# US 12,005,029 B2 · Density flow meter for pharmaceutical formulation dosing

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- Number: US 12,005,029 B2
- Document ID: US12005029B2
- Status: Granted
- Kind: B2
- Application number: 17/529,731
- Filed: 2021-11-18
- Published: 2022-03-10
- Granted: 2024-06-11
- Earliest claimed: 2019-07-31
- Assignees: Catalent U.K. Swindon Zydis Limited
- Applicants: Catalent U.K. Swindon Zydis Limited
- Inventors: David Waddington; Matthew Wort; Katherine Arneil
- Web page: https://patentgrep.com/patent/US12005029B2

## CPC

- A61J 1/20: Arrangements for transferring {or mixing} fluids, e.g. from vial to syringe
- G16H 10/00: ICT specially adapted for the handling or processing of patient-related medical or healthcare data (for medical reports G16H15/00; for therapies or health-improving plans G16H20/00; for the handling or processing of medical images G16H30/00)
- B65B 3/003: {Filling medical containers such as ampoules, vials, syringes or the like}
- B65B 3/12: mechanically, e.g. by pistons or pumps
- G01F 1/84: Coriolis or gyroscopic mass flowmeters
- G01N 9/002: {using variation of the resonant frequency of an element vibrating in contact with the material submitted to analysis (G01N9/34 takes precedence)}
- A61J 1/035: {Blister-type containers (blisters in general B65D75/36)}
- A61K 47/20: containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
- 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
- G16H: HEALTHCARE INFORMATICS, i.e. INFORMATION AND COMMUNICATION TECHNOLOGY [ICT] SPECIALLY ADAPTED FOR THE HANDLING OR PROCESSING OF MEDICAL OR HEALTHCARE DATA
- B65B: MACHINES, APPARATUS OR DEVICES FOR, OR METHODS OF, PACKAGING ARTICLES OR MATERIALS; UNPACKING (bundling and pressing devices for cigars A24C1/44; devices for tensioning and securing binders adapted to be supported by the article or articles to be bound B25B25/00; applying closure members to bottles, jars or similar containers B67B1/00-B67B6/00; concurrent cleaning, filling and closing of bottles B67C7/00; emptying bottles, jars, cans, casks, barrels or similar containers B67C9/00)
- G01F: MEASURING VOLUME, VOLUME FLOW, MASS FLOW OR LIQUID LEVEL; METERING BY VOLUME
- G01N: INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES (measuring or testing apparatus or processes other than immunoassay, involving enzymes or microorganisms C12M, C12Q)
- 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)

## Abstract

Provided are systems and method for dosing a pharmaceutical formulation. These methods and systems can displace the pharmaceutical formulation through a density flow meter, wherein the density flow meter is configured to measure a density of the pharmaceutical formulation. Next, the pharmaceutical formulation can be dosed into preformed molds and the dosing process can be stopped when the density of the pharmaceutical formulation measured by the density flow meter is below a predetermined threshold.

## Claims

### Claim 1

A system for dosing a pharmaceutical formulation comprising:
a recirculation system comprising a density flow meter configured to measure a density of the pharmaceutical formulation;
at least one pump fluidly connected to the recirculation system, wherein the at least one pump is configured to displace the pharmaceutical formulation from the recirculation system into preformed molds and is configured to stop displacing the pharmaceutical formulation when the density of the pharmaceutical formulation measured by the density flow meter is below a predetermined threshold.

### Claim 2 (depends on 1)

The system of claim 1, further comprising a computer, wherein the computer, the density flow meter, and the at least one pump are communicatively coupled with one another.

### Claim 3 (depends on 2)

The system of claim 2, wherein the density flow meter is configured to send data comprising the density of the pharmaceutical formulation to the computer.

### Claim 4 (depends on 3)

The system of claim 3, wherein the computer is configured to send one or more instruction or control signals to the at least one pump to alter an activation state of the pump.

### Claim 5 (depends on 4)

The system of claim 4, wherein the activation state comprises an on configuration and an off configuration.

### Claim 6 (depends on 5)

The system of claim 5, wherein the one or more instruction or control signals sent from the computer to the at least one pump comprises a signal to turn the at least one pump off when the data comprising the density of the pharmaceutical formulation is below a predetermined threshold.

### Claim 7 (depends on 2)

The system of claim 2, wherein the computer, the density flow meter, and the at least one pump are wirelessly communicatively coupled with one another.

### Claim 8 (depends on 1)

The system of claim 1, wherein the pharmaceutical formulation comprises at least one surfactant.

### Claim 9 (depends on 8)

The system of claim 8, wherein the surfactant comprises at least one of sodium lauryl sulfate and sodium docusate.

### Claim 10

A method for dosing a pharmaceutical formulation, the method comprising:
measuring a density of the pharmaceutical formulation;
dosing the pharmaceutical formulation into preformed molds;
stopping the dosing of the pharmaceutical formulation into preformed molds when the measured density of the pharmaceutical formulation is below a predetermined threshold.

### Claim 11 (depends on 10)

The method of claim 10, wherein a density flow meter is configured to send data comprising the density of the pharmaceutical formulation to a computer.

### Claim 12 (depends on 11)

The method of claim 11, wherein the computer is configured to send one or more instruction or controls signals to stop the dosing of the pharmaceutical formulation when the data comprising the density of the pharmaceutical formulation is below a predetermined threshold.

### Claim 13 (depends on 12)

The method of claim 12, wherein the computer sends the one or more instruction or control signals to stop dosing of the pharmaceutical formulation to at least one pump.

### Claim 14 (depends on 10)

The method of claim 10, wherein the pharmaceutical formulation comprises at least one surfactant.

### Claim 15 (depends on 14)

The method of claim 14, wherein the surfactant comprises at least one of sodium lauryl sulfate and sodium docusate.
