The role of the screw profile on granular structure and mixing efficiency of a high-dose hydrophobic drug formulation during twin screw wet granulation

Rahimi, Shahab Kashani; Paul, Shubhajit; Sun, Changquan Calvin; Zhang, Feng

doi:10.1016/j.ijpharm.2019.118958

Cited by 20 publications

(11 citation statements)

References 55 publications

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“…Mixing both increases the overall diffusion of the system and decreases the diffusion layer thickness, increasing the tendency of the drug to dissolve within the molten polymer. 19,20 Conversion to the amorphous state significantly below a composition's melting point has been reported for systems that utilize mixing. Hot stage-polarized light microscopy (HS-PLM) can be used to better understand this phenomenon.…”

Section: Introductionmentioning

confidence: 99%

Selective Laser Sintering 3-Dimensional Printing as a Single Step Process to Prepare Amorphous Solid Dispersion Dosage Forms for Improved Solubility and Dissolution Rate

Davis

Thakkar

et al. 2021

Journal of Pharmaceutical Sciences

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This study reports the development of ritonavir-copovidone amorphous solid dispersions (ASDs) and dosage forms thereof using selective laser sintering (SLS) 3-dimensional (3-D) printing in a single step, circumventing the post-processing steps required in common techniques employed to make ASDs. For this study, different drug loads of ritonavir with copovidone were processed at varying processing conditions to understand the impact, range, and correlation of these parameters for successful ASD formation. Further, ASDs characterized using conventional and advanced solid-state techniques including wide-angle X-ray scattering (WAXS), solid-state nuclear magnetic resonance (ssNMR), revealed the full conversion of the crystalline drug to its amorphous form as a function of laser-assisted selective fusion in a layer-by-layer manner. It was observed that an optimum combination of the powder flow properties, surface temperature, chamber temperature, laser speed, and hatch spacing was crucial for successful ASD formation, any deviations resulted in print failures or only partial amorphous conversion. Moreover, a 21fold increase in solubility was demonstrated by the SLS 3-D printed tablets. The results confirmed that SLS 3-D printing can be used as a single-step platform for creating ASD-based pharmaceutical dosage forms with a solubility advantage.

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Section: Introductionmentioning

confidence: 99%

Selective Laser Sintering 3-Dimensional Printing as a Single Step Process to Prepare Amorphous Solid Dispersion Dosage Forms for Improved Solubility and Dissolution Rate

Davis

Thakkar

et al. 2021

Journal of Pharmaceutical Sciences

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show abstract

“…In conventional pharmaceutical processes, granulation techniques have been utilized to solve these mass transfer issues [23][24][25]. Unfortunately, conventional pharmaceutical granulation methods (wet granulation, dry granulation, melt granulation) are not particularly suitable for the 3D printing techniques under discussion as the produced granules from such processes are 200-400µm in size [26].…”

Section: Introductionmentioning

confidence: 99%

Synergistic application of twin-screw granulation and selective laser sintering 3D printing for the development of pharmaceutical dosage forms with enhanced dissolution rates and physical properties

Thakkar

Zhang

Maniruzzaman

2021

European Journal of Pharmaceutics and Biopharmaceutics

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“…The most commonly used immediate release binders in twin screw wet granulation of drug-loaded formulations are cellulose derivatives such as hydroxypropylmethylcellulose (HPMC) [ 12 , 21 , 57 , 66 ] and hydroxypropylcellulose (HPC) [ 26 , 29 , 67 , 68 , 78 , 79 ] as well as synthetic polymers such as polyvinylpyrrolidone (PVP) [ 14 , 25 , 59 ]. Although cellulosic binders are also commonly used in batch manufacturing, they are not always the most suitable choice for twin screw granulation.…”

Section: Influence Of Raw Materials Propertiesmentioning

confidence: 99%

Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design

Portier

Vervaet

2021

Pharmaceutics

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Continuous twin screw wet granulation is one of the key continuous manufacturing technologies that have gained significant interest in the pharmaceutical industry as well as in academia over the last ten years. Given its considerable advantages compared to wet granulation techniques operated in batch mode such as high shear granulation and fluid bed granulation, several equipment manufacturers have designed their own manufacturing setup. This has led to a steep increase in the research output in this field. However, most studies still focused on a single (often placebo) formulation, hence making it difficult to assess the general validity of the obtained results. Therefore, current review provides an overview of recent progress in the field of continuous twin screw wet granulation, with special focus on the importance of the formulation aspect and raw material properties. It gives practical guidance for novel and more experienced users of this technique and highlights some of the unmet needs that require further research.

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The role of the screw profile on granular structure and mixing efficiency of a high-dose hydrophobic drug formulation during twin screw wet granulation

Cited by 20 publications

References 55 publications

Selective Laser Sintering 3-Dimensional Printing as a Single Step Process to Prepare Amorphous Solid Dispersion Dosage Forms for Improved Solubility and Dissolution Rate

Selective Laser Sintering 3-Dimensional Printing as a Single Step Process to Prepare Amorphous Solid Dispersion Dosage Forms for Improved Solubility and Dissolution Rate

Synergistic application of twin-screw granulation and selective laser sintering 3D printing for the development of pharmaceutical dosage forms with enhanced dissolution rates and physical properties

Continuous Twin Screw Granulation: A Review of Recent Progress and Opportunities in Formulation and Equipment Design

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