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RESPIRATORY

THE OPTIONS FOR CREATING A MORE SUSTAINABLE INHALER
EXPERT VIEW
Phil Seeney
THE OPTIONS FOR CREATING A MORE SUSTAINABLE INHALER
With growing pressure to tackle climate change, Phil Seeney looks at the arguments in favour of creating more sustainable inhalers, and examines potential strategies to accomplish it.
DEVELOPING AN IN VITRO DISSOLUTION AND RELEASE SYSTEM FOR ORALLY INHALED DRUG PRODUCTS
RESPIRATORY
Dr Robert Price
Nanopharm
DEVELOPING AN IN VITRO DISSOLUTION AND RELEASE SYSTEM FOR ORALLY INHALED DRUG PRODUCTS
Robert Price critiques regulatory routes for the development of generic OINDPs, runs through recent announcements and developments of note from regulators, and describes how Nanopharma has pioneered the concept of structural Q3 equivalence.
ASTHMA & COPD: ENVIRONMENTAL SUSTAINABILITY & PATIENT-CENTRICITY
PHARMA VIEW
Dr Sara Panigone
ASTHMA & COPD: ENVIRONMENTAL SUSTAINABILITY & PATIENT-CENTRICITY
Sara Panigone, Federica Sandri and Gabriele Nicolini provide a considered and well-referenced analysis of carbon-minimal pMDIs for asthma and COPD, stressing the importance of balancing environmental sustainability with therapeutic efficacy to provide a sustainable and patient-centred solution.
INNOVATIVE DRUG-ELUTING ADHESIVES: APPLICATION IN CHRONIC RHINOSINUSITIS
EARLY INSIGHT
Dr Maria Pereira
INNOVATIVE DRUG-ELUTING ADHESIVES: APPLICATION IN CHRONIC RHINOSINUSITIS
Maria Pereira, Elise DeVries and Camille Legros introduce novel applications in the treatment of chronic rhinosinusitis for the company’s programmable synthetic polymers and an associated delivery device.
Inhaled and nasal Covid-19 vaccine progress
Inhaled and nasal Covid-19 vaccine progress
Specialist respiratory drug product news publication OINDP News, has reported progress from several intranasal and inhaled COVID-19 vaccine development programmes, including from Altimmune, APEPTICO, a partnership between Neurimmune and Ethris, and a partnership between UW–Madison, FluGen and Bharat Biotech.
THERAVANCE ADVANCES TO CLINICAL TRIALS WITH TD-0903 IN COVID-19 ACUTE LUNG INJURY
THERAVANCE ADVANCES TO CLINICAL TRIALS WITH TD-0903 IN COVID-19 ACUTE LUNG INJURY
Theravance Biopharma is advancing TD-0903, a lung-selective nebulised Janus kinase inhibitor (JAKi) into clinical development to assess its utility in preventing the cytokine storm associated with acute lung injury (ALI) in patients hospitalised COVID-19 patients. The goal is the prevention of disease progression to ARDS.
BIOHAVEN GIVEN FDA GO-AHEAD TO BEGIN PHASE II TRIAL OF INTRANASAL VAZEGEPANT IN COVID-19 LUNG INFLAMMATION
BIOHAVEN GIVEN FDA GO-AHEAD TO BEGIN PHASE II TRIAL OF INTRANASAL VAZEGEPANT IN COVID-19 LUNG INFLAMMATION
Biohaven is to initiate a Phase II trial within weeks of intranasal vazegepant, its third-generation, high-affinity, selective small molecule CGRP receptor antagonist, in pulmonary complications of COVID-19 disease. The clinical trial will assess the potential benefits of CGRP receptor-blockade in mitigating an excessive immune response which in some cases can be fatal in COVID-19.
Insmed Provides Covid-19 Business Update
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.
NEXT-GENERATION CONNECTED DRUG DELIVERY SUPPORTS DATA LIQUIDITY & COST SAVINGS
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.
THE CURRENT STATE OF PLAY IN CONNECTED DEVICES
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.
CHOOSING THE RIGHT CONNECTIVITY FOR DRUG DELIVERY AND MEDICAL PRODUCTS
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.
DRY POWDER INHALERS: TOWARDS EFFECTIVE, AFFORDABLE, SUSTAINABLE RESPIRATORY HEALTHCARE
PULMONARY
Dr João Ventura Fernandes
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.
PATIENT SAFETY: KEY DRIVER TO PRESERVATIVE-FREE NASAL SPRAY DEVELOPMENT
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.
MANUFACTURING DPIS: CASE STUDY OF IMA ADAPTA<sup>®</sup> WITH BOEHRINGER INGELHEIM SPIRIVA<sup>®</sup>
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.
ENHANCING INHALATION THERAPY BY REINTRODUCING ANTIBIOTICS USING MESH TECHNOLOGY
PULMONARY
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.
REDUCING VASCULAR MORTALITY IN PATIENTS WITH SUSPECTED ACUTE MI
EARLY INSIGHT
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
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.
HOW A DIGITAL APPROACH CAN UNPICK CLINICAL TRIAL CHALLENGES AND IMPROVE OUTCOMES
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.
IN VITRO BIOEQUIVALENCE – WHERE ARE WE NOW?
PULMONARY
Mark Parry
Intertek Pharmaceutical Services
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.
HOW TO GAIN A FULL UNDERSTANDING OF POWDER FLOW PROPERTIES, AND THE BENEFITS OF DOING SO
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.
WHEN EVERY SECOND COUNTS…
NASAL
Dr Todd Pizitz
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.
REGULATORY AFFAIRS: THE UNDERESTIMATED ROLE OF PRIMARY PACKAGING
RESPIRATORY
Dr Antje Caelers
Sanner Group
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.
F2V: A STERILE, CUSTOMISABLE LIQUID FILL-FINISH PLATFORM FOR THE TOTAL LIFECYCLE
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 OF INHALATION PRODUCTS: OVERCOMING HURDLES AT COMMERCIAL SCALE
EXPERT VIEW
Robin Heath
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.
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