OUR UNIQUE EDGE
Our patented drug delivery platform is built to be versatile, not restrictive. It seamlessly incorporates any API meeting our baseline criteria into rapid-dissolving mucosal thin films to deliver exact-dose efficacy that patients can actually tolerate.
OUR SCIENCE-DRIVEN FORMULATION FRAMEWORK
Step 01
Preformulation (1 to 2 weeks)
Objective: Establish a robust scientific foundation by identifying the optimal API-excipient strategy and defining the Target Product Profile (TPP).
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Key Activities: Evaluating the active pharmaceutical ingredient (API) through rigorous screening of its potency, solubility, and thermal stability, alongside excipient testing to ensure optimal polymer compatibility, polarity, and mucoadhesivity. Simultaneously, the team defines the Target Product Profile (TPP) by outlining the exact clinical indication, target population, dosing frequency, and ideal release profile required for the film.
Step 02
Formulation Optimization (1 to 3 weeks)
Objective: Iteratively refine the formulation to achieve a high-quality film that meets precise physical and performance metrics.
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Key Activities: Assessing the physical characteristics of the finished film by measuring its visual homogeneity, folding endurance, thickness, mass, and mouthfeel. This physical assessment is coupled with rigorous performance screening, utilizing disintegration, dissolution, and adhesion testing to guarantee that the formulation will function effectively on the target mucosa.
Step 03
Batch Release Testing (2 to 3 weeks)
Objective: Ensure every compounded batch meets rigorous quality and regulatory standards prior to advancing to human or animal trials.
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Key Activities: Executing comprehensive finished product testing. This includes verifying drug loading and content uniformity (ensuring strict pharmacopeia compliance), assessing mechanical properties, water activity, moisture content, real-time/accelerated stability, and microbial safety.
Step 04
In Vivo Testing (months, as necessary)
Objective: Demonstrate real-world safety, efficacy, and tolerability in the target population (human or veterinary) to support regulatory pathways and commercialization.
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Key Activities: Conducting comparative studies against existing therapies, executing pharmacokinetic (PK) studies to prove systemic absorption, validating clinical endpoints, and ensuring the study design is fully regulatory-compliant.
