Shire Laboratories, Inc.

Shionogi, Inc.

Supernus Pharmaceuticals, Inc.

Disposerx, Inc.

Shire Llc, USA

Shire LLC

Beth A Burnside

Henry H Flanner

Edward M Rudnic

Richard Alan Couch

Rong-Kun Chang

Charlotte M McGuinness

Xiaodi Guo

Colin E Rowlings

Sandra E Wassink

Jill E Pinkett

Donald Treacy

Donald J Treacy

Amir H Shojaei

Susan P Clausen

Kimberly Fiske

Donald J Treacy, Jr

John A McCarty

Scott A Ibrahim

Robert J Guttendorf

Carol E Mattes

George W Belendiuk, Deceased

Bruce X Cao

Sanna Tolle-Sander

Marcus Schestopol

John W Holaday

Alexander K Tustian

Scott Ibrahim

George W Belendiuk

Edward M Rudnik

Krystyna Belendiuk

Charlotte M McGuiness

Lisa C McKnight

George Belenduik

Rong Kun Chang

Likan Liang

John A Bonck

Matt R Baker

Charlotte M Mc Guinness

Lisa C Mcknight

Richard Couch

Richard A Couch

Composition to aid in the sequestration and/or disposal of unused human or animal pharmaceutical drug or medication. The composition comprises a disposal composition material that contains a gelling or massing agent and optionally other components, and can be in the form of pellets, beads, beadlets, granules, or the like. The disposal composition material can be incorporated into a sachet or other disposal container or its cap to prevent the use of the medicament or the removal/extraction of active agent(s) from a pharmaceutical dosage form intended for disposal, to an appreciable extent and/or rate. With in the disposal agent, or fill material there may also be additional ingredients to promote mixing, sequestration or destruction of the active agent. The disposal composition is contained in a sachet and dispensed with a medicament for use when the patient has finished with the medication and there is material left over for disposal. In addition, the sachet could be made available for use with non-prescription drugs and other materials.

Disposal of medicaments

An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cfor the antibiotic product being reached in less than about twelve hours after the initial release of antibiotic. In one embodiment, there is a delayed release dosage form, as well as two or more delayed sustained release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a Cat different times.

Antibiotic product, use and formulation thereof

Drug formulations having reduced abuse potential which contain one or more of (1) a bittering agent, (2) a bright deterrent/indicator dye and (3) fine insoluble particulate matter. The bittering agent and dye are in a form which does not affect proper administration of the drug, but the bittering agent creates a bitter side effect when the dosage form is crushed or chemically extracted and nasally, orally, buccally or sublingually administered and the dye produces a bright color when crushed and contacted. The fine insoluble particulate matter hinders extraction of the drug from the dosage form and, when crushed, can deter intravenous injection because of the presence of the insoluble particles or hinder injection by blocking an intravenous needle. The bright color of the dye, when extracted, also has a psychologically deterrent effect on intravenous abusers.

Drug formulations having reduced abuse potential

Disclosed are pharmaceutical products for providing pulses of at least one pharmaceutically active ingredient from a patient's stomach, or from a subsequent gastrointestinal site proximal thereto, for absorption thereof at a site(s) more distal in the gastrointestinal tract than the patient's stomach, or than the subsequent gastrointestinal site proximal thereto. The product comprises first, second, and third pharmaceutical dosage forms, each of which comprises at least one pharmaceutically active agent and a pharmaceutically acceptable carrier. The product is formulated such that at least two of the first, second, and third pharmaceutical dosage forms further comprise means for providing temporary gastric-retention of the at least two of the first, second, and third pharmaceutical dosage forms within the patient's stomach, or at the subsequent gastrointestinal site proximal thereto.

Gastric release pulse system for drug delivery

An amoxicillin product comprising: at least one modified release component(s), wherein the at least one modified release component(s) comprises at least amoxicillin and a pharmaceutically acceptable carrier; and wherein when administered to a patient or subject in the fed state said amoxicillin product exhibits a pharmacokinetic profile for amoxicillin in the plasma characterized as follows: (1) the ratio of the portion of the AUC as measured from 2 hours post-administration to 5 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 2.0:1; and (2) the ratio of the portion of the AUC as measured from 5 hours post-administration to 12 hours post-administration to the portion of the AUC as measured from administration to 2 hours post-administration is at least 1.1:1.

Modified release amoxicillin products

Compositions and methods for making robust pellets that contain a high percentage, by weight, of active drug agent, and which also contain additional components that enhance the absorption and solubility of the active drug agent within the gastrointestinal tract (GI tract) without diminishing the robust nature of the pellet, are disclosed.

Robust pellet

A pharmaceutical tablet comprising an immediate release portion containing an active ingredient and a delayed release portion, wherein the delayed release portion comprises an enteric-coated layer and within the enteric-coated layer there is at least one member selected from the group consisting of enteric-coated microparticle dosage forms containing an active ingredient and enteric-coated mini-tablet dosage forms containing an active ingredient, is disclosed.

Tablet for pulsed delivery

An antibiotic product is comprised of at least three dosage forms, each of which has a different release profile, with the Cfor the antibiotic product being reached in less than about twelve hours after the initial release of antibiotic. In one embodiment, there are two delayed release dosage forms, as well as a delayed sustained release dosage form, with each of the dosage forms having a different release profile, wherein each reaches a Cat different times.

An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cfor the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, as well as two or more sustained release dosage forms, with each of the dosage forms having a different release profile, wherein each reaches a Cat different times.

Disclosed are once-a-day penicillin-type antibiotic products comprising at least one modified release dosage form comprising penicillin-type antibiotics and pharmaceutically acceptable carriers, which compositions provide T&#x3e;MICin the serum for at least 5 hours (preferably for at least five consecutive hours), within a 24-hour dosing interval, for a given bacterial pathogen's MIC, while providing a total dosage of the penicillin-type antibiotic for a 24-hour dosing interval.

Compositions and methods for improved efficacy of penicillin-type antibiotics

An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cfor the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, a sustained release dosage form, and a delayed release dosage form, with each of the dosage forms having a different release profile, wherein each reaches a Cat different times.

An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cfor the antibiotic product being reached in less than about twelve hours. In one embodiment, there is an immediate release dosage form, a delayed release dosage form, and a sustained release dosage form, with each of the dosage forms having a different release profile, wherein each reaches a Cat different times.

A process for treating a bacterial infection with an antibiotic, comprising: administering to a patient with a bacterial infection a product that includes a modified release dosage form containing an antibiotic, said product being administered once-a-day in a dosage and for a number of days that provides a Total T&#x3e;MIC sufficient to achieve at least the minimum amount of bacterial eradication for treatment of said bacterial infection.

Pharmaceutical compositions and methods for improved bacterial eradication

Growing community of inventors

Bethesda, MD, United States of America

Beth A Burnside