Synopsys

Only time and the scientific method will ascertain whether a new paradigm is applicable to human physiology and treatment of its derangements.  Our insight into these possibilities is dependent on the contribution of one unique healing plant; for clinical cannabis has become a therapeutic compass to what modern medicine fails to cure.

EM3 Methodology specializes in MDI and DPI Technology

EM3 has been researching aerosolized and dry powder cannabinoid delivery to the pulmonary tract of the human body since the summer of 2001.  Unlike others found on the internet, we have actually created a method for formulating your API ( active pharmaceutical ingredient ) into a usable formula that will land in the correct part of the deep lung that will ensure immediate transfer into the systemic blood circulation.

We use a NGI ( next generation impactor ) for our particle size classification and a Agilent 1100 HPLC for our chromatography analysis.  Our customers get the added benefit of this equipment as we test ALL of our customers products to ensure maximum effectiveness.

Em3 is here to help take all the guess work out of building the Metered Dose Inhaler and Dry Powder Inhalers.  Although the MDI & DPI seem very straight forward and easy to build, there are a lot of unseen parameters. If done incorrectly will result in failure of the product or worse.

Em3 offers a simple, turn key package of equipment and supplies, delivery, set-up, training, formulation, that when used properly, will put new products on your shelves in the shortest amount of time.

The aerosol equipment can also be used for other aerosol products besides MDI. It can also make mouth spray,  nasal spray, skin spray or just about anything you could think of that is driven by propellant.

WHY REINVENT THE WHEEL  –  I TAKE OUT ALL OF THE GUESS WORK

Em3 stands above all of the other equipment suppliers on the market today.   We provide you with a complete solution. We do not brand or co-brand your device, we do not charge any royalties. We teach you how to formulate your own recipe. I provide the quickest path for new products on your shelves. Our formulation process and actuator size will ensure immediate onset of your API

Because of the delicate nature of aerosolized medication, the owner of EM3  personally travels to your facility and spends up to 30 days with you training you on the science of formulating MDI’s using customized equipment and procedures that he has personally developed for the cannabinoid group of essential oils.

We all have to make money in some manner, this is the way it works, right?  We make money by selling you the consumables, the cans, valves and actuators.  The only way we will ever make any money is if you completely succeed in marketing and selling your MDI’s.  This manner of doing business is a guarantee that we will do everything within our power to help you be successful.

FDA information on

E-Cig and Vape Pen

The FDA has started down the road of controlling the E-Cig device. They consider any device that has a battery or power supply, on/off button, coil of nichrome wire, a holding reservoir, or wick to be a medication delivery device.  Although the cannabis industry is not regulated by the FDA, the importation of the device will be. The FDA will enforce the importation of this device thru their friendly neighbor US Customs.

What does this mean for the cannabis industry ? This means that anyone wanting to import the E-Cig type device, into the USA will have to have an FDA license, and the device will have to be approved by the FDA as a medication delivery device.

Currently the FDA has set a date for this ban to take effect. Whether this BAN actually happens on this date or not, does not really mater. The fact is, the FDA is going to regulate the device.

If your interested, you can read the FULL FDA ruling by clicking here.

Our skin is in your game !

We make money by selling you the consumables ( cans, valves and actuators ). When you are successful at building and selling MDI’s, you buy more consumables from us.  You make money, we make money ! It’s that simple !  Em3 does not brand or co-brand your inhaler. You built it, it’s yours 100%.

Set-Up and Training

Our package deals include, full set up and calibration, training using the aerosol equipment and compliance gauges, re-calibration and complete instruction on the anatomy of the inter-workings of the MDI all at your facility.

We then provide you with up to 30 days of free in-service training, again at your facility using your medication to build your MDI.

Laboratory / Chemist Consulting

In addition to MDI’s, Em3 also offers consulting and training services for lab set up and design, method and training on HPLC, GC, MS, NGI, SOP’s, Extraction, Advanced purification, Freeze Drying, Isolation and droplet size classification.

Continuing Education

Delivering essential oil thru the MDI is not an exact science.  Although it looks very simple from the videos on YouTube, there are a lot of specific parameters that must be met to ensure the MDI will perform properly. As this newly emerging delivery method is refined we learn new way to process and package MDI’s that will improve the overall patient experience.

40 Million Inhalers

Sold per year in the USA

100’s of Colors

Actuators

6 States

Currently Sold In

20 Years

Experience in Medical Field

When the MDI can is depressed into the actuator, the can and valve deliver an exact metered volume of the liquid contents from within the can.  This liquid contains the active drug, non-active co-solvents and non-active propellant all in liquid form.

These three liquid portions are forced thru a very small orifice that creates a plume of very small droplets that are directed to the lungs during inhalation by the patient.

For the active drug to reach the deep lung where it can be immediately absorbed into the systemic circulation, the droplets must be between 2µm and 5µm in size.  During the process of inhalation, about 50% of the droplets will start to stick together, this is called flocculation. So in reality, only about 50% of the active medication reaches the systemic blood circulation immediately.  The other 50% is not lost, it is absorbed into the system similarly to a oral dose.

The instrument shown in the picture is used to measure the specific size of the droplets as they exit the actuator of the MDI.

This instrument is called a NGI ( Next Generation Impactor ).

I have personally run thousands of combinations of cannabinoids, valve and actuator sizes thru the NGI to determine the exact combination that creates the best aerodynamic particle size for maximum effectiveness.

Em3 Offerings

Due to the complexity of formulation, droplet size, crimp height, orifice diameter, jet length, excipients, co-solvents and propellant, we feel the only way our customers can immediately succeed is to provide them complete turn key systems.

Our turn key systems provide you the shortest path to building and selling inhalers on the market today.

We also sell equipment and supplies separately.

We carry parts and supplies in stock. Please contact us for pricing.

MISSION STATEMENT

We believe that medication delivery is very serious matter, FDA controlled or not.  We ONLY sell equipment and supplies that are currently on file with the FDA.

Filling, crimping and gassing inhalers is a very easy process, In fact, anyone can do it. However, adjusting viscosity, ensuring miscibility and most importantly adjusting the flavor profile is is what it takes to make the inhaler successful in the retail marketplace.

EM3 provides these essential key processes

PLEASE NOTE

Due to the EXCESSIVE amount of non-business calls we receive day and night.

Please either text me prior to your call or leave a voice mail.

Jae or I will call you back as soon as possible.

Rick Adams – 5Am to 8Pm MST- 520-591-7159 – rick@em3methodology.com

Jae Rossi – 9Am to 5Pm MST – 520-306-7290 – jae@em3methodology.com