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We previously prepared and pharmaceutically evaluated ginger orally disintegrating (OD) tablets, optimized the base formulation, and carried out a clinical trial in healthy adults in their 20 s and 50s to measure their effect on salivary substance P (SP) level and improved swallowing function. In this study, we conducted clinical trials using the ginger OD tablets in older people to clinically evaluate the improvements in swallowing function resulting from the functional components of the tablet. The ginger OD tablets were prepared by mixing the excipients with the same amount of mannitol and sucrose to a concentration of 1% ginger. Eighteen healthy older adult volunteers aged 63 to 90 were included in the swallowing function test. Saliva was collected before and 15 min after administration of the placebo and ginger OD tablets. Swallowing endoscopy was performed by an otolaryngologist before administration and 15 min after administration of the ginger OD tablets. A scoring method was used to evaluate the endoscopic swallowing. Fifteen minutes after taking the ginger OD tablets, the salivary SP amount was significantly higher than prior to ingestion or after taking the placebo (p<0.05). Among 10 subjects, one scored 1-3 using the four evaluation criteria. Overall, no aspiration occurred and a significant improvement in the swallowing function score was observed (p<0.05) after taking the ginger OD tablets. Our findings showed that the ginger OD tablets increased the salivary SP amount and improved swallowing function in older people with appreciably reduced swallowing function.Key words older people; dysphagia; ginger; orally disintegrating tablet; substance P; saliva The Japanese population is aging rapidly with older people (≥65 years) making up greater than 22% with further increases anticipated. Older people often suffer reduced vital functions from a combination of underlying disease and reduced physical and cognitive abilities. In particular, dysphagia is a serious problem and combined with reduced cough reflex, leads to increased risk of aspiration pneumonia. Currently pneumonia is the third leading cause of death in Japan, and the cause of death in greater than 90% of older patients. Aspiration is the speculated cause in many of the pneumonia related deaths. 1-3) Dysphagia also leads to malnutrition, dehydration, and loss of pleasure in eating, decreasing the patients' quality of life. The swallowing reflex is controlled by substance P (SP). Secretion of SP from nerve endings in the bronchial mucosa and oral cavity 4,5) is essential to proper swallowing function and reduced SP secretion is the cause of dysphagia. Swallowing dysfunction can be caused by decreased production of dopamine and SP. Salivary SP levels in older people are reported to be significantly lower than in healthy younger individuals. 6) When basal ganglia are disturbed, such as with cerebral infarction, dopaminergic nerve function decreases and then SP secretion decreases. These effects combined with reduced cough and swallowing reflex in...

Minerals are essential for life, as they are a vital part of protein constituents, enzyme cofactors, and other components in living organisms. Deep sea water is characterized by its cleanliness and stable low temperature, and its possible health-and medical benefits are being studied. However, no study has yet evaluated the physical properties of the numerous commercially available deep sea water products, which have varying water sources and production methods. We analyzed these products' mineral content and investigated their effect on living organism, focusing on immune functions, and investigated the relation between physiological immunoactivities and mineral intake. We qualitatively analyzed the mineral compositions of the deep sea water drinks and evaluated the drinks' physical properties using principal component analysis, a type of multivariate analysis, of their mineral content. We create an iron and copper-deficient rat model and administered deep sea water drinks for 8 weeks. We then measured their fecal immunoglobulin A (IgA) to evaluate immune function. Principal component analysis suggested that physical properties of deep sea water drinks could be determined by their sources. Administration of deep sea water drinks increased fecal IgA, thus tending to stimulate immune function, but the extent of this effect varied by drink. Of the minerals contained in deep sea water, iron showed positive correlations with the fecal IgA. The principal component analysis used in this study is suitable for evaluating deep sea water containing many minerals, and our results form a useful basis for comparative evaluations of deep sea water's bioactivity.

Eicosapentanenoic acid ethyl ester (EPA-E) formulation is a drug derived from fish oil. Some EPA-E formulations have a special odor depending on the manufacturing process and the type of sardine raw materials used. This odor affects the compliance of some patients. In this study, we report our assessment of the odors in each EPA-E formulation with gas chromatography/mass spectrometry (GC/MS). We used 3 lots of an original drug and 5 generic EPA-E formulations. EPA-E formulations were incubated at 40℃ in the absence of light. We collected the volatiles for 24 h immediately and 7 days later. The collected volatiles that were ultrasonically extracted with dichloromethane were used as GC/MS samples. We estimated the components on the basis of the fragment pattern and peak retention time on GC/MS. We performed principal component analysis (PCA) by using the peak area and 2-dimensional mapping, and evaluated the results. There was no change in the appearance of any of the formulations at 7 days, compared at the beginning of the experiment. However, the GC/MS measurements revealed the presence of 1-heptadecanal and 1-eicosanal, which were presumed to be oxidation decomposition products, in some formulations. These products were predicted to be the source of odors, and their intensities increased after 7 days. This difference was observed in the score plot between the 6 formulations as a result of PCA. The odors due to the decomposition products may influence the compliance of patients, and a detailed examination will be required.

The introduction of generic drugs is promoted from the perspective of medical economics. In this context, we need to understand not only the bioequivalence of generic drugs speciˆed in``the Guidelines for Bioequivalence Studies of Generic Products'', but also formulation properties to consider their eŠect on pharmacological therapy. We evaluated the pharmaceutical characteristics of rebamipide formulations, a brand-name drug and two generic drugs, and their clinical functionality by using rat models of gastric mucosal injury induced by non-steroidal anti-in‰ammatory drugs （NSAIDs). Pharmaceutical evaluation showed signiˆcant diŠerences in hardness. The inter-lot variation was small in all rebamipide formulations. In the clinical functionality study, biochemistry test values 7 d after the administration of rebamipide showed no diŠerences among formulations. Higher levels of mucosal ‰uid secretion and antioxidative enzymes were observed in the groups administered rebamipide than in the control group. The levels of lipid peroxide were lower in the groups administered rebamipide than the control group. Multivariate analysis showed slight divergence between the brand-name and generic drugs. In future, it will be necessary to select generic drugs after careful consideration of bioequivalence, clinical functionality, and therapeutic equivalence by reviewing scientiˆc evidence such as indication and formulation design, not to mention stable provision.