• Journal of Veterinary Clinics
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• v.11 no.1
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• pp.377-381
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• 1994

This study was performed to investigate the usefulness of the radiopaque material as a disintegration test of enteric coated capsules radiologically. The results obtained were as follows; 1. The times that the enteric coated capsules passed the pylorus(GI transition times) were the first 150 minute and the last 390 minutes. Therefore, the GI transition times largely differ from each animal and each enteric coated capsule. 2. The disintegration times of enteric coated capsules were similar in vitro test and in vitro test. 3. The disintegration test of enteric coated capsules using Barium sulfate, radiopaque material for the gastrointestinal track, was useful to check the time pass through the pylorus and the time enteric coated capsules were disintegration.

• Korean Journal of Veterinary Research
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• v.35 no.2
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• pp.391-398
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• 1995

This study was carried to investigate the usefulness of the radiopaque material as the GI transition and disintegration test of enteric coated capsules radiologically. The obtained results were as follows; 1. The GI transition times that the enteric coated capsules pass through the pylorus were that the time of the first capsule was 210 minutes and the time of the last capsules was more than 300 minutes. Therefore, the GI transition times largely differ from each animal and each enteric coated capsule. 2. The disintegration times of enteric coated capsules were similar in vitro test and in vivo test. 3. The GI transition and disintegration test of enteric coated capsules using barium sulfate, radiopaque material for the gastrointestinal track, was useful to investigate the times that the capsules passed through the pylorus and disintegrated in intestinal track.

• 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.22 no.4
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• pp.281-287
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• 1992

Omeprazole (OMZ) is very unstable in acidic solution, which selectively inhibit the release of the gastric juice in the gastric mucosa, In order to stabilize (OMZ) in oral solid dosage form, the enteric-coated microcapsules and compression-coated OMZ tablets containing lysine or arginine as stabilizer were prepared and their dissolution and stability test were performed. The haif life of OMZ microcapsules containing arginine was 194 days at $30^{\circ}C$ and OMZ was completely released in 60 min. The half-lives of enteric coated and non-coated compression-coated OMZ tablets with lysine were 292 and 95 days at $30^{\circ}C$, respectively. The half-lives of enteric coated and non-coated compression-coated tablets with arginine were 1752 and 293 days at $30^{\circ}C$, respectively, and OMZ were released completely in 20 min in the 2nd fluid of K.P.VI. Consequently, the enteric-coated compression-coated OMZ tablets with arginine as stabilizer provided a good formulation for oral solid dosage form.

• Korean Journal of Clinical Pharmacy
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• v.11 no.1
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• pp.13-18
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• 2001

Omeprazole is usually administered as encapsulated enteric-coated granules and enteric-coated tablets because of its acid-labile nature. For children and patients who can not swallow, it can be mixed with water or other liquid after a capsule is opened or a tablet is crushed. This study was performed to compare omeprazole liquid formulations of tablet and capsule Omeprazole 20 mg capsule containing enteric coated granules was opened and 20 mg entric-coated tablet was ground to be mixed with sodium bicarbonate solution, orange juice or water. Each liquid formulation was poured into dissolution tester, mixed with first solution (artificial gastric juice; pH 1.2) for two hours, then with second solution (artifical enteric juice; pH 6.8) for thirty minutes. pH was measured periodically for two and half hours. Samples were drawn periodically, mixed with lansoprazole as an internal standard, and injected to HPLC. As results, pH of sodium bicarbonate solution of omeprazole was significantly higher than that of orange juice or water in first solution (6.2-7.4 vs. 1.2, p<0.005). At 150 min, concentrations of omeprazole in three diluents with granules and in sodium bicarbonate solution of tablet powder sustained significantly higher than in other solution of tablet powder (p<0.001). In conclusion, enteric-coated granules from capsule with three diluents and powder from tablet in sodium bicarbonate solution was stable during dissolution test, which would be appropriate and recommended for patient who can not swallow solid preparations.

• The Korean Journal of Food And Nutrition
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• v.25 no.4
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• pp.1027-1032
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• 2012

We investigate the changes of fatty acids in blood for an evaluation of the effects of soft and enteric coated capsules containing omega 3 fatty acids. Fish oil, which contained 62.87 g/100 g of sum of EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), was used as nutracueticals for omega 3 fatty acids. Lipid releasing amount in soft capsule was 70% in stomach condition. However, there was 10% of releasing amount of lipid observed in enteric coated capsule in stomach condition. In intestinal condition, 50% of lipid releasing amount in enteric coated capsule showed until 6 hr, but soft capsule until 90 min. EPA and DHA contents in soft capsule administration showed higher level than those in enteric coated capsule until 8 hr. However, the administration of enteric coated capsule showed higher level of EPA and DHA in blood after 8 hr. After 24 hr, mono-, poly-unsaturated and saturated fatty acids contents with enteric coated capsule showed higher level than those with soft capsule. The enteric coated capsule containing omega 3 fatty acids was expected to sustain omega 3 fatty acids.

• 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.

• Korean Journal of Clinical Pharmacy
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• v.21 no.4
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• pp.347-352
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• 2011

Health insurance review & Assessment service (HIRA) has enforced cutting the drug costs when physicians prescribe split extended release drugs, starting from December, 2010. The objective of this study is to analyze extended release and enteric coated drugs on pharmaceutical reimbursement list in Korea, and to investigate the impact and barriers of the health insurance review on splitting extended-release formulation drugs. By using the ingredient code, extended release and enteric coated formulations make up 7.8% of all drugs in April, 2011. The most frequently used drugs are agent affecting circulatory and digestive system. From the extended release and enteric coated formulations (n=112), 34.8% (n=39) were not available in other dosage forms. According to questionnaire survey for 169 pharmacists (response rate: 73.8%), the rate of splitting and crushing of extended release and enteric coated drugs decreased. When pharmacists correct physician's prescription errors, the biggest problem was lack of other dosage forms. So it is necessary to develop variety of other dosage forms, and computerized checking system for splitting extended-release drugs. It is also important to inform physicians and patients in regard to the problems of split prescription of extended release and enteric coated drugs.

• 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.

• Journal of Pharmaceutical Investigation
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• v.34 no.6
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• pp.471-475
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• 2004

Tamsulosin has been frequently used for the treatment of benign prostatic hyperplasia. To avoid dose-dependent side effects of tamsulosin upon oral administration, the development of sustained-release delivery system is required, that can maintain therapeutic drug levels for a longer period of time. The aim of this study was therefore to formulate sustained-release tamsulosin matrix tablets and assess their formulation variables. We designed enteric coated sustained-release tamsulosin matrices to fulfill above statement. Aqueous microchannels in the enteric film need to be formed in order to obtain tamsulosin release even in an acidic environment such as gastric region. In the sustained-release tamsulosin matrix, low viscosity hydroxypropylmethylcellulose was used as a rate controller. Povidone K30 was also added to the matrices to facilitate water uptake so that a decrease in the release rate of tamsulosin as time elapses was prevented, possibly leading to pseudo zero-order release of the drug. The matrices were enteric-coated with hydroxypropylmethylcellulose phthalate (HPMCP), along with povidone K30 as an aqueous microchannel former. With the aqueous microchannels formed within the enteric film, tamsulosin could be released in an acidic condition. The release of tamsulosin decreased with increasing thickness of HPMCP membrane while the release rates of tamsulosin from those having different HPMCP thickness in pH 7.2 aqueous media were not considerably different, indicating that the enteric film was promptly dissolved at pH 7.2. These results clearly suggest that the sustained-release oral delivery system for tamsulosin could be designed with satisfying drug release profile approved by the KFDA.