• 약학회지
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• 제55권4호
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• pp.324-331
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• 2011

Although the dissolution test can serve as an effective tool for quality control and predictor of in vivo performance, there are a number of drugs with no established dissolution specifications in Korean Pharmaceutical Codex (KPC). Among those commercially available, Piracetam Tablets and Fenoterol hydrobromide Tablets were selected to develop the dissolution testing method. The dissolution condition was determined based on the "Guidelines on Specifications of Dissolution tests for Oral dosage forms" of Korea Food & Drug Administration (KFDA). The dissolution test for Piracetam Tablets was carried out under sink condition with distilled water as dissolution medium, paddle rotation speed at 50 rpm and medium volume of 900 ml. More than 80% of its label claim was released within 30 min. In case of Fenoterol hydrobromide Tablets, distilled water was also found to be suitable to ensure sink condition. The rotation speed of 50 rpm and 900 ml of dissolution medium were used to evaluate the dissolution profile. The dissolution rate of fenoterol hydrobromide was over 90% in 15 min. The HPLC analysis methods were validated in terms of accuracy, precision, specificity, linearity, quantitation limit and range. The results suggested that the analytical methods used are simple and suitable to measure the dissolution rate of piracetam and fenoterol hydrobromide. Therefore, the analysis methods could be utilized in setting dissolution specifications of Piracetam Tablets and Fenoterol hydrobromide Tablets in the revised version of KPC.

• 약학회지
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• 제55권5호
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• pp.411-418
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• 2011

The dissolution test method and an analytical procedure by HPLC were developed and validated for nafronyl oxalate capsules and tramadol hydrochloride capsules. These drugs were not yet characterized by the dissolution specifications in the Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for nafronyl oxalate capsules was carried out under sink conditions as follows: dissolution medium phosphate buffer pH 6.8, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 80% of its label amount was released within 30 min in this method. Also the dissolution test for tramadol hydrochloride capsules was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 15 min in this method. The dissolution samples were analyzed with a validated HPLC analytical procedure. The analytical methodology showed acceptable values in terms of specificity, linearity, precision and accuracy. The dissolution test methods described above were adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of nafronyl oxalate capsules and tramadol hydrochloride capsules. Furthermore, the outcomes of this study were expected to help create an environment where safe and high quality drugs would be distributed on the domestic market making contributions to advancing public health.

• 약학회지
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• 제55권2호
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• pp.131-137
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• 2011

The dissolution test method and an analytical procedure by HPLC were developed and validated for dobesilate calcium tablets and acepifylline tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for dobesilate calcium tablets was carried out under sink conditions as following: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for acepifylline tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of dobesilate calcium tablets and acepifylline tablets.

• 방사성폐기물학회지
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• 제3권4호
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• pp.335-340
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• 2005

Single-pass flow-through (SPFW) 방법에 의한 유리고화체의 용해율 측정에서 정밀도를 구하기 위하여 연구소간 실험프로그램의 하나로서 붕규산유리고화체의 정용해율을 구하였는데, 이 SPFT 방법은 American Society for Testing and Materials (ASTM)에서 표준화를 위하여 작성되었다. 이를 위해 100/200 mesh 크기의 모의 저방사능 유리고화체 분말시료를 $70^{\circ}C$, 알곤 분위기에서 SPFT 방법으로 리튬 완충용액 (pH=10)을 이용하여 용해실험을 시도하였다. 얻어진 용출액 중 규소와 붕소의 농도에 따라 용해율의 변화를 구한 결과, 유리의 정용해율이 $2.7\times10^{-5}g{\cdot}m^{-2}{\cdot}s^-1$ 부근으로 나타났다.

• 약학회지
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• 제54권5호
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• pp.348-353
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• 2010

The dissolution test method and an analytical procedure by HPLC were developed and validated for viquidil hydrochloride capsules and alibendol tablets. These drugs were not yet characterized by the dissolution specifications in Korean Pharmaceutical Codex. So, with each reference and test drugs, we did the preliminary and standard experiments based on the Korean Pharmacopeia Guideline of dissolution testing for solid oral dosage forms. The dissolution test for viquidil hydrochloride capsules was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 50 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 30 min in this method. Also the dissolution test for alibendol tablets was carried out under sink conditions as follows: dissolution medium water, paddle rotation speed 100 rpm and vessel volume 900 ml. More than 90% of its label amount was released within 45 min in this method. The dissolution samples were analyzed with a precise and accurate HPLC method. The developed dissolution test showed specificity, linearity, precision and accuracy within the acceptable range. The dissolution testing method described above was adequate for the purpose and may be proposed as a pharmacopeial standard to assess the performance of viquidil hydrochloride capsules and alibendol tablets.

• Journal of Pharmaceutical Investigation
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• 제32권4호
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• pp.321-325
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• 2002

IVIVC (In vitro/in vivo correlation) is useful for predicting in vivo results from in vitro data. The aim of this study was to develop IVIVC of sustained release diltiazem. For this purpose, three types of diltiazem tablets with different in vitro dissolution rates were prepared. An in vitro dissolution testing method comprising of paddle apparatus, 50 rpm, water as dissolution medium was developed. Under these condition, we demonstrated that AUCinf could be predicted by evaluating $d_{70%}$ (time dissolved 70%) in vitro since the in vivo AUCinf was correlated with the in vitro $d_{70%}$ (r=-0.9981).

• 한국건축시공학회지
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• 제17권5호
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• pp.437-444
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• 2017

개량 아스팔트 방수시트 위에 폴리 우레탄 도막방수재가 도포되는 복합방수공법의 경우 시공성 향상을 위하여 도막 방수재에 유기용제를 희석해 사용하고 있지만, 유기용제가 폴리 우레탄 도막방수재의 완전 경화 전에 전부 휘발되지 못하고 시트재와 도막재 사이에 잔류하게 되고 이는 아스팔트 층을 융해시켜 방수층 손상 및 누수문제를 발생시켰다. 이에 용제에 의한 융해 문제를 개선하기 위해 내용제성이 강한 PA 필름을 개량 아스팔트 시트에 코팅(적층)하였고, 그 결과 융해에 대한 안전성을 육안을 관찰하였고, SEM 분석, EDX 분석을 통하여 PA 필름에 대한 내용제성을 정량적으로 확인하였다.

• 약학회지
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• 제55권5호
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• pp.419-425
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• 2011

To secure the good quality of pharmaceutical products, dissolution specifications for Octylonium bromide tablets and Pinaverium bromide tablets are needed to be established, which are enrolled in KPC (Korea Pharmaceutical Codex) with having no appropriate specifications. For establishing dissolution specifications, a number of experiments based on the "Guideline of Dissolution Testing for Solide Oral Dosage Forms" were performed. The results of this study will be used for revising KPC and it is expected to contribute to the incessant production of quality ensured drugs.

• 약학회지
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• 제34권3호
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• pp.161-165
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• 1990

An automated, simple, and reliable method was developed for determining in vitro drug release rate from transdermal delivery dosage forms. The patch is held in position in the heating block by sandwiching it between the middle plate and the bottom plate of diffusion cell. The dissolution profile of the commercially available transdermal scopolamine patch was determined over a 72-h period, and the results were compared with those obtained with other methods; paddle-over-disk method, reciprocating method, and diffusion cell method. It was demonstrated that the flow-through method is equivalent in terms of release rate profile and accumulated released drug amount over the lifetime of the dosage form tested. Also this method is simple, reliable and reproducible. Therefore, this technique can be used in a quality control for assuring product uniformity.

• Restorative Dentistry and Endodontics
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• 제41권4호
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• pp.246-254
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• 2016

Objectives: The aim of this investigation was to give insights into the impact of carbohydrate-electrolyte drinks on the likely capacity of enamel surface dissolution and the influence of human saliva exposure as a biological protective factor. Materials and Methods: The pH, titratable acidity (TA) to pH 7.0, and buffer capacity (${\beta}$) of common beverages ingested by patients under physical activity were analyzed. Then, we randomly distributed 50 specimens of human enamel into 5 groups. Processed and natural coconut water served as controls for testing three carbohydrate-electrolyte drinks. In all specimens, we measured surface microhardness (Knoop hardness numbers) and enamel loss (profilometry, ${\mu}m$) for baseline and after simulated intake cycling exposure model. We also prepared areas of specimens to be exposed to human saliva overnight prior to the simulated intake cycling exposure. The cycles were performed by alternated immersions in beverages and artificial saliva. ANOVA two-way and Tukey HDS tests were used. Results: The range of pH, TA, and ${\beta}$ were 2.85 - 4.81, 8.33 - 46.66 mM/L and 3.48 - $10.25mM/L{\times}pH$, respectively. The highest capacity of enamel surface dissolution was found for commercially available sports drinks for all variables. Single time human saliva exposure failed to significantly promote protective effect for the acidic attack of beverages. Conclusions: In this study, carbohydrate-electrolyte drinks usually consumed during endurance training may have a greater capacity of dissolution of enamel surface depending on their physicochemical proprieties associated with pH and titratable acidity.