My inhaler tastes like petroleum ?

The current FDA certified propellant used in all metered dose inhalers in the USA is called HFA-134a or HFA-227.  The HFA-134a is very similar to the refrigeration Freon that is sold for automobiles.  The Medical propellant is controlled and not just anyone can buy it legally with certificates of authentication and traceability.

Because the cannabis  industry is not regulated by anyone, it is possible for manufactures to short cut the system and use automotive Freon for the propellant in their inhalers.  This is possibly the reason for the petroleum smell or taste.  This is a guaranteed what to hurt someone.

 

My inhaler burns when I use it.

This is a very common problem with most all of the cannabis MDI manufactures that have chosen to try to develop a product without consulting anyone from the aerosol industry.

The burning sensation can be caused by several things, poor quality cannabis, droplet size to big, incorrect actuator size or poor formulation.

In order to produce a quality inhaler that works as it was designed, not burn and deliver the exact amount of API for each dose, 7 or 8 different things have to be manufactured within very tight specification. If any one of these things are slightly off, the inhaler will not work as designed and usually cause a burning sensation.

Bioavailability

Simply put, Bioavailability is the term used for how much drug is lost or destroyed based on the route of administration.  The book ends of this word Bioavailability would be and I.V. ( intravenous ) 100% Bioavailable Vs. Topical ( applying to skin ) 7% Bioavailable.

Clearly the higher the bioavailability of the delivery device  or route of administration, the less drug you have to administer to achieve the same effect with a lower bioavailability.

Below are some basic examples of bioavailability.

 

I.V.     100%

MDI-DPI     98%

Sub-Lingual     80%

Rectal     65%

Smoking-Vape     50%

P.O.     40%

Topical-trans dermal     7% to 10%

With the cost of Medication increasing day by day, why not use a device that get the most of it into you where it can be used effectively.

 

 

 

cGMP and FDA certified equipment

With the proliferation of the internet, anyone can purchase basically anything they might want from any country on the globe.  When it comes to medical devices, there are reasons that the FDA certifies the aerosol equipment we use.  The reasons and rules are usually written in blood, this means that people have died from improper equipment or training.  If your MDI manufacture is using equipment or supplies from anyone other than three cGMP/FDA suppliers, you are at very high risk of harm or death if your using their device.

The hard part is how do you tell  if your manufacturer has the correct training and equipment to manufacture the device in a safe as possible manner.  Ask questions, if they do not have answers, you should not buy the device.

Unforeseen dangers of the MDI

Our bodies in general are designed to reject harmful substances that we are exposed to on a daily basis.  Regarding our lungs and breathing, we have numerous built in systems that block and trap most dust, mold, viruses from entering our bodies, although some get through a majority are rejected.  This is mostly based on particle size.

When we manufacture a formula for use inside of a MDI and it is built correctly, we are bypassing ALL of the saftey features mentioned above.  This means that everything inside the container of the MDI will be delivered to directly to the systemic blood circulation of the human body.  Clearly this could cause potential harm or death to a patient.

For this reason alone, it is advisable for anyone that thinks they want to manufacture MDI’s to consult with someone that is familiar with  unforeseen dangers of the manufacturing process.

 

Droplet Size

When delivering an API to the pulmonary tract of the human body, the droplet size of the formulation exiting the actuator must be the correct size to travel to the deep lung and enter the alveoli for absorption.  When the droplet size is correct, the API will be delectable in the systemic blood circulation within about 5 to 8 seconds at 75% of total dose administered.  The other 25% will enter the systemic blood circulation within 5 to 8 minutes.

In order to ensure this 5 to 8 second onset, each formula MUST be tested with equipment and instruments that can measure this very fine particle size.  In fact this is how we determine which actuator needs to be used with each formula.  There are three different parts inside the actuator that have a direct effect on the droplet size of the formula as the aerosol exits the mouthpiece of the actuator.  Stem size, jet length and the orifice all play a huge role in droplet size and here is the kicker, with 3 different size stems, 12 different jet lengths and 22 different orifices, the combinations of actuators are endless.  You can not just guess which one will deliver the correct droplet size, it has to be developed.

Formulations: Shake or Not ?

I get asked this question a lot, Do my formulated MDI’s have to shaken before use.  This is the big difference between a properly formulated MDI’s and a manufacture whom thinks they can just figure it out.

If the formula is not 100% homogeneous, the MDI will have ” shake well before use ” listed on the package, This is a clear sign that the formula is not correct and the manufacture has decided to ” figure it out on their own “.

All formulas that we build DO NOT HAVE TO BE SHAKEN BEFORE USE. All of our formulas are 100% homogeneous and 100% stable thru the life of the device.

Why is this important you ask, oil based API, in this case cannabiniods, are easily dissolved into a solution of solvent and liquid propellant under pressure.  The metering valve and plastic actuator perform the best when the formulas are in a solution.  This is the way they were originally intended to perform.

Some pharmaceutical compounds and drugs will not dissolve and become a solution and that’s why the Pharma MDI’s say shake well before use.

BLISTair disposable DPI

Perlen Manufacturing has released their new BLISTair disposable dry powder device for pharmaceutical drug delivery in North America.

This device revolutionize CBD drug delivery for the cannabis space.