Continuous direct tablet compression: effects of impeller rotation rate, total feed rate and drug content on the tablet properties and drug release

Järvinen, Maiju; Paaso, Janne; Paavola, Marko; Leiviskä, Kauko; Juuti, Mikko; Muzzio, Fernando J.; Järvinen, Kristiina

doi:10.3109/03639045.2012.738681

Cited by 41 publications

(37 citation statements)

References 16 publications

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“…Among the aforementioned manufacturing routes, direct compression has the advantage of being straightforward and including fewer unit operations than either wet or dry granulation. However, it is also more sensitive to variability in powder properties and may not be ideal for low drug load formulations, products with tight content uniformity constraints or materials with poor flow properties [33][34][35]. Granulation tends to reduce variability in composition and improve the flow properties and compactibility of materials prior to tableting [36,37].…”

Section: Formulation and Manufacturing Routementioning

confidence: 99%

“…It is beyond the scope of this chapter to describe each of these unit operations and the potential sequences in which they may be combined during manufacturing in detail. Further discussion of individual unit operations, the mathematical modeling of these operations, and the development of drug product manufacturing processes in general is provided in the literature [30][31][32][33]. Among the aforementioned manufacturing routes, direct compression has the advantage of being straightforward and including fewer unit operations than either wet or dry granulation.…”

Section: Formulation and Manufacturing Routementioning

confidence: 99%

“…The constraints on the critical quality attributes are shown in Eqs. (33) and (34), for the ribbon thickness and the ribbon density respectively. The bounds given in (35) describe the limitations on the control variables.…”

Section: Case Study: Feasibility Analysis Of a Roller Compaction Processmentioning

confidence: 99%

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Mathematical Tools for the Quantitative Definition of a Design Space

Rogers

Ierapetritou

2016

Methods in Pharmacology and Toxicology

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This chapter focuses on the application of process modeling to determination of design space for pharmaceutical manufacturing processes. The first two sections define design space and related terms from a regulatory perspective and discuss how these apply in practice during pharmaceutical process development. In Sect. 3, a variety of mathematical techniques that can be used to guide design space development are introduced. An emphasis is placed on the use of feasibility analysis and the relationship between process feasibility and design space. Statistical techniques, including latent variable and Bayesian methods, are also discussed in detail. For methods that have been reported in the literature for pharmaceutical manufacturing applications, an overview of the relevant case studies is provided. If methods have not yet been applied to pharmaceutical processes, potential applications for these techniques are indicated. To illustrate the applicability of these concepts to pharmaceutical manufacturing processes, a brief case study is presented in Sect. 4. A discussion of design space verification and issues related to scale-up is provided in Sect. 5. Finally a brief summary of the concepts presented and their potential role in design space development for pharmaceutical processes is given in Sect. 6. This chapter is intended to provide readers with an understanding of mathematical techniques that can be used during process development to assist in the determination of process design space. An overview of the problem formulation and solution approaches for each method are presented. More detailed mathematical developments for each technique are available in the references provided. Table 1 provides a list of symbols that are used throughout this chapter, while Table 2 describes acronyms used within this chapter.

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Section: Formulation and Manufacturing Routementioning

confidence: 99%

Section: Formulation and Manufacturing Routementioning

confidence: 99%

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Mathematical Tools for the Quantitative Definition of a Design Space

Rogers

Ierapetritou

2016

Methods in Pharmacology and Toxicology

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“…Operating parameters of interest for a tablet press include the powder feed rate and the compression force applied to the tablets as well as the rate of tablet production. Tableting speed and powder feed rate are related to tablet weight and weight variability while compression force affects tablet properties like hardness and density [22,76]. The performance of tableting processes can be assessed based on tablet active ingredient content, content uniformity, weight variability, and physical properties such as friability, hardness and dissolution performance.…”

Section: Tablet Press (With Integrated Hopper and Feed Frame)mentioning

confidence: 99%

“…Tablets are among the most common oral solid dosage forms for drugs [22]. The exact manufacturing process for solid dosage forms vary from compound to compound, as the properties of the active pharmaceutical ingredient (API) molecule play a significant role in the development of an appropriate formulation.…”

Section: Process Overviewmentioning

confidence: 99%

Modeling of Particulate Processes for the Continuous Manufacture of Solid-Based Pharmaceutical Dosage Forms

2013

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Abstract:The objective of this work is to present a review of computational tools and models for pharmaceutical processes, specifically those for the continuous manufacture of solid dosage forms. Relevant mathematical methods and simulation techniques are discussed, as is the development of process models for solids-handling unit operations. Continuous processing is of particular interest in the current study because it has the potential to improve the efficiency and robustness of pharmaceutical manufacturing processes.

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Perspectives on the continuous manufacturing of powder‐based pharmaceutical processes

Ierapetritou

Muzzio

Reklaitis³

2016

AIChE Journal

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140

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Continuous direct tablet compression: effects of impeller rotation rate, total feed rate and drug content on the tablet properties and drug release

Abstract: In conclusion, tablets could be successfully prepared by a continuous direct compression process and process conditions affected to some extent tablet properties.

Cited by 41 publications

References 16 publications

Mathematical Tools for the Quantitative Definition of a Design Space

Mathematical Tools for the Quantitative Definition of a Design Space

Modeling of Particulate Processes for the Continuous Manufacture of Solid-Based Pharmaceutical Dosage Forms

Perspectives on the continuous manufacturing of powder‐based pharmaceutical processes

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