Dose performance of the OnDosis Minitablet Dosage Manager

Introduction

The need for individualised dosing of medicines is increasingly recognised in therapeutic areas where optimal outcomes depend on finely balancing efficacy against side effects, particularly in domains such as psychiatry, neurology, paediatrics, and rare diseases, where patient variability and treatment sensitivity demand precise dose control. Conventional oral solid dosage forms—typically tablets, capsules, stick packs and sachets—are manufactured in a limited number of fixed strengths, restricting the ability to fine-tune dosing and personalise treatment. As a result, clinicians face challenges when attempting to adjust doses within narrow therapeutic windows or titrate treatments in small, incremental steps.

To overcome these limitations, OnDosis has developed a Minitablet Dosage Manager, an electromechanical technology designed to deliver flexible and precise doses of minitablets only a few millimetres in size. The system enables dose adjustments in small and fully flexible dose increments, supporting fine titration within the therapeutic range. Beyond dosing flexibility, the device is engineered to support patient safety, usability, and adherence. Programmable dose limits, digital dose feedback, a dose history log, and child-resistant functionality support safe use in home environments.

This white paper presents laboratory performance data evaluating the accuracy and robustness of the dosage manager across a broad range of dose sizes. The study includes assessments of dose accuracy and the physical integrity of minitablets after dispensing.

Technology description

The Minitablet Dosage Manager* is a handheld electromechanical device under development which is designed to deliver individualised, precise doses of oral solid medicines formulated as minitablets (Figure 1). The system integrates mechanical dispensing technology with embedded software to ensure reproducible dose delivery. It comprises three main components:

Control unit (reusable) – The control unit houses the electromechanical driving mechanism and embedded software that controls dosing. It includes an interface with a display and buttons for dispensing, dose adjustments, and visual feedback. A personal PIN code ensures secure access. The system supports programmable dosing schedules and limits which can be tailored to each specific medicine, enabling safe, compliant use in home and clinical settings.

Cartridge (replaceable, medicine-containing) – The multi-dose cartridge holds the minitablets and interfaces with the control unit, which activates the internal dispensing mechanism to deliver the programmed number of tablets. With common minitablet sizes each cartridge can contain approximately 1000-3000 units, providing several weeks to months of treatment per cartridge depending on the prescribed dosing regimen. Cartridges are pre-filled during manufacturing.

Cup (detachable) – A detachable cup at the bottom of the cartridge collects the dispensed dose for oral administration.

* The dosage manager is currently under development by OnDosis AB and is not regulatory approved.

Materials & Methods

Two (2) placebo minitablet formulations from separate undisclosed manufacturers were included in the evaluation (Figure 2). Both formulations were cylindrical in shape and manufactured with a coating. The formulations differed in dimensions and hardness, and each batch displayed a level of intra-batch variability typically observed in minitablet production.

Prior to dose performance tests, each formulation was characterised for dimensions (diameter and height) using digital microscopy at 10X magnification (Swift Pro 200×100, Vision Engineering) and for hardness using a force gauge (FH500, Elastocon).

The dose performance tests consisted of sequentially dispensing pre-programmed dose sizes ranging from 1 to 30 minitablets. The dosage manager cartridges were filled with a predefined number of minitablets for each test run and then attached to a control unit for dispensing. Dispensed minitablets were collected in the cartridge cup and manually counted. Dose performance was calculated as the number of dispensed minitablets versus target.
The physical integrity of dispensed minitablets was assessed after each test by visual inspection.

Results

Minitablet characterisation

Detailed dimensional and hardness results are presented in Table 1. Formulation 1 had an average diameter of 2.13 mm and height of 2.22 mm. The corresponding values for Formulation 2 were 2.06 mm and 2.18 mm. The mean hardness (measured as the breaking force, expressed in Newton) was 31.7 N (force applied to cylindrical surface) and 24.8 N (force applied to top surface) for Formulation 1. The corresponding values for Formulation 2 were 21.2 and 19.8 N.

Table 1. Results from characterisation and hardness tests. Data presented as Mean, Median (Min, Max)

See the full White Paper on OnDosis Minitablet Dosage Manager here

(click the picture to download the white paper)

Source: OnDosis white paper OnDosis Minitablet Dosage Manager

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