An application of the computer optimization technique to wet granulation process involving explosive growth of particles

1997 ◽  
Vol 149 (1) ◽  
pp. 25-36 ◽  
Author(s):  
Yousuke Miyamoto ◽  
Shigeo Ogawa ◽  
Masaharu Miyajima ◽  
Masayuki Matsui ◽  
Hiroshi Sato ◽  
...  
Keyword(s):  
Optimization Technique ◽  
Wet Granulation ◽  
Granulation Process ◽  
Computer Optimization

Formulation and Evaluation of Baclofen Orally Disintegrating Tablets

1970 ◽  
Vol 2 (4) ◽  
pp. 733-738
Author(s):  
Dumpeti Janardhan ◽  
Joginapally Sreekanth ◽  
P.Theja Pavan Kumar ◽  
M.Vamshi Krishna
Keyword(s):  
Pilot Scale ◽  
Taste Masking ◽  
Wet Granulation ◽  
Physical Parameters ◽  
Disintegration Time ◽  
Granulation Process ◽  
Good Taste ◽  
Orally Disintegrating Tablets ◽  
Human Volunteers ◽  
Eudragit Epo

The purpose of this study was to evaluate the potential of polymers for masking the taste of bitter drugs when incorporated into orally disintegrating tablets. The tablets were produced by simple wet granulation technique with a model compound (baclofen) which is moderately bitter. The formulating procedure had two variables to obtain good taste masking with desirable characteristics. The optimal granulation process parameters were polymer selection and its concentration (w/w), suitable for pilot scale level. Dextrates, β- cyclodextrin, eudragit EPO and PVP K-30 were used in preparation of granules by using water and iso-propyl alcohol. Crospovidone was used intra and extra granularly as superdisintegrant.  Sodium bicarbonate and citric acid were used as effervescent for fast disintegration of tablets, which also optionally act as desensitizer of taste buds. Results from evaluation of tablets indicated a disintegration time (avg) of 30-35 sec and 100% drug release was achieved within 5 min. But taste masking was achieved by only with eudragit EPO. Results from an evaluation by a panel of six human volunteers demonstrated that the orally disintegrating tablets which are prepared by using polymer Eudragit EPO (5% and 7.5% w/w of tablet) and PVP (7.5% w/w of tablet) improved taste, significantly. On studying physical parameters, F9 formulation demonstrated acceptable level of hardness and friability with good taste masking and it was thus considered as an optimized formulation

Efficient Global Sensitivity-Based Model Calibration of a High-Shear Wet Granulation Process

2021 ◽  
pp. 116569
Author(s):  
Aaron S. Yeardley ◽  
Stefan Bellinghausen ◽  
Robert Milton ◽  
James D. Litster ◽  
Solomon F. Brown
Keyword(s):  
Model Calibration ◽  
Wet Granulation ◽  
High Shear ◽  
Granulation Process ◽  
Global Sensitivity ◽  
High Shear Wet Granulation

scholarly journals Identifying Critical Binder Attributes to Facilitate Binder Selection for Efficient Formulation Development in a Continuous Twin Screw Wet Granulation Process

Pharmaceutics ◽  
2021 ◽  
Vol 13 (2) ◽  
pp. 210
Author(s):  
Lise Vandevivere ◽  
Maxine Vangampelaere ◽  
Christoph Portier ◽  
Cedrine de Backere ◽  
Olaf Häusler ◽  
...  
Keyword(s):  
Dissolution Kinetics ◽  
Wet Granulation ◽  
Continuous Manufacturing ◽  
Formulation Development ◽  
Granulation Process ◽  
Low Viscosity ◽  
Twin Screw ◽  
Poorly Soluble ◽  
Selection For ◽  
The Impact

The suitability of pharmaceutical binders for continuous twin-screw wet granulation was investigated as the pharmaceutical industry is undergoing a switch from batch to continuous manufacturing. Binder selection for twin-screw wet granulation should rely on a scientific approach to enable efficient formulation development. Therefore, the current study identified binder attributes affecting the binder effectiveness in a wet granulation process of a highly soluble model excipient (mannitol). For this formulation, higher binder effectiveness was linked to fast activation of the binder properties (i.e., fast binder dissolution kinetics combined with low viscosity attributes and good wetting properties by the binder). As the impact of binder attributes on the granulation process of a poorly soluble formulation (dicalcium phosphate) was previously investigated, this enabled a comprehensive comparison between both formulations in current research focusing on binder selection. This comparison revealed that binder attributes that are important to guide binder selection differ in function of the solubility of the formulation. The identification of critical binder attributes in the current study enables rational and efficient binder selection for twin-screw granulation of well soluble and poorly soluble formulations. Binder addition proved especially valuable for a poorly soluble formulation.

scholarly journals Solid Form and Phase Transformation Properties of Fexofenadine Hydrochloride during Wet Granulation Process

Pharmaceutics ◽  
2021 ◽  
Vol 13 (6) ◽  
pp. 802
Author(s):  
Suye Li ◽  
Hengqian Wu ◽  
Yanna Zhao ◽  
Ruiyan Zhang ◽  
Zhengping Wang ◽  
...  
Keyword(s):  
Phase Transition ◽  
Phase Transformation ◽  
Water Content ◽  
Scale Up ◽  
Small Scale ◽  
Dissolution Behavior ◽  
Wet Granulation ◽  
Water Addition ◽  
Granulation Process ◽  
And Performance

The quality control of drug products during manufacturing processes is important, particularly the presence of different polymorphic forms in active pharmaceutical ingredients (APIs) during production, which could affect the performance of the formulated products. The objective of this study was to investigate the phase transformation of fexofenadine hydrochloride (FXD) and its influence on the quality and performance of the drug. Water addition was key controlling factor for the polymorphic conversion from Form I to Form II (hydrate) during the wet granulation process of FXD. Water-induced phase transformation of FXD was studied and quantified with XRD and thermal analysis. When FXD was mixed with water, it rapidly converted to Form II, while the conversion is retarded when FXD is formulated with excipients. In addition, the conversion was totally inhibited when the water content was <15% w/w. The relationship between phase transformation and water content was studied at the small scale, and it was also applicable for the scale-up during wet granulation. The effect of phase transition on the FXD tablet performance was investigated by evaluating granule characterization and dissolution behavior. It was shown that, during the transition, the dissolved FXD acted as a binder to improve the properties of granules, such as density and flowability. However, if the water was over added, it can lead to the incomplete release of the FXD during dissolution. In order to balance the quality attributes and the dissolution of granules, the phase transition of FXD and the water amount added should be controlled during wet granulation.

The Effect of the Wet Granulation Process on Drug Dissolution

1988 ◽  
Vol 14 (10) ◽  
pp. 1327-1349 ◽  
Author(s):  
Hoshang M. Unvala ◽  
Joseph B. Schwartz ◽  
Roger L. Schnaare
Keyword(s):  
Drug Dissolution ◽  
Wet Granulation ◽  
Granulation Process

scholarly journals Hydroxypropylcellulose controlled release tablet matrix prepared by wet granulation: effect of powder properties and polymer composition

2009 ◽  
Vol 52 (1) ◽  
pp. 157-162 ◽  
Author(s):  
Antonio Zenon Antunes Teixeira
Keyword(s):  
Drug Release ◽  
Release Rate ◽  
Hydrophilic Polymers ◽  
Polymer Composition ◽  
Wet Granulation ◽  
Granulation Process ◽  
Powder Properties ◽  
Low Levels ◽  
Tablet Matrix ◽  
Best Fit

The aim of this study was to attain 100% drug release of caffeine after 24 h from hydroxypropylcellulose (HPC) tablet matrices and to investigate the effect of co-excipient. Physical properties of the powders were evaluated and suggested for a wet granulation process. The tablet containing caffeine was formulated by different weight ratios of hydrophilic polymers. The results of polymer evaluation confirmed that the increase of HPC level with the same drug content significantly decreased the rate of drug release. The presence of co-polymer excipients carboxymethylcellulose (CMC) and polyvinylpyrrolidone (PVP) in the tablet matrix was also investigated. The release rate was also controlled by low levels of CMC (<10%) while PVP did not show any considerably effect. The best fit release rate 100% at 24 h was obtained when 10% of α-lactose monohydrate was added to the formulation.

scholarly journals Real-time monitoring of granule properties during high shear wet granulation by near-infrared spectroscopy with a chemometrics approach

RSC Advances ◽  
2017 ◽  
Vol 7 (61) ◽  
pp. 38307-38317 ◽  
Author(s):  
F. Shikata ◽  
S. Kimura ◽  
Y. Hattori ◽  
M. Otsuka
Keyword(s):  
Infrared Spectroscopy ◽  
Real Time ◽  
Near Infrared Spectroscopy ◽  
Near Infrared ◽  
Wet Granulation ◽  
High Shear ◽  
Monitoring Method ◽  
Granulation Process ◽  
High Shear Wet Granulation ◽  
Granule Properties

An in-line near-infrared spectroscopy monitoring method was developed for analyzing granule properties during a high shear wet granulation process.

DESIGN AND EVALUATION OF DOMPERIDONE FAST DISINTEGRATING TABLETS BY WET GRANULATION TECHNIQUES USING PLANTAGO OVATA MUCILAGE

INDIAN DRUGS ◽  
2014 ◽  
Vol 51 (06) ◽  
pp. 49-54
Author(s):  
S M Shahidulla ◽  
◽  
Mohib Khan ◽  
K N Jayaveera
Keyword(s):  
Wet Granulation ◽  
Content Uniformity ◽  
Plantago Ovata ◽  
Short Term ◽  
Granulation Process ◽  
Term Stability ◽  
Drug Content ◽  
Starch Paste ◽  
Fast Disintegrating Tablets

In the present study, fast disintegrating tablets of domperidone were prepared to enhance patient compliance by wet granulation method. In the study, fast disintegrating tablets of the drug using, Plantago ovata mucilage and Crospovidone were used as superdisintegrants (2.5 to 10 % w/w) along with starch paste as a binder. The disintegrant was incorporated during the wet granulation process as an extra granular incorporation. The prepared tablets were evaluated for hardness, friability, drug content uniformity, wetting time, water absorption ratio and in vitro dispersion time. Based on in vitro dispersion time (approximately 12 s), the two formulations were tested for in vitro drug release, short term stability (at 40o /75 % RH for 3 months) and drug excipient interaction (IR spectroscopy). Among the two promising formulations, the formulations prepared by using 10% w/w of Plantago ovata mucilage and 32% w/w of starch paste emerged as the overall best formulation (t50 % 2.90 min) compared to conventional commercial tablets formulations (t50% 7.85 min). Short-term stability studies on the formulations indicated that there are no significant changes in drug content and in vitro dispersion time (p<0.05).

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