Technical challenges in obtaining an optimized powder/DPI combination for inhalation delivery of a bi-component generic drug

Hejduk, Arkadiusz; Urbańska, Agnieszka; Osiński, Andrzej; Lukaszewicz, Piotr; Domański, Maciej; Sosnowski, Tomasz R.

doi:10.1016/j.jddst.2018.01.019

Cited by 9 publications

(6 citation statements)

References 26 publications

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“…When we examine the adaptability of an inhalation device for the designed inhalation formulation, parameters as evaluation indexes like FPD, FPF, MMAD, GSD, drug deposition, drug delivery rate, total amount of delivery, and delivery dose homogeneity should be taken into consideration. In other words, an inhalation device that is compatible with an inhaled formulation should ensure a suitable and uniform aerodynamic diameter, a good lung deposition rate, and rapid delivery to the site of action, as well as adequate and quantitative dosage [ 90 , 91 , 92 , 93 , 94 ].…”

Section: Industrial Translation Of Inhalable Nano-formulations Is Lim...mentioning

confidence: 99%

“…DPIs are categorized into single-dose, multi-unit dose, and multi-dose types. The rate of drug deposition in the lungs varies considerably between products, typically 12–40% [ 37 , 93 , 102 , 103 ]. DPI formulations are of solid state, stable for long-term storage, and easy to transport.…”

Section: Various Inhalation Devices Are Used Clinicallymentioning

confidence: 99%

“…The mechanism of drug delivery by DPIs is that the microscale powder consisting of the drug and carrier (generally lactose) is dispersed into the lungs in the form of an aerosol, through turbulence generated by the patient’s inhalation and the internal resistance of the device [ 93 ]. From this angle, we can interpret that the main issues to be examined in the DPIs for nano-formulations are (i) whether the nano-formulation is affected in the drying process; (ii) how the nano-formulation forms solid microscale powder and whether it can be effectively deposited in the lungs; and (iii) whether the solid microscale powder deposited in the lungs can be dispersed in the initial nano-formulation form.…”

Section: Vibrating Mesh Nebulizers Are Suitable For Inhalable Nano-fo...mentioning

confidence: 99%

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Nano-Formulations for Pulmonary Delivery: Past, Present, and Future Perspectives

Peng,

Wang,

Zhang

et al. 2024

Pharmaceutics

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With the development of nanotechnology and confronting the problems of traditional pharmaceutical formulations in treating lung diseases, inhalable nano-formulations have attracted interest. Inhalable nano-formulations for treating lung diseases allow for precise pulmonary drug delivery, overcoming physiological barriers, improving aerosol lung deposition rates, and increasing drug bioavailability. They are expected to solve the difficulties faced in treating lung diseases. However, limited success has been recorded in the industrialization translation of inhalable nano-formulations. Only one relevant product has been approved by the FDA to date, suggesting that there are still many issues to be resolved in the clinical application of inhalable nano-formulations. These systems are characterized by a dependence on inhalation devices, while the adaptability of device formulation is still inconclusive, which is the most important issue impeding translational research. In this review, we categorized various inhalable nano-formulations, summarized the advantages of inhalable nano-formulations over conventional inhalation formulations, and listed the inhalable nano-formulations undergoing clinical studies. We focused on the influence of inhalation devices on nano-formulations and analyzed their adaptability. After extensive analysis of the drug delivery mechanisms, technical processes, and limitations of different inhalation devices, we concluded that vibrating mesh nebulizers might be most suitable for delivering inhalable nano-formulations, and related examples were introduced to validate our view. Finally, we presented the challenges and outlook for future development. We anticipate providing an informative reference for the field.

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Section: Industrial Translation Of Inhalable Nano-formulations Is Lim...mentioning

confidence: 99%

Section: Various Inhalation Devices Are Used Clinicallymentioning

confidence: 99%

Section: Vibrating Mesh Nebulizers Are Suitable For Inhalable Nano-fo...mentioning

confidence: 99%

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Nano-Formulations for Pulmonary Delivery: Past, Present, and Future Perspectives

Peng,

Wang,

Zhang

et al. 2024

Pharmaceutics

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“…Nevertheless, because proper dose intake is also dependent on device characteristics, DPI resistance should be accounted for in order to meet the patient’s inspiratory capacity [ 32 ]. In fact, selection of DPIs with proper aerodynamic resistance is fundamental for optimal patient–device matching [ 33 ], especially for certain patient categories, such as the elderly, children, and individuals with compromised lung function such as asthma, chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF) disease, who cannot achieve sufficient inspiratory airflows [ 24 ]. An out-of-tune patient–device match can often result in incomplete drug emission and/or oropharynx deposition [ 34 , 35 ].…”

Section: Limitations Of Currently Available Dpismentioning

confidence: 99%

Dry Powder Inhalers in the Digitalization Era: Current Status and Future Perspectives

et al. 2021

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During the last decades, the term “drug delivery systems” (DDSs) has almost fully replaced previously used terms, such as “dosage forms”, in an attempt to emphasize the importance of the drug carrier in ensuring the claimed safety and effectiveness of the product. However, particularly in the case of delivery devices, the term “system”, which by definition implies a profound knowledge of each single part and their interactions, is not always fully justified when using the DDS term. Within this context, dry powder inhalers (DPIs), as systems to deliver drugs via inhalation to the lungs, require a deep understanding of the complex formulation–device–patient interplay. As of now and despite the progress made in particle engineering and devices design, DPIs’ clinical performance is limited by variable patients’ breathing patterns. To circumvent this pitfall, next-generation DPIs should ideally adapt to the different respiratory capacity of individuals across age, health conditions, and other related factors. In this context, the recent wave of digitalization in the health care and industrial sectors may drive DPI technology towards addressing a personalized device–formulation–patient liaison. In this review, evolving technologies are explored and analyzed to outline the progress made as well as the gaps to fill to align novel DPIs technologies with the systems theory approach.

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“…they form a mixture of two or more active compounds delivered during single inhalation, while the dose of each compound is significantly different (e.g., as 10:1). In such cases the problem of the reproducible delivery of each compound in one dose of inhaled aerosol particles with the desired size distribution becomes much more complex and requires a more thorough analysis [17].…”

Section: Fig 2 a Scheme Of Inhalation As A Route Of Drug Deliverymentioning

confidence: 99%

Particles and lungs - where chemical engineering meets medicine

Sosnowski¹

2019

Chemical Technology and Engineering. Proceedings.2019.№1

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Technical challenges in obtaining an optimized powder/DPI combination for inhalation delivery of a bi-component generic drug

Cited by 9 publications

References 26 publications

Nano-Formulations for Pulmonary Delivery: Past, Present, and Future Perspectives

Nano-Formulations for Pulmonary Delivery: Past, Present, and Future Perspectives

Dry Powder Inhalers in the Digitalization Era: Current Status and Future Perspectives

Particles and lungs - where chemical engineering meets medicine

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