PULMONARY

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.

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.

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.

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.

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.

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.

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 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.

INDUSTRIALISATION

Jose Luis Encinas

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.

Eric Dessertenne

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.

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.

Dr Benjamin Jung

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.

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.

Guillaume Brouet

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.

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.

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.

Dr Rajoshi Biswas

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.

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.

Dr John N Pritchard

NEBULISERS: TIME TO REINVENT THE WHEEL

John Pritchard discusses the history of the nebuliser, its fall in popularity with the advent of DPIs and pMDIs, and its current resurgence due to the success of the mesh nebuliser, continuing on to how changing the development paradigm to utilise nebuliser technology more effectively can have significant benefits.

Susana Ecenarro Probst

University of Parma

INHALABLE THERAPEUTIC BIOLOGICS, A PARADIGM SHIFT FOR NON-INVASIVE EFFICIENT MEDICAL TREATMENTS

Susana Ecenarro Probst and Francesca Buttini discuss the rising prominence of biologics in the pharmaceuticals market and how dry powder inhalers utilising hard capsules are a promising potential delivery method for these new drugs.

Dr Andrew K Dickerson

Fluids and Structures (FaST) Laboratory

CITRUS FRUITS INSPIRE THE NEXT GENERATION OF AIRBORNE DRUG DELIVERY

Andrew Dickerson discusses recent research undertaken by his team into the mechanics of liquid microjets created naturally by citrus fruits, and how they could be the key to a new design of drug delivery device.

BILL WELCH, PHILLIPS-MEDISIZE & JOHN PATTON, DANCE BIOPHARM

In this exclusive interview with ONdrugDelivery Magazine, Bill Welch and John Patton discuss inhaled insulin, connectivity and their two companies’ close partnership

Proveris Scientific

REDUCING VARIABILITY IN TEST RESULTS FOR OINDPS WITH AUTOMATED ACTUATION

Heli Chauhan and Linda (Lingzhi) Liao discuss the importance of automated actuation for testing inhalation and spray devices to avoid variability introduced by manual method.

Dr Gunilla Petersson

PIPELINE TRENDS AND CHALLENGES IN PULMONARY DELIVERY

Gunilla Petersson provides an overview of the inhalables sector from a pharma perspective, covering the three major device types – DPIs, pMDIs and nebulisers.

Copley Scientific

VARIABILITY IN CASCADE IMPACTION: SOURCES, IMPACT AND STRATEGIES FOR REDUCTION

Mark Copley considers cascade impaction as a method for determining the aerodynamic particle size distribution of orally inhaled drug products, and how techniques to improve air flow control and semi-automation of the process can significantly reduce the variability involved.

MANUFACTURING DPIS: AN ENGINEERING PERSPECTIVE

Pietro Pirera and Stefano Crivellaro discuss the rising prominence of the DPI in inhalable drug delivery, how this has been facilitated by industrial filling technologies and how dosators in particular provide high-precision industrial-scale filling.

Intertek Melbourn

INTERTEK’S CENTRE OF EXCELLENCE FOR INHALED AND NASAL BIOLOGICS

Chris Vernall discusses the significance and difficulties of biologics in the inhalables sector, and how Intertek’s Centre of Excellence for Inhaled and Nasal Biologics provides valuable services for those developing products in this area.

INDUSTRIALISATION

GAS PLASMA PROCESSING: A LONG-TERM SOLUTION FOR RESPIRATORY DEVICES

Ameet Sule, Head of H&T Presspart’s Inhalation Product Technology Centre (IPCT), discusses the new challenges arising in metered dose inhaler design since the change from CFC to HFA propellants.

MONITORING NEBULISER USAGE & LUNG FUNCTION IN CLINICAL TRIALS

Carola Fuchs and Yvonne Koehler, explain how PARI’s special eTrack^® Controller can be used to monitor adherence during inhalation therapy which facilitates objective and remote monitoring.

CONNECTED DRUG DELIVERY SECTOR OVERVIEW

Tom Oakley gives an overview of the state of connected devices in the drug delivery world, touching on various approaches, benefits and challenges in the sector today.

Dr Kian Min Lim

LISTEN TO YOUR INHALER, IT MIGHT BE TELLING YOU SOMETHING

Kian Min Lim and David Harris discuss how tailored algorithms can accurately detect inhalers’ acoustic signatures, effectively adding connectivity without having to add a chip to the inhaler.

Dr Benjamin Jung

THE FUTURE OF CONNECTED ASTHMA AND COPD CARE: A STEPWISE DEVELOPMENT

Benjamin Jung outlines possible scenarios for the likely steps in the development and adoption of connected devices in the field of asthma and COPD care.

A POSITIVE SPIN ON DPI FORMULATION

Bert Dekens outlines some of the considerations that go into developing and processing dry powder inhaler formulations, and discusses the merits of conical high-shear mixers.

Dr Karlheinz Seyfang

POWDER MICRODOSING WITH 100% IN-LINE FILL WEIGHT CONTROL BY X-RAY

Karlheinz Seyfang discusses the need for filling verification in pre-metered DPI blister filling lines, going on to detail the role X-ray analysis could play in an automated verification process.

Proveris Scientific

COMPLETE SOLUTION FOR PMDI PRODUCTS: FROM DEVELOPMENT TO QUALITY CONTROL TESTING

Heli Chauhan outlines the major challenges encountered in testing pressurised metered dose inhalers, and how Proveris’ portfolio of instruments can be an invaluable addition to the testing workflow.

REALISTIC PULMONARY DELIVERY SYSTEM TRAINERS

Craig Baker discusses the prevalence of improper use and how addressing this issue via training devices is of benefit to manufacturers, healthcare providers and patients.

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