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AN EXTENDED RELEASE FORMULATION OF RABEPRAZOLE

IP.com Disclosure Number: IPCOM000222375D
Publication Date: 2012-Sep-27
Document File: 8 page(s) / 91K

Publishing Venue

The IP.com Prior Art Database

Abstract

The present disclosure relates to an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides a mean plasma AUC0-∞ between 200-5200 ng*hr/mL, and other desirable pharmacokinetic parameters, such as a mean plasma Cmax between 25-2000 ng/ mL, Tmax between 8 hours to 24 hours, dosage-corrected AUC0-∞ less than 650 nghr/ mL*mg and dosage corrected Cmax less than 250 ng/ mL*mg.

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AN EXTENDED RELEASE FORMULATION OF RABEPRAZOLE

Abstract

The present disclosure relates to an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides a mean plasma AUC0-∞ between 200-5200 ng*hr/mL, and other desirable pharmacokinetic parameters, such as a mean plasma Cmax between 25-2000 ng/ mL, Tmax between 8 hours to 24 hours, dosage-corrected AUC0-∞ less than 650 nghr/ mL*mg and dosage corrected Cmax less than 250 ng/ mL*mg.

Reported herein is an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides a mean plasma AUC0-∞ of rabeprazole between 200 ng*hr/mL to 5200 ng*hr/mL.

Reported herein is an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides mean plasma Cmax of rabeprazole between 25 ng/mL to 2000 ng/mL.

Reported herein is an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides a Tmax between 8 to 24 hours.

Also, reported herein is an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides a mean plasma AUC0-∞ of rabeprazole between 200 ng*hr/mL to 5200 ng*hr/mL, and the mean plasma Cmax is between 25 ng/mL to 2000 ng/mL.

This disclosure also includes an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides the mean plasma
AUC0-∞ of rabeprazole between 200 ng*hr/mL to 5200 ng*hr/mL, mean Cmax is between 25 ng/mL – 2000 ng/mL and Tmax is between 8 to 24 hours.

This disclosure also included an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides the dosage-corrected plasma AUC0-∞ of rabeprazole as less than 650 ng*hr/mL*mg.

This disclosure also includes an extended-release formulation of rabeprazole comprising 20 mg to 80 mg of rabeprazole or a pharmaceutically acceptable salt thereof, wherein a single oral dose administration of said formulation to a human subject provides the dosage corrected plasma Cmax of rabeprazole as less than 250 ng/mL*mg.

The extended-release for...