How the Cannabis Industry Can Benefit from Leveraging Pharmaceutical Resources

February 3, 2020
Christian Sweeney

,
Shehzad Hoosein

Volume 3, Issue 1

Currently in the cannabis industry, the standards and benchmarks for drug delivery, analytics and testing, consumer reporting, and packaging are basic in nature with substantial room for more sophistication and technology. Here’s how it can be improved.

Currently in the cannabis industry, the standards and benchmarks for drug delivery, analytics and testing, consumer reporting, and packaging are basic in nature with substantial room for more sophistication and technology. In these areas, the cannabis industry can immensely benefit from leveraging the hundreds of years of pharmaceutical study and research. Here’s how.

With the rise of cannabis legalization across North America has come a rise in the prevalence of niche expertise in the cannabis sector. As cannabis enterprises and partnerships continue to form across the continent, the industry as a whole is maturing and refining itself at a rapid rate, but with what benchmarks?

Currently in the cannabis industry, the standards and benchmarks for drug delivery, analytics and testing, consumer reporting, and packaging are basic in nature with substantial room for more sophistication and technology. In these areas, the cannabis industry can immensely benefit from leveraging the hundreds of years of pharmaceutical study and research. Here’s how.

Drug Delivery

The route of cannabis administration has a vast impact on efficacy, duration, and time of onset. These are critical components when designing any specific cannabis-infused product. What the cannabis industry needs from the pharmaceutical industry is the insight into methods the pharmaceutical experts use to make these molecules more bioavailable for consumer consumption, which can lead to more accurate information on dosing and increased efficiency of cannabis intake. Additionally, the cannabis industry can also benefit from adapting current pharmaceutical drug delivery systems, such as nasal spray devices or microneedle patches. Combining both, the cannabis industry has the power to greatly strengthen current drug delivery practices.

For decades, biomedical engineers have researched various ways in which certain drugs can be delivered to the human body. How a drug moves through cells and tissues dictates how it’s delivered, at what speed, the form in which the medicine takes, and how it eventually impacts the user. While the traditional recreational cannabis market has focused on user experience often at the expense of efficacy, truly therapeutic products must still ensure patient compliance by being discrete, minimally invasive, and high in sensory acceptability.

When it comes to delivery method several variables are at play including routes of delivery, delivery systems (delivery devices and formulated delivery vehicles), and targeting strategies. Any variation of these elements can result in unwanted side-effects. Most negative side effects occur when a drug comes into contact with tissues that are not the target of that specific drug. To decrease side effects, clinicians have often utilized medicine that locally targets areas of the body affected by disease. By treating an ailment locally it minimizes those unintentional interactions, and in turn results in fewer negative side effects. This type of targeted treatment also lessens the amount of medicine needed and increases the likelihood of positive treatment outcomes.

When it comes to route of delivery, medications are typically delivered in the following ways: swallowing, inhaling either through the nose or mouth, absorbing through the skin (topical) or sublingually through tissues within the mouth, or by intravenous injection. While some exhibit higher patient compliance than others, not all delivery methods are created equal. In addition, while some delivery methods require formulations that are less stable, requiring demanding storage conditions, others are so simple they can be administered at home by the patient themselves.

One of the most interesting areas for further research and development is the transdermal route of delivery. The pharmaceutical industry has already optimized the current transdermal patch delivery mechanism, and is now looking towards novel transdermal delivery systems, such as microneedle. As previously referenced, microneedle drug delivery is a relatively new pharmaceutical method that delivers medicine topically through the skin. Microneedle patches consist of dozens of microscopic needles that can penetrate the skin to deliver medicine transdermally with fast uptake and high bioavailability. The National Institute of Biomedical Image and Bioengineering (NIBIB) has reported that they are currently developing a patch containing dissolvable microneedles that could serve as vaccine delivery. Unlike its traditional counterpart, these patches will be easy to use and do not require special storage or disposal methods, and thus could effectively be used by the patient at home. This method could also greatly serve communities with fewer resources and storage options needed for traditional, refrigerated medicine.

In addition to drug delivery devices, formulated delivery vehicles also greatly impact the efficacy of certain drugs. In recent months, nanotechnology researchers have found promising results when directly injecting nanoparticles into infected tumors. This could effectively replace a type of gene therapy that uses viruses, which can have negative side effects and unexpected outcomes. Other researchers are developing formulated drug delivery vehicles via bacteria that have magnetic and oxygen sensing navigation. It is evident that optimized drug delivery systems, consisting of validated delivery devices, coupled with formulated delivery vehicles is an area the pharma industry has significant expertise. If this knowledge and technology were applied to cannabis therapeutics, it could open the door to a host of new treatment opportunities.

Targeting strategies, which refer to local or systemic delivery, is another focus of research that could greatly benefit the cannabis industry. Pharmaceutical drugs typically target organs, tissues, infected cells, or the structures within the cells.

By implementing traditional pharmaceutical practices the cannabis industry has the opportunity to improve the therapeutic outcomes of newly developed products. Being able to utilize pharmaceutical data to minimize unwanted side effects and negative drug interactions could dictate the ways cannabis is ingested or applied. Improving onset time and bioavailability through unique drug delivery technology such as microneedles and nanoparticles will allow for the creation of a new generation of highly efficacious and minimally invasive cannabis derived therapies.

Analytics and Testing

A cannabis-chemist successfully creates a more effective administration route, but how do they measure against industry standards? The pharmaceutical industry, because of U.S. Food and Drug Administration (FDA) oversight, has developed a rigorous approach to testing and reporting, ensuring that all information from medical studies, laboratories, and clinical trials is public and reported in the same database with the same benchmark standards. Currently, the cannabis industry does not have industry metrics because of the lack of FDA regulations, making analysis and reporting very difficult at the clinical level. If the cannabis industry can adopt the pharmaceutical industry’s ability to efficiently create a set of industry metric standards, anticipating the rigor of strict FDA regulations in the meantime, the creation of new products, distribution methods, and therapy techniques will expand at a rapid rate. By using FDA best practices in the development of new products, the cannabis industry can insure product integrity and improve consumer perception about the reliability of cannabis therapies.

As it stands today, the FDA regulates manufacturing of pharmaceuticals mainly through current good manufacturing practices (cGMPs). The FDA states (1)

“cGMPs provide for systems that assure proper design, monitoring, and control of manufacturing processes and facilities. Adherence to the cGMP regulations assures the identity, strength, quality, and purity of drug products by requiring that manufacturers of medications adequately control manufacturing operations. This includes establishing strong quality management systems, obtaining appropriate quality raw materials, establishing robust operating procedures, detecting and investigating product quality deviations, and maintaining reliable testing laboratories.”

When implemented properly, these standards and regulations aim to maintain the integrity of the product, and protect the consumer from drug contamination, deviations, errors, and failures-among other potential dangers associated with consuming pharmaceutical drugs.

It’s important to note that the implementation of cGMPs are flexible in nature, allowing each manufacturer to utilize its own design, methods, and procedures to adhere to the industry standards. Despite modern technology arming companies with the tools they need to achieve the desired results, not all manufacturers have access to the same resources. This means that the FDA is less concerned with how a manufacturer achieved industry standard, only with the fact that they met the requirements in the end product. It’s also important to note that cGMPs are an industry minimum standard, and leading manufacturers are implementing new processes and systems to ensure and increase the quality standard of pharmaceuticals on the market.

The FDA also enforces standards by implementing mandatory inspections across pharmaceutical manufacturing facilities worldwide. These inspections follow a standard set of procedures to evaluate both facilities that produce active ingredients as well as final products. The FDA relies on these inspections in conjunction with reports filed by the public and the industry regarding potentially defective or dangerous products on the market.

By creating a central organization and set of standards for manufacturers to abide by, the FDA made an infrastructure to protect the general population. As one would imagine, a general consumer isn’t, and shouldn’t have to be, armed with the knowledge to determine whether or not a pharmaceutical drug is safe. When considering cannabis, the expectations should be no different. Cannabis can take a lesson from pharmaceuticals by creating standards that are required by manufacturers. A number of organizations such as ASTM International have begun the development of these standards, but buy-in from key industry stakeholders is required to ensure those standards are met.

Consumer Reporting

Currently, in the pharmaceutical industry, there is a structured protocol to consumption and patient reporting on outcomes. A patient will be prescribed a certain dosage, complete dosage properly, and report back to the doctor if the prescription worked or not. When using cannabis as a medical tool, the reporting system between doctor and patient is at a very early stage of development. The cannabis industry needs a more structured feedback loop between doctor, patient, and dispensary. If adopting current protocols that the pharmaceutical industry already has in place for successful feedback retrieval, a cannabis professional will be able to better understand, and improve, cannabis usage for various medical purposes.

The Center for Drug Evaluation and Research (CDER) is a division of the U.S. FDA that monitors most drugs as defined in the Food, Drug, and Cosmetic Act. The primary job of the CDER is to evaluate drugs before they can be sold to the general public, and to monitor the use of drugs for new and unreported health risks once they’ve been released. If the CDER determines there are new, unanticipated risks that were not previously reported it’s their responsibility to take necessary actions including informing the public, changing marketing materials and labels, and even sometimes removing the product from the market.

As an extension of this evaluation, the CDER also regularly consults with the American people to help make decisions about the drugs they are using. This, in conjunction with MedWatch, the FDA program that enables health care professionals and consumers to report suspected problems with their drugs, creates a comprehensive reporting system that allows the FDA to ensure the drugs that it approves consistently meet and abide by industry quality standards and minimums. The CDER often holds public meetings inviting experts and consumers alike to gather input regarding certain drugs that are being evaluated. To remain transparent, the CDER announces most decisions in advance of actually finalizing them so the public can provide input and suggestions before anything is set in stone. Those who typically provide insight are the general public, members of academia, industry and trade associations, consumer interest groups, and relevant professional societies. The CDER also holds annual meetings with patient and consumer groups, professional societies, and professional trade associations to ensure they’re receiving proper feedback regarding their current and future initiatives. This has driven stronger and stricter policies over the years to promote the center’s mission, which is “to ensure that the benefits of drug products made available to the public outweigh all known risks.”

As cannabis gains in prevalence amongst consumers, there needs to be a system in place that allows them to relay drug feedback to their doctor and to dispensaries. For the cannabis industry to continue growing and evolving, this information needs to be protected as it is relayed back to the proper regulatory programs and organizations. Public events and regularly scheduled meetings will provide a safe space for consumers and industry professionals alike to provide feedback on current products, and shed light on voids that have not yet been able to be addressed by cannabis. Transparency around decision making ahead of finalization will ensure that consumers know what to expect with current and future initiatives, just as the CDER does with pharmaceuticals today. This will also help to create a cohesive community around the use of cannabis, encouraging communication within the space to elevate the industry as a whole.

Packaging

The pharmaceutical industry coined child-resistant packaging in the 1950s, making it an industry standard across all fields. The cannabis industry is slowly moving to mandatory child-resistant packaging, but not fast enough. With a variety of products now on the market, current cannabis professionals cannot always find the needed child resistant closure (CRC) packaging for the products on the market (for example, infused lip balm). If the pharmaceutical industry offers their current technology and packaging techniques to the cannabis industry, this will rapidly expand the amount of safety technology for consumers, creating yet again, another industry standard.

According to the Consumer Products Healthcare Association (CPHA) (2), “Child-resistant (C-R) packaging, also referred to as ‘special packaging,’ is used to reduce the risk of poisoning in children via the ingestion of potentially hazardous items including certain prescription and over-the-counter (OTC) medications, pesticides, and household chemicals. The U.S. Consumer Product Safety Commission (CPSC) has the authority to regulate C-R packaging via the Poison Prevention Packaging Act (PPPA) which became effective in 1972.”

There are several ways in which the industry determines what is and isn’t CR approved packaging. First and foremost, pharmaceuticals containing specific common ingredients, such as acetaminophen, aspirin, diphenhydramine, and ibuprofen (to name a few), must be contained within child resistant packaging.

The United States Pharmacopeial Convention has established requirements for drug containers that are compliant with child resistant legislation. Each package has its own set of standards for drug manufacturers and marketers. For capsules and tablets, regulations typically relate to the container in which they come, requiring it to be tight, well-sealed, and often light-resistant. For injectables, construction materials are often addressed, but also pertain to storage, and single or multiuse function. Something interesting of note is that the potential intensity of the medicine or drug, as well as the state the patient will be when they’ll be ingesting the drug, is taken into consideration when evaluating the complexity and accessibility of the packaging. For example, inhalation drug products are typically intended for respiratory-tract compromised patients, which is directly reflected in the complexity of the packaging. While inhalation drug products rank among the highest degree of concern associated with the administration method, the fact that the patient will be potentially compromised of oxygen or optimized respiratory function when trying to access the medicine is taken into consideration when designing the packaging. But before diving into packaging, it’s important to know about the most common methods of consumption when it comes to cannabis.

The most common forms of cannabis consumption are through inhalation, oral ingestion, sublingually, and topically. According to the U.S. Department of Health and Human Services, the FDA, the CDER, and the Center for Biologics Evaluation and Research (CBER), oral, sublingual, and topical fall within the lowest level of concern when it comes to both administration and thus packaging. Nasal administration falls just below inhalation in terms of level of concern. Following these guidelines, we can look into specific packaging that could contain cannabis in its most commonly consumed forms.

Pharmaceutical packaging is constantly innovating, which will allow cannabis to follow suit. Closure systems with child-proof screw caps and tamper-proof sealing strips prevent children from opening a bottle while the adult can still access the medication. Tear-resistant packaging could be used for cannabis gum and chews. Certain pharmaceutical packaging even requires activating, which prevents children from taking out tablet-form medicine. In this case, a specific mechanism is integrated into the box that makes sure tablets can only be dispensed one at a time. To get more than one tablet, patients have to use both hands-one to slide the button to the side and hold it in place, and the other to grab the tablet. Once the hand is removed, the container automatically reverts to its initial position.

Conclusion

As it stands today, cannabis is evolving at an alarmingly fast rate. With widespread adoption comes cut corners as various players scramble to get their product to market. It is then the responsibility of leading industry players to implement and incorporate organizations, regulations, and standards to maintain the efficacy of the industry, products, and consumers.

First and foremost, the industry needs to establish and appoint a regulatory body to implement standards and quality minimums that apply to all brands and products within the industry. This body will focus on the ingredients, products, and analytical and production methods used to make various cannabis products. Research done within this body will focus on optimizing products, taking things such as routes of delivery, delivery vehicles, contents, and targeting strategies into consideration.

As brands bring their products to market, new methods of analytics and testing will come to the forefront, driving new regulations which will ensure all products and processes are up to industry standards. With more products coming to market, consumer reporting will play an increasingly critical role in the developments of new cannabis treatments. The ways in which consumers relay this information will ensure their feedback is securely stored for consideration when evaluating the state of the market. All of these elements will run smoothly in the background, ensuring that the final product is secure and safe once it makes its way to the consumer.

Just as with pharmaceuticals, it is not the responsibility of the consumer to know or understand the efficacy or the product or the processes in which its been through. However, with such a lucrative and growing industry, it is imperative we create a series of systems and regulations to ensure that cannabis remains safe for consumers. With the undeniable medical and recreational benefits that cannabis has proven to address, being able to utilize research and findings from the pharmaceutical industry will help the cannabis space to thrive to its utmost potential for years to come.

References:

  1. https://www.fda.gov/drugs/pharmaceutical-quality-resources/current-good-manufacturingpractice-cgmp-regulations.
  2. https://www.cpsc.gov/Regulations-Laws--Standards/Statutes/Poison-Prevention-Packaging-Act/.

About the Authors:

Christian Sweeney is the Vice President of Science and Technology at Cannabistry in Denver, Colorado. Shehzad Hoosein is the Executive Vice President and VP of Research & Development at Cannabistry. Direct correspondence to: contact@cannabistry.com

How to Cite This Article

C. Sweeney and S. Hoosein, Cannabis Science and Technology3(1), 30-33 (2020).

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