AeroCount* Dose Counter (TMAI)
The AeroCount* Dose Counter provides patients with a visual indication of remaining medication in their pressurized Metered Dose Inhaler (MDI).
The AeroCount* Dose Counter was first approved by the US FDA in conjunction with Alvesco in 2008, becoming the first approved dose counter available for pharmaceutical developers
In the last two years, the second generation of the AeroCount* Dose Counter (Top Mounted Actuation Indicator or TMAI) has been approved by the FDA in conjunction with three more MDI programs, including:
- NDA 208294. 2016
- NDA 021730. 2017
AeroCount* Dose Counter is designed to satisfy the FDA’s 2003 guidance on “integrated dose counters”, as well as meeting the needs of patients and prescribers, including:
- Seamless integration thereby maintaining the intuitive and familiar use of the MDI
- Easy to read numeric indication and low medication warning in colour
- Delivery of a dose without the possibility of jamming the valve
Design Features and Benefits
- Compatible with a wide range of popular MDI components (actuators, canisters, valves)
- Easy to attach to canister with a label over-wrap providing seamless integration
- Ability to be integrated with the canister allows for maintaining count integrity
- No interference with airflow and aerosol generation
- Complete service from product development to commercial manufacturing compliant with cGMP
- Proven execution of design verification and Drug Master Files (DMF) to support partner regulatory submissions
- Over 50 issued patents and patents pending in dose counting technologies with the first dating back to January 1998
- Production capabilities meet rigorous global standards, including ISO 13485:2003 Registered Quality System
- Fully automated and validated production carried out in ISO Class 8 clean rooms
- 100% in-process testing and Process Analytical Technologies (PAT)
- Shipped in bulk ready for final packaging
With over a decade of experience in research and development in the dose indicator and counter field, you can leverage our experience to integrate one with your MDI.
TMI is interested in working in collaboration with pharmaceutical partners throughout the world to customize and supply commercial dose indicators and counters.
If you are a looking for more information, please contact us.