The natural solution for your drug delivery needs
DelSiTech is an innovative drug delivery and drug development company that works with its partners to turn their active agents into novel and commercially viable therapeutic drug products. DelSiTech offers a one-stop shop opportunity in drug delivery up to early clinical proof of concept. When working with DelSiTech, you can choose from a simple feasibility study or a project that provides you with a full development program for a new product. We use a staged approach in our project design so that key end points are reached for our clients. DelSiTech can also offer full analytical support for each project as well as non-GMP manufacture of test products, e.g. for early preclinical studies, or full GMP manufacture at pilot scale for clinical and commercial grade material. In addition, we are happy to discuss technology transfer at various stages of the process as this has already been successfully undertaken.
DelSiTech has an advanced proprietary drug delivery technology, Silica Matrix, for parenteral and local administration of injectable depot and implant dosage forms. The drug delivery technology is based on biodegradable amorphous silica (SiO2) matrix into which the active agent is embedded using the sol-gel encapsulation technique. The nanoporous matrix can be designed to biodegrade at the required rate to ensure a tightly controlled release of the active substance by surface erosion of the matrix, providing a better therapeutic effect in situ and causing lower systemic and local adverse effects than alternative delivery systems. The technology was originally discovered and developed by researchers at the University of Turku and Åbo Akademi University in Turku, Finland and is fully owned and patented by DelSiTech. In fact, the company has 11 patents protecting its technology up to 2035. The silica-based drug delivery technology has multiple competitive advantages over other alternative delivery technologies. Silica (silicon dioxide) is one of the most commonly found biomaterials in nature and has FDA generally regarded as safe (GRAS) status. One of the main benefits of DelSiTech’s Silica Matrix is superior safety; silica is a natural, endogenous component of the body and it is fully biocompatible and non-toxic. The local irritation is minimal as silica does not lower the tissue pH when dissolved, and there is no risk of sudden burst release event at accidental break-down of the dosage form.
DelSiTech’s Silica Matrix provides a large range of applications in delivery of therapeutic agents. We have developed dozens of silica-based formulations to various sized small molecules, ranging from practically water-insoluble drugs to highly-water soluble hydrophilic compounds. The release time has varied from a few days to several months. Also, heat and/or organic solvent sensitive molecules can be encapsulated as the manufacturing process can be performed at low temperatures in aqueous solutions. DelSiTech’s Silica Matrix is the method of choice for controlled drug delivery of biological macromolecules. We have successfully developed long acting formulations of small and large peptides and proteins in a range of therapeutic indications. The release rate is strictly controlled by silica biodegradation and the biological activity of the encapsulated molecules is well preserved. Also, complex carbohydrates, such as heparins, and nucleic acid therapeutics (e.g. siRNA) can be administered with our technology. Silica Matrix is now also being used to deliver monoclonal antibodies over periods of 1 to 3 months or longer. For the first time, it is now possible to administer viral vectors, e.g. in gene therapy, in a controlled fashion for longer time periods using Silica Matrix. Silica encapsulation also offers other unforeseen benefits to virus-based therapeutic products, such as the possibility to store final products at 4°C for up to 2 years or more. This feature means that viral vectors and vaccines encapsulated in Silica Matrix would not need storage conditions of -25°C to -80°C, a great advantage when transporting such products in the developing world and maintaining biological activity.
Silica Matrix can be used in an unlimited number of human therapeutic indications including oncology, metabolic disorders, gene therapy, pain and ocular disease. For example, molecules can be delivered both intravitreally or subconjunctively using a pain-free needle (27-30G) for 6 months or more release by being encapsulated inside silica microparticles, or silica microimplants can be developed and the biological activity of biopharmaceuticals can be maintained because the water content inside the implant can easily be controlled. In addition, silica eye drops can be developed that release over 1-2 days to overcome the constant need for topical re-application. Ocular delivery is now a major part of DelSiTech’s business and an in-house developed intravitreal (IVT) dissolution model helps to predict the in vitro/in vivo correlation. A new area of focus for DelSiTech is abuse deterrent formulations of drugs with abuse potential. Abuse deterrent properties make certain types of abuse, such as crushing a tablet in order to snort the contents or dissolving a capsule in order to inject the active agent, more difficult or less rewarding. DelSiTech has shown that solvent extraction or crushing/grinding of the matrix does not lead to greater drug release. The company is also very active in animal health and recently signed a licensing deal with a company developing novel medical products for companion animals.
DelSiTech develops its own drug products by combining its silica-based drug delivery technology platform with known active substances to produce supergeneric/505(b)(2) products with superior characteristics over the original brand product. Supergeneric drug development provides a low-risk alternative to the traditional new chemical entity focused business model in the pharmaceutical industry. With superior characteristics in comparison to the original brand product, supergeneric drug products can generate significant cash-flow in much shorter time and with less investment. The first in-house drug product under development is the product candidate 1308, which is an injectable silica formulation of the hepatitis B (HBV) antiviral entecavir (marketed as the oral product Baraclude). HBV is the world’s most common viral infection, with over 2 billion infected people globally and 350 million chronic patients. The depot drug product is injected subcutaneously in a single dose and after injection, the silica matrix erodes to release encapsulated entecavir in the body over a period of 3 months. 1308 addresses significant unmet medical and commercial needs in chronic HBV therapy where patient compliance is a major issue. The product has finished preclinical development, clinical trial material is currently being manufactured and Phase I will begin later in 2016. DelSiTech is poised to become a significant player in the controlled release supergeneric product field, beginning with a more patient-friendly, 3 month sustained release product for sale in the major global market areas.