A comprehensive review on process and engineering aspects of pharmaceutical wet granulation

Suresh, Palaniswamy; Sreedhar, I.; Vaidhiswaran, R.; Venugopal, A.

doi:10.1016/j.cej.2017.07.091

Cited by 122 publications

(60 citation statements)

References 340 publications

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“…This is the most widely used method, due to a greater likelihood that the granulation will meet all the physical requirements for the compression of good tablets. The main disadvantages are the number of steps involved and the time necessary to carry out the procedure, especially on a large scale [148].…”

Section: High Shear Wet Granulationmentioning

confidence: 99%

Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps

Jacques

Alexandridis

2019

Applied Sciences

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Oral solid dosage formulations and/or tablets have remained the preferred route of administration by both patients and health care practitioners. Oral tablets are easy to administer, they are non-invasive and cause less risk adversity. Because of the lack of commercially available tablet dose options, tablets are being split or partitioned by users. Tablet scoring refers to the breakage of a tablet to attain a desired efficacy dose and is an emerging concept in the pharmaceutical industry. The primary reason for the tablet scoring practice is to adjust the dose: dose tapering or dose titrating. Other reasons for tablet partitioning are to facilitate dose administration, particularly among the pediatric and the geriatric patient population, and to mitigating the high cost of prescription drugs. The scope of this review is to: (1) evaluate the advantages and inconveniences associated with tablet scoring/portioning, and (2) identify factors in the formulation and the manufacturing of tablets that influence tablet splitting. Whereas tablet partitioning has been a common practice, there is a lack of understanding regarding the fundamentals underpinning the performance of tablets with respect to splitting. Several factors can influence tablet partitioning: tablet size, shape, and thickness. A requirement has recently been set by the European Pharmacopoeia and the U.S. Food and Drug Administration for the uniformity of mass of subdivided tablets. For breaking ease, an in-vivo reference test and a routinely applicable in-vitro test need to be established.

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Section: High Shear Wet Granulationmentioning

confidence: 99%

Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps

Jacques

Alexandridis

2019

Applied Sciences

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“…) with the diameter l i as caracteristic size, the relation v i $ l 3 i can be used to adapt Eqs. (13), (14), and (15).…”

Section: Modeling the Breakage Phenomenamentioning

confidence: 99%

“…The granule final properties are also determined by the interaction of phenomena coexisting in the granulation process simultaneously [1]: physical transformations of the powder particles with relevant kinetic mechanisms (wetting and nucleation, consolidation and growth, and breakage and attrition) and aggregation rate are controlled by operating conditions and feeding material properties [3]. Therefore, for the quantitative analysis of the granulation process, both a careful characterization of the feed-material properties and knowledge of operating parameters and phenomenological aspects are needed [3,13]. Basically, the granulation methods are divided into dry and wet ones.…”

Section: Introductionmentioning

confidence: 99%

Inside the Phenomenological Aspects of Wet Granulation: Role of Process Parameters

Simone¹,

Caccavo²,

Dalmoro³

et al. 2018

Granularity in Materials Science

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Granulation is a size-enlargement process by which small particles are bonded, by means of various techniques, in coherent and stable masses (granules), in which the original particles are still identifiable. In wet granulation processes, the powder particles are aggregated through the use of a liquid phase called binder. The main purposes of sizeenlargement process of a powder or mixture of powders are to improve technological properties and/or to realize suitable forms of commercial products. A modern and rational approach in the production of granular structures with tailored features (in terms of size and size distribution, flowability, mechanical and release properties, etc.) requires a deep understanding of phenomena involved during granules formation. By this knowledge, suitable predictive tools can be developed with the aim to choose right process conditions to be used in developing new formulations by avoiding or reducing costs for new tests. In this chapter, after introductive notes on granulation process, the phenomenological aspects involved in the formation of the granules with respect to the main process parameters are presented by experimental demonstration. Possible mathematical approaches in the granulation process description are also presented and the one involving the population mass balances equations is detailed.

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“…Thus, DEMs tend to be more computationally expensive as compared with PBMs . A comprehensive review on the modeling of granulation processes has been reported in literature . In this work, wet granulation in a batch fluid bed granulator has been modeled using PBM.…”

Section: Introductionmentioning

confidence: 99%

“…Wet granulation and drying is a bottleneck for continuous formulation procedures comprehensive review on the modeling of granulation processes has been reported in literature. 14,15 In this work, wet granulation in a batch fluid bed granulator has been modeled using PBM. A general length-based population balance equation for batch systems that describes the rate of change in the particle diameter number density function n(t,L) is represented as [16][17][18] where n(t,L) ≥ 0 is the number density function in terms of the particle diameter L ∈ ]0, ∞[ with unit 1/m 3 at time t. The term β(t,L,λ) is the length-based aggregation kernel that describes the chance of coalescence of particles with diameters L and λ to form a particle of volume (L 3 + λ 3 ), b(t,L|λ) is the fragments distribution function or the breakage function that describes the frequency of formation of particles of diameter L from the breakup of particles of diameter λ, S(t,L) is the length-based breakage selection rate that is the frequency of breakage of a particle of diameter L into smaller sizes, N(t,L) is the nucleation rate with units (1/m 3 /s), and G(t,L) is the growth rate due to coating/layering with units (m/s).…”

Section: Introductionmentioning

confidence: 99%

Investigation on agglomeration kinetics of acetaminophen using fluidized bed wet granulation

Suresh

Kumar

Surasani

2020

Asia-Pacific J Chem Eng

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Acetaminophen is a well‐known medicine frequently used as analgesic in fever treatment. In pharmaceutical formulation procedure, batch fluidized bed wet granulation is a bottleneck process for the continuous processing of acetaminophen from powder to solid dosage form. To meet the market demand and reduce operating costs, fluid bed wet granulation needs process intensification by converting batch to continuous process. For the scale‐up and batch to continuous conversion procedure, investigation on acetaminophen agglomeration kinetics is necessary. Therefore, this work investigates agglomeration kinetics of acetaminophen through batch fluidized bed wet granulation experiments, and the kinetic parameters are estimated using inverse modeling. Experiments are conducted on a 5‐L capacity pilot scale batch fluidized bed granulator. The effects of various process parameters, namely, binder concentration, spray rate, atomization pressure, and batch size, on particle size distribution are investigated. A 1‐D population balance model with Equi‐Kinetic Energy kernel for agglomeration is simulated to compare with the experimental data. The mean particle diameter increased when binder spray rate and binder concentration are increased and that the mean particle diameter decreased with increase in the atomization pressure and batch size. Experiments data comparison with the model can be used for process intensification with reasonable accuracy.

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A comprehensive review on process and engineering aspects of pharmaceutical wet granulation

Cited by 122 publications

References 340 publications

Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps

Tablet Scoring: Current Practice, Fundamentals, and Knowledge Gaps

Inside the Phenomenological Aspects of Wet Granulation: Role of Process Parameters

Investigation on agglomeration kinetics of acetaminophen using fluidized bed wet granulation

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