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PULMONARY

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.
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.
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.
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.
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.
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.
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.
QUALI-V EXTRA DRY: A NOVEL CAPSULE FOR DELIVERING HYGROSCOPIC FORMULATIONS
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.
COMPLETING ITS TRANSITION FROM GENESIS TO MATURITY, BIOCORP OPENS NEW HORIZONS
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.
CONNECTED DEVICES – MEDICATION DELIVERY JUST GOT PERSONAL
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.
THE FUTURE OF CONNECTED ASTHMA AND COPD CARE: A NETWORK PERSPECTIVE
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.
BEST PRACTICES FOR DEVELOPING EFFECTIVE TRAINING DEVICES FOR PULMONARY HEALTHCARE
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.
GUILLAUME BROUET, APTAR PHARMA
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.
THE CHALLENGES OF DELIVERING QBD IN NOVEL RESPIRATORY DEVELOPMENT
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.
IS THERE A FUTURE FOR THE RESPIRATORY DELIVERY OF BIOLOGICS?
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.
CAPMEDIC™: SIMPLIFYING INHALERS FOR REGULAR AND CORRECT USE
CONNECTIVITY
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
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.
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