• 한국산학기술학회논문지
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• 제22권3호
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• pp.323-332
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• 2021

본 연구의 목적은 배뇨장애 치료를 위한 실로도신과 솔리페나신 숙신산염을 함유한 새로운 복합 정제를 개발하는 것이다. 이러한 목표를 달성하기 위하여 실로도신과 솔리페나신 숙신산염의 동시 정량법을 확립하였다. 두 약물은 다양한 완충액에서 1 mg/ml 이상의 수용해도 값을 나타내었으며, 실로도신과 솔리페나신 숙신산염이 함유된 시판제품의 용출은 다양한 용출조건에서 30분 이내에 완료되었다. 시차 주사 열량계를 사용하여 부형제와 약물 간 상호 반응성을 확인하여 선정된, 약물과 반응성이 없는 부형제를 사용하여 습식 과립화 방법을 사용하여 결합제와 붕해제의 사용에 따른 다양한 처방을 제조한 후 용출시험을 진행하였다. 제조한 정제의 처방 중 실로도신, 솔리페나신 숙신산염, 유당, 미결정셀룰로오스 PH101, 소듐라우릴설페이트, 포비돈 K-30, 크로스포비돈 및 스테아린산마그네슘이 8/10/56/112/2/6/6/2(w/w)의 비율로 제조된 정제는 트루패스정(실로도신 시판 제품) 및 베시케어정(솔리페나신 숙신산염 시판 제품)과의 비교용출 시험시 동등성을 나타내는 것을 확인하였다. 따라서, 본 연구를 통해 얻어진 복합 정제는 각 약물의 시판 제품과 동등한 생체이용률을 나타낼 수 있을 것으로 판단되며, 향후 배뇨 장애 치료에 복약순응도가 우수한 의약품으로 활용될 수 있을 것으로 사료된다.

• 한국임상약학회지
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• 제31권4호
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• pp.324-331
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• 2021

To investigate signals of adverse drug reactions of finasteride by using the Korea Adverse Events Reporting System (KAERS) database. This pharmacovigilance was based on the database of the drug-related adverse reactions reported spontaneously to the KAERS from 2013 to 2017. This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of finasteride. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). The signals of finasteride were compared with those of the other drugs; dutasteride (similar mechanism of action), minoxidil (different mechanism but similar indications for alopecia), silodosin (different mechanism but similar indications for BPH). It was examined whether the detected signals exist in drug labels in Korea. The total number of adverse event-drug pairs was reported 2,665,429 from 2013 to 2017, of which 1,426 were associated with finasteride. The number of investigated signals of finasteride was 42. The signals that did not include in the drug label were 29 signals, including mouth dry, hypotension, dysuria etc. The signal of finasteride was similar to that of dutasteride and silodosin but was different to that of minoxidil. Early detection of signals through pharmacovigilance is important to patient safety. We investigated 29 signals of finasteride that do not exist in drug labels in Korea. Further pharmacoepidemiological studies should be needed to evaluate the signal causality with finasteride.

• 한국임상약학회지
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• 제33권2호
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• pp.86-96
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• 2023

Background: Using KIDS-KAERS database (KIDS-KD) from 2016 to 2020, the aim is to investigate signals of adverse events of alpha-adrenoceptor antagonists and to present adverse events that are not included in the precautions for use when marketing approval. Methods: This study was conducted by disproportionality analysis. Data mining analysis was performed to detect signals of alpha-adrenoceptor antagonists, such as terazosin, doxazosin, alfuzosin, silodosin, and tamsulosin. The signal was defined by three criteria as proportional reporting ratio (PRR), reporting odds ratio (ROR), and information component (IC). Detected signals were compared with product labeling and the European Medicines Agency-Important Medical Events list. Results: Out of the total number of 408,077 reports for adverse events, 6,750 cases were reported as adverse events of alpha-adrenoceptor antagonists. Dizziness, mouth dryness, hypotension postural, and oedema peripheral are identified as common adverse events of five alpha-adrenoceptor antagonists and are typically listed on drug labels. However, new signals were detected for pneumonia, chronic obstructive airway disease, eye diseases such as glaucoma and cataracts, fracture, and ileus of tamsulosin that were not previously listed on the drug labels in Korea. Conclusions: This study identified signals related to adverse drug reactions of alpha-adrenoceptor antagonists and presented serious adverse events, suggesting new adverse reactions to be aware of when using alpha-adrenoceptor antagonists.