The Experts below are selected from a list of 72 Experts worldwide ranked by ideXlab platform
George L. Reid - One of the best experts on this subject based on the ideXlab platform.
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Feed-Forward Process Control Strategy for Pharmaceutical Tablet Manufacture Using Latent Variable Modeling and Optimization Technologies
IFAC Proceedings Volumes, 2016Co-Authors: Koji Muteki, Vidya Swaminathan, Sonja S Sekulic, George L. ReidAbstract:Abstract In pharmaceutical Tablet manufacturing processes, a major source of disturbance affecting drug product quality is the (lot to lot) variability of the incoming raw materials. A Feed-Forward process control strategy that compensates for raw material variability is presented. The approach involves building PLS (partial least squares) models that combine raw material attributes and Tablet process parameters and relate these to final Tablet attributes. The resulting models are used in an optimization framework to then find optimal process parameters which can satisfy all the desired requirements for the final Tablet attributes, subject to the incoming raw material lots, prior to performing a batch. The connectivity obtained between the three sources of variability (materials, parameters, attributes) can be considered a design space consistent with Quality by Design (QbD) principles, which is defined by the ICH-Q8 guidance [1]. To implement the FF control, an in-house process simulator is presented. The effectiveness of the methodologies is illustrated through a common industrial Tablet manufacturing case study.
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de risking pharmaceutical Tablet Manufacture through process understanding latent variable modeling and optimization technologies
Aaps Pharmscitech, 2011Co-Authors: Koji Muteki, Vidya Swaminathan, Sonja S Sekulic, George L. ReidAbstract:In pharmaceutical Tablet manufacturing processes, a major source of disturbance affecting drug product quality is the (lot-to-lot) variability of the incoming raw materials. A novel modeling and process optimization strategy that compensates for raw material variability is presented. The approach involves building partial least squares models that combine raw material attributes and Tablet process parameters and relate these to final Tablet attributes. The resulting models are used in an optimization framework to then find optimal process parameters which can satisfy all the desired requirements for the final Tablet attributes, subject to the incoming raw material lots. In order to de-risk the potential (lot-to-lot) variability of raw materials on the drug product quality, the effect of raw material lot variability on the final Tablet attributes was investigated using a raw material database containing a large number of lots. In this way, the raw material variability, optimal process parameter space and Tablet attributes are correlated with each other and offer the opportunity of simulating a variety of changes in silico without actually performing experiments. The connectivity obtained between the three sources of variability (materials, parameters, attributes) can be considered a design space consistent with Quality by Design principles, which is defined by the ICH-Q8 guidance (USDA 2006). The effectiveness of the methodologies is illustrated through a common industrial Tablet manufacturing case study.
Yorinobu Yonezawa - One of the best experts on this subject based on the ideXlab platform.
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pharmaceutical evaluation of multipurpose excipients for direct compressed Tablet Manufacture comparisons of the capabilities of multipurpose excipients with those in general use
Drug Development and Industrial Pharmacy, 1999Co-Authors: Kenta Goto, Hisakazu Sunada, Kazumi Danjo, Yorinobu YonezawaAbstract:Recently, a novel type of multipurpose excipient (MPE) with high binding characteristics and high fluidity has been developed. In this study, the capabilities of MPEs (Ludipress and Microcelac) were compared with those of excipients in general use. Also, the effects on powder and Tableting characteristics of the physical properties and contents of active ingredients were examined in Tablets prepared with these MPEs by the direct compression method. Multipurpose excipients mixed with adjuvants such as fillers, binders, lubricants, disintegrants, and the like show superior fluidity and compressibility. Tablets containing very small amounts of highly active ingredients with little dispersion were prepared. However, with increases in active ingredient content, each of the physical properties was affected strongly by the properties of the active ingredient. Tablets with appropriate hardness and disintegration characteristics could be prepared by mixing of different types of MPEs.
Adrian L Kelly - One of the best experts on this subject based on the ideXlab platform.
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influence of type of granulators on formation of seeded granules
Chemical Engineering Research & Design, 2020Co-Authors: Victoria R Kitching, Neda Rahmanian, Nurul Hanis Jamaluddin, Adrian L KellyAbstract:Abstract It has been shown that seeded granules of calcium carbonate can be produced in commercial batch high shear granulators such as the Cyclomix high-shear impact mixer. Seeded granules are attractive to the pharmaceutical industry due to their high uniformity and good mechanical properties which can assist efficient Tablet Manufacture. In the current study, attempts to produce seeded granules of Durcal 65 and PEG 4000 binder using hot melt granulation are reported, in response to the recent shift towards continuous pharmaceutical manufacturing. Various screw configurations and rotation speeds were investigated in a series of experiments to determine the relationship between process conditions and granule properties. Particle size analysis, strength measurement and structural characterisation were used to quantify granule properties. It was found that using a series of kneading elements arranged at a 60° staggering angle located near to the feed section of the extruder screw generated strong, spherical granules. From structural characterisation approximately 5-15% of extruded granules were found to be seeded. Twin screw melt granulation is therefore considered to be a promising technique for continuous production of seeded granules, although a more detailed investigation is required to optimise yield and quality.
A Lopezgalindo - One of the best experts on this subject based on the ideXlab platform.
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pharmaceutical applications of some spanish clays sepiolite palygorskite bentonite some preformulation studies
Applied Clay Science, 1999Co-Authors: Cesar Viseras, A LopezgalindoAbstract:In this work, a pharmaceutical preformulation study of four Spanish clays (two sepiolites, one palygorskite and one bentonite) is presented, comparing the results obtained with those of three mineral products currently used in pharmaceutical technology. The results showed that the mineralogical and chemical purity of these clays is similar and even higher than that of the three commercial products. The microorganism content is inside the range required for non-sterile pharmaceutical forms. We also determined two parameters concerning the clays' suitability for use in Tablet Manufacture (colour and water content) and one indicating appropriateness as an antidiarrheic product (adsorption capacity of methylene blue). The clays are yellowish white in colour, although correction does not seem necessary; water content varies according to the structure of the clay and storage conditions. Adsorption capacity of methylene blue is affected by the amount of hydration water present, dehydration temperature and the type of interchangeable cation found in the clay.
Koji Muteki - One of the best experts on this subject based on the ideXlab platform.
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Feed-Forward Process Control Strategy for Pharmaceutical Tablet Manufacture Using Latent Variable Modeling and Optimization Technologies
IFAC Proceedings Volumes, 2016Co-Authors: Koji Muteki, Vidya Swaminathan, Sonja S Sekulic, George L. ReidAbstract:Abstract In pharmaceutical Tablet manufacturing processes, a major source of disturbance affecting drug product quality is the (lot to lot) variability of the incoming raw materials. A Feed-Forward process control strategy that compensates for raw material variability is presented. The approach involves building PLS (partial least squares) models that combine raw material attributes and Tablet process parameters and relate these to final Tablet attributes. The resulting models are used in an optimization framework to then find optimal process parameters which can satisfy all the desired requirements for the final Tablet attributes, subject to the incoming raw material lots, prior to performing a batch. The connectivity obtained between the three sources of variability (materials, parameters, attributes) can be considered a design space consistent with Quality by Design (QbD) principles, which is defined by the ICH-Q8 guidance [1]. To implement the FF control, an in-house process simulator is presented. The effectiveness of the methodologies is illustrated through a common industrial Tablet manufacturing case study.
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de risking pharmaceutical Tablet Manufacture through process understanding latent variable modeling and optimization technologies
Aaps Pharmscitech, 2011Co-Authors: Koji Muteki, Vidya Swaminathan, Sonja S Sekulic, George L. ReidAbstract:In pharmaceutical Tablet manufacturing processes, a major source of disturbance affecting drug product quality is the (lot-to-lot) variability of the incoming raw materials. A novel modeling and process optimization strategy that compensates for raw material variability is presented. The approach involves building partial least squares models that combine raw material attributes and Tablet process parameters and relate these to final Tablet attributes. The resulting models are used in an optimization framework to then find optimal process parameters which can satisfy all the desired requirements for the final Tablet attributes, subject to the incoming raw material lots. In order to de-risk the potential (lot-to-lot) variability of raw materials on the drug product quality, the effect of raw material lot variability on the final Tablet attributes was investigated using a raw material database containing a large number of lots. In this way, the raw material variability, optimal process parameter space and Tablet attributes are correlated with each other and offer the opportunity of simulating a variety of changes in silico without actually performing experiments. The connectivity obtained between the three sources of variability (materials, parameters, attributes) can be considered a design space consistent with Quality by Design principles, which is defined by the ICH-Q8 guidance (USDA 2006). The effectiveness of the methodologies is illustrated through a common industrial Tablet manufacturing case study.
