• 대한수의학회지
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• 제35권2호
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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.

• 한국식품영양학회지
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• 제25권4호
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• pp.1027-1032
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• 2012

본 연구에서는 혈액 내에서의 오메가-3 지방산의 함량 변화를 측정하여 연질 캡슐과 장용성 캡슐의 차이를 검토하였다. Fish oil 중의 EPA와 DHA의 총합의 함량이 62.87 g/100 g으로 대부분을 차지하고 있다. 연질 캡슐의 경우, 제 1시험액(위액)에서는 내부의 지방이 70% 용출된 반면, 장용성의 경우 10% 정도만이 용출되었다. 제 2액(소장액)에서도 6시간까지 50% 정도 용출되어 90분에 50%가 용출된 일반 연질 캡슐과 대조적이었다. 기존에 사용하였던 연질 캡슐의 EPA 및 DHA는 흡수 초기에 장용성 캡슐에 비하여 다소 높은 비율을 보인 반면, 8시간 이후 장용성 캡슐 섭취한 경우 EPA와 DHA의 혈액내 함량이 비율이 증가하는 경향을 보였다. 경구 투여 48시간 후 지방산 조성은 장용성 캡슐에서는 mono-, poly-unsaturated fatty acid 혈액 내의 함량이 다소 높은 경향을 보였으며, saturated fatty acid 함량 역시 다소 높은 경향을 보였다. EPA와 DHA의 함량은 혈액 내에서 각 지방 분획에서의 함량 차이를 정확하게 측정하기 힘들었다. 이상의 결과에 의하면 장용성 캡슐은 위장관을 통과하여 장에서 용출되는 특성 때문에 지속적인 효과를 기대할 수 있을 것으로 추정된다.

• 한국임상수의학회지
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• 제11권1호
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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.

• 한국임상약학회지
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• 제11권1호
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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.

• 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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• 제23권1호
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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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• 제37권2호
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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.

• 대한약리학회지
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• 제13권1호
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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.