Delben, V.A.O. Development and characterization of a dry powder inhaler formulation for the treatment of lung diseases.Orally inhaled drugs are of great pharmaceutical interest, as they quickly and effectively provide treatment to various respiratory tract problems such as asthma and COPD (chronic obstructive pulmonary disease) and also non-respiratory diseases like diabetes. Its formulations are usually quite simple, composed by an active pharmaceutical ingredient (API) and a carrier, usually lactose. The development of generic and similar are complex due to high batch-to-batch variability in the reference listed drugs, which are due to differences in the particle size distribution (PSD), morphology, surface area, roughness, moisture, cohesive and adhesive strength.To obtain APIs with the ideal particle size for inhalation, it's necessary that the material is submitted to a micronization process, in which the particles collide with enough energy to break and downsize. Micronized particles suffer electrostatic interactions and agglomerate, hindering the APIs uniformity in the finished product. There are several kinds of inhalable grade α-lactose monohydrate (carrier) available on the market, which differ by particle size and production process (grinding, sieving or micronization). Carrier particles interact with each other and with the API, smaller excipient particles interact with the surface of larger particles and occupy positions that APIs can take place. This carrier-carrier interaction may modify the absorption profile of the APIs because it alters the particle surface energy and surface roughness.The approval for the developed product by ANVISA (Brazilian Health Regulatory Agency) requires desempenho of the inhaled powder with the delivery of APIs in the lung similar to that of its comparator. Thus, ANVISA determined standards and tests to prove equivalence and in-vitro desempenho to be carried out for inhaled drugs by RDC278/19 (Resolution of the Collegiate Board) and by IN33/2019 (Normative Instruction).In this work, the particle sizes of APIs and possible carriers present in the reference listed drug were evaluated. Reverse engineering was effective in conducting studies for the best components for faster and more effective development. PSD and CRM (Confocal Raman Microscopy) of the reference product were correlated and compared to the PSD of 3 API manufacturer, aiming to identifying critical points of the inhaled drug product process and to selecting the best manufacturer for the development of the product. Different pharmaceutical process was evaluated and tested in order to compare desempenho of the prototypes with the reference listed product by air jet sieving, with sample collections at increasing times of sieving and quantification by spectrophotometry UV-vis. Studies indicate that the mixing process with geometric dilution with micronized carrier produces mixtures with higher similarity to the reference medicine studied.