JPWO2021028679A5 - - Google Patents

Claims (15)

(i) encifenthrin particles;
(ii) coarse lactose particles having a Dv50 between 40 μm and 80 μm; and (iii ) fine lactose particles having a Dv50 between 5 μm and 10 μm, said dry powder pharmaceutical composition suitable for inhaled administration,
A dry powder pharmaceutical composition wherein the fine lactose particles are present in an amount of 0.1 % to 6.0 % by weight relative to the total weight of the dry powder pharmaceutical composition. 2. According to claim 1, wherein the amount of fine lactose particles is 0.5% to 5.0%, preferably 3.5% to 4.0% by weight relative to the total weight of the dry powder pharmaceutical composition. A dry powder pharmaceutical composition as described. Claim 1, wherein the coarse lactose particles are present in an amount of 80.0% to 99.0 %, preferably 90.0% to 96.0% by weight relative to the total weight of the dry powder pharmaceutical composition. Or the dry powder pharmaceutical composition according to 2. Dry powder pharmaceutical composition according to any one of the preceding claims, wherein the coarse lactose particles have a Dv50 between 50 μm and 70 μm, preferably between 55 μm and 65 μm . The preceding claim wherein the encifenthrin particles are present in an amount of 0.1% to 10%, preferably 0.2% to 6.0% by weight relative to the total weight of the dry powder pharmaceutical composition. The dry powder pharmaceutical composition according to any one of Claims 1 to 3. The preceding claim, wherein the encifenthrin particles comprise at least 90% by weight, preferably at least 95.0% by weight of encifenthrin or a pharmaceutically acceptable salt thereof, relative to the total weight of the encifenthrin particles. The dry powder pharmaceutical composition according to any one of Claims 1 to 3. Encifenthrin particles are 0 . Dry powder pharmaceutical composition according to any one of the preceding claims, having a Dv50 between 5 μm and 5.0 μm, preferably between 1.0 μm and 2.0 μm. of the preceding claim, wherein the total amount of encifenthrin particles, coarse lactose particles and fine lactose particles is at least 90.0% by weight, preferably at least 95.0% by weight relative to the total weight of the dry powder pharmaceutical composition. A dry powder pharmaceutical composition according to any one of the preceding paragraphs. 4. A dry powder pharmaceutical composition according to any one of the preceding claims, wherein the dry powder pharmaceutical composition is suitable for administration by a dry powder inhaler. A dry powder inhaler comprising a dry powder pharmaceutical composition according to any one of the preceding claims. A dry powder pharmaceutical composition according to any one of claims 1 to 9 for use in the treatment of the human or animal body. Asthma, allergic asthma, hay fever, allergic rhinitis, bronchitis, emphysema, bronchiectasis, chronic obstructive pulmonary disease (COPD), adult respiratory distress syndrome (ARDS), steroid-resistant asthma, severe asthma, childhood asthma , cystic fibrosis, pulmonary fibrosis, pulmonary fibrosis, interstitial lung disease, skin disorders, atopic dermatitis, psoriasis, eye inflammation, cerebral ischemia, inflammatory diseases and autoimmune diseases or a dry powder pharmaceutical composition according to any one of claims 1 to 9 for use in treating or preventing a condition. 13. A dry powder pharmaceutical composition for use according to claim 12, wherein the disease or condition is chronic obstructive pulmonary disease (COPD). A dry powder pharmaceutical composition according to any one of claims 1 to 9 for use in a method of treating a disease or condition as defined in claims 12 or 13,
the method comprising inhaling a dry powder inhaler containing the dry powder pharmaceutical composition;
A dry powder pharmaceutical composition wherein the fine particle fraction of encifenthrin particles after inhalation is at least 20%. 15. Dry powder pharmaceutical composition for use according to claim 14, wherein the fine particle fraction of the encifenthrin particles after inhalation is at least 30%, preferably at least 35%.