In order to properly create a formula for a MDI that will actually flow thru the valve and actuator without clogging it and delivering a consistent dose from the first actuation ( puff ) thru the last actuation, several factors must be considered.
Will you be formulating a Solution or a Suspension, Topical or Systemic deposition, Amorphous or Crystalline, PH range and finally EtOH %. Once you have this information you can pick the correct type of metal can and lining along with the correct valve. Currently there are about 600 combinations.
Once you have the above information all figured out, you will have a MDI that actually sprays out an API ( Active Pharmaceutical Ingredient ), now for the hard part. API particle size, shape and density, along with the stem diameter, stroke, expansion chamber, nozzle size and jet length will determine if the inhaled formula will land in the correct part of the lung for immediate transfer into the blood stream. If it does not land in the correct part of the lung, the API will be swallowed and become simply an oral dose.
As you can see from the above BRIEF outline above, building a successful MDI is quite complicated.
Our team at EM3 Methodology provides answers to all of these questions listed above and provides all of the formulation steps needed to successfully formulate your MDI into a successful product that will be effective in the retail market place.
Our training takes approximately 3 to 4 weeks depending on the background of the employees we are given to train. Like riding a bike, we must start from the beginning and work thru to the end, there are no shortcuts when it comes to building MDI’s.
After we have formulated a few of what will be known as your first formulas, we provide the testing and validation of the finished MDI. We use the NGI for particle size classification, Envision laser for plume geometry and Dosage Unit Sampling Apparatus ( DUSA ) for uniform dose testing.
If you goal is to get a working product on your shelves within 6 to 10 months, EM3 Methodology can provide this for you.