Effect of roll compaction on granule size distribution of microcrystalline cellulose–mannitol mixtures: computational intelligence modeling and parametric analysis
نویسندگان
چکیده
Dry granulation using roll compaction is a typical unit operation for producing solid dosage forms in the pharmaceutical industry. Dry granulation is commonly used if the powder mixture is sensitive to heat and moisture and has poor flow properties. The output of roll compaction is compacted ribbons that exhibit different properties based on the adjusted process parameters. These ribbons are then milled into granules and finally compressed into tablets. The properties of the ribbons directly affect the granule size distribution (GSD) and the quality of final products; thus, it is imperative to study the effect of roll compaction process parameters on GSD. The understanding of how the roll compactor process parameters and material properties interact with each other will allow accurate control of the process, leading to the implementation of quality by design practices. Computational intelligence (CI) methods have a great potential for being used within the scope of quality by design approach. The main objective of this study was to show how the computational intelligence techniques can be useful to predict the GSD by using different process conditions of roll compaction and material properties. Different techniques such as multiple linear regression, artificial neural networks, random forest, Cubist and k-nearest neighbors algorithm assisted by sevenfold cross-validation were used to present generalized models for the prediction of GSD based on roll compaction process setting and material properties. The normalized root-mean-squared error and the coefficient of determination (R2) were used for model assessment. The best fit was obtained by Cubist model (normalized root-mean-squared error =3.22%, R2=0.95). Based on the results, it was confirmed that the material properties (true density) followed by compaction force have the most significant effect on GSD.
منابع مشابه
Use of Mercury Porosimetry and Nitrogen Adsorption in Characterisation of the Pore Structure of Mannitol and Microcrystalline Cellulose Powders, Granules and Tablets
USE OF MERCURY POROSIMETRY AND NITROGEN ADSORPTION IN CHARACTERISATION OF THE PORE STRUCTURE OF MANNITOL AND MICROCRYSTALLINE CELLULOSE POWDERS, GRANULES AND TABLETS Sari Westermarck, 2000, University of Helsinki (FIN), pp. 50. ISBN952-91-2534-8 The effects of pretreatment and scanning speed of mercury porosimetry on the mercury porosimetry results of non-hygroscopic mannitol and hygroscopic mi...
متن کاملComputational intelligence models to predict porosity of tablets using minimum features
The effects of different formulations and manufacturing process conditions on the physical properties of a solid dosage form are of importance to the pharmaceutical industry. It is vital to have in-depth understanding of the material properties and governing parameters of its processes in response to different formulations. Understanding the mentioned aspects will allow tighter control of the p...
متن کاملImproved tabletability after a polymorphic transition of delta-mannitol during twin screw granulation.
In most formulations processed via continuous twin screw granulation microcrystalline cellulose (MCC) and/or lactose are used as excipients, but mannitol is also a preferred excipient for wet granulation and tableting due to its non-hygroscopicity and inertness. Therefore, the aim of the current study was to investigate the influence of process parameters on critical quality attributes of granu...
متن کاملInfluence of Tableting on Enzymatic Activity of Papain along with Determination of Its Percolation Threshold with Microcrystalline Cellulose
The binary mixture tablets of papain and microcrystalline cellulose (MCC), dicalcium phosphate dihydrate (DCP), carrageenan, tragacanth, and agar were prepared by direct compression. Carrageenan, tragacanth, and agar provided maximum protection to enzyme activity compared to MCC and DCP. However, stability studies indicated highest loss of enzyme activity with carrageenan, tragacanth, and agar....
متن کاملComparative Study of Different Binders for Roll Compaction/Dry Granulation
H. Mangal , M. Kirsolak , B. Ehlig , P. Kleinebudde 1 1 Heinrich Heine University, 2 Nisso Chemical Europe GmbH Purpose Tablets produced from granules, which were obtained by roll compaction/dry granulation show reduced tensile strength compared to tablets produced by direct compression or after wet granulation. This emphasizes the importance of binders for this application besides their genera...
متن کامل