Pulmonary Drug Delivery

During the past decade, pulmonary drug delivery (PDD) technology advanced substantially due to several inventions in propellants, excipients, and device technologies. Human lungs’ large surface area with rich blood supply, rapid onset of action, high bioavailability, and other physiological advantages make it a potential route for treating asthma, COPD, and other pulmonary disorders. Minimally invasive drug delivery through the lung would be achieved using environment-friendly propellants, non-aqueous inhalers, user-friendly dry powder inhalers, and jet or ultrasonic nebulizers. For these devices to effectively deliver micronized drug particles in the aerosolized form, drug particles of the appropriate respirable size range and innate electrostatic charge are required. Several different methods may perform characterization of the pulmonary drug aerosols. Those properties indicate the stability and performance of the drug and the device. Assuming the quality of the drug-aerosol is appropriate for lung deposition, it is also necessary to demonstrate that a high-performing PDD may deliver sufficient drugs to accomplish the desired therapeutic effect in a reproducible way. The PDD has many potentials to be successful for systemic inhalation delivery. The current understanding of in vitro and in vivo relationships for PDD products still needs to be completed and is still evolving. The correlations showed that in vitro data can be used more widely to compare different inhaler devices during product development. Pulmonary drug formulation and delivery device technologies are advancing rapidly as the pharmaceutical industry moves to adopt the potential advantages of the pulmonary route as an alternative to oral and parenteral delivery methods. These advances attract new players and investment, accelerating the pace and number of new pulmonary drug candidates entering the drug development pipeline. Demand profile of inhaled drugs quietly winding new combination products such as drugs for treating endometriosis, several forms of cancer, hemophilia, neurological disorders, and pain management through the development and clinical trials. Several of these drugs will significantly impact the pulmonary drug delivery market. In response, regulatory bodies such as the US Food and Drug Administration (US FDA), US Pharmacopeia and expert groups have devoted heavily to developing and introducing appropriate test methods. The recent inhalation product guidance from the European Medicines Agency, the draft pharmacopeia monographs of the US FDA, and the soon-to-be-completed International Standards Organization standards for drug delivery devices are examples of the ongoing nature of this work