Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for 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 Cmax at different times.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: 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.

Abstract: A device for the neutralization and disposal of unused medicaments, such as drugs or medications. The device generally comprises a means of storing disposal device material, which can render medicaments unusable, and a means of exposing the disposal device material to the medicaments when they are no longer in use. The device may be a medicament container comprising a reservoir to store the disposal device material, and a means to expose the disposal device material to the medicaments. Alternatively, the device may be a medicament closure or lid for use with a medicament container, in which the closure comprises a reservoir for storing the disposal device material and a means to expose the disposal device material to the medicaments.

Abstract: Device for the neutralization and disposal of unused human or animal pharmaceutical medicament. The device comprises a disposal device material that contains one or more disposal device agents. The disposal device material may also contain additional components to promote mixing, or neutralization of the active agent of the medicament. The disposal device material can be in the form of pellets, beads, beadlets, granules, or the like, and can be incorporated into a disposal device reservoir. The disposal device can be dispensed with a medicament, and the device can be used when the patient has finished using the medicament and there is material left over for disposal.

Abstract: 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.

Abstract: 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.

Abstract: An antibiotic product is comprised of at least three dosage forms, each of which has a different release profile, with the Cmax for 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 Cmax at different times.

Abstract: An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for 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 Cmax at different times.

Abstract: 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>MIC90 in 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 MIC90, while providing a total dosage of the penicillin-type antibiotic for a 24-hour dosing interval.

Abstract: An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for 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 Cmax at different times.

Abstract: An antibiotic product is comprised of at least three dosages forms, each of which has a different release profile, with the Cmax for 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 Cmax at different times.

Abstract: 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>MIC sufficient to achieve at least the minimum amount of bacterial eradication for treatment of said bacterial infection.