Pharmaceutical Technology Editors

Lonza, a global manufacturer for the pharma, biotech, and nutrition industries, announced on March 31, 2022 that it has become a member in the International Pharmaceutical Aerosol Consortium on Regulation and Science (IPAC-RS). The membership will benefit Lonza’s inhalation- related business through collaborating with other industry leaders to advance the research and development of inhalation technologies. Lonza will also be able to actively engage and contribute to discussions on regulations and standards that affect international trends and requirements in the industry.

Due to the global prevalence of respiratory diseases, inhaled drug products are increasing in popularity. Nasal or pulmonary delivery points and the lung’s absorptive capacity are also being explored with goals of decreasing adverse medical events and improving patient convenience.

Lonza’s access to membership in IPAC-RS will benefit Lonza’s inhalation-related businesses in many ways, including participation in collaborative research, leverage in industry benchmarking, collection and analyzation of data, engagement with regulators, and development of best practices.

“Drug delivery via the lung is complex but gaining importance in the market with significant opportunities in unmet clinical needs,” said Jason Bertola, executive director, commercial development, small molecules, Lonza, in a press release. “This results in increasing demand for formulation development, particle engineering and manufacturing of inhalation products, with an emphasis on speed. At Lonza, we understand this challenge and plan to contribute and further our expertise in this area to better serve our customers.”

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Lonza has joined IPAC-RS, providing benefits to Lonza’s inhalation- related businesses due to IPAC-RS’ global voice of the orally inhaled and nasal drug products industry.

Lonza Joins IPAC-RS, an International Consortium Advancing the Regulatory Science of Inhalation Products

ViiV Healthcare, a company specializing in HIV majority-owned by GlaxoSmithKline, Pfizer, and Shionogi, announced that FDA has approved a new dispersible tablet formulation of the fixed-dose combination of abacavir, dolutegravir, and lamivudine for the treatment of HIV in pediatric patients weighing 10 kgs to <25 kgs. A new supplemental drug application for Triumeq tablets has also been approved, which lowers the minimum weight that a child must be to be prescribed this medicine from 40 kgs to 25 kgs.

Approximately 1.7 million children globally were living with HIV in 2020, with most AIDS-related deaths among the population occurring within the first five years of life, according to UNAIDS. The approval of this tablet regimen containing dolutegravir increases age-appropriate treatment options for children living with HIV, which is crucial for ensuring young children can access optimal care.

“Children are still disproportionality impacted by the HIV epidemic with only half of the 1.7 million children living with HIV accessing the lifesaving treatment they need and even fewer still reaching viral suppression,” said Chip Lyons, president and CEO of the Elizabeth Glaser Pediatric AIDS Foundation, in a press release. “An obvious barrier to treatment is that for young children, tablets can be hard to swallow or unpleasant in taste and this presents a real challenge to many caregivers’ ability to administer life-saving medicine. Today’s approval of a child-friendly formulation of a single tablet regimen will help meet the urgent needs of this vulnerable population.”

“We are delighted with today’s FDA approval because it gives children living with HIV another age-appropriate treatment option,” added Deborah Waterhouse, CEO of ViiV Healthcare, in a press release. “Developing paediatric formulations of anti-retroviral treatments is a priority for ViiV Healthcare because we want to ensure that no one living with HIV is left behind and this approval means that we are one step closer to closing the gap between HIV treatment options available for adults and children.”
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ViiV Healthcare announced that FDA has approved Triumeq PD, a dispersible single tablet regimen containing dolutegravir, a once-daily treatment for children living with HIV. 

ViiV Healthcare Announces FDA Approval of Once-Daily Treatment for Children Living with HIV

ROSS Batch High Shear Mixers equipped with the solids/liquid injection manifold (SLIM) technology deliver powders in an efficient manner for quick wet-out and complete dispersion into low-viscosity liquids.

In a conventional rotor/stator mixer, materials are continually drawn from below the mixing head and then expelled at high velocity through the stator openings. A SLIM mixer assembly with Progressive Spiral Porting creates a powerful vacuum that draws powders directly into the high shear zone and rapidly disperses individual solid particles into the liquid vehicle. This method of adding powder dramatically reduces the formation of lumps (fisheyes), prevents floating powders, eliminates dusting, and accelerates mixing time.

A versatile tool, the SLIM can also be used to introduce minor liquid components and create fine emulsions. To easily raise and lower the high shear mixer in and out of the mix vessel, ROSS offers a floor-mounted design equipped with an air/oil hydraulic lift. Safety limit switches prevent operation of the mixer while in a raised position or without a mix vessel in place.

ROSS Batch High Shear Mixers are a versatile tool for powder delivery and dispersion of low-viscosity liquids.

Batch High Shear Mixers

Suncombe’s PureVessel range of systems are designed for sanitary and sterile liquid storage, preparation, thermal treatment, and mixing in laboratories and research institutes. They have been developed to operate within a hybrid bioprocessing model, wherein a processing facility employs a combination of single-use technologies and stainless-steel multi-use equipment.

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The PureVessel series provides modular storage, preparation, treatment, and mixing of liquids.

Modular Liquid Processing Systems

The DynaPro NanoStar II instrument from Wyatt Technologies can perform high-quality measurements of size, particle concentration, molar mass, and stability. According to Wyatt, the NanoStar II offers an ease of use, with an intuitive on-board touch-screen app that enables walk-up measurements of proteins, polymers, and nanoparticles for novice and casual users.

The NanoStar II uses dynamic light scattering and static light scattering to determine fundamental physical properties of solutions and nanosuspensions. This analysis requires 2 μL in a quartz cuvette or 4 μL in a high-quality, disposable microcuvette. According to the company, it can measure size and liter in just a few seconds, then assesses stability versus temperature. This analysis is available with

The DynaPro NanoStar II introduces advanced walk-up capabilities in DLS technology. 

Dynamic Light Scattering Technology

Rockwell Automation’s PanelView Plus 7 Graphic Performance Series B graphic terminal is the latest in their series of process control visualization hardware. Relative to the Series A model, Series B has increased user storage, product security, and support for modern peripherals. Designed for use with the FactoryTalk View Machine Edition software, the PanelView Plus 7 Series B allows customers to build applications, simplify configurations, and strengthen integrated architecture solutions. The terminals also include Ethernet connectivity and are capable of remote monitoring via VNC and FactoryTalk ViewPoint connectivity.

The Series B has been updated to run on a modern operating system and uses updated components that are part of a more robust, future-proofed supply chain. Additionally, a hardware maintenance menu button has been added to resolve potential corruption issues.

Rockwell Automations newest graphic terminals increase user storage, product security, and support for modern peripherals. 