Whitepapers

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.

Once APIs move into later phases of development, an advanced impurity control strategy is vital and demands a comprehensive analytical methods approach.

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.

Expand your mAb NBE candidate pipeline numbers by leveraging ProtaGene's flexible analytical capacities. Get a complete overview of ProtaGene's end to end services.

Long-acting products, such as Long-Acting Injectables (LAIs) and implantables, have gained significant traction in recent years, revolutionizing patient treatment and medication adherence. By reducing the number of doses required, long-acting products improve patient compliance and eliminate the risk of missed doses. Moreover, they minimize toxicity and side effects, offering a more comfortable patient experience. This article delves into the numerous benefits of long-acting drug delivery systems, including their ability to harness highly potent APIs, streamline development and intellectual property protection, and provide consistent drug release over extended periods. You’ll explore their applications in various medical fields, such as CNS disorders, cancers, diabetes, substance abuse, eye diseases, HIV treatment and prevention, and contraception. Discover how Lubrizol Life Science – Health overcomes challenges in developing these innovative drug delivery systems and gain insights into successful long-acting drug development. Whether you’re a healthcare professional, researcher, or simply curious about the future of medicine, this article offers valuable knowledge and opens up new possibilities in patient care.

Iterion Therapeutics, a clinical stage biotechnology company, is dedicated to developing novel cancer therapeutics for a broad range of cancers. When Iterion’s lead product, Tegavivint, demonstrated low solubility in water, they needed a partner who could not only solve their bioavailability challenges, but also develop a scalable formulation with a viable manufacturing strategy. They turned to the experts at Lubrizol Life Science Health (LLS Health). In this case study, you’ll learn how LLS Health combined its nanomilling expertise and GMP manufacturing capabilities to maximize bioavailability, improve patient experience, and take Iterion’s poorly soluble compound into clinical studies

CONRAD is a biomedical research and development organization dedicated to improving the reproductive health of women, especially in developing countries. They have developed a first-in-class, multipurpose intravaginal ring (IVR) that combines levonorgestrel with tenofovir to provide contraception while preventing against acquisition of Human Immunodeficiency Virus (HIV) and Herpes Simplex Virus (HSV). To bring this novel concept into the clinic, CONRAD needed the support of a contract development and manufacturing organization (CDMO) with specialized expertise in long-acting implant and IVR development. Lubrizol Life Science – Health was able to provide CONRAD with comprehensive support throughout the project from technology transfer to manufacturing. Their experts were proactive and creative in streamlining manufacturing of the product, and they integrated quality control and assurance from the very beginning of the project. As a result, we helped CONRAD to bring a novel, life-changing product to the clinic, and they are committed to helping other organizations develop and commercialize innovative drug eluting devices (DED).

The eye’s anatomy is highly resistant to penetration of therapeutic agents, and successfully bypassing its protective barriers requires in-depth knowledge of ocular delivery, as well as specialized formulation and development expertise. In this guide, we will discuss how new and existing technologies can be employed to optimize ophthalmic formulations. We will then review the top considerations for an ocular drug delivery project to maximize the probability of success.

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

Sustained Release Orally Disintegrating Tablets (ODTs) Comprising Coated Microparticles to Improve Acceptability in Patients with Dysphagia

Nanopharma Solutions platform is based on physical vapor deposition (PVD) Technology and makes drug nanoparticles with no excipients or solvents. NanoPharma Solutions nanodrug particles can be used in pills, nasal sprays, creams/salves, inhalers, eye drops, or injectables

Formulating a Fixed Dose Combination (FDC) of Artesunate (AS) and Amodiaquine (AQ) as taste masked micropellets for oral administration to children under 5 years.

To support the growing need for nitrosamine testing, SGS has expanded its volume for nitrosamine testing beyond its current service offering in Mississauga, Canada. SGS has added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) at its West Chester, PA and Markham, Canada laboratories to allow for expanded capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.

Unlock the full potential of your pharma/biopharma laboratory with our comprehensive guide on mastering liquid handling techniques for any liquid type.

You can rely on Pfizer CentreOne as your CDMO for high-quality API synthesis, from process development through long-term supply. Our capabilities include complex organic synthesis, fermentation and bioprocessing up to 150,000-liter scale, milling and micronizing, process optimization and scale-up, and process industrialization.

Development of novel small molecule active pharmaceutical ingredients (APIs) is increasingly turned over to outsourced partners who have become the primary drivers of the product’s overall development and go-to-market strategy. With hundreds of potential partners that drug owners can choose from to develop and manufacture small molecule APIs, choosing the best partner can be a challenging task. In this white paper, we explore the importance of purposefully aligning the overall drug development strategy with a partnering strategy. We also review how increasing development of novel drugs are also impacting the industry’s go-to-market efforts, driving new demand for expert small molecule API suppliers. Finally, we consider how small molecule API development projects can be executed by leveraging the experience of embedded contract development and manufacturing (CDMO) partners.

To support the growing need for nitrosamine testing, SGS has expanded its volume for nitrosamine testing beyond its current service offering in Mississauga, Canada. SGS has added capacity and instrumentation to offer nitrosamine testing, including drug substance-related impurities (NDSRIs) at its West Chester, PA and Markham, Canada laboratories to allow for expanded capacity for nitrosamine testing, while staying ahead of the curve as regulations continue to evolve.

There has been a Growing concern among regulators driving a need for awareness for manufacturers to understand the risk associated with nitrosamines in pharmaceutical and biopharmaceutical products. In this session of Changing the Conversation with SGS Live, we tackled a variety of aspects of this important issue from the risk associated with nitrosamine contamination to discovery and mitigation of nitrosamine impurities. Our experts shared the current testing requirements, along with how SGS is helping drug manufacturers along the path of development to ensure their products are free from nitrosamine contamination.

Here, we explain how results from DLS instruments at different wavelengths and scattering angles are related using practical examples and established light scattering theory