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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 

The move towards “pharma 4.0” requires a major shift, both ideologically and technologically, to adapt current processes to a framework that will automate much of today’s manufacturing.

Pharma 4.0: What are Industry Leaders Prioritizing in the Modernization of Pharmaceutical Manufacturing? 

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

The ROSS Model 42N-10 has a working capacity of 10 cubic feet and is designed for free-flowing materials with bulk densities up to 100 lbs per cubic foot.

Ribbon Blenders for Bulk Blending

The ROSS FDA-50 Fixed Tank Dual Shaft Mixer is built to handle a wide range of formulations and viscosities and is ideal for processes that require meticulous control over mixing, temperature, and pressure.

Fixed Tank Dual Shaft Mixer/Pressure Reactor

As a GMP manufacturing method, 3D printing offers benefits for modified release and personalized dosages. 

Exploring 3D Printing for Solid Dosage Drugs

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.

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.

Manufacturing, Solid and Semi-Solid Dosage Drugs

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