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10. June 2012 Inhalation Formulation and characterization of nasal sprays An examination of nasal spray formulation parameters and excipients and their influence on key in vitro tests. Vitthal Kulkami and Charles Shaw DPT Laboratories, Ltd. Introduction Administration of drugs through the nose in the spray dosage form is a non-invasive method that gives rapid onset of drug action, Because the nasal spray dosage form is fective, easy to use/catty and self-admi trable, it has high patient compliance. Thesefore, nasal deug deliver ular coute of drug admin- istration and has strong growth opportunity. A published report indicates that the combined sale for inhalation and intranasal drug delivery products exceeded US $20 billion, fn 2009! and itis expected to grow y has become ‘The total surface area of the nasal cavity of an average adult is approximately 180 cm2, It is richly vasculatized for tapid blood flow and has mictovilli in epithelial cells23 Therefore, the nasal mucosal membrane has potential advantages for quick bioavailability and fast onset of drug action. Traditionally, nasal drug delivery ‘was limited to teeating the a gies. Recently however, there has been growing interest in developing nasal drug delivery systems for systemic livery as an alternative to oral ot injectable dosage ims, including small molecular weight drugs, proteins and vaccines.§4 In addition, have been several studies since the 1970s that have suggested vel intranasal dug delivery could be used to dugs nto the centcal nervous system via the olfactory epithe- yypassing the blood brain battier.* Only relatively recently have specially-designed devices emerged that f sprays o powders to the thereby enabling delivery of enteal necvous system.*7 This can target the delivery olfactory region of the n the deug dit article exam excipients and thei in es nasal spray formulation parameters and. uence on key in vitro tests. Critical parameters affecting nasal spray formulation performance and bioavailability Physical properties of formulations. Nasal