Austin-based Mystic Pharmaceuticals, Inc. is now shipping its Javelin sublingual drug delivery device that incorporates Mystic’s proprietary VersiDoser and VRx2 platform technology. Javelin dispensers are available in mono-dose and multi-dose configurations.
Mystic’s sublingual and buccal delivery systems provide non-invasive, dosing of drugs, peptides, proteins and enzymes through mucosal surfaces in the oral cavity, a route that avoids first pass metabolism, provides rapid systemic uptake into the body and can be self-administered by the patient.
Javelin applications include precise dose delivery for liquid, powder and reconstituted powder pharmaceutical, bio-pharmaceutical and biologics medications, for pain management, hormone replacement, seizures, anxiety & depression, allergy, nicotine replacement the delivery of drugs, and proteins and peptides for pain, cardiovascular, allergy, seizure, sedation, emesis, hormones, and diabetes, as well as vaccines. All Javelin dispensers incorporate patient-centric ergonomic design features such as side actuation, no priming and contoured surfaces to facilitate ease of use, comfort and safety for the patient.
Sublingual Delivery Systems
A paper titled “Buccal delivery systems “ by J. Hao and P.W,.Heng of the National University of Singapore Department of Pharmacy, published in the journal Drug Development and Industrial Pharmacy, notes that “The oral cavity is an attractive site for drug delivery due to ease of administration and avoidance of possible drug degradation in gastrointestinal tract and first-pass metabolism.
According to Pharmainfo.net’s Manish S. Wani, advantages of drug delivery via the buccal lining include bypass of the gastrointestinal tract and hepatic portal system, increasing the bioavailability of orally administered drugs that otherwise undergo hepatic first-pass metabolism. Additionally, the medication is protected from degradation due to pH and digestive enzymes of the middle gastrointestinal tract.
Also cited are improved patient compliance due to the elimination of associated pain with injections; administration of drugs in unconscious or incapacitated patients; convenience of administration as compared to injections or oral medications, relatively rapid onset of action compared with the oral route, faster initiation and decline of delivery than with transdermal patches, less variability between patients, resulting in lower intersubject variability as compared to transdermal patches, and the large contact surface of the oral cavity contributes to rapid and extensive drug absorption
Limitations of buccal drug delivery cited by Mr. Wali include rapid elimination of drugs due to the flushing action of saliva or ingestion of food may lead to the requirement for frequent dosing, non-uniform distribution of drugs within saliva on release from a solid or semisolid delivery system could mean that some areas of the oral cavity may not receive effective levels, patient acceptability in terms of taste, irritancy and ‘mouth feel’ is an issue, and the relative impermeability of oral cavity mucosa with regard to drug absorption, especially for large hydrophilic biopharmaceuticals.
Another paper, “Buccal Mucosa As A Route For Systemic Drug Delivery: A Review,” by Amir H. Shojaei of the University of Alberta Faculty of Pharmacy and Pharmaceutical Sciences at Edmonton, Alberta, Canada, published by the Canadian Society for Pharmaceutical Science’s Journal of Pharmacy & Pharmaceutical Science, notes that the buccal region offers an attractive route of administration for systemic drug delivery, thanks to the buccal mucosa having a rich blood supply and being relatively permeable.
Dr. Shojaei, formerly an Assistant Professor of Pharmaceutical Sciences at Texas Tech University, School of Pharmacy, Amarillo, notes that amongst the various routes of drug delivery, oral route is perhaps the most preferred by patients and clinicians alike. However, he observes that peroral administration of drugs has disadvantages such as hepatic first pass metabolism and enzymatic degradation within the GI tract, that prohibit oral administration of certain classes of drugs especially peptides and proteins. Dr. Shojaei concludes that buccal drug delivery is a promising area for continued research with the aim of systemic delivery of orally inefficient drugs as well as a feasible and attractive alternative for non-invasive delivery of potent peptide and protein drug molecules.
Mystic has innovated two unique delivery platforms to solve a variety of patient adherence, drug delivery and package performance challenges associated with buccal administration. Their VersiDoser Delivery Platform is designed to package and deliver liquid drugs, biopharmaceuticals and biologics, while the VRx2 Delivery Platform is designed for powders or reconstituted powders.
TheVersiDoser Delivery Platform is designed to package and deliver liquid drugs, biopharmaceuticals and biologics. With proprietary Vjet dispensing technology, the platform delivers precise, efficient dosing of liquids across a wide range of volumes and fluid properties.
The VRx2 Delivery Platform is designed to package and deliver powders and combination liquids. Also using Vjet dispensing technology, the VRx2 offers unit dose packaging of powders dispensed as powder, or auto-reconstituted inside the device, and dispensed as a liquid as an integrated aspect of the device operation by the patient.
Mystic’s delivery systems utilize a novel unit dose blister technology that can be precisely calibrated to deliver a targeted dose in liquid or powder form. VersiDoser liquid delivery systems can be calibrated to dispense a precise dose spanning a range of 25 to several hundred microliters. VRx2 powder delivery systems can be configured to dispense a powder or auto-reconstitute a powder to a liquid within the device at the time of self administration. Auto-recombination of two separately packaged liquids at the time of self-administration is also supported.
VersiDoser and VRx2 sublingual delivery devices are available in several different configurations including mono-dose disposable, mono-dose reloadable, and multi-dose systems.
Each Javelin dispenser is customized to the pharma manufacturers Target Product Profile and technical specifications through Mystic’s product integration process. Utilizing the VersiDoser or VRx2 Delivery Platform technology, Mystic can cost effectively provide an optimized commercial product that delivers value for both the patient and the pharmaceutical manufacturer. This approach eliminates the compromises that often arise with commodity off the shelf dispensers.
Each dose is individually packaged in a unit dose blister and pre-loaded into a device or into a cartridge that can be easily loaded by the patient at the time use. Mystic’s engineered multi-layered aluminum foil laminates provide barrier properties against oxygen, water vapor, light transmission and microbial contamination to ensure long-term stability and sterility of the product in both nominal and austere environmental conditions.
Key performance features of VersiDoser and VRx2 delivery solutions include:
- Precise dosing that can be calibrated to a specified dose volume
- Side actuation dispenser device for ease of use
- No device priming required
- User independent device actuation
- Dose counter
- Optimized dispense
- Metal free fluid delivery path
- Tamper resistant packaging
- Lock Up design to prevent mis-use or re-purposing after use
- Compact design form factor making the device easy to store, transport and carry
- Patient-centric ergonomic design facilitates first use
- Commercially scalable, cost efficient
Both the VersiDoser and VRx2 delivery platforms offer a variety of device configurations including disposable or reloadable multi-dose, bi-dose or mono-dose options; and both platforms are designed for optimization to meet your targeted product and market requirements.
Mystic will produce and fill Javelin Sublingual dispensers at its Austin, Texas manufacturing facility and internationally through its strategic manufacturing partners. For more information visit:
Mystic Pharmaceuticals, Inc.
Journal of Pharmacy & Pharmaceutical Science
Drug Development and Industrial Pharmacy
Mystic Pharmaceuticals, Inc.