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CLIPhaler – INHALATION DEVICE DESIGN REDUCED
TO THE MAXIMUM

Inventor Klaus-Dieter Beller discusses the advantages of the inhalation route of administration, how his principle of design simplicity has informed the design of novel inhalation devices and introduces CLIPhaler, his latest and simplest device.

WHY ARE INHALATION DEVICES SO DIFFICULT TO DEVELOP?

Orest Lastow discusses the challenges of developing inhalation products and how best to keep costs down and prevent project delays.

INDUSTRIALISATION

ENGINEERING EXPERTISE: DESIGN FOR EXCELLENCE

Drew Jelgerhuis looks at how a design-for-excellence (DFX) systematic approach can help manufacturers achieve their objectives.

STEPS TO SUCCESS IN NOSE-TO-BRAIN DRUG DELIVERY

STEPS TO SUCCESS IN NOSE-TO-BRAIN DRUG DELIVERY

Reenal Gandhi and Gemma Budd consider the multiple hurdles associated with developing nasal drug delivery solutions, current understanding of the associated biology and the advantages of alternative device designs and state-of-the-art formulation practice.

CREATING A PLATFORM FOR NEBULISATION OF A WIDE RANGE OF DRUG TYPES AND FORMULATIONS

Dr Elijah Nazarzadeh

CREATING A PLATFORM FOR NEBULISATION OF A WIDE RANGE OF DRUG TYPES AND FORMULATIONS

Elijah Nazarzadeh and John Pritchard introduce Nebu~Flow – a novel class of nebuliser technology that represents a major step in the ability to deliver drugs efficiently to the lungs. overcoming the limitations of current systems and unlocking the potential of the inhalation route, including for systemic delivery.

A ROADMAP FOR DRUG-NEBULISER COMBINATION PRODUCT DEVELOPMENT

Edgar Hernan Cuevas Brun

HCmed Innovations

A ROADMAP FOR DRUG-NEBULISER COMBINATION PRODUCT DEVELOPMENT

Edgar Hernan Cuevas Brun and Yuan-Ming Hsu lay out HCmed Innovations’ roadmap for the development of drug-nebuliser combination products.

AN AIRLESS SPRAY NOZZLE TO PRODUCE A FINE AND SOFT MIST

Dr Claire Authesserre

AN AIRLESS SPRAY NOZZLE TO PRODUCE A FINE AND SOFT MIST

Claire Authesserre and Florian Corne discuss the current challenges faced by the topical spray-based delivery of therapeutics and how EVEON’s Ad-Mist™ spray nozzle overcomes these challenges to harness the potential of this delivery route.

GETTING A GRIP ON FRICTION – A CRUCIAL CONSIDERATION FOR INHALER DESIGN

GETTING A GRIP ON FRICTION – A CRUCIAL CONSIDERATION FOR INHALER DESIGN

Bryan Deacon discusses the importance of considering friction when developing a new inhaler design, providing an overview of some of the basic considerations friction raises, as well as highlighting how optimising friction early with the aid of a materials expert can reduce risk, lower cost and lead to a better product overall.

EXPLORING NEW IN VITRO TESTS TO DEMONSTRATE BIOEQUIVALENCE IN INHALATION PRODUCTS

Proveris Scientific

EXPLORING NEW IN VITRO TESTS TO DEMONSTRATE BIOEQUIVALENCE IN INHALATION PRODUCTS

Proveris Scientific looks at recent advances in in vitro testing in inhalation products to demonstrate bioequivalence and discusses the company’s INVIDA platform that replicates human usage of the device.

EXPANDING THE DESIGN OF CHARACTERISATION STUDIES FOR ACCURATE HANDLING-ERROR ASSESSMENT

Dr Yannick Baschung

EXPANDING THE DESIGN OF CHARACTERISATION STUDIES FOR ACCURATE HANDLING-ERROR ASSESSMENT

Yannick Baschung discusses the importance of a comprehensive and accurate assessment of patient handling errors when it comes to inhaled product development.

THE INFLUENCE OF UNCERTAINTY ON CHEMICAL CHARACTERISATION

THE INFLUENCE OF UNCERTAINTY ON CHEMICAL CHARACTERISATION

James Silk discusses the importance of accounting for uncertainty when characterising the extractables profile of a medication, with particular reference to the ISO 10993 standard.

POWDER CHARACTERISATION FOR DPI PERFORMANCE IN CAPSULE-BASED INHALERS

Dr Salvatore Pillitteri

POWDER CHARACTERISATION FOR DPI PERFORMANCE IN CAPSULE-BASED INHALERS

Salvatore Pillitteri, Aurélien Neveu and Sarah Zellnitz-Neugebauer discuss the analysis of three powder blends of salbutamol sulphate with distinct lactose grades, using tapped density and rotating drum methods.

DELIVERING BIOLOGICS WITH SOFT MIST INHALERS – A MARKET POISED TO EXPAND

Dr Philippe Rogueda

DELIVERING BIOLOGICS WITH SOFT MIST INHALERS – A MARKET POISED TO EXPAND

Philippe Rogueda discusses the inhalable biologics market, how the introduction of soft mist inhalers represents a significant opportunity for new and old therapeutics alike, and how the market is poised for a major expansion in therapeutic application, size and value.

HIGH-PRECISION INJECTION MOULDS FOR INHALERS: CHALLENGES AND SOLUTIONS

INDUSTRIALISATION

HIGH-PRECISION INJECTION MOULDS FOR INHALERS: CHALLENGES AND SOLUTIONS

Rob Doorakkers and Erwin van Huijksloot discuss the challenges and solutions of engineering and manufacturing high-precision injection moulds for inhalers.

THE INNOVATIONS TACKLING CHALLENGES & MAXIMISING OPPORTUNITIES IN INHALATION

THE INNOVATIONS TACKLING CHALLENGES & MAXIMISING OPPORTUNITIES IN INHALATION

Marco Franza and Nadine Khoury look at how the latest digital technologies, manufacturing techniques and packaging materials are combining to take the manufacture of inhalers to a new level.

TAKING THE STING OUT OF VACCINES

Dr Heather Jameson

TAKING THE STING OUT OF VACCINES

Heather Jameson, Juliette Ngan and Omar Shah discuss the potential advantages and challenges of intranasal and inhaled vaccines in the context of global respiratory pandemics.

SOLVING COMPLEX FORMULATION & DELIVERY CHALLENGES FOR INTRANASAL DRUGS

SOLVING COMPLEX FORMULATION & DELIVERY CHALLENGES FOR INTRANASAL DRUGS

Paul Kippax discusses the analytical techniques used for in vitro characterisation of nasal sprays, and how their use can accelerate and de-risk both innovator and generic nasal drug development.

NASAL DELIVERY – A GALAXY NOT SO FAR AWAY… A BRIEF MARKET HISTORY OF THE NASAL DELIVERY LANDSCAPE

NASAL DELIVERY – A GALAXY NOT SO FAR AWAY… A BRIEF MARKET HISTORY OF THE NASAL DELIVERY LANDSCAPE

Mark Ignaczak provides an insight into the history of nasal drug delivery and looks at the advantages of the nasal delivery route.

SUSTAINABLE DESIGN & MANUFACTURE IN MEDICAL DEVICES: WHERE TO START

SUSTAINABLE DESIGN & MANUFACTURE IN MEDICAL DEVICES: WHERE TO START

Cormac O’Prey discusses the challenges and advantages of implementing circular economy principles in the medical device sector, with a particular consideration of the difficulty of making remanufacturing work for high-volume, low-value devices.

WHY PARTNERSHIPS ARE KEY TO A MORE SUSTAINABLE PHARMA INDUSTRY

WHY PARTNERSHIPS ARE KEY TO A MORE SUSTAINABLE PHARMA INDUSTRY

Peter Hirst argues that careful selection of partners and better collaboration throughout the supply chain are key to optimising the sustainability of the pharmaceutical industry.

CONSIDERING THE SUSTAINABILITY IMPACT OF CONNECTED INHALERS IN THE TREATMENT OF ASTHMA

Dr Iain Simpson

Phillips-Medisize

CONSIDERING THE SUSTAINABILITY IMPACT OF CONNECTED INHALERS IN THE TREATMENT OF ASTHMA

Iain Simpson and Vinith Bhandari consider the sustainability impact of device connectivity specific to asthma inhalers through the reduction of greenhouse gas emissions.

YPSOMED’S TWO-STEP APPROACH TO ACHIEVING NET ZERO

Sebastian Gerner

YPSOMED’S TWO-STEP APPROACH TO ACHIEVING NET ZERO

Sebastien Gerner discusses Ypsomed’s approach to achieving its net zero objectives, both looking back at Step One of the company’s approach and outlining the upcoming Step Two.

THE ENVIRONMENTAL IMPACT OF GLOBAL SUPPLY CHAIN LOGISTICS & SUPPLIER SELECTION

Alastair Willoughby

THE ENVIRONMENTAL IMPACT OF GLOBAL SUPPLY CHAIN LOGISTICS & SUPPLIER SELECTION

Alastair Willoughby looks at the factors affecting sustainability when considering global supply chain logistics and supplier selection.

CLIMATE CHANGE AND THE PHARMACEUTICAL INDUSTRY: TOO LITTLE, TOO LATE?

Catriona Eldridge

CLIMATE CHANGE AND THE PHARMACEUTICAL INDUSTRY: TOO LITTLE, TOO LATE?

Catriona Eldridge and Omar Shah discuss the findings of a recent investigative assessment into the environmental impact of healthcare products, and consider whether or not the pharmaceutical industry is doing enough to combat climate change.

SUSTAINABLE DESIGN FOR MEDICAL DEVICES

Stefano Vicenzetto

SUSTAINABLE DESIGN FOR MEDICAL DEVICES

How do you meet environmental and sustainability objectives when designing medical devices? And what design considerations enable the technical cycles, known as the 4R loops of circular economy: reuse, repair, remanufacture and recycle? Stefano Vicenzetto explores the Flex approach to design for environment for medical devices.

THE NEW YPSOMATE™ 5.5 – TAKING HANDHELD SELF-INJECTION BEYOND VOLUMES OF 2 ML

THE NEW YPSOMATE™ 5.5 – TAKING HANDHELD SELF-INJECTION BEYOND VOLUMES OF 2 ML

Reto Jost introduces YpsoMate 5.5, the staked-needle-syringe-based, two-step autoinjector for injection volumes in the 2.0–5.5 mL range, and discusses the drivers of the demand for high-volume, high-rate subcutaneous drug delivery using handheld autoinjectors.

INDUSTRIALISATION OF CUSTOMISABLE PRODUCT PLATFORMS IN LIFE SCIENCES

INDUSTRIALISATION

Umit Ismail Tsavous

INDUSTRIALISATION OF CUSTOMISABLE PRODUCT PLATFORMS IN LIFE SCIENCES

Umit Ismail Tsavous, Carsten Köhler and Tom Nägele discuss customisation of product platforms in the life sciences field.

ENLARGING THE VOLUME OF AUTOINJECTORS: TRAVERSING INJECTION BOUNDARIES

Gary Calderwood

ENLARGING THE VOLUME OF AUTOINJECTORS: TRAVERSING INJECTION BOUNDARIES

Gary Calderwood, Raluca Ganea and Gene Rhode Fuensalida Pantig review how the parenteral space has transformed over the past decade and reports how the company’s portfolio of autoinjector technologies has evolved to deliver subcutaneous parenteral drugs of varying formulations, including higher administration volumes.

DEVELOPING, MANUFACTURING AND DELIVERING A FILL-FINISH PILOT LINE FOR TUB-BASED PREFILLED SYRINGES

INDUSTRIALISATION

DEVELOPING, MANUFACTURING AND DELIVERING A FILL-FINISH PILOT LINE FOR TUB-BASED PREFILLED SYRINGES

Jake Canner discusses the latest project arising out of 3P innovation’s partnership with Cambridge Pharma and its sister company Oval Medical Technologies – including the challenges involved and how they were overcome.

ADVANCED DELIVERY DEVICE TECHNOLOGY TO SIMPLIFY THE RECONSTITUTION OF LYOPHILISED DRUGS

Dr Fred Metzmann

ADVANCED DELIVERY DEVICE TECHNOLOGY TO SIMPLIFY THE RECONSTITUTION OF LYOPHILISED DRUGS

Fred Metzmann and Chris Muenzer present Haselmeier’s innovative approach to the development of reconstitution devices that allow easy and convenient administration of freeze-dried biologics.

Interview with Biocorp’s Arnaud Guillet

Interview with Biocorp’s Arnaud Guillet

In this exclusive interview, Arnaud Guillet of Biocorp talks with ONdrugDelivery about connectivity in the injectables space, sharing some of the insights Biocorp has gained from its decade of experience in developing connected drug delivery devices.

ISO 11608: WHAT THE NEW STANDARD MEANS FOR NIS MANUFACTURERS

Cambridge Design Partnership

ISO 11608: WHAT THE NEW STANDARD MEANS FOR NIS MANUFACTURERS

Steve Augustyn looks at ISO 11608 and what it means for needle-based injection device manufacturers.

SILICONE-OIL-FREE, COATING-FREE, TUNGSTEN-FREE PREFILLABLE SYRINGES

PREFILLED SYRINGES

SILICONE-OIL-FREE, COATING-FREE, TUNGSTEN-FREE PREFILLABLE SYRINGES

Taras Bredel and Bernd Zeiss present the studies, development, performance and benefits of the Injecto lubrigone plunger stopper combined with the Gerresheimer RTF^® glass syringe – a silicone-oil-free, coating-free, tungsten-free, low-particle prefilled syringe solution for sensitive drug products.

DESIGN STRATEGY & CONSIDERATIONS FOR COMPRESSED GAS-POWERED DEVICE APPLICATIONS

DESIGN STRATEGY & CONSIDERATIONS FOR COMPRESSED GAS-POWERED DEVICE APPLICATIONS

Jack Auld discusses the potential of compressed gas as a power source for drug delivery devices, and explains how Altaviz can empower drug developers with the expertise to make full use of this exciting technology.

UNLIMITED POSSIBILITIES BY USING A GAS-PRODUCING DRY CELL

UNLIMITED POSSIBILITIES BY USING A GAS-PRODUCING DRY CELL

Marc Beutler and Matthias Meier discuss the myriad advantages of using a gas-producing dry cell as a drive system for injectable drug delivery devices, as compared with spring-based and electromechanical drives.

A HIGH-QUALITY AND ROBUST SAFETY SYSTEM FOR HIGH-VOLUME BIOLOGICS AT HOME

PREFILLED SYRINGES

A HIGH-QUALITY AND ROBUST SAFETY SYSTEM FOR HIGH-VOLUME BIOLOGICS AT HOME

Audrey Chandra and Cécile Gross discuss Nemera’s development of a new product for the safe delivery of high-volume biologics at home.

REACHING A NEW ZENITH IN PROTECTING LARGER-VOLUME SENSITIVE MOLECULES, FROM FILLING TO SELF-ADMINISTRATION

PREFILLED SYRINGES

Victoria Morgan

West Pharmaceutical Services

REACHING A NEW ZENITH IN PROTECTING LARGER-VOLUME SENSITIVE MOLECULES, FROM FILLING TO SELF-ADMINISTRATION

Victoria Morgan and Eric Kurtz, discuss how West Pharmaceutical Services' Daikyo Crystal Zenith™ insert needle prefilled syringe system meets the needs presented by the healthcare sector’s shift to home-based care and the increasing prevalence of biologics in the pharmaceutical pipeline.

OVERCOMING THE CHALLENGES OF ULTRA-LARGE-VOLUME SUBCUTANEOUS INFUSIONS

KORU Medical Systems

OVERCOMING THE CHALLENGES OF ULTRA-LARGE-VOLUME SUBCUTANEOUS INFUSIONS

Rob Limouze looks at the obstacles facing ultra-large-volume subcutaneous infusion drug delivery and highlights how the KORU Freedom infusion system meets these challenges.

AUTOINJECTORS: HISTORICAL ACHIEVEMENTS & COMPELLING NEEDS DRIVING NEXT-GENERATION DEVICES

Richard Whelton

AUTOINJECTORS: HISTORICAL ACHIEVEMENTS & COMPELLING NEEDS DRIVING NEXT-GENERATION DEVICES

Richard Whelton and Philip Green summarise the history of autoinjectors, highlight success stories to date, review the unmet needs that remain and consider emerging needs that could drive continued innovation in autoinjectors to ensure safety, patient satisfaction and pharma commercial success.

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Matt Kempton
Snr Project Engineer
Corning Incorporated

I am extremely impressed with the comprehensive presentation of information and problem/solution points detailed ... Kudos to you for an extremely well written article with succinct and robust scientific body of knowledge.

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I‘m working on the development of microparticles for the release of veterinary antibiotics, and polymeric nanoparticles for siRNA and chemotherapeutic delivery. ONdrugDelivery has been a very usefull platform to connect the scientific research, and marketed drug development.

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President
Micro Engineering Solutions

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Plan Strategic

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