• Journal of the Korean Applied Science and Technology
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• v.22 no.3
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• pp.234-240
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• 2005

In this study, we have prepared three kinds of enteric tablet coating formulations for prevention the crack incidence and enhanced process improvement of enteric tablet using aqueous system. we determined the mechanical strength of three formulatons on the enteric film-coating process. The compared experiment of one-layer and two-layer (A), (B) coating treated having placebo tablets without breakline and logo. In result, the breaking force time of two-layer (B) film strength was found to increase 0.8min than two-layer (A). We confirmed the half reduction of working hour and the simplification in the one-layer coating process, and the coating troubles was solved as setting up a dehumidifier in inlet of coater. In result, we recovered that optimum running capacity(g/kg) of dehumidifier is 10g/kg and below.

• YAKHAK HOEJI
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• v.5 no.1
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• pp.31-36
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• 1960

The importance of enteric coating technique among the pharmaceutical firms has recently risen very significantly. This study of enteric coating bases was made in order to determine the most suitable bases and dusting powders. Materials and equipment used in this experiment are shown in table 1 and kinds of enteric coating bases and their formulas are shown in table 2. The evaluation of the suitability for enteric coating bases and dusting powder was made by disintergration test after measuring the thickness of the enteric coated layer as shown in the tables 4 and 5. Based on the results of this study, the base D(shellac 20 Gm, anhydrous lanoline 5 Gm, 96% alcohol 75 ml) and the base E (shellac 10 Gm, cetyl alcohol 10 Gm. acetone 80 ml) are selected among the 8 kinds of bases studied in a preliminary test and it was found that Mg-stearate and CA-stearate were in most suitable dusting powders among the 6 kinds studied for the bases D and E. Further study on base D and E was carried out by varying the proportions of the materials which were the original constituents of bases D and E. According to the result of this further study shown in table 6, the shellac 15 Gm cetyl alcohol 5 Gm Acetone 80 ml of base E is recommended as the most suitable dusting powder.

• Journal of the Korean Society of Food Science and Nutrition
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• v.44 no.2
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• pp.260-267
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• 2015

We investigated the applicability of polyethylene glycol (PEG) as a plasticizer in enteric-coated soft capsules based on determination of quality characteristics according to molecular weight and concentration of enteric-coating PEG solution. There was no difference according to molecular weight of PEG, whereas a low PEG concentration in the enteric-coating solution was associated with higher whiteness index and slower disintegration time in pH 6.8 media. Brittleness was observed in the coating film at seam areas in 5% PEG enteric-coating solution after 2 weeks of storage at room temperature. The enteric-coating properties of PEG were compared with those of acetylated monoglyceride (AMG) and triacetin, which are enteric-coating plasticizers. Enteric-coated soft capsule containing PEG as a plasticizer showed a lower whiteness index and faster dissolution profile than AMG and triacetin. Moreover, enteric-coated soft capsule containing AMG and triacetin as plasticizers showed coating film brittleness at seam areas after 2 months of accelerated storage [$40^{\circ}C$, relative humidity (RH) 75%] but no difference at room temperature storage ($25^{\circ}C$, RH 60%). The present study suggests that concentration of PEG is important to determine enteric-coating quality, regardless of the molecular weight of PEG. In conclusion, PEG has potential as a plasticizer due to its transparency and storage stability in enteric-coated soft capsules.

• Journal of Pharmaceutical Investigation
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• v.41 no.4
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• pp.211-215
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• 2011

The aim of this study was to develop a stable enteric coated diclofenac sodium (DFS) tablets using Aqua-Polish E without using a subcoat. DFS uncoated tablets were manufactured through the non direct compression process. AquaPolish E white aqueous coating dispersion was used as enteric coating material. This film forming polymer is a mixture of selected polymethacrylic/ethylacrylate copolymers. The stability of the obtained enteric coated tablets was evaluated according to ICH guidelines. No signs of disintegration or cracking was observed when they placed in 0.1N HCl solution (pH1.2), but they were completely disintegrated within 10 minutes when they placed in buffered solution at pH6.8. Dissolution test was also conducted by placing tablets in 0.1 N HCl for 2 hours and then 1 hour in phosphate buffer at pH 6.8. Less than 0.9 % of drug was released in the acidic phase and up to 97% in the basic medium. These findings suggest that aqueous enteric coating with AquaPolish E system is an easy and economical approach for preparing stable DFS enteric coat without the use of a subcoating layer.

• Korean Journal of Food Science and Technology
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• v.44 no.2
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• pp.168-172
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• 2012

This article presents an evaluation of the effects of coating conditions on the enteric coating quality of soft gelatin capsules containing Omega-3 fatty acids. Three conditions were controlled: concentration of hydroxypropyl methylcellulose phthalate (6, 8, and 10 wt% in solution), temperature of the inlet air (32, 35, and $38^{\circ}C$), and the coating solution feed rate (7.5, 11.25, and 15.0 g/min). The transparency of the enteric coated soft gelatin capsules was evaluated by measuring the degree of whiteness of the surface using a spectrophotometer. Results showed that the most important parameter in the enteric coating process was the coating solution feed rate. As the coating solution feed rate decreased and inlet air temperature increased, the degree of whiteness of coating surfaces decreased. We also evaluated the disintegration properties of the enteric coated capsules in accordance with the Korea Health Functional Food Code.

• KSBB Journal
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• v.32 no.2
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• pp.108-116
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• 2017

Omeprazole, a benzimidazole derivative, suppresses gastric acid secretion by inhibiting $H^+/K^+$ ATPase in gastric parietals cells, and by reducing $H^+$ concentration. To improve stability of esomeprazole magnesium dihydrate (ESMD), enteric-coated preperation was composed of core tablet, subcoating and enteric coating layer. We were evaluated in vitro dissolution characteristics between test and reference ESMD preparation and stability. We could prepare enteric-coated formulation of ESMD by controlling disintegrating agent and coating ratio which could rapidly dissolved in neutral or alkali medium. The formulation D5 with crospovidone of 1.25% and coating ratio of 16.25% had a similar dissolution behavior compare to reference preparation. Difference factor ($f_1$) and similarity factor ($f_2$) were 0~15 and 50~100 and there was no significant difference in bioequivalence between formulations. The content and dissolution rate of formulation D5 were $96.54{\pm}0.21$ and $78.56{\pm}0.87%$ without change of color in accelerated condition ($40^{\circ}C$, RH 75%, high density polyethylene (HDPE) container) for 6 months. This study concluded that our enteric coated preparation of ESMD could be an useful method to improve stability of unstable drug without direct contact with coating material.

• Journal of Pharmaceutical Investigation
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• v.8 no.1
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• pp.27-36
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• 1978

Spherical granules of anti-inflammatory enzyme were prepared by mixer granulation and the recovery rate of enzyme activity by processing was compared with tablet ones. In the enteric granule coating .processing, the effect of the amount of coating solution and the conentration of fatty alcohol on disintegration and stabilities on the accelerated conditions were also studied. Being prepared in non-pressure and non-aqueous condition, spherical granules of enzyme made better recovery of enzme activity than tablet ones by 10 times. Combined processing of both mixer granulation and enteric granule film coating provided the noble enteric coated granules, in the sense of disintegration and stabilities, was obtained from using 0.125% fatty alcohol in coating solution.

• Journal of Pharmaceutical Investigation
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• v.32 no.4
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• pp.277-284
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• 2002

Lansoprazole, pharmaceutics for acid-related diseases, is unstable in low pH environments and generally coated with enteric polymer to obtain gastroresistance in stomach. Because its storage stability is influenced by acidic substitutes of enteric polymer, alkaline chemicals wεre generally addεd to dosage form as a stabilizer. In this experience, we coated lansoprazole bead with sodium alginate and evaluated the effect of bead size and sodium alginate coating on the storage stability and dissolution profile of lansoprazole. Sodium alginate solution containing lansoprazole was sprayed as a droplet into 3% (w/v) $CaCl_2$ solution and the resultant bead was coated with starch, sodium alginate, and hydroxypropyl methylcellulose phthalate. The content of lansoprazole granule not coated with sodium alginate decreased to 57.96% of initial content when stored at a severe condition for 4 weeks, but that of lansoprazole granule coated with sodium alginate before enteric coating decreased little and as the thickness of sodium alginate film increased, the content of bead didn't decreased for 4 weeks. Sodium alginate film also improved the gastroresistance without much influencing the maximum dissolution rate.

• YAKHAK HOEJI
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• v.39 no.6
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• pp.593-599
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• 1995

Erythromycin was formulated as enteric-coated pellets in order to reduce degradation in stomach and gastromtestmal irritation, and to maximize the absorption in intestine followmg its oral administration. Core pellets were prepared using fluid-bed granulator with two different methods (powder layering and solvent spraying) and enteric-coated with two different coating polymers (HPMCP and Eudragit E30D). Physical characteristics md dissolution rates of core pellets and enteric-coated pellets were evaluated to optimize the formulation. Powder layering method resulted in shorter initial dissolution time than solvent spraying method, but physicochmical properties of the product were worse than solvent spraying method with respect to hardness, ftiability and density. The dissolution rate of the drug was increased with the addition of surfactants, showing concentration-dependence. The scanning electron microscopic observation of pellets revealed significant differences on the surface appearances prepared with solvent spraying method. The core pellet made with powder layering method had crystals on the surface, which resulted in poor physical properties of the pellets. The dissolution profiles of erythromycin pellets coated with HPMCP or Eudragit L30D were close to that of commercially available erythromycin enteric-coated product.

• Journal of Pharmaceutical Investigation
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• v.18 no.3
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• pp.161-165
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• 1988