RESPIRATORY

PULMONARY

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.

EXPERT VIEW

INDUSTRIALISATION OF INHALATION PRODUCTS: OVERCOMING HURDLES AT COMMERCIAL SCALE

Robin Heath discusses the typical challenges in scaling-up drug products from small-scale production to commercial manufacturing – and how these can be overcome.

COVID-19 NEWS

Insmed Provides Covid-19 Business Update

Insmed implements corporate initiatives in response to the novel coronavirus (SARS-CoV-2) global pandemic including a remote working policy to allow infectious disease specialists and pulmonologists to focus on treating patients and containing the virus. Arikares trainers will now offer remote training and onboarding for patients who initiate treatment with ARIKAYCE.

CONNECTIVITY

Neil Williams

Phillips-Medisize

NEXT-GENERATION CONNECTED DRUG DELIVERY SUPPORTS DATA LIQUIDITY & COST SAVINGS

Neil Williams discusses medication non-adherence, the toll it takes on the healthcare system and how integration, analytics and more affordable connectivity in drug delivery devices as part of a connected health ecosystem improves patient care and lowers costs.

CONNECTIVITY

Marcus Bates

Aptar Pharma

THE CURRENT STATE OF PLAY IN CONNECTED DEVICES

Marcus Bates; Joachim Koerner and Jerôme Prraquin discuss the current state of play, what connected device advocates are doing to enable faster implementation, and how we can optimise connected technology while reducing the cost and improving human factors.

EXPERT VIEW

Dr Juan Nogueira

CHOOSING THE RIGHT CONNECTIVITY FOR DRUG DELIVERY AND MEDICAL PRODUCTS

Juan Nogueira; Tommaso Borghi and Marco Vergani discuss the factors that need to be taken into account in the selection of connectivity technology for a drug delivery device or other medical product.

PULMONARY

Dr João Ventura Fernandes

Hovione Technology Ltd

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

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.

NASAL

Benoit Guillard

Nemera

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.

INDUSTRIALISATION

Rainer Bauer

IMA Group

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.

EARLY INSIGHT

Mark Stansfield

Otitopic

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.

RESPIRATORY

Dr Jag Shur

Nanopharm

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.

EXPERT VIEW

Dr Matt Ash

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.

PULMONARY

Mark Parry

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.

RESPIRATORY

Dr Geoffroy Lumay

Granutools

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.

NASAL

Dr Todd Pizitz

CounterAct

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.

RESPIRATORY

Dr Antje Caelers

Sanner

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.

INDUSTRIALISATION

Simon Strothers

3P Innovation

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. 

INDUSTRIALISATION

Jose Luis Encinas

Qualicaps

QUALI-V EXTRA DRY: A NOVEL CAPSULE FOR DELIVERING HYGROSCOPIC FORMULATIONS

Jose Luis Encinas and Susana Ecenarro explore how the use of Quali-V^® Extra Dry capsules can help improve product stability and, crucially, lead to efficiencies and savings in drug product manufacture.

INDUSTRIALISATION

Steve Wardell

ATS Automation

AUTOMATING PREVIOUSLY IMPOSSIBLE MANUAL INSPECTIONS USING MACHINE LEARNING & CONCURRENT VALIDATION

Steve Wardell and Catherine Thacker explore how machine learning technology is enabling the automation of challenging, or previously impossible, manual inspections.

CONNECTIVITY

Eric Dessertenne

Biocorp

COMPLETING ITS TRANSITION FROM GENESIS TO MATURITY, BIOCORP OPENS NEW HORIZONS

As Biocorp prepares for the market launch of its connected injector pen add-on, Mallya, Eric Dessertenne and Arnaud Guillet share insights about key steps in the company’s development. The article discusses the many partnership Biocorp has entered in to, and includes a mini-interview with Sergio Monti, Plant Manager for one such partner, V.A.R.I.

CONNECTIVITY

Thierry Decock

Nemera

CONNECTED DEVICES – MEDICATION DELIVERY JUST GOT PERSONAL

Thierry Decock and Hadrien Gremillet explore how the obstacles to the adoption of connectivity can be overcome and how connected devices can deliver truly patient-centric care that will clearly improve adherence rates, whilst demonstrating a clear cost benefit to the pharmaceutical partner.

CONNECTIVITY

Dr Benjamin Jung

H&T Presspart

THE FUTURE OF CONNECTED ASTHMA AND COPD CARE: A NETWORK PERSPECTIVE

Benjamin Jung uses a network theory approach to look at the ongoing issue of adherence when it comes to the treatment of asthma and COPD, and the players involved in overcoming it.

CONNECTIVITY

Matt Jones

DCA

DON’T DEVELOP A CONNECTED DRUG DELIVERY DEVICE WITHOUT READING THIS

Matt Jones summarises some of the key challenges and opportunities in the development of connected drug delivery devices, focusing in detail on deciding what a connected drug delivery device should do, designing for a coin cell, direct cellular connection and antenna design.

EXPERT VIEW

Mark Tunkel

USER-CENTRED DEVICE CONNECTIVITY

Mark Tunkel and Carolyn Rose discuss the benefits of taking a user-needs approach, and mapping the patient journey, in a connectivity strategy.

CONNECTIVITY

Neil Williams

Phillips-Medisize

LOW-COST CONNECTIVITY MEETS PATIENT & PHARMA MEDICATION MANAGEMENT NEEDS

Neil Williams describes the potential connected drug delivery systems hold to address serious challenges in healthcare, including poor adherence, and also deliver substantial value, and outlines the company’s highly scalable enterprise platform, the Connected Health Platform.

RESPIRATORY

Joe Reynolds

Noble

BEST PRACTICES FOR DEVELOPING EFFECTIVE TRAINING DEVICES FOR PULMONARY HEALTHCARE

Joe Reynolds discusses the current state of pulmonary drug delivery device trainers, including their value to patients, the complexities of modern design and the stringent quality requirements.

EXPERT VIEW

Simon Drexler

AUTOMATING UNDER UNCERTAINTY – GOOD PRACTICES

Simon Drexler discusses lessons learned and good practices when dealing with uncertainty at the various stages of automation development for drug delivery device manufacturing.

INTERVIEW

Guillaume Brouet

Aptar Pharma

GUILLAUME BROUET, APTAR PHARMA

Guillaume Brouet talks with ONdrugDelivery Magazine about how Aptar Pharma uses its device development expertise and infrastructure to provide its pharmaceutical company customers a comprehensive services offering around device development, global regulatory approval and commercialisation.

EXPERT VIEW

David Belton

THE CHALLENGES OF DELIVERING QBD IN NOVEL RESPIRATORY DEVELOPMENT

David Belton discusses the meaning of quality by design in novel respiratory drug delivery device development. He covers how, with more novel devices, prior knowledge may be insufficient for a standard FMEA-style risk analysis, and alternate science-based methods, such as functional mapping and knowledge scoring, can help in achieving QbD.

INTERVIEW

Paul Allsop

Consort Medical

PAUL ALLSOP, MILES KOTTMAN, HANNAH PRIESTLY & JON REED, CONSORT GROUP

Consort Medical's Paul Allsop, Miles Kottman, Hannah Priestly and Jon Reed talk with ONdrugDelivery Magazine about the company’s integrated formulation and device offering, and focus on its simple, low-cost, single unit-dose, spring powered nasal device, Unidose Xtra.

NASAL

Dr Todd Pizitz

CounterAct

130 A DAY AND GROWING: ANSWERING THE US OPIOID OVERDOSE EPIDEMIC

Todd Pizitz and Donald Mealing discuss the ongoing opioid crisis in the US and the current use of the opioid reversal medication naxalone, and introduce the CounterAct device for naxalone home use.

EXPERT VIEW

Dr Igor Gonda

IS THERE A FUTURE FOR THE RESPIRATORY DELIVERY OF BIOLOGICS?

Igor Gonda covers the field of nasal and pulmonary delivery of biologics, considers past failures and successes, and proposes answers to the challenges faced, from biological, biopharmaceutical and commercial standpoints.

RESPIRATORY

Dr Laurent Vecellio

University of Tours

DEPOSITION IN THREE NASAL CAST MODELS USING RETRONOSE CONCEPT

Laurent Vecellio, Déborah Le Pennec, Guillaume Grevin and Alain Regard discuss a study conducted to test particle deposition characteristics of the RetroNose device prototype for nasal drug delivery.

CONFERENCE SHOWCASE

Dr Barbara Rothen-Rutishauser

ISAM - International Society of Aerosols in Medicine

2019 ISAM CONGRESS PREVIEW

Prof Dr Barbara Rothen-Rutishause previews the 22nd Congress of the International Society for Aerosols in Medicine (ISAM), which will be held in Montreux, Switzerland, from May 25-29, 2019.

VIDEO

Consort Medical

BK814 The Unidose™ Xtra nasal spray device: designed for simplicity

In this Video Consort Medical's Bespak division introduces its single dose Unidose™ Xtra nasal spray device offers unique performance advantages through the use of IP-protected mechanisms that control device actuation and aqueous drug delivery.

CONNECTIVITY

Eric Dessertenne

Biocorp

SUCCESSFUL CONNECTED DEVICE DEVELOPMENT REQUIRES A ROBUST VALUE PROPOSITION

Eric Dessertenn discusses the current status of connectivity in healthcare, its future, benefits both in terms of addressing adherence and big data analysis, and emphasises the need for a robust business case.

CONNECTIVITY

Dr Rajoshi Biswas

Cognita Labs

CAPMEDIC™: SIMPLIFYING INHALERS FOR REGULAR AND CORRECT USE

Rajoshi Biswa discusses the CapMedic device, which transforms a typical metered dose inhaler into a more user-friendly, efficacious delivery system.

CONNECTIVITY

Dr Andreas Alt

Sensirion

FLOW MEASUREMENT IN SMART INHALERS FOR CONNECTED DRUG DELIVERY

Andreas Alt discusses the value of adding sensor technology to inhalers by means of an add-on device, both to help patients track and manage their disease, and to improve compliance by providing feedback on inhalation technique.