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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.

SPRAY CHARACTERISATION TESTING FOR ORALLY INHALED AND NASAL DRUG PRODUCTS

Francois Billard

SPRAY CHARACTERISATION TESTING FOR ORALLY INHALED AND NASAL DRUG PRODUCTS

Francois Billard and Lei Mao look at measurement systems for spray pattern and plume geometry dispensed by orally inhaled and nasal drug products.

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.

INTEGRATED TURNKEY SOLUTIONS: KEY TO SUCCESSFUL NASAL COMBINATION PRODUCT DEVELOPMENT

INTEGRATED TURNKEY SOLUTIONS: KEY TO SUCCESSFUL NASAL COMBINATION PRODUCT DEVELOPMENT

Alain Regard, Audrey Chandra and Pascale Farjas discuss the use of the nasal route for locally and systemic-acting drug treatments.

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.

THE PIVOTAL ROLE PLAYED BY DEVICE DEVELOPERS TO IMPROVE PATIENT EYE CARE

THE PIVOTAL ROLE PLAYED BY DEVICE DEVELOPERS TO IMPROVE PATIENT EYE CARE

Zoë Davidson and Carolyn Rose discuss the challenges glaucoma and dry eye patients face with eye drop administration and present the Novelia^® system featuring patented PureFlow^® technology, which controls the medication flow.

DRUG DELIVERY TO THE EYE: OVERCOMING THE CHALLENGES OF INTRAVITREAL PREFILLED SYRINGES

Dr Suresh Gupta

DRUG DELIVERY TO THE EYE: OVERCOMING THE CHALLENGES OF INTRAVITREAL PREFILLED SYRINGES

Suresh Gupta discusses the challenges of developing a PFS product for intravitreal injection, highlighting how designing for the intravitreal space, rather than the standard parenteral, imposes a number of additional requirements on the design.

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.

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.

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