Inhalation

INH0616

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Inhalation JUNE 2016 11 Nasal and sublingual spray delivery devices: Market opportunities and unmet medical needs Uses and advantages of nasal drug and sublingual spray delivery Nasal drug delivery devices have been in use for more than 40 years and are a widely recognized route for topi- cal treatment of local diseases in the nasal cavity such as allergic and non-allergic rhinitis and nasal congestion. 1 In addition, nasal drug delivery has emerged as a success- ful option for needle-free delivery of systemic drugs where rapid absorption and onset of action are necessary, for instance, in pain management, migraine crisis and opioid overdosing episodes. 1 The advantages of nasal mucosal and sublingual spray delivery are well known 1 and include non-invasiveness (compared to injections); easy accessibility for adminis- tration; use of a relatively large, highly vascularized, mucosal surface area; high systemic bioavailability for some drugs; avoidance of hepatic first pass metabolism and the potential for rapid onset of drug action. Other attractive features are the potential for increased patient compliance and improvements in pharmacokinetic profiles. Nasal delivery devices also have limitations that must be considered. These include limited absorption for higher molecular weight compounds (greater than 1,000 dal- tons); concerns about a patient's ability for nasal clearance and the influence of patient nasal physiology (due to colds, allergies, etc.); and difficulty in reaching some targeted areas of the nasal anatomy. 1 Nasal drug delivery holds further promise and this article will look at a variety of unmet medical needs and market opportunities it could address. Increasing global health care needs By 2030, there will be 1 billion people over 65 years of age worldwide compared to 600 million currently, 2 and healthcare must adapt to this changing demography. In addition, healthcare costs are rising globally and there is a growing demand for therapeutically relevant medications that can be developed quickly and at reasonable costs for a variety of diseases and high unmet medical needs. Several obvious adaptations are necessary, including shortened in- patient hospital stays; increased outpatient care; more self- administration of drugs and greater palliative care. Nasal and sublingual spray delivery devices can play a role in these scenarios as they can be easily adapted for elderly patient use from the viewpoint of ergonomics, portability and ease of self-administration. Unmet needs in CNS diseases In 2015, the global pharma prescription market was val- ued at approximately $1,120 billion US dollars with an impressive 6% growth rate over 2014. 3 Within this, the market for central nervous system (CNS) therapy was valued at $143 billion US dollars. The CNS market is of interest as it comprises several areas, some with high unmet medical needs, such as depression, schizophrenia, Alzheimer's disease, Parkinson's disease, migraine, insomnia, ADHD (attention deficit hyperac- tivity disorder), anxiety disorders and bipolarism, where non-invasive nasal delivery—in particular unit dose and bidose approaches as opposed to multidose—could prove very beneficial. Although many CNS diseases are of a chronic nature, strong opportunities also exist for acute treatments such as seizures and overdosing episodes. A brief look at new options Gerallt Williams Aptar Pharma Photo courtesy of Aptar Pharma

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