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Gelteq centers its technology on a proprietary, customizable gel platform designed for precise drugdelivery, supporting prescription drugs, nutraceuticals, pet care and sports supplements.
FDA recently released a much-anticipated draft guidance to address these frequent questions: Essential DrugDelivery Outputs for Devices Intended to Deliver Drugs and Biological Products. Drugdelivery includes successful product preparation and the initiation, progression, and completion of dose delivery.
While the industry is seeing advances in alternative drugdelivery systems, oral solid doses, such as pills, capsules and soft gels, remain at the forefront of the industry. Tablet manufacturing, which is the most common OSD form, takes an API dry powder ingredient and compresses it to form tablets, which can be coated or uncoated.
Interestingly, over the past few years, drug developers focused on non-respiratory diseases have also shifted their attention towards intranasal drug formulations. This can be attributed to ease of delivery, increased bioavailability and by-pass of first-pass metabolism offered by this type of route of administration.
Over the last decade, one of the major challenges faced by pharmaceutical companies across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical drugs approved by regulatory organizations exhibit poor bioavailability / solubility.
Therefore, a variety of excipients, which are pharmacologically inert substances themselves, are used to stabilize biologics during the manufacturing process and storage. Additionally, biopharmaceutical excipients act as bulking agents, antioxidants or preservatives.
Owing to their unique size and physicochemical properties ( surface roughness, surface area, surface energy, crystal structure and shape ), nanoparticles can be widely used as a contrasting agent in medical imaging, a vesicle to cross the blood-brain barrier and a carrier for targeted delivery of genes / drugs, proteins, vaccines and antibiotics.
Over the last decade, one of the major challenges faced by pharmaceutical players across the globe is low drug solubility. In fact, it has been observed that around 40% of the pharmaceutical products approved by regulatory organizations exhibit poor bioavailability / solubility.
However, it is important to highlight that there are still several challenges which need to be addressed in order to develop biologic drugs capable of effectively being administered via the oral route without undergoing significant losses in specificity and / or bioavailability. Oral Protein / Peptide-based Drugs. Web: [link].
Construction of commercial drugmanufacturing facility in Germany.
Development of oral biosensor and contract development & manufacturing.
Psychedelic transdermal and sublingual drug formulation development.
Four clinical studies in neurological indications in 2021.
1 Good Manufacturing Practice. Nanoform’s capabilities span the small to large molecule development space and the company focuses on solving key issues in drug solubility and bioavailability and on enabling novel drugdelivery applications. Edward Hæggström, CEO. edward.haeggstrom@nanoform.com.
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