Roundtable Part 1: Can you tell us why oral solid dosage products continue to be the world’s most popular dosage form?

Krizia Karry, Ph.D., Head of Global Technical Marketing, Pharma Solutions, BASF: From a manufacturer perspective, what I can share is that they are, of course, cheaper to manufacture. You have the ability to brand yourself and also with regard to the supply chain. They are easier to transport, ship, to also package. So there are a lot of advantages to using oral solid dosage forms.

Anil Kane, Ph.D., Global Head of Technical and Scientific Affairs, Pharma Services Group, Thermo Fisher Scientific: Oral solid dose forms are really very, very patient friendly as these apply in different age groups from teens to adults or geriatric patients, and oral solid dosage forms are easy to self-administer or administer by a clinician or a caregiver as compared to other dosage forms.

Oral solid dosage forms are going to stay as a popular dosage form primarily because they are patient-friendly dosage forms. Also, from the development perspective, optimizing the drug delivery and targeting the drug delivery is possible with oral delivery. Oral solid dosage forms can be developed using a variety of different techniques based on the properties and the absorption distribution, metabolism, and excretion profiles, and optimizing the efficacy of these molecules by oral drug delivery is going to be feasible. Targeting drug delivery in the stomach in the small intestine or in the distal part of the intestine is easily feasible with the technologies we have today. So whether it’s developing sustained-release dosage forms, modified-release dosage forms, or targeted drug delivery, whether it is for a single ingredient or fixed-dose combinations, designing the right release profile of small molecules is feasible in older, solid-dose delivery. If we look at the FDA approvals, 20 of the drug products were approved out of 37 approved by the FDA in 2022. This confirms and proves that older solid dosage forms are going to be popular dosage forms as compared to other dosage forms and delivery groups.

Michael Kallelis, CEO, Mikart: The first reason is just the biology and anatomy of human beings. As long as we ingest materials through our mouth orally and digest them in our gastrointestinal system where nutrients are absorbed, that’s going to be the most convenient way for people to administer medication. Of course, there are sterile parenteral drugs, but you need an I.V. bag. You need an injection from a qualified nurse or doctor. Oral solid doses are more readily available to convenience and conveniently pop them in your mouth and ingest them. As long as that continues to be the way that we absorb and digest foods. Oral solid-dose medications will continue to be popular.

Gus Labella, Director of Formulation Development, Mikart: Solid oral dosage forms are very convenient and easy for customers to manage. And I think this is what really drives their popularity in the marketplace. These are things that you can take with you a small bottle or a blister pouch or something in your pocket or purse. And the convenience of those, as well as the dosing ease really drives their use. A lot of people, you know, you see a lot of new products that are injectable products. A lot of people are still afraid of needles and don’t want to inject themselves. Plus, a lot of the injectable products must be refrigerated. So again, it’s another inconvenience feature where you can’t just take something along with you in the car or, you know, on a trip.

Sam Bejaoui, Director of Portfolio Services for Global OSD, Thermo Fisher Scientific: Oral solid dosage products are the most popular dosage form globally due to their convenience, stability, accuracy, and cost-effectiveness. They’re easy to administer and widely accepted by patients, eliminating the need for injections or other invasive methods. these doses, forms have a longer shelf life ensuring the efficacy and safety of the medication over an extended period of time. Manufacturers have precise control over the formulation, allowing for accurate dosing and uniform drug distribution.

James Hulvat, Ph.D., Director of Pharma Development Services, Thermo Fisher Scientific: Oral solid dosage drug products continue to be the world’s most popular dosage form and will continue to be in the future. They offer unique advantages to patients in terms of ease and convenience of use, along with good performance instability for most drug products. The manufacturability stability, ease of distribution, and patient convenience are really at the core of the popularity of the oral dosage form in the 20th century today and well into the future.

Tom Selling, CEO, Adare Pharma Solutions: Oral solid doses are the most popular dosage form in the world today. There are three main reasons. And a number of sub-points underneath each of those under patient preference, there’s a number of sub-points. So ease of administration certainly is first and foremost taking a pill for patients is often the easiest and most palatable dosage form. Secondly, things like taste, masking, and dose titration of products are also important for patients. So as you think about why patients take pills, today are still a number of key benefits. The second is cost efficiency. So as you look at products today, producing an oral solid product compared to a biologic compared to a selling gene therapy, is certainly some major cost advantage. There is a large, well-established industry that is producing products at scale, producing them quite efficiently and therefore cost-effectively. The third advantage is some of the technical advantages of oral solid products, just the ability to take a small molecule, and put it into a variety of different dosage forms within oral solids, allows the technology to be deployed into patients quite easily.

Dale Natoli, President of Natoli Engineering, Natoli: Oral solid dosage is the most efficient method of manufacturing a solid dose. So when it comes to tablets and capsules, your tablets would be probably your number one choice as far as efficiency. Now, when we talk about efficiency, we’re also talking about the accuracy of the dose. So in order to manufacture the drug in a highly productive environment, you’re really going to want to ensure that you’ve also got the accuracy of that dose. And solid dose is going to be your best method, the most efficient method to deliver that.