Biphasic drug delivery platform visualization
US Patent 10,940,159 B2

The Biphasic Delivery Platform.

A patented immediate-release / delayed-release oral delivery architecture engineered to optimize the pharmacokinetic performance of short half-life pharmaceuticals — from a single, once-daily dosage form.

1
Oral dose
2
Release phases
24h
Therapeutic window
505(b)(2)
Regulatory pathway
The Challenge

Short half-life drugs are commercially constrained.

Many clinically valuable small-molecule drugs share a common limitation: a short plasma half-life. Standard immediate-release formulations rise to a rapid peak, then decline below therapeutic exposure long before the next scheduled dose.

The downstream consequences are commercial as well as clinical — multiple daily dosing, peak-to-trough fluctuations, adherence challenges, and a ceiling on differentiated product positioning.

Inside the Dosage Form

Two engineered populations, one capsule.

The biphasic architecture co-formulates uncoated immediate-release granules with enteric-coated delayed-release beads — each tuned to release at a distinct point along the GI tract.

  • IR granules
    Uncoated, dissolve on contact in the stomach.
  • DR beads
    pH-triggered enteric coating delays release until the targeted intestinal window.
IMMEDIATE RELEASEuncoated granules · rapid onsetDELAYED RELEASEenteric-coated · pH-triggeredpolymer coat
Mechanism · Biphasic Platform

How the biphasic platform works.

A live walk-through of a single dosage form — from administration through to a complete dual-peak pharmacokinetic profile.

STOMACHSMALL INTESTINESYSTEMIC CIRCULATIONIR LAYERDR LAYERENTERIC COATPLASMA CONCENTRATION · 24 H0h12h24h
Live readoutStage 01 / 06
Release event
Pre-administration
GI location
Oral cavity
Formulation
Capsule intact
Phase
T0 — dosing
PK profile
Baseline
Time since dose
0 min
  1. Stage 01
    Administration

    A single oral dose is taken

    One capsule, once a day. Inside: two engineered drug populations sitting side-by-side — an immediate-release fraction and an enteric-protected delayed-release fraction.

  2. Stage 02
    Stomach environment

    Immediate-release phase begins

    Within minutes, the IR layer dissolves in gastric fluid. Drug particles disperse and free molecules begin entering the bloodstream — establishing therapeutic coverage almost immediately.

    Onset · 0–30 min
  3. Stage 03
    Upper GI absorption

    First plasma peak rises

    Released drug crosses the intestinal epithelium and enters systemic circulation. Plasma concentration climbs through Peak #1 — the immediate-release event.

    Peak #1 — IR
  4. Stage 04
    Protected transit

    Delayed-release component stays intact

    The DR beads are shielded by a pH-responsive enteric coating. They resist gastric acid and continue through the GI tract, payload preserved.

    Gastric protection
  5. Stage 05
    Secondary release

    Targeted dissolution at the absorption window

    On reaching the targeted intestinal pH, the polymer coat dissolves and the DR fraction unloads — a second wave of drug molecules enters circulation hours after the first.

    Peak #2 — DR
  6. Stage 06
    Dual-peak pharmacokinetics

    Sustained therapeutic exposure across the day

    Two engineered peaks combine into a single 24-hour exposure profile — smoother peak-to-trough, fewer doses, differentiated product positioning.

    24-hour coverage
Absorption Window Targeting

Releasing the second dose where the drug is actually absorbed.

Many small molecules have a narrow region of the GI tract where bioavailability is maximized. The platform programs the delayed-release phase to dissolve precisely within that window — protecting potency and preserving exposure.

StomachpH 1–3DuodenumpH 5–6JejunumpH 6–7IleumpH 7–8ColonpH 6–7IR release0–30 minTARGETED ABSORPTION WINDOWDR releaseprogrammed · 3–5 hingestiontransit time
pH-responsive triggering
Coating chemistry dissolves at the targeted intestinal pH.
Time-of-transit alignment
Polymer thickness tunes when the second peak emerges.
Compound-specific tuning
Each formulation is calibrated to the molecule's absorption profile.
Pharmacokinetic Profile

From single peak to sustained dual-peak coverage.

IR Only
24h
Cptime

Conventional formulation. Rapid peak, rapid decline below therapeutic threshold.

DR Only
24h
Cptime

Single delayed peak. Late onset; no early therapeutic coverage.

Biphasic IR + DR
24h
Cptime

Two engineered peaks. Sustained exposure across the full dosing interval.

Side-by-side dual-peak comparison
IR-only vs. Biphasic IR + DR · simulated profile
24-hour window
0h6h12h18h24hPlasma Concentrationtherapeutic windowTraditional Immediate ReleaseImmediate + Delayed Release
Disclosed Embodiments

A flexible pharmaceutical delivery architecture.

The platform was designed to support multiple formulation strategies and future product opportunities — not a single fixed product. Hover any component to explore.

BIPHASICPLATFORM
Embodiment
Enteric Coatings
pH 1.2 (gastric)pH 7.4 (intestinal)DR COREenteric polymerAPI microcrystals

pH-responsive polymer coatings (e.g. methacrylic acid copolymers) that remain intact in gastric acid and dissolve above pH ~5.5, protecting the delayed-release payload until it reaches the small intestine.

Hover another component to continue exploring
Why It Matters

From a single product to a platform technology.

Most patents protect one molecule, one product. The biphasic architecture is engineered as a platform — the same delivery system applies across many compounds, formulations, and therapeutic areas.

Traditional patent
One molecule. One product.
  1. 01Traditional Patent
  2. 02One Molecule
  3. 03One Product
Linear path — value capped at the lifecycle of a single asset.
Biphasic platform
A multiplying architecture.
  1. 01Biphasic Platform
  2. 02Multiple Molecules
  3. 03Multiple Formulations
  4. 04Multiple Therapeutic Areas
  5. 05Multiple Product Opportunities
Compounding optionality
What It Delivers

Clinical performance. Commercial differentiation.

The biphasic platform is a vehicle for re-engineering the value of established and developmental molecules — improving the patient experience while unlocking new product positioning.

Once-daily dosing
Replace multi-dose regimens with a single daily administration.
Smoother PK
Reduced peak-to-trough variability across the dosing interval.
505(b)(2) pathway
Established APIs in a differentiated, patent-protected delivery form.
Lifecycle extension
New IP and product positioning for mature molecules.
Beyond Single Compounds

The Future of Combination Therapy.

The biphasic delivery platform is designed not only to optimize individual compounds, but also to enable differentiated combination therapies built around established pharmaceutical agents.

Today
Traditional Treatment
  1. Metformin Tablet
  2. SGLT2 Tablet
  3. Two Separate Products
  4. Multiple Dosing Events
  5. Lower Convenience
Tomorrow
Platform Vision
Potential Future Product
  1. Biphasic Combination Platform
  2. Single Oral Dose
  3. Immediate Release Component
  4. Delayed Release Component
  5. Coordinated Therapeutic Exposure
  6. Differentiated Product
Inside the Combination Dosage Form

Engineering Therapeutic Sequencing.

The biphasic platform may enable pharmaceutical developers to engineer the timing and sequence of drug exposure within a single dosage form — creating opportunities for innovative formulations that go beyond simply combining multiple drugs into one tablet.

Drug A
Metformin
Immediate Release
Early Therapeutic Activity
Drug B
SGLT2 Inhibitor
Delayed Release
Sustained Activity Later In The Day
Combined Outcome
Coordinated Exposure
Optimized Profile
Patient Convenience · Differentiated Product Opportunity
Plasma concentration over time — one dose, two sequenced peaks
A single biphasic tablet releases Drug A immediately, then Drug B hours later — producing two distinct pharmacokinetic peaks from one swallow instead of two separate pills taken at different times.
Illustrative PK
0255075100Plasma concentration (% of Cmax)0h2h4h6h8h10h12h14hTime after single doseSingle doseDrug A · MetforminTmax ≈ 2h (IR)Drug B · SGLT2Tmax ≈ 8h (DR)
Immediate release — early activity
Delayed release — sustained activity later in the day
The Commercial Re-Architecture

From Two Products To One Platform.

What today's market treats as two commodity prescriptions, the biphasic platform can potentially convert into a single, differentiated, IP-protected product.

Today's Therapy
Two products. Two scripts.
Metformin
+
SGLT2
Two Prescriptions
Two Products
Commodity Generic Market
Tomorrow's Opportunity
Differentiated
Biphasic combination product.
Biphasic Combo Capsule
Single Differentiated Product
New Intellectual Property
505(b)(2) Opportunity
Premium Commercial Positioning
Metabolic Disease Ecosystem

One platform. An entire metabolic disease ecosystem.

Hover any category to see how the biphasic platform could support future product development opportunities across the metabolic disease landscape.

Center
Metabolic
Disease
Platform Opportunity
Combination Therapies

The strategic core: differentiated multi-agent products from a single oral platform.

Designed For The Next Generation Of Combination Therapies.

The platform may support the development of combination therapies where multiple agents are commonly prescribed together — delivering each component on its optimal release schedule from a single dosage form.

Example combinations
Metformin + SGLT2SGLT2 + GLP-1Metabolic Disease CombinationsFuture Cardiometabolic Products
Discuss Partnership Opportunities
Drug A
Immediate Release
Rapid onset, postprandial coverage.
Drug B
Delayed Release
Programmed second-phase exposure.
Engineered into
Single Optimized Product
One dosage form. Two release schedules. New IP estate.

A Platform Technology, Not A Single Product.

The value of the patent lies in its ability to support the development of multiple differentiated pharmaceutical products across numerous therapeutic categories.

Patent Platform
Biphasic Drug Delivery
Platform™
SGLT2 Inhibitors
GLP-1 Receptor Agonists
Metabolic Disease Therapies
Cardiovascular Drugs
CNS Therapies
Anti-Infectives
Combination Products
Future Small Molecule Therapies

Explore where this platform could fit.

See the therapeutic categories, product opportunities, and licensing pathways enabled by the biphasic platform.