IP Library Granted Patent US 12,310,922
Granted Patent B2
US 12,310,922 · App. 18/243,211 · Granted May 27, 2025

System and method for making personalized individual unit doses containing pharmaceutical actives

Inventors: Alexander Mark Schobel (Warren, NJ); Keith Kendall (Warren, NJ); Dan Barber (Warren, NJ); Theresa Wood (Warren, NJ); Peter Boyd (Warren, NJ); John Maxwell (Warren, NJ)
Assignee: Aquestive Therapeutics, Inc.
A61J3/00G16H20/13G16H20/17A61J2200/70A61J2205/10A61J2205/20
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Quick Facts
Patent No.
US 12,310,922
App. No.
18/243,211
Granted
May 27, 2025
Kind
B2
Abstract

Systems and methods for making and delivering personalized, medically prescribed pharmaceuticals to an individual patient are described. Individual unit doses (IUDs) of medicine may be prepared specific to the individual in need of same, by using a system, which includes a networked control system in combination with manufacturing assemblies specific to the IUDs and delivering the medicine to the patient directly from the manufacturer.

Claims (16)

1. A method for creating one or more personalized individual unit doses (IUDs) containing a prescribed amount of active for distribution and administration to an individual, the method comprising:

providing a medical professional with personal health information of the individual;

prescribing by the medical professional, a medical prescription comprising an amount of active to be administered to the individual as determined, at least in part, on the personal health information, the medical prescription comprising a treatment regimen for administering a prescribed amount of the active per personalized individual unit dose (IUD);

electronically communicating at least a part of the medical prescription to a manufacturer of IUDs;

manufacturing the IUD using one or more apparatus for making personalized IUDs; and

distributing the IUDs to the individual;

wherein manufacturing the IUD includes one or more of the following steps:

providing carrier matrix selected from the group consisting of polyethylene oxide, polyvinyl pyrrolidone, polyvinyl alcohol, cellulosic polymers, polysaccharides, gums, and combinations thereof to one or more of the apparatus;

providing the active to the one or more of the apparatus;

combining the active and carrier matrix in the one or more of the apparatus comprising a mixing and film forming process or a matrix depositing assembly; and

forming the carrier matrix and the active into a film.

2. The method of claim 1 , wherein the one or more apparatus further comprises a blending (mixing) assembly, a powder-forming assembly, a granulating assembly, a spray-drying assembly, an extruder assembly, a compounding assembly, a packaging assembly, a labeling assembly, an embossing assembly, a scoring assembly, a quality control assembly and combinations thereof.

3. The method of claim 2 , wherein the medical professional is provided with the personal health information via a networked system.

4. The method of claim 2 , wherein manufacturing the IUD further comprises packaging the IUD for distribution to the individual.

5. The method of claim 1 , wherein the active is selected from the group consisting of: small molecules, macromolecules, biologics, microorganisms, allergens, enzymes, and combinations thereof.

6. The method of claim 1 , wherein the active is a pharmaceutical or bioactive substance selected from the group consisting of ace-inhibitors, anti-anginal drugs, anti-arrhythmia drugs, anti-asthmatics, anti-cholesterolemics, analgesics, anesthetics, anti-convulsants, anti-depressants, anti-diabetic agents, anti-diarrhea preparations, antidotes, anti-histamines, anti-hypertensive drugs, anti-inflammatory agents, anti-lipid agents, anti-manics, anti-nauseants, anti-stroke agents, anti-thyroid preparations, anti-tumor drugs, anti-viral agents, acne drugs, alkaloids, amino acid preparations, anti-tussives, antiuricemic drugs, anti-viral drugs, anabolic preparations, systemic and non-systemic anti-infective agents, anti-neoplastics, anti-parkinsonian agents, anti-rheumatic agents, appetite stimulants, biological response modifiers, blood modifiers, bone metabolism regulators, cardiovascular agents, central nervous system stimulates, cholinesterase inhibitors, contraceptives, decongestants, dietary supplements, dopamine receptor agonists, endometriosis management agents, erectile dysfunction therapies, fertility agents, gastrointestinal agents, homeopathic remedies, hormones, hypercalcemia and hypocalcemia management agents, immunomodulators, immunosuppressives, migraine preparations, motion sickness treatments, muscle relaxants, obesity management agents, osteoporosis preparations, oxytocics, parasympatholytics, parasympathomimetics, prostaglandins, psychotherapeutic agents, respiratory agents, sedatives, smoking cessation aids, sympatholytics, tremorso preparations, urinary tract agents, vasodilators, laxatives, antacids, ion exchange resins, anti-pyretics, appetite suppressants, expectorants, anti-anxiety agents, anti-ulcer agents, anti-inflammatory substances, coronary dilators, cerebral dilators, peripheral vasodilators, psycho-tropics, stimulants, anti-hypertensive drugs, vasoconstrictors, migraine treatments, antibiotics, tranquilizers, anti-psychotics, anti-tumor drugs, anti-coagulants, anti-thrombotic drugs, hypnotics, anti-emetics, anti-nauseants, anti-convulsants, neuromuscular drugs, hyper- and hypo-glycemic agents, thyroid and anti-thyroid preparations, diuretics, anti-spasmodics, uterine relaxants, anti-obesity drugs, erythropoietic drugs, anti-asthmatics, cough suppressants, mucolytics, DNA and genetic modifying drugs, and combinations thereof.

Assignments (1)
SECURITY INTEREST Recorded May 12, 2026
From: AQUESTIVE THERAPEUTICS, INC.
To: OAKTREE FUND ADMINISTRATION, LLC, AS ADMINISTRATIVE AGENT
Reel/Frame 075561/0782 →
Continuity (5)
Division 16447107 · Jun 20, 2019
Provisional Application 62729051 · Sep 10, 2018
Provisional Application 62700444 · Jul 19, 2018
Provisional Application 62688107 · Jun 21, 2018
Related Publication 20230414452A1 · Dec 28, 2023
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