The Company has optioned the exclusive worldwide rights for a novel patent pending technology titled Modified Alginate Hydrogels for Therapeutic Agents (USPTO Pending #15/606/769 & PCT Pending # PCT/US/17/34748) and a second filing titled Modified Carbohydrates, Compositions Comprising the Same, and Methods of Making and Using the Same (PCT Pending # PCT/US/17/40283).
The technology revolutionizes how prescription and non-prescription medications, veterinary medicines, probiotics, and dietary supplements are delivered orally while being protected from damaging stomach acids and enzymatic actions. This technology also creates an entirely new mechanism of time release. Where maximum time release is required the hydrogels can be coated with a naturally derived mucoadhesive polymer.
Once a drug is embedded in the hydrogel it is inseparable from the hydrogel, thereby eliminating the concentration, dilution, or nasal inhalation of the powdered drug. This is critically important when dealing with controlled substance drugs such as opioids and morphine derivatives, antidepressants and stimulants.
The patent filing describes the unique chemistry of the hydrogel technology as well as a broad range of potential uses and applications. For example, the hydrogels can be used to deliver prescription and non-prescription pain relief medications that often cause nausea and stomach upset when released in the stomach.
The hydrogels can be supplied in RSI’s patent pending straw-like pouches (see Abuse Deterrence Packaging Technology) and can be mixed wherein fast acting hydrogels, and slow extended time release hydrogels, are contained in the same pouch proportioned to the specific drug application.
The tasteless, colorless, and odorless hydrogels can be delivered in an edible form for drug delivery to humans and animals, in hermetically sealed disposable pouch style straws, or placed in standard capsules. If desired, particularly in pediatric and elderly applications, the pouches can also contain flavor crystals.
The hydrogels are small enough (300-500um) that delivery can be readily accomplished where water is contaminated or not available at all. They are easily swallowed by saliva alone.
Abuse Deterrence Tracking Technology
An important step in improved abuse-deterrent technology for drug products such as opioids, antidepressants and stimulants, RSI’s hydrogel beads are supplied in patent pending* individual dose, straw-like pouches that are sealed and clearly marked with coded serial identifiers (CSIs). The hydrogel beads can also be provided in standard capsules, however, standard capsules do not provide space for the placement of millions of different individual coded serial identifiers.
The coded serial identifier pouches provide critical information such as the name of the prescribing physician, along with tracking information including the date and location of manufacturer, distributor and retail pharmacy name and address.
These individual pouches are then placed in factory-sealed and coded bottles provided to the pharmacy in frequently prescribed quantities. The pharmacy adheres their label to the unopened factory bottle. The pharmacy does not dispense the doses from a large bottle and handle individual dose pouches. This eliminates another weak link in the distribution chain.
This packaging technology serves as a disincentive for practitioners who overprescribe opioids or other addictive medications.
*”Imprinted Medical Packages and Methods of Making and Using the Same” (Pending #US/62,555,168)