Whitepapers

Hot Melt Extrusion (HME) is a widely utilized pharmaceutical technique designed to enhance the bioavailability of poorly soluble drugs through solid molecular dispersions. Effective analytical characterization plays a critical role in the efficient development of HME formulations.

Hot Melt Extrusion (HME) is a widely utilized pharmaceutical technique designed to enhance the bioavailability of poorly soluble drugs through solid molecular dispersions. Effective analytical characterization plays a critical role in the efficient development of HME formulations.

This technical note explores the sources of error in gravimetric measurements used for aerosol photometer calibration, emphasizing the impact of discrepancies in aerosol properties, temporal instability, and flawed experimental procedures. It supports the two-point calibration practice to minimize errors, particularly at lower concentrations, and recommends measures such as improved aerosol systems and automation to enhance calibration accuracy. The findings aim to ensure reliable photometer performance for critical applications.

This technical note discusses the rationale for using two-point calibration and multi-point verification in the calibration of aerosol photometers. It explains the theoretical basis for the linear relationship between photometric response and aerosol mass concentration, highlights practical challenges with multi-point calibration, and advocates for two-point calibration to minimize errors. The combination of two-point calibration and multi-point verification ensures the accuracy and performance of the photometer in critical applications.

Example of how we offer creative and interesting solutions to our customers to improve efficiency in production.

We want to inform our customers that we have an excellent tech center available to assist them to develop together tailor-made solutions and personalized technologies, solve problems and complete hands-on training on our machines.

Highlighting the importance for our clients to prepurchase multi-year maintenance contracts, in order to avoid their machines breaking or stopping to work suddenly and unexpectedly, to minimize the risk of interrupted production and emergency maintenance costs.

Lipid nanoparticle (LNP) formulation development begins on a small scale, often with homemade or benchtop setups, using syringe pumps and easily accessible micro-mixing systems. Once a promising formulation has been identified, the next step is to transition to standardized large-scale impingement mixing systems, such as the high flow T-mixing pumps that were used to produce the COVID-19 vaccines (Sealy 2021). Formulators need to consider a number of factors when scaling up novel LNP systems. These include flow rates that affect LNP particles, solvent removal, risk factors when changing equipment, and the impact of tangential flow filtration sensitivity. In this technical note, we discuss these factors and what needs to be considered when developing a cost- and time efficient large-scale process.

A must-read for anyone in the industry looking to enhance their micronization processes. Discover how adding low percentages of SYLOID® mesoporous silica can significantly improve the run time and yield of jet milling processes for hard-to-process Active Pharmaceutical Ingredients (APIs). Imagine achieving a more consistent feed rate and a homogenous final product simply by pre-blending SYLOID® mesoporous silica with your APIs. Grace & Microsize conducted experiments that reveal substantial improvements in both run time and yield, making this paper an essential guide for professionals aiming to optimize their manufacturing processes and boost efficiency and feed rate consistency.

An article describing the technological advancement from one process controller to the new one.

Stevanato Group’s integrated offering addressing mAbs challenges includes Aidaptus®, a 2-step single-use auto-injector accommodating 1mL and 2.25mL PFSs in the same base device, supporting a range of drug viscosities for reliable delivery.

Don't miss this webinar delving into: - How to streamline the selection of the primary container and delivery device - How to overcome silicone challenges in PFSs - How to enhance the delivery of highly viscous drug formulation

The release of subvisible silicone particles and the risks associated with silicone oil droplets are major factors that can compromise the safety and efficacy of sensitive drugs. Download this white paper and discover how Stevanato Group's innovative syringe platform answers this challenge.

For new drug products, it is essential that pharmaceutical companies utilize the experience of container suppliers as early as possible. Read this white paper and discover how Stevanato Group can support you from start to finish.

Commercializing a drug-device combination product is a complex challenge to handle alone. Learn how Stevanato Group’s Technology Excellence Centers can provide guidance and execution through the various steps of a Validation Master Plan.

3D screen printing provides innovative drug development capabilities that are difficult or impossible to achieve with traditional methods, including complex multi-layered formulations, precision control over drug release profiles, and near-endless possibilities in the geometric shaping of dosage forms. In this article, learn how 3D screen printing offers unmatched flexibility to tailor formulations for specific therapeutic needs and redefines what’s possible in drug development and manufacturing.

Collaborating with a CDMO that has the necessary expertise, equipment, and systems in place is crucial to optimizing the scale-up process and accelerating timelines.

This article explores the challenges found in manufacturing of a pressure vessel as main component for freeze drying technology

ROSS Ribbon Blenders meet the toughest standards for quality and long-term performance. Known worldwide for heavy-duty robust construction, high quality materials and fine craftsmanship, these blenders are available in a variety of customizable configurations ranging from laboratory sizes to 1000 cubic feet. We pay close attention to every detail in design and fabrication, a commitment that translates to higher production value for the end user.

This white paper presents an overview of mixing technologies implemented across many of today’s highly competitive pharmaceutical and medical industries, as well as new equipment designs that are increasingly being recognized as potential solutions to prevailing mixing challenges. Mixing applications falling within the broad spectrum of mass produced pharmaceutical goods and medical devices are too many and complex to discuss in detail hence this paper will touch on a few general classifications as well as a few examples within that mixing category. Phase and viscosity are used as bases for classification.

An inline rotor/stator mixer equipped for powder induction offers flexibility, capability and portability to serve multiple mix vessels of virtually any size. Its straightforward operation and convenience further maximize equipment utility while simplifying material handling.

Consider upgrading your emulsification process to an ultra-high shear mixer to obtain finer droplet sizes and handle higher viscosity emulsions.