Tray Drying of Pharmaceutical Wet Granulations

Carstensen, J.T.; Zoglio, M.A.

doi:10.1002/jps.2600710109

Cited by 9 publications

(2 citation statements)

References 18 publications

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“…Solid dosage forms can also be prepared by spray‐drying method 6,21. The drying methods and drying conditions have a profound effect on the structure and physico‐mechanical properties of the final dosage forms, and thus affect the migration and release of drugs in the dosage forms 22–37…”

Section: Introductionmentioning

confidence: 99%

Drying of poloxamer hydrogel films

Alexandridis

2004

Journal of Pharmaceutical Sciences

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The drying of hydrogel films formed by Poloxamer 407 poly(ethylene oxide)-poly(propylene oxide)-poly(ethylene oxide) amphiphilic block copolymer was investigated at various air relative humidity (RH) conditions ranging from 11 to 97%. Initially, the amount of water lost increased linearly with the drying time. After this linear region (stage I), a nonlinear behavior was observed (stage II). The drying rate increased with decreasing RH, thus greatly shortening the drying time. A decrease of the film thickness also shortened the drying time; however, the drying mechanism did not change. Three models for one-dimensional water diffusion were used to fit the experimental results at different RH conditions and film thicknesses. Model 1 assumes semi-infinite medium and constant diffusion coefficient, and fits very well the data in stage I of the drying process. The fitted water diffusion coefficient (D) is 5 Â 10 À10 m 2 /s, whereas the effects of the RH are captured by a proportionality constant (a) that appears in the boundary condition. Model 2 considers a finite (constant) film thickness and captures the experimental observations over the whole drying period for the same D and a as in Model 1. The analytical solutions available for Models 1 and 2, used together with the experimentally derived model parameters D and a, allow for easy estimation of drying time and water loss from Poloxamer hydrogel films of various compositions and thicknesses and at different relative humidities. Numerical solutions for water diffusion under conditions of decreasing film thickness and diffusion coefficient being a function of concentration are also presented (Model 3). It becomes apparent from the fit of the data to the different models that the drying rate is more sensitive to the boundary condition at the film-air interface (represented by a) than to the diffusion in the film. It is notable that the a values obtained from the fits of the Poloxamer hydrogel drying rate are comparable to those obtained from drying of water films under the same experimental conditions. ß

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Section: Introductionmentioning

confidence: 99%

Drying of poloxamer hydrogel films

Alexandridis

2004

Journal of Pharmaceutical Sciences

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“…Tray drying is a stagnant powder bed method; thus, drying effi ciency is inversely related to bed depth (Carstensen and Zoglio 1982 ) . Tray drying is therefore most applicable to small batch sizes where the powder can be spread thinly over the tray surfaces.…”

Section: Tray Dryingmentioning

confidence: 99%

Spray-Drying Technology

Miller

Gil

2011

Formulating Poorly Water Soluble Drugs

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This chapter provides an in-depth review of spray-drying technology and its application to the formulation of poorly water-soluble drugs. In the early part of the chapter, the fundamentals of the process are discussed, including process theory, process components, equipment options, equipment by scale, various feeds, and typical solvent systems. In the latter part of the chapter, the application of spray drying to the formulation of poorly water-soluble drugs is discussed. Particular emphasis is given to spray drying for amorphous solid dispersion systems. The path toward developing an amorphous spray-dried dispersion and conversion to a fi nal dosage form is covered in detail. Additionally, several academic and industrial examples are presented, illustrating the benefi ts of the process as a formulation technology and its commercial viability. Finally, the application of spray drying to inhalation as well as emerging applications, i.e., spray congealing and micro-encapsulation, are reviewed. This chapter provides comprehensive coverage of the spray-drying process and its uses as a formulation technology toward the enhancement of drug delivery with poorly water-soluble compounds. BackgroundAt its essence, spray drying is a continuous means of extracting dry solids from a fl uid by evaporation of the carrier liquid. By this process, one can start with a solution, suspension, slurry, emulsion, low-viscosity paste, or the like and covert it into a

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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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Tray Drying of Pharmaceutical Wet Granulations

Cited by 9 publications

References 18 publications

Drying of poloxamer hydrogel films

Drying of poloxamer hydrogel films

Spray-Drying Technology

Mathematical Tools for the Quantitative Definition of a Design Space

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