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 Methodology is not a cannabis company. We do not sell cannabis inhalers.

Em3 Methodology provides turn key aerosol systems to licensed cannabis manufactures that wish to ad the cannabis inhaler to their product line.  We provide aerosol equipment, supplies,training, specific formulations, aerodynamic particle size testing and total dose testing to our customers.

We utilize a NGI 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.

The MDI was not designed to be an oral mouth ( swallowed ) or sub-lingual spray.  The MDI, if manufactured correctly, the MDI delivers API to the deep lung where it can be absorbed directly into the systemic blood stream for delivery directly to the brain without passing thru the liver first, about 95% bioavailability.

In order to get the API to travel into the deep lung, several components of the MDI and the formulation have to developed in a very specif manner.  After a formula is created for taste and mg/A is decided, the formula has to be dispensed thru numerous sized actuators to determine which actuator has the best nozzle and jet length for that specif formula.

To do this Em3 has created a mobile lab that consists of  NGI and HPLC analytical equipment that can measure the exact aerodynamic particle size of the API so that the correct actuator can be ordered from the suppliers.

Our equipment and testing can provide the cannabis manufactures with the MMAD and GSD figures as proof the API has been developed and the correct actuator has been selected for their product.  Our lab is mobile and all testing is done on the licensed facility grounds.

Em3’s method is so highly refined, we are able to formulate 100% homogeneous formulas that do not require the end user to shake the inhaler before use!

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.

UPDATE 5-15-19 !!!!!! Federal Judge ordered the FDA to regulate the E-Cig and Vape Pens.

https://thehill.com/policy/healthcare/443960-federal-judge-orders-fda-to-start-regulating-e-cigarettes

https://www.washingtonpost.com/business/judge-orders-fda-to-begin-regulating-e-cigarettes/2019/05/15/691e4cb2-775d-11e9-a7bf-c8a43b84ee31_story.html?noredirect=on&utm_term=.54d056c475e2

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.

EM3 Formulations

Our formulations are what set us apart from the others manufacturing cannabis MDI’s.  Our formulation are homogeneous, this means you do not have to shake the inhaler before use.  This is the KEY to a successful medication delivery device.

If you read about other people experiencing problems with clogging or excessive build up of medication inside the mouth piece, they probable do not have a stable, homogeneous formula. Unfortunately, these company’s  have elected to ” figure it out ” without the help from anyone in the aerosol business.

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 measuring the aerodynamic particle size is what it takes to make the inhaler successful in the retail marketplace.

EM3 provides these essential key processes

Rick Adams – 5AM to 8PM MST- 520-539-6550 – rick@em3methodology.com

UPDATE:     7-8-2019,       With the pending FDA regulation on the E-Cig / Vape device, we are currently currently receiving 15 to 20 calls per day.  Our voice mail will have instructions for you to expedite a return call from us. Get a pen and paper and give us a call.