Drug administration inhalation

Draft Guidance for Industry Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products, Chemistry, Manufacturing, and Controls Documentation Draft, U.S. Department of Health and Human Serviees, Food and Drug Administration. Rockville, MD, Oetober 1998. 

Begin drug administration as soon as possible after suspected or confirmed exposure to B. anthracis spores. This indication is based on a surrogate endpoint, ciprofloxacin serum concentrations achieved in humans, reasonably likely to predict clinical benefit. Total duration c ciprofloxacin administration (IV, IR, or oral) for inhalational anthrax (postexposure) is 60 days. 

U.S. Food and Drug Administration (FDA) (1998, Oct.), Guidance for industry Metered dose inhaler and dry powder inhaler drug products, FDA Washington, DC. 

Drugs may be atomized or volatilized and inhaled as droplets or particulates in air a common example is the smoking of drugs. The advantages of this route include rapid transport into the blood, avoidance of first pass hepatic metabolism, and avoidance of the medical problems associated with other routes of illicit drug administration. Disadvantages include local irritant effect on the... 

Drug Albuterol Primary Receptor Beta-2 Route of Administration Inhalation Oral Onset of Action (min) 5-15 15-30 Time to Peak Effect 1- 1.5 2- 3 Duration of Action (hr) 3-6 8 or more... 

Various characteristics of the molecule influence its chances of reaching its target receptor since they influence the nature and extent of the body s effect on it. A drug s pharmacokinetic profile therefore determines the extent of the drug s opportunity to exert its pharmacodynamic effect. While there are various routes for human drug administration (oral rectal intravenous, subcutaneous, intramuscular, and intra-arterial injections topical and direct inhalation into the lungs), the most common for small-molecule drugs is oral administration, and discussions in the first part of this chapter therefore focus on oral administration. (In contrast, biopharmaceuticals are typically administered by injection, often directly into the bloodstream.)... 

Today, there are a number of methods that can be used to introduce a drug into the body. Because of its convenience, the most common delivery system is the oral route. However, sometimes the oral route is not the most appropriate. In addition to the oral route, some of the alternative routes of drug administration with the oldest history include, not surprisingly, inhalation, and, surprisingly, rectal and vaginal, as illustrated by the following examples. 

Since that time, a significant number of variations on that theme have been placed into clinical trials and, in some cases, such as Aztreonam 28, into commerce. Recently (late 2007, early 2008), this compound was submitted for approval in the EU and the USA as the lysinate salt for the inhalation treatment of Pseudomonas aeruginosa in cystic fibrosis under an Orphan drug category. As of late 2008, the Food and Drug Administration (FDA) was requiring further information and the status of the EU application was not yet known. 

O-methyl metabolite, with up to about 15% of the dose as unchanged drug after inhalation or oral administration, 68 to 94% of a dose is excreted as conjugated isoprenaline, with about 2 to 8% of a dose as the 3-0-methyl conjugate and less than 5% as unchanged drug or free 3-0-methylisoprenaline small amounts of a dose are excreted in the bile, mainly as metabolites. 

U.S. Food and Drug Administration. (2001b). Commentary on non-labeled dosing of oral amoxicillin in adults and pediatrics for post-exposure inhalational anthrax. U.S. Food and Drug Administration Center for Drug Evaluation and Research. Retrieved March 13, 2007 from http //www.fda.gov/cder/ drugprepare/amox-anthrax.htm... 

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