• 한국응용과학기술학회지
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• 제22권3호
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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.

• 약학회지
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• 제5권1호
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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.

• 한국식품영양과학회지
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• 제44권2호
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• pp.260-267
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• 2015

본 연구에서는 장용성 연질캡슐 코팅가소제로서 PEG(polyethylene glycol)의 활용가능성에 대하여 알아보고자 PEG의 분자량 및 첨가 농도에 따른 코팅 품질을 확인하였으며, 기존에 보고된 가소제인 AMG(acetylated monoglyceride)와 triacetin을 사용하여 코팅된 장용성 연질캡슐의 품질 특성을 비교하였다. PEG 분자량(400, 4,000, 6,000)에 따른 코팅 품질에는 큰 차이가 없었으나 PEG 첨가 농도의 경우 고형분 대비 5% PEG를 사용한 코팅에서는 연질캡슐 피막 접착부에서 코팅 필름 갈라짐이 발생하였으며, PEG 첨가량이 낮을수록 인공장액에서의 붕해시간이 연장되고 백색도가 증가하는 결과를 나타내었다. 용출시험에서 용출의 초기 구간(30~90분)에서는 PEG의 용출 속도가 상대적으로 빠른 모습을 나타내었으며, PEG, AMG 및 triacetin 간의 유의적 차이가 일부 시점에서 관찰되었으나 전체적인 용출 양상은 큰 차이를 보이지 않았다. 또한 PEG 코팅에 비해 AMG와 triacetin 코팅의 경우 백색도가 유의적으로 높았고 가속조건인 고온다습한 환경에서 2개월간 보관 후에 코팅 필름이 갈라졌으며, 붕해시험에서 부적합한 결과를 확인하였다. 결론적으로 우수한 물리 화학적 특성으로 의약품 등에 널리 사용되는 첨가제인 PEG는 장용성 연질캡슐 코팅 가소제로서 활용가능성이 충분하다고 판단하였다.

• Journal of Pharmaceutical Investigation
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• 제41권4호
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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.

• 한국식품과학회지
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• 제44권2호
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• pp.168-172
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• 2012

본 연구는 프탈산히드록시메틸셀룰로오스를 장용성 기제로 이용하여 오메가-3 지방산이 충진된 연질캡슐을 코팅조건에 따른 연질캡슐의 표면에 미치는 영향을 살펴보고자 하였다. HPMCP 농도, 코팅분사 액량 및 흡기 온도를 변화시켜 장용코팅 시 캡슐표면의 백색도를 측정 비교한 결과, 코팅분사 액량이 감소할수록 흡기 온도가 증가할수록 백색도가 감소하는 것을 알 수 있었다. 그리고 붕해시험으로 코팅 후 캡슐이 장용 특성을 가지는 것을 확인할 수 있었다. 주사전자현미경으로 미세구조를 관찰한 결과, 피막에 균일하게 HPMCP가 코팅이 된 것을 알 수 있었다. 이와 같이 HPMCP를 이용하여 오메가-3 연질캡슐의 장용코팅 효과를 확인할 수 있었으며, 투명도가 높은 코팅표면을 얻을 수 있는 코팅 조건을 확인할 수 있었다.

• KSBB Journal
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• 제32권2호
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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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• 제8권1호
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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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• 제32권4호
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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.

• 약학회지
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• 제39권6호
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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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• 제18권3호
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• pp.161-165
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• 1988