ARE Labs has been recently granted a Schedule 1 Research Drug License approved by DEA, NIH/NIDA & FDA for research into the feasibility of delivery of THC and THC-CBD via dry powder for Marinol® and Medical Marijuana.
The approved research study entitled Research into the Feasibility for Development of a Therapeutic Respiratory Delivery of THC and a THC-CBD Combination Drug via Dry Powder Inhaler will commence in Q4 of 2015. The study will be conducted at ARE Labs to test the feasibility using a THC dry powder inhaler delivery method for THC and a dual THC-CBD drug combination to the alveolar regions of the lungs. Partial funding for the project will be provided by Serologix, LLC (San Diego, CA). Dry powder aerosol drug development is one of ARE Labs specialties and hopes to mitigate the problems associated with orally delivered THC products. The study will use Marinol developed by AbbVie Pharmaceutical (Chicago, IL) and THC-CBD dual combination drug formulation from whole plant extract.
It has been noted in multiple research articles that THC and cannabinoid extracts from Marijuana have therapeutic benefits for MS patients, chronic pain sufferers, cancer, and AIDS patients. One key objective is to investigate a combination THC–CBD drug that can be delivered in a respirable form to patients that will be more effective, have better dose control, and have enhanced efficiency in delivery and therapeutic effect than current methods. The clinical significance of this development could lead to controlled and reproducible dose delivery and a more effective method for patients that are provided medical marijuana or Marinol® (synthetic THC) which are currently available by prescription.
The proposed dry powder delivery platform would provide direct delivery of drug to the alveolar region of the lungs for direct absorption into the systemic circulation system providing much greater bio-availability than an oral dose, and provide the same therapeutic effect at lower concentrations of delivered drug. The methods to generate the THC dry powder inhaler particles will involve mufti-tiered approach consisting of: Loading and Encapsulation onto to FDA approved excipients, Spray Drying, Jet Milling, Cyclone Elutriation , Charge Masking and Surfactant Coatings. The studies initial phases will investigate loading ratios, particle size, stability and delivery of drug to a human model (ventilated mannequin with controllable tidal volume, I:E ratios and breathing rates).
THC dry powder inhaler feasibility study will be conducted in a two Phase process (Phase 1A & 1B). Phase 1A will be to examine the feasibility of developing a dry powder inhalation formulation using Marinol® (synthetic THC) which is currently available by prescription. Marinol® is currently an orally administered synthetically derived Δ9-THC prescription. Phase 1B will examine the feasibility of developing a dry powder formulation using whole plant extract, as a surrogate, for THC-CBD combination drug dry powder.
Aerosol Research and Engineering is excited to be involved with investigating a new dry powder delivery method for THC and THC-CBD combination drug which will give a wide variety of patients options for managing and treating their ailments with reduced side-effects and lower overall systematic doses compared with currently orally available medications.