Roundtable Part 4: What do you see as the future for OSD products, particularly with the current industry focus on biopharmaceuticals, vaccines, cell and gene therapies, etc.?

Karry: I think there is an opportunity for coexistence. OSD products are here to stay. What I think will happen is that Biopharmaceuticals will transition to OSD products as part of lifecycle management. There will always be a population that is averse to injections, for example. And in terms of ease of supply chain, there is nothing easier than transporting tablets or solid oral dosage products.

Kane: Oral solid dose is here to stay. We believe that oral solid dose drug products are going to stay as popular dosage forms as they are the most patient-friendly dosage forms. Small molecules are typically developed in oral solid dose, but we see a trend now that even large molecules such as peptides, proteins, and oligonucleotides are enzymes, or even in some cases monoclonal antibodies are being evaluated in oral drug delivery. We do see a trend that oral delivery of not only small molecules but also large molecules will be here to be a popular dosage form.

Kallelis: I don’t see the great progress in biologics and gene therapy as being a deterrent to oral solid dose. You know, oral solid dose is still the most convenient form of medication to take and administer simply by popping a pill. That will continue to be the way it is as long as we are designed, the way we are as human beings and people. However, oral solid dose is moving ahead. It’s moving ahead with new technologies to improve the bioavailability and solubility of difficult drugs. It is also moving ahead with respect to manufacturing techniques where we’re able to make more products at a lower cost than we ever have before. That does come at a price. It takes significant capital investment to offer those solutions. Things like continuous manufacturing is one example, but those things will continue to progress and oral solid dose will continue to evolve just the way it has over the last 100-plus years. So it’s not going away.

Labella: The large molecule business is growing and you’ll see it continue to grow throughout the future. But I don’t think several dose forms and liquid oral dosage forms are going away any time soon. These are you know, the mainstay of the market. They’re very well known. The regulatory agencies understand their manufacturing processes. And I think customers are just going to find new ways in order to manufacture these types of products more efficiently, more effectively, such as continuous manufacturing. So I don’t think they’ll be going away any time soon.

Bejaoui: Looking ahead, the future of OSD products looks very promising, especially with the growing demand for innovative OSD formulations that can deliver complex therapies in a convenient and patient-friendly manner. Advancements in formulation technologies and manufacturing processes will lead to the development of more effective and targeted OSD products, enabling improved patient outcomes and expanding treatment options. With ongoing research and development efforts, OSI products are expected to continue playing a vital role in the healthcare industry. With ongoing research and development efforts, OAC products are expected to continue playing a vital role in the healthcare industry.

Hulvat: I think the future is bright for oral drug products. The most popular dosage form in the 20th century is going to continue to dominate the new drug product landscape in the 21st century. Complex manufacturing technologies are enabling once-a-day single-tablet drugs through multi-particulates and other complex dosage forms that enable drugs to be delivered in a convenient and patient-centric way.

Selling: As we look into the future, I anticipate even greater collaboration between universities and academic settings. CDMO and pharmaceutical and biotech companies. The interaction and being able to leverage best practices, being able to incorporate newer technologies in research capabilities is very exciting and something that I think is going to continue to power the the market and demand for newer and newer oral solid products. So as you think about the regulatory impact on the industry, one area, one great example is certainly around the Nitrosamines. Nitrosamines are an impurity found in a number of pharmaceutical products. I think guidance came out recently that will provide guidelines and limit levels for nitrosamine content in products. There are around 250 to 300 or so products that are affected by these nitrosamine limits. impact is that manufacturers are going to have to find ways of reformulating their products and being able to adhere to the guidelines and the limits for Nitrosamines in in the future. By 2025 to stay under the nitrosamine limits.

Sedlock: The future of OSD products in my mind is evolving trends with an emphasis on advanced oral drug technologies, including nanoparticles, combination products with multiple APIs, personalized medicine, tailored dosage forms for individual patient characteristics, and genetic profile and treatment responses, or digital technologies like smart pills. As a matter of fact, we’re helping one of our customers right now develop a smart pill, such as an electronic capsule for a targeted drug delivery system.