One of the fundamental limitations of conventional oral drug delivery is first-pass metabolism.
When a drug is swallowed, it passes through the liver before reaching systemic circulation.
For many APIs, this results in substantial pre-systemic clearance, high inter-patient variability, and reduced bioavailability—often requiring higher doses and more frequent administration.
These challenges are well documented across multiple therapeutic areas and are a key reason why systemic exposure from oral dosing is often unpredictable, particularly in chronic use.
That is why buccal systemic absorption is so attractive.
Buccal delivery enables drugs to enter systemic circulation directly through the oral mucosa, bypassing hepatic first-pass metabolism. Published clinical and pharmacokinetic studies consistently demonstrate that buccal administration can:
However, these advantages have not translated well into extended-release products.
In practice, buccal delivery faces a major unresolved limitation, particularly for release durations beyond short time windows. Most existing buccal systems rely either on unidirectional absorption at the adhesion site or on uncontrolled multidirectional exposure, which often includes gastrointestinal loss.
The primary reason for these limitations is that most current buccal technologies are passive systems.
They rely entirely on the patient’s baseline saliva production to dissolve the drug, as well as on limited contact between the dosage form and the buccal mucosa to support absorption. This variability directly impacts dissolution, absorption, comfort, and patient adherence.
Extended residence time further exacerbates these issues. As a result, despite decades of research, there are very few marketed buccal products that demonstrate reliable systemic extended release beyond approximately 30 minutes.
That is exactly the gap our technology addresses.
Our technology enables controlled multidirectional delivery, in which the drug is released into saliva, with primary systemic absorption occurring across the buccal mucosa, and only a minimal fraction—ideally as small as possible—lost to hepatic first-pass metabolism.
Our buccal mucoadhesive extended-release technology is designed to be active, stable, and patient-centric.
In effect, we transform the mouth from a passive conduit into an active, scalable systemic absorption interface.
For patients, this translates into:
For products based on our technology, this results in:
Our technology directly addresses the fundamental biological and usability barriers that have historically limited buccal extended-release drug delivery.
Saliva Stimulation Mechanism – Using controlled-release of agents that enhance saliva production and secretion via gustatory and mechanical stimulation of salivary glands in the buccal region. This mechanism addresses the fundamental challenge of maintaining adequate moisture for dissolution without relying solely on baseline saliva production.
Sequential Release Architecture – Employs a multi-phase release profile where flavoring agents and active ingredients are released in alternating patterns to prevent sensory adaptation (dysgeusia/taste desensitization), maintaining continuous physiological stimulation throughout the usage period.
Lipophilic Solubilization System – Incorporates pharmaceutical excipients that enable the dissolution and absorption of lipophilic APIs (logP >3) in the aqueous salivary environment, expanding the range of compatible active ingredients beyond traditional hydrophilic compounds.
Taste-Masking Technology for Prolonged Release – Utilizes controlled-release coatings and complexation strategies to minimize perception of bitter or unpleasant-taste of the APIs.
