Dry Powder Inhalers and THC
5/6/15 There is a huge amount of interest focused on the medical use of marijuana these days. Tetrahydrocannabinol (THC) is the chemical responsible for most of marijuana’s psychological effects, and changes behaviour by binding to receptors on nerve cells, which then respond with a change in activity.
Cannabinoid receptors are concentrated in certain areas of the brain associated with thinking, memory, pleasure, coordination, and time perception. There are also cannabinoid receptors on nerves in other parts of the body, and these can help relieve pain, avoiding the need to use opiates such as morphine which can have substantial and undesirable side effects. Indeed it is in the area of chronic pain relief that the use of marijuana is gaining momentum.
The debate on the possible medicinal benefits of marijuana is not new.
For nausea and vomiting associated with cancer chemotherapy, anorexia and cachexia in HIV/AIDS, chronic (especially neuropathic) pain, spasticity in multiple sclerosis, and spinal cord injury there is strong evidence for medical benefits. But there is also a growing body of research that suggests its use is positive in the treatment of glaucoma, epilepsy, asthma, dependency withdrawal, psychiatric symptoms, autoimmune diseases, and inflammation.
What is obvious is that in the short- to medium-term, the use of marijuana in medical treatments will grow. The regulatory environment around its use is being relaxed, and opportunities exist for big and small pharma alike to capitalize on its use.
So then the question becomes how to deliver the drug. In common with a number of medicines, the inhalation route is one that should be looked at as an efficient and cost-effective way of administering medical grade marijuana, and the use of dry powder inhalers (DPIs) in particular could be an attractive option.
DPIs have been available for delivering drugs to the lungs for over 40 years, but more recently there has been a big increase in DPI development, resulting partly from recognized limitations in other types of inhaler devices such as the aerosol-based inhalers commonly called metered-dose inhalers (MDIs).
DPIs are now commonly used for asthma and COPD therapy, and more and more applications are adopting the delivery mechanism such as for antibiotics and peptides/proteins. Alongside the development of device functionality there are also important developments in more and more sophisticated formulations that disperse easily in the inhaled air-stream and which can be delivered by more simple inhaler devices.
There is a growing body of thought that DPIs could become the device category of choice for a wide range of therapies involving both local and systemic drug delivery, and medical grade marijuana is bouncing around near the top of this list. Inhalation in general is seen as a fast and effective way to administer drugs, and it is seen that lower doses of drug can be used when inhaled to achieve the same therapeutic effect.
Obviously, there is an illegal market for marijuana as a recreational drug, and as such there is a necessary focus by pharma companies and regulatory bodies alike on ways in which it can be administered that reduce the chance of it being resold on the black market. Administering marijuana via DPIs means that tiny doses are used compared with alternative administration routes, and as it is in powder form, it is not an attractive target for illicit distribution.
DPIs in particular are seen as easier to use than MDIs, which are also expensive to manufacture, and are attracting more and more regulatory attention most especially centred around their use of propellants.
Beyond the speed of drug action and reduced dosage needed using DPIs, they are also typically easy to carry, handle, and use, and require no co-ordination from the patient, drug delivery relying solely on inhalation. When the patient activates the DPI and inhales, air flow through the device creates shear and turbulence which is introduced into the powder bed and fluidizes the powder, which then enters the patient’s airways. When excipients are used, drug particles separate from the carrier particles and are carried deep into the lungs, while the larger carrier particles impact in the oropharaynx and are cleared.
Micro Engineering Solutions (MES) has significant experience in drug delivery, and has worked with an array of medical device OEMS and pharmaceutical companies on every conceivable route to drug administration from transdermal options, needle micro arrays, conventional single and multi-use needle devices, and many more.
In the area of inhaler technology, MES has the exclusive worldwide rights to sell one of the most innovative DPIs available today, the DoseOne™ Single Dose Powder Inhaler.
Development of the DoseOne™ single dose powder inhaler (US Patent #7,832,399 B2 and #8,360,057 B2) required a multi-disciplinary team approach, as any such drug delivery device needs to combine not just design skills, but also software and mechanical engineering capabilities, and expertise in analytical science and industrialisation. MES worked on the DoseOne™ device from concept creation, allowing the design to be sympathetic to the requirements for mass manufacture and regulatory compliance.
As is so often the case, the key advantage of the DoseOne™ is its simplicity. Through the expeditious use of design and micro manufacturing expertise, DoseOne™ is an easy to manufacture and assemble 3-component device.
The DoseOne™ is equipped with a simple dose readiness indicator and a dose delivery indicator — which means it conforms with strict FDA patient-compliance regulations previously only attained by expensive MDIs and multi-use DPIs. With the DoseOne™, the potential for a device that can provide a cost-effective and efficient means of delivering medical grade marijuana or other drugs is obvious, and MES is actively looking to pursue its use with any interested pharma manufacturer.
Expertise in micro manufacturing is the key to the success of DoseOne™. Each of the three components that make up the device is easy to manufacture. The simplicity of the device in terms of the number of components used and the ease of assembly are of huge importance as this makes it an inexpensive drug delivery option, costing $0.30 per device at full volume. The ultra precise nature of the design and components also ensures that the device is small, which makes it easy to carry and package for mass drug distribution.
DoseOne™ is a perfect example of what can be achieved if an innate understanding of micro manufacturing design and manufacturing is combined with an understanding of the regulatory environment that exists around drug delivery devices these days, and a realisation of the potential for innovative solutions that cater for mass “self” administration of drugs in a cost effective and safe way.
So for any pharma manufacturer out there that is looking to locate a novel, cost-effective, and efficient drug delivery option for its next generation of medical grade marijuana drugs, or indeed any other preparations that would benefit from administration via inhalation, please email Donna Bibber at donna@microengineeringsolutions.com. For full details of DoseOne™ see www.dose-one.com
ENDS
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