Orally disintegrating tablets (ODTs) are often prescribed for older people and children whose swallowing abilities are poor, as they disintegrate easily in saliva in the mouth without the need for additional water.1) Recently, ODT formulations have been developed for various medicines, and many generic products are now available on the market.2) When ODTs disintegrate in the mouth, the concentration of dissolved drug in the mouth is greater than that which is found when conventional tablets are kept in the mouth. Thus, taste masking is an important issue for ODTs.Famotidine orally disintegrating tablet (FODT) was the first ODT on the Japanese market and currently, after expiry of the patent, there are eight generic forms of this product on the market. Although some characterization of generic FODT products has been reported previously, [3][4][5] the article which compares the palatability of the original and generic products are quite few. 6) Tachiki et al. evaluated 20 mg-famotidine containing orally disintegrating tablet using multichannel taste sensor SA402B (Intelligent Sensor Technology and Co., Ltd.) in the previous article.6) In the article, they evaluated FODT using one sensor (AN0) showing the largest sensor output value for famotidine. The sensor output using AN0 shows comparatively good correlationship with the bitterness evaluated by six-stage image score, for 7 products. Neverthelss, the masking effect of sweeteners or other additives for each product was not demonstrated on the article. The reason for different bitterness or palatability was not also mentioned in the article.In the present study, therefore, we focused on differences of taste between the original 10 mg-famotidine containing orally disintegrating tablet and eight generic versions of FODTs. Taste was evaluated using human gustatory sensation tests, in a study of release profiles, and using a quantitative taste sensor, the a-Astree Electronic Tongue (Alpha MOS, France); the taste sensor output of the sensor was used to calculate the Euclidean distance, a variable used to quantify the taste of the sample medium.7) The taste sensor a-AS-TREE is able to evaluate the overall taste of product by using the output value from all sensors (a-ASTREE consists of seven sensors) for the analysis. In the present study, we try to compare not only the bitterness of famotidine but also the overall taste of 10 mg-famotidine containing drug product.In the human gustatory sensation tests, not only bitterness intensity but also sweetness intensity (aspartame is the main sweetener used) were evaluated, as described in a previous study, 8) since sweetness and bitterness are the critical factors determining palatability. The release rates of famotidine and aspartame from FODTs were also quantified using HPLC, as the release rates seem to be directly correlated with bitterness or sweetness (although the quantities of released famotidine and aspartame did not reflect the extent of disintegration of the FODTs).As for the sweetener, we focused the release profile...
Famotidine, a histamine-2 receptor antagonist, is widely available as a treatment for gastric ulcers. The bitterness of famotidine is the main obstacle to good compliance for this medicine; the drug is frequently administered as an orally disintegrating tablet so that high concentrations of famotidine are delivered directly into the mouth. Therefore the quantitative evaluation of the effect of various sweeteners such as sugar alcohols, which are included in the formulation, on the bitterness-suppression of famotidine seems so important. Hashimoto et al. provided in Japanese Patent No. 2705787 1) that sugar alcohols suppress famotidine's bitterness. But it's not desirable to examine a bitterness-suppression by human repeatedly. If an alternative method is found, without exposures of famotidine or any medicine, more bitterness-suppression formulations are able to be produced easily and safely.Some articles reported on the quantitative evaluation of the bitterness of medicines, amino acids and elemental diets using the artificial taste sensor.2-4) The sensor was also successful in evaluating or predicting the bitterness-suppression of quinine hydrochloride by phospholipids, [5][6][7][8] which suppress bitterness by selectively competing at the bitterness receptor, or by adsorbing and coating the bitter substances. This result demonstrated that it is possible to predict the bitterness-suppression of human medicines at peripheral site (receptor sites in human taste cells) using the sensor's response to bitterness. However, it has been more difficult for the sensors to predict bitterness-suppression by sweet substances, 6) since bitterness-suppression seems to occur during the process of neurotransmission, which means the central bitterness-suppression. It also has been reported that the receptors for bitterness and for sweetness are different. 9-15)Therefore a sensor which responds to bitterness would be unable to evaluate bitterness-suppression by sweet substances.The purpose of the present study was to develop a quantitative prediction method for the bitterness-suppressing effect of sweeteners (sucrose and several sugar alcohols) on famotidine solutions, and also to examine the bitterness intensity of commercially available, orally disintegrating tablets containing famotidine, using the artificial taste sensor.Firstly, we characterized this newly developed sweetnessresponsive sensor 16) for sweet-tasting substances such as sucrose and sugar alcohol solutions. We found that the negative output values of the various sweeteners became larger as the sweetener concentrations increased. Secondly, we used two different methods (indirect and direct) for the quantitative evaluation of bitterness-suppression, and demonstrated the usefulness of the sweetness-responsive sensor in this evaluation. In both methods, we tried to evaluate bitterness-suppression of famotidine or quinine sulfate solution by using obtained sensor output of unknown concentrated sucrose or sugar alcohols. We fixed the concentrations of famotidine (1 ...
Phosphorus is important not only for maintaining healthy bone metabolism but also for many other biological functions such as cell membrane integrity and cellular energy systems. In patients with end-stage renal disease, decreased renal excretion of phosphorus results in hyperphosphatemia, which causes secondary hyperparathyroidism and/or an increase in the serum calcium x phosphorus product. A high serum calcium x phosphorus product accelerates vascular calcification, 1 which is reported to be independently associated with mortality in patients on hemodialysis. 2,3 Hyperphosphatemia also is an independent risk factor for mortality in these patients. 2-4 For example, the relative mortality risk at a serum phosphate concentration greater than 6.5 mg/dL is more than twice (2.02; CI 1.10 to 3.73) that of a normal serum phosphate concentration (3.0-5.0 mg/dL), after adjusting for several factors. 5 A serum phosphate concentration greater than 5.0 mg/dL is independently associated with an increased risk of death in hemodialysis patients. 4 MINORI SATOH, AKIKO KOIZUMI, SATOSHI IZUMI, YASUHIRO KUGOH, ERIKOKIRIYAMA, EMIKO OGUMA, TAKU FURUKUBO, CHIHARU MATSUNAGA, TOMOYUKI YAMAKAWA, DAISUKE KADOWAKI, AND SUMIO HIRATA Background: Patient adherence to a phosphate binder treatment regimen is crucial in the management of hyperphosphatemia. Nonadherence may be due to a lack of patient knowledge of the nature and treatment of the illness.Objective: To investigate the effectiveness of pharmacist-provided education regarding phosphate binders and hyperphosphatemia on serum phosphate concentration and calcium x phosphorous product in hemodialysis patients. Methods:A total of 398 hemodialysis patients who were prescribed phosphate binders participated in a pharmacist-run, education-based intervention session regarding phosphate binders and hyperphosphatemia. Each session was individualized on the basis of patient knowledge, assessed via a questionnaire. Particular attention was given to correcting patient misconceptions. Patients with elevated serum phosphate received additional education. Mean serum concentrations of phosphate and calcium, averaged from 4 measurements obtained at both baseline and postintervention, were compared to evaluate the efficacy of the intervention.Results: Postintervention, patients with the highest baseline serum phosphate concentrations (≥7.0 mg/dL) showed a significant decrease in mean ± SD serum concentrations of phosphate and calcium-phosphate product (7.4 ± 0.4 mg/dL and 72.6 ± 6.4 mg 2 /dL 2 to 6.5 ± 0.8 mg/dL and 63.1 ± 8.4 mg 2 /dL 2 , respectively; p < 0.001). Likewise, patients with serum phosphate concentrations ranging from 6.0-6.9 mg/dL showed a significant decrease in both parameters after educational intervention (p < 0.05 and p < 0.005, respectively).Conclusions: An education session regarding phosphate binders and hyperphosphatemia, provided by pharmacists for hemodialysis patients, appeared effective in reducing serum phosphate concentrations and calcium x phosphorus product, thus contri...
It is weli known that an interaction exists between smoking and exposure to asbestos in the occurrence of lung cancer, whereas occurrence of malignant mesothelioma has not been related to smoking. In the case of pleural thickening related to asbestos, there is a disagreement in previous studies as to the effect of smoking. This could be because the diagnosis of pleural changes has a subjective element. Taking this into account, in the present work the maximum width of the pleura was used as an index of pleural changes.
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