Methods for administering weight loss medications
Inventors
McKinney, Anthony A • Tollefson, Gary D. • Weber, Eckard • Soltero, Richard
Assignees
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Publication Number
US-12048769-B2
Publication Date
2024-07-30
Expiration Date
Abstract
Methods and systems for administration of pharmaceuticals using a unit dosage package that includes a first unit dosage that has a first drug and a second drug, a second unit dosage that has the first drug and the second drug, where the second unit dosage includes a different amount of the second drug than the first unit dosage and a unit dosage package is configured to hold the first unit dosage and the second unit dosage. In preferred embodiments the methods and systems are used for administration of weight loss medications.
Core Innovation
The invention relates to reducing the risk of side effects associated with the administration of naltrexone and bupropion using a staged, daily dosing regimen over multiple weeks. A first amount of a pharmaceutical formulation is administered for a first week, and then a second amount is administered for a second week, followed by a third amount for a third week and a fourth amount for a fourth week. The amounts increase over time so that later weekly amounts comprise greater amounts of bupropion and naltrexone than the first-week amount.
The staged regimen is described as reducing initial adverse side effects and improving patient compliance through gradual increase from an initial dosage to higher dosages. In the described formulations, bupropion and naltrexone are provided in sustained release formulations for daily administration. The regimen is also described in the context of weight loss and obesity-related condition management, including suppressing appetite.
The described implementations include pharmaceutical packaging concepts and dosage forms configured to deliver first and second unit dosages in a patient-directed sequence. A unit dosage package is configured to hold a first unit dosage and a second unit dosage, with administration instructions and optional labeling such as day/time labels. Additionally, a multilayer tablet structure is described, including a multilayer tablet with sustained release layers and an intermediate layer configured to dissolve rapidly in vivo.
Claims Coverage
The independent claims include two inventive methods, each centered on reducing the risk of side effects from administering naltrexone and bupropion using week-by-week daily dosage escalation. Across the independent claims, the inventive features emphasize staged increases in bupropion and naltrexone amounts, sustained release formulations, and delivery in single oral dosage forms, with an additional limitation that the individual is obese in the dependent coverage described for the regimen.
Week-by-week daily dosage escalation for reducing side effects
A method of reducing the risk of side effects associated with the administration of naltrexone and bupropion by administering a first amount daily for a first week, then administering a second amount daily for a second week, a third amount daily for a third week, and a fourth amount daily for a fourth week, wherein each later weekly amount comprises about a multiple (about twice, about three times, and about four times) of bupropion and naltrexone amounts relative to the first amount.
Sustained release single oral dosage form staged regimen
A method of reducing the risk of side effects associated with the administration of naltrexone and bupropion by providing a first amount for daily administration during a first week, followed by providing a second amount, a third amount, and a fourth amount for daily administration during respective weeks, wherein the first amount is in a single oral dosage form and includes bupropion and naltrexone both in sustained release formulations, and wherein each later weekly amount comprises about twice, about three times, and about four times bupropion and naltrexone amounts relative to the first amount.
Applying the staged regimen to an obese individual
The method is practiced for an individual who is obese, applied to reducing the risk of side effects associated with the administration of naltrexone and bupropion using the staged daily dosing escalation regimen.
Overall, the claim coverage focuses on staged daily administration where bupropion and naltrexone amounts increase week-by-week from a first amount to higher second, third, and fourth amounts, with sustained release formulations and delivery in single oral dosage forms, and (in the described dependent coverage) application to an obese individual.
Stated Advantages
Reducing the risk of side effects associated with the administration of naltrexone and bupropion.
Reducing initial adverse side effects.
Improving patient compliance.
Documented Applications
Weight loss treatment using a regimen with naltrexone and bupropion for affecting weight loss and suppressing appetite in an obesity-related condition.
Reducing adverse side effects during treatment of an obese individual using a staged daily dosing regimen of naltrexone and bupropion.
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