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| home > epc > summer 2003 > the application of regimen assurance and assistance devices for future inhaleable pain management therapie |
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European Pharmaceutical Contractor
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In the increasingly competitive pharmaceutical market, the importance of medical delivery devices with features that enable the non-invasive delivery of new drugs - or drugs previously delivered invasively - is obvious. To the pharmaceutical company, devices of this nature can extend the patent life of existing compounds and have the potential to open new markets for safe self-administration. This article considers the future importance of regimen assurance devices (RADs), their application to potentially inhaleable pain management therapies and the promise this area of drug delivery has for the pharmaceutical market in terms of safety, patient compliance and more effective treatment programmes.
The Changing Role of the Pressurised Metered Dose Inhaler
For more than four decades, pressurised metered dose inhalers (pMDIs) have offered a tried and tested route for the delivery of medication to the lungs. Historically, this delivery method has been used to treat pulmonary-related diseases including asthma, emphysema and bronchitis. Today, of the estimated 50 billion drug doses delivered annually via pMDI, a significant proportion are administered for the treatment of asthma. More recently, variants of the pMDI have been used to deliver drugs to the buccal cavity, facilitating rapid uptake through the thin membranes and into the bloodstream via the highly vascularised environment found within the mouth.
In 2001, the US Food & Drug Agency (FDA) issued draft guidelines recommending that dose counters be considered for inclusion in all future pMDI therapies. Designed to track the number of times a pMDI has been fired or actuated, dose counters are simple RADs which can provide patients and prescribers with accurate feedback on the number of reproducible metered doses left in a device.
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Industry Events |
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4th Annual Patient Recruitment and Retention in Clinical Trials
13-15 October 2008, Amsterdam
Patient recruitment
is now consuming thirty percent of clinical trial time - more time than any
other clinical trial activity - and almost half of all trial delays result from
patient recruitment problems.
As the
recruiting culture becomes more sophisticated and the forces affecting patient
enrollment grow more numerous and complex, pharmaceutical companies are
striving to discover new strategies to facilitate enrollment in clinical
trials.
With
increasing industry pressure to develop, test and market greater numbers of new
drugs faster, pharmaceutical companies need to perform clinical trials as
quickly as possible. Inefficient patient recruitment processes is a formidable
barrier to pharmaceutical companies' success in launching new products.
Improving the patient recruitment process is imperative to avoid wasted
investments and eliminate costly delays in bringing new drugs to market --
today and even more so in the not-so-distant future. Improved patient
recruitment presents one of the largest opportunities for pharmaceutical
companies to eliminate delays in clinical trials, thereby making it possible to
reduce time to market. With patent time limits and large overheads
meaning that any delays in the development timeline can be disastrous, a good
understanding of how to successfully recruit patients for trials is vital for
any company looking to succeed.
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News and Press Releases |
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Azopharma Product Development Group, Inc
HOLLYWOOD, Fla. – Azopharma Product Development Group, Inc. (“Azopharma”) announced today the addition of innovative state-of-the-art equipment at its formulation and manufacturing division, ApiCross Drug Delivery Technologies in Hollywood, Florida. The most recent acquisition is the MG Futura Capsule Filler which delivers the latest in capsule filling technology. The company has also added a Bausch & Strobel Aseptic Filling Isolator, equipment that is ground-breaking in the powder filling process. These additions support our previously implemented XcelodoseTM powder micro-dosing system. With these technologies, Azopharma is able to provide its clients with all forms of the capsule filling process. The new equipment is part of Azopharma’s recent manufacturing expansion which includes 17 new manufacturing suites for GMP, cytotoxic and aseptic products...
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