Enabling Platforms
A data-driven enabling technologies platform for solubility and bioavailability enhancement — spray drying, hot melt extrusion, nanosuspensions, and lipid formulations, assessed in parallel where the optimal route is not yet clear.
Spray Drying
A Versatile Platform for Solubility Enhancement and Advanced Particle Engineering
Spray drying is one of the most powerful and commercially proven technologies for improving the oral bioavailability of poorly soluble drug candidates. By engineering the API and a stabilising polymer into a single amorphous solid dispersion, it unlocks solubility performance that crystalline formulations cannot achieve — with multiple FDA and EMA approved products providing a clear regulatory pathway.
Significant solubility and bioavailability enhancement
spray dried dispersions consistently deliver among the highest improvements of any enabling technology, with multiple FDA and EMA approved products providing a clear regulatory pathway.
Suitable for thermally sensitive APIs
spray drying never exposes the API to sustained high temperatures, making it the technology of choice for compounds that would degrade under melt-processing conditions.
Precise particle engineering
particle size, morphology, density, and residual solvent content are independently controllable through process parameters.
Continuous and scalable
scales predictably from laboratory to commercial production with well-established scale-up principles and strong regulatory familiarity.
At Ardena, spray drying sits within an integrated enabling technology platform alongside Hot Melt Extrusion, Nanosuspensions, and Lipid Formulations. Your compound is assessed against all relevant options — technology selection is driven by data, not default.
Early feasibility and micro-evaporation screening
formulation candidates ranked before a single spray drying run, minimising API consumption and development time.
Deep ASD formulation expertise
polymer selection based on thermodynamic modelling and experimental miscibility data, not empirical guesswork.
End-to-end process development
from lab-scale Büchi units through to GMP pilot-scale manufacturing.
Integrated downstream development
spray-dried intermediate directly into tablet or capsule with no technology transfer step.
The result is a formulation strategy that performs in the clinic and holds all the way to commercial supply.
Ready to assess your compound for Spray Drying? Talk to our formulation scientists →
Hot Melt Extrusion (HME)
A Robust, Solvent-Free Platform for Amorphous Solid Dispersions
Hot melt extrusion converts a crystalline API into an amorphous solid dispersion through heat and mechanical energy alone — no solvents, no drying, no solvent recovery. For poorly soluble compounds that are thermally stable and compatible with melt processing, HME combines solubility enhancement with a lean, scalable manufacturing process that carries from early development all the way to commercial production.
Solvent-free processing
no organic solvents at any stage, eliminating recovery infrastructure and simplifying the manufacturing footprint. A significant advantage for cytotoxic compounds and moisture-sensitive APIs.
Continuous, highly reproducible manufacturing
inherent batch-to-batch consistency with the same screw design principles transferring predictably from 11 mm R&D units to 27 mm commercial extruders.
Excellent content uniformity
intensive mixing under shear delivers molecular-level homogeneity of the API within the polymer matrix.
High drug loading potential
supports higher drug loadings than many solvent-based ASD systems, keeping tablet size practical even at significant doses.
Strong commercial scalability
one of the most commercially mature ASD manufacturing technologies, with well-established regulatory expectations.
At Ardena, HME is embedded within a broader enabling technologies framework. No single technology is applied by default — each compound is assessed on its own physicochemical merits, and HME is recommended when the data supports it.
In-silico polymer selection
Hansen solubility parameter modelling and thermodynamic phase diagram construction from API chemical structure.
Material-sparing screening
DSC, TGA, HSM, and VCM micro-prototype development from sub-gram API quantities.
Full process development
screw design, CPP characterisation, DoE-based design space definition on the 11 mm lab extruder.
Matched equipment scale-up
11 mm (R&D) → 18 mm (Phase I/II GMP) → 27 mm (Phase III/commercial).
Integrated downstream manufacturing
milling, blending, tablet compression, and capsule filling at the same site, with no technology transfer step between ASD intermediate and finished dosage form.
Could Hot Melt Extrusion be the right platform for your molecule? Talk to our scientists →
Nanosuspensions
Enhancing Oral Bioavailability Through Particle Size Reduction
Nanosuspensions reduce the API to the nanometre range — typically 100 to 500 nm — dramatically increasing surface area for dissolution and accelerating drug absorption without ever converting the crystalline API to the amorphous form. No polymer-drug miscibility requirement, no glass transition temperature to manage, no recrystallisation risk — a physically simpler and inherently more stable route to enhanced bioavailability for the right compound.
Crystalline form retained
no amorphous instability, no recrystallisation risk. A meaningful simplification for the right compound.
No solvents, no thermal stress
wet bead milling is an aqueous, ambient-temperature process, simplifying safety management and analytical testing.
High drug loading
no polymer matrix limiting drug loading, making nanosuspensions the natural choice for high-dose APIs.
Rapid, dose-flexible FIH entry
a liquid nanosuspension can be rapidly prepared and dose-adjusted, making it one of the fastest formulation routes to first-in-human studies.
Convertible to solid oral dosage forms
the nanosuspension intermediate can be processed into tablets or capsules without compositional reformulation.
At Ardena, nanosuspension development is embedded within our broader enabling technologies platform — evaluated alongside Spray Drying, Hot Melt Extrusion, and Lipid Formulations as part of a science-driven, data-first technology selection process.
Material-sparing parallel screening
10 to 20 stabiliser concepts evaluated from milligram quantities of API.
Advanced particle characterisation
laser diffraction, DLS and zeta potential, and TEM throughout development and manufacturing.
Scalable wet milling platform
roller mill to Dynomill, covering preclinical through GMP clinical batch sizes.
End-to-end cleanroom manufacturing
vehicle preparation, milling, dilution, and primary packaging.
Integrated technology comparison
where the optimal strategy is not clear, nanosuspension, lipid formulations, HME and ASD platforms screened in parallel.
Could a Nanosuspension unlock your compound’s potential? Talk to our formulation scientists →
Lipid Formulations
Solubilisation-Driven Strategies for Oral Bioavailability Enhancement
For highly lipophilic drug candidates, the challenge is not how quickly the API dissolves — it is whether it can remain in solution long enough to be absorbed at all. Lipid-based formulations present the drug pre-dissolved in a vehicle that spontaneously emulsifies on contact with gut fluids, keeping the API in a solubilised, absorbable state throughout GI transit. For the right compound, the bioavailability improvement is transformative.
Immediate solubilisation-driven bioavailability enhancement
the API is in solution from the moment of administration. Bioavailability improvements of several-fold are commonly achieved.
Lymphatic absorption for the most lipophilic molecules
lipid formulations are the only dosage form that meaningfully enables lymphatic uptake, bypassing hepatic first-pass metabolism.
Food-effect mitigation
a well-designed self-emulsifying formulation significantly reduces fed/fasted variability — a meaningful advantage in both clinical development and commercial use.
Two clinical formats from one development programme
the same formulation filled into vials for preclinical dosing and subsequently into hard capsules for patient supply, with no compositional reformulation required.
At Ardena, lipid formulation development is fully integrated across the development continuum and sits within our broader enabling technologies platform alongside Spray Drying, Hot Melt Extrusion, and Nanosuspensions. Where the optimal technology is not immediately clear, we run parallel assessments — giving you comparative data rather than assumptions.
Lipid solubility profiling
across 20+ excipients from milligram quantities of API — the essential first step in any lipid formulation programme.
SEDDS and SMEDDS formulation development
excipient selection, self-emulsification assessment, drug precipitation risk evaluation, and in vitro dissolution under simulated GI conditions.
Physical and chemical stability assessment
stress testing and compatibility screening with capsule shell materials from early prototype stage.
Parallel technology assessment
lipid and ASD screening run concurrently where technology selection is not clear-cut, with comparative in vitro and in vivo data to support the decision.
Could a Lipid Formulation unlock your compound’s bioavailability? Talk to our formulation scientists →
Four platforms. One data-driven framework.
Each compound is screened against the platforms that fit its chemistry — and assessed in parallel where the right route is not yet clear. The output is comparative in vitro and in vivo data, not assumed defaults. The result is a formulation strategy chosen because the data supports it — and one that holds from preclinical proof-of-concept through to commercial supply.
