PROCESS VALIDATION OF DRY POWDER INHALERS (GENERALIZED APPROACH, THEORY AND PRACTICES): A REVIEW

Abstract

Drugs can be delivered to the lungs by inhalation, oral, parenteral routes. Different types of devices such as pressurised metered dose inhalers (p-MDI's), nebulizers or dry powder inhalers (DPI's) are used for the pulmonary delivery of drugs .This present review article focus on the process validation of dry powder inhalers. Dry powder inhaler is a device that deliver medication to the lungs in the form of dry powder. Validation of dry powder inhaler is done to ensure that a specific manufacturing process will consistently produce a product meeting its pre-determined specifications and quality attributes. Validation is defined as the collection and evaluation of data, from the process design stages through commercial production, which establishes scientific evidences that a process is capable of consistently delivering quality product. The purpose of setting validation parameters is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it. Three consecutive batches of dry powder 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 for powder for inhalation. Once the validation process is complete a Batch Manufacturing Record (BMR) can be written. Any changes in BMR can be made in accordance with change control procedure.