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Article

A Hybrid Model to Predict Formulation Dependent Granule Growth in a Bi-Component Wet Granulation Process

Department of Chemical and Biochemical Engineering, Rutgers, The State University of New Jersey, Piscataway, NJ 08854, USA
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Academic Editor: Colin Hare
Pharmaceutics 2021, 13(12), 2063; https://doi.org/10.3390/pharmaceutics13122063
Received: 17 October 2021 / Revised: 18 November 2021 / Accepted: 25 November 2021 / Published: 2 December 2021
(This article belongs to the Special Issue Recent Advances in Secondary Processing of Pharmaceutical Powders)
In this study, a hybrid modeling framework was developed for predicting size distribution and content uniformity of granules in a bi-component wet granulation system with components of differing hydrophobicities. Two bi-component formulations, (1) ibuprofen-USP and micro-crystalline cellulose and (2) micronized acetaminophen and micro-crystalline cellulose, were used in this study. First, a random forest method was used for predicting the probability of nucleation mechanism (immersion and solid spread), depending upon the formulation hydrophobicity. The predicted nucleation mechanism probability is used to determine the aggregation rate as well as the initial particle distribution in the population balance model. The aggregation process was modeled as Type-I: Sticking aggregation and Type-II: Deformation driven aggregation. In Type-I, the capillary force dominant aggregation mechanism is represented by the particles sticking together without deformation. In the case of Type-II, the particle deformation causes an increase in the contact area, representing a viscous force dominant aggregation mechanism. The choice between Type-I and II aggregation is determined based on the difference in nucleation mechanism that is predicted using the random forest method. The model was optimized and validated using the granule content uniformity data and size distribution data obtained from the experimental studies. The proposed framework predicted content non-uniform behavior for formulations that favored immersion nucleation and uniform behavior for formulations that favored solid-spreading nucleation. View Full-Text
Keywords: wet granulation; multicomponent; population balance model; content uniformity wet granulation; multicomponent; population balance model; content uniformity
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MDPI and ACS Style

Muthancheri, I.; Ramachandran, R. A Hybrid Model to Predict Formulation Dependent Granule Growth in a Bi-Component Wet Granulation Process. Pharmaceutics 2021, 13, 2063. https://doi.org/10.3390/pharmaceutics13122063

AMA Style

Muthancheri I, Ramachandran R. A Hybrid Model to Predict Formulation Dependent Granule Growth in a Bi-Component Wet Granulation Process. Pharmaceutics. 2021; 13(12):2063. https://doi.org/10.3390/pharmaceutics13122063

Chicago/Turabian Style

Muthancheri, Indu, and Rohit Ramachandran. 2021. "A Hybrid Model to Predict Formulation Dependent Granule Growth in a Bi-Component Wet Granulation Process" Pharmaceutics 13, no. 12: 2063. https://doi.org/10.3390/pharmaceutics13122063

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