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Nose-to-brain delivery Another option generating much attention is the possi- bility of treating CNS diseases by the so-called "nose-to- brain" route. It is well known that only about 1% of existing drugs can pass through the blood brain barrier (BBB), 4 whose function is blocking molecules it consid- ers harmful or toxic to the brain. Drugs targeted at the olfactory region in the upper por- tion of the nasal cavity could be transported to the brain and bypass the BBB, although this is still a somewhat controversial subject. 4 The olfactory region is difficult to access because of the restricted nasal anatomy, with the turbinates lying in the way. However, much interest and progress is being reported in this area 5 and specifically designed delivery devices hold promise for finding solu- tions to this difficult challenge in successful delivery of drugs to the CNS. Delivery of small molecules; Options for life cycle management In order to harness the total value of a drug product, nasal delivery devices with their established technology and well-documented regulatory guidelines can enhance product life cycle management (LCM). The LCM strat- egy is not new. Recently up to 30-40% of the drugs or biologics approved or launched for the first time in the United States were either existing drugs repositioned for new indications, reformulations or new combinations of existing drugs. With fewer non-biologic new molecules in the R&D pipeline, 3 pharma and specialty pharma companies are actively searching for lower-risk development options. Due to this change in market dynamics, numerous opportunities are appearing in the nasal drug delivery area for small molecules to treat unmet medical needs such as Alzheimer's and Parkinson's disease. These can often be focused on either LCM opportunities for inno- vative formulations of established drugs in new devices or on development of known drugs for new applica- tions. This is another area where opportunities can lie for nasal delivery, including unit dose and bidose drug deliv- ery systems. Preservative-free formulations Preservatives are used to protect the liquids in nasal spray and liquid sublingual spray formulations from bacterial contamination during storage and use-life. However, typical preservatives such as benzalkonium chloride, parabens and ethylene diamine tetra-acetic acid (EDTA) have been reported to cause damage to the nasal mucosa when used in chronic therapies and have side effects such as hindrance of the ciliary clearing functions within the nasal cavity. 1 Nasal delivery devices that contain dry powders or preservative-free formulations offer opportunities to avoid the use of preservatives and their potential compli- cations. Several options now exist including unit dose and bidose drug delivery spray devices, in both liquid 12 JUNE 2016 Inhalation Figure 1 A unit dose powder device Figure 2 A unit dose liquid device (Photo enlarged to show detail) (Photo enlarged to show detail)