The humble eye dropper has been the predominant delivery system for ophthalmic drugs for over a century, with ninety-five percent of all ophthalmic drugs currently being delivered by this method. However, Mystic Pharmaceuticals, Inc., an integrated pharmaceutical manufacturer specializing in precision unit dose delivery solutions based in the Austin, Texas suburb of Cedar Park, contends that this common, extremely low-tech delivery method creates problems related to the physics of the eye drop, fluid dynamics and gravity.
Mystic claims that relying on gravity to administer a drop to the eye, the liquid must reach a volume of 25-40 micro liters to overcome adhesion to the bottle tip. Since the human eye can only hold about 10 micro liters of liquid, overflow or intake through the body’s natural drainage system, the tear ducts, often occurs. Unintended side effects can follow, such as systemic drug absorption, patient discomfort, eyelid allergic reactions, drug waste and inaccurate dosing.
Mystic Pharmaceuticals, Inc. has announced the availability of its new Arrowfish nasal drug and biologic delivery system as a more sophisticated and precise solution. This next generation delivery system utilizes Mystic’s patented VersiDoser and VRx2 packaging and delivery platform technology.
Mystic’s ArrowFish delivery systems provide non-invasive systemic delivery of drugs, peptides, proteins and vaccines systemically through the nose. This route of administration avoids first pass metabolism, provides rapid systemic uptake into the body and can be either caregiver administered or self-administered by the patient.
“The development phase of the ArrowFish delivery system was accelerated from years to months demonstrating the power of our engineered platform approach,” says Mystic CEO Timothy Sullivan in a release. “ArrowFish applications include the delivery of vaccines for infectious diseases such as flu, Ebola and therapeutics for pain, migraine, seizure, sedation, emesis, hormones and diabetes.”
Mystic’s latest line of advanced nasal delivery devices is offered in a variety of mono-dose and multi-dose configurations. Based on the company’s novel VersiDoser and VRx2 packaging technology, ArrowFish dispensers provide precise dose delivery for liquid, powder and reconstituted powder medications. All ArrowFish 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.
Mystic employs a product integration process to optimize the final configuration of the ArrowFish delivery device to the pharma manufacturers Target Product Profile and technical specifications. Mystics approach eliminates the compromises that often arise with using conventional, off-the-shelf pharmaceutical packaging and delivery systems.
Mystic’s simple yet elegant proprietary VersiDoser Delivery Platform was engineered for delivery of ophthalmic drugs with advantages not available with any other existing device, including ultra-precise and consistent dose delivery across a range of dose volumes starting at 5 microliters, preservative free multi dose packaging, orientation independent operation and unparalleled ease of use for self-administration.
Mystic’s successful efforts to innovate a new approach to ophthalmic drug delivery yielded a much broader solution for significantly improving the packaging and delivery of drugs and biologics for nasal, otic, dermal, buccal, sublingual and other applications.
In bringing these technological advances to patients, Mystic supplied a VersiDoser delivery system to elderly patients participating in a clinical trial treating Age Related Macular Degeneration (AMD) in January 2009. The study showed that patients were able to safely and effectively self-administer the drug MC-1101 throughout the trial at home. Eighty seven percent (87%) of the elderly patients participating in the trial, ranging in age from 50 to 81 expressed a strong favorable preference for the VersiDoser device over traditional eyedrop delivery bottles for its ease of use and comfort.
Presently, Mystic Pharmaceuticals is advancing the development and commercialization of two delivery platforms — VersiDoser and VRx2. Mystic’s 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.
The company has more than a dozen pending/issued patents and is currently advancing collaboration with pharmaceutical manufacturers, biotech companies, and academic research organizations to license the technology and co-develop combination products.
Mystic Continues Focus On Patient-Centric Drug Delivery
Innovative drug delivery technology plays an expanding role in the overall strategy for improving the patient health outcomes. Novel packaging and delivery technology can enable medications that would not otherwise be feasible, reduce drug waste, improve ease of use, and even provide useful information to the patient, such as embedded dose reminders and regimen tracking aids.
According to the company, the VersiDoser Delivery Platform is designed to package and deliver liquid drugs, biopharmaceuticals and biologics. Using Mystic’s proprietary Vjet nozzle dispensing technology, VersiDoser dispensers provide precise, efficientt, and safe 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.
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 targeted product and market requirements.
VersiDoser and VRx2 precision metered dose intranasal delivery systems are designed for non-invasive systemic delivery of drugs or biologics via the nasal route. Nasal delivery applications include pharmaceutical, bio-pharmaceutical and biologics for pain management, migraine crisis, hormone replacement, seizures, emesis, anxiety and depression, hypoglycemia and diabetes, growth deficiency, proteins and peptides, vaccines, immunomodulators and biomedical countermeasures.
Mystic’s nasal 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 nasal delivery systems can be calibrated to dispense a precise dose volume across a range of 25 to 150 l. VRx2 powder delivery systems can be configured to auto-reconstitute a powder to a liquid within the device at the time of self administration or dispensed a packaged powder as a powder and do not require an external motive force such as compressed gas. Auto-recombination of two separately packaged liquids at the time of self-administration is also supported.
VersiDoser and VRx2 nasal delivery systems are available in a variety of disposable, reloadable, mono-dose and multi-dose configurations.
Each dose is individually packaged in our novel unit dose blister and pre-loaded into a device or into a cartridge that can be easily loaded into the device by the end user prior to use. Mystic’s engineered multi-layered aluminum foil laminates provide exceptional 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 ofVersiDoser and VRx2 nasal delivery solutions include:
• Precise dosing that can be calibrated to a specified dose volume
Unit dose aseptic packaging for preservative free formulations
• Primary containers can be terminally sterilized if required
• Side actuation dispenser device for ease of use
• No device priming required
• User independent device actuation
• Configurable spray plume (stream, spray, aerosolized spray)
• 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
• Intuitive design and operation facilitates first use
• Commercially scalable, cost efficient design for manufacturing
Mystic Pharmaceuticals Co-Founder, President & CEO Timothy Sullivan has over the past 37 years created novel technologies, products, and services and grown seven companies, three of which were acquired by major corporations. Mr. Sullivan is co-inventor of Mystic’s proprietary drug delivery technology platforms and responsible for defining both the technological and strategic direction of Mystic. He has recruited and led an accomplished team of scientists, engineers and business professionals through early stage R&D programs, clinical trials and the deployment of a cGMP production facility for Mystics innovative delivery technologies. He holds ten issued/pending patents in the field of drug/biologic packaging and delivery.
Previously, Mr. Sullivan was co-founder of INFUSE Corporation, a strategy-consulting firm where he served as a Principal Consultant for organizations ranging from Fortune 500 companies to emerging companies spanning telecommunications, energy, life sciences, high technology and education. Mr. Sullivan served as a planning and technology commercialization consultant to NASA at the Johnson Space Center and was a Co-founder of the Space Business Research Institute. He was selected as one of the top 100 notable people in the medical device industry in 2008 by MD&DI and served as the 2010 Chairman of BioAustin. Mr. Sullivan serves on the Life Science Advisory Board for the Austin Technology Incubator at the University of Texas at Austin. Mr. Sullivan holds undergraduate and graduate degrees in Business, Physics, and Strategic Foresight from the University of Wisconsin-Oshkosh and the University of Houston.
Mystic will produce ArrowFish nasal dispensers at its Austin, Texas manufacturing facility and internationally through its strategic manufacturing partners. For more information, visit