A view on

We are back! Discover the latest in pharmaceutical innovation from CPHI Milan with A View On! This episode explores advancements in bioconjugates, AI-driven drug development, targeted capsule delivery, and new solutions in cell and gene therapy that are transforming patient care. Tune in to hear from Lonza experts on the future of pharma and biotech.

Tracing the Evolution and Future of Capsule Manufacturing   In this episode, we are joined by Ljiljana Palangetic, Associate Director of Hard Capsules R&D, and Bram Baert, Senior Director of Regulatory Affairs from Lonza, to delve into the intricacies of capsule manufacturing and the evolution of drug delivery technologies.  Your grandmother might have told you to “just swallow your medicine,” suggesting that you may have to endure something unpleasant but necessary. Today, however, this old saying might not ring true, as capsules have become ubiquitous in modern medicine. Favored by 44% of consumers, capsules simplify medication intake with their ease of swallowing and ability to mask unpleasant tastes. From ancient Egyptian leather pouches to modern high-tech production lines, capsules have undergone significant transformations, seamlessly integrating into our daily lives. Swallowing one’s medicine has never been so easy.   Yet the role of capsules has expanded far beyond taste masking. Today, they are engineered to deliver drugs to specific parts of the intestine, dissolve at controlled rates, and even contain multiple medications in one unit. This adaptability not only improves patient compliance but also caters to a myriad of medical needs. As we look toward the future, the potential for capsules in drug delivery is boundless, driven by continuous innovation and a deep understanding of materials science.  As mentioned in the podcast, if you haven’t already listened to episode 9 of this season, you can find out more about targeted drug delivery using capsules here.    Curious to Know More?  Join us in this conversation hosted by Martina Hestericova with Lonza's Ljiljana Palangetic and Bram Baert as they unveil the advancements in capsule manufacturing technologies and their impact on modern drug delivery systems.    KEY TERMS IN CONTEXT:  Regulatory Affairs are crucial for ensuring that all pharmaceutical products, including capsules, adhere to legal and regulatory standards. Professionals in regulatory affairs navigate the complex landscape of pharmaceutical manufacturing, particularly focusing on consumer and patient safety, by collaborating with health authorities to establish and update regulations that ensure the safety and efficacy of capsules.  Two-piece Capsules consist of a cap and a body that fit together, making them a versatile choice for different types of medication delivery. The design innovations of two-piece capsules have evolved significantly since their inception in the mid-19th century. They accommodate a multitude of materials such as powders or granules and playing a crucial role in modern automated manufacturing processes.  Designed to pass through the stomach intact and dissolve in the intestines, enteric capsules are crucial for drugs that can be deactivated by stomach acid or may cause irritation to the stomach lining. This technology ensures that medication is released in the part of the gastrointestinal tract where its absorption is optimized, thereby enhancing both the drug's effectiveness and patient comfort.  The use of polymer solutions is integral to forming the shells of capsules, particularly in technologies where a capsule is dipped into the solution, allowing the polymer to dry and harden. The choice of polymer affects the capsule's dissolution rate and stability, which is critical for ensuring that the drug is released at the correct rate and location in the body.  Made from thin membranes derived from the small intestines of sheep, SAPARIS capsules are an early form of specialized drug delivery technology. They were designed to allow for a slow dissolution rate, aiming to improve the timing of drug release within the body. This technology showcases the evolution of capsule materials from organic origins to today's synthetic and semi-synthetic materials used in capsule manufacturing. 

Simulating the Journey of Oral Medications: A Leap Towards Personalized Medicine  In this episode, we are joined by Deanna Mudie, a senior principal engineer at Lonza, and John DiBella, president of PBPK & Cheminformatics at Simulations Plus, to discuss new techniques in enhancing the bioavailability of drugs.  When you swallow a pill, have you ever pondered the intricate journey it undertakes to deliver its therapeutic effect? This voyage, crucial for the drug's effectiveness, is at the heart of pharmaceutical R&D's quest to enhance bioavailability - the proportion of the drug that enters circulation and reaches the target area.  By simulating how drugs interact with the body, scientists can optimize therapeutic outcomes by tailoring medications to the needs of individual patients. This approach promises a future where drugs are not only more effective but also safer, with reduced side effects. Listen as we delve into the cutting-edge world of Physiologically Based Pharmacokinetic (PBPK) modeling. These computer models integrate factors like gastrointestinal physiology and population characteristics, shedding light on how drugs behave in various body systems without the need for extensive patient testing.   Curious to Know More?  Join us in this conversation hosted by Martina Hestericová with Lonza's Deanna Mudie and Simulations Plus's John DiBella as they unveil the potential of PBPK modeling to revolutionize drug development and personalized medicine.     KEY TERMS IN CONTEXT:  In the context of pharmaceuticals, drug bioavailability refers to the proportion of a drug that enters the circulation when introduced into the body and is thereby able to have an active effect. It's a critical factor in determining the drug's effectiveness, as it measures how much of a drug in a dosage form (like a tablet or injection) becomes available at the target site of action.  PBPK modeling is a sophisticated computational modeling technique used to predict the absorption, distribution, metabolism, and excretion (ADME) of drugs within animals and humans. This approach aids in understanding a drug's bioavailability and supports the design of more effective and safer drug therapies.  Gastrointestinal Physiology refers to the study of the functions and processes of the digestive system or gastrointestinal (GI) tract. In the context of PBPK modeling, understanding gastrointestinal physiology is crucial for predicting how a drug is absorbed into the body, especially for orally administered medications. It includes factors like stomach acid levels, GI transit time, and the surface area available for absorption.  "In silico" refers to the use of computer simulations or digital analyses to conduct experiments or procedures virtually rather than in a laboratory or real-world setting. In silico tools in drug development include software and algorithms used for modeling and simulation, such as PBPK models, which allow researchers to predict how drugs interact with animals and humans, aiding in drug design, testing, and the customization of therapies for personalized medicine. 

Capsules for Targeted Therapy: A Game-Changer in Modern Medicine  In this episode we are joined by Vincent Jannin, Lonza's R&D Director, to explore Enprotect, the Award-Nominated Capsule Technology.  Imagine starting your day with a simple capsule that goes beyond simply dissolving in your stomach to reach the place in your body where it is needed most before releasing its medicine. That’s just what Lonza’s Enprotect enteric capsules do. They are designed to release medication directly into the small intestine, which represents a significant leap in pharmaceutical delivery. They improve patient compliance without increasing production costs and offer targeted delivery for specific therapies such as live biotherapeutic products. This targeted approach is crucial for treatments that require local delivery, for example for Crohn's disease, exocrine pancreatic insufficiency, or Clostridium difficile infection.    In this episode we hear from Vincent Jannin about how advances in polymer science have ushered in this new era of capsules capable of targeted drug delivery. This marvel of modern medicine combines the fields of chemistry, nanoscience, biology, and physics. The creation of a bilayer capsule—comprised of a structural layer for shape and a functional layer for targeted release—both required the development of new technologies and could itself serve as an enabling technology for future therapies.    Vincent Jannin and his team have published several peer-reviewed studies in open access scientific journals, which were mentioned in the podcast:  In Vivo Evaluation of a Gastro-Resistant Enprotect Capsule under Postprandial Conditions (https://www.mdpi.com/1999-4923/15/11/2576)  In Vivo Evaluation of a Gastro-Resistant HPMC-Based “Next Generation Enteric” Capsule (https://www.mdpi.com/1999-4923/14/10/1999)  In vitro evaluation of the gastrointestinal delivery of acid-sensitive pancrelipase in a next generation enteric capsule using an exocrine pancreatic insufficiency disease model (https://www.sciencedirect.com/science/article/pii/S0378517322009966)  Curious to Know More?  Join us this episode as we explore the journey from a simple capsule to a sophisticated drug delivery system and how this advancement reflects a remarkable fusion of science and innovation. Discover how the Enprotect technology not only offers hope for more effective treatments but also exemplifies the relentless pursuit of medical advancement for the benefit of patients everywhere.     KEY TERMS IN CONTEXT:  An enteric capsule is a type of capsule specifically designed to bypass the acidic environment of the stomach and release its contents into the small intestine. The term 'enteric' relates to the small intestine. These capsules are formulated to remain intact in the stomach and dissolve only when they reach the more neutral pH levels of the intestine, ensuring targeted drug delivery.  Enteric polymers are materials used in the construction of enteric capsules. They are chosen for their ability to withstand acidic conditions (like those in the stomach) and dissolve at higher pH levels like those found in the small intestine. HPMC Acetate Succinate is an example of an enteric polymer used for the outer layer of the capsule to ensure the treatment’s proper dissolution and release in the intestine.  Live Biotherapeutics (LBPs) refer to live microorganisms used for therapeutic purposes. They are designed to interact with the human microbiome, particularly in the small intestine, and are sensitive to stomach environments. The protection LBPs need before their release in the desired intestinal location is facilitated by specialized capsules.  Fecal Material Transfer refers to a medical treatment involving the transfer of fecal matter from a healthy donor to a patient, often used for conditions like Clostridium difficile infections. The podcast highlighted the potential use of enteric capsules for the delivery of such treatments directly to the small intestine, thereby offering an alternative to more invasive procedures.