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Tripulse release stimulant formulations

A stimulant and release agent technology, applied in the field of three-pulse release stimulant preparations, can solve problems such as failure

Inactive Publication Date: 2018-01-02
CINGULATE THERAPEUTICS LLC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Efforts to achieve this effect in a single dosage form have failed so far

Method used

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  • Tripulse release stimulant formulations
  • Tripulse release stimulant formulations
  • Tripulse release stimulant formulations

Examples

Experimental program
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Effect test

Embodiment 1

[0097] Pulse release dosage forms can be manufactured using the apparatus and procedures provided herein, for example at Figure 1A and 1B Pulse release dosage form as described in . The process may use compression, dual punch molding equipment that includes an upper punch and a lower punch that are positioned perpendicular to the die. Each of the upper punch and the lower punch has a dual structure (ie, a two-cam (cam) system) that includes a center punch and an outer punch surrounding the periphery of the center punch. The center punch and the outer punch carry out independent sliding movements and pressing operations.

[0098] To form the lower portion of the outer layer of the dosage form, the lower central punch can be placed relative to the lower outer punch to form a space above and inside the lower central punch (the lower central punch and the lower outer punch as a die) swipe down together). Next, a first erosion matrix material is applied from the feed blade into...

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PUM

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Abstract

A single dosage form that delivers a tripulse (i.e., three pulses) release profile is provided. The dosage form includes at least three dosage units inside the final dosage form. By providing a singledosage form with multiple dosage units, the dosing frequency is decreased since precise blood levels of the active over a prolonged time period are controlled and achieved.

Description

Background technique [0001] Patients treated with stimulants for various disorders such as attention deficit hyperactivity disorder (ADHD) typically take one or more doses during the patient's waking hours to achieve the desired therapeutic level of stimulant. In one example, the patient takes a single dosage form that releases the stimulant in two discrete doses or pulses (e.g., where the second pulse occurs about 3-5 hours after the first release. Although therapeutically effective levels of stimulants are usually provided for the first 8 hours or more after initial administration, many patients require additional doses to maintain the same therapeutic effect throughout the day. These patients typically take a separate immediate-release dosage form of the same drug later in the day to prolong the therapeutic effect. Efforts to achieve this effect in a single dosage form have so far failed. Therefore, there remains a need for a single, once-daily dosage form that delive...

Claims

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Application Information

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IPC IPC(8): A61K9/22
CPCA61K9/2009A61K9/2013A61K9/2018A61K9/2027A61K9/2054A61K9/209A61K31/137A61K31/4458A61P25/14A61K9/0053A61K9/2072A61P25/00
Inventor M·布拉姆斯R·斯尔瓦A·斯特劳恩
Owner CINGULATE THERAPEUTICS LLC