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Injectable Drug Delivery120

Issue No #120 May/Jun 2021 May 28th, 2021

Issue 120 - May 2021

Inside the magazine

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.

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

Dr Radoslaw Romanczuk

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.

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.

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

Asmita Khanolkar

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

Marcus Agunloye and 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.

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

Miranda Newbery

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.

SAFE AND AUTOMATIC DEVICE TO IMPROVE DRUG PREPARATION FROM MULTIDOSE VIALS

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.

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.

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