Although biologics are usually given by injection or intravenous infusion, oral formulations might be possible. In general, oral drugs offer many benefits, from simplified distribution to overall cost reductions for patients, as well as being easier use and often have better patient compliance. Nonetheless, acids and enzymes in the stomach can degrade biologics even before they get absorbed, and the liver can eliminate biologics that survive the stomach. To address these challenges, scientists explore various routes to developing safe and effective oral delivery of biologics.
The most common approach to developing oral formulations of biologics depends on the delivery device. As one example, Joshua Myers, clinical research director at Rani Therapeutics, and his colleagues recently reported on an oral formulation of biologics to treat osteoporosis. That work used what Rani Therapeutics describes as a robotic pill, because it remains intact until it reaches the intestine, “where it delivers the drug via transenteric injection,” according to the company. In testing this method to treat osteoporosis, the researchers found that, compared to delivery by subcutaneous injection, the robotic pill provided threefold higher bioavailability of the drug and a similar safety level.
It’s also possible that bioprocessing could be used to make a biologic that can survive the gut environment. Finding such biologics, though, could be difficult. So, Vivtex developed a microplate-based, robotic drug-testing system that mimics the environment of the gastrointestinal tract. This platform can be used to test biologics alone or with a drug-delivery system. The ability to test so many forms of drugs produced from bioprocessing might reveal some that can be taken orally and still reach their intended targets.
Developing safe and effective oral formulations of biologics will probably require high-throughput testing capabilities, because pill-based biologics can fail to reach their targets or even create safety concerns. As one example, during nonclinical development of a pill-based form of a GLP-1 receptor agonist—the class of drugs best known for treating type 2 diabetes and obesity—scientists at AstraZeneca found that enteric-coated tablets produced toxicity in the kidneys of dogs, but non-enteric-coated tablets caused no kidney issues. So, every feature of an oral formulation of a biologic must be assessed.
Instead of developing new approaches to making oral formulations of biotherapeutics, though, the easiest method might be the oldest—plants. Nearly a decade ago, scientists at the University of Verona in Italy reported on molecular farming—making recombinant therapeutic proteins in plants—and pointed out that “[o]ne of the most promising approaches is the use of edible plant organs expressing biopharmaceuticals for direct oral delivery.” Some companies are exploring this approach. For example, Boulder, CO-based Enveda Biosciences is working on plant-based treatments that can be taken orally and are designed to be absorbed in the gut before being destroyed.
Despite the advantages of creating oral formulations of biologics, many challenges remain in making this method successful. So far, it’s uncertain if these challenges can be resolved, especially for wide use in biologics.
For another GEN article on this topic see “Squid Game: Direct Drug Delivery Into GI Tract Using Cephalopod-Inspired Capsules.”
The post Can Oral Formulations of Biologics Work? appeared first on GEN - Genetic Engineering and Biotechnology News.
The most common approach to developing oral formulations of biologics depends on the delivery device. As one example, Joshua Myers, clinical research director at Rani Therapeutics, and his colleagues recently reported on an oral formulation of biologics to treat osteoporosis. That work used what Rani Therapeutics describes as a robotic pill, because it remains intact until it reaches the intestine, “where it delivers the drug via transenteric injection,” according to the company. In testing this method to treat osteoporosis, the researchers found that, compared to delivery by subcutaneous injection, the robotic pill provided threefold higher bioavailability of the drug and a similar safety level.
Surviving the gut environment
It’s also possible that bioprocessing could be used to make a biologic that can survive the gut environment. Finding such biologics, though, could be difficult. So, Vivtex developed a microplate-based, robotic drug-testing system that mimics the environment of the gastrointestinal tract. This platform can be used to test biologics alone or with a drug-delivery system. The ability to test so many forms of drugs produced from bioprocessing might reveal some that can be taken orally and still reach their intended targets.
Developing safe and effective oral formulations of biologics will probably require high-throughput testing capabilities, because pill-based biologics can fail to reach their targets or even create safety concerns. As one example, during nonclinical development of a pill-based form of a GLP-1 receptor agonist—the class of drugs best known for treating type 2 diabetes and obesity—scientists at AstraZeneca found that enteric-coated tablets produced toxicity in the kidneys of dogs, but non-enteric-coated tablets caused no kidney issues. So, every feature of an oral formulation of a biologic must be assessed.
Instead of developing new approaches to making oral formulations of biotherapeutics, though, the easiest method might be the oldest—plants. Nearly a decade ago, scientists at the University of Verona in Italy reported on molecular farming—making recombinant therapeutic proteins in plants—and pointed out that “[o]ne of the most promising approaches is the use of edible plant organs expressing biopharmaceuticals for direct oral delivery.” Some companies are exploring this approach. For example, Boulder, CO-based Enveda Biosciences is working on plant-based treatments that can be taken orally and are designed to be absorbed in the gut before being destroyed.
Despite the advantages of creating oral formulations of biologics, many challenges remain in making this method successful. So far, it’s uncertain if these challenges can be resolved, especially for wide use in biologics.
For another GEN article on this topic see “Squid Game: Direct Drug Delivery Into GI Tract Using Cephalopod-Inspired Capsules.”
The post Can Oral Formulations of Biologics Work? appeared first on GEN - Genetic Engineering and Biotechnology News.