Da;
- (iv) sequentially filling and compressing the placebo layer blend, followed by the active layer blend, and finally the push layer blend into a tablet dye;
- and finally compressing the three blends into a multilayer tablet core;
- (v) coating the multilayer core with a semipermeable membrane coat;
- and
- (vi) laser drilling an orifice in the semipermeable membrane coat, wherein the layers in the multilayer core are placed in the following order:
- the placebo layer facing the orifice in the semipermeable membrane;
- the active layer;
- and the push layer facing away from the orifice.
Dependencies are inferred from the claim text.