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Details for Patent: 6,475,521

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Summary for Patent: 6,475,521

Title:	Biphasic controlled release delivery system for high solubility pharmaceuticals and method
Abstract:	A biphasic controlled release delivery system for pharmaceuticals which have high water solubility, such as the antidiabetic metformin HCl salt, is provided which provides a dosage form that has prolonged gastric residence so that a dosing regimen of at least one gram metformin, once daily, may be achieved while providing effective control of plasma glucose. The delivery system includes (1) an inner solid particulate phase formed of substantially uniform granules containing a pharmaceutical having a high water solubility, and one or more hydrophilic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, and (2) an outer solid continuous phase in which the above granules of inner solid particulate phase are embedded and dispersed throughout, the outer solid continuous phase including one or more hydrophilic polymers, one or more hydrophobic polymers and/or one or more hydrophobic materials such as one or more waxes, fatty alcohols and/or fatty acid esters, which may be compressed into tablets or filled into capsules. Methods for forming the so-described biphasic controlled release delivery system and using such biphasic controlled release delivery system for treating diabetes are also provided.
Inventor(s):	Timmins; Peter (Irby, GB), Dennis; Andrew B. (Barnston, GB), Vyas; Kiren A. (Canterbury, GB)
Assignee:	Bristol-Myers Squibb Co. (Princeton, NJ)
Application Number:	09/398,107
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 6,475,521
Prior Art and Litigation Support	Order Prior Art and Litigation support for Patent 6,475,521
Patent Claim Types: see list of patent claims	Formulation; Compound; Dosage form; Process; Delivery;

Drugs Protected by US Patent 6,475,521

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate

International Family Members for US Patent 6,475,521

Country	Patent Number	Estimated Expiration	Supplementary Protection Certificate	SPC Country	SPC Expiration
African Regional IP Organization (ARIPO)	1224
Australia	3182899
Australia	736951