PROCESS VALIDATION OF METERED DOSE INHALER: A REVIEW
Journal Title: International Research Journal of Pharmacy (IRJP) - Year 2012, Vol 3, Issue 3
Abstract
The purpose of this work is to present an introduction and general overview on process validation of Metered dose inhaler.The word validation simply means, “Assessment of validation or action of proving effectiveness”. The most common dosage form for inhalation is the metered-dose inhaler (MDI), by which the drug is delivered from a pressurized container using a liquefied gas propellant.Inhalation is the convenient way to deliver drugs to respiratory tract in treatment of respiratory disease like ASTHMA.The process validation process parameters are derived from the specifications for the device, component or other entity to be produced by the process. The process is developed in such a way that the required parameters are achieved and it ensures that the output of the process will consistently meet the required parameters during routine production, the process is validated. A manufacturer can assure through careful design of the device, processes, process controls and packaging that all manufactured units will meet specifications and have uniform quality. However, in-process and finished product testing still play an important role in assuring that products meet specifications Validation is defined as a collection and evaluation of data , from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. MDI is pocket-sized, hand-held, pressurise multiple-dose inhalation delivery system. It delivers small, precisely measured therapeutic doses, greatly minimizing the risk of adverse side effects. A metered dose inhaler (MDI) is a device that delivers a specific amount of medication to the lungs in the form of a short burst of aerosolized medicine that is inhaled by the patient. Three consecutive batches of metered dose inhaler shall be taken up for process validation. Based on the results of all the 3 batches, suitable conclusions will be drawn with respect to the suitability of proposed method of manufacture for metered dose inhaler. This review covers need of validation, elements of validation, principles of Validation, Types of validation; brief introduction on MDI includes uses, components, materials and manufacturing.
Authors and Affiliations
Gaganpreet Kaur , A. C. Rana , Nimrata Seth , Rajni Bala
Keywords
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