ONdrugDelivery - ONdrugDelivery - drug delivery industry specialised b2b information

PATIENT-CENTRICITY: THE IMPORTANCE OF HUMAN FACTORS IN THE PANDEMIC ERA

Oval's Marcus Agunloye and SMC's Asmita Khanolkar discuss how patient-centricity is at the heart of drug delivery device design and innovation, and how the global pandemic has highlighted the importance of patient-centric development in this field.

THE ADDED VALUE OF A PLATFORM APPROACH: PEN INJECTOR CASE STUDY

Radosław Romańczuk, Severine Duband and Audrey Chandra discuss the development of the company’s pen-injector platforms and how they are tailored to meet the customer’s needs.

SAFE AND AUTOMATIC DEVICE TO IMPROVE DRUG PREPARATION FROM MULTIDOSE VIALS

Benjamin Morel and Claire Authesserre discuss the challenges and opportunities presented by multidose vials.

PRACTICAL INSIGHTS INTO LACTOSE-BASED DPI FORMULATIONS, WITH & WITHOUT MAGNESIUM STEARATE

PRACTICAL INSIGHTS INTO LACTOSE-BASED DPI FORMULATIONS, WITH & WITHOUT MAGNESIUM STEARATE

Partners DFE Pharma, Hosokawa Micron and Harro Höfliger describe their unique multidisciplinary study into lactose-based DPI formulations including magnesium stearate, whose findings will give generic players a head-start in the development process so that they can tap into this rapidly growing market. The three companies announce that they will be presenting the key insights from their research to interested parties during a joint webinar on the June 30th, 2020.

PRODUCT SHOWCASE: Evonik’s newly launched EUDRACAP™ functional, ready-to-fill capsules

PRODUCT SHOWCASE: Evonik’s newly launched EUDRACAP™ functional, ready-to-fill capsules

Evonik introduces EUDRACAP™, its newly launched platform of functional ready-to-fill HPMC capsules, which helps optimise release profile, protects sensitive active ingredients, and speeds time to market.

ENSURING FUNCTIONAL PERFORMANCE AND REGULATORY COMPLIANCE OF ELASTOMER STOPPERS FOR MULTIPIERCING SITUATIONS

ENSURING FUNCTIONAL PERFORMANCE AND REGULATORY COMPLIANCE OF ELASTOMER STOPPERS FOR MULTIPIERCING SITUATIONS

Bruno Morchain, Sébastien Cordier and Estelle Verger discuss a series of experiments conducted on Aptar Pharma’s PremiumCoat^® vial stoppers to demonstrate their compliance with EU and US Pharmacopeia standards and their excellent performance in multipiercing situations

FROM PROCESS TO PRODUCT: OPTIMISING PROCESS DEVELOPMENT STRATEGIES FOR VARIABLE DRUG-DEVICE REQUIREMENTS

Markus Goldinger

FROM PROCESS TO PRODUCT: OPTIMISING PROCESS DEVELOPMENT STRATEGIES FOR VARIABLE DRUG-DEVICE REQUIREMENTS

Markus Goldinger and Erik Alexandersson discuss the benefits to process development provided by SHL’s fully in-house, vertically integrated model, and how those benefits are applied throughout the process from initial design work to final assembly of the drug delivery device and primary container.

TOWARDS USER-CENTRIC SPECIFICATION OF AUTOINJECTOR TECHNICAL ATTRIBUTES: INSIGHTS FROM EMPIRICAL WORK

Dr Andreas Schneider

TOWARDS USER-CENTRIC SPECIFICATION OF AUTOINJECTOR TECHNICAL ATTRIBUTES: INSIGHTS FROM EMPIRICAL WORK

Andreas Schneider discusses an empirical study into both users’ ability to remove the cap from an autoinjector and the difficulty those patients perceived in doing so. The study builds a quantitative model relating the empirical data to patient perception.

DRIVERS FOR CHANGE IN ASEPTIC AUTOMATION

Dr Dave Seaward

DRIVERS FOR CHANGE IN ASEPTIC AUTOMATION

Dave Seaward and David Phasey discuss the factors that have led to recent growth in aseptic automation within the pharmaceutical industry.

HOW TO ENSURE THE FUTURE DEMAND FOR BIOLOGICS CAN STILL BE DELIVERED BY INJECTABLES

Stevanato Group

HOW TO ENSURE THE FUTURE DEMAND FOR BIOLOGICS CAN STILL BE DELIVERED BY INJECTABLES

Anthony Vico and Enrico Barichello discuss the demands that high-viscosity biologic formulations place on prefilled syringes, and how pharmaceutical companies can make the most of this growing market segment to deliver improved quality of life for patients.

FORMULATION & DEVICE DEVELOPMENT: A SYMBIOTIC RELATIONSHIP

Caroline Zakrzewski

Cambridge Design Partnership

FORMULATION & DEVICE DEVELOPMENT: A SYMBIOTIC RELATIONSHIP

Caroline Zakrzewski considers the interaction between formulation and device development and the challenges that drive innovation in the field. Her work frequently sits in the overlap between formulation and device development, navigating the interwoven steps that lead to the sweet spot, where formulation and a device work in tandem, providing safe and effective delivery of the drug.

HOW OWEN MUMFORD CARRIED OUT USABILITY TESTING UNDER COVID-19 RESTRICTIONS

Miranda Newbery

Inspired Usability

HOW OWEN MUMFORD CARRIED OUT USABILITY TESTING UNDER COVID-19 RESTRICTIONS

Miranda Newbery describes working with Owen Mumford Pharmaceutical Services on usability testing for a platform autoinjector under covid-19 restrictions.

RE-USABLE ELECTRONIC AUTOINJECTOR – FLEXIBLE PERFORMANCE

Bjarne Sørensen

Phillips-Medisize

RE-USABLE ELECTRONIC AUTOINJECTOR – FLEXIBLE PERFORMANCE

Bjarne Sørensen discusses the ability of electronically driven injection devices to cater for a broad range of liquid drug properties within a single device platform.

ADDRESSING THE CHALLENGES OF VISCOUS INJECTABLE ADMINISTRATION

Dr Andrew Donnelly

ADDRESSING THE CHALLENGES OF VISCOUS INJECTABLE ADMINISTRATION

Andrew Donnelly and Shahid Uddin look at the challenges of self-administration of injectable viscous formulations and the technology that is helping to overcome these issues.

SUBCUJECT WBI: LOW-COST, LARGER VOLUME, HIGH-VISCOSITY WEARABLE BOLUS INJECTOR – USING STANDARD GLASS PRIMARY PACKAGING

Claus Schmidt Moeller

SUBCUJECT WBI: LOW-COST, LARGER VOLUME, HIGH-VISCOSITY WEARABLE BOLUS INJECTOR – USING STANDARD GLASS PRIMARY PACKAGING

Claus Schmidt Moeller introduces the company’s wearable bolus injector for single use and discusses the advantages of the device.

OPHTHALMIC DRUGS: PATHWAY TO OVERCOME PRIMARY PACKAGING AND DRUG PRODUCT MANUFACTURING CHALLENGES

Rainer Glockler

OPHTHALMIC DRUGS: PATHWAY TO OVERCOME PRIMARY PACKAGING AND DRUG PRODUCT MANUFACTURING CHALLENGES

Rainer Glöckler, Carole Delauney, Dr Nicolas Eon and Katsuyuki Takeuchi discuss the myriad complexities of developing drug products for intravitreal injection, and how the partnership between swissfillon and Terumo can ease and accelerate these products to market. The first article, published in April, covered how swissfillon’s state-of-the-art filling line meets the complex requirements of ophthalmic drug products.

COMPARATIVE EXTRACTABLE STUDIES FOR INJECTABLES AND MEDICAL DEVICES ALIGNED WITH USP <1663> AND ISO 10993 GUIDELINES

Dr Matthias Bicker

COMPARATIVE EXTRACTABLE STUDIES FOR INJECTABLES AND MEDICAL DEVICES ALIGNED WITH USP <1663> AND ISO 10993 GUIDELINES

Matthias Bicker, Michael Müller, Marc Mittermüller, Daniel Haines and Uwe Rothhaar discuss the regulatory requirements that need to be considered when designing an extractables and leachables study for a drug product or medical device. To illustrate the subject further, the authors provide two example studies, each following a different set of regulatory guidelines.

THE CRITICAL ROLE OF TRAINING IN THE USE OF NASAL RESCUE THERAPIES

THE CRITICAL ROLE OF TRAINING IN THE USE OF NASAL RESCUE THERAPIES

Tim McLeroy discusses the role of nasally administered rescue treatments in preventing deaths from opioid overdose or misuse – highlighting the importance of training and treatment availability.

CHARACTERISATION OF LACTOSE POWDERS FOR DPI APPLICATIONS

Dr Aurelien Neveu

CHARACTERISATION OF LACTOSE POWDERS FOR DPI APPLICATIONS

Aurélien Neveu, Michael Crowley and Tony McGorisk discuss the characterisation of lactose powders for use as excipients in DPI formulations. The authors go on to discuss an analysis of six Kerry lactose powders using GranuTools technology.

HOW EVOLVING PATIENT NEEDS HAVE FUELLED THE DEVELOPMENT OF NASAL DRUG DELIVERY

HOW EVOLVING PATIENT NEEDS HAVE FUELLED THE DEVELOPMENT OF NASAL DRUG DELIVERY

Julie Suman considers how the needs of the patient have driven advances in nasal drug delivery and looks at the latest developments and benefits of this method of drug delivery.

BIOCOMPATIBILITY OF MEDICINAL PRODUCT MEDICAL DEVICE COMBINATIONS FOR AIRWAY DELIVERY

BIOCOMPATIBILITY OF MEDICINAL PRODUCT MEDICAL DEVICE COMBINATIONS FOR AIRWAY DELIVERY

Mark Turner discusses biocompatibility testing for inhaled medical products, with particular reference to ISO 18562, and what Medical Engineering Technologies has learned from three years of breathing component biocompatibility testing.

NASAL DELIVERY: AN OPPORTUNITY FOR SIGNIFICANT IMPROVEMENTS IN PATIENT CARE

Dr Stuart Madden

NASAL DELIVERY: AN OPPORTUNITY FOR SIGNIFICANT IMPROVEMENTS IN PATIENT CARE

Stuart Madden discusses the advantages of the nasal route of administration for the systemic delivery of therapeutics.

FORMULATION OPTIONS IN NASAL DRUG DELIVERY

Dr Richard Johnson

FORMULATION OPTIONS IN NASAL DRUG DELIVERY

Richard Johnson discusses the advantages of nasal delivery and why there is growing interest in this route of administration, as well as considering some of the challenges that may arise during the development of nasal formulations for use in the clinic, and the regulatory and testing requirements associated with them.

ASSESSING THE NASAL DRUG DELIVERY LANDSCAPE

ASSESSING THE NASAL DRUG DELIVERY LANDSCAPE

Jon Volmer, Jon Lenn and Professor Marc Brown discuss the role of reconstituted nasal epithelium in intranasal drug delivery.

CONSIDERATIONS FOR OPHTHALMIC DRUG DELIVERY AND DEVELOPMENT

CONSIDERATIONS FOR OPHTHALMIC DRUG DELIVERY AND DEVELOPMENT

Robert Lee discusses recent advances in ophthalmic dosage forms and how companies are meeting these challenges to better serve their customers.

STATE-OF-THE-ART SOLUTIONS FOR OPHTHALMIC STERILE DRUG PRODUCT MANUFACTURING

Rainer Glockler

STATE-OF-THE-ART SOLUTIONS FOR OPHTHALMIC STERILE DRUG PRODUCT MANUFACTURING

In the first in a series of two articles, Rainer Glöckler and Carole Delauney discuss how the company’s state-of-the-art filling line meets the requirements and complexities that are particular to ophthalmic drug product manufacturing. The second article, to be published in May, will explore partnerships between pharma, CDMOs and syringe manufacturers in more detail.

LINKING THE “D” & “M” IN CDMO

LINKING THE “D” & “M” IN CDMO

John Ross looks at the role of CDMOs in product development through to commercialisation and considers the benefits of consolidated “DM” models.

SPRAY CHARACTERISATION TESTING

SPRAY CHARACTERISATION TESTING

Ann Flodin introduces the company’s SprayVIEW^® measurement and automated actuation stations for the development and quality control of container closures and finished products.

ANALYTICAL TECHNIQUES FOR THE FORMULATION OF GASTRORETENTIVE TABLETS

ANALYTICAL TECHNIQUES FOR THE FORMULATION OF GASTRORETENTIVE TABLETS

Jamie Clayton, Phil Bone and Kyu Mok Hwang discuss the value of analyses such as mercury porosimetry and powder rheology in characterising excipients for gastroretentive tablet formulation, and go on to detail a case study investigating polymer excipients for a novel bilayer floating tablet.

HOSTAFORM<sup>®</sup> POM ECO-B – PROVEN, VERSATILE, EASY AND SUSTAINABLE

HOSTAFORM^® POM ECO-B – PROVEN, VERSATILE, EASY AND SUSTAINABLE

Kevin Norfleet and Rob Haley discuss the need for environmentally sustainable materials in the medical device industry, and how Celanese’s Hostaform^® MT^® POM ECO-B meets that need, being an exact equivalent to the company’s existing material but produced using up to 97% bio-content using a potential greenhouse gas as feedstock, accounted for using the mass balance approach.

I-PLATFORM DEVICE: THE SMART DEVICE WITH APTITUDE

I-PLATFORM DEVICE: THE SMART DEVICE WITH APTITUDE

Jimmy Fan outlines the capabilities and benefits of the I-Platform smart drug delivery device.

SURFACE-MEDIATED AGGREGATION – CONTROL OF THE LIQUID-SOLID INTERFACIAL STRESS

PREFILLED SYRINGES

Glycome BioPharma

SURFACE-MEDIATED AGGREGATION – CONTROL OF THE LIQUID-SOLID INTERFACIAL STRESS

Shane Smith, Eoin Scanlan and Paula Colavita discuss how the company’s technology has evolved to create a stable and biocompatible coating that maintains device performance and safety.

INTERVIEW WITH BENJAMIN DIETIKER, WEIDMANN MEDICAL TECHNOLOGY

Benjamin Dietiker

Weidmann Medical Technology

INTERVIEW WITH BENJAMIN DIETIKER, WEIDMANN MEDICAL TECHNOLOGY

Benjamin Dietiker, Weidmann Medical Technology, talks with ONdrugDelivery about how the company has successfully implemented a growth strategy by focusing on key areas, plans for expansion, the effect of covid-19 on the business, and how the company differentiates itself from larger competitors by focusing on quality and service.

ROOM FOR INNOVATION?

ROOM FOR INNOVATION?

Darren Mansell examines US FDA guidance on biosimilar interchangeability and asks whether there is room for innovation.

CONSIDERATIONS FOR DEVICE SELECTION IN PARENTERAL APPLICATIONS

CONSIDERATIONS FOR DEVICE SELECTION IN PARENTERAL APPLICATIONS

Mark Tunkel looks at the challenges involved in the selection of drug devices for combination products and the optimisation of the development process.

TOP FIVE DRUG DELIVERY TRENDS FOR 2021

TOP FIVE DRUG DELIVERY TRENDS FOR 2021

Tom Oakley provides an overview of the top five trends to expect in drug delivery in 2021.

PLATFORM TRAINING SOLUTIONS ADD VALUE FOR PHARMACEUTICAL COMPANIES

PLATFORM TRAINING SOLUTIONS ADD VALUE FOR PHARMACEUTICAL COMPANIES

Alex Catino discusses the unmet need in healthcare for proper patient onboarding and training in the field of prefilled syringes and injection devices. Ms Catino uses Noble’s training device for Ypsomed’s YpsoMate^® autoinjector as a case study for how bespoke training devices can be used to help improve the patient experience and adherence rates.

TACKLING PARENTERAL DRUG LABELLING’S SURGING COMPLEXITY

TACKLING PARENTERAL DRUG LABELLING’S SURGING COMPLEXITY

Lars Skole discusses emerging trends and challenges associated with growing parenteral packaging and labelling complexity – and how pharmaceutical developers and manufacturers can meet the challenges ahead.

INJAY: SIMPLE BY CHOICE, ADAPTABLE BY DESIGN

INJAY: SIMPLE BY CHOICE, ADAPTABLE BY DESIGN

Arnaud Guillet discusses Biocorp’s Injay solution for adding connectivity to a wide variety of PFS devices, focusing on how Injay’s designed-in simplicity and flexibility makes it easily applicable across the spectrum of PFS platforms on the market today.

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Plan Strategic

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Corning Incorporated

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