ONdrugDelivery - ONdrugDelivery - drug delivery industry specialised b2b information

REMOVING CLINICAL TRIAL BIAS WITH OVER-ENCAPSULATION

Lonza's Frédérique Bordes-Picard, Julien Lamps and Stephen Rode discuss the considerations to take into account when using over-encapsulation to blind clinical trials, including the advantages of hydroxypropyl methylcellulose over gelatin as a material.

FORMULATION SOLUTION FOR MOISTURE-SENSITIVE DRUGS

Laura Canalejas outlines the benefits of Quali-V^® Extra Dry – a hypromellose capsule designed for moisture-sensitive formulations.

SMARTER MEDICINES TO SECURE PRODUCTS AND PROMOTE PATIENT ENGAGEMENT

Gary Pond looks at digital authentication and discusses how on-dose microtaggants can provide a high level of security in authenticating tablets and capsules in the fight against counterfeit products.

GASTRIC FLOATING MICROCAPSULES FOR THE MANAGEMENT OF PARKINSON’S DISEASE

Dr Sashi Kesavapany

GASTRIC FLOATING MICROCAPSULES FOR THE MANAGEMENT OF PARKINSON’S DISEASE

Kaarunya Sampathkumar, Joachim Loo and Sashi Kesavapany discuss current treatments for Parkinson’s disease and introduce an extended-releasing technology for polypharmacy oral formulations.

NANOPARTICLE ENGINEERING AND 3DP DELIVERY FOR GAME-CHANGING ORAL THERAPEUTICS

NANOPARTICLE ENGINEERING AND 3DP DELIVERY FOR GAME-CHANGING ORAL THERAPEUTICS

Niklas Sandler and Thomas West consider the technological advances in nanoparticle engineering that can improve the bioavailability and delivery of oral therapeutics.

ADDRESSING ONGOING AND NEW BIOAVAILABILITY CHALLENGES

Dr Stephanie Emory

ADDRESSING ONGOING AND NEW BIOAVAILABILITY CHALLENGES

Stephanie Emory explores the pros and cons of various technologies for enhancing solubility and bioavailability for oral drug formulations. Further, Dr Emory draws on her experience as a reviewer at the US FDA to discuss how developers can view the FDA as a partner to aid success when leveraging innovative approaches.

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.

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.

PATENTS ARE IMPORTANT FOR SMART HEALTHCARE PRODUCTS

Napoleon Monroe

New Directions Technology Consulting

PATENTS ARE IMPORTANT FOR SMART HEALTHCARE PRODUCTS

Napoleon Monroe discusses the value of internet-connected smart devices in present-day healthcare, and introduces the mMed patent portfolio, of which Mr Monroe is the sole inventor, and which contains five US patents for key connected health technologies.

THE POWER OF ONBOARDING: BUILDING PERSUASIVE USER EXPERIENCES FOR COMPANION APPS

THE POWER OF ONBOARDING: BUILDING PERSUASIVE USER EXPERIENCES FOR COMPANION APPS

Ben Cox discusses the value of onboarding in drug delivery device companion apps, and how it is a key component of converting a one-time user to a repeat user, unlocking the true value of companion apps as a tool for combating poor adherence to medications and gathering high-quality data.

IMPROVING PATIENT OUTCOMES WITH ADVANCED DIGITAL BIOMARKERS

Sagentia Innovation

IMPROVING PATIENT OUTCOMES WITH ADVANCED DIGITAL BIOMARKERS

Matthew Sarkar and Imantha Samaranayake consider the contribution digital biomarker devices make towards healthcare and the challenges faced by the evolution of such devices.

MEANING-CENTRED PRODUCT DEVELOPMENT: THE KEY TO SUCCESSFUL CONNECTED DISEASE MANAGEMENT

Christina Philpott

MEANING-CENTRED PRODUCT DEVELOPMENT: THE KEY TO SUCCESSFUL CONNECTED DISEASE MANAGEMENT

Christina Philpott, Miles Hawley and Natasha French, discuss the future of connected disease management and the potential benefits for asthma treatment.

CYBERSECURITY AND CONNECTED DRUG DELIVERY – AN INTEGRATED RISK-BASED APPROACH

John Whitehouse

CYBERSECURITY AND CONNECTED DRUG DELIVERY – AN INTEGRATED RISK-BASED APPROACH

John Whitehouse, Rob Veasey and Shane Day, discuss the value of integrating cybersecurity into a holistic, multidisciplinary approach to risk management for connected medical devices.

SPECIALTY LCP COMPOUNDS FOR ELECTRONICS INTEGRATION IN CONNECTED MEDICAL DEVICES

SPECIALTY LCP COMPOUNDS FOR ELECTRONICS INTEGRATION IN CONNECTED MEDICAL DEVICES

Young Kim, Don DeMello and Philip Wilson, discuss the benefits of recent advances in liquid crystal polymer for connected medical devices.

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.

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.

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

Marcus Agunloye

Oval Medical Technologies

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

Marcus Agunloye and Asmita Khanolkar, Senior Director 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

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.

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.

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.

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.

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