Custom-pill compounding system with filler-free capability

• US 9,168,223 B2
• Filed: 02/03/2013
• Issued: 10/27/2015
• Est. Priority Date: 12/23/2010
• Status: Active Grant

• Current Assignee: Tailorpill Technologies, LLC
• Original Assignee: Tailorpill Technologies, LLC
• Inventors: Alfano, Kenneth Mimnaugh
• Primary Examiner(s): MAUST, TIMOTHY LEWIS
• Application Number:
  US13/757,828
• Publication Number:
  US 20130149377A1
• Time in Patent Office: 996 Days
• Field of Search: 141/83, 141100-105, 141144-147, 424/451
• US Class Current: 1/1
• CPC Class Codes: A61J 1/00 Containers specially adapted for medical or pharmaceutical purposes capsules or the like for oral use A61J3/07; specially adapted for surgical or diagnostic appliances or instruments A61B50/30; containers for radioactive substances G21F5/00
• CPC Class Codes: A61J 3/06 into the form of pills, lozenges or dragees
• CPC Class Codes: A61J 3/07 into the form of capsules or similar small containers for oral use
• CPC Class Codes: A61J 3/074 Filling capsules; Related operations
• CPC Class Codes: A61K 9/0087 Galenical forms not covered by A61K9/02 - A61K9/7023
• CPC Class Codes: B65B 1/34 Adjusting weight by trickle feed
• CPC Class Codes: G05D 11/134 by sensing the weight of the individual components
• CPC Class Codes: G16H 20/10 relating to drugs or medications, e.g. for ensuring correct administration to patients
• CPC Class Codes: G16H 20/13 delivered from dispensers

Abstract

A system and associated aspects thereof are disclosed regarding custom-compounding of drug products such as pills and polypills for particular patients, herein involving adaptations of “micro-dosing” technology to permit sufficiently small and precise amounts of drug substances or optionally formulations thereof to be controllably and automatably handled and dispensed so as to help create customized drug products that do not necessitate bulking or dilution of the drug substances.

Claims

1. A pharmaceutical polypill compounding system having automated micro-dosing capability, comprising:

an interface configured to receive prescription information, said prescription information comprising patient-specific dose levels corresponding to respective drugs; and

a capsule-filling machine adapted for patient-specific usage based on said prescription information, said capsule-filling machine comprising a dispenser for placing said drugs into capsules at said dose levels without manual weighing, said dispenser not being a fluid-drop generator, and said dispenser incorporating a micro-dosing technology that makes volume enhancement via inactive ingredient(s) unnecessary in order for said drugs to be dispensable at said dose levels;

said systems being configured for producing polpills comprising solid particles, via dispensation of multiple different active pharmaceutical ingredients into the same capsules,via administration of mechanical disturbances to multiple respective dispensing heads each containing at least one of daid active pharmaceutical ingredients, said disturbances having a force or duration or frequency that gets adjusted according to gravimetric data obtained form recurring sensing of accumulating mass within said capsules during said dispensation.

2. The system of claim 1, wherein said dispenser is configured to dispense powder.

3. The system of claim 1, wherein said system is capable of dispensing a raw active pharmaceutical ingredient in a form neither processed nor formulated.

4. The system of claim 1, wherein said system is capable of dispensing particles comprising a functional coating.

5. The system of claim 1, wherein a supply of at least one drug(s) or inactive ingredient(s) is housed within a respective removable container(s) from which said supply can be dispensed by said system into capsules.

6. A process of utilizing a pharmaceutical polypill compounding system having automated micro-dosing capability, comprising:

providing prescription information to a capsule-filling device, said prescription information comprising dose levels corresponding to respective drugs for a specific patient; and

operating said device in producing for said patient a customized drug product or set thereof based on said prescription information, whereby said drugs are placed into capsules at essentially said dose levels in non-liquid form without manual measurement and without requiring that said drugs be enhanced by mass or volume relative to that of said drugs'"'"' respective active pharmaceutical ingredients;

said drug product being a polypill, a polypill being a pill comprising multiple distinct active pharmaceutical ingredients.

7. The process of claim 6, wherein said capsules are multi-compartment capsules.

8. The process of claim 6, wherein at least one of said drugs is placed into said capsules as microspheres.

9. The process of claim 6, wherein at least one of said distinct active pharmaceutical ingredients is pre-formulated.

10. The process of claim 6, wherein said process is directed toward reducing pill burden on patients having multi-drug regimens and/or toward reducing medication administration errors by healthcare personnel.