ONdrugDelivery - ONdrugDelivery - drug delivery industry specialised b2b information

PULMONARY

DRY POWDER INHALERS: TOWARDS EFFECTIVE, AFFORDABLE, SUSTAINABLE RESPIRATORY HEALTHCARE

Hovione Technology's João Ventura Fernandes and Peter Villax look at the trends shaping the development of dry powder inhalers, highlighting the need for a shift in industrial strategy towards effective, globally affordable, sustainable devices.

PATIENT SAFETY: KEY DRIVER TO PRESERVATIVE-FREE NASAL SPRAY DEVELOPMENT

Benoît Guillard, Pascale Farjas and Audrey Chandra look at the effects of preservatives in nasal sprays, and the challenges and advantages of delivering preservative-free nasal spray drugs.

A FASTER, MORE COST-EFFECTIVE ALTERNATIVE TO GENERIC BIOEQUIVALENCE

Jag Shur explores the challenges companies face in bringing generic respiratory and nasal therapies to market – and how some organisations have proactively addressed the challenge and developed services to integrate the device and the formulation, introducing the Aptar Pharma Services offering.

INDUSTRIALISATION

MANUFACTURING DPIS: CASE STUDY OF IMA ADAPTA^® WITH BOEHRINGER INGELHEIM SPIRIVA^®

Pietro Piera and Rainer Bauer investigate the optimal process parameters for low-dose dry powder inhalers achieved by dosator technology, presenting a case study in which IMA’s capsule filler, Adapta^®, is used to fill Boehringer Ingelheim’s Spiriva^® (tiotropium) dry powder inhaler.

Edgar Hernan Cuevas Brun

HCmed Innovations

ENHANCING INHALATION THERAPY BY REINTRODUCING ANTIBIOTICS USING MESH TECHNOLOGY

Edgar Hernan Cuevas Brun looks at how the administration of some old antibiotics could be a valuable response to fight infections.

Mark Stansfield

REDUCING VASCULAR MORTALITY IN PATIENTS WITH SUSPECTED ACUTE MI

Mark Stansfield and Kambiz Yadidi discuss initial results of their pilot Phase I clinical study of dry powder inhalation formulation of aspirin for the treatment of acute myocardial infarction.

HOW A DIGITAL APPROACH CAN UNPICK CLINICAL TRIAL CHALLENGES AND IMPROVE OUTCOMES

Matt Ash, Tom Lawrie-Fussey and Bastiaan De Leeuw look at the role digital technology can play in the development of drug-device combination products.

Intertek Melbourn

IN VITRO BIOEQUIVALENCE – WHERE ARE WE NOW?

With a focus on bioequivalence testing in generic inhalables development, Mark Parry highlights shortcomings of aerodynamic particle size distribution and delivered dose testing, and introduces newer testing techniques.

Dr Geoffroy Lumay

HOW TO GAIN A FULL UNDERSTANDING OF POWDER FLOW PROPERTIES, AND THE BENEFITS OF DOING SO

Geoffroy Lumay, Naveen Mani Tripathi and Filip Francqui show how the association of three recently developed flow measurement techniques can be used to gain valuable insights into powder properties and characteristics.

WHEN EVERY SECOND COUNTS…

Todd Pizitz and Donald Mealing look at efforts to reduce the number of opioid-related deaths in the United States, and introduce a nasal device that delivers naloxone.

Dr Antje Caelers

REGULATORY AFFAIRS: THE UNDERESTIMATED ROLE OF PRIMARY PACKAGING

Antje Caelers explains how increasingly complex products and production chains, restrictive industry standards and differing regulations mean that regulatory affairs are becoming more important than ever.

Dr Jeffrey Philippson

THE INTERFACE BETWEEN PREFILLED SYRINGE AND AUTOINJECTOR – A DEVELOPMENT FRAMEWORK

Jeffrey Philippson and Tom Kemp outline the challenges for autoinjector developers at the interface between the device and the prefilled syringe – and describe a framework to formalise analysis of the interface.

West Pharmaceutical Services

SIMPLIFYING THE PROCESS OF DEVELOPING PREFILLED SYRINGES

Tibor Hlobik describes how the use of cyclic olefin polymer delivery systems is gaining in popularity because of the benefits they have over glass systems for complex drug applications, and explains what this advance in technology can offer drug manufacturers.

Dr Fred Metzmann

DEVELOPMENTS IN SELF-INJECTION DEVICES FOR COMBINATION PRODUCTS

Fred Metzmann reports on the latest state-of-the-art developments in innovative injection devices for combination products in subcutaneous self-application. He outlines Haselmeier's product platform strategy for single-use (D-Flex) and re-usable (i-pen²) injection-pen systems, and related services and looks at the company’s connected digital solutions.

PREFILLED SYRINGES

LED-GENERATED UV FOR ADHESIVE CURING IN MEDICAL DEVICES

Roland Lindner, Matthias Schulze and Bill Jaworski discuss how the needs around adhesive use in the manufacture of medical devices such as glass syringes have evolved and how ATS sortimat has developed a new process to meet industry demands.

INDUSTRIALISATION

Simon Strothers

F2V: A STERILE, CUSTOMISABLE LIQUID FILL-FINISH PLATFORM FOR THE TOTAL LIFECYCLE

Simon Strothers presents an integrated fill-finish platform, F2V, designed to represent a commercial filling system as a bench-top solution. The article also includes a recent case study where the F2V was used by Consort Medical to help develop and industrialise a flagship delivery device.

Napoleon Monroe

PATIENTS, MANUFACTURERS & PRACTITIONERS CAN LEAD ADOPTION OF CONNECTED COMBINATION PRODUCTS

Napoleon Monroe asks why connectivity has failed to advance rapidly, and argues that many stakeholders can benefit if the adoption of connectivity for drug delivery can be accelerated. While this article will centre on pharmaceutical combination products, the essential points also relate more broadly to pharmaceuticals and medical devices.

ASSESSING USABILITY EARLY FOR OPTIMAL INJECTION PEN DESIGN

David Fink and Stefan Gaul use the example of Haselmeier’s D-Flex system to explain why it is important to undertake a full use-related risk analysis for injection pen products to assess their usability and identify any risks, highlighting the importance of considering usability right from the start.

PREFILLED SYRINGES

Tomohiro Suzuki

Mitsubishi Gas Chemical

LATEST UPDATE ON OXYCAPT™ MULTILAYER PLASTIC VIAL AND SYRINGE

Tomohiro Suzuki gives an update on the development of the OXYCAPT™ multilayer plastic vial and syringe – highlighting the results of recent tests comparing it with existing glass syringes.

INDUSTRIALISATION

Berthold Schopferer

Z.BLIZZARD AUTOMATION SYSTEM FOR PFS: IMPROVING THE LIVES OF PATIENTS

With the ultimate objective of improving patients’ lives, Berthold Schopferer provides an overview of the company’s customer-specific automated manufacturing and assembly equipment offering for prefillable polymer syringes.

INDUSTRIALISATION

Wolfgang Moersch

PRODUCT SHOWCASE: ZwickRoell Parenteral Device Testing Platform

ZwickRoell provides an overview of its parenteral device testing platform including roboTest, and associated software testXpert III and autoEdition3.

Marta Vilaplana

Oval Medical Technologies

FUNCTION-BASED PRIMARY PACKAGING DESIGN FOR INJECTING VISCOUS NON-NEWTONIAN FORMULATIONS

Marta Vilaplana; Alex Vasiev and Susie White explore the challenges of delivering high-viscosity, non-Newtonian fluids emphasising the importance of robust tools to characterise specific device and formulation parameters in light of increasing regulatory scrutiny.

CO-PACKAGED COMPONENTS IMPROVE PATIENT EXPERIENCE AND ENSURE CONSISTENT DRUG DELIVERY

Chris Franzese and Amy Rinaldi explore the challenges and benefits of co-packaging for manufacturers, healthcare workers and patients.

Dr Iain Simpson

Phillips-Medisize

HOW CONNECTIVITY ADDS VALUE TO INJECTABLE DRUG DELIVERY DEVICES

In the context of the growing shift in emphasis from improving adherence to the better outcomes that can arise from doing so, Iain Simpson discusses why connectivity is becoming increasingly important in injectable drug delivery, and how it can benefit patients, providers and pharmaceutical manufacturers.

Chantal Wierckx

ADDING VALUE TO PREFILLED SYRINGES: SAFETY AND CONNECTIVITY

Chantal Wierckx and Arnaud Guillet provide an update on Newguard™, Biocorp’s integrated safety device for prefilled syringes, and explore the possible advantages connectivity can bring in the context of traceability for anti-counterfeiting, in clinical trials and in vaccination campaigns.

PREFILLED SYRINGES

DEVELOPING DEMONSTRATORS TO INCREASE PATIENT CONFIDENCE AND REDUCE ANXIETY

Joe Reynolds discusses the value of demonstrators for making patients comfortable and effective with their prefilled syringe, leading to a significant improvement in treatment adherence and patient quality of life.

PREFILLED SYRINGES

Mr Maximilian Vogl

Gerresheimer Expands Gx RTF^® ClearJect^® Product Line

Maximilian Vogl describes how Gerresheimer is expanding its range of prefillable polymer syringes to include a new product: the Gx RTF^® ClearJect^® polymer syringe, 2.25 mL.

Matthew Huddleston

Enable Injections

KEY CHALLENGES IN SUCCESSFUL WEARABLE DRUG DELIVERY & PATIENT SELF-ADMINISTRATION

Matthew Huddleston, Andrew Eibling and Jennifer King look at the key challenges involved in successful wearable drug delivery technology and patient self-administration.

E3D – Elcam Drug Delivery Devices

EVOLUTION OF AN ON-BODY BOLUS INJECTOR: FROM DRUG-SPECIFIC DEVICE TO PLATFORM

Tsachi Shaked introduces E3D’s On-body Bolus Injector, OBI, a versatile platform that uses gas generating microcells as its engine, has no electromechanical components, and only one moving part.

Hans Peter Manser

LARGE-VOLUME WEARABLE DRUG DELIVERY: A VISION BECOMES REALITY

Hans Peter Manser, Christoph Egloff and Martin C King introduce LV DDS , a flexible-form, low-profile wearable injector platform, for large-volume drug delivery.

SHARING IS CARING: POLYMER SUPPLIERS AS MEDICAL DEVICE DEVELOPMENT PARTNERS

Manuel Scherer looks at whether the advent of wearable injectors calls for a more collaborative approach between polymer suppliers and medical device developers.

WEARABLE INJECTORS: CHOOSING & TESTING OPTIMAL ADHESIVES

Neal Carty and Deepak Prakash highlight the importance of choosing and testing adhesives for optimal wearable drug delivery device performance.

Stevanato Group

CAN WEARABLE DEVICES BRIDGE THE GAP BETWEEN PEN INJECTOR AND PUMP?

Steven Kaufman and Paolo Golfetto explore the potential for wearable injectors to be disruptive technologies in the drug delivery market.

BD (Becton Dickinson & Company)

THE CHANGING DRUG DELIVERY PARADIGM

Beth DiLauri sets out the fundamental case for the adoption of wearable injectors, outlines the specific barriers they overcome and describes how the design and development of the BD Libertas™ wearable injector platform make it an attractive proposal for pharma companies.

TRAINING PATIENTS IN THE USE OF WEARABLE INJECTORS

Joe Reynolds highlights the projected growth in popularity of wearable injector devices, and shows that it is imperative for healthcare providers (HCPs) both to train their patients properly in the office, and offer training devices that patients can take home and practice with.

Dominique Bauert

PRIMARY PACKAGING FOR WEARABLE INJECTION DEVICES

Dominique Bauert and Anil Kumar Busimi provide an overview of existing wearable injector solutions and new requirements, with a focus on the role of the primary packaging inside the devices.

Claus Schmidt Moeller

DEVELOPMENT OF AN OSMOTIC LARGER VOLUME WEARABLE BOLUS INJECTOR

Claus Schmidt Moeller provides an overview of the mechanism, functionality and applications of the company’s osmotic, single-use, low-cost, versatile wearable bolus injector.

LARGE-VOLUME PATCH-INJECTION VIA YPSODOSE: SIMPLER FOR PHARMA COMPANIES & PATIENTS

Ian Thompson updates us on the company’s prefilled large-volume patch injector platform, YpsoDose, which simplifies the approach to wearable patch injectors for both pharma companies and patients.

Mikron Automation

SCALABLE ASSEMBLY SOLUTIONS – FULLY INTEGRATED, TRULY GLOBAL

Rolf Rihs and Jean-François Bauer look at how Mikron has specialised in flexible, modular assembly solutions that are easy to evolve during the different stages of a product lifecycle: from development through to fully automated, maximum-performance production.

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