• Journal of the Korea Academia-Industrial cooperation Society
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• v.22 no.3
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• pp.323-332
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• 2021

This study was undertaken to develop a new combination tablet containing silodosin and solifenacin succinate for treating urination disorders, for which a simultaneous analytical method of silodosin and solifenacin succinate was established. The aqueous solubility of silodosin and solifenacin succinate was determined to be higher than 1 mg/ml in various buffers, and dissolution of the silodosin and solifenacin succinate commercial products was accomplished within 30 minutes. The drug-excipients compatibility test was subsequently evaluated using differential scanning calorimetry. Excipients without compatibility were selected, and various combination formulations were prepared applying the wet granulation method. Of these, the formulation comprising silodosin, solifenacin succinate, lactose hydrate, MCC PH101, sodium lauryl sulfate (SLS), Povidone K30, crospovidone and magnesium stearate, having a weight ratio of 8/10/56/112/2/6/6/2, respectively, showed equivalence comparative to the dissolution achieved with the commercial products of silodosin (Thrupas tab) and solifenacin succinate (Vesicare tab). Thus, we propose that compared to the currently available commercial products, this novel combination tablet containing silodosin and solifenacin succinate is an effective alternative for the treatment of urination disorders.

• Korean Journal of Clinical Pharmacy
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• v.31 no.4
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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.

• Korean Journal of Clinical Pharmacy
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• v.33 no.2
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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.