Drug product development
Solid dosage forms
Solid dosage forms remain the gold standard in pharmaceutical development since they are stable, reliable, and easy to transport and store. Xedev supports you in developing the right solid formulation for your molecule, whether that means powders, granules, capsules or tablets. We apply the right process to meet your project goals and ensure readiness for clinical development.
With over 14 years of experience and a wide range of in-house technologies—including spray drying, granulation, and tableting—we formulate your solid drug product tailored to your compound and study needs.
Powders and granules
Powders
Do you want to develop a powder formulation for your molecule? Are you looking for increased stability or aiming to change specific properties of your molecule? We develop your powder through techniques such as spray drying and spray congealing—selecting the right approach based on your molecule’s requirements.
Did you know spray drying allows fine-tuning of your desired particle size, shape, density, surface area and flowability by adjusting the process parameters?
Granules
When flowability, compressibility, or reduced dust formation are critical for a smooth and reproducible downstream processing, granulation offers a reliable solution. Xedev develops granules using various methods, including:
- Dry granulation
- Fluid bed granulation
- High-shear batch granulation
- Continuous twin-screw granulation
Depending on your formulation, we apply pressure (dry granulation), liquid (wet granulation), or temperature (melt granulation) to achieve the right granule attributes.
Tablets and capsules
As a solid dosage form, tablets and capsules are widely preferred due to their accurate dosing, easy handling and storage.
Capsules
We offer capsule filling for powders, granules, or beads—from small to large batches. Capsule sizes can be tailored to your study (e.g. DPI capsules or animal studies).
Furthermore, we provide capsule coating to ensure performance, protection, or identification of your capsule-based formulation.
Tablets
Tablet compression is performed using the STYL’One compaction simulator, enabling the development of various tablet formats, including multi-layer or mini-tablets.
Do you have a potent pharmaceutical compound that you wish to develop as a tablet? Our containment solutions support safe development of high-potency drug formulations.
Additionally, coating can be applied for identification or added functionality. Our experts ensure your tablet formulation is robust, reproducible, and ready for clinical use.
Inhalables and nasal formulations
Inhalables
Looking to formulate your molecule as an inhalable powder for use in a dry powder inhaler (DPI)? Inhalation drug delivery requires highly specific material properties to ensure therapeutic effectiveness. Using spray drying and our expertise in particle engineering and formulation development, we optimize the fine powder fraction (FPF) and emitted dose (ED) to improve aerodynamic flow and lung deposition of your molecule.
With the right formulation and process parameters, we prepare your molecule for efficient pulmonary delivery.
Nasal powders
Formulated nasal powders are used for both local and systemic delivery and allow a rapid release into the brain. Compared to liquid nasal formulations, nasal powders can deliver higher active doses and low-soluble compounds.
Just like inhalables, nasal powders require the right attributes for precise delivery. With our extensive knowledge in spray drying, we target the right particle size for your molecule. Additionally, with formulation optimization, we reduce nasal clearance, resulting in better absorption, ensuring that your molecule performs as intended.
Injectables
Do you want to formulate your molecule as an injectable product? We use spray drying and particle engineering for the product development of:
- Biologics, proteins, enzymes and monoclonal antibodies
- High concentration protein formulations via density adaptation
- Depot systems
We are working under low bioburden conditions, the optimal conditions for the R&D development of your biologic into an injectable formulation.