We provide formulation process development from the API’s powder to the final dosage form. We also have extensive experience in the development of amorphous solid dispersions (ASDs) with great know-how in upstream (melt extrusion, nanofiber spinning, spray drying) and downstream processes to generate oral or parenteral formulations.
The pharmaceutical industry has not been using the nanofiber spinning process yet although it provides numerous benefits. Thanks to the huge surface area of the nanofibers and amorphization effect of the fast drying process, nanofibrous materials have great potential in dissolution and bioavailability enhancements and biodrug formulations. Our proprietary scaled-up electrospinning technology enables us to produce large amounts of fibrous materials.
Spray drying is a well-known drying process in food and pharmaceutical fields. With the application of different spraying nozzles, we can formulate different particles matching your specific requirements on particle size and characteristics. We are ready to design your particle formulating process with our lab-scale spray dryer.
Dry granulation / Roller compaction
Roller compaction (dry granulation) is inherently a continuous technology as the active pharmaceutical ingredient, along with excipients, is fed into the compactor at the top of it, and after a compaction and grinding step the granules can be continuously taken away at the bottom of it. The particles, usually with low particle size, are adhering to each other (forming larger particles) due to the compaction generated by two rolls. The main goals of roller compaction are to improve flowability and increase the bulk density of powders. The originally poor flowability or low bulk density can hinder an industrially applicable tableting process.
On our GMP compatible roller compactor, we can study the compaction process of different materials, especially in pilot plant scale (from ~100 g). In case of one of our main research areas, amorphous solid dispersions, roller compaction can gain large interest. In amorphous solid dispersions, water can act as a plasticizer, which is decreasing the glass transition temperature of the dispersion. Thereby, when contacting with water or high humidity there is a higher probability that the amorphous drug will be converted to crystalline state. Therefore, roller compaction can mean an engaging solution for formulation scientists.
We are very enthusiastic about roller compaction of amorphous solid dispersions and other materials. There is also a proper analytical background that is needed for successful research and development. We would like to encourage you if you have any questions about roller compaction.
Wet granulation is fundamentally a batch process, which can be divided into two types: high shear and fluid bed granulation. In the course of wet granulation, small and/or irregular shaped particles (e.g. needle crystals) are cohered together with the help of a granulation liquid (usually water or a certain alcohol) and a binder material (e.g. polyvinylpyrrolidone) to form larger and more spherical particles. The main purpose of the granulation is to improve the flowability and increase the bulk density of the powder to facilitate the tableting process.
The batch type wet granulations are foreseen to be replaced by continuous wet granulation in the pharmaceutical industry in the near future. The shift from batch to continuous technologies has been recommended by Food and Drug Administration. This continuous wet granulation technology can be carried out on a twin-screw extruder into which solid materials and water can be fed at various parts. In the extruder, the materials are mixed and granulated due to the intermesh of the screws, especially at the kneading elements. We are ready and eager to investigate continuous wet granulation of your material on our lab-scale, GMP compatible extruder.
Melt extrusion is used for enhancing the solubility of poorly soluble drugs by creating amorphous solid dispersions. This continuous formulation method offers good chance for process control. Thanks to our co-developed lab-scale extruder you can minimize your material cost by reducing the amount of API needed for feasibility studies. The continuously produced extrudate can be ground and homogenized with excipients before tableting. We are ready to investigate melt extrusion of different materials on our new lab-scale, GMP twin-screw extruder developed together with Quick2000 Ltd.
When it comes to producing fibers, no other fiber formation technique can conquer melt blowing due to its simplicity, excellent productivity, and solvent-free operation. During melt blowing a polymer melt is extruded through small nozzles surrounded by high speed blowing gas. In other words, melt blowing is a special type of extruder die to produce fine fibers. While the diameter of electrospun fibers can even deviate around a few hundred nanometers, melt blown fibers have at least a few microns of thickness, and submicronic melt-blown fabrics are rarely produced. However, selecting the right factor levels and applying some modifications in the equipment of melt blowing can yield acceptable nanofibers. With the nano melt-blown technique not only drug delivery systems with fast release rates are achievable but high value reinforced composites and filtration materials can be also produced.
A GMP compatible pharmaceutical melt blowing configuration is under development, further details are available upon request.
We are offering different types of grinding and milling techniques fitting to continuous pharmaceutical manufacturing. The grinding process of the material is carried out in order to focus on optimizing particle size, distribution and tableting parameters.