Background <p>Proniosomes are dry, free-flowing, carrier-based systems designed to enhance pulmonary drug delivery and improve the aerosolization of therapeutic agents. Such systems are gaining attention for optimizing the performance of dry powder inhalers (DPIs) in inhalation therapy.</p> Objective <p>This study aimed to develop and optimize a proniosomal powder system for dual pulmonary delivery of Salbutamol sulfate (SS) and Carvacrol (CAR) using the Box–Behnken design (BBD).</p> Methods <p>Proniosomes were prepared by the slurry method. A three-factor, three-level BBD was employed to assess the influence of Span 60, lactose monohydrate, and mannitol concentrations on particle size, entrapment efficiency (% EE), and drug loading capacity (% LC). The optimized formulation was characterized by FTIR, XRD, and SEM to confirm drug–excipient compatibility, amorphous dispersion, and surface morphology.</p> Results <p>The optimized proniosomal powder exhibited desirable particle size (827.4 ± 33.65&#xa0;nm), high drug entrapment (SS: 84.37 ± 2.04%; CAR: 95.5 ± 1.52%), and efficient aerosolization performance. FTIR and XRD results confirmed chemical compatibility and amorphous nature of the entrapped drugs. <i>In vitro</i> release studies indicated sustained drug release pattern (SS: 67.34%; CAR: 68.89% over 24&#xa0;h). Stability studies over 6&#xa0;months demonstrated a good shelf-life and retention of vesicle-forming capability upon hydration.</p> Conclusion <p>The developed dual-drug proniosomal powder offers a promising approach for pulmonary drug delivery. Its optimized physicochemical and aerosolization characteristics suggest potential utility in the effective management of respiratory disorders through sustained release and improved lung deposition.</p> Graphical Abstract <p></p>

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Development of Proniosomal Dry Powder for Dual Pulmonary Delivery of Salbutamol Sulfate and Carvacrol: A Design of Experiment Approach

  • Deepa Neopane,
  • Poonam Kushwaha,
  • Badruddeen

摘要

Background

Proniosomes are dry, free-flowing, carrier-based systems designed to enhance pulmonary drug delivery and improve the aerosolization of therapeutic agents. Such systems are gaining attention for optimizing the performance of dry powder inhalers (DPIs) in inhalation therapy.

Objective

This study aimed to develop and optimize a proniosomal powder system for dual pulmonary delivery of Salbutamol sulfate (SS) and Carvacrol (CAR) using the Box–Behnken design (BBD).

Methods

Proniosomes were prepared by the slurry method. A three-factor, three-level BBD was employed to assess the influence of Span 60, lactose monohydrate, and mannitol concentrations on particle size, entrapment efficiency (% EE), and drug loading capacity (% LC). The optimized formulation was characterized by FTIR, XRD, and SEM to confirm drug–excipient compatibility, amorphous dispersion, and surface morphology.

Results

The optimized proniosomal powder exhibited desirable particle size (827.4 ± 33.65 nm), high drug entrapment (SS: 84.37 ± 2.04%; CAR: 95.5 ± 1.52%), and efficient aerosolization performance. FTIR and XRD results confirmed chemical compatibility and amorphous nature of the entrapped drugs. In vitro release studies indicated sustained drug release pattern (SS: 67.34%; CAR: 68.89% over 24 h). Stability studies over 6 months demonstrated a good shelf-life and retention of vesicle-forming capability upon hydration.

Conclusion

The developed dual-drug proniosomal powder offers a promising approach for pulmonary drug delivery. Its optimized physicochemical and aerosolization characteristics suggest potential utility in the effective management of respiratory disorders through sustained release and improved lung deposition.

Graphical Abstract