Trudell Medical International
Overview
Visit us at
Drug Delivery to the Lungs
December 8-10 – Edinburgh, UK
Drug Delivery to the Lungs
December 8-10 – Edinburgh, UK
First Commercial Supplier of Dose Indicators
The AeroCount* Dose Indicator, developed by Trudell Medical International, is a device that provides patients with a visual indication of whether drug remains in their pressurized Metered Dose Inhaler (MDI). Prior to the availability of dose counters and indicators , there was no reliable method by which a patient could determine whether any drug remained in their MDI.Various means of testing inhalers (e.g., shaking the canister) are unreliable and some in addition may damage the MDI (e.g., the float-test, placing the canister in water).
AeroCount* Dose Indicators are designed to satisfy the FDA’s 2003 guidance on “integrated dose counters”, as well as meeting the needs of patients and prescribers, including
The AeroCount* Dose Indicator, developed by Trudell Medical International, is a device that provides patients with a visual indication of whether drug remains in their pressurized Metered Dose Inhaler (MDI). Prior to the availability of dose counters and indicators , there was no reliable method by which a patient could determine whether any drug remained in their MDI.Various means of testing inhalers (e.g., shaking the canister) are unreliable and some in addition may damage the MDI (e.g., the float-test, placing the canister in water).AeroCount* Dose Indicators are 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
Technical Information
TMAI-200 Series
- Cap
- Indicator Gear
- Drive Gear
- Coil Spring
- Base
AeroCount* Top Mounted Actuation Indicator (TMAI)
Design Features and Benefits
Delivering Solutions
- New TMAI-200 mechanism designed to rapidly reset the counter
- 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
- Canister and indicator can be removed from the actuator boot for cleaning
Delivering Solutions
- 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)
- TMAI shipped in bulk ready for final packaging
Reference Material
FAQs
Frequently Asked Questions
- Is the AeroCount* Dose Indicator commercially available on any Metered Dose Inhalers (MDI)?
Yes. The AeroCount* Dose Indicator is integrated with the Alvesco† (ciclesonide) Inhalation Aerosol in the US market. - How much additional force is required to use the MDI with an AeroCount* Dose Indicator?
Due to the operational design, no additional force is required to use the MDI when integrated with the AeroCount* Dose Indicator. - Can a patient still wash and clean their actuator?
The AeroCount* Dose Indicator is attached to the MDI canister and is removed with the canister for washing and cleaning of the actuator, if required. By keeping the dose indicator affixed to the MDI canister, the count integrity is maintained. - Can the AeroCount* Dose Indicator be customized to my drug development program?
Working with pharma partners, Trudell Medical International customizes the AeroCount* Dose Indicator, including the starting count, to suit the formulation. Trudell can also customize the display printing on the indicator and exterior colors.
Product Inquiries
Product Inquiries
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.
Trudell Medical International 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.
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.Trudell Medical International 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.