Study of the capsule-filling dosator process via calibrated DEM simulations

Madlmeir, Stefan; Loidolt, Peter; Khinast, Johannes G.

doi:10.1016/j.ijpharm.2019.06.032

Cited by 7 publications

(3 citation statements)

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“…105 Madlmeir et al also applied DEM simulations to study the impact of dosator geometry and some other process parameters on the filling performance. 106 Notably, particles are modeled as spheres for this above-mentioned exploratory work. Further simulation studies are recommended in the areas such as (i) validating the feasibility of using a spherical shape to represent real DPI particles or modeling DPI particles using different shapes if needed, (ii) the necessity of considering a DPI carrier/fine particle as an integral particle or discrete particles for the DEM simulation of DPI particle filling processes, (iii) exploring potential events such as agglomeration, adhesion/ deadhesion during the filling process using the DEM simulation, and (iv) developing models for different filling instruments.…”

Section: Modeling and Simulation Formentioning

confidence: 99%

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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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Section: Modeling and Simulation Formentioning

confidence: 99%

“… Madlmeir et al . also applied DEM simulations to study the impact of dosator geometry and some other process parameters on the filling performance . Notably, particles are modeled as spheres for this above-mentioned exploratory work.…”

Section: Overview For Modeling Inhalable Dry Powder Filling Processesmentioning

confidence: 99%

Emerging Process Modeling Capabilities for Dry Powder Operations for Inhaled Formulations

Lou,

Ding,

et al. 2023

Mol. Pharmaceutics

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“…Capsule shells are typically made of gelatin or hypromellose (hard gelatin capsules) and consist of two parts: the body and the cap. After filling the body, the cap is automatically placed on the body, in addition, they are frequently used for powders and in dry powder inhalers for the administration of a medicine [15]. Recently on the market, a larger number of pharmaceutical or cosmetic products with the combination of many herbal extracts [16].…”

Section: Discusionmentioning

confidence: 99%

Manufacture of Hard Gelatin Capsules From a Lyophilisate of the Morus Nigra Fruit

Hernández-González¹,

García-Castañeda²,

Alba-Romero³

et al. 2021

SJMH

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Morus nigra L. (M. nigra L.) belongs to the Moraceae family. Traditional medicine for its physicochemical properties. To evaluate the physicochemical composition and pharmaceutical stability of hard gelatin capsules of the freeze-dried fruit of M. nigra L. The content of total phenols (CFT) and antioxidant capacity (CA) were evaluated by spectrophotometry, the content of ash, moisture, protein, fat and fiber were determined according to their own standard. The CFT and CA were 25.4 mg gallic acid equivalents/g of sample, and 74.1% inhibition, respectively. On the other hand, the values of ash, moisture, protein, fat and fiber were 4.2%, 7.9%, 3.9%, 0.5% and 3.6%, respectively. Lyophilized M. nigra fruit may be a novel candidate for the development of gelatin hard capsules and other new pharmaceutical products.

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Recent quality by design approaches for process optimization and quality enhancement of dry powder inhalers

Jeong,

Choi,

Yoo

et al. 2024

J. Pharm. Investig.

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Study of the capsule-filling dosator process via calibrated DEM simulations

Cited by 7 publications

References 50 publications

Emerging Process Modeling Capabilities for Dry Powder Operations for Inhaled Formulations

Emerging Process Modeling Capabilities for Dry Powder Operations for Inhaled Formulations

Manufacture of Hard Gelatin Capsules From a Lyophilisate of the Morus Nigra Fruit

Recent quality by design approaches for process optimization and quality enhancement of dry powder inhalers

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