Prediction of tablet weight variability in continuous manufacturing

Razavi, Sonia M.; Scicolone, James V.; Snee, Ronald D.; Kumar, Ashish; Bertels, Johny; Cappuyns, Philippe; Assche, Ivo Van; Cuitiño, Alberto M.; Muzzio, Fernando J.

doi:10.1016/j.ijpharm.2019.118727

Cited by 12 publications

(4 citation statements)

References 16 publications

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“…Both materials showed a good flow (1.13 and 1.14 for HR) and very good compressibility (11.93 and 12.38 for IC), but it can be affirmed that the calcium lactate synthetized from mussels displays a better ability for direct compression. The results were not at all predictable, as it is unusual for a powder with a natural origin to have superior compressibility than a material specially processed to fulfill this function [26][27][28][29][30][31].…”

Section: Calcium Lactate Pharmacotechnical Propertiesmentioning

confidence: 97%

Development of Immediate Release Tablets Containing Calcium Lactate Synthetized from Black Sea Mussel Shells

et al. 2022

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Nowadays, the use of marine by-products as precursor materials has gained great interest in the extraction and production of chemical compounds with suitable properties and possible pharmaceutical applications. The present paper presents the development of a new immediate release tablet containing calcium lactate obtained from Black Sea mussel shells. Compared with other calcium salts, calcium lactate has good solubility and bioavailability. In the pharmaceutical preparations, calcium lactate was extensively utilized as a calcium source for preventing and treating calcium deficiencies. The physical and chemical characteristics of synthesized calcium lactate were evaluated using Fourier Transform Infrared Spectroscopy, X-ray diffraction analysis and thermal analysis. Further, the various pharmacotechnical properties of the calcium lactate obtained from mussel shells were determined in comparison with an industrial used direct compressible Calcium lactate DC (PURACAL®). The obtained results suggest that mussel shell by-products are suitable for the development of chemical compounds with potential applications in the pharmaceutical domain.

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Section: Calcium Lactate Pharmacotechnical Propertiesmentioning

confidence: 97%

Development of Immediate Release Tablets Containing Calcium Lactate Synthetized from Black Sea Mussel Shells

et al. 2022

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“…The resulting model and formulation–tablet press-specific optimum process conditions provided a comprehensive overview of the behaviour of direct compression formulations with varying flow behaviour across a range of press types. The modelling approach used advances the conventional QbD approach, where process-related models and desired processing parameters are generally limited to a single tablet press model [ 33 ].…”

Section: Discussionmentioning

confidence: 99%

“…Earlier studies have focused on the effect of feeder design and tablet press control strategy on tablet weight variability and optimise designs to reduce tablet weight variability [ 20 , 33 ]. The objective of this study was not to compare the capability of different tablet press designs but to develop a modelling approach to predict how formulations would behave on tablet presses with standard feeder systems and control strategies employed routinely in an industrial setting.…”

Section: Discussionmentioning

confidence: 99%

Process Model Approach to Predict Tablet Weight Variability for Direct Compression Formulations at Pilot and Production Scale

et al. 2021

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Optimizing processing conditions to achieve a critical quality attribute (CQA) is an integral part of pharmaceutical quality by design (QbD). It identifies combinations of material and processing parameters ensuring that processing conditions achieve a targeted CQA. Optimum processing conditions are formulation and equipment-dependent. Therefore, it is challenging to translate a process design between formulations, pilot-scale and production-scale equipment. In this study, an empirical model was developed to determine optimum processing conditions for direct compression formulations with varying flow properties, across pilot- and production-scale tablet presses. The CQA of interest was tablet weight variability, expressed as percentage relative standard deviation. An experimental design was executed for three model placebo blends with varying flow properties. These blends were compacted on one pilot-scale and two production-scale presses. The process model developed enabled the optimization of processing parameters for each formulation, on each press, with respect to a target tablet weight variability of <1%RSD. The model developed was successfully validated using data for additional placebo and active formulations. Validation formulations were benchmarked to formulations used for model development, employing permeability index values to indicate blend flow.

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“…Process modelling facilitates an understanding of these relationships and enables the identification of the target process parameters that achieve the defined product quality attributes. Process modelling allows the analysis of complex interactions between formulation and process parameters and the generation of process knowledge that can then be applied to assure product quality [1][2][3][4].…”

Section: Introductionmentioning

confidence: 99%

Modelling the Compaction Step of a Platform Direct Compression Process

et al. 2022

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The ability to predict formulation behaviour at production scale during formulation design can reduce the time to market and decrease product development costs. However, it is challenging to extrapolate compaction settings for direct compression formulations between tablet press models during scale-up and transfer from R&D to commercial production. The aim of this study was to develop statistical process models to predict tablet tensile strength, porosity and disintegration time from compaction parameters (pre-compression and main compression force, and press speed), for three formulations, with differing deformation characteristics (plastic, brittle and elastic), on three tablet press models (one pilot-scale tablet press (KG RoTab) and two production-scale presses (Fette 1200i and GEA Modul P)). The deformation characteristics of yield pressure and elastic recovery were determined for the model placebo formulations investigated. To facilitate comparison of dwell time settings between tablet press models, the design of experiments (DoE) approach was 9 individual 16-run response surface DoEs (3 formulation × 3 press models), whose results were combined to create a polynomial regression model for each tablet property. These models predicted tablet tensile strength, porosity and disintegration time and enabled the construction of design spaces to produce tablets with specified target properties, for each formulation on each press. The models were successfully validated. This modelling approach provides an understanding of the compaction behaviour of formulations with varying deformation behaviour on development and commercial tablet press models. This understanding can be applied to inform achievable production rates at a commercial scale, during the formulation development.

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Prediction of tablet weight variability in continuous manufacturing

Cited by 12 publications

References 16 publications

Development of Immediate Release Tablets Containing Calcium Lactate Synthetized from Black Sea Mussel Shells

Development of Immediate Release Tablets Containing Calcium Lactate Synthetized from Black Sea Mussel Shells

Process Model Approach to Predict Tablet Weight Variability for Direct Compression Formulations at Pilot and Production Scale

Modelling the Compaction Step of a Platform Direct Compression Process

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