The Effect of the Physical States of Binders on High-Shear Wet Granulation and Granule Properties: A Mechanistic Approach Toward Understanding High-Shear Wet Granulation Process. Part II. Granulation and Granule Properties

Li, Jinjiang; Tao, Li; Dali, Mandar; Buckley, David; Gao, Julia; Hubert, Mario

doi:10.1002/jps.22261

Cited by 26 publications

(30 citation statements)

References 27 publications

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“…In pharmaceutical manufacturing, wet granulation is the most efficient and commonly applied process for improving flow and compressibility of the material, especially when large doses of APIs with poor characteristics are to be processed (18). Processing of atenolol and excipients was carried out by standard wet granulation protocol, consisting of;…”

Section: Processing (Granulation) Of Api and Excipientsmentioning

confidence: 99%

Intrinsic dissolution testing: A tool for determining the effect of processing on dissolution behavior of the drug

Khan¹,

Iqbal²,

Khan³

et al. 2017

Dissolution Technol.

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Intrinsic dissolution testing has been applied for characterization of pure API with respect to its dissolution behavior. The effect of formulation factors and processing parameters on dissolution rate is evaluated by dissolution testing of the final product, which is a time and resource-consuming process. Our objective was to use intrinsic dissolution testing for determining the effect of processing parameters on drug release. In the present study, an intrinsic dissolution testing method was developed for atenolol and validated according to the standard guidelines using USP-recommended dissolution media. Various experimental variables (compaction pressure and rotation speed of the disk) were optimized by studying at three levels. Atenolol was subjected to granulation in a super mixer granulator by applying standard wet granulation protocols. Granulation time and binder concentration were taken as process variables while dissolution rate was a response variable. Dissolution media had no interference with sample analysis, and all validation parameters for the developed method were in an acceptable range (%RSD > 1). The intrinsic dissolution rate of atenolol (1.84 ± 0.13 mg/cm 2 min) was high due to its better solubility in dissolution media. The dissolution rate of atenolol was decreased by granulating with PVP under different conditions. We concluded that intrinsic dissolution testing method can be applied for determining the effect of processing parameters on dissolution rate of the API at the pre-compression level. This method will reduce experimentation for optimization of dissolution rate and will spare time and resources.

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Section: Processing (Granulation) Of Api and Excipientsmentioning

confidence: 99%

Intrinsic dissolution testing: A tool for determining the effect of processing on dissolution behavior of the drug

Khan¹,

Iqbal²,

Khan³

et al. 2017

Dissolution Technol.

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“…As described previously,1,2 high‐shear wet granulation process, in which powder particles are agglomerated to increase their size and density, and to alter their shape, is a key unit operation in pharmaceutical and other industries such as those pertaining to food and fertilizer production 3. Compared with roller compaction, wet granulation process is more tolerable to the variability of physical and mechanical properties of the input materials (e.g., particle size, bulk density, flow, etc.)…”

Section: Introductionmentioning

confidence: 99%

“…In pharmaceutical industry, the current trend is to first blend a polymeric binder with other ingredients in a dry state, followed by addition of a granulating liquid such as water 7. In our previous work, the effect of binder type (composition and/or molecular weight) on the size and the mechanical properties of the granules was investigated 2. It was found that granulation did not occur when a binder remained in its glassy state; it started only when the binder underwent a state change from the glassy to rubbery solution state (G to R‐S) 2.…”

Section: Introductionmentioning

confidence: 99%

“…In our previous work, the effect of binder type (composition and/or molecular weight) on the size and the mechanical properties of the granules was investigated 2. It was found that granulation did not occur when a binder remained in its glassy state; it started only when the binder underwent a state change from the glassy to rubbery solution state (G to R‐S) 2. In addition, the strength of the granules was found to increase with an increase in the molecular weight of the binders used.…”

Section: Introductionmentioning

confidence: 99%

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Effect of Physical States of Binders on High-Shear Wet Granulation and Granule Properties: A Mechanistic Approach Toward Understanding High-Shear wet Granulation Process, Part 3: Effect of Binder Rheological Properties

Tao

Buckley

et al. 2012

Journal of Pharmaceutical Sciences

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“…The accurate modelling of pharmaceutical granulation processes involving a multi-component system correlates with the rate of granule growth, due to a larger availability of surface-wet granules with increased 17 liquid dosage [35,36]. Similarly, granule porosity is an essential parameter having significant effect on 18 granule growth and breakage behaviour, deformability and strength [36].…”

mentioning

confidence: 99%

Model-based analysis of high shear wet granulation from batch to continuous processes in pharmaceutical production – A critical review

Kumar

Gernaey

Beer

et al. 2013

European Journal of Pharmaceutics and Biopharmaceutics

106

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The manufacturing of pharmaceutical dosage forms, which has traditionally been a batch-wise process, is now also transformed into a series of continuous operations. Some operations such as tabletting and milling are already performed in continuous mode, while the adaptation towards a complete continuous production line is still hampered by complex steps such as granulation and drying which are considered to be too inflexible to handle potential product change-overs. Granulation is necessary in order to achieve good flowability properties and better control of drug content uniformity. This paper reviews modelling and supporting measurement tools for the high shear wet granulation (HSWG) process, which is an important granulation technique due to the inherent benefits and the suitability of this unit operation for the desired switch to continuous mode. For gaining improved insight of the complete system, particle-level mechanisms are required to be better understood, and linked with an appropriate meso-or macro-scale model. A brief review has been provided to understand the mechanisms of the granulation process at micro or particle-level such as those involving wetting and nucleation, aggregation, breakage and consolidation. Further, population balance modelling (PBM) and the discrete element method (DEM), which are the current state-of-the-art methods for granulation modelling at micro-to meso-scale, are discussed. The DEM approach has a major role to play in future research as it bridges the gap between micro-and meso-scales. Furthermore, interesting developments in the measurement technologies are discussed with a focus towards inline measurements of the granulation process to obtain experimental data which are required for developing good models. Based on the current state of the developments, the review focuses on the twin screw granulator as a device for * Email address: ingmar.nopens@ugent.be, Tel.: +32 (0)9 264 61 96; fax: +32 (0) continuous HSWG and attempts to critically evaluate the current process. As a result, a set of open research questions are identified. These questions need to be answered in the future in order to fill the knowledge gap that currently exists both at micro-and macro-scale, and which is currently limiting the further development of the process to its full potential in pharmaceutical applications.

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The Effect of the Physical States of Binders on High-Shear Wet Granulation and Granule Properties: A Mechanistic Approach Toward Understanding High-Shear Wet Granulation Process. Part II. Granulation and Granule Properties

Cited by 26 publications

References 27 publications

Intrinsic dissolution testing: A tool for determining the effect of processing on dissolution behavior of the drug

Intrinsic dissolution testing: A tool for determining the effect of processing on dissolution behavior of the drug

Effect of Physical States of Binders on High-Shear Wet Granulation and Granule Properties: A Mechanistic Approach Toward Understanding High-Shear wet Granulation Process, Part 3: Effect of Binder Rheological Properties

Model-based analysis of high shear wet granulation from batch to continuous processes in pharmaceutical production – A critical review

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