Understanding the links between drug delivery route and in vitro test methods — Copley Scientific
In this white paper, we review the drug product characteristics that define the success of delivery via given routes, and the tests used to evaluate them, using the product types that Copley offers solutions by way of example. A key focus is the link between the mechanisms of drug delivery and the test conditions applied.
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Establishing a robust environment for inhaler testing — Copley Scientific
This white paper focuses on just one potential source of variability – the test environment.We will examine how the poor control of temperature, relative humidity (RH), and electrostaticscan influence inhaler testing. We consider how these variables affect the performance of OIPs thereby influencing both aerodynamic particle size distribution (APSD) measurement by cascade impaction and delivered dose uniformity (DDU) testing. Separately, we assess their impact on the performance of cascade impactors, concluding with a discussion of solutions that can help. The aim is to increase awareness of the various ways that the test environment may be influencing results and to provide practical suggestions for improvement.
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Using Breathing Simulators to Enhance Inhaled Product Testing — Copley Scientific
Breathing simulators, machines designed to generate and apply an inhalation and/or exhalation profile that mimics that of a human subject, are becoming an increasingly routine part of orally inhaled product (OIP) testing. Advances in breathing simulator technology have brought sophisticated, cost-efficient solutions to the industrial marketplace, opening up opportunities to improve the clinical relevance of in vitro OIP testing techniques. The application of a range of appropriate breathing profiles is now enshrined in recently updated pharmacopoeial monographs for nebulisers but beyond this, researchers are starting to look at the broader value of working with a representative inhalation profile in order to fully scope product performance.
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Why are Inhalation Devices so Difficult to Develop? — Iconovo
The development of inhalation products is very difficult and therefore seen as time consuming and associated with a high risk. Even though the pharmaceutical companies developing new inhalation products are experienced in the inhalation field, the projects drag out for years due to technical flaws and loop-backs. The reason for the high cost and long time is the complexity of the inhalation product. A typical dry powder inhaler can be split into four fundamental parts; drug, formulation, manufacturing process and device. The interaction between these four product parts is very complex and their contribution to the performance is inextricable. To this, the operating environment and interaction with the user must be added. Together, these six components give the full performance of the product.
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Developing An In Vitro Dissolution And Release System For Orally Inhaled Drug Products — Nanopharm
In this article, Robert Price, PhD, Chief Scientific Officer, Nanopharm, critiques regulatory routes for the development of generic OINDPs, runs through recent announcements and developments of note from regulators, and describes how Nanopharm has pioneered the concept of structural Q3 equivalence.
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Exploring A Faster, More Cost-Effective Alternative To Generic Bioequivalence — Nanopharm
Jag Shur, PhD, Chief Executive Officer of Nanopharm, an Aptar Pharma company, explores the challenges companies face in bringing generic respiratory and nasal therapies to market – and how some organisations have proactively addressed the challenge and developed services to integrate the device and the formulation, introducing the Aptar Pharma Services offering.
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UniDose: The development of a novel aerosol collectionapparatus for dissolution testing of orally inhaled drug products — Nanopharm
The case study highlights the concerns with current aerosol collection systems for dissolution studies of OIDPs and the development of Nanopharm’s UniDose apparatus as a robust method for collection and discriminating the dissolution properties of the aerosolized dose of inhalable formulations.
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From Conception to Completion — Presspart
Contract Manufacturing Organizations (CMOs) have long been associated with the global pharmaceutical industry primarily as outsourcing providers of finished medicines. In today’s ever changing world of Drug Delivery, the CMO “label” has been extended to include organizations that design, develop, and manufacture components and devices that deliver medicines. CMOs include those that provide a range of proprietary products such as injection pens, oral actuators, dispensing valve and pumps as well as those who provide bespoke products.
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Modifying MDI Canister Surfaces — Presspart
Hydrofluoroalkane (HFA)-based propellants are widely used in modern metered-dose inhalers (MDIs), due to their lack of hazardous and environmentally-damaging effects. However, an HFA’s active pharmaceutical ingredient can interact with the canister substrate, causing deposition of the drug to the canister walls, or interact with the solution, causing degradation and resulting in increased impurity levels.
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Technological Developments Towards Consistent Respiratory Drug Delivery — Presspart
Devices for delivering drugs have evolved considerably over time. The choice of device may depend on factors such as the patient’s age, severity of condition, and the ability to operate the device effectively, as these can all affect the therapy’s efficacy. Several challenges still remain for manufacturers to ensure that the correct dose of drug is delivered to the appropriate part of the respiratory system with every activation of the device.
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Addressing the challenges in nasal device testing: Evaluation of pump performance – Proveris Scientific
Proveris Scientific addresses the challenges faced by the OINDP industry, with a particular emphasis on nasal spray devices. Solutions are offered in the form of the fully automated Indizo® system and Vereo® actuators. These instruments expedite the analysis by effectively streamlining the workflow and eliminating manual processes. They can be used to conduct a variety of the required regulatory tests in a reproducible manner while simulating human use of the product.
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Complete solution for pMDI products: From development to quality control testing – Proveris Scientific
Proveris Scientific outlines the major challenges encountered in testing pressurized metered dose inhalers, and how Proveris’ portfolio of instruments can be an invaluable addition to the testing workflow.
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Reducing variability in test results for OINDPS with automated actuation – Proveris Scientific
Proveris Scientific discusses the importance of automated actuation for testing inhalation and spray devices to avoid variability introduced by manual methods, and how Proveris’ portfolio of instruments and services can ensure the accuracy and reproducibility of results.
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What is Quality by Design and why should you care? – Proveris Scientific
Quality by Design (QbD) is a scientific approach that formalizes product design, automates manual testing, and streamlines troubleshooting. A QbD approach is an indispensable tool for successfully developing inhaled and nasal drug products as well as critical to creating effective manufacturing processes for released products.
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