World Pharma Today: Solid Dose Pharmaceuticals to Remain Strong

World Pharma Today – 8 June, 2022

Editor of World Pharma Today Interviews Dr. Brittany Hayes, Director, Global Highly Potent & Oncology Platform

Oral Solid Dosage (OSD) Tablet Manufacturing in CordenPharma Plankstadt (DE).

Oral Solid Dosage Forms Raise the Bar On Pharma Standards

The oral route has for long been the most common and convenient of the different delivery routes. Oral Solid Dosage Forms (tablets and capsules) are among the most widely used and convenient drug delivery modalities. After more than a century of development, the process, equipment, and technology may be produced in a non-sterile environment, and the method, tools, and techniques are well defined and known.

As one would expect from a dynamic vertical like pharmaceuticals, there have been rapid and innumerable innovations that are taking place under the gamut of OSD. With API’s becoming more jumbled, it becomes pretty critical that the solid dosage forms become compliant with their attributes with no room for any fall out. Because OSD’s inherent nature is patient centric, their ability to adapt to innovations, be they technological or otherwise, is far easier. As formulations have become increasingly varied and are susceptible to external forces, having a full-proof OSD makes sense, and this can be possible only when there is a complete thrust given to the technological realm that goes into it.

Keeping this in mind, World Pharma Today recently put the OSD’s existence in the era we are in, on the table of industry leaders and the elements that encircle it to make it more relevant, and the replies that we have received show a lot more intent and promise, and to an extent, dependence on its success.

Here is a detailed interview that took place between the editor of WPT and the executives from various organisations on the existence, relevance, and future of the OSD’s.

Q&A on Solid Dose Pharmaceuticals to Remain Strong

Contributor:
Brittany L. Hayes, Ph.D.
Director, Global Highly Potent & Oncology Platform
CordenPharma International

Q1. What OSD manufacturing capabilities are currently in-demand? Do you foresee this shifting in the next 3-5 years?

One of the requests that we see frequently is minitablets or pellets in capsules. This dosage form is easily adjusted for higher and lower dosage strengths by adding more or less minitablets or pellets. It is also a good dosage form for pediatrics (or geriatrics) because you can open up the capsules and sprinkle the contents into food. For highly potent APIs, coated tablets have been the dosage form of choice for several years. This is based on safety aspects to prevent the patients or employees in hospitals from having direct contact to the API in the tablets.

Additionally, 70-90% of APIs in development are highly insoluble and suffer from bioavailability issues. This trend will increase over the next few years, requiring efficient strategies or technologies to solve this issue. Demand has increased for technologies such as spray drying, hot melt extrusion, and nanomilling or micronization.

Q2. Complex APIs are increasingly becoming the norm, what strategies are you implementing to overcome solubility and bioavailability challenges?

In the last 10 years, CordenPharma has seen more and more complex APIs entering clinical Phase I. The complexity is mainly solubility/bioavailability driven. In order to overcome these issues, CordenPharma is working on an early-stage concept between API development and Drug Product development for First-in-Human clinical studies. We are installing this early-phase platform at the CordenPharma Liestal, Switzerland and CordenPharma Plankstadt, Germany sites. The Liestal site will conduct solid-state characterization, polymorph, salt screening, and biopharmaceutical characterization of the API (e.g. solubility testing, small-scale dissolution testing). And, in Plankstadt, we will be installing small-scale equipment for spray drying, hot melt extrusion, nanomilling, and micronization. We will then be able to prepare small-scale prototypes in our R&D laboratory for animal studies. Further development and scale-up for clinical studies can then be conducted in larger scale GMP equipment in Plankstadt, or one of our other facilities in the network.

Q3. OSDs continue to be relevant within the pharmalandscape. Are there other routes of administration that you feel will become more predominant in the future? What makes OSD so attractive as a route of administration?

I believe that OSDs will continue to be a predominant route of administration within the pharma landscape. Many patients prefer swallowing tablets and capsules versus injections or infusions. They can also be sent home with these medications, instead of having to go into hospitals for administration of treatments. In addition, they are generally more simple, stable, flexible, and more cost-effective dosage forms to manufacture.

Q4. What recent OSD technologies or methods might be proving extra capable of improving a given OSD’s therapeutic performance as well as challenges surrounding patient centricity?

One key methodology that improves both therapeutic performance and is patient-centric is a modified release dosage form. Modified release drug products enable drug release over a defined period of time, or at specific locations within the GI tract for prolonged or targeted drug delivery. This allows for less frequent dosing, which can increase patient compliance, resulting in fewer side effects by reducing peaks and troughs in blood levels. This is a huge therapeutic advantage for patients if the debilitating effects of a disease appear quickly once the drug concentration falls out of the therapeutic window.

Newer technologies that will be interesting to see how they progress in our industry are 3D printing and digital/eHealth dosage forms. And, of course continuous manufacturing. Together with PAT tools, this is suitable for development, clinical manufacturing, and small-scale commercial manufacturing.

Q5. Are there any new OSD technologies that you are excited about that may revolutionize the industry in the coming years? What challenges do these technologies aim to solve?

3D Printing is very interesting. It is currently still in an early development phase and is a slow process (compared to conventional drug product manufacturing technologies), but it can create personalization of dose and specific combinations of APIs. It will be highly challenging from a regulatory standpoint.

Conclusion

The needs of drug developers are changing, and they are seeking even more complex dosage form production procedures. Another example of a technology capable of delivering abilities more effectively is osmotic pump tablets. By 2028, the global market is estimated to be worth USD 38.84 billion, with a CAGR of 8.4% from 2021 to 2028. With this in mind, HPAPI manufacturing capabilities are likely to be in high demand for the coming years. The fact remains that the advantages of OSD’s outweigh the cost, which is involved in its research, technological upgrade, and tweaks. Pharmaceutical firms are increasingly favouring OSD over injectables because of the inherent patient-centred benefits it provides. Patients continue to favour tablet and capsule forms of medication because they are better and easier to self-administer, particularly outside of a clinical setting. The oral solid dose (OSD) market is estimated to reach $926 billion by 2027, up from $493 billion in 2017, a 6.5% CAGR. CDMOs are witnessing an increased demand for OSD development help for their projects. 

With all these facts that make the OSD’s imprint thicker, their growth at a brisk pace can never be ruled out throughout this decade.

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