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I.
Why Devices for Drug Delivery? |
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In an ideal world, there would be no need for drug delivery devices. In this Utopia, all drugs would be perfectly efficacious, free of side effects, and delivered orally. In reality, many drugs cannot be delivered orally, are more efficacious, or have less severe side effects if they are delivered by an alternative route. |
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Alternative routes of administration are preferred because of the particular characteristics of the molecule or the indication. For example, first-pass metabolism, low bioavailability in the gastrointestinal tract, the need for topical action, and systemic side effects are all phenomena which dictate alternative routes of administration. Consequently, many drugs must be delivered or are better delivered, for example, by injection, inhalation, implantation, or transdermally. The devices with access to these routes, such as injectors, IV systems, inhalers, IUDs, iontophoretic patches and so on, are being developed in numbers greater than ever before. |
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II.
The Changing Device Business |
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The time has passed when pharmaceutical companies could regard these devices as the sole province of device suppliers: companies which develop, manufacture, and market standard products. Of course, the need for off-the-shelf devices remains, and the device supply industry is growing and becoming more sophisticated. Pharmaceutical companies, however, must regard customized devices optimized for their individual needs as a priority. There are several reasons for this: |
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Increasingly, new chemical entities which require nonoral administration are being developed in conjunction with the delivery device, so that the complete development links the drug and the device development programs, and the drug and device combination can be regarded as the complete product. |
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Devices often provide positive differentiating factors which promote a competitive advantage for the pharmaceutical company. Examples abound, but some of the more well known include Astra's Turbuhaler®, the insulin injector pens of Novo and other diabetes care companies, Glaxo-Wellcome's inhalers and its antimigraine injection device, and smoking cessation patches and inhalers. |
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Regulatory requirements and the needs of patients cause substantial customization, even of catalogue devices, and the modifications to satisfy the pharmaceutical company's needs for particular dose size |
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