Application of Tumbling Melt Granulation (TMG) Method to Prepare Controlled-Release Fine Granules.

Maejima, Toru; Kubo, Makoto; Ôsawa, Takashi; Nakajima, Kingo; Kobayashi, Masao

doi:10.1248/cpb.46.534

Cited by 6 publications

(4 citation statements)

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“…Cooling of the agglomerated powder and the consequent solidification of the molten or soften binder complete the granulation process. 31,32 Low melting binders can be added to the granulation process either in the form of solid particles that melt during the process (melt-in procedure or in situ melt granulation) or in the form of molten liquid, optionally containing the dispersed drug (spray-on or pump-on procedure), which displays a variety of options to design final granular properties. More specifically, the melt-in procedure of melt granulation process includes heating a mixture of drug, binder and other excipients to a temperature within or above the melting range of the binder.…”

Section: Recent Progress In Wet Granulationmentioning

confidence: 99%

“…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%

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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%

Section: Recent Progress In Wet Granulationmentioning

confidence: 99%

Granulation techniques and technologies: recent progresses

2017

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“…HCO was gradually fed on the pre-heated beads, which were subsequently cooled to room temperature to yield the controlled release beads of four different drugs with different solubility, namely, nicotinamide, isoniazid, theophylline, and salicylic acid. [10] In another prior art, the melt granulation technique was evaluated to improve the dissolution properties of a poorly water-soluble drug, griseofulvin. Granules were prepared by melt granulation of the drug with hydrophilic meltable binders and other excipients in a lab-scale high shear mixer.…”

Section: Introductionmentioning

confidence: 99%

Development of Mebeverine HCl Prolonged release Mini-tablets by thermoplastic granulation technique

Ramani¹,

Patel²

2020

Int. J. Pharm. Sci. Drug Res.

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Mebeverine HCl is a BCS class-I drug and thus it possesses high solubility in aqueous media across the biological pH range. The marketed reference product is a multi-unit particulate system (MUPS) containing prolonged release pellets filled in hard gelatin capsule. In conventional manufacturing process, a huge quantity of solvents (aqueous and/or organic) is used to manufacture such dosage form. Additionally, it demands more processing time and efforts. Therefore, a prolonged release capsules dosage form of Mebeverine HCl was formulated using thermoplastic (melt) granulation technique without usage of any solvent. Prolonged release minitablets sized 2 mm in diameter were developed as per quality by design principles. A 23 full-factorial design of experiment was applied to optimize levels of drug release controlling ingredients which includes a hydrophobic meltable binder (hydrogenated castor oil) cum matrixing agent, a hydrophilic meltable binder (polyethylene glycol) which may act as pore former also, and a release controlling polymer (ethyl cellulose). The optimized formulation was found stable. Dissolution profiles of the optimized formulation were found similar to the marketed reference product in different media across the physiological pH range. In conclusion, the explored solvent less process was capable to manufacture the MUPS dosage form of Mebeverine HCl prolonged-release capsules, which is stable and pharmaceutically equivalent with the reference product. The developed process is more beneficial to small and medium scale industry, as it does not require any special and costly equipment, significantly decreases manufacturing cost and increases productivity compared to conventional process, which is mentioned in literature.

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“…Firstly, to evaluate the possibility of finer particle coatings, there are numerous reports of successful finer particle coating using a core particle that is larger than [13][14][15][16][17][18][19] 100 mm. Ichikawa et al succeeded in coating fine cornstarch powder with composite latex using a spouted bed coater equipped with draft tube.…”

Section: Introductionmentioning

confidence: 99%

A novel approach to a fine particle coating using porous spherical silica as core particles

Ishida

Uchiyama

Isaji

et al. 2013

Drug Development and Industrial Pharmacy

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The applicability of porous spherical silica (PSS) was evaluated as core particles for pharmaceutical products by comparing it with commercial core particles such as mannitol (NP-108), sucrose and microcrystalline cellulose spheres. We investigated the physical properties of core particles, such as particle size distribution, flow properties, crushing strength, plastic limit, drying rate, hygroscopic property and aggregation degree. It was found that PSS was a core particle of small particle size, low friability, high water adsorption capacity, rapid drying rate and lower occurrence of particle aggregation, although wettability is a factor to be carefully considered. The aggregation and taste-masking ability using PSS and NP-108 as core particles were evaluated at a fluidized-bed coating process. The functional coating under the excess spray rate shows different aggregation trends and dissolution profiles between PSS and NP-108; thereby, exhibiting the formation of uniform coating under the excess spray rate in the case of PSS. This expands the range of the acceptable spray feed rates to coat fine particles, and indicates the possibility of decreasing the coating time. The results obtained in this study suggested that the core particle, which has a property like that of PSS, was useful in overcoming such disadvantages as large particle size, which feels gritty in oral cavity; particle aggregation; and the long coating time of the particle coating process. These results will enable the practical fine particle coating method by increasing the range of optimum coating conditions and decreasing the coating time in fluidized bed technology.

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Application of Tumbling Melt Granulation (TMG) Method to Prepare Controlled-Release Fine Granules.

Cited by 6 publications

References 1 publication

Granulation techniques and technologies: recent progresses

Granulation techniques and technologies: recent progresses

Development of Mebeverine HCl Prolonged release Mini-tablets by thermoplastic granulation technique

A novel approach to a fine particle coating using porous spherical silica as core particles

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