# US 10,307,376 B2 · Methods for administering weight loss medications > Agents: this data is available as JSON from the patentgrep API and MCP server — see https://patentgrep.com/llms.txt - Number: US 10,307,376 B2 - Document ID: US10307376B2 - Status: Granted - Kind: B2 - Application number: 16/101,853 - Filed: 2018-08-13 - Published: 2018-12-20 - Granted: 2019-06-04 - Earliest claimed: 2006-11-09 - Assignees: Nalpropion Pharmaceuticals LLC - Applicants: Nalpropion Pharmaceuticals, Inc. - Inventors: Anthony A. McKinney; Gary Tollefson; Eckard Weber; Rick Soltero - Web page: https://patentgrep.com/patent/US10307376B2 ## CPC - A61K 9/209: {containing drug in at least two layers or in the core and in at least one outer layer} - A61J 1/035: {Blister-type containers (blisters in general B65D75/36)} - A61J 7/04: Arrangements for time indication or reminder for taking medicine, e.g. programmed dispensers - A61K 31/135: having aromatic rings {, e.g. ketamine, nortriptyline (methadone A61K31/137)} - A61K 31/137: Arylalkylamines, e.g. amphetamine, epinephrine, salbutamol, ephedrine {or methadone} - A61K 31/138: Aryloxyalkylamines, e.g. propranolol, tamoxifen, phenoxybenzamine (atenolol A61K31/165; pindolol A61K31/404; timolol A61K31/5377) - A61K 31/35: having six-membered rings with one oxygen as the only ring hetero atom - A61K 31/42: Oxazoles - A61K 31/423: condensed with carbocyclic rings - A61K 31/485: Morphinan derivatives, e.g. morphine, codeine - A61K 31/551: having two nitrogen atoms, e.g. dilazep - A61K 31/5513: 1,4-Benzodiazepines, e.g. diazepam {or clozapine} - A61K 31/7048: having oxygen as a ring hetero atom, e.g. leucoglucosan, hesperidin, erythromycin, nystatin {, digitoxin or digoxin} - A61K 45/06: Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca - A61P 3/00: Drugs for disorders of the metabolism (of the blood or the extracellular fluid A61P7/00) - A61P 3/04: Anorexiants; Antiobesity agents - A61P 3/06: Antihyperlipidemics - A61P 3/10: for hyperglycaemia, e.g. antidiabetics - A61P 9/12: Antihypertensives - A61P 43/00: Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00 - B65D 75/36: one sheet or blank being recessed and the other formed of relatively stiff flat sheet material, e.g. blister packages {, the recess or recesses being preformed (B65D73/0057, B65D73/0092 take precedence)} - A61J 7/0454: {for dispensing of multiple drugs} - A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D) - A61J: CONTAINERS SPECIALLY ADAPTED FOR MEDICAL OR PHARMACEUTICAL PURPOSES; DEVICES OR METHODS SPECIALLY ADAPTED FOR BRINGING PHARMACEUTICAL PRODUCTS INTO PARTICULAR PHYSICAL OR ADMINISTERING FORMS; DEVICES FOR ADMINISTERING FOOD OR MEDICINES ORALLY; BABY COMFORTERS; DEVICES FOR RECEIVING SPITTLE - A61P: SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS - B65D: CONTAINERS FOR STORAGE OR TRANSPORT OF ARTICLES OR MATERIALS, e.g. BAGS, BARRELS, BOTTLES, BOXES, CANS, CARTONS, CRATES, DRUMS, JARS, TANKS, HOPPERS, FORWARDING CONTAINERS; ACCESSORIES, CLOSURES, OR FITTINGS THEREFOR; PACKAGING ELEMENTS; PACKAGES ## 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. ## Claims ### Claim 1 A method of promoting weight loss in an individual in need thereof, the method comprising: administering a first amount of a pharmaceutical formulation every day for a first week, wherein the first amount of a pharmaceutical formulation comprises about 90 mg of bupropion or a pharmaceutically acceptable salt thereof and about 4 mg to about 8 mg of naltrexone or a pharmaceutically acceptable salt thereof; administering a second amount of a pharmaceutical formulation every day for a second week, wherein the second amount of a pharmaceutical formulation comprises bupropion, or a pharmaceutically acceptable salt thereof, and naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the second amount of a pharmaceutical formulation comprises about twice as much bupropion or salt thereof and about twice as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation; administering a third amount of a pharmaceutical formulation every day for a third week, wherein the third amount of a pharmaceutical formulation comprises bupropion, or a pharmaceutically acceptable salt thereof, and naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the third amount of a pharmaceutical formulation comprises about three times as much bupropion or salt thereof and about three times as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation; and administering a fourth amount of a pharmaceutical formulation every day for a fourth week, wherein the fourth amount of a pharmaceutical formulation comprises bupropion, or a pharmaceutically acceptable salt thereof, and naltrexone, or a pharmaceutically acceptable salt thereof, and wherein the fourth amount of a pharmaceutical formulation comprises about four times as much bupropion or salt thereof and about four times as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation. ### Claim 2 (depends on 1) The method of claim 1, wherein the first amount of a pharmaceutical formulation comprises about 8 mg naltrexone or salt thereof. ### Claim 3 (depends on 1) The method of claim 1, wherein the first amount of a pharmaceutical formulation comprises about 4 mg naltrexone or salt thereof. ### Claim 4 (depends on 1) The method of claim 1, wherein the first amount of a pharmaceutical formulation is in a single oral dosage form. ### Claim 5 (depends on 4) The method of claim 4, wherein the single oral dosage form is selected from the group consisting of a tablet, a pill and a capsule. ### Claim 6 (depends on 4) The method of claim 4, wherein the second amount of a pharmaceutical formulation comprises two of the single oral dosage forms. ### Claim 7 (depends on 6) The method of claim 6, wherein the third amount of a pharmaceutical formulation comprises three of the single oral dosage forms. ### Claim 8 (depends on 7) The method of claim 7, wherein the fourth amount of a pharmaceutical formulation comprises four of the single oral dosage forms. ### Claim 9 (depends on 1) The method of claim 1, wherein the bupropion or salt thereof is in a sustained release formulation and the naltrexone or salt thereof is in a sustained release formulation. ### Claim 10 (depends on 9) The method of claim 9, wherein the first amount of a pharmaceutical formulation is in a single oral dosage form, wherein the second amount of a pharmaceutical formulation comprises two of the single oral dosage forms, wherein the third amount of a pharmaceutical formulation comprises three of the single oral dosage forms, and wherein the fourth amount of a pharmaceutical formulation comprises four of the single oral dosage forms. ### Claim 11 (depends on 10) The method of claim 10, wherein the single oral dosage form is a multilayer tablet comprising a first pharmaceutical layer comprising the sustained release formulation of bupropion or salt thereof and a second pharmaceutical layer comprising the sustained release formulation of naltrexone or salt thereof, and an intermediate layer between the first and the second pharmaceutical layers, wherein the intermediate layer is configured to dissolve rapidly in vivo. ### Claim 12 (depends on 9) The method of claim 9, wherein the first amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion or salt thereof in a first single oral dosage form and the sustained release naltrexone in a second single oral dosage form, wherein the second amount of a pharmaceutical formulation consists of two of the first single oral dosage forms and two of the second single oral dosage forms, wherein the third amount of a pharmaceutical formulation consists of three of the first single oral dosage forms and three of the second single oral dosage forms, and wherein the fourth amount of a pharmaceutical formulation consists of four of the first single oral dosage forms and four of the second single oral dosage forms. ### Claim 13 (depends on 9) The method of claim 9, wherein the first amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion or salt thereof having a first single oral dosage form and the sustained release naltrexone having a second single oral dosage form, wherein the second amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion or salt thereof having a third single oral dosage form, and the sustained release naltrexone having a fourth single oral dosage form, and wherein the third amount of a pharmaceutical formulation consists of two single oral dosages forms, the sustained release bupropion or salt thereof having the first single oral dosage form and the third single oral dosage form, and the sustained release naltrexone having the second single oral dosage form and the fourth single oral dosage form, wherein the fourth amount of a pharmaceutical formulation consists of two of the third single oral dosage forms and two of the fourth single oral dosage forms. ### Claim 14 (depends on 1) The method of claim 1, wherein the individual is obese. ### Claim 15 (depends on 10) The method of claim 10, wherein the individual is obese. ### Claim 16 (depends on 11) The method of claim 11, wherein the individual is obese. ### Claim 17 A method of promoting weight loss in an individual in need thereof, the method comprising: providing to the individual a first amount of a pharmaceutical formulation for daily administration during a first week, wherein the first amount of a pharmaceutical formulation comprises about 90 mg of bupropion or a pharmaceutically acceptable salt thereof and about 8 mg of naltrexone or a pharmaceutically acceptable salt thereof, wherein the bupropion or salt thereof is in a sustained release formulation and the naltrexone is in a sustained release formulation, and wherein the first amount of a pharmaceutical formulation is in a single oral dosage form; providing to the individual a second amount of a pharmaceutical formulation for daily administration during a second week, and wherein the second amount of a pharmaceutical formulation comprises about twice as much bupropion or salt thereof and about twice as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation; providing to the individual a third amount of a pharmaceutical formulation for daily administration during a third week, wherein the third amount of a pharmaceutical formulation comprises about three times as much bupropion or salt thereof and about three times as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation; and providing to the individual a fourth amount of a pharmaceutical formulation for daily administration during a fourth week, wherein the fourth amount of a pharmaceutical formulation comprises about four times as much bupropion or salt thereof and about four times as much naltrexone or salt thereof as the first amount of a pharmaceutical formulation. ### Claim 18 (depends on 17) The method of claim 17, wherein the individual is obese. ### Claim 19 (depends on 17) The method of claim 17, wherein the second amount of a pharmaceutical formulation comprises two of the single oral dosage forms, wherein the third amount of a pharmaceutical formulation comprises three of the single oral dosage forms, and wherein the fourth amount of a pharmaceutical formulation comprises four of the single oral dosage forms. ### Claim 20 (depends on 19) The method of claim 19, wherein the individual is obese.