US-20260124117-A1 - DELIVERY DEVICE FOR DRUG PELLETS

US20260124117A1US 20260124117 A1US20260124117 A1US 20260124117A1US-20260124117-A1

Abstract

There is provided a device for dispensing one or more drugs in pellet form, including a cartridge including a chamber for containing a plurality of drugs in pellet form, a screw pump configured to receive pellets from the chamber and, upon rotation of the screw pump, transport the pellets from the chamber to be dispensed from the device via the screw pump, and a rotating member extending through the cartridge and configured to rotate the screw pump so as to dispense pellets therefrom.

Inventors

Robert Axelsson
Emelie Margareta Svensson
Ronny BRAKHYA
Lubomir Petrov Gradinarsky
John Charles Price Hayman
Per Magnus Karemyr
Martin Olovsson
Anders Jimgren
Philip-Jan Alfons Constant Flebus
Oscar Emil Nilsson

Assignees

ONDOSIS AB

Dates

Publication Date: 20260507
Application Date: 20250929
Priority Date: 20171215

Claims (20)

1 - 20 . (canceled)
21 . A hand-held and portable device for dispensing a drug or medicament in pellet form, the device comprising: an actuator providing a housing; a cartridge insertable into the housing, wherein the cartridge comprises: a chamber for containing the plurality of medicament pellets; and a screw pump configured to receive the medicament pellets from the chamber and, upon rotation of the screw pump, transport the medicament pellets from the chamber to be dispensed from the device via the screw pump; and a rotating member extending through the cartridge and configured to rotate the screw pump so as to dispense medicament pellets therefrom; wherein the cartridge is removable from the actuator so that different cartridges can be connected to the same actuator, wherein the actuator comprises: a motor configured to rotate the rotating member of the cartridge to cause medicament pellets to be dispensed from the device; and a battery configured to power the motor.
22 . The handheld and portable medicament dispenser as claimed in claim 21 , further comprising a valve connected to an outlet of the screw pump and configured to prevent medicament pellets from being dispensed from the screw pump outside of a dispensing operation when the screw pump is not being rotated, and to permit medicament pellets to be dispensed from the screw pump during a dispensing operation upon rotation of the screw pump.
23 . The handheld and portable medicament dispenser as claimed in claim 22 , wherein outside of a dispensing operation the valve is configured to prevent medicament pellets within the chamber from running through and leaking from the screw pump by providing a resistive force to the medicament pellets.
24 . The handheld and portable medicament dispenser as claimed in claim 22 , wherein the valve flexes open to allow medicament pellets to be dispensed as the screw pump rotates during each dispensing operation, and then flexes back when the screw pump is not rotating, so as to stop medicament pellets falling out of the screw pump outside of a dispensing operation.
25 . The handheld and portable medicament dispenser as claimed in claim 21 , further comprising a plunger movable along the rotating member and driven so as to force medicament pellets contained within the chamber towards the screw pump as it moves along the rotating member, so as to pack them tightly within the chamber towards the screw pump.
26 . The handheld and portable medicament dispenser as claimed in claim 25 , wherein the plunger is configured to press onto the medicament pellets within the chamber and force the medicament pellets towards the dispensing end of the cartridge to pack the medicament pellets tightly within the chamber as the rotating member rotates during each dispensing operation.
27 . The handheld and portable medicament dispenser as claimed in claim 25 , wherein a surface of the plunger forms one end of the chamber, such that as the plunger moves along the rotating member in use the volume of the chamber gradually decreases
28 . The handheld and portable medicament dispenser as claimed in claim 21 , wherein the motor is configured such that upon actuation thereof the motor causes the rotating member to rotate by a predetermined amount, wherein the predetermined amount of rotation corresponds to a precise volume of medicament pellets, and therefore a precise dose, to be dispensed.
29 . The handheld and portable medicament dispenser as claimed in claim 21 , wherein the cartridge is a replaceable unit comprising the chamber, the screw pump, and the rotating member.
30 . The handheld and portable medicament dispenser as claimed in claim 21 , wherein the rotating member of each cartridge physically connects to the actuator when the cartridge is inserted into the housing.
31 . The handheld and portable medicament dispenser as claimed in claim 30 , wherein only upon said physical connection can the motor rotate the rotating member to cause medicament pellets to be dispensed from the device via the screw pump as aforesaid.
32 . The handheld and portable medicament dispenser as claimed in claim 21 , wherein the screw pump is configured to transport the medicament pellets from the chamber to outside of the cartridge by rotation of the screw pump without linear translation of the rotating member.
33 . The handheld and portable medicament dispenser as claimed in claim 21 , wherein the cartridge comprises a unitary piece having the same cross-section extending the entire length of the chamber, the interior of which forms the walls of the chamber.
34 . The handheld and portable medicament dispenser as claimed in claim 21 , further comprising an exit tube that extends from the chamber, wherein the rotating member extends into the exit tube, such that the inner cylindrical surface of the exit tube forms an inner cylindrical surface of the screw pump.
35 . The handheld and portable medicament dispenser as claimed in claim 34 , wherein the cartridge comprises a frustoconical or tapered portion at one end of the chamber that directs pellets contained in the chamber into the exit tube.
36 . The handheld and portable medicament dispenser as claimed in claim 35 , wherein the cartridge comprises a unitary piece comprising the chamber and the exit tube.
37 . The handheld and portable medicament dispenser as claimed in claim 21 , further comprising a plurality of free-flowing medicament pellets contained in the chamber.
38 . The handheld and portable medicament dispenser as claimed in claim 21 , wherein: the screw pump has a screw thread with a channel depth, and wherein the channel depth of the screw thread is between about 1.1 and about 4 times the largest dimension of the pellets; the screw thread has a flight width, and wherein the flight width of the screw thread, defined as the pitch minus the channel width, is less than about 10 times the largest dimension of the pellets; and the screw thread with a channel depth, and wherein the channel depth of the screw thread is between about 1.1 and about 4 times a largest dimension of the pellets.
39 . A device for dispensing a drug or medicament in pellet form, comprising: a cartridge comprising a chamber for containing a plurality of pellets; a screw pump configured to receive pellets from the chamber and, upon rotation of the screw pump, transport the pellets from the chamber to be dispensed from the device via the screw pump; and a rotating member extending through the cartridge and configured to rotate the screw pump so as to dispense pellets therefrom; wherein the screw pump comprises a screw thread, and the screw thread cooperates with an inner cylindrical surface of the cartridge to form the screw pump, such that, as the rotating member rotates in use, the screw thread rotates within the inner cylindrical surface, causing pellets contained within the chamber to enter the screw thread, and travel down the screw thread for dispensing from the screw pump; and wherein the device is a hand-held device operable using only one hand.

Description

This application is a continuation of U.S. patent application Ser. No. 16/772,460 filed Jun. 12, 2020, which is a national stage application of PCT Application No. PCT/EP2018/085320 filed on Dec. 17, 2018, which claims priority GB Patent Appln. No. 1721065.9 filed Dec. 15, 2017, which are hereby incorporated by reference in their entireties. BACKGROUND OF THE INVENTION 1. Technical Field The present disclosure relates generally to delivery devices for drug pellets (e.g., a drug or medicament in pellet form) and various aspects of such devices relating, for example, to the dispensing of pellets from the device, the operation and mechanics of such devices and also certain aspects of the control systems for such devices. 2. Background Information Solid oral dosage forms (“ODF”) medications can be manufactured in, e.g., a tablet or pellet form. A tablet or pellet could contain different substances where the main ingredient(s) is/are the active pharmaceutical ingredient (“API”). Drug pellets could be administered to patients as prefilled capsules or compressed in a tablet with help filling materials. Dispensing mechanisms for various forms of ODF drugs are known, and can range from blister-pack type devices, wherein individual tablets can be retained within pockets and retained therein by the use of foil, to dispensing bottles. Various more complicated mechanisms are also known, in particular for other types of drug formulation, for example those in the form of pellets, which may typically be less than 10% of a particular dosage per unit. The advantage of dispensing drugs in pellet form can be that the dose can be varied using the same dispensing device. Another advantage is that the pellets could be easy to swallow by patients having difficulty swallowing, who are currently crushing the tablets in order to swallow. Crushing or dividing of tablets is also used today by patients to get, e.g., half a dose from a prescribed drug, a process which is not recommended and can be avoided if a device can dispense different flexible amounts of pellets. Variable dosing of pellets allows for a more exact tuning of the dose than what may be achieved using larger dosage forms such as tablets or capsules. Furthermore, for modified release formulations, pellets are often more robust against food interactions than larger dosage forms such as tablets. It is desired to improve the mechanism by which drugs in pellet form are dispensed, for example in case of pediatric medicine; antibiotics for easier swallowing, in case of geriatric medicine; chronic medication for easier swallowing, in the case of certain controlled substances such as stimulants for ADHD or pain medications such as opioids; for improved control over the dispensed dose or limit the risk for overdosing, or for medications that require titration at initiation or flexible adjustments as a result of disease variability or as a result of achieved outcomes, for example in case of immunosuppression after organ transplant, for psychiatric disorders such as depression or for neurological disorders such as epilepsy. SUMMARY OF THE INVENTION Herewith will be described various aspects and embodiments of a dispensing device that may be used in the present invention, and in relation to any of the aspects and embodiments of the invention described herein insofar as they are suitable therefor. As will be appreciated, all of the devices operate on similar principles. In an aspect of the present invention, there is provided a device for dispensing pellets (e.g., a drug or medicament in pellet form). As described below, a largest dimension (e.g., width or diameter) of the pellets may be between about 150 μm and about 1200 μm (or even about 1500 μm), optionally between about 200 μm and about 300 μm, between about 300 μm and about 500 μm, between about 500 μm and about 700 μm. In various embodiments the largest dimension (e.g., width or diameter) of the pellets may be between about 700 μm and about 900 μm or between about 800 μm and about 1100 μm. The device comprises: a cartridge comprising a chamber for containing or holding a plurality of pellets; a screw pump, e.g., an Archimedes screw, configured to receive pellets from the chamber and, upon rotation of the screw pump, transport the pellets from the chamber to be dispensed from the device (and, e.g., the cartridge and/or chamber) via the screw pump; a rotating member extending through the cartridge and configured to rotate the screw pump so as to dispense pellets therefrom. The above device solves the problem of how to accurately and easily administer pellets that may provide an oral dosage form (especially, but not exclusively those having a size between about 150 μm and about 1200 μm or even about 1500 μm), in that the use of a screw pump allows a precise dose to be administered from the device in a simple manner. Previously (and as discussed above) pellet-type medicaments have been administered to patients as prefilled capsules