[Development of an Inhalation Dry Powder Preparation Method without Heat-drying Process].

Area of Science:

• Biopharmaceutical drug delivery
• Pulmonary medicine
• Materials science for drug formulation

Context:

• Biopharmaceuticals offer targeted action but face delivery challenges due to low stability and high molecular weight, necessitating alternatives to injection.
• Pulmonary drug delivery via inhalation is a promising, non-invasive route for lung diseases, but requires maintaining biopharmaceutical integrity under stress.
• Current manufacturing processes for dry powder inhalers (DPIs) often involve heat, potentially degrading sensitive biopharmaceuticals.

Purpose:

• To present a novel, non-thermal preparation method for biopharmaceutical dry powder inhalers (DPIs).
• To develop a method that preserves the integrity and inhalation characteristics of biopharmaceuticals during DPI formulation.
• To establish an alternative to heat-drying techniques for creating stable DPIs.

Summary:

• A novel spray-freeze-drying technique, a non-thermal process, was employed to prepare biopharmaceutical dry powder inhalers (DPIs).
• This method produced porous powders with excellent inhalation properties, successfully formulating a model drug, plasmid DNA (pDNA).
• The resulting pDNA-loaded DPIs maintained drug integrity for 12 months under dry conditions and demonstrated superior gene expression in mouse lungs compared to solution delivery.

Impact:

• This innovative spray-freeze-drying method offers a viable alternative for manufacturing stable biopharmaceutical DPIs.
• It addresses the critical need for non-thermal processing to maintain the integrity of sensitive biologics.
• The technique has the potential to expand the clinical applications of inhaled biopharmaceuticals, improving patient treatment options.