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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 |
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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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| >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 | Start Trial | |||
| Australia | 3182899 | Start Trial | |||
| Australia | 736951 | Start Trial | |||
| Brazil | 9908911 | Start Trial | |||
| Canada | 2320900 | Start Trial | |||
| China | 1203846 | Start Trial | |||
| China | 1295467 | Start Trial | |||
| >Country | >Patent Number | >Estimated Expiration | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration |
