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Purpose <p>Pulmonary fibrosis is a progressive and life-threatening interstitial lung disease characterized by excessive collagen deposition and irreversible deterioration of respiratory function. Current pharmacological therapies, such as nintedanib and pirfenidone, offer only partial disease control and are frequently associated with systemic adverse effects.</p> Methods <p>In recent years, phytoceuticalsbioactive plant-derived compounds with antioxidant and antifibrotic potential—have gained attention as alternative therapeutic candidates. However, their clinical translation is limited by poor aqueous solubility, stability issues, and low pulmonary bioavailability. Dry powder inhalers (DPIs) provide a non-invasive and efficient pulmonary delivery platform, enabling direct drug deposition in the lungs, rapid onset of action, and reduced systemic exposure. To ensure formulation robustness, reproducibility, and regulatory compliance, the Quality by Design (QbD) approach offers a systematic and science-based framework for DPI development. QbD incorporates the definition of Quality Target Product Profile (QTPP), identification of Critical Quality Attributes (CQAs) and Critical Material Attributes (CMAs), and risk-based optimization through Design of Experiments (DoE).</p> Results <p>The objective of this review is to critically summarize recent advances in phytoceutical-based DPI formulations for pulmonary fibrosis using a QbD-guided development strategy. The review highlights key formulation and process parameters influencing aerosolization performance, physicochemical stability, and therapeutic efficacy.</p> Conclusion <p>The novelty of this work lies in integrating QbD principles with phytoceutical DPI development, providing a structured and translational framework to support the design of robust, patient-centric pulmonary drug delivery systems for pulmonary fibrosis.</p> Graphical Abstract <p> Integration of pulmonary fibrosis pathophysiology, rational selection of phytoceuticals, and QbD-guided dry powder inhaler (DPI) development</p> <p></p>

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Quality by Design-Based Development of Phytoceutical Dry Powder Inhalers for Pulmonary Fibrosis Therapy

  • 期刊论文

  • 发表日期：

    2026年2月4日

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  • Yogendra Malviya,
  • Swapnil Goyal,
  • Deepak Joshi

摘要

Purpose

Pulmonary fibrosis is a progressive and life-threatening interstitial lung disease characterized by excessive collagen deposition and irreversible deterioration of respiratory function. Current pharmacological therapies, such as nintedanib and pirfenidone, offer only partial disease control and are frequently associated with systemic adverse effects.

Methods

In recent years, phytoceuticalsbioactive plant-derived compounds with antioxidant and antifibrotic potential—have gained attention as alternative therapeutic candidates. However, their clinical translation is limited by poor aqueous solubility, stability issues, and low pulmonary bioavailability. Dry powder inhalers (DPIs) provide a non-invasive and efficient pulmonary delivery platform, enabling direct drug deposition in the lungs, rapid onset of action, and reduced systemic exposure. To ensure formulation robustness, reproducibility, and regulatory compliance, the Quality by Design (QbD) approach offers a systematic and science-based framework for DPI development. QbD incorporates the definition of Quality Target Product Profile (QTPP), identification of Critical Quality Attributes (CQAs) and Critical Material Attributes (CMAs), and risk-based optimization through Design of Experiments (DoE).

Results

The objective of this review is to critically summarize recent advances in phytoceutical-based DPI formulations for pulmonary fibrosis using a QbD-guided development strategy. The review highlights key formulation and process parameters influencing aerosolization performance, physicochemical stability, and therapeutic efficacy.

Conclusion

The novelty of this work lies in integrating QbD principles with phytoceutical DPI development, providing a structured and translational framework to support the design of robust, patient-centric pulmonary drug delivery systems for pulmonary fibrosis.

Graphical Abstract

Integration of pulmonary fibrosis pathophysiology, rational selection of phytoceuticals, and QbD-guided dry powder inhaler (DPI) development