Step-wise approach to developing a scale-independent design space for functional tablet coating process

Debevec, Veronika; Ljubin, Tijana Stanić; Jeraj, Žiga; Peterka, Tanja Rozman; Bratuž, Borut; Gašperlin, Dušan; Srčič, Stanko; Horvat, Matej

doi:10.1080/03639045.2020.1742140

Cited by 3 publications

(6 citation statements)

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“…It has also been used as an emulsifier in the formulation of drug loaded micro sponges [44]. In solid dosage forms PVA is used in coating formulations for tablets as a film forming polymer [45]. In this study our aim was to characterize the erosion of water-soluble PVAbased 3D printed systems with particle size analysis of colloidal PVA particles which appeared during in vitro mimicked dissolution conditions.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Biodegradable PVA-Based 3D Printed Carriers during Dissolution

et al. 2021

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The presence of additive manufacturing, especially 3D printing, has the potential to revolutionize pharmaceutical manufacturing owing to the distinctive capabilities of personalized pharmaceutical manufacturing. This study’s aim was to examine the behavior of commonly used polyvinyl alcohol (PVA) under in vitro dissolution conditions. Polylactic acid (PLA) was also used as a comparator. The carriers were designed and fabricated using computer-aided design (CAD). After printing the containers, the behavior of PVA under in vitro simulated biorelevant conditions was monitored by gravimetry and dynamic light scattering (DLS) methods. The results show that in all the dissolution media PVA carriers were dissolved; the particle size was under 300 nm. However, the dissolution rate was different in various dissolution media. In addition to studying the PVA, as drug delivery carriers, the kinetics of drug release were investigated. These dissolution test results accompanied with UV spectrophotometry tracking indirectly determine the possibilities for modifying the output of quality by computer design.

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Section: Introductionmentioning

confidence: 99%

Evaluation of Biodegradable PVA-Based 3D Printed Carriers during Dissolution

et al. 2021

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“…The extent of spray drying is greatly influenced by the amount of smaller droplets present. In the case of coating with API, spray drying can result in a lower assay, whereas in the case of enteric coating, an inadequate drug-release profile can be a consequence of ineffective membranes [7,15,43,44]. The potential for spray drying is greater in the case of organic solvents, which are frequently used in the case of pellet coatings, as compared to aqueous-based dispersions [43,44].…”

Section: Discussionmentioning

confidence: 99%

“…Droplet characteristics impact the uniformity of the barrier membrane thickness as well as the agglomeration tendency [10,14]. Among other parameters, such as product temperature, droplet size is a crucial scale-independent coating process parameter [13,[15][16][17]. If droplet size is kept constant, one of the scale-up impacts is omitted, and, consequently, a reproducible scale-up of the coating process is made possible [12].…”

Section: Introductionmentioning

confidence: 99%

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Development of a Semi-Empirical Model for Droplet Size Determination of a Three-Channel Spray Nozzle for Pellet Coating Based on the Optical Method Concept

Vidovič

Bizjak²,

Sitar

et al. 2022

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The purpose of this study was to investigate the droplet size obtained with a three-channel spray nozzle typically used in fluid bed devices and to construct a semi-empirical model for prediction of droplet size. With the aid of a custom-made optical method concept, the impact of the type of polymer and solvents used through dispersion properties (viscosity, density, and surface tension), dispersion flow rate, atomization pressure, and microclimate pressure on droplet size was investigated. A semi-empirical model with adequate predictability for calculating the average droplet size (R2 = 0.90, Q2 = 0.73) and its distribution (R2 = 0.84, Q2 = 0.61) was constructed by employing dimensional analysis and design of experiments. Newtonian and non-Newtonian dispersion and process parameters on laboratory and on production scale were included, thereby enabling constant droplet size irrespective of the scale. Based on the model results, it would be possible to scale-up the atomization process (e.g., coating process) from laboratory to production scale in a systematic fashion, regardless of the type of solvent or polymer used. For the system investigated, this can be performed by understanding the dispersion properties, such as viscosity, density, and surface tension, as well as the following process parameters: dispersion flow rate, atomization, and microclimate pressure.

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“…The smaller FBPs and CPNs are using for the pilot plant, experimental, and developmental operations, while the larger FBPs 21, 22, and CPNs for industrial and commercial production batches 14,23,24 .…”

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confidence: 99%

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2022

IJPSR

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The presentation of this work aims to update readers on issues associated with coating pan (CPN), having applicability in the pharmaceutical field. The coating process (CPR) is an important pharmaceutical unit operation that finds pertinence in various product areas extending from conventional (immediate) release to modified release. The CPR involves the substrate coating by spraying the coating material in liquid medium onto them, kept in motion using either CPN or fluid bed processor (FBP). The FBP is used preferably for coating of multi-particulates and powders and rarely for tablets, while CPNs are used for coating tablets and capsules, thus are in extensive use. Conventional CPNs and perforated coating pan (PPN) are the major categories of the CPNs. The PPNs are preferred for the products that call for improved drying efficiency where the drying efficiency of the drying air (DA) is highest. The perforated pan system (PPNSY) is used in the coating system based on the aqueous solvent, with preference to that based on the volatile organic solvent (VOS). Comprehensive reviews on the technical aspect of CPNs are rare, necessitating this work. Thereupon the information was studied, summarised, and attempted to be presented for convenience and enrichment of the readers. The contained information will be updating pharmaceutical professionals in this regard. INTRODUCTION:Coating is a process in which a dry outer layer of coat is applied over a substrate (commonly solid particle or dosage form) to provide certain benefits over uncoated form, that range from protecting products (from environmental factors such as air, light, temperature, gastric acid 1, 2 , moisture 2 , to simplify production 3, 4 , product identification 4 , 5 ,

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Step-wise approach to developing a scale-independent design space for functional tablet coating process

Abstract: Supplemental Discussion 2. Genetic algorithms for selection of scale-dependent parameters .... Supplemental Discussion 3. Calibration of the model for product temperature .

Cited by 3 publications

References 28 publications

Evaluation of Biodegradable PVA-Based 3D Printed Carriers during Dissolution

Evaluation of Biodegradable PVA-Based 3D Printed Carriers during Dissolution

Development of a Semi-Empirical Model for Droplet Size Determination of a Three-Channel Spray Nozzle for Pellet Coating Based on the Optical Method Concept

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