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/Antidiabetic Oral Dosage Forms
Abstract

An oral dosage form of an antidiabetic pharmaceutical composition comprises a core portion, an outer portion, and a controlled membrane film sandwiched therebetween. The core portion comprises metformin and a release-preventing agent. The controlled membrane film is provided with at least one passageway. The outer portion comprises a non-biguanide antidiabetic agent. In the oral dosage form, the metformin has a dissolution profile such that upon dissolving in a medium with a pH of approximately 6.8 at approximately 37° C., less than 15% is released from the oral dosage form at 2 hours, approximately 60-70% is released at 12 hours, and more than 80% is released at 20 hours. Upon a single-dose oral administration, the time that the oral dosage form provides a maximum plasma concentration of the metformin in a subject is from approximately 8 to 20 hours after administration.

Full Text

What is claimed is:

An oral dosage form of an antidiabetic pharmaceutical composition comprises a core portion, an outer portion, and a controlled membrane film sandwiched therebetween. The core portion comprises metformin and a release-preventing agent. The controlled membrane film is provided with at least one passageway. The outer portion comprises a non-biguanide antidiabetic agent. In the oral dosage form, the metformin has a dissolution profile such that upon dissolving in a medium with a pH of approximately 6.8 at approximately 37° C., less than 15% is released from the oral dosage form at 2 hours, approximately 60-70% is released at 12 hours, and more than 80% is released at 20 hours. Upon a single-dose oral administration, the time that the oral dosage form provides a maximum plasma concentration of the metformin in a subject is from approximately 8 to 20 hours after administration.
Timeline
Filed
02/19/2026
Published
06/25/2026
Granted
Not Available
IPC Codes(4)
A61K 9/24:Layered or laminated unitary dosage forms
A61K 9/20:Pills, lozenges or tablets
A61K 31/155:Amidines (), e.g. guanidine (H2N—C(=NH)—NH2), isourea (HN=C(OH)NH2), isothiourea (HN=C(SH)—NH2)