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Mastering Change in Inhalation Drug Delivery — 3M Drug Delivery Systems
Currently, $39 billion of the inhalation market is divided between MDIs and dry powder inhalers (DPIs), which make up 40 and 60 percent of sales value, respectively. With 940 million devices sold annually, pharmaceutical companies have big opportunities for their inhalation products, but they also face big risks—from generic competition, changing regulatory environments, and much more. This paper will explore some of the common changes that impact the inhalation market, as well as how pharmaceutical companies can position themselves for success in the face of these challenges.
Applications of capsule dosing techniques for use in dry powder inhalers — Capsugel
Dry powder inhaler (DPI) devices that utilize two-piece capsules as the dose-holding system can require specialized dosing equipment to fill the capsules. Such products are known as “premetered” because they contain previously metered doses in a dose carrier (the capsule). The capsule is either inserted into the device during manufacture or by the patient prior to use.
Hard Capsules for Dry Powder Inhalers: Performance on Puncturing — Capsugel
The study presented describes the behavior of various dry powder inhaler (DPI) hard capsules under puncture, at different relative humidities (RH). Hard gelatin-based capsules have been used for pulmonary applications for several decades now. More recently, capsules from hypromellose (HPMC) were developed and became available for use in DPI devices. These capsules have lower moisture content, and their mechanical properties are less sensitive to changes in relative humidity.
Inhalation Technology – A breath of fresh air in drug delivery! — Capsugel
The inhalation route is a fast and effective way of delivering medication locally to the lungs and also for the systemic administration of certain agents. Inhalation drug therapy is used extensively to treat respiratory conditions such as asthma and Chronic Obstructive Pulmonary Disease (COPD). Recently, it has been shown that pulmonary drug delivery could also be an effective route to deliver drugs to the systemic circulation thanks to the large surface area of the lungs with highly vascularised epithelia.
Refining Inhaled Product Testing: A Review — Copley Scientific
Across the pharmaceutical industry there is a strong drive towards greater efficiency, from faster time to market, through to better manufacturing practice. Over the last decade, the regulatory environment has changed, as exemplified by the introduction of Quality by Design (QbD), but so too have the economics of the market place, with a buoyant generics sector intensifying the requirement for cost-effective production. Extending knowledge and understanding to promote best practice is now a primary concern.
Understanding the Links Between Drug Delivery Route and In Vitro Test Methods — Copley Scientific
In vitro tests are widely used, from R&D through to QC, to improve the efficacy of drug delivery and confirm product consistency. Ensuring a drug reaches its intended site of action in vivo, in an appropriate state, is a crucial first step towards meeting clinical performance goals. Drugs may be delivered by the gastrointestinal tract; or via the rectal and vaginal mucosal membranes; through the surface of the skin; or by inhalation via the nose or lungs. In each case the requirements for effective delivery are different and the tests applied to assess drug performance differ accordingly. In this introductory white paper we review the drug product characteristics that define the success of delivery via any given route, and the tests used to measure them. A key focus is the link between the mechanisms of drug delivery and the test conditions applied.
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.
Powder Characterization for Inhaled Drug Delivery — Freeman Technology
Manipulating and controlling powder behaviour is a demanding but essential element of pharmaceutical manufacturing. The development and production of dry powder inhalers (DPIs) exemplifies and highlights the difficulties faced, arguably presenting the industry with its toughest powder engineering challenge. Fine by necessity, to ensure deposition in the lung, dry powder formulations tend to be highly cohesive and difficult to handle. The need to understand the aerosolisation processes that ensure successful drug delivery adds an additional and substantial layer of complexity.
Analysis of Aggregates in Nasal Spray Suspensions — Gateway Analytical
A recently introduced technique that uses Raman Chemical Imaging (RCI) for ingredient-specific particle sizing (ISPS) provides a greatly improved method of analyzing aggregates and agglomerates in nasal spray suspension formulations. Performed in a GMP environment by skilled analysts who develop validated methods for each individual formulation, the RCI technique has the potential to address the FDA’s Critical Path Opportunity (CPO) for direct measurement of particle size equivalence in nasal spray suspensions, possibly allowing for a waiver of in vivo biostudies and savings of millions of dollars in development costs and up to half of the time required for clinical studies.
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.
An Integrated Method for Determination of Force profile and Stroke to fire on pMDIs — Nemera
Dose counters, which are increasingly common on pMDIs (Pressurized Metered Dose Inhalers), impose specific requirements on the valve as they rely on displacement or force to indirectly count remaining doses. Indirect counters typically fail in one of two modes: Undercounting through fire-not-count events or overcounting through count-not-fire events. Undercounting is considered the more serious failure mode since it misleads a patient to believe a dose is present when it may not be. So strong design requires the dose counter to decrement the count before the valve releases the dose.
Generic pMDI Product Development — Next Breath
Currently there are no generic Asthma/COPD inhalers available in the United States. This includes both categories of standard asthma treatment: rescue medication for quick relief and controller medications for long term prevention. The average cost of the above inhaler medicines ranges from $35 – $300, rendering the treatment expensive for both insured and uninsured consumers. At the same time, the opportunity is ripe for generic companies racing to be the first to market and to grab a slice of the 5 billion dollar pie.
Opthalmic Product Development — Next Breath
The global market value for ophthalmic products was estimated around $15 billion in 2009 and is expected to increase to over $20 billion in 2014 (1, 2). An aging population worldwide coupled with higher occurrence of eye conditions and diseases such as diabetic retinopathy, dry eye, glaucoma, and age-related macular degeneration (AMD), have resulted in increased growth in the eye care market (2). The emergence of novel formulations like Restastis®, a cyclosporine oil-in-water emulsion formulation, sophisticated dispensing systems such as the Ophthalmic Squeeze Device (OSD – Figure 1), and ophthalmic injections such as Lucentis® will inevitably lead to higher expectations and scrutiny from the US Food and Drug Administration (FDA) to gain product approvals.
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.
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.
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.
7 Questions to Ask to Accelerate Spray or Aerosol Product Development — Proveris
Most OINDP development projects require far more time and money than any pharma company expects, because companies become stuck on a merry-go-round of out of specification (OOS) or out of tolerance (OOT) disruptions. These projects routinely take longer to gain FDA approval than other drug product
categories, and 2 out of 3 submissions are sent back for more work (usually additional testing)—round and round the development goes. Successful OINDP development—getting off the merry-go-round—requires three
• Adequate in-house expertise;
• An automated system with many literature references; and
• The right partner to help transform test data into useful knowledge.
Taming the Demons of OINDP Development with Quality by Design — Proveris
This white paper addresses the challenges pharmaceutical organizations face when developing OINDPs, introduces the concept of QbD, explains how QbD improves on traditional processes, and then describes Proveris by Design, a proprietary QbD process that’s been field-proven in over 100 spray product development projects.