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This discussion looks at some of the challenges facing broader industry adoption of continuous manufacturing, how process analytical technology data can be used for process control or for real-time release, and how implementation of continuous manufacturing approaches is evolving. Jennifer Markarian, manufacturing reporter, talks about continuous manufacturing of oral solid-dosage drugs with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company.

 presents the Drug Solutions podcast, where the editors will chat with industry experts from across the pharmaceutical and biopharmaceutical supply chain. Join us as experts share insights into your biggest questions—from the technologies, to strategies, to regulations related to the development and manufacture of drug products.

Podcasts

In this episode of the Drug Solutions Podcast, Jennifer Markarian, manufacturing reporter, talks about continuous manufacturing of oral solid-dosage drugs with Lawrence De Belder, executive consultant at Pharmatech Associates, a USP company.

Drug Solutions Podcast: Drug Manufacturing Technology 

New manufacturing methods are being explored, but challenges are still present in personalized medicine development.

Personalized and Patient-Centric Administration of Oral Medicines

Rivaroxaban, long known under the brand name Xarelto, is an anticoagulant, a classification that is among the most-prescribed medications in the United States.

FDA Approves First Generics of Rivaroxaban Tablets

The approval makes Evrysdi the first and only tablet for treating spinal muscular atrophy.

FDA Approves Evrysdi Tablet from Roche for Spinal Muscular Atrophy

Lonza will work with Iconovo to develop spray-dried formulations for an intranasally delivered biologic using a reformulated biologic drug candidate for obesity.

Lonza and Iconovo Team Up on Intranasal Biologic Candidate

This paper explores the legal and regulatory framework around 3D drug printing, particularly for personalized medicine, considering regulatory compliance, business concerns, and intellectual property rights.

Legal and Regulatory Perspectives on 3D Printing: Drug Compounding Applications

This episode of Drug Digest will discuss the oral solid dosage market and the main challenges to drug developers, explain how CDMOs are leveraging expert techniques to improve OSD bioavailability, and look into the future of advancements in drug delivery.

Patient Preference Driving Solid Dosage Trends

In this exclusive Drug Digest video interview, Patrick Lavery, Editor, 

Group, interviews an industry expert about solid dosage formulation trends. During the discussion, the expert will detail what the challenges to developers are, what are currently some of the most frequently sought-after expert techniques, how contract development and manufacturing organizations (CDMOs) can leverage their experience in performing those techniques to improve oral solid dosage (OSD) bioavailability, and what the future holds in terms of advancements in OSD drug delivery.

Adi Kaushal, Director and Technology Head, Bioavailability Enhancement, Lonza

Adi Kaushal is the Director and Technology Head for Bioavailability Enhancement (BAE) at Lonza Bend. He has over 20 years of formulation experience and has been with Lonza (previously Bend Research) since 2010. Adi is responsible for overall BAE technology strategy and progression of customer programs from feasibility to commercialization. Adi’s group of over 50 experienced scientists and engineers are engaged in bringing new BAE technologies to product development, customer-centric advancements, and continuous improvement of Lonza internal systems. Adi also supports collaboration with internal R&D within the Lonza Small Molecules business unit.

Drug Digest is a tech talk video series with the 

® editors, who interview industry experts to discuss the emerging opportunities, obstacles, and advances in the pharmaceutical and biopharmaceutical industry for the research, development, formulation, analysis, upstream and downstream processing, manufacturing, supply chain, and packaging of drug products.

 Developments in Small Molecule APIs, Excipients, and Ingredients

Videos

In this exclusive Drug Digest video, Adi Kaushal from Lonza summarizes the current state of the oral solid dosage market, identifies the main challenges to drug developers, explains how CDMOs are leveraging expert techniques to improve OSD bioavailability, and looks into the future of advancements in drug delivery.

Drug Digest

PharmTech News

Drug Digest: Patient Preference Drives Solid Dosage Trends

A discussion on the most significant/innovative ingredients over the past year and a look ahead at new innovative ingredients anticipated. 

DCAT Week 2025: Key Ingredients in Pharmaceutical Manufacturing

In an interview with the PharmTech Group ahead of DCAT Week 2025, Christine Mya-San, a global account manager at Roquette Pharma Solutions, highlights the standout pharmaceutical ingredients in the past year. These important ingredients are those that logically address the pharmaceutical industry's biggest topics and biggest challenges, she says. 

A good example of such ingredients are low nitrite excipients that support drug manufacturers and their ongoing mission to reduce the risk posed by nitrosamines, she points out. Roquette has worked to assess and certify its existing low-nitrite products to support reformulation efforts. In addition, the company is developing solutions to enhance medication adherence, such as β-cyclodextri

 (Kleptose DC), which improves solubility and provides effective taste-masking, and mannitol (Pearlitol 200 GT), which offers enhanced compressibility and resistance to tablet capping, thus enabling the production of smaller, more convenient mini-tablets, Mya-San notes.

Looking ahead, Mya-San anticipates that pharmaceutical ingredients such as high-performance tablet coatings will optimize tablet manufacturing compared to traditional sugar coatings. "Recently, we put the spotlight on high-performance coatings, highlighting features such as low processing temperatures, which help in two-fold: first, for reduced energy usage, and second for that lowered nitrosamine formulation [risk]," she states.

Meanwhile, in terms of innovation, she highlights the potential of 3D drug printing and artificial intelligence to play a central role in the identification and large-scale production of new therapeutic ingredients. Three-dimensional printing, for example, could enable the printing of customized medicines tailored to individual patient needs, including the combination of multiple medications into a single dosage form.

DCAT Week 2025 is being held March 17–20 in New York City.

Christine Mya-San, Global Account Manager, Roquette Pharma Solutions

Christine Mya-San is a global account manager at Roquette Pharma Solutions. Her love of the sciences started as a Cancer Research Fellow at the National Institutes of Health. Post fellowship, she started working at Covance as a risk mitigation specialist and sales representative. Mya-San has worked at notable companies such as Sigma-Aldrich (Merck KGaA) and at Honeywell Research Chemicals. Previous roles at Roquette include Americas channel management and global market management for the over-the-counter and nutraceuticals markets. Mya-San received her Bachelor of Science in biology at Dickinson College (Carlisle, Penn.) and her Master of Business Administration from Saint Louis University.

Roquette Pharma Solutions' Christine Mya-San, global account manager, highlights the most significant pharma ingredients at play over the past year and discusses future ingredient innovation.

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At AAPS PharmSci 360, Karunakar Sukuru, global vice-president, Catalent Pharma Solutions, discussed lipid-based formulations and tackling bioavailability challenges for oral biologics.

AAPS PharmSci 360: LBFs and Tackling Oral Biologic Formulations

® spoke with Karunakar Sukuru, RPh, PhD, global vice president of Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, about the advantages and new challenges with lipid-based formulations (LBFs). Sukuru also discussed the challenges of addressing bioavailability in the search for developing oral formulations for biologics.

“Lipid-based drug delivery systems are not new,” Sukuru said, noting, though, that although lipid-based drug delivery systems exist, there is, today, an increased need for them, particularly considering that of the almost 8500 or so molecules—small molecular entities—in development, 70% of them are poorly bioavailable. “Because [these small molecules] are either poorly soluble, or poorly soluble and poorly absorbed, [that] is where the lipid-based formulation comes into play … they have a very demonstrated and valuable utility,” he stated. LBFs enhance bioavailability, so that a molecule may not necessarily need to have aqueous solubility.

Meanwhile, delivering biologics or proteins through an oral route is very challenging because of their high molecular weight. “[There] [are] certain limitations; the body does not allow absorb[tion of] these high molecular weights … with most monoclonal antibodies or biologics, they are in the hundreds of 1000s of Daltons [in size],” Sukuru pointed out. “However, there are a lot of efforts going on, and novel formation and answers are showing good promise, where they open the tight junctions, facilitating the absorption of the molecules,” he added. Another challenge he emphasized is stabilizing the biologic molecule once it is delivered to the intestine, where it would otherwise be destroyed by an acidic environment.

Attendees can visit Catalent at Booth #1141 at AAPS PharmSci 360, which is taking place on Oct. 20–23, 2024 in Salt Lake City, Utah.

Karunakar (Karu) Sukuru, RPh, PhD, Global Vice President, Rx Product Development, Pharma and Consumer Health, Catalent Pharma Solutions

Karunakar Sukuru (Karu) RPh, PhD is the global vice president of Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions. With over 29 years of experience in the pharmaceutical industry, he has led the development and manufacturing of various drug delivery systems and technologies and has been responsible for product development and execution of projects globally. Sukuru had technical oversight of more than a dozen contract development and manufacturing organizations worldwide while working at Endo Pharma. In his current role at Catalent, he works with hundreds of pharmaceutical clients, including leading biopharma companies, globally. He has developed innovative controlled-release platform technologies in softgel form (three granted patents) and has over 27 pending patent applications in the field of modified shell and fill suitable for capsules for enteric and colonic delivery and lyophilization. After completing his PhD in Pharmaceutics from IIT-BHU, India, in 1995, Sukuru began his career at Natco Pharma in India, where he developed a variety of oral dosage forms for two years. He then joined Banner Pharmacaps in India, and later in Banner Pharmacaps USA, he worked on softgel and gel enrobed tablets. Sukuru joined Endo Pharma in 2006 and Catalent in 2016 as the vice president of Product Development. He is also a registered pharmacist.

At AAPS PharmSci 360, Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, discussed lipid-based formulations and tackling bioavailability challenges for oral biologics.

Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, spoke on recent challenges and trends in softgel formulations. 

AAPS PharmSci 360: Challenges and Trends in Softgel Formulations

® spoke with Karunakar Sukuru, RPh, PhD, the global vice-president-Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions, during AAPS PharmSci 360 to discuss recent challenges and trends in softgel formulations.

“Recent challenges are mostly related to enhancing the solubility and making those solubilized molecules stabilized in the systems, particularly in softgels, and enhancing the bioavailability,” Sukuru said. He noted that there is an increasing demand for non-animal products by the industry, particularly in Europe where gelatin, an animal byproduct, is used as a shell component. Although gelatin is a good material to use in terms of its ability to make robust, subgenerative capsules, it also has some disadvantages, such as cross-linking challenges, Sukuru pointed out. “That is where [there is need] to address both the non-animal byproduct need, using plant-based materials, as well as … the cross linking issues,” he stated.

, which is on Monday, Oct. 21, at 3:30 pm MT (2:30 pm PT, 5:30 pm ET), centers around the missed opportunity for superior bioavailability and the ability to develop moderated drug release products using softgels. “Softgel is one of the most versatile dosage forms, and you could deliver [a] drug through any orifice in the body, literally,” Sukuru said. “There are products that we manufacture commercially to deliver through oral route, ophthalmic route, nasal, otic, vaginal, and every route of delivery, but it's very underutilized. [Futhermore] there are a lot of myths and misconceptions about softgels being very expensive. No, they are not. In fact … compared to spray drying and some other bioavailability enhancing technologies, they are not.”

Attendees can visit Catalent at Booth #1141 at AAPS PharmSci 360, which is taking place on Oct. 20–23 in Salt Lake City, Utah.

Karunakar (Karu) Sukuru, RPh, PhD, Global Vice-President-Rx Product Development, Pharma and Consumer Health, Catalent Pharma Solutions

Karunakar Sukuru (Karu) RPh, PhD is the global vice-president of Rx Product Development, Pharma and Consumer Health, at Catalent Pharma Solutions. With over 29 years of experience in the pharmaceutical industry, he has led the development and manufacturing of various drug delivery systems and technologies and has been responsible for product development and execution of projects globally. Sukuru had technical oversight of more than a dozen contract development and manufacturing organizations worldwide while working at Endo Pharma. In his current role at Catalent, he works with hundreds of pharmaceutical clients, including leading biopharma companies, globally. He has developed innovative controlled release platform technologies in softgel form (three granted patents) and has over 27 pending patent applications in the field of modified shell and fill suitable for capsules for enteric and colonic delivery and lyophilization. After completing his PhD in Pharmaceutics from IIT-BHU, India, in 1995, Sukuru began his career at Natco Pharma in India, where he developed a variety of oral dosage forms for two years. He then joined Banner Pharmacaps in India, and later in Banner Pharmacaps USA, he worked on softgel and gel enrobed tablets. Sukuru joined Endo Pharma in 2006 and Catalent in 2016 as the vice-president of Product Development. He is also a registered pharmacist.

CPHI Milan 2024: Evolution of Coating Design

 Europe spoke with Ali Rajabi-Siahboomi, vice president and chief innovation officer at Colorcon, about the evolution of coating design and how it has impacted investment, as well as innovations in packaging for oral solid dosage products.

Coating design for solid dosage products has evolved from sugar coating to film coating to solvent-based and then to aqueous coating over the years, according to Rajabi-Siahboomi. “But the development of this robust and optimized formulation that we've had, and the umbrella of the Opadry system, has made it much easier to have the right film coating, but at the same time, apply it much more efficiently,” he says. 

The functionalities of film coating have changed over the years as well, according to Rajabi-Siahboomi. “Many years ago, [film coating] was just more for adding color and recognizing different dosages and different product. Nowadays, we apply functionalities [such as] moisture barrier … putting tags in those film coating so that we can identify them as part of authentication and counterfeiting, anti-counterfeiting. So, there has been a whole evolution, but when we talk about some of these challenges, … it highlights the need for continuously focusing on innovating, bringing continuous improvement and innovation in this field.”

Click the above video to watch the full interview.

 is being held from Oct. 8–10, 2024 in Milan, Italy.

Ali Rajabi-Siahboomi is the vice-president and chief innovation officer at Colorcon, based at the Global Headquarters, USA. Rajabi-Siahboomi has held various academic positions in Nottingham and Liverpool JM Universities in the United Kingdom before joining Colorcon as technical director, responsible for Europe, the Middle East, and Africa, in 2000. His main research interests are solid dosage form pharmaceutics, pharmaceutical technology with emphasis on oral drug delivery systems, solubility enhancement to improve bioavailability, and consistency of drugs and bioequivalence formulations. He has published more than 300 articles, book chapters, abstracts, and patents and obtained his B.Pharm. and PhD in pharmacy from the University of Nottingham (UK).

Pharmaceutical Technology Europe spoke with Ali Rajabi-Siahboomi, vice president and chief innovation officer at Colorcon, about the evolution of coating design and how it has impacted investment, as well as innovations in packaging for oral solid dosage products.

CPhI News

Camille Dumont, PhD, manager, customer applications, Lonza, discussed current industry trends that are having an impact on development work in oral solid dose formulations.

CPHI Milan 2024: Industry Trends Impacting Oral Solid Dose Formulation

At CPHI Milan, Camille Dumont, PhD, manager, customer applications for Innovaform Accelerator at the Capsules & Health Ingredients business of Lonza, spoke with 

about bio/pharmaceutical industry trends and their influence on oral solid dose formulations. 

“One of the trends we see with our customers, with the rise of inflamed bowel disease occurrence, is the oral delivery of live biotherapeutic products, which are originally administered for very invasive techniques,” she said. “[N]ow, we see lots of people working to have [these products] administered as a solid oral dosage form. Another important trend is the oral delivery of biologics such as peptides, proteins, mAbs [monoclonal antibodies], or mRNA [messenger RNA]. Most of these drug modalities are currently injected.”

Dumont pointed out that the injection route of administration can reduce patient adherence and can have a significant cost on healthcare systems. She emphasized that these types of APIs are fragile, however, and so require innovative solutions to achieve significant oral bioavailability. “Most of the time, only a combination of various strategies will result in [achieving] significant bioavailability and efficacy of these drug modalities, such as [using] enabling formulation devices and so on.

We offer formulation and targeted release capsule innovation to support this kind of need,” she stated.

To increase the bioavailability of many of these new drugs and new chemical entities, Dumont observed that there is a need for enabling formulation strategies, including permeation enhancers. “Recently, we have seen that a lot of biotechs [are] work[ing] on smart devices that are able to deliver fragile drug modalities directly by injection into the wall of the gastrointestinal tract. We can see that most of these innovations … rely on target release of the formulation … Solutions for target deliveries such as functional capsules appear as really interesting solutions for the pharmaceutical industry,” Dumont said.

With Lonza for about three years, Dumont is a chemical engineer with a PhD in pharmaceutical sciences from the University of Lyon, France. She has 10 years of experience in the pharma industry in developing innovative solutions for bioavailability enhancement, with particular expertise in lipid-based formulation and oral bioavailability enhancement of small and large molecules.

Attendees can visit Lonza at Booth 6A2. CPHI Milan is being held from Oct. 8–10, 2024 in Milan, Italy.

CPHI Milan 2024: Trends in Oral Solid Dosage Forms

 sat down with Uwe Hanenberg, Head of Product Implementation at Recipharm, to talk about key trends shaping the oral solid dosage market, including technology advances and industry investments.

Hanenberg sees the oral solid dosage market growing, in part by the aging population, as well as a trend toward reducing the number of suppliers and the creation of strategic partnerships. Oral biologics are a popular development in the industry, because of the easy method of administration, as well as the push for continuous manufacturing processes, according to Hanenberg.

Investment will continue in the oral solid dosage market, according to Hanenberg, pointing out the popularity of glucagon-like peptide-1 (GLP-1) diabetes and weight loss drugs. “There will come further big products. And that is certainly not to be executed on an existing tablet line or blister line,” says Hanenberg. “That is something where you need more investment … I expect to see announcement on investment in high-potent capabilities, especially in CDMO [the contract development and manufacturing organization] space, anything that is related to completion of offerings to reach an integrated solution, which means I expect a further consolidation of the CDMO market. Then I expect a very significant investment in continuous manufacturing. There are big companies who have a commitment to produce, in future, 50–80% of all new launches on continuous manufacturing.”

Uwe Hanenberg, Head of Product Implementation, Oral Solid Dose


Dr. Uwe Hanenberg is Head of Product Implementation, Oral Solid Dose (OSD) at Recipharm. Uwe is responsible for implementing and executing the OSD Product Development strategy that assures science driven, timely development of new products or services. Uwe has 25 years of experience in the pharmaceutical industry with Bayer, Altana, Grünenthal and Catalent. He has held several leading positions in quality, manufacturing and packaging, product development, project management within the Science & Technology sphere. His areas of expertise are oral formulation development, oral manufacturing technologies, stick pack technologies and pharmaceutical contract services and project management.

Pharmaceutical Technology Europe sat down with Uwe Hanenberg, Head of Product Implementation at Recipharm, to talk about key trends shaping the oral solid dosage market, including technology advances and industry investments. 

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