Recent progress in continuous and semi-continuous processing of solid oral dosage forms: a review

Teżyk, Michał; Milanowski, Bartłomiej; Ernst, Andrzej; Lulek, Janina

doi:10.3109/03639045.2015.1122607

Cited by 65 publications

(32 citation statements)

References 143 publications

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“…The polymer of a decision can be either ethylcellulose or hydroxypropyl cellulose, relying upon the kind of discharge wanted. At long last, the item coasts on the gastric liquid while discharging the drug bit by bit over a drawn-out span [6][7][8] .…”

Section: Fig 1: Classification Of Fddsmentioning

confidence: 99%

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2021

IJPSR

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Section: Fig 1: Classification Of Fddsmentioning

confidence: 99%

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2021

IJPSR

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“…The white paper of the conference follows the previously accepted FDA and International Conference on Harmonization (ICH) guidelines [44][45][46][47] and on that basis, process monitoring and control have been emphasized peculiarly on the conference [43]. Summing up, batch technologies still dominate in the pharmaceutical industry but changing the mindset and opening towards continuous opportunities could denote significant advantages during the production of medicines [48].…”

Section: The Current State Of Continuous Productionmentioning

confidence: 99%

Continuous Formulation Approaches of Amorphous Solid Dispersions: Significance of Powder Flow Properties and Feeding Performance

et al. 2019

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Preparation and formulation of amorphous solid dispersions (ASDs) are becoming more and more popular in the pharmaceutical field because the dissolution of poorly water-soluble drugs can be effectively improved this way, which can lead to increased bioavailability in many cases. During downstream processing of ASDs, technologists need to keep in mind both traditional challenges and the newest trends. In the last decade, the pharmaceutical industry began to display considerable interest in continuous processing, which can be explained with their potential advantages such as smaller footprint, easier scale-up, and more consistent product, better quality and quality assurance. Continuous downstream processing of drug-loaded ASDs opens new ways for automatic operation. Therefore, the formulation of poorly water-soluble drugs may be more effective and safe. However, developments can be challenging due to the poor flowability and feeding properties of ASDs. Consequently, this review pays special attention to these characteristics since the feeding of the components greatly influences the content uniformity in the final dosage form. The main purpose of this paper is to summarize the most important steps of the possible ASD-based continuous downstream processes in order to give a clear overview of current course lines and future perspectives.

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“…The pharmaceutical industry is undergoing a gradual switch from batch to continuous manufacturing caused by multiple drivers, including reduction of cost, improved process efficiency, better control strategies, and lowering the environmental footprint [1][2][3][4][5]. Transition to continuous manufacturing is often based on the same formulation as used for batch processing in order to avoid additional studies [6].…”

Section: Introductionmentioning

confidence: 99%

Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

et al. 2021

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The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable efficient formulation development. Therefore, the current study identified binder attributes affecting the binder effectiveness in a wet granulation process of a highly soluble model excipient (mannitol). For this formulation, higher binder effectiveness was linked to fast activation of the binder properties (i.e., fast binder dissolution kinetics combined with low viscosity attributes and good wetting properties by the binder). As the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate) was previously investigated, this enabled a comprehensive comparison between both formulations in current research focusing on binder selection. This comparison revealed that binder attributes that are important to guide binder selection differ in function of the solubility of the formulation. The identification of critical binder attributes in the current study enables rational and efficient binder selection for twin-screw granulation of well soluble and poorly soluble formulations. Binder addition proved especially valuable for a poorly soluble formulation.

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Recent progress in continuous and semi-continuous processing of solid oral dosage forms: a review

Abstract: A mind-set change is needed to be able to face, and fully assess, the advantages and disadvantages of switching from batch to continuous mode production.

Cited by 65 publications

References 143 publications

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Continuous Formulation Approaches of Amorphous Solid Dispersions: Significance of Powder Flow Properties and Feeding Performance

Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

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