Compositions used as mood stabilizers

Abstract

A composition for use as a mood-regulating enhancer is disclosed, which comprises a gum base containing 0.1 to 1 wt% lavender oil.

Description

【Technical Field】 【0001】 The present invention relates to a composition used as a mood regulator. 【Background Art】 【0002】 Uehleke, B. et al., “‘Phase II trial on the effects of Silexan in patients with neurasthenia, post-traumatic stress disorder or somatization disorder’, Phytomedicine, year 2012, issue 19, page 665 to 671” discloses that lavender is known to be used as an antidepressant having sedative and anti-anxiety effects, and thus also as a sedative. 【Summary of the Invention】 【0003】 An object of the present invention is to identify another use of lavender. 【0004】 According to one aspect of the present invention, the composition contains lavender oil as a pharmaceutically active ingredient in the treatment of concentration disorders and attention deficit disorder (ADD), and a gum base, and the gum base contains lavender oil as an active ingredient at a concentration of 0.1 to 1 wt%, preferably 0.2 to 0.4 wt%, more preferably 0.3 wt%. 【0005】 Based on tests, it has been found that lavender oil can also be used as a promoter. Therefore, this effect reverses to an antidepressant having sedative and anti-anxiety effects, activates cognition, and eliminates fatigue. 【0006】 However, lavender taken orally shows side effects such as gastrointestinal disorders in the form of indigestion and nausea. Allergic reactions are also known. 【0007】 In particular, users tend to take high doses of the potential active ingredients frequently throughout the day, which further exacerbates the aforementioned side effects. 【0008】 Therefore, in order to use lavender as a mood-regulating agent, the present invention proposes administration in the form of chewing gum so that lavender oil is absorbed into the cheek or under the tongue. Through testing, it has been shown that the above-mentioned cognitive enhancement and fatigue-relieving effects can be obtained with a significantly smaller amount of lavender compared to other dosage forms such as capsules and tablets. 【0009】 In one embodiment of the composition, lavender oil is the sole active ingredient. In another embodiment of the composition, the gum base is 0.25 N / mm² for use with facial muscles. 2 and 4N / mm 2 It has tensile strength in between. 【0010】 In another embodiment, the gum base includes synthetic and / or natural gum as a consistency former. 【0011】 In one embodiment of a particular chewing gum, the amount of lavender oil is between 0.2 wt% and 0.4 wt%. During buccal and sublingual administration, a significantly higher concentration of lavender oil enters the bloodstream, which is further stimulated by chewing. An optimal effect can be obtained with a lavender oil concentration of 0.3 wt%. 【0012】 In additional embodiments of the particular invention, the particular composition further comprises 0.05 to 0.5 wt%, preferably 0.08 to 0.2 wt%, and particularly preferably 0.1 wt%, of trace elements. In particular, the trace element zinc supports the regeneration of the oral mucosa and, in the case of long-term intake of the particular composition, ensures that the lavender oil released when chewing the gum block can be optimally absorbed through the oral mucosa. 【0013】 In additional embodiments of a particular invention, the particular composition contains 0.1 wt% to 1 wt%, preferably 0.15 wt% to 0.35 wt%, and particularly preferably 0.25 wt% of a salt. Salts such as sodium chloride salt have antibacterial, disinfectant, sedative, decongestant, and anti-inflammatory effects on the oral mucosa. This reduces bacteria in the mouth and prevents inflammation and infection. In cases of throat inflammation, the salt also supports the function of the mucosa by moistening irritated and dried mucosa. Salt also has cleansing and blood circulation-promoting effects. The film and mucus from the mucosa are loosened, and gum regeneration occurs. In this way, the absorption of lavender oil through the oral mucosa is further improved and may be optional. 【0014】 In further embodiments, the particular composition further contains 0.05 wt% to 0.5 wt%, preferably 0.09 wt% to 0.3 wt%, and more preferably 0.15 wt%, of vitamin B. Vitamin B, such as pantothenic acid and niacin, contributes to the maintenance of the oral mucosa and therefore ensures the efficient absorption of lavender oil when the particular composition is taken over a long period of time. 【0015】 In further embodiments, the particular composition further comprises 0.1 wt% to 1 wt%, preferably 0.2 wt% to 0.4 wt%, and particularly preferably 0.3 wt%, of vitamin D. Vitamin D such as biotin contributes to the maintenance of the oral mucosa and therefore ensures the efficient absorption of lavender oil when the particular composition is taken over a long period of time. 【0016】 In specific embodiments, certain compositions further include an acidity modifier. The acidity modifier can be used to regulate saliva production in the oral cavity, thereby further improving the absorption of lavender oil through the oral mucosa. For this purpose, citric acid has been found to be the most suitable acidity modifier. 【0017】 In another embodiment of a particular composition, the gum base contains a sugar alcohol or mixture of sugar alcohols such as sorbitol, mannitol, isomalt, maltitol, lactitol, xylitol, erythritol, or polyglycitol syrup in an amount between 50 wt% and 99 wt%, preferably between 70 wt% and 80 wt%, and particularly preferably 75 wt%. The sugar alcohols have a slight cooling effect in the oral cavity, which also has a positive effect on the buccal or sublingual absorption of lavender oil. 【0018】 The above-mentioned characteristics, features, and advantages of the present invention, as well as the methods by which they are achieved, will become clearer in connection with the following description of embodiments, which will be described in more detail with reference to the drawings. [Brief explanation of the drawing] 【0019】 [Figure 1] This figure shows the mean values ​​plotted over time for positively implied moods of subjects who ingested the composition according to the present invention, according to the Brief Mood Introspection Scale (BMIS, 3rd edition, February 26, 2019). [Figure 2] This figure shows the mean values ​​plotted over time for positively implied moods of subjects who consumed the alternative composition, according to the Brief Mood Introspection Scale (BMIS, 3rd edition, February 26, 2019). [Figure 3] This figure shows the mean values ​​plotted over time for negatively implied moods of subjects who ingested the composition according to the present invention, according to the Brief Mood Introspection Scale (BMIS, 3rd edition, February 26, 2019). [Figure 4]A figure having average values plotted over time for the negatively implied mood of subjects who ingested an alternative composition, according to the Brief Mood Introspection Scale (abbreviated as BMIS, 3rd edition, February 26, 2019). [Figure 5] A figure showing an evaluation of test data collected on the "pleasant - unpleasant" scale by the Brief Mood Introspection Scale (abbreviated as BMIS, 3rd edition, February 26, 2019). [Figure 6] A figure showing an evaluation of test data collected on the "excited - calm" scale by the Brief Mood Introspection Scale (abbreviated as BMIS, 3rd edition, February 26, 2019). [Figure 7] A figure showing an evaluation of test data collected on the "positive - tired" scale by the Brief Mood Introspection Scale (abbreviated as BMIS, 3rd edition, February 26, 2019). [Figure 8] A figure showing an evaluation of test data collected on the "negative - relaxed" scale by the Brief Mood Introspection Scale (abbreviated as BMIS, 3rd edition, February 26, 2019). 【Mode for Carrying Out the Invention】 【0020】 In the drawings, the same technical elements are denoted by the same reference numerals and are described only once. 【0021】 The efficacy of the claimed composition was determined using examples of embodiments of the claimed composition in clinical trials and compared with alternative compositions. 【0022】 Examples of embodiments of the claimed composition were multiple chewing gums, each weighing 2 g. Each chewing gum contained 1.5 g of a sugar alcohol blend of sorbitol, maltiol and mannitol, as well as a blend of vitamins and minerals of 5 mg of salt, 2 mg of zinc, 2 mg of niacin, 0.8 mg of pantothenic acid and 6.5 μg of biotin. Additionally, 2 mg of citric acid and 6 mg of lavender oil were added to the composition. The remainder of each chewing gum consisted of skin softeners, humectants, antioxidants, flavoring agents, coloring agents and emulsifiers that did not contribute to the claimed effect of the composition. 【0023】 Alternative compositions were various tablets. Each tablet contained, for example, 50 mg of lavender flower extract, 10 mg of lavender oil, 1.1 mg of vitamin B1, 1.4 mg of vitamin B2, 6 mg of pantothenic acid, 1.4 mg of vitamin B6 and 5 μg of vitamin B12, such as those sold under the trade name Doppelherz aktiv Lavendel by Queisser Pharma GmbH & Co. KG. 【0024】 Thus, each tablet of the alternative composition contained approximately twice the amount of lavender extract compared to the chewing gum according to an example of an embodiment of the claimed composition. 【0025】 To collect clinical trial data, 80 subjects were divided into a group of 40 subjects who ingested chewing gum according to an example of an embodiment of the claimed composition and a group of 40 subjects who ingested tablets according to the alternative composition. Depending on the group, the subjects ingested one chewing gum according to an example of an embodiment of the claimed composition or two tablets according to the alternative composition, twice a day for 14 days. 【0026】 To collect test data, participants completed a questionnaire on days 1, 3, 5, 8, 11, and 14 using the Brief Mood Introspection Scale (BMIS, 3rd edition, February 26, 2019), providing information about their mood on various scales. 【0027】 In each questionnaire, the participant's mood was assessed using 16 different mood scales. Each mood scale is defined by BMIS and includes scales for how lively the participant feels (BMIS: "Lively"), how happy the participant feels (BMIS: "Happy"), how sad the participant feels (BMIS: "Sad"), how tired the participant feels (BMIS: "Tired"), how caring the participant feels (BMIS: "Caring"), how content the participant feels (BMIS: "Content"), and how depressed the participant feels (BMIS: "Gloomy"), The questionnaire asks about the following mood scales: how nervous (BMIS: "Jittery") the subject feels; how drowsy (BMIS: "Drowsy") the subject feels; how grouchy (BMIS: "Grouchy") the subject feels; how energetic (BMIS: "Peppy") the subject feels; how nervous (BMIS: "Nervous") the subject feels; how calm (BMIS: "Calm") the subject feels; how loving (BMIS: "Loving") the subject feels; how fed up (BMIS: "Fed up") the subject feels; and how active (BMIS: "Active") the subject feels. 【0028】 For each scale, participants could determine whether the mood on the corresponding scale definitely applied to them, whether it probably applied to them, whether it probably did not apply to them, or whether it definitely did not apply to them. If the mood was definitely true for the participant, the participant's decision was assigned a value of 4. If the mood was probably true for the participant, the participant's decision was assigned a value of 3. If the mood was probably not true for the participant, the participant's decision was assigned a value of 2. If the mood was definitely not true for the participant, the participant's decision was assigned a value of 1. 【0029】 The questionnaires were first analyzed by averaging the results for all participants in each group and each scale for each day. 【0030】 Table 1 below shows the results of this averaging for groups administered chewing gum according to an example of an embodiment of the claimed composition. JPEG0007873181000001.jpg123170 【0031】 In contrast, Table 2 below shows the averaged results for the group administered tablets according to the alternative composition. JPEG0007873181000002.jpg114170 【0032】 In Figures 1-4, values ​​of 1 from Tables 1 and 2 are plotted against time 2. Figure 1 shows the values ​​of 1 for the positively implied mood scales from Table 1. These are the mood scales: lively 4, happy 6, caring 7, content 8, energetic 10, calm 12, loving 14, and active 16. In Figure 2, the same positively implied mood scales are plotted, but from Table 2. 【0033】 Figure 3 shows the negatively implied mood scale values ​​of 1 from Table 1. These are sad (18), tired (20), depressed (22), nervous (24), sleepy (25), grumpy (26), tense (28), and fed up (30). Figure 4 plots the same negatively implied mood scales, but from Table 2. 【0034】 Figures 1 and 2 show that all stimulating mood scales show a positive trend for both the requested composition and the alternative composition. The calm mood scale (calm 12) is significant in a single rating for the requested composition, and the lively mood scale (lively 4) is significant in a single rating for the alternative composition. When the subject groups for both compositions are pooled, the satisfied mood scale (satisfied 8) shows a significant improvement. 【0035】 The moods belonging to the mood scales in Figures 1 and 2 are perceived as cheerful, stimulating, and positive, as shown in Table 1.1 of the Brief Mood Introspection Scale (BMIS, 3rd edition, February 26, 2019). Both the requested composition and the alternative composition were capable of tending to or significantly increasing all of these positive moods. 【0036】 Figures 3 and 4 show that all inhibitory mood scales show a consistent trend for both the requested and alternative compositions. Even the slightest decrease in fatigue (20) with the requested composition is significant in individual assessments, though this is less noticeable with the alternative composition. Participants were more agile and focused. 【0037】 Next, for further evaluation, the values ​​for the four subscales of the BMIS were calculated from the daily average values ​​for each day: the daily values ​​for the satisfaction scale (according to the BMIS, "pleasant-unpleasant"), the excitement scale (according to the BMIS, "excited-calm"), the fatigue scale (according to the BMIS, "positive-tired"), and the relaxation scale (according to the BMIS, "negative-relaxed"). 【0038】 Table 3 below shows the subscale values ​​for the groups administered chewing gum according to an example of the claimed composition embodiment. JPEG0007873181000003.jpg40170 【0039】 In contrast, Table 4 below shows the subscale values ​​for the group administered tablets according to the alternative composition. JPEG0007873181000004.jpg42170 【0040】 The values ​​calculated in this way for the subscales were plotted against time 2 in the graphs shown in Figures 5-8 to evaluate the results. Figure 5 shows the chewing gum satisfaction curve 36 with daily values ​​for chewing gum using an example embodiment of the claimed composition, and the tablet satisfaction curve 38 with daily values ​​for tablets using an alternative composition, over time 2 for the satisfaction scale 34 (according to BMIS, "pleasant-unpleasant"). Figure 6 shows the chewing gum excitement curve 46 with daily values ​​for chewing gum using an example embodiment of the claimed composition, and the tablet excitement curve 48 with daily values ​​for tablets using an alternative composition, over time 2 for the excitement scale 44 (according to BMIS, "excited-calm"). Figure 7 shows the chewing gum fatigue curve 56 with daily values ​​for chewing gum using an example embodiment of the claimed composition, and the tablet fatigue curve 58 with daily values ​​for tablets using an alternative composition, over time 2 for the fatigue scale 54 (according to BMIS, "positive-tired"). Figure 8 shows the chewing gum recreation curve 66 with daily values ​​for chewing gum by an example embodiment of the claimed composition and the tablet recreation curve 68 with daily values ​​for tablets by an alternative composition over time 2 for the recreation scale 64 (according to BMIS, “negative-relaxed”). 【0041】 The curves in Figures 5–8 support the results interpreted from Figures 1–4, which indicate that both compositions reduced negative moods or at least kept them constant while improving positive moods. Subjects felt more alert and more attentive.

Claims

[Claim 1] A pharmaceutical composition for the treatment of concentration disorders, comprising lavender oil and a gum base, wherein the gum base contains lavender oil as an active ingredient at a concentration of 0.3 wt%, the gum base comprising 0.08 to 0.2 wt% of trace elements and 0.15 to 0.35 wt% of salt, the trace element being zinc and the salt being sodium chloride, and characterized in that it significantly improves calmness and fatigue reduction in BMIS and enables concentration. [Claim 2] The composition according to claim 1, characterized in that the lavender oil is a single active ingredient. [Claim 3] The aforementioned gum base is 0.25 N / mm for use with facial muscles. ２ and 4 N / mm ２ The composition according to claim 1 or 2, characterized by having a tensile strength between [a certain value]. [Claim 4] The composition according to claim 1, characterized in that the gum base comprises synthetic and / or natural gum as a consistency former. [Claim 5] The composition according to claim 1, characterized in that the gum base contains 0.05 wt% to 0.5 wt% of vitamin B. [Claim 6] The composition according to claim 5, characterized in that the vitamin B comprises niacin and / or pantothenic acid. [Claim 7] The composition according to claim 1, characterized in that the gum base contains 0.1 wt% to 1 wt% of vitamin D. [Claim 8] The composition according to claim 7, characterized in that the vitamin D is biotin. [Claim 9] The composition according to claim 1, characterized in that the gum base further comprises an acidity modifier. [Claim 10] The composition according to claim 9, characterized in that the acidity adjusting agent is citric acid. [Claim 11] The composition according to claim 1, characterized in that the gum base contains a sugar alcohol.

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