Transfer and scale-up of the manufacturing of orodispersible mini-tablets from a compaction simulator to an industrial rotary tablet press

Lura, Ard; Elezaj, Valentinë; Kokott, Marcel; Fischer, Björn; Breitkreutz, Jörg

doi:10.1016/j.ijpharm.2021.120636

Cited by 10 publications

(3 citation statements)

References 35 publications

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“…The effects of compaction pressure and the use of certain co-processed excipients on the quality profile of ODMTs have been studied several times. Lura et al conducted studies on the capacity of Ludiflash and galenIQ™ (isomalt-based co-processed excipient) to be used for the manufacturing of ODMTs [39], later optimising the process for scaleup from laboratory to industrial scale [40]. From the same research group, Kokott et al proved the capacity of Parteck ODT and Hisorad to be compressed into sturdy ODMTs that disintegrate quickly, both in a compaction simulator and on an industrial-grade tablet press [41].…”

Section: Minitablets (Odmts)mentioning

confidence: 99%

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

et al. 2022

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The paediatric population has always suffered from a lack of medicines tailored to their needs, especially in terms of accurate dosage, stability and acceptability. Orodispersible dosage forms have gone through a resurrection as an alternative to liquid formulations or fractioned solid formulations, although they are still subject to several inconveniences, among which the unpleasant taste and the low oral bioavailability of the API are the most significant hurdles in the way of achieving an optimal drug product. Nanostructures can address these inconveniences through their size and variety, owing to the plethora of materials that can be used in their manufacturing. Through the formation and functionalisation of nanostructures, followed by their inclusion in orodispersible dosage forms, safe, stable and acceptable medicines intended for paediatric use can be developed.

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Section: Minitablets (Odmts)mentioning

confidence: 99%

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

et al. 2022

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“…One of the challenges, speci cally for the pediatric doses of ODTs is the scale-up process. Even with the pre-compressed excipients, the compactibility of the nal formulation after the addition of the drug must be shown in addition to uniformity and dosage homogeneity [20]. To test the mechanical properties and disintegration time, the single-dose ber mats were transformed into a tablet shape using a custom-made tablet compression tool as described above.…”

Section: Tablet Formation From Electrospun Ber Matsmentioning

confidence: 99%

Desloratadine-Loaded Flexible Orally Dissolvable Tablets Made of Electrospun Fiber Mats

Azizoğlu,

Dönder,

İnal

et al. 2023

Preprint

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Patient compliance and personalized dose adjustments are important factors, especially in pediatric care. Orodispersible tablets (ODTs) are gaining importance as they increase patient compliance compared to other solid oral dosage forms. ODTs are solid dosage forms that disintegrate within seconds upon contact with a small amount of liquid. However, the main drawback of the ODTs is their brittle nature which requires special packaging and careful handling and use. In this study, flexible ODTs were fabricated with the electrospinning method. The formulation composed of Kollidon 90F and ethanol was selected for desloratadine-loaded fiber fabrication due to its ease of production and reduced electrospinning time. The single-dose fiber mat fabrication time was adjusted to 2 and 4 minutes to obtain a pediatric dose of 2.5 mg and a 5 mg adult dose, respectively. A 3D-printed tablet compression tool was successfully used to transform the electrospun fibers into ODTs. Fabricated ODTs were compared with commercial desloratadine ODTs and the results showed that they both have similar disintegration times. However, ODTs fabricated from electrospun mats demonstrated a distinct advantage in terms of flexibility, as they did not fracture under applied pressure by a texture profile analyzer. The manufacturing process, along with the utilization of 3D-printed tools, streamlined the production of flexible ODTs and simplified dose adjustments. These advancements hold the potential to facilitate customized therapies for individual patients, thereby enhancing patient compliance, particularly among pediatric populations.

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“…It has been observed that certain powder materials would have different tablet properties, such as tensile strength, when scaling up from the compaction simulator to the rotary tableting machine. 28) Moreover, the feeding system remains a key challenge to be further investigated in the simulation of the rotary tableting machine on a compaction simulator. 29) Therefore, it is essential to quickly rationalize and predict the occurrence of tableting failures during production.…”

Section: Introductionmentioning

confidence: 99%

Development of a Simple In-Die Method for Determination of Capping Tendency in Rotary Tableting Machines

Imayoshi

Ohsaki

Nakamura

et al. 2023

CHEMICAL & PHARMACEUTICAL BULLETIN

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A rotary tableting machine is used for the continuous tableting process. Tableting conditions often result in capping, leading to serious problems during production. Several studies have been conducted to predict the tablet capping tendency. However, as most previous studies were conducted using a compaction simulator, there is a lack of technology that can be readily applied during actual production. Therefore, the present study aimed to develop a novel method for predicting tablet capping in a rotary tableting machine. We hypothesized that capping occurs when residual stress of the tablet inside a die exceeds the critical stress immediately before ejection.Residual stress was evaluated by measuring the in-line die-wall pressure in a rotary tableting machine. Additionally, critical stress was estimated from the tablet strength inside the die using the Rumpf's equation. The critical and residual stresses were compared to determine the capping tendency to some extent. The findings of this study will substantially contribute to the rapid detection of tablet capping during tablet production.

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Transfer and scale-up of the manufacturing of orodispersible mini-tablets from a compaction simulator to an industrial rotary tablet press

Cited by 10 publications

References 35 publications

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

Orally Dispersible Dosage Forms for Paediatric Use: Current Knowledge and Development of Nanostructure-Based Formulations

Desloratadine-Loaded Flexible Orally Dissolvable Tablets Made of Electrospun Fiber Mats

Development of a Simple In-Die Method for Determination of Capping Tendency in Rotary Tableting Machines

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