Metered-dose inhaler control

Draft Guidance for Industry-Metered Dose Inhaler (MDI) and Dry Powder Inhaler (DPI) Drug Products Chemistry, Manufacturing, and Controls Documentation, Nov. 13, 1998. 

Farr, S.J., Rowe, A.M., Rubsamen, R., and Taylor, G., Aerosol deposition in the human lung following administration from a microprocessor controlled pressurised metered dose inhaler. Thorax, 50 639-644 (1995). 

Pressurized metered dose inhalers are still the most frequently used systems and they have proven their value in therapy. However, their application in early phases of biopharmaceuti-cal research and further development of dosage forms seems less convenient, since they require special components including propellants, special containers, metering valves, and controlled filling conditions (pressure-filling or cold-filling). 

FDA. Metered dose inhaler (MDI) and dry powder inhaler (DPI) drug products chemistry, manufacturing, and controls documentation. CDER/FDA, 1998. 

A change in the primary packaging components for any product when the primary packaging components control the dose delivered to the patient (e.g., the valve or actuator of a metered-dose inhaler). 

Table 3 Quality control and analytical tests for the characterization of metered dose inhalers...

Blumenthal, M.N. Casale, T.B. Fink, J.N. Uryniak, T. Casty, F.E. Evaluation of a non-chlorofluorocarbon formulation of cromolyn sodium (intal) metered-dose inhaler versus the chlorofluorocarbon formulation in the treatment of adult patients with asthma a controlled trial. J. Allergy Clin. Immunol. 1998, 101 (1), 7-13. 

The National Asthma Education and Prevention Program recommends inhaled SAB As be used as needed for acute asthma exacerbation. The usual dose is 360 to 720 pg per four to eight puffs every 20 minutes up to 4 hours for albuterol metered-dose inhaler (MDI). This recommendation contrasts with previous ones for regular use of 180 pg per two puffs for albuterol MDI three to four times daily. Regular use of SABAs has been a standard approach without the scientific basis since 1970s [12]. Current guidelines indicate that inhaled LABAs (usual dose, 84 pg per two puffs for salmeterol MDI twice daily) should be combined with ICSs for asthma control, rather than used as a stand-alone therapy. 

Farr S, Rowe A, Rubsamen R, Taylor G. Optimisation of aerosol inhalation from metered dose inhalers by use of a novel microprocessor controlled device. Pharm Res 1994 11-158. 

Donelly JE, DoneUy WJ, Thong YH. Parental perceptions and attitudes towards asthma and its treatment a controlled study. Soc Sci Med 1987 24 431 37. DeBlaquiere P, Christensen DB, Carter WB, Martin TR. Use and misuse of metered-dose inhaler. Am Rev Respir Dis 1989 140 910-916. 

Brown RW, O Brien CD, Martin UJ, Uryniak T, Lampl KL. Long-term safety and asthma control measures with a budesonide/formoterol pressurized metered-dose inhaler in African American asthmatic patients a randomised controlled trial. J Allergy Clin Immunol August 2012 130(2) 362-7. e9. 

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