Drug product development
Advanced solutions
Is poor bioavailability your major concern?
At Xedev, we understand that bioavailability can be a major hurdle in your drug development journey. That is why we offer tailored solutions to enhance your molecule’s effectiveness. Whether you need a specific drug release profile or a particular particle shape and/or size, our team of specialists is here to help you every step of the way. Beyond improving bioavailability, we bring extensive experience in formulation of peptides and biologics.
Partner with us to create the most stable formulation possible.
Spray drying
Spray drying is one of our core competencies. As global experts in formulation and process development of this enabling technique, we know how to effectively process and formulate your molecule.
Fast and cost-effective screening
Our initial screening experiments require only a minimal amount of API (less than 10 mg per batch). This allows you to quickly and cost-effectively evaluate your drug product’s potential.
Enhancing bioavailability
Spray drying is the leading technology for improving the bioavailability of your compound by e.g. creating an amorphous solid dispersion (ASD) or co-spray drying your compound with different excipients.
Versatile applications
- Inhalation and nasal applications: We can tailor the size and shape of dried powders for effective delivery. Read more about inhalables and nasal formulations.
- Controlled and targeted release: Need specific release profiles? Spray drying can provide the solution.
- Taste masking and encapsulation: Enhance your formulation with our expertise in these areas.
How does spray drying work?
Spray drying transforms liquid feeds – whether solutions, suspensions, or emulsions – into dry powders through rapid solvent evaporation.
- Atomization: the feed is atomized into fine droplets using a nozzle system.
- Drying chamber: these droplets are sprayed into a hot gass passing through the drying chamber, where instant solvent evaporation takes place. The molecules in the droplets are protected against degradation, thanks to the evaporative cooling effect, making spray drying suitable for heat sensitive molecules (e.g. biologics and proteins).
- Particle formation: this instant process results in particle formation, which are separated from the humidified gas, by cyclone technolgy.
At Xedev, we utilize the advanced Procept spray drying technology for all our development and manufacturing projects.
Targeted release profiles
To achieve the desired therapeutic effect, your molecule must be released at the desired site and at a specific rate. Whether you need your molecule to be released over time, targeted to a specific site in the body (e.g. colon, nose, lungs, brains), or protected from the acidic environment of the stomach, various excipients can be used to ensure you achieve the specific drug release profile you need.
Are you looking to develop controlled release formulations for e.g. parental delivery? Xedev’s experts can create matrix or reservoir systems with your active ingredient to establish the desired release profile. With our in-depth knowledge in formulation development and a range of technologies – including spray drying, spray congealing, and for both melt or wet applications, fluid bed coating, granulation or extrusion – we ensure that the most suitable excipients and techniques are employed for your molecule!
Particle Engineering Technologies
Spray drying
With spray drying, particle shape and size can be finely tuned through the right combination of excipients, solvents and process parameters.
Did you know that simply changing a solvent or molecular weight of e.g. polymers can dramatically impact your spray-dried particle? Or that subtle shifts in process parameters can improve the density and flowability of your powder?
At Xedev, we help you optimize every variable to achieve the exact particle performance you require.
Granulation
If your formulation contains particles of varying sizes or shape, it can lead to segregation and poor processability.
Through granulation, particles are consolidated and densified to establish larger, uniform granules that improve e.g. flowability and compactability – facilitating the downstream processability and the final product performance (e.g. tablet uniformity).
Depending on the attributes of your molecule, target dosage form, or release profile, Xedev uses the Procept granulation technologies – from high-shear and fluid-bed granulation to continuous, melt and wet processes – ensuring that the most suitable technique is applied.
Hot Melt Extrusion (HME) / Extrusion
In extrusion, materials are forced through a die to create a product with uniform shape and high density – all in a continuous, solvent-free, and eco-friendly process.
It is ideal for:
- Enhancing bioavailability of poorly soluble drugs
- Creating high-density intermediates for e.g. capsule filling
- Producing filaments for 3D printing or mini-tablets
At Xedev, we offer HME formulation and process development starting from small batches (as little as 500 mg API) – scalable to production.
Extrusion-Spheronisation
If your goal is to develop a multiparticulate drug delivery system, extrusion-spheronization might be the right approach.
This agglomeration technique transforms fine powders into free-flowing spherical pellets (typically 0.5-2.5 mm) that can be easily filled into capsules or sachets. They can also be coated for controlled or sustained release or combined for multi-drug formulations.
Xedev provides full support – from early formulation development to process optimization – helping you obtain pellets that perform exactly as intended.
Oral peptides
Are you looking into the development of oral peptides or biologics? With years of experience handling complex molecules, Xedev supports you in creating stable, high-performing formulations.
Oral administration of peptides remains very challenging and is generally known as very complex. Peptides are often unstable in the gastrointestinal tract due to e.g. enzymatic degradation, low membrane permeability and pH-related instability.
Improving the oral bioavailability of peptides requires precise formulation and process design. Approaches such as permeability enhancers, encapsulation or solid lipid nanoparticles can improve peptide absorption and stability.
Spray drying for oral peptide formulation
An effective technology for oral peptide delivery is spray drying. This process enables the transformation of peptide solutions or suspensions into stable powders that protect the sensitive molecule and allow precise control over particle properties.
At Xedev, we know exactly how to fine-tune spray drying parameters to ensure your peptides withstand the thermal and mechanical stress of the process – maintaining biological activity and stability.
By optimizing formulation composition, excipient selection, and process conditions, we help you to achieve:
- Improved peptide stability
- Enhanced bioavailability and absorption
- Scalable oral peptide dosage forms
Biologics
Working with biologics? Xedev brings extensive experience in formulation and process development for biologics, helping you transform these sensitive molecules into stable, scalable and high–performing products.
Biologics such as monoclonal antibodies and enzymes are prone to aggregation or denaturation during processing, are sensitive to thermal and mechanical stress, and often show instability in liquid form. Achieving a stable biologic formulation that preserves activity and efficacy throughout manufacturing and storage, requires formulation insight and precise process control.
Spray drying is an enabling technology used for the stabilization of biologics. The transition of liquid formulations into solid powders protects the molecule from degradation and enables a longer shelf life and improved handling. As Xedev is expertized in spray drying using the Procept spray dryers, our team knows exactly how to adapt the spray drying conditions to minimize stress and maintain the biological functionality after processing.
We combine the right protective excipients, stabilizers and process parameters to enhance the biologic stability, shelf life and are able to target different dosage forms such as inhalables, orals and parenterals products.
Want to move your biologic formulation into GMP manufacturing?
Discover how we prepare your formulation for clinical manufacturing.