Aptar Pharma

PULMONARY

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.

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.

POLYMERIC EMI SHIELDING: PROVIDING A MORE SECURE FUTURE FOR PATIENTS

POLYMERIC EMI SHIELDING: PROVIDING A MORE SECURE FUTURE FOR PATIENTS

Marnik Vaes, Leen-Pieter Deurloo and Martin Sas discuss the role of polymeric electromagnetic interference shielding in providing a more secure future for patients in a connected world.

INTERVIEW WITH SAI SHANKAR, ADAM SHAIN & MARCUS BATES

INTERVIEW WITH SAI SHANKAR, ADAM SHAIN & MARCUS BATES

Sai Shankar, Adam Shain and Marcus Bates discuss the full potential of connectivity, coronavirus as a potential accelerator of adoption, and the place of connected drug delivery systems within Aptar Pharma’s broader offering to industry.

UNLOCKING INSIGHT FOR PATIENT SUPPORT PROGRAMMES

Phillips-Medisize

UNLOCKING INSIGHT FOR PATIENT SUPPORT PROGRAMMES

Neil Williams and Andrew Tubb discuss how insights delivered by a cloud-based connected health system help patient support programmes to monitor and improve medication adherence.

Adding value to Drug Delivery with Connectivity

Phillips-Medisize

Adding value to Drug Delivery with Connectivity

In this video presentation, Kevin Deane looks at how connectivity applied in drug delivery technologies can provide better solutions for patients and for industry and add value for all stakeholders.

SENSOR ADVANCEMENTS IN DRUG DELIVERY IMPROVE COMPLIANCE

Salvatore Forte

SENSOR ADVANCEMENTS IN DRUG DELIVERY IMPROVE COMPLIANCE

Salvatore Forte discusses various advancements in sensors that are transforming drug delivery systems, making complex devices more automated, easier to use, and improving patient compliance as a result.

EU MDR DEADLINE DELAY: WHAT DOES IT MEAN FOR THE MEDICAL DEVICE INDUSTRY?

EU MDR DEADLINE DELAY: WHAT DOES IT MEAN FOR THE MEDICAL DEVICE INDUSTRY?

With the compliance deadline for the EU Medical Device Regulation recently delayed by a year due to the novel coronavirus pandemic, Beth Crandall looks at what it means for the medical device industry.

Telemedicine gains acceptance amid the COVID-19 pandemic

Telemedicine gains acceptance amid the COVID-19 pandemic

Noble highlights how telemedicine is poised to become a mainstream alternative to the traditional in-person methods of care delivery, with the COVID-19 pandemic easing barriers to acceptance and introducing patients to the safety and convenience of telehealth technology.

WEBINAR: WORKING WITH POWDERS

Freeman Technology

WEBINAR: WORKING WITH POWDERS

In this on-demand webinar, the first in a series, Tim Freeman, Managing Director, Freeman Technology, introduces the challenges associated with understanding and predicting powder flowability and looks at how quantifying powder behaviour can aid process performance.

Pulmonary Delivery Could Make Niclosamide Effective Against COVID-19

Pulmonary Delivery Could Make Niclosamide Effective Against COVID-19

A novel inhaled formulation of the approved antihelminthic drug, niclosamide, is under development at the College of Pharmacy at The University of Texas at Austin for COVID-19. The compound was recently confirmed to exhibit antiviral efficacy in SARS-COV-2 infected cells and indeed was more potent compared with chloroquine, lopinavir and remdesivir, the group said.

IS NOW THE TIME TO SHAKE UP THE pMDI ENVIRONMENT?

IS NOW THE TIME TO SHAKE UP THE pMDI ENVIRONMENT?

Chris Baron explores how the use of propellants in pressurised metered dose inhalers has evolved – and how alternative propellants could be a catalyst for greater patient adherence.

NEW DRUG-NEBULISER COMBINATION PRODUCTS: CONSIDERATIONS BEYOND PERFORMANCE

Dr Nicolas Schwenck

NEW DRUG-NEBULISER COMBINATION PRODUCTS: CONSIDERATIONS BEYOND PERFORMANCE

Nicolas Schwenck and Michael Hahn summarise the critical success factors for bringing a new vibrating membrane nebuliser for a drug-device combination product to the market. They highlight opportunities and pitfalls – starting from the evaluation phase, through the development phase and finally during commercialisation.

OFF-THE-SHELF OR CUSTOM-MADE? CHOOSING A DRY POWDER INHALER

Dr Philippe Rogueda

OFF-THE-SHELF OR CUSTOM-MADE? CHOOSING A DRY POWDER INHALER

Philippe Rogueda discusses the manifold factors that need to be taken into account when choosing a dry powder inhaler – beyond just the target disease, formulation and patient population.

RESPIRATORY DRUG DELIVERY: THEN, NOW AND SOON

RESPIRATORY DRUG DELIVERY: THEN, NOW AND SOON

Brennan Miles takes a look back at respiratory drug delivery over the last few decades to see what we can learn from the past – and looks ahead to what the future might look like, covering sustainability, device regulation, and formulation milestones.

PUBLIC INTEREST & INCENTIVES FOR INNOVATORS OF INHALED PRODUCTS

PUBLIC INTEREST & INCENTIVES FOR INNOVATORS OF INHALED PRODUCTS

Igor Gonda, David Cipolla and Philippe Rogueda discuss the changes needed to increase the number of approved generic orally inhaled drug products (OIDPs) whilst providing additional incentives to innovators to meet the needs of the general public.

ADVANCING ASPRIHALE<sup>®</sup> TO PIVOTAL PK/PD STUDY

Mark Stansfield

ADVANCING ASPRIHALE^® TO PIVOTAL PK/PD STUDY

Mark Stansfield and Kambiz Yadidi discuss results of their pilot Phase I clinical study of dry-powder inhalation of aspirin.

HOSOKAWA EXTENDS BLENDER RANGE FOR DPI FORMULATIONS

Hosokawa Micron

HOSOKAWA EXTENDS BLENDER RANGE FOR DPI FORMULATIONS

Bert Dekens announces the extension of the the company’s established Cyclomix modular blending technology range, to include small (R&D) scale, mid-range and large-scale systems.

THE OPTIONS FOR CREATING A MORE SUSTAINABLE INHALER

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.

ASTHMA & COPD: ENVIRONMENTAL SUSTAINABILITY & PATIENT-CENTRICITY

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

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

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.

MANUFACTURING DPIS: CASE STUDY OF IMA ADAPTA<sup>®</sup> WITH BOEHRINGER INGELHEIM SPIRIVA<sup>®</sup>

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.

ENHANCING INHALATION THERAPY BY REINTRODUCING ANTIBIOTICS USING MESH TECHNOLOGY

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

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

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?

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.

INDUSTRIALISATION OF INHALATION PRODUCTS: OVERCOMING HURDLES AT COMMERCIAL SCALE

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

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

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

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

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

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

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

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.

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