Lonza

International Journal of Pharmceutics: In Vitro: The dissolution characteristics of five capsules (Next Generation Enteric [NGE], Vcaps® Enteric [VCE], VCE DUOCAP® [VCE/VCE] system, Hard Gelatin Capsule [HGC] as negative control, and Creon® 10,000 U as market reference) were evaluated using an in vitro simulation of the stomach and upper intestinal tract with an acidic duodenal incubation (pH 4.5 for the first 10 min, pH 6 for the remaining 17 min) to simulate exocrine pancreatic insufficiency. Caffeine was a marker of capsule dissolution, and tributyrin to butyrate conversion measured pancrelipase activity. All capsules were filled with pancrelipase; the NGE, VCE, VCE/VCE, and HGC capsules also contained 50 mg caffeine. Caffeine was released first from the HGC capsule, followed by the VCE, NGE, and VCE/ VCE capsules. Pancrelipase activity followed this trend and demonstrated a similar activity level over time for the NGE, VCE/VCE, and Creon® capsules. The HGC formulation confirmed gastric degradation of unprotected pancrelipase. NGE capsules provided similar protection to the simple fill formulation as observed for the complex formulation of the Creon® capsule in a setting with increased pepsin activity and may hasten the time needed to go from formula development to first-in-human studies for pH sensitive drugs or those requiring small intestine targeting.

Introducing Lonza Capsules & Health Ingredients' groundbreaking enteric manufacturing technology - the Capsugel® Enprotect® capsule. This unique bi-layer capsule with the Coni-Snap® secure closure design utilizes HPMC and HPMC-AS polymers. It protects acid-sensitive APIs and enables rapid dissolution release at pH 6.8 without the need for additional excipients. The bi-layer manufacturing technology streamlines drug development processes, while personalized oral dose customization enhances product differentiation. Partner with us to revolutionize the microbiome market, overcome enteric delivery challenges, and drive innovation in modern healthcare.

Invivo: Many orally dosed APIs are bioavailable only when formulated as an enteric dosage form to protect them from the harsh environment of the stomach. However, an enteric formulation is often accompanied with a higher development effort in the first place and the potential degradation of fragile APIs during the coating process. Ready-to-use enteric hard capsules would be an easily available alternative to test and develop APIs in enteric formulations, while decreasing the time and cost of process development. In this regard, Lonza Capsugel® Next Generation Enteric capsules offer a promising approach as functional capsules. The in vivo performance of these capsules was observed with two independent techniques (MRI and caffeine in saliva) in eight human volunteers. No disintegration or content release in the stomach was observed, even after highly variable individual gastric residence times (range 7.5 to 82.5 min), indicating the reliable enteric properties of these capsules. Seven capsules disintegrated in the distal part of the small intestine; one capsule showed an uncommonly fast intestinal transit (15 min) and disintegrated in the colon. The results for this latter capsule by MRI and caffeine appearance differed dramatically, whereas for all other capsules disintegrating in the small intestine, the results were very comparable, which highlights the necessity for reliable and complementary measurement methods. No correlation could be found between the gastric residence time and disintegration after gastric emptying, which confirms the robust enteric formulation of those capsules

The Lonza Capsule Application Lab is uniquely focused on solving technical issues and creating new solutions related to dosage form and delivery. We work together to leverage our scientific and technical knowledge helping to improve your manufacturing process and methodology to deliver customized solutions.

Oral administration is the preferred route of delivery for therapeutic molecules due to its convenience. However, most New Chemical Entities (NCE) exhibit physico-chemical properties limiting their absorption in the gastrointestinal (GI) tract, with almost 70% of identified molecules facing solubility issues in aqueous GI fluids according to Pharmacircle data from March 2022. Lipid-based formulations (LBF) is an interesting approach to enhance oral bioavailability of poorly water-soluble (PWS) drugs, including small molecules and macromolecules such as peptides and proteins.

Webinar Date/Time: Thu, Sep 28, 2023 11:00 AM EDT

Biotherapeutics that allow for inhaled delivery and months of room-temperature stability are made possible with spray-drying techniques.

Successfully develop and commercialize new medicines with a highly accomplished collaborator.

Webinar Date/Time: Thu, Jun 15, 2023 11:00 AM EDT

A growing proportion of drugs in the development pipeline nowadays start out life at small biotech companies, rather than big pharma businesses. While this means the biotechs are taking on more risk, they will also reap greater rewards in the event of success. When it comes to choosing your CDMO partner, there is no substitute for a careful selection process to determine the right CDMO to make and manage your precious potential drug. In this podcast, David Hall, Senior Director, Commercial Development at Lonza Small Molecules, provides insights on how small and emerging pharmaceutical and biotech companies can navigate the evolving pharma development pipeline.

A growing proportion of drugs in the development pipeline nowadays start out life at small biotech companies, rather than big pharma businesses. While this means the biotechs are taking on more risk, they will also reap greater rewards in the event of success. When it comes to choosing your CDMO partner, there is no substitute for a careful selection process to determine the right CDMO to make and manage your precious potential drug. In this podcast, David Hall, Senior Director, Commercial Development at Lonza Small Molecules, provides insights on how small and emerging pharmaceutical and biotech companies can navigate the evolving pharma development pipeline.

Webinar Date/Time: Wed, Mar 1, 2023 11:00 AM EST

Webinar Date/Time: Thu, Feb 23, 2023 11:00 AM EST

Webinar Date/Time: Thu, Oct 27, 2022 11:00 AM EDT

Newer, more complex targeted therapies are entering clinical development at rapid speeds, requiring facilities to increase manufacturing capacity levels in order to keep up with demands and under the strictest levels of containment.

Learn more about the Capsugel® Enprotect™ capsule and our breakthrough enteric manufacturing technology.

Learn more about the Capsugel® Enprotect® capsule and our breakthrough enteric manufacturing technology.

Learn more about the Capsugel® Enprotect® capsule and our breakthrough enteric manufacturing technology.

Learn more about the Capsugel® Enprotect™ capsule An innovative capsule for enteric delivery with no additional coating required for low pH protection.

Learn more about the Capsugel® Enprotect™ capsule and our breakthrough enteric manufacturing technology.

Drug development is a complicated process, with a huge number of processes and activities required to bring a drug successfully to market. How can an integrated CDMO help a small biotech move a project into and through the clinic, and onto the market? In this podcast, Henny Zijlstra, Senior Director, Commercial Development at Lonza, details why is it faster and more efficient to work with a single supplier.

Learn how the right integrated CDMO can help small biotech companies move a project into and through the clinic and onto the market with ease.

Tuesday, June 14th, 2022 at 7:30am PDT | 9:30am CDT | 10:30am EDT Join Lonza and Quench Medical in a joint discussion about process engineering for the respiratory delivery of gemcitabine to treat lung cancer

Wednesday March 2, 2022 at 11am EST | 4pm GMT | 5pm CET Compounds that are poorly soluble in water are still prevalent in the pharmaceutical industry drug development pipeline. Enabling technologies such as lipid-based formulations (LBF) and amorphous solid dispersions (ASDs) can address these bioavailability limitations, enabling the creation of effective drug products.

Wednesday, February 23rd 2022 at 11am EST | 5pm CET | Molecules with solubility challenges continue to dominate drug development pipelines, increasing the demand for formulation technologies that can solve these issues. Join CMC Consultant, Peter Timmins, Lonza’s Sr. Research Fellow, David Lyon, and Quotient Sciences’ CSO, Peter Scholes, as they outline how a variety of data-driven strategies and integrated program designs can simplify development processes and reduce costs. Using expert insight and case studies they will showcase how spray drying can solve solubility challenges, and demonstrate how integrating GMP manufacturing and clinical testing can rapidly accelerate development timelines.