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Are Cannabis Regulations Calling for the Impossible? New Study Says “No”!

By Jonathan Gilinski

When asked about the future of medical cannabis regulations, I reverently gaze towards New York’s Compassionate Care Act, which to me looks like the Holy Grail for cannabis legislation.

I believe that the basic tenets of this Act should be, and will become, the model for medical cannabis regulations nationwide. Steering the industry away from combustible forms of marijuana will help the Cannabis Industry progress as a whole.

By prohibiting all forms of combustible cannabis, as well as the unhealthy brownies, candies and other popular “dessert-like” foods, New York is showing the rest of the world that you don’t have to smoke or ingest cannabis in its raw form, or consume unhealthy edibles, in order to receive its medicinal benefits.

In fact, there are only three delivery methods that are allowed by New York’s medical cannabis laws: “An extract in oil for sublingual administration, an extract for vaporization, or an extract in a capsule for ingestion.” By mandating more “medical” delivery systems – and requiring that products comply with specific dosage standards – New York is helping to move the industry away from recommending the use of “pot” and towards prescribing patients beneficial medicine that happens to be derived from cannabis.

Is it possible to meet New York’s dosage standards?

New York’s Compassionate Care Act lays out very specific dosage standards that products must meet:

“‘Brand’” means a defined medical marihuana extraction product that has a homogenous and uniform cannabinoid concentration and product quality, produced according to an approved and stable processing protocol. The specified brand shall have a total THC and total CBD concentration that is within 95 – 105 percent of that specified in milligrams per dose for that brand and shall have the same composition and concentration of inactive ingredients as that defined for the brand.”

There’s a misconception in the market that the technology is not available to carry out these types of rules. People say that this level of accurate dosage control just isn’t possible with current cannabis delivery systems. Furthermore, if accurate dosage control isn’t possible, what good does this aspect of the legislation do?

Capsule stability issues can make compliance difficult

My area of expertise is encapsulation and formulation. I know that capsules can provide accurate and specific dosage control — if the capsules are sufficiently stable to hold the dose long enough for the patient to take the proper amount.

That, unfortunately, is not always the case.

I’ve been attending numerous industry trade shows and events. Everywhere I go, producers tell me about the problems they’ve had with capsule stability. They say they’ve tried encapsulation for their liquid concentrates, but the capsules often break or leak. Strict dosage standards are ineffective if a portion of the fill material is lost due to capsule leakage or rupturing.

Study examined causes of capsule instability

As the first step towards solving this widespread capsule stability problem, a third party verified lab recently conducted a 13-week capsule stability study. Their hypothesis going-in was that the capsule stability problem was being caused by the “dirty cannabis concentrate” problem. The thought was that when contaminated with residual solvents, the chemicals in these solvents (butane, propane, hexane, CO2 etc.) react to heat and cause the cannabis capsules to break and/or leak.

To test this hypothesis, they encapsulated four different liquid cannabis concentrate samples of varying levels of purity (“extremely dirty,” “3-hour purge,” “6-hour purge,” and “0 ppm”) in three different types of premium high-quality capsules (glycerin-based, vegetable-based and gelatin-based). All of these capsules were then stored in three different temperature environments – including some very harsh environments that you’re not likely to see outside of the test lab – for a period of three months. Once a week the researchers examined each of the samples and noted their weight, appearance and any changes that had taken place.

The study results were more nuanced than expected

What the third party lab found was that cannabis purity, capsule type, and storage temperature all play important roles in capsule stability.

As stated in the research report:

“The gelatin based capsules had the highest rate of capsule malfunctions throughout this study. The capsules stored in warm environments were more prone to leaking and separation. Of the various concentrate oils analyzed within the capsules, the ‘dirty’ sample had the most continuous set of complications. Overall, there was less probability of seeing a compromised capsule with the cleaner concentrate oil samples in the colder environment.”

In sum, the study found that for greatest capsule stability, producers should use high-grade HPMC vegetarian capsules, fill them with a very pure concentrate, and then keep the product out of the heat and stored in recommended temperature controlled environment.

What this means for the Cannabis Industry

We can and will solve the capsule stability issue. With a new found understanding of capsule stability, we now have the capability to enforce strict dosage standards, not just in New York State but also across all 23 medical marijuana states. Our industry can now offer patients accurately dosed medical cannabis in a format that has been the standard for medicine delivery for over 60 years. In doing so, we will be one step closer to legitimizing our industry and broadening marijuana’s medicinal appeal.

It is clear to me that we are a long ways from maxing out on the potential use of this plant. Every time a new innovation is discovered, people start to think that we now fully understand the medicinal benefit of the plant; this just isn’t the case.

There is still a great deal of research to be conducted, and innovative technologies and methods to be discovered.

Jonathan Gilinski

Founder & CEO

[email protected]

Jonathan Gilinski

Jonathan Gilinski

About the Author

Jonathan Gilinski is an authority in the hard-capsule field with more than 20 years of experience in capsule manufacturing and encapsulation. Over ten years ago, Jonathan founded Capsuline, a company which has become a top provider of capsule products worldwide. At Capsuline he further developed his detailed knowledge of all aspects of the hard capsule manufacturing process, including capsule formulation, proper material handling, product design, branding, equipment function and more.

The Capsule Consulting Group (TCCG) is Jonathan’s latest venture where he operates as Founder & CEO. TCCG utilizes Jonathan’s expertise and extensive network of industry resources to provide capsule consulting services to the emerging cannabis markets. Jonathan can be reached at [email protected]

This Post Has One Comment
  1. Not to take exception with Jonathan and his perspective but, the NY legislation is not the holy grail of cannabis legislative initiatives. It is cumbersome, overloaded with oversight by a department of health that in fact has no real experience in the space instead relying on the limited experience of a few well placed advisory resources, and very restrictive as to what few products are allowed. This in addition to the State of New York (DOH) having final say over pricing? I am not sure but that sounds to me like all kinds of headaches for the five chosen. I like a lot of what Jonathan has alluded to but feel ‘nirvana’ is not currently achieved in this initiative and that the losers (38) in this race may end up being the winners in the long run. Thanks Jonathan; look forward to meeting you in the future!

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