Application of Melt Granulation Technology to Enhance Tabletting Properties of Poorly Compactible High-Dose Drugs

Lakshman, Jay P.; Kowalski, James; Vasanthavada, Madhav; Tong, Wei-Qin; Joshi, Yatindra M.; Serajuddin, Abu T.M.

doi:10.1002/jps.22369

Cited by 86 publications

(63 citation statements)

References 12 publications

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“…36 Moreover, in comparison with the conventional wet granulation process, it proposes several advantages. 31,32,34,37,38 Generally, organic or aqueous solvents are not demanded for the melt granulation process, hence the environmental requirements of organic solvent capture and recycling are eliminated, while the absence of water excludes the wetting and drying phases, making the entire process less energy- and time-consuming. Melt granulation method could be efficiently applied in order to enhance the stability of moisture sensitive drug and further to improve the poor physical properties of the drug substance.…”

Section: Recent Progress In Wet Granulationmentioning

confidence: 99%

Granulation techniques and technologies: recent progresses

2017

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Granulation, the process of particle enlargement by agglomeration technique, is one of the most significant unit operations in the production of pharmaceutical dosage forms, mostly tablets and capsules. Granulation process transforms fine powders into free-flowing, dust-free granules that are easy to compress. Nevertheless, granulation poses numerous challenges due to high quality requirement of the formed granules in terms of content uniformity and physicochemical properties such as granule size, bulk density, porosity, hardness, moisture, compressibility, etc. together with physical and chemical stability of the drug. Granulation process can be divided into two types: wet granulation that utilize a liquid in the process and dry granulation that requires no liquid. The type of process selection requires thorough knowledge of physicochemical properties of the drug, excipients, required flow and release properties, to name a few. Among currently available technologies, spray drying, roller compaction, high shear mixing, and fluid bed granulation are worth of note. Like any other scientific field, pharmaceutical granulation technology also continues to change, and arrival of novel and innovative technologies are inevitable. This review focuses on the recent progress in the granulation techniques and technologies such as pneumatic dry granulation, reverse wet granulation, steam granulation, moisture-activated dry granulation, thermal adhesion granulation, freeze granulation, and foamed binder or foam granulation. This review gives an overview of these with a short description about each development along with its significance and limitations.

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Section: Recent Progress In Wet Granulationmentioning

confidence: 99%

Granulation techniques and technologies: recent progresses

2017

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“…The SNV correction was performed to eliminate the additive baseline offset variations and multiplicative scaling effects due to shadowed regions near a large granule. (2). Segmentation was performed to remove the background pixels from the analysis.…”

Section: Friability Of Granulesmentioning

confidence: 99%

“…However, some pharmaceutical actives are not suitable for wet processing and drying because of stability and degradation problems. Hot melt granulation (HMG) or thermoplastic granulation can be a valuable alternative to process moisture sensitive drugs as it uses a molten binder to agglomerate the pharmaceutical powder particles (1,2). As no liquids or solvents are used, no drying step is needed, reducing the process time and energy consumption.…”

Section: Introductionmentioning

confidence: 99%

The use of Rheology Combined with Differential Scanning Calorimetry to Elucidate the Granulation Mechanism of an Immiscible Formulation During Continuous Twin-Screw Melt Granulation

et al. 2016

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“…Due to the hydrophobic nature of lipids, they can be utilised as lipid matrix systems to produce solid lipid microparticles (SLMs) for sustained drug delivery. Various studies have highlighted the production of SLMs using a variety of techniques, ranging from simple methods such as coacervation, solvent evaporation (Reithmeier et al, 2001a,b;Cortesi et al, 2002) and melt dispersion method (Bodmeier et al, 1992;Giannola et al, 1993;Masters and Domb, 1998;Yener et al, 2003;Sanna et al, 2004), to more equipment-intensive methods, including hot melt extrusion (Vithani et al, 2013), spray drying (Eldem et al, 1991;Killeen, 1996;Brasseur et al, 2000), spray congealing (Akiyama et al, 1993;Rodriguez et al, 1999;Passerini et al, 2002;Savolainen et al, 2002;Passerini et al, 2003;Savolainen et al, 2003) and melt pelletisation (Hamdani et al, 2002;Lakshman et al, 2011). Earlier methods such as coacervation, solvent evaporation and melt dispersion required the use organic solvents, whereas current technologies such as homogenisation and spray drying employ harsh conditions of high pressure and temperature.…”

Section: Introductionmentioning

confidence: 98%

Spray congealing as a microencapsulation technique to develop modified-release ibuprofen solid lipid microparticles: the effect of matrix type, polymeric additives and drug–matrix miscibility

Wong

Heng

Chan

2015

Journal of Microencapsulation

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This study aimed to achieve modified-release of ibuprofen (IBU) by encapsulation within lipid-based matrix materials [cetyl alcohol (CA), stearic acid (SA) and glyceryl dibehenate (GB)] using spray congealing to produce solid lipid microparticles (SLMs). Polymeric additives, polyvinyl-2-pyrrolidone-vinyl-acetate and ethylcellulose, were employed as release-modifying agents. Spray-congealed SLMs yield, scanning electron microscopy (SEM)-based morphology, particle size, drug content and entrapment efficiency were investigated. The influence of matrix type, additive type and concentration and drug-matrix miscibility on release of IBU was elucidated. Yields (81.4-96.4%) and drug encapsulation efficiencies (88.4-100%) of SLMs were high for all formulations. SLMs were generally discrete, spherical and dense. Increasing additives concentration led to not only larger median size SLMs but also faster drug release due to increased hydrophilicity conferred by the additives. Solid solution systems (SA-IBU, GB-IBU) sustained the release of IBU better than solid dispersion system (CA-IBU). CA- and GB-based SLMs closely adhered to the Weibull model of drug release, while SA counterparts followed the Korsmeyer-Peppas model.

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Application of Melt Granulation Technology to Enhance Tabletting Properties of Poorly Compactible High-Dose Drugs

Cited by 86 publications

References 12 publications

Granulation techniques and technologies: recent progresses

Granulation techniques and technologies: recent progresses

The use of Rheology Combined with Differential Scanning Calorimetry to Elucidate the Granulation Mechanism of an Immiscible Formulation During Continuous Twin-Screw Melt Granulation

Spray congealing as a microencapsulation technique to develop modified-release ibuprofen solid lipid microparticles: the effect of matrix type, polymeric additives and drug–matrix miscibility

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