In situ fluidized hot melt granulation using a novel meltable binder: Effect of formulation variables on granule characteristics and controlled release tablets

Prado, Héctor Juan; Bonelli, Pablo Ricardo; Cukierman, Ana Lea

doi:10.1016/j.powtec.2014.05.058

Cited by 10 publications

(4 citation statements)

References 37 publications

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“…Following particle agglomeration and consolidation, the granules are cooled to room temperature and a solid end product with a granular structure is formed [7][8][9][10]. For this granulation method, the drying step, which is required after wet granulation, is eliminated, hence the process time and energy requirements are significantly reduced.…”

Section: Introductionmentioning

confidence: 99%

Quantitative and qualitative use of thermal analysis for the investigation of the properties of granules during fluid bed melt granulation

Regdon

Korteby

2017

J Therm Anal Calorim

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This study describes a novel approach for the use of thermal analysis to study the aftermath of the fluid bed melt granulation process and to depict the growth mechanism of the granules by quantifying the enthalpies of the granules at every physicochemical change using DSC and their mass loss through TG coupled to MS for a qualitative determination of the composition and amount of the evolved gases for the corresponding fragment ion. The experiments were made in-situ with lactose monohydrate and two viscosity grades of PEG (2000 and 6000) as meltable binders with different contents and size fractions. DSC showed the presence of a beta lactose endotherm peak after the melting of alpha lactose and a proportional increase in its intensity with the increase of the particle size and the content of the binder, which suggested a relation with the agglomeration growth. Interestingly, TG and MS showed a larger reduction in the water content from lactose with the increase in the binder particle size, making it possible to evaluate the dehydration during the melt granulation. Indeed, during the distribution mechanism the low binder particle size and viscosity exposed lactose to a high heat transfer from the fluidizing air. However, a high binder particle size results in lactose immersed in the PEG particles, causing water to be trapped inside the granules and hence a larger reduction in water mass loss indicating the immersion mechanism. Therefore, thermal analysis is a promising tool for granulation growth control.

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Section: Introductionmentioning

confidence: 99%

Quantitative and qualitative use of thermal analysis for the investigation of the properties of granules during fluid bed melt granulation

Regdon

Korteby

2017

J Therm Anal Calorim

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“…The absence of water eliminates the wetting and drying steps, making this process less energy or time consuming. Nevertheless, the use of high temperatures may result in thermal degradation or oxidative instability of formulation components [84,88,89].…”

Section: Wet Granulationmentioning

confidence: 99%

A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing

Arshad

Zafar

Yousef

et al. 2021

Advanced Drug Delivery Reviews

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“…Sa druge strane, supstance sa izrazito niskom temperaturom topljenja mogu dovesti do omekšavanja i lepljenja proizvoda u toku rukovanja i čuvanja. Pregled uobičajeno korišćenih sredstava za vezivanje pri granulaciji topljenjem dat je u Tabeli I. Hidrofilna i amfifilna sredstva za vezivanje se mogu koristiti sa ciljem postizanja trenutnog oslobađanja aktivne supstance i poboljšanja bioraspoloživosti slabo rastvorljivih supstanci (11)(12)(13)(14)(15), dok su hidrofobna sredstva za vezivanje pogodna za formulaciju preparata sa produženim oslobađanjem (16)(17)(18)(19)(20).…”

Section: Vrsta Sredstva Za Vezivanjeunclassified

Melt granulation as an alternative technique in solid dosage forms manufacture

Aleksić¹,

Djuriš²,

Cvijić³

et al. 2015

Arh farmaciju

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Konvencionalne metode granulacije pokazuju brojne nedostatke što je razlog za sve veće interesovanje i ulaganje u razvoj alternativnih metoda. Granulacija topljenjem predstavlja alternativnu metodu koja ima značajan potencijal za primenu u proizvodnji čvrstih farmaceutskih oblika. Podrazumeva primenu vezivnih sredstava koja imaju relativno nisku temperaturu topljenja (50 do 100°C), a čiji rastop omogućava aglomeraciju čestica praška. Kako rastvarač nije potreban, izbegava se faza sušenja, pa su broj procesnih koraka i troškovi smanjeni u odnosu na tradicionalni postupak vlažne granulacije. Postupak je pogodan za aktivne supstance podložne hidrolizi, a izborom odgovarajućeg vezivnog sredstva može se primeniti za izradu preparata sa modifikovanim ili trenutnim oslobađanjem, uz poboljšanje bioraspoloživosti slabo rastvorljivih aktivnih supstanci, kao i u cilju maskiranja gorkog ukusa. Granulacija topljenjem se može izvoditi u uređajima koji se uobičajeno koriste za vlažnu granulaciju, kao što su mikseri/granulatori velike brzine, uređaji tipa fluidizirajućeg sistema, ekstruderi. Brojni faktori formulacije, procesni parametari, kao i faktori vezani za dizajn i vrstu opreme mogu uticati na mehanizam aglomeracije i karakteristike dobijenih granula. Dobro kontrolisan postupak granulacije topljenjem podrazumeva podrobno poznavanje i razumevanje uticaja ovih faktora, zbog čega ova oblast i dalje zahteva intenzivan, a često i multidisciplinarni istraživački rad.

show abstract

In situ fluidized hot melt granulation using a novel meltable binder: Effect of formulation variables on granule characteristics and controlled release tablets

Cited by 10 publications

References 37 publications

Quantitative and qualitative use of thermal analysis for the investigation of the properties of granules during fluid bed melt granulation

Quantitative and qualitative use of thermal analysis for the investigation of the properties of granules during fluid bed melt granulation

A review of emerging technologies enabling improved solid oral dosage form manufacturing and processing

Melt granulation as an alternative technique in solid dosage forms manufacture

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