An innovative wax-based enteric coating for pharmaceutical and nutraceutical oral products

Habashy, Rober; Khoder, Mouhamad; Zhang, Sitong; Pereira, Beatriz C.; Bohus, Marton; Wang, Julie; Isreb, Abdullah; Alhnan, Mohamed Albed

doi:10.1016/j.ijpharm.2020.119935

Cited by 12 publications

(9 citation statements)

References 28 publications

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“…In addition to failing to construct the gastro-resistant barrier, F1 delayed and/or slowed drugs' release in intestinal medium (Supplementary Figure S1). In our recently published study, alginate emulsion-based coatings (corresponding to F2 formulation in Table 1) were able to provide excellent gastro-resistant properties (at pH 1.2) and instant release upon pH increase in SIF [4]. Similarly, alginate and cellulosederivative-based coatings were able to resist gastric pH 1.2 [2].…”

Section: Resultsmentioning

confidence: 85%

“…Table 1 describes the formulations of different coating layers. While F1 is a ceresin wax-based monolayer coating obtained by drum coater, F2 is a single coating made of O/W wax-Alg emulsion, using GMS as emulsifier and a Strea-1 fluidised bed coating (GEA Pharma Systems AG, Aeromatic-Fielder, Bubendorf, Switzerland) to achieve a 10% coating weight gain as previously detailed [4]. Both F3 and F4 are bilayer coatings, and F1 coating was added either as a sub-coat (SC) or an overcoat (OC) to F2 Alg-based coating, respectively.…”

Section: Coated Tabletsmentioning

confidence: 99%

“…However, it suffers from major batch-to-batch variations and a slowed drug release upon storage [2]. Several products such as Protect TM and Swanlac ® were marketed based on ammoniated shellac with the addition of alginate to regulate shellac dissolution in the intestinal phase [4]. However, such strategies proved to have limited success due to a slow dissolution particularly at pH 6.8 [2].…”

Section: Introductionmentioning

confidence: 99%

“…However, shellac-based systems showed slow responses at pH 7.4 in both phosphate and bicarbonate buffers [11]. In addition, alginate-based coatings such as Nutrateric ® and Aquateric ® failed to provide sufficient protection at elevated pHs (fed state) [4,12]. More recently, methacrylate-based coating to provide enteric production was introduced by Evonik under Eudraguard Control ® and Biotic ® .…”

Section: Introductionmentioning

confidence: 99%

“…We have previously reported the use of fatty glycerides dispersion in aqueous alginate solution to provide a pH-dependent release profile [10]. More recently, an O/W emulsion of waxes in alginate solution was developed to boost the gastric-resistant properties of the coated films [4]. The reported coating showed a significant pH-responsive enteric coating in comparison to commercially available synthetic and semi-synthetic coating solutions.…”

Section: Introductionmentioning

confidence: 99%

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A Novel Multilayer Natural Coating for Fed-State Gastric Protection

et al. 2022

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Several nutraceutical products require gastric protection against the hostile environment in the stomach. Currently marketed synthetic and semi-synthetic coatings suffer from major shortcomings such as poor gastric protection, slow-release response to pH change, and the use of artificial ingredients. The challenge of coating natural products is further exacerbated by the relatively high gastric pH in the fed state. In this work, a novel natural enteric coating is presented as a breakthrough alternative to current solutions. Two coating systems were devised: (i) a triple-layer coating that comprises a wax layer embedded between two alginate-based coatings, and (ii) a double-layer coating, where an overcoat of organic acids (fumaric or citric acid) is applied to an alginate-based coating. The multi-layer architecture did not impact the pH-responsive nature of the coating even when more biologically relevant Krebs bicarbonate buffer of lower buffer capacity was used. Interestingly, the gastric protection barrier of organic acid-based coating remained resistant at elevated gastric pH 2, 3, or 4 for 2 h. This is the first report of using an alginate-based coating to provide gastric protection against fed-state stomach conditions (pH 2–4). Being biodegradable, naturally occurring, and with no limit on daily intake, the reported novel coating provides a superior platform to current coating solutions for pharmaceutical and nutraceutical products.

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Section: Resultsmentioning

confidence: 85%

Section: Coated Tabletsmentioning

confidence: 99%