Bead Manufacture by Extrusion/spheronization – a Statistical Design for Process Optimization

Ku, Cathy C.; Joshi, Yatindra M.; Bergum, James; Jain, N.B.

doi:10.3109/03639049309069323

Cited by 26 publications

(13 citation statements)

References 9 publications

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“…In the area of bead production, Ku et al (1993), Krogars et al (2000) and Agrawal et al (2004) applied a response surface technique to elucidate the roles of multiple formulation and process variables and their effects on the bead properties. For this approach, a central composite design provides an efficient choice as it differentiates between interactive and other effects and minimises confidence intervals, compared to factorial designs and therefore, numerous examples of application can be found in literature (Mamatha et al 2008;Kaur et al 2009;Colla et al 2009;Sguarezi et al 2009;Ko et al 2009;Shankar et al 2009;Vardenega et al 2009).…”

Section: Choice Of Experimental Design and Data Analysis Methodsmentioning

confidence: 99%

“…Bead shape and size distribution also influence the reproducibility and control of subsequent film coating processes (Baert et al 1993;Ku et al 1993;Sparks et al 1999). Maronga (1998), Sudsakorn and Turton (2000) and Chan et al (2006) reported that when a batch of polydispersed particles were coated in a fluidized bed system, the coating was not equally deposited on all particles, and the variation in the coating amount received was a strong function of the particle diameter.…”

Section: Microencapsulation and Extrusion-spheronisationmentioning

confidence: 97%

“…The process involves four steps: (a) preparation of the wet mass (granulation); (b) shaping the wet mass into cylinders (extrusion); (c) breaking up the extrudate and rounding of the particles into spheres (spheronisation) and finally (d) drying (Vervaet et al 1995). Because all these stages are strongly related to each other (Baert et al 1993;Ku et al 1993;Newton et al 1995;Sousa et al 2002;Agrawal et al 2004;Liew et al 2007), the quality of the beads obtained is also strongly dependent on the process factors. Furthermore, the operating conditions may vary with the different starting materials (Ku et al 1993;Heng and Koo 2001;Sousa et al 2002;Agrawal et al 2004;Sinha et al 2007).…”

Section: Microencapsulation and Extrusion-spheronisationmentioning

confidence: 98%

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An Analysis of the Influence of Multiple Processing Factors on the Characteristics of Bioactive-Loaded Beads Prepared by Extrusion–Spheronisation

Kuang

Oliveira

Crean

2009

Food Bioprocess Technol

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The objective of this study was to determine optimum extrusion-spheronisation parameters for producing bioactive-loaded beads with maximum consistency. The Taguchi method for robust engineering design was applied, using an L 9 orthogonal array (fractional factorial design). The processing parameters analysed were spheronising speed, time and the amount of granulating liquid. The potential importance of some interactive effects was assessed by applying a response surface analysis to the data. The amount of granulating liquid, spheronising speed and the interaction between these two parameters were found to have a statistically significant influence on the size, with the amount of granulating liquid being the most dominant factor. The diameter of beads increased with the amount of granulating liquid and consequently, reduced the yield in the desired range (600-1,180 µm). The roundness of the beads was strongly influenced by the spheronising time. The beads became rounder with increasing spheronising time, up to a limit when the effect was observed to level off. Similar optimum conditions were indicated by a response surface method and the Taguchi method: low amount of granulating liquid (50%, w/w) and extrudates spheronised at the highest speed (1,800 rpm) for 15 min. However, the predicted response values using the Taguchi method were physically more acceptable: yield in the desired size range of 98.83%, D 50 of 662 µm and roundness of 0.82.

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Section: Choice Of Experimental Design and Data Analysis Methodsmentioning

confidence: 99%

Section: Microencapsulation and Extrusion-spheronisationmentioning

confidence: 97%

Section: Microencapsulation and Extrusion-spheronisationmentioning

confidence: 98%

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An Analysis of the Influence of Multiple Processing Factors on the Characteristics of Bioactive-Loaded Beads Prepared by Extrusion–Spheronisation

Kuang

Oliveira

Crean

2009

Food Bioprocess Technol

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“…O aumento do diâmetro médio de pellets foi observado por O'Connor et al (1984) e Wan et al (1993) enquanto que Bianchini et al (1992) observaram a produção de pellets mais homogêneos em termos de uma distribuição do tamanho dos pellets mais estreita. No entanto, o tempo de esferonização pode influenciar na obtenção de uma fração de tamanho de pellets específi-ca (Malinowski, Smith, 1975;Chariot et al, 1987;Hasznos et al, 1992;Baert et al, 1993a;Ku et al, 1993;Umprayn et al, 1999).…”

Section: Placa Velocidade Tempo E Carga De Esferonizaçãounclassified

Obtenção de pellets por extrusão e esferonização farmacêutica: parte I. avaliação das variáveis tecnológicas e de formulação

Santos¹,

Veiga²,

Pina³

et al. 2004

Rev. Bras. Cienc. Farm.

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INTRODUÇÃOA administração oral de uma forma farmacêutica é a via mais usual, confortável e conveniente para a liberação de uma substância ativa no organismo.Dentre as diversas formas farmacêutica para a via oral em que os sistemas de liberação de uma substância ativa podem ser concebidos, os pellets têm despertado crescente interesse devido às diversas vantagens tecnológicas e terapêuticas apresentadas (Reynolds, 1970;Bechgaard, Hegermann Nielsen, 1978;Eskilson 1985;Dietrich, 1989). Salientam-se as suas ótimas propriedades de escoamento, devido, principalmente, à forma esférica, estreita distribuição de tamanho de partículas, superfície suscetível ao revestimento por película com interesse à proteção entérica ou à liberação controlada ou sustentada, incorporação de grande quantidade de substância ativa e de substâncias ativas incompatíveis numa mesma forma farmacêutica, grande dispersão no trato gastrintestinal e conseqüente redução da irritação do trato por fármacos gastro-irritantes e baixo risco de efeitos adversos por superdosagem.O processo de produção de pellets, denominado peletização, consiste na aglomeração de pós finos de substância ativa e excipientes em pequenas unidades esféricas, assim denominadas pellets. Estas unidades esféricas diferenciam-se do produto obtido no processo de granulação clássica não apenas no que respeita ao processo pelo qual são produzidas, mas também pelas características físicas apresentadas.O interesse pela utilização de pellets como forma farmacêutica remonta à segunda metade da década de 1940. Em 1952, a Smith Kline & French (SKF) lançou no mercado uma nova forma farmacêutica, o Spansule, que consistia em cápsulas cheias com pellets revestidos que dissolveriam a tempos diferentes. Os pellets eram produzidos por revestimento em camadas a partir de núcleos de açúcar por uma técnica até então não empregada na in-*Correspondência:

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“…13). 31 reported the use of microwave oven in the final phase of the production process of pellets to evaporate the slurry of the extruded mass during drying process. Huyghebaert et al, 2005 32 reported the use of freeze dryer in order to maintain viability of living bacterial spores.…”

Section: B) Wet Massingmentioning

confidence: 99%

Untitled

2011

IJPSR

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Pelletization process first came into existence way back during the 1950s, when the first product was introduced to the market. These pelletized dosage forms have gained popularity considerably from then because of their distinct advantages, such as ease of capsule filling because of better flow properties of the perfectly spherical pellets; enhancement of drug dissolution; ease of coating; sustained, controlled, or site-specific delivery of the drug from coated pellets; uniform packing; even distribution in the GI tract; and less GI irritation. Pelletized dosage forms can be prepared by a number of techniques, including drug layering on nonpareil sugar or microcrystalline cellulose beads, spray drying, spray congealing, roto granulation, hot-melt extrusion, and spheronization of low melting materials or extrusion-spheronization of a wet mass. The present review outlines the recent findings on the manufacturing and evaluation of spherical pellets. The techniques namely extrusion-spheronization, hot melt extrusion, freeze pelletization, cryopelletization have been discussed along with formulation requirements for the process, parameters affecting pelletization. Evaluation of quality of the pellets is discussed with reference to the size distribution, shape, surface morphology, specific surface area, friability, tensile strength.

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Bead Manufacture by Extrusion/spheronization – a Statistical Design for Process Optimization

Cited by 26 publications

References 9 publications

An Analysis of the Influence of Multiple Processing Factors on the Characteristics of Bioactive-Loaded Beads Prepared by Extrusion–Spheronisation

An Analysis of the Influence of Multiple Processing Factors on the Characteristics of Bioactive-Loaded Beads Prepared by Extrusion–Spheronisation

Obtenção de pellets por extrusão e esferonização farmacêutica: parte I. avaliação das variáveis tecnológicas e de formulação

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