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Pulmonary Delivery System
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Pulmonary systems have been in development for many years and are seen as
one of the few technologies that could overtake the popularity of oral
delivery. We are not talking about your standard Meter Dose Inhaler systems
(MDIs), but the newer pulmonary technologies as they are being developed by
Mektar Therapeutics, Novo Nordisk, and many other companies.
Inhalation delivery systems have made significant advances in recent years.
Now, using microscopic, lighter-than-air microcrystals and aerosols, this
industry is capable of administering active drugs and chemicals into the human
body simply by having you take a breath.
The key challenge is getting the drug to reach the deep lung. Historically,
aerosol formulations have not been able to move the medication into the deep
lung efficiently, and until recently, companies developed pulmonary drug
delivery systems to dispense drugs to the airways only for local applications.
MDIs, breath-activated dry powder inhalers (DPIs), liquid jet, and ultrasonic
nebulizers have proved useful in the management of asthma, but such devices are
not designed to deliver drugs into the deep lung.
For optimal deep lung delivery of costly proteins and peptides, it is important
to use the correct aerosol particle size. Studies have established that these
particles should range from 1 µm to 3 µm in diameter for optimal deposition
efficiency.
The main advantage of delivering drugs deep into the lungs is the fact that it
completely circumvents the gastrointestinal (GI) tract and thus potentially
could deliver certain drugs that cannot withstand the pH conditions of the GI
tract, such as the large peptide and protein molecules. Other advantages
include rapid onset and patient compliance, since patients now can take a
breath instead of an intravenous injection.
One technology getting very close to commercialization is the use of a handheld
device to administer insulin by way of inhalation directly into a patient's
lungs. This new treatment form will revolutionize the way diabetic patients’
treat their disease and has the potential to greatly decrease the number of
patients using needles. Another use for this inhaler will be in the
administration of pain medication to patients who are unable to tolerate strong
analgesics by mouth. Potential markets include pain treatment for late-stage
cancer or pre-operative and post-operative pain medications for patients unable
to swallow.
For these types of applications, Aclar® laminates are providing the moisture
barrier to protect the drug from the environment as well as ensure the purity
and concentration of the drug formulation. This transparent film provides
benefit for quality assurance during manufacturing as well as the opportunity
for visual inspection by the patients before use.
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