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RESPIRATORY

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.

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.

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.

#96_2019_Noble_featured

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.

#96 ATS Featured

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.

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.

CONFERENCE SHOWCASE

RDD ASIA 2018 CONFERENCE REVIEW AND UPCOMING RDD EVENTS

RDD showcases its three biennial conferences – RDD (the North American event), RDD Europe and RDD Asia, which have become a series of must-attend events for researchers, product developers and vendors concerned with all aspects of nasal and inhaled pharmaceuticals.

CounterAct_featured

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.

#96 2019 ISAM featured

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.

#100 Gattefosse featured

SYNERGISING EXCIPIENTS TO BOOST SKIN DELIVERY

Cécile Morin and Delphine Marchaud discuss combining polar and apolar excipients in topical formulations in order produce synergies that maximise the performance of the drug.

PREFILLED SYRINGES

SOLUTIONS FOR HIGH-VOLUME DRUG DELIVERY

SHL Group introduces the high-volume variation of its Molly^® family of products, the Molly^® 2.25, and discusses more broadly the advantages that the Molly^® business model offers to pharmaceutical and biotech clients.

PREFILLED SYRINGES

TECHNOLOGY SHOWCASE: teamtechnik’s LED Cannula Gluing Process

Ingo Stephan introduces a new gluing process for attaching cannulas using LEDs from teamtechnik.

PREFILLED SYRINGES

Justin Schroeder

PCI Pharma Services

BIOLOGIC MEDICINES AND PATIENT-CENTRICITY – A NEW PHASE OF HOPE

Justin Schroeder discusses how the increasing biologics and biosimilars market has driven innovation and a trend towards self-administration and user-centricity in the injectable drug delivery device market.

BD (Becton Dickinson & Company)

SAGAR BEJALWAR, BD MEDICAL – PHARMACEUTICAL SYSTEMS

Sagar Bejalwar discusses the product and clinician needs in delivering hyaluronic acid for cosmetic applications.

HAZARDOUS DRUG HANDLING AND INVESTIGATIONAL DRUGS: LESSONS TO LEARN

Marino Kriheli discusses the need for closed-system transfer devices when handling hazardous drugs, particularly as they relate to investigational drugs, not only as key to patient and healthcare practitioner safety, but also in the context of upcoming US regulation.

PREFILLED SYRINGES

Dr Eric Chappel

LOW-COST DISPOSABLE WEARABLE INJECTOR PLATFORM FOR LARGE VOLUMES OF VISCOUS DRUGS

Eric Chappel, Dimitry Dumont-Fillon and Laurent-Dominique Piveteau discuss Debiotech’s novel wearable injector technology, which utilises a propellant vapour system to drive the injection, making the device both space- and cost-efficient.

SIX TECHNIQUES FOR RAPID EARLY-STAGE MEDICAL DEVICE DEVELOPMENT

Stuart Curtis runs through six techniques which, in his experience, are invaluable for accelerating the early development stages of drug delivery device design and can therefore be of great use when trying to accelerate a product’s time to market.

PREFILLED SYRINGES

Hideaki Kiminami

Terumo Pharmaceutical Solutions

DEVELOPMENT OF PREFILLABLE SYRINGES TO MITIGATE THE RISK OF PARTICLE FORMATION IN BIOPHARMACEUTICALS

Hideaki Kiminami and Philippe Lauwers discuss the problem of particle formation in biopharmaceuticals packaged in prefilled syringes.

PREFILLED SYRINGES

Mitsubishi Gas Chemical

MULTILAYER PLASTIC VIALS & SYRINGES FOR BIOLOGICS

Shota Arakawa and Tomohiro Suzuki discuss OXYCAPT™ Plastic Vial and Syringe, which provides a product with all the advantages of plastic, coupled with strong oxygen and UV barrier properties.

PREFILLED SYRINGES

UV STERILISATION & THE CASE FOR PREFILLED & PRELOADED DRUG DELIVERY SYSTEMS

Mindy Katz and Ori Ben-David review the different fill form configurations of drug delivery devices, outlining the importance of the prefilled and preloaded device configuration for self-administering patients.

THE ROAD TO PREFILLED DEVICES IN NOVEL COMBINATION PRODUCTS

Lior Shtram discusses three approaches to delivering novel combination products – user-filled, user-loaded and prefilled – through the lens of sterilisation processes and requirements at the industrial manufacturing scale.

PREFILLED SYRINGES

IMPROVING PATIENTS’ SELF-INJECTION EXPERIENCE

Jeff Lettman and Josh Hopkins explain how they worked with a client to develop a product that would function with the pre-existing drug delivery device to help rheumatoid arthritis patients with reduced dexterity.

PREFILLED SYRINGES

BD (Becton Dickinson & Company)

DRUG-DEVICE CO-PACKING SOLUTIONS TO ENHANCE DIFFERENTIATION AND IMPROVE EXPERIENCE

Janice Adkins discusses the benefits that co-packing, the practice of providing drug preparation and delivery systems along with a medication, can bring to pharmaceutical manufacturers, clinicians and patients.

SAFE, CONVENIENT AND EFFICIENT: INDIVIDUALISING PREFILLED SYRINGES

Ursula Hahn discusses the value of individualised prefilled syringes and explains how small changes in design or components can make a huge difference for doctors, patients and pharmaceutical manufacturers alike.

Charlotte Harvey

HOW SAFETY FEATURES MAKE OR BREAK INFUSION PUMP DESIGN

Charlotte Harvey and Tim Frearson overview the safety systems required when designing an infusion pump system, with a focus on free-flow prevention, occlusion detection and air-in-line detection.

BD (Becton Dickinson & Company)

ALICE MADEN & LIONEL MARITAN, BD MEDICAL – PHARMACEUTICAL SYSTEMS

Alice Maden and Lionel Maritan discuss with detailed expert knowledge the benefits of using integrated systems for sophisticated drug device combination products with multiple device subsystems.

PREFILLED SYRINGES

Hans Peter Manser

LYCAJECT: AUTOMATIC RECONSTITUTION PATCH INJECTOR

Hans Peter Manser, Christoph Egloff and Martin C King introduce the LyCaJect Patch Injector, Weibel CDS’ offering in the field of wearable injectors, with automatic reconstitution as a headline feature.

TO SUBSTITUTE OR NOT TO SUBSTITUTE? THAT IS THE ANDA QUESTION

Natalie Shortt, Maija Smith and Venetia Dickinson discuss the US FDA’s Draft Guidance on how human factors relate to the ANDA process, and how its encouragement to stay close to the reference product may result in some negative consequences.

PREFILLED SYRINGES

Florence Buscke

INNOVATIVE SOLUTIONS FOR PACKAGING BIOLOGICS

Florence Buscke, Nicolas Eon and Tom Van Ginneken outline SCHOTT’s offering across both glass and polymer primary containers for pharmaceuticals, emphasising their advantages in the rapidly growing biologics market.

PREFILLED SYRINGES

Carina Van Eester

Datwlyer Sealing Solutions

DURA COAT COMBISEALS – DATWYLER’S NEXT GENERATION IN ALUMINIUM

Carina Van Eester covers the advantages presented by the company’s new abrasion-resistant material, Dura Coat, used for combiseals on cartridges.

CONFERENCE REVIEW

2018 UNIVERSE OF PRE-FILLED SYRINGES AND INJECTION DEVICES

In October 2018, the Universe of Pre-Filled Syringes and Injection Devices conference, organised by the Parenteral Drug Association (PDA), was held in Orlando, FL, US.

Silgan Dispensing

USING MARKET RESEARCH TO CREATE A PRESERVATIVE-FREE MULTIDOSE EYEDROPPER

Thomas Grinnan and Ralf Hergenröther explain how extensive market research and consumer testing led to the development of an eyedropper that meets patients’ and physicians’ needs for an easy-to-use device, which offers precise dosing and anti-microbial integrity.

USER TESTING: CRITICAL FOR TRULY UNDERSTANDING PATIENT NEEDS

Fanny Sellier presents a trio of comparative user studies between Nemera’s Novelia^® preservative-free, multidose eyedropper and similar products from competitors

Dr Gautam N Shetty

Congruence Medical Solutions

ACCURATE, PRECISE MICROLITRE DOSING WITH PREFILLABLE SYRINGES FOR OPHTHALMIC INJECTIONS

Gautam Shetty discusses the challenges inherent to delivering microlitre dosage volumes accurately from a standard prefilled syringe, and introduces Congruence’s Microlitre Dosing Syringe (MDS) platform as a solution.

Dr Christian Roesky

BREAKING THE VICIOUS CIRCLE OF DRY EYE DISEASE

Christian Roesky discusses the underserved condition of dry eye disease, and presents two products in Novaliq’s pipelinefor the treatment of different types of DED.

Hoffmann Neopac

KEEPING PRESERVATIVE-FREE EYEDROPS STERILE WITH THE STERIDROP™ TUBE

Ralf Künzi introduces the SteriDrop™ tube – a new multidose eyedrop delivery solution made in collaboration with Aptar Pharma.

THE CHALLENGES AND OPPORTUNITIES OF DRUG DELIVERY THROUGH A COMPLEX BARRIER

Jon Volmer, Marc Brown and Jeremy Drummond discuss the development and use of advanced ex vivo and in vitro models for testing new ocular medicines to meet a growing unmet need.

Frazer P Coutinho

TARGETING DRUGS TO DISEASED OCULAR CELLS

Frazer Coutinho, Colin Green and Ilva Rupenthal discuss the targeted delivery of ocular therapeutics to diseased cells, using the cell-penetrating peptide, Xentry.

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Corning Incorporated

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President
Micro Engineering Solutions

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