• 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.

• 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 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 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.

• 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.23 no.1
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• pp.41-49
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• 1993

The bioequivalence of two omeprazole enteric-coated products was evaluated in 16 normal male volunteers (age 26-32 yr, body weight 57-75 kg) following single oral administration. Test product was enteric-coated KD-182 tablet (Chong Kun Dang Corp., Korea) and reference product was $Rosec^{\circledR}$ capsule containing enteric-coated pellets of omeprazole (Yuhan Corp., Korea). Both products contain 20 mg of omeprazole. One tablet or capsule of the test or the reference product was administered to the volunteers, respectively, by randomized two period cross-over study ($2\;{\times}\;2$ Latin square method). Average drug concetrations at each sampling time and pharmacokinetic parameters calculated were not significantly different between two products(p>0.05); the area under the concentrationtime curve to last sampling time (8 hr) $(AUC_{0-8hr})$ $(1946.5{\pm}675.3\;vs\;2018.3{\pm}761.6\;ng{\cdot}hr/ml)$, AUC from time zero to infinite $(AUC_{o-\infty})$ $(2288.6{\pm}1212.8\;vs\;2264.9{\pm}1001.3\;ng{\cdot}hr/ml)$, maximum plasma concentration $(C_{max})$ $(772.5{\pm}283.3\;vs\;925.8{\pm}187.7\;ng/ml)$, time to maximum plasma concentration $(T_{max})$ $(2.38{\pm}1.06\;vs\;2.34{\pm}1.09\;hr)$, apparent elimination rate constant $(k_{\ell})$ $(0.5339{\pm}0.2687\;vs\;0.5769 {\pm}0.2184\;hr^{-I})$, apparent absorption rate constant $(k_a)$ $(1.1536{\pm}0.5278\;vs\;0.9739{\pm}0.9507 hr^{-1})$ and mean residence time (MRT) $(3.13{\pm}0.73\;vs \;3.41{\pm}1.04\;hr)$. The differences of mean $(AUC_{0-8hr})$, $C_{max}$, $T_{max}$ and MRT between the two products (3.69, 19.83, 1.32 and 8.99%, respectively) were less than 20%. The power $(1-{\beta})$ and treatment difference $(\triangle)$ for $AUC_{o-8hr}$ $C_{max}$ and MRT were more than 0.8 and less than 0.2, respectively. Although the power for $T_{max}$ was under 0.8, $T_{max}$ of the two products was not significantly different each other(p>0.05). These results suggest that the bioavailability of KD-182 tablet is not significantly different from that of $Rosec^{\circledR}$ capsule. Therefore, two products are bioequivalent based on the current results.

• Journal of Pharmaceutical Investigation
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• v.37 no.2
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• pp.119-126
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• 2007

Tablet splitting is used in pharmacy practice to adjust the dose to be administered. However, it also causes several problems such as undesirable effect for sustained release or enteric-coated dosage form, inaccuracy of dose, and pharmacist's safety by splitting hazardous drugs. This study investigated the current status of oral dosage form splitting for patients older than 19 years by analyzing Korea National Health Insurance Claims Database. Out of oral solid drugs prescribed (N=1,486,584) 9.8% of them included tablets (or capsules) split. There were some splitting cases even in sustained release (4.9%), enteric-coated forms (1.3%) and hazardous drugs (2.7%) that were selected by NIOSH (The National Institute for Occupational Safety and Health). The most frequently split drugs were antihistamines, neuropsychotics and steroids. In case of digoxin and warfarin, unit doses in a domestic market were not diverse compared to foreign markets. Guidelines for splitting oral solid dosage forms, approval of diverse doses and conducting dose-response studies for the commonly splitting ingredients on Korean people are needed for the saff and effective use of oral solid drugs.

• The Korean Journal of Pharmacology
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• v.13 no.1 s.21
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• pp.1-6
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• 1977

The physicochemical equivalencies of drugs are not usually correlate to the generic equivalencies of drugs and the generic equivalencies of drugs produced by different manufacturers or different formulations are being called in question frequently. The bioabailability of two formulations of oxytetracycline and erythromycin stearate were performed in healthy human volunteers. At the same time, the disintegration testes were performed with randomly sampled materials in question. For the biological evaluation of new oxytetracycline formulation; tablet(250mg), two-way cross over study in 10 healthy young volunteers was performed using oxytetracycline capsule (250mg) as reference, Erythromycin stearate (250mg) tablets and capsules produced by different manufacturers were compared in a two-way cross over study in 12 subjects with same manner of oxytetracyclines. oxytetracycline tablets showed somewhat slow disintegration rate, but appeared not statistical differences in serum concentrations from the reference, up to six hours after ingestion. Erythromycin stearate capsules disintegrated more rapidly than enteric coated tablets. Serum concentrations of capsules were more variable and markedly lower (P<.005 after 2hrs) than the enteric coated tablets. Rapid disintegration of capsules may result in destruction of active chemicals owing to the interaction with gastric acid and the above factor may contribute mainly to the low serum level after ingestion of capsules.