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Acetamide derivative having defined particle size

Inactive Publication Date: 2002-01-15
CEPHALON INC
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Benefits of technology

"An effective amount", as used herein, is an amount of the pharmaceutical composition that is effective for treating a somnolent or somnolescent state, i.e., an amount of modafinil of a defined particle size that is able to reduce or eliminate the symptoms of a somnolescent state. An effective amount of a pharmaceutical composition of the invention is useful for enhancing alertness, or increasing regularity of sleep rhythms.

Problems solved by technology

Pathological somnolence, whether due to narcolepsy or other causes, is disabling and potentially dangerous.
Whether due to narcolepsy or other causes, pathological somnolence produces episodes of unintended sleep, reduced attention, and performance errors.

Method used

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  • Acetamide derivative having defined particle size

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Experimental program
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Effect test

Embodiment Construction

We first briefly describe the drawings.

I. Drawings

FIG. 1 is a graph depicting particle size distributions for six lots of modafinil: Lots L-1, L-2, E-A, E-B, E-C and E-D.

FIG. 2 is a scanning electron micrograph of a sample of modafinil Lot E-D at 50.times. magnification.

FIG. 3 is a scanning electron micrograph of a sample of modafinil Lot E-D at 100.times. magnification.

FIG. 4 is a scanning electron micrograph of a sample of modafinil Lot L-1 at 50.times. magnification.

FIG. 5 is a scanning electron micrograph of a sample of modafinil Lot L-1 at 100.times. magnification.

FIG. 6 is a graph depicting the dissolution rate of modafinil particles from Lot E-D (median particle size 94.05 .mu.m) and Lot L-1 (median particle size 50.18 .mu.m).

FIG. 7 is a graph depicting the dissolution rate of modafinil particles from Lot E-B (median particle size 89.10 .mu.m), Lot E-D (median particle size 94.05 .mu.m) and Lot L-1 (median particle size 50.18 .mu.m).

FIG. 8 is a graph depicting mean plasma con...

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Abstract

Pharmaceutical compositions comprising modafinil in the form of particles of defined size. The particle size of modafinil can have a significant effect on the potency and safety profile of the drug.

Description

BACKGROUND OF THE INVENTIONPublications cited in this document are incorporated herein by reference.This invention relates to the acetamide derivative modafinil. Modafinil (C.sub.15 H.sub.15 NO.sub.2 S), is 2-(benzhydrylsulfinyl)acetamide, and is also known as 2-[(diphenylmethyl)sulfinyl]acetamide.Modafinil has been described as presenting a "neuropsychopharmacological spectrum characterized by the presence of excitation with hyperactivity and of hypermotility; and by the absence of stereotypy (except in high doses) and of potentialisation of the effects of apomorphine and amphetamine" (U.S. Pat. No. 4,177,290; hereinafter the "'290 patent," which is incorporated herein by reference). A single administration of modafinil results in increased locomotor activity in mice and increased nocturnal activity in monkeys (Duteil et al., Eur. J. Pharmacol. 180:49 (1990)). The neuropsychopharmacological profile of modafinil has been distinguished from that of amphetamines (Saletu et al., Int. J...

Claims

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Application Information

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IPC IPC(8): A61K9/14A61K31/165A61K9/16A61K31/16A61P25/00A61P25/24A61P25/26A61P25/28
CPCA61K9/14A61K9/16A61K31/165A61P25/00A61P25/24A61P25/26A61P25/28
Inventor GREBOW, PETER E.CORVARI, VINCENTSTONG, DAVID
Owner CEPHALON INC
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