Low powder mass filling of dry powder inhalation formulations

Eskandar, Fadi; Lejeune, Morgane; Edge, Stephen

doi:10.3109/03639045.2010.489561

Cited by 16 publications

(5 citation statements)

References 9 publications

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“…Each API must be evaluated itself for feasibility, and we have not yet scaled micronized TIG to these instruments. Typically, low fill weights exacerbate difficulty in achieving capsule target weight uniformity; however, in the case of high dose powders some of this concern is reduced. − In addition, the observed lack of flow rate-dependent changes and efficient dispersion of micronized TIG at lower pressures indicates lack of cohesivity, which is likely to translate to good powder handling as well as makes it a promising drug to be administered via inhalation, which is robust to changes in patient characteristics. Future studies will evaluate scaling powder filling to capsules.…”

Section: Discussionmentioning

confidence: 99%

Inhalable Excipient-Free Dry Powder of Tigecycline for the Treatment of Pulmonary Infections

Nair,

Smyth

2023

Mol. Pharmaceutics

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Section: Discussionmentioning

confidence: 99%

Inhalable Excipient-Free Dry Powder of Tigecycline for the Treatment of Pulmonary Infections

Nair,

Smyth

2023

Mol. Pharmaceutics

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“…developed a process from lab scale to pilot scale for low-mass filling using the OMNIDOSE filling technology. The experience gained from this study suggested that the filling performance on lab-scale instruments can provide useful information for formulation development and scale-up Figure provides a schematic for both dosator and vacuum drum fillers.…”

Section: Overview For Modeling Inhalable Dry Powder Filling Processesmentioning

confidence: 99%

“…The experience gained from this study suggested that the filling performance on lab-scale instruments can provide useful information for formulation development and scale-up. 99 Figure 7 provides a schematic for both dosator and vacuum drum fillers. Tamp filling systems, unlike dosator systems, are automated filling devices that require less formulation compaction and are ideal for loading highly potent drugs.…”

Section: Introduction To the Filling Instrumentsmentioning

confidence: 99%

Emerging Process Modeling Capabilities for Dry Powder Operations for Inhaled Formulations

Lou,

Ding,

et al. 2023

Mol. Pharmaceutics

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Dry powder inhaler (DPI) products are commonly formulated as a mixture of micronized drug particles and large carrier particles, with or without additional fine particle excipients, followed by final powder filling into dose containment systems such as capsules, blisters, or reservoirs. DPI product manufacturing consists of a series of unit operations, including particle size reduction, blending, and filling. This review provides an overview of the relevant critical process parameters used for jet milling, highshear blending, and dosator/drum capsule filling operations across commonly utilized instruments. Further, this review describes the recent achievements regarding the application of empirical and mechanistic models, especially discrete element method (DEM) simulation, in DPI process development. Although to date only limited modeling/simulation work has been accomplished, in the authors' perspective, process design and development are destined to be more modeling/simulation driven with the emphasis on evaluating the impact of material attributes/process parameters on process performance. The advancement of computational power is expected to enable modeling/simulation approaches to tackle more complex problems with better accuracy when dealing with real-world DPI process operations.

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“…However, lowdose filling leads to challenges during manufacturing. Modern capsule-filling technologies [173][174][175] take into account these challenges and apply special adjustment to the machines for accurate dosing. For example, high-end continuous dosator machines like the Planeta 100 ( Fig.…”

Section: Low-dose Fillingmentioning

confidence: 99%

An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms

Sacher

Khinast

2016

Methods in Pharmacology and Toxicology

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In this chapter, the main processing steps and manufacturing aspects of solid dosage forms are described and the relevant literature is reviewed. Starting with powder feeding, powder blending, granulation (dry and wet), and drying the most important unit operations to make compactable granules are reviewed. As an alternative to granulation, hot-melt extrusion is introduced, together with the various downstream processing choices. Next, tableting and capsule filling-for making a final dosage form-are discussed, followed by a section on coating. In all sections scale-up methods are reviewed and an outlook for future developments is provided. The last two sections are devoted to process analytical technology (PAT) and continuous manufacturing.

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Low powder mass filling of dry powder inhalation formulations

Abstract: Initial studies suggest that the OMNIDOSE((®)) technology is readily adaptable for the dosing of low masses of DPI excipients and formulations and demonstrate the value of thoroughly evaluating powder performance at laboratory scale prior to pilot scale.

Cited by 16 publications

References 9 publications

Inhalable Excipient-Free Dry Powder of Tigecycline for the Treatment of Pulmonary Infections

Inhalable Excipient-Free Dry Powder of Tigecycline for the Treatment of Pulmonary Infections

Emerging Process Modeling Capabilities for Dry Powder Operations for Inhaled Formulations

An Overview of Pharmaceutical Manufacturing for Solid Dosage Forms

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