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Pharmaceutical tablets are often coated with a layer of polymeric material to protect the drug from environmental degradation, facilitate the packaging process, and enhance patient compliance. However, the detailed effects of such coating layers on drug release are not well understood. To investigate this, flat-faced pure microcrystalline cellulose tablets with a diameter of 13 mm and a thickness between 1.5 mm to 1.6 mm were directly compressed, and a film coating layer with a thickness of 80 μm to 120 μm was applied to one face of these tablets. This tablet geometry and immediate release film coating were chosen as a model system to understand how the film coating interacts with the tablet core. The coating hydration and dissolution process was studied using terahertz pulsed imaging, while optical coherence tomography was used to capture further details on the swelling process of the polymer in the coated tablet. The study investigated the film coating polymer dissolution process and found the gelling of dissolving polymer restricted the capillary liquid transport in the core. These findings can help predict the dissolution of film coating within the typical range of thickness (30 μm to 40 μm) and potentially be extended to understand modified release coating formulations., Competing Interests: Declaration of competing interest The authors declare the following financial interests/personal relationships that may be considered as potential competing interests: M. Ma reports that financial support was provided by CSC. J.A. Zeitler reports equipment, drugs, or supplies was provided by Colorcon Ltd., (Copyright © 2024 The Author(s). Published by Elsevier B.V. All rights reserved.)

Coated tablets introduce complexity to the dissolution process, even with readily soluble immediate release coating layers. Therefore, a more detailed understanding of the physical steps involved in the dissolution process can improve the efficiency of formulation and process design. The current study uses terahertz pulsed imaging to visualise the hydration process of microcrystalline cellulose (MCC) tablet cores that were film coated with an immediate release coating formulation upon exposure to the dissolution medium. Film coated tablets that were prepared from three levels of core porosity (10%, 20% and 30%) and with coating thickness in the range of 30μm to 250μm were investigated. It was possible to resolve and quantify the distinct stages of wetting of the coating layer, swelling of the MCC particles at the core surface, and dissolution of the coating layer followed by the ingress of dissolution media into the tablet core. The liquid transport process through the coating layer was highly consistent and scalable. The penetration rate through the coating layer and the tablet core both strongly depended on coating thickness and core porosity., Competing Interests: Declaration of Competing Interest The authors declare the following financial interests/personal relationships which may be considered as potential competing interests: R. Dong reports financial support was provided by CSC. J.A. Zeitler reports equipment, drugs, or supplies was provided by Colorcon Ltd., (Copyright © 2022 The Authors. Published by Elsevier B.V. All rights reserved.)

Acceptability of medicines is critical for effective pharmacotherapy. The aim of this study was to investigate the oral sensory properties of tablet coatings to determine how mouthfeel can improve acceptability. A randomised double-blind study was performed in 84 adult volunteers (51% ≥55 years). Each participant received 4 placebo tablets (3 coated and 1 uncoated) to evaluate (i) ease of swallowing and (ii) palatability. Visual analogue scales (VAS) were used to capture sensory parameters. Acceptability was assessed using the following parameters: ease of swallowing; amount of water taken with the tablet; rank order of preference; roughness; adhesiveness and slipperiness. Ease of swallowing was determined to be the most sensitive measure of acceptance. The best coating was the one that was reported to be the most slippery and smooth. The presence of a coating improved ease of swallowing, mouthfeel and overall palatability. This study demonstrates that slippery coatings improve acceptability of tablets. The study also demonstrates the value of VAS to measure the sensory attributes of coated tablets., (Copyright © 2019 Elsevier B.V. All rights reserved.)

Ethylcellulose is one of the most commonly used polymers to develop reservoir type extended release multiparticulate dosage forms. For multiparticulate extended release dosage forms, the drug release is typically governed by the properties of the barrier membrane coating. The ICH Pharmaceutical Development Guideline (ICH Q8) requires an understanding of the influence of critical material attributes and critical process parameters on the drug release of a pharmaceutical product. Using this understanding, it is possible to develop robust formulations with consistent drug release characteristics. Critical material attributes for ethylcellulose were evaluated, and polymer molecular weight variation (viscosity) was considered to be the most critical attribute that can impact drug release. To investigate the effect of viscosity variation within the manufacturer's specifications of ethylcellulose, extended release multiparticulate formulations of two model drugs, metoprolol tartrate and acetaminophen, were developed using ETHOCEL™ as the rate controlling polymer. Quality by Design (QbD) samples of ETHOCEL Std. 10, 20, and 100 Premium grades representing the low, medium, and high molecular weight (viscosity) material were organically coated onto drug layered multiparticulates to a 15% weight gain (WG). The drug release was found to be similar (f 2  > 50) for both metoprolol tartrate and acetaminophen multiparticulates at different coating weight gains of ethylcellulose, highlighting consistent and robust drug release performance. The use of ETHOCEL QbD samples also serves as a means to develop multiparticulate dosage formulations according to regulatory guidelines.

This work describes a quality-by-design (QbD) approach to determine the optimal coating process conditions and robust process operating space for an immediate release aqueous film coating system (Opadry® 200). Critical quality attributes (CQAs) or associated performance indicators of the coated tablets were measured while coating process parameters such as percent solids of the coating dispersion, coating spray rate, inlet air temperature, airflow rate and pan speed were varied, using a design of experiment protocol. The optimized process parameters were then confirmed by independent coating trials. Disintegration time of coated tablets was not affected by the coating process conditions used in this study, while tablet appearance, as determined by measurement of tablet color, coating defects and gloss was determined to be a CQA. Tablet gloss increased when low spray rate and low percent solids were used, as well as with increased coating pan speed. The study used QbD principles and experimental design models to provide a basis to identify ranges of coating process conditions which afford acceptable product quality. High productivity, color uniformity, and very low defect levels were obtained with Opadry 200 even when using a broad range of coating process conditions.