Dry powder formulation comprising a corticosteroid and a beta-adrenergic for administration by inhalation

A dry powder formulation, comprising:

• a) a fraction of fine particles having a mass median diameter lower than 10 micron comprising particles of alpha-lactose monohydrate;
• b) a fraction of coarse particles constituted of alpha-lactose monohydrate having a mass diameter comprised between 60 and 500 micron and the ratio between the fine particles and the coarse particles being comprised between 1:99 and 30:70 percent by weight;
• and
• c) formoterol fumarate dihydrate in combination with beclometasone dipropionate (BDP) as active ingredient both in form of micronized particles;
• wherein i) no more than 10% of said BDP particles have a volume diameter lower than 0.6 micron, ii) no more than 50% of said particles have a volume diameter comprised between 1.5 micron and 2.0 micron;
• and iii) at least 90% of said particles have a volume diameter lower than 4.7 micron,
• wherein said formulation is contained in a dry powder inhaler and
• wherein said dry powder inhaler delivers formoterol fumarate dihydrate in a therapeutical dose of 6 or 12 μg, and BDP in a therapeutical dose of 100 or 200 μg per actuation of the inhaler;
• and whereby said formulation is therapeutically equivalent a formulation for pressurized metered dose inhalers (pMDIs) comprising the same amounts of BDP and formoterol fumarate dihydrate dissolved in a mixture of ethanol and HFA134a propellant.