MUMBAI, India, Aug. 12 -- Intellectual Property India has published a patent application (202611079458 A) filed by Noida Institute Of Engineering And Technology Niet on June 27, 2026, for Ensifentrine-Mannitol-Trehalose Binary Mixture For Enhanced Aerosolization, Packing Efficiency, And Stability In Dry Powder Inhaler.
Inventors include Dr. Saumya Das; and Dr. Avijit Mazumder.
The application for the patent was published on August 07, 2026, under issue no. 32/2026.
Abstract: The present invention presents dry powder inhaler formulations of micronized Ensifentrine with a binary Mannitol–Trehalose carrier system. Unlike conventional lactose carriers that undergo Maillard-type degradation with Ensifentrine’s amine groups, this system ensures chemical compatibility, superior moisture control, and improved mechanical properties. Correlations between unconsolidated mechanical properties and aerosolization performance enable rapid optimization without costly cascade impactor testing. Formulations exhibit bulk density of 0.65–0.72 g/cm³ and Hausner ratios below 1.18, confirming excellent flowability. Aerosolization yields fine particle fractions of 25–35% with MMAD of 2.8–3.8 µm, representing 40–95% improvement over lactose systems. Stability studies show 94–99% potency retention after 12 months accelerated storage, compared to 78% with lactose. Manufacturing uses simple solvent-free dry blending, reducing costs and environmental impact. Blend state transitions are mechanistically defined between 0.5–15% drug loading. The formulation is suitable for chronic obstructive pulmonary disease, asthma, and related respiratory disorders.
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