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Prediction of quality attributes (mechanical strength, disintegration behavior and drug release) of tablets on the basis of characteristics of granules prepared by high shear wet granulation.
PLoS One. 2021; 16(12):e0261051.Plos

Abstract

High shear wet granulation is commonly applied technique for commercial manufacturing of tablets. Granulation process for tablets manufacturing is generally optimized by hit and trial which involves preparation of granules under different processing parameters, compression of granules and evaluation of the resultant tablets; and adjustment is made in granulation process on the basis of characteristics of tablets. Objective of the study was to optimize the process of high shear wet granulation and prediction of characteristics of tablets on the basis of properties of granules. Atenolol granules were prepared by high shear wet granulation method, using aqueous solution of polyvinyl pyrrolidone (PVP k-30) as binder. Concentration of binder solution and granulation time were taken as process variables, both studied at three levels. Different combinations of process variables were determined by Design Expert software. Granules were evaluated for different parameters on the basis of SeDeM-ODT (Sediment Delivery Model-Oro Dispersible Tablets) expert system. Granules from all the trials were compressed using round (10.5 mm) flat faced punches at compression weight of 250 mg/tablet. Tablets were evaluated of different quality control parameters as per USP. Results showed that both the process variables had positive effect on mechanical strength of tablets and negative effect on disintegration and dissolution rate. Granule prepared with highest level of binder concentration (15%) and highest granulation time (60 sec) resulted in tablets with highest crushing strength (11.8 kg), specific crushing strength (0.328 kg/mm2), tensile strength (0.208 kg/mm2), lowest value of friability (0.19%) and highest disintegration time (10.9 min), as predicted from granules characteristics on the basis of SeDeM-ODT expert system. Drug release from Trial-13 (processed under highest level of both process parameters) was also lower than rest of the trials. It is concluded from the study that quality characteristics of tablets can be predicted from granules characteristics using SeDeM-ODT expert system. Furthermore, SeDeM-ODT expert system can also be used for optimization of the process of high shear wet granulation.

Authors+Show Affiliations

Department of Pharmacy, Kohat University of Science and Technology (KUST), Kohat, Pakistan.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

34882723

Citation

Khan, Amjad. "Prediction of Quality Attributes (mechanical Strength, Disintegration Behavior and Drug Release) of Tablets On the Basis of Characteristics of Granules Prepared By High Shear Wet Granulation." PloS One, vol. 16, no. 12, 2021, pp. e0261051.
Khan A. Prediction of quality attributes (mechanical strength, disintegration behavior and drug release) of tablets on the basis of characteristics of granules prepared by high shear wet granulation. PLoS One. 2021;16(12):e0261051.
Khan, A. (2021). Prediction of quality attributes (mechanical strength, disintegration behavior and drug release) of tablets on the basis of characteristics of granules prepared by high shear wet granulation. PloS One, 16(12), e0261051. https://doi.org/10.1371/journal.pone.0261051
Khan A. Prediction of Quality Attributes (mechanical Strength, Disintegration Behavior and Drug Release) of Tablets On the Basis of Characteristics of Granules Prepared By High Shear Wet Granulation. PLoS One. 2021;16(12):e0261051. PubMed PMID: 34882723.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Prediction of quality attributes (mechanical strength, disintegration behavior and drug release) of tablets on the basis of characteristics of granules prepared by high shear wet granulation. A1 - Khan,Amjad, Y1 - 2021/12/09/ PY - 2021/09/25/received PY - 2021/11/24/accepted PY - 2021/12/9/entrez PY - 2021/12/10/pubmed PY - 2022/1/8/medline SP - e0261051 EP - e0261051 JF - PloS one JO - PLoS One VL - 16 IS - 12 N2 - High shear wet granulation is commonly applied technique for commercial manufacturing of tablets. Granulation process for tablets manufacturing is generally optimized by hit and trial which involves preparation of granules under different processing parameters, compression of granules and evaluation of the resultant tablets; and adjustment is made in granulation process on the basis of characteristics of tablets. Objective of the study was to optimize the process of high shear wet granulation and prediction of characteristics of tablets on the basis of properties of granules. Atenolol granules were prepared by high shear wet granulation method, using aqueous solution of polyvinyl pyrrolidone (PVP k-30) as binder. Concentration of binder solution and granulation time were taken as process variables, both studied at three levels. Different combinations of process variables were determined by Design Expert software. Granules were evaluated for different parameters on the basis of SeDeM-ODT (Sediment Delivery Model-Oro Dispersible Tablets) expert system. Granules from all the trials were compressed using round (10.5 mm) flat faced punches at compression weight of 250 mg/tablet. Tablets were evaluated of different quality control parameters as per USP. Results showed that both the process variables had positive effect on mechanical strength of tablets and negative effect on disintegration and dissolution rate. Granule prepared with highest level of binder concentration (15%) and highest granulation time (60 sec) resulted in tablets with highest crushing strength (11.8 kg), specific crushing strength (0.328 kg/mm2), tensile strength (0.208 kg/mm2), lowest value of friability (0.19%) and highest disintegration time (10.9 min), as predicted from granules characteristics on the basis of SeDeM-ODT expert system. Drug release from Trial-13 (processed under highest level of both process parameters) was also lower than rest of the trials. It is concluded from the study that quality characteristics of tablets can be predicted from granules characteristics using SeDeM-ODT expert system. Furthermore, SeDeM-ODT expert system can also be used for optimization of the process of high shear wet granulation. SN - 1932-6203 UR - https://www.unboundmedicine.com/medline/citation/34882723/Prediction_of_quality_attributes__mechanical_strength_disintegration_behavior_and_drug_release__of_tablets_on_the_basis_of_characteristics_of_granules_prepared_by_high_shear_wet_granulation_ L2 - https://dx.plos.org/10.1371/journal.pone.0261051 DB - PRIME DP - Unbound Medicine ER -