Multiphase tablet having sleep-promoting effect

Abstract

The present invention relates to the field of medicine and of dietary supplements, in particular the technical (i.e. medical-pharmaceutical or food-technology) field of sleep problems and sleep disorders. In particular, the present invention relates to a dosage form, in particular a dietary-supplement dosage form or pharmaceutical dosage form, in particular for oral administration, preferably for promoting or supporting sleep health or sleep behavior or preferably for use in the prophylactic or therapeutic treatment of sleep disorders or dysregulation of the natural day / night rhythm or the circadian rhythm.

Description

[0001] Multiphase tablet with sleep-promoting effect

[0002] The present invention relates to the field of medicine and food supplements, in particular the technical (i.e. medical-pharmaceutical or food-technical) field of sleep problems and sleep disorders (synonymously also referred to as insomnia, agrypnia or hyposomnia), in particular with the related difficulties in falling asleep and staying asleep.

[0003] In this context, the present invention relates in particular to the technical field of promoting or supporting sleep health or sleep behavior, in particular the ability to fall asleep or stay asleep, as well as the treatment of related sleep disorders or associated dysregulation of the natural day / night rhythm or the circadian rhythm.

[0004] In particular, the present invention relates to a dosage form, in particular a dietary supplement or pharmaceutical dosage form, in particular for oral administration, preferably for promoting or supporting sleep health or sleep behavior or preferably for use in the prophylactic or therapeutic treatment of sleep disorders or dysregulation of the natural day / night rhythm or the circadian rhythm.

[0005] In this context, the present invention also relates to the use of the dosage form according to the invention in the dietary supplement sector, in particular for the non-therapeutic or non-medical promotion or support of healthy sleep or sleep behavior, in particular the ability to fall asleep or stay asleep, and the like. Furthermore, the present invention also relates to the use of the dosage form according to the invention (for the production of a medicament) for the prophylactic or therapeutic medical treatment of sleep disorders or dysregulations of the natural day / night rhythm or the circadian rhythm. Furthermore, the present invention also relates to a related medicament, pharmaceutical, medical device or homeopathic remedy, as well as the related use (for the production of a medicament) for the prophylactic or therapeutic treatment of the diseases or complaints mentioned here.

[0006] Furthermore, the present invention also relates to a dietary supplement as such, in particular for the non-therapeutic or non-medical promotion or support of sleep behavior or restful sleep, or for the promotion and / or support of the natural day / night rhythm or the natural circadian rhythm. In this context, the present invention also relates to a related use of the dietary supplement according to the invention.

[0007] Furthermore, the present invention relates to a method for the prophylactic or therapeutic medical treatment of sleep disorders or dysregulation of the natural day / night rhythm or the circadian rhythm, as well as to a method for the non-therapeutic or non-medical promotion or support of sleep health or sleep behavior or restful sleep or the natural day / night rhythm or the natural circadian rhythm.

[0008] Finally, the present invention also relates to a packaging unit which contains at least one dosage form according to the invention.

[0009] Restful sleep is an important prerequisite for health and performance. The term "sleep" generally describes a state of external rest, in which many vital signs differ from those of the waking state. In particular, heart rate, respiratory rate, and blood pressure decrease during sleep, and changes in brain activity can also be observed. Sleep is of great vital importance for human life and health. Even though sleep is characterized by very low physical activity and a barely existent perception of the environment, it is nevertheless an active, highly organized sequence of events and physiological states, especially since sleep is necessary for the functioning of the brain and the survival of the entire organism.The initiation of sleep, its maintenance, and the underlying sleep phases are primarily controlled neurophysiologically, with endogenous substances and neurotransmitters playing a significant role in this regard. For example, when sleep is initiated, the autonomic system stimulates the release of the body's own melatonin from the pineal gland. Melatonin is released in greater quantities in the evening hours and contributes to sleep induction. The body also contains other neurotransmitters that can contribute to an increased need for sleep ("tiredness"). To maintain sleep, functional systems in the brain vary the depth of sleep at intervals, alternating between deep sleep phases and less deep sleep. When these sleep phases alternate at increasingly shorter intervals towards the end of sleep, usually after about six to eight hours or longer, the sleeper awakens.This cyclical process is also called the sleep rhythm. Sleep also serves to regenerate the body and process experiences from waking hours, and a connection between sleep and memory performance is also suspected.

[0010] Disturbed sleep patterns are generally referred to as dyssomnia. Insomnia or sleep disorders, particularly those associated with difficulty falling asleep and staying asleep, are referred to as agrypnia, or synonymously as insomnia or hyposomnia. The aforementioned terms thus refer specifically to a lack of sleep or the absence of sleep, particularly with regard to a disruption in the targeted induction of sleep and difficulty staying asleep.

[0011] Sleep disorders are widespread, and in addition to external factors (such as excessive noise, too bright light), psychological factors (such as anxiety, stress), behavioral factors (sleep hygiene) and biological factors can also cause such sleep disorders. The lack of restorative sleep impairs performance, and in the medium or long term, this can also lead to a deterioration in overall health or the onset of illnesses triggered by long-term sleep disorders. Sleep disorders or insomnia, particularly difficulty falling asleep and staying asleep, but also early morning waking and impaired daytime well-being, are a widespread symptom in the population, affecting around one fifth to one third of the adult population in industrialized countries. According to further studies, approx.50% of the population over 60 years of age experience sleep disturbances more than once a week.

[0012] Balanced and sufficient sleep therefore contributes significantly to well-being, especially since approximately one-third of life is spent sleeping. Therefore, good and sufficient sleep is beneficial and important for health and well-being. Restful, healthy sleep is necessary, promotes regeneration, and is essential for the immune system, well-being, quality of life, and cognitive and physical performance. Conversely, sleep deprivation or sleep disorders are associated with unpleasant symptoms such as fatigue, difficulty concentrating, and other stress factors or physical and psychological symptoms that impair well-being.

[0013] Sleep problems are often complex: excitement, hectic daily life, stress, tension, and negative thoughts ("thought carousels") are often triggers for poor sleep. Many people occasionally suffer from sleep problems, but these vary greatly from individual to individual. For example, 28% of the population find it difficult to fall asleep, while 39% suffer from light, restless, and unrefreshing sleep. 45% of those affected suffer from frequent waking during the night.

[0014] The stages and states of sleep are controlled by finely tuned nerve signals and hormones in the brain, as previously mentioned. Anything that impairs or changes this interaction also disrupts the natural sleep rhythm. Excessive consumption of stimulants such as coffee, tea, nicotine, or alcohol can have a particularly negative impact on sleep. Psychologically based factors, such as negative thoughts, anxiety, stress, or other conflicts, can also have a negative impact on sleep, as they trigger the release of stress hormones and lead to restlessness throughout the organism. With age, the natural level of the sleep hormone melatonin, which not only regulates sleep but also controls the human body's day-night rhythm, also decreases. Low melatonin levels can therefore lead to problems falling asleep and staying asleep.The same applies to bright and blue light from screens, exposure to which can also lower the melatonin level in the sleeper's body, resulting in delayed sleep onset.

[0015] Other factors that contribute to sleep problems include late or advanced physical activities and significant changes in the daily routine, which can cause or promote hormonal fluctuations and thus lead to restless sleep.

[0016] Sleeping pills are widely used to treat sleep problems or improve sleep patterns. These include benzodiazepine receptor agonist hypnotics (e.g., benzodiazepines, cyclopyrrolones, imidazolepyridines, etc.). Due to the risk of addiction with daily use over extended periods and side effects such as severe muscle relaxation or respiratory depression, hypnotics are increasingly viewed with skepticism, especially for mild sleep disorders. Other sleeping pills currently on the market, such as sedative antidepressants or low-potency neuroleptics, are generally associated with anticholinergic and antialpha-adrenergic side effects and are therefore inadequate for balanced treatment, especially for mild sleep disorders.

[0017] Against this background, phytopharmaceuticals or plant-based sleep aids cover a wide range of the treatment spectrum – especially for mild sleep problems. Plant-based sleep aids have been used for centuries to treat sleep disorders. The primary indication for the use of phytopharmaceuticals is the treatment of mild to moderate sleep disorders (insomnia), especially those that do not significantly affect the patient's daytime well-being. EP 3 153 174 A1 relates to a composition based on plant extracts, which is intended to be used as a sedative and, in particular, for the treatment or prevention of sleep disorders, attention deficits, and states of heightened nervousness.

[0018] Good tolerability and fewer drug interactions are key advantages of phytopharmaceuticals. The spectrum of side effects is significantly narrower than that of synthetic sleep aids. However, the use of phytopharmaceuticals is not without controversy. The efficacy of the majority of phytopharmaceutical-based substances and combinations of substances available on the market is sometimes insufficient.

[0019] As a result, approximately 67% of sleep product users experience significant distress, and approximately 70% of sleep product users are even dissatisfied with the product.

[0020] Against this background - particularly due to the widespread prevalence of sleep disorders - there is a great need to provide suitable compositions or dosage forms as well as therapy concepts for the treatment of sleep disorders, in particular with regard to improving sleep quality and the ability to fall asleep and / or stay asleep.

[0021] Overall, in view of the state of the art, there is still a need to provide an efficient concept or a technical solution with regard to the prophylactic or therapeutic medical treatment of sleep disorders or dysregulation of the natural day / night rhythm or the circadian rhythm on the one hand, and with regard to a particularly non-therapeutic or non-medical promotion or support of sleep health or sleep behavior on the other. In particular, a high level of effectiveness should be guaranteed in this regard with overall good tolerability, while also enabling easy and safe use or application. In addition, habituation effects should be avoided. Against the background of the previously described state of the art, the present invention is therefore based on the object of providing an efficient concept orto provide a corresponding dosage form which enables an efficient effect in relation to the treatment of the sleep disorders in question and / or a particularly preventive or curative promotion or support, in particular of sleep health or sleep behaviour, whereby in this context the previously mentioned disadvantages of the prior art are also to be overcome or at least mitigated.

[0022] In particular, the present invention is based on the object of providing appropriate dosage forms that enable or ensure excellent efficacy combined with good tolerability and uncomplicated application in the treatment of sleep disorders or dysregulations of the natural day / night rhythm or the circadian rhythm, in particular also associated with difficulty falling asleep and staying asleep, or in the promotion and / or support of healthy sleep or sleep behavior, in particular with the related behavior of falling asleep and staying asleep. The aim is also to reduce the occurrence of side effects and avoid habituation, and to provide a stable, particularly storage-stable, composition or dosage form.

[0023] Furthermore, a further object of the present invention is to provide a corresponding dosage form, in particular in the form of a dietary supplement or in the form of a pharmaceutical dosage form or medicament, which has overall defined active properties, in particular with regard to the onset and duration of action, particularly against the background of the sleep disorders to be treated or the promotion or support of sleep health or sleep behavior. In particular, the present invention is intended to ensure a rapid onset of action after administration or application, with the effect of the dosage form according to the invention being maintained over the duration of sleep. In addition, there should also be coordination in this regard with regard to the corresponding active properties and profiles of the active ingredients used.In a completely surprising way, the applicant has now found that a very special dosage form, in particular for oral administration (with release of the active ingredient in the gastrointestinal tract, in particular in the stomach or intestine), is outstandingly suitable for the prophylactic or therapeutic treatment of sleep disorders or dysregulation of the natural day / night rhythm or the circadian rhythm and / or as a concept for promoting or supporting healthy sleep or sleep behavior, in particular the behavior of falling asleep and staying asleep, in particular with regard to enabling normalized sleep behavior with improved falling asleep and staying asleep, which is in each case based on the advantageous combination of active ingredients in the dosage form according to the invention on the one hand and the special design of the dosage form as a multi-phase tablet with a special distribution orArrangement of the active ingredients in the respective phases and, in this regard, special and coordinated disintegration and active ingredient release behavior on the other hand.

[0024] Overall, the dosage form according to the invention is therefore highly suitable and advantageous for use as a dietary supplement and as a pharmaceutical composition or medicinal product or drug, whereby overall a high level of effectiveness with regard to the underlying sleep disorders or with regard to the promotion of sleep health or sleep behavior is ensured, while at the same time being well tolerated.

[0025] As also described in detail below, the dosage form according to the invention is in the form of a multi-phase tablet which has at least two different phases or layers (inventive design as a two-layer tablet) and preferably three different phases or layers (preferably design as a three-layer tablet), wherein the respective phases or layers have different disintegration times or dissolution times (or durations) or different active ingredient release rates in the gastrointestinal tract, in particular in the stomach or intestine.The respective layers each contain specific and coordinated active ingredients, so that, against this background, an overall optimized release of the active ingredients is provided to ensure optimized efficacy in the treatment of sleep disorders, also in terms of time and in relation to the underlying natural sleep physiology. To solve the problem described above, the present invention thus proposes - according to a first aspect of the present invention - a dosage form, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, preferably for promoting or supporting sleep health or sleep behavior, or preferably for use in the prophylactic or therapeutic treatment of sleep disorders and the like, according to claim 1.Advantageous further developments and embodiments of this aspect of the invention are the subject of the relevant subsidiary or dependent claims.

[0026] A further subject matter of the present invention—according to a second aspect of the present invention—is the use of a dosage form according to the present invention in the field of dietary supplements or as a dietary supplement, in particular for the non-therapeutic or non-medical promotion or support of healthy sleep or sleep behavior or restful sleep or the natural day / night rhythm and / or the natural circadian rhythm according to the independent claim in this regard. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaim.

[0027] The present invention also relates—according to a third aspect of the present invention—to the use of a dosage form according to the invention, in particular for oral administration (for the production of a medicament or drug) for the prophylactic or therapeutic medical treatment of sleep disorders or dysregulations of the natural day / night rhythm and / or circadian rhythm, according to the independent claim in this regard. Advantageous further developments and refinements of this aspect of the invention are the subject of the relevant subclaim.

[0028] A further subject matter of the present invention—according to a fourth aspect of the present invention—is a related medicament, pharmaceutical, medical device, or homeopathic remedy containing or consisting of the dosage form according to the invention, according to the independent claim. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaim.

[0029] A further subject matter of the present invention—according to a fifth aspect of the present invention—is, in this context, the use of the medicament, pharmaceutical, medical device, or homeopathic remedy (for the production of a medicament or drug) for the prophylactic or therapeutic medical treatment of sleep disorders as well as the other complaints or illnesses mentioned herein, according to the independent claim in this regard. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaim.

[0030] Furthermore, according to a sixth aspect of the present invention, the present invention also provides a dietary supplement containing or consisting of the dosage form according to the invention, according to the independent claim in this regard. Advantageous further developments and refinements of this aspect of the invention are the subject of the relevant subclaim.

[0031] A further subject matter of the present invention—according to a seventh aspect of the present invention—is, in this context, the use of a dietary supplement according to the invention for the non-therapeutic or non-medical promotion or support of sleep health or sleep behavior, as well as the natural day / night rhythm or the natural circadian rhythm, according to the independent claim in this regard. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaim.

[0032] A further subject matter of the present invention—according to an eighth aspect of the present invention—is the method according to the invention for the prophylactic or therapeutic medical treatment of sleep disorders or dysregulations of the natural day / night rhythm or the natural circadian rhythm, according to the independent claim in this regard. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the related subclaim.

[0033] A further subject matter of the present invention—according to a ninth aspect of the present invention—is also the inventive method for the non-therapeutic or non-medical promotion or support of sleep health or sleep behavior or the natural day / night rhythm as well as the natural circadian rhythm according to the independent claim in this regard. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaim.

[0034] Finally, a further subject matter of the present invention—according to a tenth aspect of the present invention—is also the packaging unit according to the invention, which contains the dosage form according to the invention, according to the independent claim in this regard. Advantageous further developments and refinements of this aspect of the invention are the subject matter of the relevant subclaim.

[0035] It goes without saying that embodiments, forms of embodiment, advantages and the like which are listed below only for one aspect of the invention for the purpose of avoiding repetition, naturally also apply accordingly to the other aspects of the invention without this requiring separate mention.

[0036] Furthermore, it goes without saying that the following specifications of values, numbers, and ranges are not to be understood as limiting; it is self-evident to the person skilled in the art that, depending on the individual case or application, deviations from the specified range or specifications may occur without departing from the scope of the present invention.

[0037] Furthermore, all values ​​or parameter specifications or the like mentioned below can generally be determined using standardized or explicitly stated determination procedures or using determination methods that are familiar to the person skilled in the art. Furthermore, with all relative or percentage, particularly weight-related, quantity specifications mentioned below, it should be noted that these specifications must be selected or combined by the person skilled in the art with regard to the reference system used (e.g., dosage form) in such a way that the total - if necessary including other components or ingredients or additives or constituents, in particular as defined below - always results in 100% or 100% by weight. This is, however, self-evident to the person skilled in the art.

[0038] Furthermore, for the description of the present invention, the features of the present invention cited in connection with the specific configurations, embodiments, advantages, examples, or the like are also deemed to be disclosed in their combination. Thus, higher-level combinations of individual or multiple features cited for respective configurations, embodiments, application examples, or the like are also deemed to be disclosed.

[0039] In particular, for the features characterizing the invention, any combination of these features is also deemed to be disclosed, whereby embodiments of the same preference of the various features in their combination are preferred (e.g. amounts or ranges of amounts of the active ingredients and ingredients in question of the same preference).

[0040] Furthermore, in this context, it is particularly important that, with regard to the quantity specifications listed below relating to the various ingredients, in particular active ingredients, of the dosage form according to the invention, in particular relative quantity specifications or absolute quantity specifications, respective combinations relating to the various ingredients, in particular active ingredients, with the same preference or preference level are also disclosed. Likewise, all other combinations (i.e., combinations based on different preferences or different preference levels) are also disclosed.

[0041] Having said this, the present invention will now be explained in detail below: The subject matter of the present invention - according to a first aspect of the present invention - is thus a dosage form, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promoting and / or supporting, preferably for preventive and / or curative promoting and / or supporting, sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulties falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm,wherein the dosage form is designed as a multi-phase tablet, preferably a multi-layer tablet, in particular a two-layer tablet, preferably a three-layer tablet, wherein the dosage form and / or the multi-phase tablet has or consists of several, in particular at least two, preferably three, different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the multi-phase tablet has: a) a first phase ("immediate phase"), in particular a first layer ("immediate layer"), with rapid and / or immediate (immediate) disintegration and / or active ingredient release in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase,especially the first layer,

[0042] (i a ) Melatonin and

[0043] (ii a ) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0044] (ib) Melatonin and

[0045] (üb) contains at least one extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably an extract of valerian (Valeriana officinalis) ("valerian extract"), c) optionally a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer,

[0046] (i c) at least one (further) extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably at least two (further) extracts of different sleep-inducing and / or sedative drugs (plants orherbs), preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.Within the scope of the present invention, it is based on the dosage form according to the invention with the special design as a multi-phase tablet, preferably a multi-layer tablet, in particular a two-layer tablet, preferably a three-layer tablet, and with a special allocation of active ingredients - according to which (1.) the sleep-promoting active ingredient melatonin is present in the first phase ("immediate phase") or first layer ("immediate layer") with rapid or immediate disintegration or release of the active ingredient and also in the second phase ("depot phase") or second layer ("depot layer") with controlled or delayed disintegration or release of the active ingredient and according to which, in a targeted and purposeful manner, the first phase or layer additionally contains a special extract, namely an extract of (2.) Ashwagandha and according to which (3.) the second phase or second layer and also the optionally present third phase ("chronophase") orA third layer ("chronolayer") with continuous disintegration or active ingredient release is specially equipped with at least one (further) extract of at least one sleep-promoting or sedative drug. It has been surprisingly successful in ensuring optimized drug release of the specifically coordinated active ingredients in the treatment of sleep disorders, even over time after administration. This results in an overall improved efficacy and high efficiency in treating the underlying sleep disorders and in promoting and / or supporting sleep health or sleep behavior, as previously defined.

[0047] On the basis of the concept according to the invention, with regard to the treatment of sleep disorders or the promotion and / or support of healthy sleep or sleep behavior, both a rapid onset of action and a long-lasting effect that is optimized with regard to the sleep phase are guaranteed. In the context of the present invention, the dosage form according to the invention in the form of a multi-phase tablet is swallowed immediately upon oral administration and is thus transferred to the stomach and optionally subsequently to the intestine, in particular the small intestine, with the disintegration of the individual tablet phases or layers containing the active ingredient components primarily taking place in these regions. According to the invention, the behavior can in particular be such that after the dosage form has been swallowed, particularly in the stomach, a rapid or immediate disintegration of the first phase orLayer with immediate or rapid release of the active ingredient. This leads to rapid absorption of melatonin, whereby melatonin contributes to shortening the time it takes to fall asleep, thus ensuring faster falling asleep. The Ashwagandha extract, which is also present in the first phase or first layer and is also released or absorbed after application or swallowing of the dosage form, synergistically supports the process of falling asleep and thus enhances the effect of the melatonin. The first phase or first layer can in particular have a disintegration time of, for example, a maximum of 30 minutes, as explained in detail below. After oral application or swallowing of the dosage form according to the invention, there is also a delayed or prolonged disintegration (which, for example,can take up to eight hours) with the associated release of active ingredients from the second phase or second layer in the stomach or intestine, so that there is also a delayed or long-lasting release and absorption of melatonin and the extract of at least one sleep-inducing or sedative drug used in this regard, in particular valerian.

[0048] As a result, the melatonin level or melatonin concentration in the body is kept at a high level, which leads to an improvement in sleep (throughout) sleep behavior, whereby this effect can be further enhanced by the relaxing or calming effect of the extract based on a sleep-promoting or sedative drug. The third phase or third layer provided according to a preferred embodiment of the invention exhibits, after oral administration and swallowing, a particularly continuous disintegration or release of the active ingredient in the stomach or intestine, which can last, for example, up to six hours. The (further) extracts of at least one sleep-promoting or sedative drug used in this regard for the third phase or third layerSedative drugs, such as valerian and / or lavender, equally support sleep behavior, especially sleeping through the night, so that overall restful sleep can be guaranteed. The above statements show that the invention provides a special concept with a targeted combination of active ingredients based on melatonin, ashwagandha extract, and extracts of sleep-promoting or sedative drugs, with active ingredient release specifically tailored to sleep behavior in a targeted sequence and type of active ingredients. This concept also takes the specific sleep physiology into account and demonstrates overall high effectiveness and efficiency with regard to the treatment of sleep disorders and the support and / or promotion of healthy sleep and sleep behavior.

[0049] Due to the active ingredients used, in particular those based on the (exogenous) melatonin, which corresponds to the natural or endogenous (messenger) substance, as well as the natural plant extracts, side effects are reduced and habituation effects are largely avoided.

[0050] In summary, within the scope of the present invention, the special design of the dosage form according to the invention as a multi-phase tablet provides a system optimized for sleep behavior. Thus, based on the first phase or immediate phase, a rapid release of melatonin and Ashwagandha extract (rapid onset and synergistic effect associated with improved sleep onset behavior) is enabled; based on the second phase or depot phase, a long-lasting, controlled or delayed release of melatonin and the extract of at least one sleep-promoting or sedative drug is enabled; and with regard to the optionally or preferably present third phase or chronophase, a continuous release of the (further) extracts of at least one sleep-promoting or sedative drug used in this regard is enabled.

[0051] The dosage form according to the invention thus promotes faster falling asleep, improved sleep through the night, and more restful sleep, effectively counteracting corresponding problems with falling asleep and staying asleep. According to the invention, a multiple and, in particular, triple (active) effect is thus achieved based on the dosage form according to the invention, with the effectiveness extending over the entire sleep period or the entire night. According to the invention, particular emphasis is placed on the targeted interaction of the active ingredients used, taking into account the temporal course of the respective active ingredient release.In this context, the type and amount(s) of the respective underlying active ingredients preferably used according to the invention also play a major role, since the effectiveness of the dosage form according to the invention can be further increased on this basis and in conjunction with other measures.

[0052] As detailed below, according to a particularly preferred embodiment of the invention, an extract of valerian ("valerian extract") is used for the extract of at least one sleep-promoting or sedative drug in the second phase or second layer. According to this preferred embodiment, it is also particularly the case that for the third phase ("chronophase"), an extract of valerian ("valerian extract") and / or an extract of lavender ("lavender extract"), preferably an extract of valerian and an extract of lavender, is used for the (further) extract of at least one sleep-promoting or sedative drug. Valerian contributes particularly to maintaining sleep and relaxation. Lavender particularly supports recovery and contributes to better sleep, with the extract of valerian in particular also supporting or improving sleep.favored.

[0053] Within the scope of the present invention, it has been possible to optimally combine the active profiles and properties of melatonin, on the one hand, and ashwagandha extract, on the other, as well as the intended additional extracts of at least one sleep-promoting or sedative drug, in particular based on a valerian extract or a lavender extract, through a balanced and coordinated release from the respective phases or layers of the dosage form according to the invention. This results in an overall improved efficacy in the treatment of sleep disorders and in the promotion and / or support of healthy sleep.of sleep behavior, whereby in this regard there is also a surprising (effective) synergism, especially since melatonin and Ashwagandha extract can have different effects on a physiological level and thus also a multiple and reinforcing (effective) approach for the improvement of sleep behavior or for the treatment of sleep disorders.

[0054] Within the scope of the present invention, there is also in particular a combination of the active ingredients leading to an improvement in effectiveness, taking into account the respective pharmacodynamics and the respective pharmacokinetics, whereby the respective disintegration or the release of the active ingredient is specifically adapted and coordinated with regard to the underlying phases or layers.

[0055] In particular, based on the dosage form according to the invention with the special combination of active ingredients and targeted, different release of the respective active ingredients, a simplification in terms of application is also made possible, so that the tolerability and acceptance by the patient is also improved.

[0056] Within the scope of the present invention, a dosage form is thus provided with different and simultaneously coordinated phases or layers, in particular based on a two-layer system or a two-layer tablet, preferably based on a three-layer system or a three-layer tablet, which is optimized overall for oral administration and for the controlled or targeted disintegration or release of the active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine (here in particular in the small intestine). The disintegration or release of the active ingredient is specifically induced or brought about by contact of the dosage form with secretions in the digestive tract, in particular in the form of gastric juice and / or intestinal juice or other secretions, in particular those rich in enzymes.

[0057] Furthermore, it should be emphasized that with regard to the dosage form according to the invention, with the targeted use of melatonin, a particularly physiological active ingredient is used, which corresponds to the melatonin produced in the human body. Melatonin has a physiological and natural sleep-promoting effect—without wishing to be limited or invoked by this theory—and thus also regulates the day / night rhythm accordingly, while simultaneously being well tolerated. Furthermore, the dosage form according to the invention is largely based on the use of plant-based extracts with outstanding active properties and good tolerability in this regard.

[0058] Due to the active ingredients used, in particular those based on the (exogenous) melatonin, which corresponds to the natural or endogenous (messenger) substance, as well as the natural plant extracts, side effects are reduced and habituation effects are largely avoided.

[0059] The term "dosage form" as used in the context of the present invention is to be understood very broadly and defines or includes, in addition to pharmaceutical preparations or pharmaceuticals and medicinal products as such, also so-called medical devices, foodstuffs, dietary supplements or the like.

[0060] The term "food supplement," as used in the context of this document, defines and encompasses food products intended, in particular, to supplement the human metabolism with certain substances, including nutrients such as vitamins, minerals, and trace elements, as well as other substances. According to the general food law of the European Union (Regulation (EC) No. 178 / 2002), food supplements are considered food (see also the Food Regulation or the Food Supplements Regulation (NemV)).

[0061] The term "pharmaceutical dosage form" defines or includes a preparation of substances intended "to cure or prevent human disease" or which are suitable for influencing physiological functions or enabling a medical diagnosis.

[0062] Furthermore, the term "oral administration" as used in the context of the present invention refers in particular to the administration or ingestion of the dosage form via the mouth. In this context, the invention particularly provides that the dosage form according to the invention is preferably swallowed immediately after oral ingestion. With regard to the dosage form according to the invention, the disintegration or release of the active ingredient takes place in particular in the stomach and / or intestine, in particular the stomach and / or small intestine, with the disintegration or release of the active ingredient being induced or brought about by contact of the dosage form with gastric juice or intestinal juice. The dosage form according to the invention is therefore, overall, an oral administration form for swallowing or ingestion, in particular without prior chewing or crushing of the dosage form in the mouth.The dosage form is therefore swallowed whole or uncrushed.

[0063] The term "active ingredient," as used in the context of the present invention, refers in particular to the active ingredients or pharmaceutically active components used for the dosage form. In particular, the term in question also refers to the melatonin used according to the invention or the extracts used according to the invention, but also to any vitamins, immunostimulants, or the like that may be present. Accordingly, the term "active ingredient release" refers in particular to the release of the active ingredients or the substances in question, particularly after (oral) administration of the dosage form, with the release in question preferably occurring in the gastrointestinal tract, in particular in the stomach and / or intestine (here in particular in the small intestine).

[0064] The term "with rapid and / or immediate (immediate) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestines, following oral administration" refers in particular to the fact that for the first phase or layer there is a disintegration or release of active ingredient that begins at least essentially immediately upon entry into the gastrointestinal tract, in particular the stomach or intestines (preferably the stomach), wherein the disintegration or release of active ingredient is completed within a relatively short time, for example within 30 minutes.

[0065] Furthermore, the term "with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, following oral administration" is to be understood in particular to mean that, on the one hand, disintegration or release of active ingredient may not occur immediately upon entry of the dosage form into the gastrointestinal tract, but rather with a certain time delay after administration (which, for example and purely illustrative purposes, may also be made possible by arranging the second phase between the first phase and the third phase according to an embodiment of the invention). On the other hand, the disintegration or release of active ingredient extends over a relatively long period of time, for example, up to eight hours.

[0066] Furthermore, the term used for the third phase or layer "with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestines following oral administration" is to be understood in particular in such a way that upon entry into the gastrointestinal tract, in particular stomach and / or intestines, the disintegration or release of active ingredient (in particular in the stomach) begins at least essentially immediately and also lasts or is maintained over a medium to long period of time, for example up to six hours.

[0067] In the preferred case according to the invention that the dosage form is provided with a coating or film, the disintegration or release of the active ingredient generally only begins after or with the dissolution of this coating or film.

[0068] The term "extract" means or encompasses, within the scope of the present invention, particularly in connection with pharmaceutical purposes, preparations obtained by extraction ("extraction") from pharmaceutical drugs, which are either used directly as medicaments or can be further processed into such. In contrast, in the food sector, "extract" is understood to mean a mixture of substances obtained by selectively enriching characteristic components from a starting material using optionally employed extraction solvent(s). In the case of plant extracts, plants or parts thereof, in processed or unprocessed form, represent the starting material.

[0069] The "drug / extract ratio" (DEV) specified below for the respective extracts describes in particular the ratio of the mass of the drug used, i.e., the respective raw material quantity of the plants used for the extracts, to the obtained native extract. The drug / extract ratios preferably sought within the scope of the present invention advantageously guarantee that the advantages and special technical effects associated with the dosage form according to the invention, in particular the advantageous physiological or therapeutic effects, can be efficiently achieved, especially since some highly effective or highly concentrated extracts are used.The use of plant extracts having the aforementioned drug / extract ratios also allows for efficient formulation with relatively reduced dosage amounts, particularly since more active concentrated starting materials are used, so that ultimately, quantity- and weight-optimized dosage or product units of the dosage form according to the invention can also be provided.

[0070] In general, it can also be provided according to the invention with regard to the extracts used that they comprise or are formulated with at least one carrier, synonymously also referred to as excipient or matrix former of the extract. The use of a carrier in or with the plant extracts to be used in dosage forms according to the invention advantageously results in better dispersibility of the extracts in the dosage form by achieving a more homogeneous and uniform distribution, while also resulting in a more stable formulation. Furthermore, the use of a carrier advantageously allows for an improvement in the shelf life of the dosage form by also achieving a preservative effect on the basis of the carrier, in particular with regard to the active ingredients or constituents of the extracts.Through this stabilization and preservation of the extracts, an overall improved storage stability for the dosage form can be achieved.

[0071] The preferably used carrier advantageously has gastric juice-soluble or gastric juice-dispersible and / or intestinal juice-soluble or intestinal juice-dispersible properties, so that the dosage form can be dissolved or disintegrated in a defined and targeted manner upon contact with gastric or intestinal juice. The use of the carrier also ensures that the extracts are evenly and homogeneously distributed throughout the dosage form. In this respect, the use of a carrier also advantageously contributes to improved dispersibility and release of the plant extracts. Furthermore, the term "sleep-promoting," as used for the extracts used according to the invention, should be understood broadly and also refers to sleep-active and / or day / night rhythm-influencing properties of the underlying extracts.

[0072] Furthermore, the term "sedative," as used equally for the extracts used according to the invention, is to be understood broadly, whereby in particular, calming and relaxing properties, as well as dampening properties, or properties that reduce or alleviate states of anxiety, excitement, or tension, can also be included. In particular, anxiolytic properties can also be included in this regard.

[0073] As for the valerian extract, this can in particular be an extract of a plant from the genus Valeriana. According to the invention, the valerian extract is preferably an extract of true valerian (true valerian or Valeriana officinalis). As for the lavender extract, this can in particular be an extract of a plant from the genus Lavandula. According to the invention, the lavender extract is preferably an extract of true lavender (true lavender or Lavandula angustifolia).

[0074] The present invention is described further and in detail below, particularly with regard to further preferred embodiments.

[0075] According to the present aspect, the present invention also relates to a dosage form, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, in particular a dosage form as defined above, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promoting and / or supporting, preferably for preventive and / or curative promoting and / or supporting, sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulties in falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is in the form of a multi-phase tablet, preferably a multi-layer tablet,in particular a two-layer tablet, preferably a three-layer tablet, wherein the dosage form and / or the multi-phase tablet has or consists of several, in particular at least two, preferably three, different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the multi-phase tablet has: a) a first phase ("immediate phase"), in particular a first layer ("immediate layer"), with rapid and / or immediate (immediate) disintegration and / or active ingredient release in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer,

[0076] (i a) Melatonin and

[0077] (ii a ) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0078] (ib) Melatonin and

[0079] (üb) contains at least one extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably an extract of valerian (Valeriana officinalis) ("valerian extract"), c) optionally a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer,

[0080] (i c) at least one (further) extract of at least one sleep-promoting and / or sedative drug (plant or herb), preferably at least two (further) extracts of different sleep-promoting and / or sedative drugs (plants or herbs), preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains the extract of Ashwagandha in a total amount of at least 50 mg, in particular in a total amount in the range of 50 mg to 1.000 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.

[0081] According to this embodiment, a specific content or a specific total amount of the extract of Ashwagandha in the composition according to the invention is thus taken into account, in particular wherein the extract of Ashwagandha is particularly preferably present only in the first phase or first layer (with immediate disintegration or release of active ingredient).

[0082] The melatonin used in the present invention is described in more detail below: As previously stated, the melatonin used in the present invention is a substance that occurs physiologically in the body, specifically with regard to the body's own regulation of the day / night rhythm and with regard to sleep promotion. In this respect, melatonin also has a defined spectrum of activity.

[0083] In particular, according to the invention, melatonin is used in synthetic form, particularly where the melatonin corresponds in terms of its chemical structure to the melatonin naturally occurring in the body. The inventive concept is based in particular on the use or addition of exogenous melatonin.

[0084] The dosage form according to the invention is characterized overall by a high content or a high amount of melatonin, which is present particularly in the first and second phases or layers. This can promote particularly good sleep. The rapid release from the first phase or layer can achieve a high initial effect ("emergence of the melatonin level"; "falling asleep"), particularly in targeted combination with the Ashwagandha extract. Furthermore, the prolonged or controlled release of melatonin from the second phase or layer, particularly in combination with the extract of at least one sleep-promoting or sedative drug, in particular valerian extract, can also ensure a long-lasting effect or duration of action throughout the entire sleep period ("maintenance of the melatonin level"; "sleeping through the night").

[0085] In general, the dosage form according to the invention can comprise the melatonin in an (absolute) amount, in particular a total amount, of at least 1.6 mg, in particular at least 1.7 mg, preferably at least 1.8 mg, more preferably at least 1.9 mg. In particular, the dosage form can comprise the melatonin in an (absolute) amount, in particular a total amount, of at most 4 mg, in particular at most 3.5 mg, preferably at most 3 mg, more preferably at most 2.5 mg. In this context, it can be provided according to the invention in particular that the dosage form comprises the melatonin in an (absolute) amount, in particular a total amount, in the range from 1.6 mg to 4 mg, in particular in the range from 1.7 mg to 3.5 mg, preferably in the range from 1.8 mg to 3 mg, more preferably in the range from 1.9 mg to 2.5 mg.

[0086] In particular, the dosage form can comprise the melatonin in a (relative) amount, in particular total amount, of at least 0.02 wt.%, in particular at least 0.05 wt.%, preferably at least 0.1 wt.%, preferably at least 0.13 wt.%, particularly preferably at least 0.16 wt.%, based on the dosage form.

[0087] In addition, the dosage form can comprise the melatonin in a (relative) amount, in particular a total amount, of at most 0.9 wt.%, in particular a maximum of 0.5 wt.%, preferably a maximum of 0.3 wt.%, preferably a maximum of 0.25 wt.%, particularly preferably a maximum of 0.22 wt.%, based on the dosage form. Overall, the dosage form can comprise the melatonin in a (relative) amount, in particular a total amount, in the range from 0.02 wt.% to 0.9 wt.%, in particular in the range from 0.05 wt.% to 0.5 wt.%, preferably in the range from 0.1 wt.% to 0.3 wt.%, preferably in the range from 0.13 wt.% to 0.25 wt.%, particularly preferably in the range from 0.16 wt.% to 0.22 wt.%, based on the dosage form.

[0088] According to the invention, it can be provided in particular that the first phase, in particular the first layer, comprises the melatonin in an (absolute) amount, in particular the total amount, of at least 0.8 mg, in particular at least 0.85 mg, preferably at least 0.9 mg, preferably at least 0.95 mg, particularly preferably at least 1 mg. In particular, the first phase, in particular the first layer, can comprise the melatonin in an (absolute) amount, in particular the total amount, of at most 2.7 mg, in particular at most 2.2 mg, preferably at most 1.9 mg, preferably at most 1.7 mg, particularly preferably at most 1.4 mg.

[0089] According to the invention, it can also be provided in particular that the first phase, in particular the first layer, contains the melatonin in an (absolute) amount, in particular the total amount, in the range from 0.8 mg to 2.7 mg, in particular in the range from 0.85 mg to 2.2 mg, preferably in the range from 0.9 mg to 1.9 mg, more preferably in the range from 0.95 mg to 1.7 mg, particularly preferably in the range from 1 mg to 1.4 mg. The defined amount of melatonin in the first phase can achieve a positive effect with regard to promoting sleep in connection with the immediate release of the active ingredient from the first phase or layer.

[0090] In addition, the second phase, in particular the second layer, can comprise the melatonin in an (absolute) amount, in particular the total amount, of at least 0.7 mg, in particular at least 0.75 mg, preferably at least 0.8 mg, preferably at least 0.85 mg, particularly preferably at least 0.9 mg. In particular, the second phase, in particular the second layer, can comprise the melatonin in an (absolute) amount, in particular the total amount, of at most 2.3 mg, in particular at most 1.8 mg, preferably at most 1.6 mg, preferably at most 1.3 mg, particularly preferably at most 1.1 mg. In addition, the second phase, in particular the second layer, can contain the melatonin in an (absolute) amount, in particular total amount, in the range from 0.7 mg to 2.3 mg, in particular in the range from 0.8 mg to 1.8 mg, preferably in the range from 0.85 mg to 1.6 mg, preferably in the range from 0.85 mg to 1.3 mg, particularly preferably in the range from 0.9 mg to 1.1 mg.

[0091] With regard to the above-mentioned amounts of the second phase or layer, the long-lasting effect of melatonin with the corresponding promotion of sleeping through the night can be further optimized with the controlled or delayed release of the active ingredient in relation to the second phase or layer.

[0092] According to the invention, it can be provided, in particular, that the (absolute) amount (weight) of melatonin in the first phase, in particular the first layer, is greater than the (absolute) amount (weight) of melatonin in the second phase, in particular the second layer. On this basis, the promotion of falling asleep on the one hand and sleeping through the night on the other hand can be further adjusted or tailored.

[0093] In this context, it can be provided in particular that the weight ratio of melatonin in the first phase, in particular the first layer, to melatonin in the second phase, in particular the second layer, is in the range from 3:1 to 1:2, in particular in the range from 2:1 to 1:1.5, preferably in the range from 1.5:1 to 1:1.1, more preferably in the range from 1.2:1 to 1:1. According to the invention, it is particularly provided that the melatonin is present and / or used in pure form, in particular wherein the melatonin has a purity of at least 95% by weight, preferably at least 97% by weight, more preferably at least 99% by weight, based on the melatonin.

[0094] This makes it possible to provide a particularly defined spectrum of activity, while also avoiding or at least reducing any side effects. According to the invention, it can also be provided in principle that the melatonin is present and / or used in the form of a derivative or precursor, in particular in the form of tryptophan, especially L-tryptophan, and / or hydroxytryptophan. In particular, the aforementioned compounds can be converted into melatonin in the body.

[0095] According to the invention, it can also be further provided that the third phase, in particular the third layer, contains at least substantially no melatonin and / or is substantially free of melatonin. In particular, it can be provided that only and / or exclusively the first phase, in particular the first layer, and the second phase, in particular the second layer, contain melatonin.

[0096] The following is a further comment on the Ashwagandha extract used in the invention:

[0097] Ashwagandha, or Withania somnifera, synonymously known as Indian ginseng, winter cherry, or Indian ginseng, belongs to the genus Withania within the nightshade family. The name Withania somnifera is specifically attributed to Michel Felix Dunal. Withania somnifera is widespread, for example, in Africa, the Canary Islands and Cape Verde, Spain, Greece, Sicily and Sardinia, the Arabian Peninsula, the Middle East and South Asia, China, and even Mauritius.

[0098] The extract is obtained primarily from the leaves and / or roots. Ashwagandha and the corresponding extracts also contain so-called withanolides, which are a group of chemical compounds, particularly lactones linked to a steroid skeleton, preferably with 28 carbon atoms, or their lactones or seco derivatives. Withanolides can exhibit corresponding active properties, for example, an anti-inflammatory effect. A high withanolide content is also a quality characteristic of corresponding Ashwagandha extracts. Ashwagandha extracts also contain other constituents, such as alkaloids, tannins, and flavonoids.

[0099] According to the invention, in particular an extract of Ashwagandha or Withania somnifera can be used, as is commercially available under the name or product name Shoden®, in particular from Arjuna Natural Ltd. Such an extract is characterized by a particularly high proportion of withanolides (in particular 35% by weight, in particular determined by HPLC).

[0100] The extract of Ashwagandha or its ingredients support in the first phase or layer with the immediate decomposition or release of active ingredients, in particular the sleep-inducing effect of melatonin, particularly in a synergistic manner, and also - without wishing to be limited to or invoke this theory - due to a physiologically different or complementary mechanism of action compared to the effect of melatonin.

[0101] In particular, Ashwagandha extract and its constituents have a sleep-promoting effect, particularly inducing sleep. Ashwagandha extract and its constituents also have an adaptogenic effect, meaning the active plant substances underlying Ashwagandha extract support the body's ability to adapt to increased physical and emotional stress, which in turn has a positive effect on sleep patterns, especially with long-term use. In particular, stress resistance can also be increased, also as a result of the long-term effects of Ashwagandha extract and its constituents.

[0102] The adaptogenic effect is particularly associated with the fact that Ashwagandha extract and its constituents support the body in responding to psychological, physical, and / or cellular stress, for example, particularly insofar as normal mental and physical body function is restored. This can reduce stress symptoms and anxiety, which also leads to a positive influence on sleep behavior.

[0103] In addition, Ashwagandha extract and its constituents have anti-stress and anti-anxiety effects, as well as immunomodulatory, antioxidant, blood-forming, anti-inflammatory, anti-aging, and anti-dementia effects. In particular, Ashwagandha extract and its constituents have positive effects on the central nervous system, hormonal balance, and the cardiopulmonary system.

[0104] Overall, this results in a targeted interaction between melatonin on the one hand and ashwagandha extract on the other. In the first phase or layer, there is a rapid or immediate joint release of melatonin and ashwagandha extract or its constituents, which contributes to shortening the time it takes to fall asleep. Ashwagandha extract further supports sleep onset and the related effects of melatonin, particularly due to its equally sleep-promoting effect and, in addition, due to the adaptogenic effect of ashwagandha extract.

[0105] According to the invention, it can be provided in particular that the dosage form comprises the extract of Ashwagandha in an (absolute) amount, in particular total amount, of at least 10 mg, in particular at least 20 mg, preferably at least 50 mg, preferably at least 100 mg.

[0106] In particular, the dosage form can comprise the extract of Ashwagandha in an (absolute) amount, in particular a total amount, of at most 1,000 mg, in particular a maximum of 600 mg, preferably a maximum of 400 mg, more preferably a maximum of 200 mg. In addition, the dosage form can comprise the extract of Ashwagandha in an (absolute) amount, in particular a total amount, in the range from 10 mg to 1,000 mg, in particular in the range from 20 mg to 600 mg, preferably in the range from 50 mg to 400 mg, more preferably in the range from 100 mg to 200 mg. In addition, the dosage form can comprise the extract of Ashwagandha in a (relative) amount, in particular a total amount, of at least 0.2 wt.%, in particular at least 0.5 wt.%, preferably at least 1 wt.%, preferably at least 5 wt.%, particularly preferably at least 8 wt.%, based on the dosage form.

[0107] In this context, the dosage form may comprise the extract of Ashwagandha in a (relative) amount, in particular total amount, of at most 50 wt.%, in particular at most 40 wt.%, preferably at most 30 wt.%, preferably at most 20 wt.%, particularly preferably at most 15 wt.%, based on the dosage form.

[0108] According to a specific and particularly preferred embodiment, the dosage form according to the invention can comprise the extract of Ashwagandha in a (relative) amount, in particular total amount, in the range from 0.2 wt.% to 50 wt.%, in particular in the range from 0.5 wt.% to 40 wt.%, preferably in the range from 1 wt.% to 30 wt.%, preferably in the range from 5 wt.% to 20 wt.%, particularly preferably in the range from 8 wt.% to 15 wt.%, based on the dosage form.

[0109] In particular with regard to the combined effect with the melatonin used according to the invention, it can be provided with regard to the first phase or layer to use the extract of Ashwagandha in specific amounts in this regard: Thus, it can be provided according to the invention that the first phase, in particular first layer, comprises the extract of Ashwagandha in an (absolute) amount, in particular total amount, of at least 10 mg, in particular at least 20 mg, preferably at least 50 mg, preferably at least 100 mg.

[0110] In particular, the first phase, in particular the first layer, can comprise the Ashwagandha extract in an (absolute) amount, in particular a total amount, of at most 1,000 mg, in particular a maximum of 600 mg, preferably a maximum of 400 mg, preferably a maximum of 200 mg. Specifically, the first phase, in particular the first layer, can comprise the Ashwagandha extract in an (absolute) amount, in particular a total amount, in the range of 10 mg to 1,000 mg, in particular in the range of 20 mg to 600 mg, preferably in the range of 50 mg to 400 mg, preferably in the range of 100 mg to 200 mg.

[0111] Furthermore, the invention can provide that the second phase, in particular the second layer, contains at least substantially no Ashwagandha extract and / or is substantially free of the Ashwagandha extract. Furthermore, the invention can provide that the third phase, in particular the third layer, contains at least substantially no Ashwagandha extract and / or is substantially free of the Ashwagandha extract.

[0112] In particular, it can be provided according to the invention that the second phase, in particular second layer, and the third phase, in particular third layer, at least substantially contain no extract of Ashwagandha and / or are substantially free of the extract of Ashwagandha.

[0113] According to a preferred embodiment of the invention, it can be provided in particular that only and / or exclusively the first phase, in particular the first layer, contains the Ashwagandha extract. This can specifically support the sleep-onset phase in conjunction with the rapid release of melatonin.

[0114] According to the invention, it can be provided, in particular, that the Ashwagandha extract is a dry extract and / or is in the form of a dry extract. In particular, the Ashwagandha extract can be a root and / or leaf extract, in particular a root and leaf extract.

[0115] Preferably, the Ashwagandha extract can have a drug / extract ratio (DEV) in the range of 10:1 to 80:1, in particular in the range of 20:1 to 60:1, preferably in the range of 30:1 to 40:1, more preferably in the range of 35:1 to 45:1. On this basis, a high efficacy with respect to the extract can be ensured.

[0116] According to a particularly preferred embodiment of the dosage form according to the invention, the Ashwagandha extract can comprise at least one carrier (excipient, matrix former) ("carrier Ashwagandha extract") or be formulated with at least one carrier (excipient, matrix former) ("carrier Ashwagandha extract"). This leads to improved distribution of the extract in the dosage form and also increases the stability of the formulation. On this basis, the release behavior is also improved.

[0117] According to the invention, the carrier in this context can be an inorganic or organic carrier. In particular, the carrier can be a gastric juice-soluble or gastric juice-dispersible and / or an intestinal juice-soluble or intestinal juice-dispersible carrier. This also improves the release of the active ingredient from the extract in the stomach or intestine.

[0118] According to the invention, the carrier of the Ashwagandha extract can be a carbohydrate-based and / or carbohydrate-containing, preferably oligosaccharide- and / or polysaccharide-based and / or carbohydrate-containing, carrier, preferably maltodextrin. Furthermore, the carrier of the Ashwagandha extract can be a carrier in the form of a silicon oxide, preferably silicon dioxide.

[0119] In general, the extract of Ashwagandha may contain the carrier(s) in an amount ranging from 1% to 75% by weight, in particular from 5% to 70% by weight, preferably from 10% to 60% by weight, more preferably from 20% to 50% by weight, based on the extract.

[0120] As previously stated, the dosage form according to the invention, and in particular the first phase or first layer, has a defined or high content of withanolide glycosides. In this context, the invention may, in particular, provide for the withanolide glycosides to be provided by the Ashwagandha extract and / or for the withanolide glycosides to be contained in the Ashwagandha extract.

[0121] According to the invention, in this regard, the Ashwagandha extract may contain the withanolide glycosides in a (relative) amount of at least 10 wt.%, in particular at least 20 wt.%, preferably at least 30 wt.%, based on the extract. Furthermore, the invention may provide that the Ashwagandha extract contains the withanolide glycosides in a (relative) amount in the range from 10 wt.% to 60 wt.%, in particular in the range from 20 wt.% to 55 wt.%, preferably in the range from 30 wt.% to 50 wt.%, based on the extract. The withanolide glycoside content can be determined, for example, by means of HPLC.

[0122] The dosage form according to the invention, preferably the first phase, in particular the first layer, can contain the withanolide glycosides in an (absolute) amount in the range from 15 mg to 400 mg, in particular in the range from 20 mg to 200 mg, preferably in the range from 25 mg to 100 mg, more preferably in the range from 30 mg to 60 mg.

[0123] In particular, the dosage form may contain the withanolide glycosides in a (relative) amount in the range from 0.1 wt.% to 50 wt.%, in particular in the range from 1 wt.% to 30 wt.%, preferably in the range from 1.5 wt.% to 10 wt.%, preferably in the range from 2 wt.% to 7 wt.%, based on the dosage form.

[0124] Furthermore, according to the invention, it can be provided in particular that the second phase, in particular the second layer, contains at least substantially no withanolide glycosides and / or is substantially free of withanolide glycosides. Furthermore, according to the invention, it is provided in particular that the third phase, in particular the third layer, contains at least substantially no withanolide glycosides and / or is substantially free of withanolide glycosides.

[0125] In particular, according to the invention, the second phase, in particular the second layer, and the third phase, in particular the third layer, each contain at least substantially no withanolide glycosides and / or are substantially free of withanolide glycosides, in particular wherein only or exclusively the first phase, in particular the first layer, contains the withanolide glycosides.

[0126] The sleep-promoting or sedative drugs used according to the invention and the corresponding extracts are described in more detail below:

[0127] According to the invention, it can generally be such that the sleep-promoting and / or sedative drug, in particular the sleep-promoting and / or sedative drug of the second and / or third phase, in particular the second and / or third layer, in particular each independently of one another, is selected from the group of valerian (Valeriana officinalis), lavender (Lavandula angustifolia), hops, St. John's wort, lavender, lemon balm, in particular lemon balm, kava-kava, passionflower, chamomile, cranberry, walnut, pistachio, golden poppy (herb), bitter orange (bitter orange leaves), orange (orange blossoms), linden (linden blossoms), bergamot, passionflower, Montmorency sour cherry, hawthorn, and combinations and mixtures thereof, preferably valerian (Valeriana officinalis) and / or lavender (Lavandula angustifolia).

[0128] In general, the aforementioned drugs have a sleep-inducing, sedative, or calming effect. This can further support sleeping through the night. The aforementioned drugs thus contribute overall to better sleep. Furthermore, the aforementioned drugs can exhibit tranquilizer, sedative, or tranquilizer properties. In particular, they can have anxiolytic and, in turn, calming and relaxing properties, which also promote sleep. Preferably, the aforementioned drugs in the form of St. John's wort, lemon balm, kava kava, passionflower, valerian, hops, orange blossom, and lavender possess tranquilizer properties and thus, in particular, anxiolytic and, in turn, calming properties. This also positively promotes sleep.

[0129] In particular, the valerian used according to the invention has a further function with regard to supporting sleep through the night, whereby the lavender preferably used according to the invention supports recovery and overall contributes to improved sleep behavior. According to the invention, the dosage form can generally comprise the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract(s) of at least one sleep-promoting and / or sedative drug of the second and optionally present third phase, in particular the second and optionally present third layer, in an (absolute) amount, in particular the total amount, in the range from 10 mg to 4,000 mg, in particular in the range from 50 mg to 3,000 mg, preferably in the range from 100 mg to 1,500 mg, more preferably in the range from 200 mg to 1,000 mg.

[0130] In addition, the dosage form can comprise the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract(s) of at least one sleep-promoting and / or sedative drug of the second and optionally present third phase, in particular second and optionally present third layer, in a (relative) amount, in particular total amount, in the range from 0.5 wt.% to 80 wt.%, in particular in the range from 1 wt.% to 70 wt.%, preferably in the range from 5 wt.% to 60 wt.%, preferably in the range from 10 wt.% to 50 wt.%, particularly preferably in the range from 15 wt.% to 40 wt.%, based on the dosage form.

[0131] Advantageously, according to the invention, the extract of at least one sleep-promoting and / or sedative drug, in particular the extract of at least one sleep-promoting and / or sedative drug of the second and / or third phase, in particular second and / or third layer, in particular each independently of one another, is a dry extract and / or is designed as a dry extract.

[0132] The drug / extract ratio (DEV) is also important with regard to extracts of at least one sleep-inducing or sedative drug, particularly with regard to ensuring a high level of efficacy of the underlying extracts.

[0133] In this context, it can be provided in particular that the extract of at least one sleep-promoting and / or sedative drug, in particular the extract of at least one sleep-promoting and / or sedative drug of the second and / or third phase, in particular second and / or third layer, in particular each independently of one another, in each case has a drug / extract ratio (DEV) in the range from 1:1 to 100:1, in particular in the range from 2:1 to 80:1, preferably in the range from 3:1 to 50:1, preferably in the range from 4:1 to 40:1.

[0134] According to the invention, it can further be provided that the extract of at least one sleep-promoting and / or sedative drug, in particular the extract of at least one sleep-promoting and / or sedative drug of the second and / or third phase, in particular the second and / or third layer, in particular independently of one another, comprises at least one carrier (excipient, matrix former, or "carrier-drug-extract") and / or is formulated with at least one carrier (excipient, matrix former, or "carrier-drug-extract"). The use of a carrier (also) for the extract of at least one sleep-promoting or sedative drug equally enables, in particular, a homogeneous distribution of the extract in the dosage form or the corresponding phases or layers, as well as, furthermore, a defined release of the active ingredient.

[0135] In this context, the invention may, in particular, provide for the carrier to be an inorganic or organic carrier. The invention may also provide for the carrier to be enteric-soluble or enteric-dispersible and / or enteric-soluble or enteric-dispersible.

[0136] In particular, the carrier can be a carbohydrate-based and / or carbohydrate-containing, preferably oligo- and / or polysaccharide-based and / or carbohydrate-containing, carrier, preferably maltodextrin. According to the invention, it can also be provided that the carrier is a carrier in the form of a silicon oxide, preferably silicon dioxide.

[0137] According to the invention, the extract of at least one sleep-promoting and / or sedative drug, in particular the extract of at least one sleep-promoting and / or sedative drug of the second and / or third phase, in particular second and / or third layer, in particular independently of one another, can contain the carrier(s) in an amount in the range from 1% by weight to 90% by weight, in particular in the range from 2% by weight to 80% by weight, preferably in the range from 3% by weight to 70% by weight, preferably in the range from 5% by weight to 60% by weight, based on the respective extract.

[0138] According to a preferred embodiment of the invention, the dosage form comprises a valerian extract, particularly in the additional and / or optionally present third phase or layer. Valerian has a particular effect on states of rest and anxiety, as well as sleep disorders, so that, particularly when combined with the other active ingredients and dosage forms according to the invention, overall sleep behavior can be improved, particularly with regard to sleep through the night.

[0139] In this context, it can be provided in particular that the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of valerian, in an (absolute) amount, in particular total amount, in the range from 10 mg to 1,200 mg, in particular in the range from 50 mg to 800 mg, preferably in the range from 100 mg to 600 mg, preferably in the range from 200 mg to 400 mg.

[0140] In addition, it can also be provided according to the invention that the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of valerian, in a (relative) amount, in particular total amount, in the range from 0.5 wt.% to 60 wt.%, in particular in the range from 1 wt.% to 50 wt.%, preferably in the range from 5 wt.% to 45 wt.%, preferably in the range from 10 wt.% to 40 wt.%, particularly preferably in the range from 15 wt.% to 35 wt.%, based on the dosage form.

[0141] According to a particularly preferred embodiment of the present invention, in the second phase, in particular the second layer, the extract of at least one sleep-promoting and / or sedative drug comprises and / or is formed from a valerian extract; and / or wherein the second phase, in particular the second layer, contains a valerian extract. In this context, it can also be provided according to the invention that the second phase, in particular the second layer, contains no further and / or different extract of at least one sleep-promoting and / or sedative drug apart from the valerian extract.

[0142] According to the invention, it can be provided, in particular, that the valerian extract is present in the second phase or layer with controlled or delayed expiration or active ingredient release. Thus, with appropriate application of the dosage form, a sustained release of the active ingredient can occur with respect to the valerian extract, accompanied by a corresponding long-term effect with regard to calming and promoting sleep through the night.

[0143] According to the invention, it can be provided in particular that the second phase, in particular second layer, comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of valerian, in an (absolute) amount, in particular total amount, in the range from 10 mg to 800 mg, in particular in the range from 20 mg to 600 mg, preferably in the range from 50 mg to 400 mg, preferably in the range from 80 mg to 200 mg.

[0144] According to the invention, it can also be provided in particular that the first phase, in particular the first layer, contains at least substantially no valerian extract and / or is substantially free of the valerian extract. Furthermore, the second phase, in particular the second layer, and the third phase, in particular the third layer, can contain the valerian extract according to the invention.

[0145] According to a preferred embodiment of the invention, it can also be provided that only or exclusively the second phase, in particular the second layer, and the (optionally present) third phase, in particular the third layer, contain the extract of valerian.

[0146] According to a preferred embodiment, it can also be provided that the third phase or layer (also) contains a valerian extract, preferably in combination with at least one further extract of at least one sleep-promoting or sedative drug, preferably in combination with a lavender extract, as also explained in detail below. According to the invention, it is thus particularly provided that in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from a valerian extract, or that the third phase, in particular the third layer, contains a valerian extract.

[0147] Thus, according to the invention, it is preferred that the third phase or layer with the continuous disintegration or release of active ingredients also contains a valerian extract. This continuous disintegration or release of active ingredients can further support sleep through the night.

[0148] According to the invention, it can be provided in particular that the third phase, in particular third layer, comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of valerian, in an (absolute) amount, in particular total amount, in the range from 15 mg to 900 mg, in particular in the range from 30 mg to 700 mg, preferably in the range from 60 mg to 500 mg, preferably in the range from 100 mg to 250 mg.

[0149] According to one embodiment of the invention, it can be provided that the (absolute) amount (weight) of valerian extract in the third phase, in particular the third layer, is greater than the (absolute) amount (weight) of valerian extract in the second phase, in particular the second layer. According to the invention, the weight ratio of valerian extract in the second phase, in particular the second layer, to valerian extract in the third phase, in particular the third layer, can be in the range from 2:1 to 1:3, in particular in the range from 1.5:1 to 1:2, preferably in the range from 1.1:1 to 1:1.5, more preferably in the range from 1:1 to 1:1.2.

[0150] As far as the valerian extract is concerned, it can be formulated in particular as follows: In particular, the valerian extract can be a dry extract or be formulated as a dry extract. Preferably, the valerian extract is a root extract. Specifically, the valerian extract can have a drug / extract ratio (DEV) in the range of 1:1 to 30:1, in particular in the range of 2:1 to 20:1, preferably in the range of 3:1 to 10:1. Furthermore, the valerian extract can specifically comprise at least one carrier (excipient, matrix former) ("carrier valerian extract") or be formulated with at least one carrier (excipient, matrix former) ("carrier valerian extract"). In this regard, the carrier can be an inorganic or organic carrier. In particular, the carrier may be a gastro-soluble or gastro-dispersible and / or an enteric-soluble or enteric-dispersible carrier.Furthermore, the carrier can be a carbohydrate-based and / or carbohydrate-containing, preferably oligo- and / or polysaccharide-based and / or carbohydrate-containing, carrier, preferably maltodextrin. Furthermore, the valerian extract can contain the carrier(s) in an amount ranging from 5 wt.% to 80 wt.%, in particular in the range from 10 wt.% to 60 wt.%, preferably in the range from 20 wt.% to 40 wt.%, based on the extract.

[0151] The lavender extract used in the invention is further described below:

[0152] In particular, it can be provided that the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of lavender, in an (absolute) amount, in particular total amount, in the range of 5 mg to 1,000 mg, in particular in the range of 10 mg to 600 mg, preferably in the range of 50 mg to 400 mg, preferably in the range of 75 mg to 200 mg.

[0153] In addition, it can be provided that the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of lavender, in a (relative) amount, in particular total amount, in the range from 0.2 wt.% to 55 wt.%, in particular in the range from 0.5 wt.% to 45 wt.%, preferably in the range from 1 wt.% to 40 wt.%, preferably in the range from 3 wt.% to 30 wt.%, particularly preferably in the range from 5 wt.% to 25 wt.%, based on the dosage form.

[0154] According to a particularly preferred embodiment of the invention, in particular in combination with a valerian extract in the relevant phase or layer, it can be provided that in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from a lavender extract, preferably comprises. In particular, it can be provided that the third phase, in particular the third layer, contains a lavender extract, in particular in combination and / or together with a valerian extract, in particular as defined above.

[0155] In particular, the third phase, in particular third layer, may comprise the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of lavender, in an (absolute) amount, in particular total amount, in the range of 10 mg to 750 mg, in particular in the range of 20 mg to 550 mg, preferably in the range of 50 mg to 350 mg, preferably in the range of 70 mg to 175 mg.

[0156] As far as the lavender extract is concerned, this can in particular be a dry extract or be in the form of a dry extract. In particular, the lavender extract is a flower extract. According to the invention, the lavender extract can have a drug / extract ratio (DEV) in the range from 1:1 to 50:1, in particular in the range from 3:1 to 25:1, preferably in the range from 5:1 to 15:1.

[0157] In addition, the lavender extract can comprise at least one carrier (excipient, matrix former) ("carrier lavender extract") or be formulated with at least one carrier (excipient, matrix former) ("carrier lavender extract"). According to the invention, the carrier can be an inorganic or organic carrier. Furthermore, the carrier can be a gastric juice-soluble or gastric juice-dispersible and / or intestinal juice-soluble or intestinal juice-dispersible carrier. Furthermore, the carrier can be a carbohydrate-based and / or carbohydrate-containing, preferably oligo- and / or polysaccharide-based and / or carbohydrate-containing, carrier, preferably maltodextrin. According to the invention, the lavender extract can contain the carrier(s) in an amount ranging from 1 wt.% to 60 wt.%, in particular in the range from 2 wt.% to 40 wt.%, preferably in the range from 5 wt.% to 20 wt.%, based on the extract.

[0158] According to an embodiment of the invention, it can also be provided that the first phase, in particular first layer, and / or the second phase, in particular second layer, preferably the first phase, in particular first layer, and the second phase, in particular second layer, at least substantially contains or contain no extract of lavender and / or is or are substantially free of the extract of valerian.

[0159] In particular, it can be provided that, as previously stated, the third phase, in particular the third layer, contains a lavender extract. Preferably, according to the invention, it can be provided that only or exclusively the third phase, in particular the third layer, contains a lavender extract.

[0160] As previously stated, according to a preferred and specific embodiment, the third phase, in particular the third layer, can contain a combination of a valerian extract and a lavender extract. According to the invention, it is particularly provided that in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of valerian and / or an extract of lavender, in particular an extract of valerian and an extract of lavender. In particular, the third phase, in particular the third layer, can contain an extract of valerian and / or an extract of lavender, in particular an extract of valerian and an extract of lavender.According to the invention, it can also be provided in this context that the third phase, in particular the third layer, contains no further and / or different extract of at least one sleep-promoting and / or sedative drug apart from the extract of valerian and / or the extract of lavender, in particular the extract of valerian and the extract of lavender.

[0161] In principle, it can be provided according to the invention that the (absolute) amount (weight) of lavender extract in the third phase, in particular the third layer, is smaller than the (absolute) amount (weight) of valerian extract in the third phase, in particular the third layer. In particular, the weight ratio of lavender extract in the third phase, in particular the third layer, to valerian extract in the third phase, in particular the third layer, can be in the range from 1.5:1 to 1:5, in particular in the range from 1.2:1 to 1:3, preferably in the range from 1.1:1 to 1:2, more preferably in the range from 1:1 to 1:1.5. According to the invention, the dosage form can contain linalool, which is preferably provided by the lavender extract. In this context, linalool represents a typical constituent or ingredient of lavender extract.Linalool is an organic compound from the group of acyclic monoterpene alcohols. Linalool has a calming and anti-inflammatory effect.

[0162] Particularly preferably, the dosage form, preferably the third phase, in particular the third layer, can contain linalool, in particular linalool provided by the extract of lavender, in particular in a total amount of at least 3 mg, in particular at least 5 mg, preferably at least 8 mg and / or in particular in a total amount in the range from 3 mg to 50 mg, in particular in the range from 5 mg to 40 mg, preferably in the range from 8 mg to 30 mg.

[0163] As previously stated, the linalool may be provided by the lavender extract or the linalool may be contained in the lavender extract. In particular, the lavender extract may contain the linalool in a (relative) amount of at least 4 wt.%, in particular at least 6 wt.%, preferably at least 8 wt.%, based on the extract. Furthermore, the lavender extract may contain the linalool in a (relative) amount ranging from 4 wt.% to 40 wt.%, in particular ranging from 6 wt.% to 30 wt.%, preferably ranging from 8 wt.% to 20 wt.%, based on the extract. In this regard, the dosage form may contain the linalool in a (relative) amount in the range of 0.05 wt.% to 25 wt.%, in particular in the range of 0.1 wt.% to 15 wt.%, preferably in the range of 0.2 wt.% to 10 wt.%, preferably in the range of 0.5 wt.% to 5 wt.%, based on the dosage form.

[0164] According to the invention, it can be provided in particular that the first phase, in particular the first layer, contains at least substantially no linalool and / or is substantially free of linalool. In particular, it can be provided that the second phase, in particular the second layer, contains at least substantially no linalool or is substantially free of linalool. In particular, the first phase, in particular the first layer, and the second phase, in particular the second layer, can each contain at least substantially no linalool and / or be substantially free of linalool. According to the invention, it can be provided in particular that only or exclusively the third phase, in particular the third layer, contains the linalool.

[0165] According to a preferred embodiment of the invention, it can be provided, in particular, that, as previously stated, the second phase or layer contains a valerian extract, and that the third phase or layer contains a valerian extract and a lavender extract. On this basis, the respective ingredients are particularly well-balanced with regard to the sleep-promoting effect of the dosage form according to the invention.

[0166] In this context, it can thus be provided that in the second phase, in particular the second layer, the extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of valerian; and / or wherein the second phase, in particular the second layer, contains an extract of valerian, in particular wherein the second phase, in particular the second layer, comprises the extract of valerian in an (absolute) amount, in particular total amount, in the range from 10 mg to 800 mg, in particular in the range from 20 mg to 600 mg, preferably in the range from 50 mg to 400 mg, preferably in the range from 80 mg to 200 mg; and that in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of valerian;and / or wherein the third phase, in particular the third layer, contains an extract of valerian, in particular wherein the third phase, in particular the third layer, comprises the extract of valerian in an (absolute) amount, in particular the total amount, in the range from 15 mg to 900 mg, in particular in the range from 30 mg to 700 mg, preferably in the range from 60 mg to 500 mg, preferably in the range from 100 mg to 250 mg; and that in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of lavender;and / or wherein the third phase, in particular third layer, contains an extract of lavender, in particular wherein the third phase, in particular third layer, comprises the extract of lavender in an (absolute) amount, in particular total amount, in the range from 10 mg to 750 mg, in particular in the range from 20 mg to 550 mg, preferably in the range from 50 mg to 350 mg, preferably in the range from 70 mg to 175 mg, and / or in particular wherein the third phase, in particular the third layer, contains linalool, in particular linalool provided by the extract of lavender, in particular in a total amount of at least 3 mg, in particular at least 5 mg, preferably at least 8 mg and / or in particular in a total amount in the range from 3 mg to 50 mg, in particular in the range from 5 mg to 40 mg, preferably in the range from 8 mg to 30 mg.;

[0167] According to the invention, the dosage form according to the invention is preferably designed as a three-layer tablet. In particular, it is preferred that the three-layer tablet has no further phase or layer besides the first phase or layer, the second phase or layer, and the third phase or layer, i.e., in terms of the number of layers, it consists of the first phase or layer, the second phase or layer, and the third phase or layer. In particular, the dosage form or three-layer tablet additionally has a coating, in particular as defined herein.

[0168] As far as the dosage form according to the invention is concerned, it can contain further ingredients or active ingredients, in particular as listed below:

[0169] Thus, according to the invention, it can in particular be provided that the dosage form contains at least one vitamin, in particular selected from the group of vitamin A, vitamins of the B group, in particular vitamin Be, vitamin B9 and / or vitamin B12, vitamin C, vitamins of the D group, in particular vitamin D2 and / or vitamin D3, vitamin E, vitamins of the K group, in particular vitamin K1 and / or vitamin K2, as well as combinations and mixtures thereof, preferably selected from the group of vitamin A, vitamins of the B group, in particular vitamin Be, vitamin B9 and / or vitamin B12, vitamin C and vitamins of the D group, in particular vitamin D2 and / or vitamin D3, as well as combinations and mixtures thereof, preferably selected from the group of vitamins of the B group, in particular vitamin Be, vitamin B9 and / or vitamin B12, and vitamins of the D group, in particular vitamin D2 and / or vitamin D3, as well as combinations and mixtures thereof.

[0170] The vitamins in question can also have an immune-stimulating effect. Without wishing to rely on or limit this theory, vitamins from the B group, C group, and D group in particular are believed to be linked to melatonin and sleep behavior. Thus, these vitamins may further promote sleep behavior.

[0171] According to the invention, it is particularly provided that the dosage form contains, in particular in respectively effective amounts, preferably in nutritionally and / or pharmaceutically effective amounts, at least one vitamin of the B group, in particular vitamin B1, vitamin B9 and / or vitamin B12, and / or at least one vitamin of the D group, in particular vitamin D2 and / or vitamin D3, preferably at least one vitamin of the D group, in particular vitamin D2 and / or vitamin D3.

[0172] Furthermore, it can be provided according to the invention that the composition contains at least one immunostimulant, in particular selected from the group of: (i) immunostimulating drugs (plants or herbs) or their ingredients, preferably echinacea, ginseng, ginger, garlic, berries and / or rockrose, in particular in the form of the respective extracts; (ii) polyphenols; (iii) minerals and trace elements, in particular zinc, preferably zinc components and / or zinc compounds, and / or selenium, preferably selenium components and / or selenium compounds; (iv) vitamins, in particular vitamins of the D group, preferably vitamin D2 and / or vitamin D3, and / or vitamin C; (v) probiotics; (vi) prebiotics; (vii) microorganisms; (viii) physiological immunomodulators, in particular lymphokines, interleukins, thymus factors and interferons; as well as combinations and mixtures thereof.

[0173] As previously mentioned, the respective phases or layers are characterized by special disintegration or drug release properties.

[0174] According to the invention, the first phase, in particular the first layer, and the second phase, in particular the second layer, and the optionally present third layer, in particular the third phase, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, have different disintegration times (dissolution times or durations), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, and / or different active ingredient release rates, in particular determined according to Ph. Eur., 10th edition, chapter 2.9.3. On this basis, a defined release of the active ingredients in targeted coordination with one another from the respective phases or layers can be enabled.

[0175] In particular, it can be provided according to the invention that the first phase, in particular first layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, of at most 30 min, in particular at most 20 min, preferably at most 10 min. In particular, the first phase, in particular first layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, can have a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range from 1 min to 30 min, in particular in the range from 2 min to 20 min, preferably in the range from 5 min to 10 min.

[0176] In particular, it can also be provided according to the invention that the second phase, in particular second layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, of at most 10 h, in particular at most 9 h, preferably at most 8 h. The second phase, in particular second layer, can have a disintegration time (dissolution time or duration) in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range from 2 h to 10 h, in particular in the range from 4 h to 9 h, preferably in the range from 6 h to 8 h.In addition, it may be the case according to the invention that the disintegration of the second phase, in particular the second layer, begins and / or starts (only) with a time delay in the range of 0.5 min to 20 min, in particular in the range of 1 min to 15 min, preferably 2 min to 10 min, after contact with a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, Chapter 5.17.1.

[0177] In particular, it can further be provided according to the invention that the third phase, in particular third layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, of at most 6 h, in particular at most 5 h, preferably at most 4 h. In particular, the third phase, in particular third layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, can have a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range from 1 h to 6 h, in particular in the range from 3 h to 6 h, preferably in the range from 4 h to 6 h.

[0178] According to the invention, the ratio of the active ingredient release rate of the first phase, in particular first layer, to the active ingredient release rate of the second phase, in particular second layer, in particular determined in each case according to Ph. Eur., 10th edition, chapter 2.9.3, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, can be > 10:1, in particular > 20:1, preferably > 30:1.

[0179] Furthermore, it can be provided that the ratio of the active ingredient release rate of the first phase, in particular first layer, to the active ingredient release rate of the third phase, in particular third layer, in particular determined in each case according to Ph. Eur., 10th edition, Chapter 2.9.3, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, Chapter 5.17.1, is > 5:1, in particular > 10:1, preferably > 15:1.

[0180] In addition, it can be provided that the ratio of the active ingredient release rate of the third phase, in particular third layer, to the active ingredient release rate of the second phase, in particular second layer, in particular determined in each case according to Ph. Eur., 10th edition, Chapter 2.9.3, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, Chapter 5.17.1, is > 1.1:1, in particular > 1.25:1, preferably > 1.5:1.

[0181] According to the invention, the disintegration or release of the active ingredients (and also with regard to the disintegration time(s) according to Ph. Eur., 10th edition, Chapter 2.9.1 or the active ingredient release rate(s) according to Ph. Eur., 10th edition, Chapter 2.9.3, in particular in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, Chapter 5.17.1) can also be adjusted or tailored by the following technical measures:

[0182] Thus, according to the invention, it can be provided in particular that the disintegration time (dissolution time or duration) of the first phase, in particular the first layer, and / or the disintegration time (dissolution time or duration) of the second phase, in particular the second layer, and / or the disintegration time (dissolution time or duration) of the third phase, in particular the third layer, preferably the mutually different disintegration times (dissolution times or durations) of the respective phases, in particular layers, in particular independently of one another, is or are set and / or predetermined by at least one of the following measures: a) use and / or selection of the type and / or quantity of at least one disintegrating and / or disintegrating additive, in particular disintegrating and / or disintegrating agent and / or disintegration-promoting filler and / or carrier; and / or at least one disintegration-retarding agent and / or at least one respective binder in the respective phases, in particular layers;b) selection and / or adjustment of the level of pressing force and / or pressing pressure during production of the dosage form, in particular during production of the respective phases, in particular layers; c) arrangement and / or shaping, in particular arrangement, of the respective phases, in particular layers, in the dosage form, in particular wherein in particular in the case of the dosage form being designed as a three-layer tablet the second phase, in particular second layer, is arranged between the first phase, in particular first layer, and the third phase, in particular third layer; d) application and / or formation of a coating and / or film onto the dosage form; and / or c) adjustment of the residual moisture in the respective phases, in particular layers.;

[0183] In particular with regard to the adjustment of the respective specific disintegration or drug release properties, the following can be provided according to the invention:

[0184] Thus, the first phase, in particular the first layer, can comprise at least one disintegrating and / or disintegrating agent and optionally at least one binder, in particular at least one disintegrating and / or disintegrating agent and at least one binder, in particular in a weight ratio of disintegrating and / or disintegrating agent(s) to binder(s) of < 1:1, in particular < 0.8:1, preferably < 0.7:1; and / or in particular wherein the first phase, in particular the first layer, contains the disintegrating and / or disintegrating agent(s) in a (relative) amount in the range from 1 wt.% to 10 wt.%, in particular in the range from 1 wt.% to 5 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the first phase, in particular the first layer; and / or in particular wherein the first phase, in particular the first layer, contains the binder in a (relative) amount in the range from 1 wt.% to 20 wt.%, in particular in the range from 1 wt.% to 10 wt.%-%, preferably in the range of 1 wt.% to 5 wt.%, based on the first phase, in particular the first layer.

[0185] Furthermore, the second phase, in particular the second layer, can comprise at least one disintegration retarder and optionally at least one binder, in particular at least one disintegration retarder and at least one binder, in particular wherein the second phase, in particular the second layer, contains the disintegration retarder(s) in a (relative) amount in the range from 5 wt.% to 50 wt.%, in particular in the range from 10 wt.% to 40 wt.%, preferably in the range from 20 wt.% to 30 wt.%, based on the second phase, in particular the second layer; and / or in particular wherein the second phase, in particular the second layer, contains the binder in a (relative) amount in the range from 1 wt.% to 15 wt.%, in particular in the range from 1 wt.% to 10 wt.%, preferably in the range from 1 wt.% to 5 wt.-%, based on the second phase, in particular the second layer; in particular wherein the second phase, in particular the second layer, contains at least substantially no disintegrating and / or disintegrating additive, in particular at least substantially no disintegrating and / or disintegrating agent.

[0186] In addition, the third phase, in particular the third layer, can comprise at least one disintegration-retarding agent, in particular wherein the third phase, in particular the third layer, contains the disintegration-retarding agent(s) in a (relative) amount in the range from 5 wt.% to 25 wt.%, in particular in the range from 7.5 wt.% to 15 wt.%, preferably in the range from 8 wt.% to 12 wt.%, based on the third phase, in particular the third layer; and / or in particular wherein the third phase, in particular the third layer, comprises at least substantially no disintegrating and / or disintegrating additive, in particular at least substantially no disintegrating and / or disintegrating agent.

[0187] In particular with regard to the above embodiments, the disintegrating and / or disintegrating agent can be selected from the group of carboxymethylcelluloses, in particular cross-linked carboxymethylcelluloses, preferably croscarmellose salts, preferably croscarmellose alkali and alkaline earth, preferably croscarmellose sodium or cross-linked sodium carboxymethylcellulose, and mixtures and combinations thereof; or the disintegrating and / or disintegrating agent can be croscarmellose sodium or cross-linked sodium carboxymethylcellulose.

[0188] In addition, the disintegration-supporting filler and / or carrier can be microcrystalline cellulose.

[0189] According to the invention, it can further be provided that the disintegration-retarding agent is a methylcellulose, preferably hydroxypropylmethylcellulose. According to the invention, it can also be provided that the binder is selected from the group of starches, in particular corn starch, potato starch, pregelatinized starches, preferably potato starch; acacia gum; and agave syrup powder; and mixtures and combinations thereof.

[0190] Furthermore, the dosage form, preferably the first phase, in particular the first layer, and / or the second phase, in particular the second layer, and / or the third phase, in particular the third layer, in particular independently of one another, can comprise at least one additive, in particular wherein the additive is selected from the group of processing aids, in particular flow agents and lubricants, coloring agents or dyes, buffers, fragrances, perfumes, extenders, binders, wetting agents and / or preservatives, pH adjusters, pH buffer substances, thickeners, aromas, flavors, sweeteners and sweeteners, acidulants, stabilizers and antiseptics and mixtures thereof.

[0191] According to the invention, it can be provided in particular that the first phase, in particular the first layer, and the second phase, in particular the second layer, and the optionally present third phase, in particular the third layer, are optically and / or visually different from one another, namely different in color. In this context, the first phase, in particular the first layer, and / or the second phase, in particular the second layer, and / or the optionally present third phase, in particular the third layer, can each independently comprise a coloring ingredient (dye). In this regard, for example, dyes in the form of chlorophyll, iron oxides, iron hydroxides, copper compounds or complexes, in particular natural coloring foods, such as fruit powders, or the like can be used.

[0192] The different optical and color formation of the respective phases or layers ensures good process, processing, and quality control both with regard to the manufacturing process and for the final product (e.g., with regard to monitoring the defined formation of the phases or layers). Furthermore, the multi-phase or multi-layer concept according to the present invention is also easily recognizable visually or optically for the user, so that the multi-phase mode of action is also visually illustrated or visually supported. Furthermore, the invention can provide that the dosage form contains at least substantially no gluten and / or is substantially free of gluten (gluten-free), or that the dosage form contains at least substantially no lactose and / or is substantially free of lactose (lactose-free). This also results in good tolerability of the composition.In particular, it can be provided that the composition according to the invention comprises gluten in an amount of less than 20 mg / kg, based on the composition, and / or that the composition according to the invention comprises lactose in an amount of at most 0.1 g / 100 g, based on the composition.

[0193] According to a preferred embodiment of the invention, it can further be provided that the dosage form or the multi-phase tablet, in particular the two-layer tablet, preferably a three-layer tablet, has a coating (film coating, coating), in particular a coating that is soluble in gastric juice or dispersible in gastric juice and / or soluble or dispersible in intestinal juice, preferably a cellulose-based coating, preferably based on hydroxypropylcellulose, optionally in combination with polyethylene glycol, or that the dosage form orThe multiphase tablet, in particular the two-layer tablet, preferably the three-layer tablet, is in coated form, in particular wherein the coating is a gastric juice-soluble or gastric juice-dispersible and / or intestinal juice-soluble or intestinal juice-dispersible coating, preferably a cellulose-based coating, preferably based on hydroxypropylcellulose, optionally in combination with polyethylene glycol. In this context, it can be provided that the dosage form or the multiphase tablet, in particular the two-layer tablet, preferably the three-layer tablet, is at least substantially completely coated and / or at least substantially completely encased by the coating.

[0194] In this context, it can also be provided that the coating has a weight in the range from 1 mg to 100 mg, in particular in the range from 2 mg to 75 mg, preferably in the range from 5 mg to 50 mg, more preferably in the range from 8 mg to 20 mg. In this regard, it can also be provided that the coating is present in a (relative) amount in the range from 0.1 wt.% to 10 wt.%, in particular in the range from 0.2 wt.% to 5 wt.%, preferably in the range from 0.5 wt.% to 2 wt.%, more preferably in the range from 0.7 wt.% to 1 wt.%, based on the dosage form or the multi-phase tablet. Furthermore, it can also be provided in this context that the coating is at least substantially colorless and / or at least substantially translucent and / or transparent.

[0195] The coating or film coating leads to increased stability of the dosage form according to the invention, including with regard to storage and long-term stability. Furthermore, oral administration and application are improved, particularly with regard to improved swallowability during oral administration. Furthermore, the coating also prevents unwanted premature dissolution or dissolution in the mouth / pharynx, as well as sticking of the dosage form in the mouth.

[0196] In general, the dosage form according to the invention can be designed to be soluble in gastric juice and / or dispersible in gastric juice, or soluble or dispersible in intestinal juice. In particular, the disintegration or release of the active ingredient can thus occur particularly in the stomach or intestine.

[0197] According to the invention, the dosage form, in particular the multi-layer tablet, can be obtained by compressing, preferably compressing, the active ingredients and ingredients forming the dosage form, in particular the tablet, and / or wherein the dosage form, in particular the tablet, is formed or is present as a pressed article.

[0198] In particular, the first phase, in particular first layer, and the second phase, in particular second layer, and the optionally present third phase, in particular third layer, can be produced in particular independently of one another and / or separately from one another and / or successively, in particular each individually by pressing, preferably by pressing the active ingredients and ingredients forming the respective phase, in particular layer.

[0199] Furthermore, the dosage form, in particular the multilayer tablet, can be obtained by joint (final) compression of the previously produced and / or compressed first phase, in particular the first layer, the previously produced and / or compressed second phase, in particular the second layer, and the optionally present, previously produced and / or compressed third phase, in particular the third layer. Furthermore, the dosage form, in particular the multilayer tablet, can be obtained by successive compression of the phases, in particular layers, forming the dosage form, in particular wherein the successive layers or phases are compressed onto or with one another, in particular so that the dosage form in the form of the multilayer tablet is obtained.

[0200] In particular, the respective disintegration or active ingredient release times of the phases or layers underlying the dosage form can also be adjusted by the compression pressure when compressing the respective layers. For example, a comparatively low compression pressure may be associated with a faster disintegration of a respective layer in the application state.

[0201] In general, the compression, in particular the compression to produce the dosage form, in particular the multi-layer tablet, and / or the compression to produce the first phase, in particular the first layer, and / or the second phase, in particular the second layer, and / or the optionally present third phase, in particular the third layer, in particular independently of one another, can be carried out with a compression force, in particular a compression force acting on the base area of ​​the dosage form and / or the respective phases or layers, in the range from 100 N to 500 N, in particular in the range from 120 N to 300 N, preferably in the range from 150 N to 200 N, and / or with a compression force, in particular a compression force acting on the base area of ​​the dosage form and / or the respective phases or layers.layers acting pressing force in the range of 10 kgf to 50 kgf, in particular in the range of 10 kgf to 30 kgf, preferably in the range of 15 kgf to 20 kgf.

[0202] According to the invention, it can also be provided, in particular, that in the respective phases or layers of the dosage form according to the invention, in particular independently of one another, the respective active ingredients and / or ingredients are at least substantially homogeneously distributed and / or present in an at least substantially intimate mixture or are compressed in the form of an intimate or homogeneous mixture. Furthermore, the disintegration or the active ingredient release time of the dosage form according to the invention can also be adjusted or influenced via the residual moisture of the underlying phases or layers.

[0203] In particular, it can be provided according to the invention that the first phase, in particular the first layer, has a residual moisture content of at most 10 wt.%, in particular at most 5 wt.%, preferably at most 3 wt.%, based on the first phase, in particular on the first layer, and / or is adjusted to the aforementioned values ​​and / or that the first phase, in particular the first layer, has a residual moisture content in the range from 0.1 wt.% to 10 wt.%, in particular in the range from 0.5 wt.% to 5 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the first phase, in particular on the first layer, and / or is adjusted to the aforementioned values.

[0204] Furthermore, it can be provided that the second phase, in particular the second layer, has a residual moisture content of at most 10 wt.%, in particular at most 5 wt.%, preferably at most 3 wt.%, based on the second phase, in particular on the second layer, and / or is adjusted to the aforementioned values ​​and / or that the second phase, in particular the second layer, has a residual moisture content in the range from 0.1 wt.% to 10 wt.%, in particular in the range from 0.5 wt.% to 5 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the second phase, in particular on the second layer, and / or is adjusted to the aforementioned values.

[0205] Furthermore, it can be provided that the third phase, in particular the third layer, has a residual moisture content of at most 10 wt.%, in particular at most 5 wt.%, preferably at most 3 wt.%, based on the third phase, in particular on the third layer, and / or is adjusted to the aforementioned values ​​and / or that the third phase, in particular the third layer, has a residual moisture content in the range from 0.1 wt.% to 10 wt.%, in particular in the range from 0.5 wt.% to 5 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the third phase, in particular on the third layer, and / or is adjusted to the aforementioned values.

[0206] In general, the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer, can have at least substantially the same residual moisture or can be adjusted to at least substantially the same residual moisture.

[0207] In addition, it can be provided according to the invention that the first phase, in particular the first layer, has a residual moisture content in the range from 0.1 wt.% to 10 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the first phase, in particular on the first layer, and / or is adjusted to the aforementioned values ​​and that the second phase, in particular the second layer, has a residual moisture content in the range from 0.1 wt.% to 10 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the second phase, in particular on the second layer, and / or is adjusted to the aforementioned values ​​and optionally that the third phase, in particular the third layer, has a residual moisture content in the range from 0.1 wt.% to 10 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the third phase, in particular on the third layer, and / or is adjusted to the aforementioned values.

[0208] In addition, it can be provided according to the invention that the dosage form, in particular the multi-layer tablet, has a (total) residual moisture of at most 10 wt.%, in particular at most 5 wt.%, preferably at most 3 wt.%, based on the dosage form, and / or is adjusted to the aforementioned values ​​and / or that the dosage form, in particular the multi-layer tablet, has a (total) residual moisture in the range from 0.1 wt.% to 10 wt.%, in particular in the range from 0.5 wt.% to 5 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the dosage form, and / or is adjusted to the aforementioned values.

[0209] As far as the dosage form according to the invention is concerned, it can also have a defined (total) weight, in particular with regard to optimising the amounts and distribution of the active ingredient as well as the application properties (swallowability).

[0210] The dosage form according to the invention, in particular the multilayer tablet, can have a (total) weight in the range of 200 mg to 8,000 mg, in particular in the range of 400 mg to 6,000 mg, preferably in the range of 600 mg to 4,000 mg, more preferably in the range of 800 mg to 2,000 mg. This also ensures good swallowability. In particular, the first phase, in particular the first layer, can have a weight in the range of 60 mg to 2,500 mg, in particular in the range of 120 mg to 1,800 mg, preferably in the range of 180 mg to 1,000 mg, more preferably in the range of 250 mg to 600 mg.

[0211] Furthermore, in particular the second phase, in particular the second layer, can have a weight in the range of 60 mg to 2,500 mg, in particular in the range of 120 mg to 1,800 mg, preferably in the range of 180 mg to 1,000 mg, preferably in the range of 250 mg to 600 mg.

[0212] In addition, in particular the third phase, in particular the third layer, can have a weight in the range of 80 mg to 3,000 mg, in particular in the range of 160 mg to 2,400 mg, preferably in the range of 240 mg to 2,000 mg, preferably in the range of 300 mg to 800 mg.

[0213] Furthermore, the ratio of the weight of the first phase, in particular of the first layer, to the weight of the second phase, in particular of the second layer, can be in the range from 5:1 to 1:5, in particular in the range from 2:1 to 1:2, preferably in the range from 1.5:1 to 1:1.5, preferably in the range from 1.2:1 to 1:1.1, particularly preferably in the range from 1.1:1 to 1:1.

[0214] In addition, the ratio of the weight of the first phase, in particular of the first layer, to the weight of the third phase, in particular of the third layer, can be in the range from 5:1 to 1:10, in particular in the range from 2:1 to 1:5, preferably in the range from 1.5:1 to 1:3, preferably in the range from 1.2:1 to 1:2, particularly preferably in the range from 1.1:1 to 1:1.5. Furthermore, the ratio of the weight of the second phase, in particular of the second layer, to the weight of the third phase, in particular of the third layer, can be in the range from 5:1 to 1:10, in particular in the range from 2:1 to 1:5, preferably in the range from 1.5:1 to 1:3, preferably in the range from 1.2:1 to 1:2, particularly preferably in the range from 1.1:1 to 1:1.5.

[0215] According to the invention, the ratio of the weight of the first phase, in particular of the first layer, to the weight of the second phase, in particular of the second layer, to the weight of the third phase, in particular of the third layer, can be in the range from 5:1:1 to 1:5:10, in particular in the range from 2:1:1 to 1:2:5, preferably in the range from 1.5:1:1 to 1:1.5:3, more preferably in the range from 1.2:1:1 to 1:1.1:2, particularly preferably in the range from 1.1:1:1 to 1:1:1.5.

[0216] This allows for the control of both the disintegration and the release of the active ingredient. The weight specifications also allow for improved absorption and defined incorporation of the active ingredient quantities in the respective phases.

[0217] With regard to the shape or physical configuration of the dosage form according to the invention, it can be provided, in particular, that the dosage form, in particular the multilayer tablet, has a cylindrical basic shape, in particular a cylindrical basic shape with oblong (oblong-shaped) or circular base surfaces, in particular oval, preferably elliptical base surfaces, in particular wherein at least one of the base surfaces, preferably both base surfaces, in particular independently of one another, are each convex and / or outwardly curved. In this context, the dosage form can be present and / or configured as a multiphase oblong tablet, in particular a multilayer oblong tablet, preferably a two-layer oblong tablet, preferably a three-layer oblong tablet.

[0218] The corresponding physical design of the dosage form is accompanied by improved manufacturing properties and also improved application properties, in particular better swallowability.

[0219] In particular, it can be provided according to the invention that the cylindrical basic shape (ie the basic shape of the dosage form) is formed by the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer. In particular, it can be provided according to the invention that the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer, in particular form respective sections of the dosage form, in particular of the multilayer tablet, preferably of the cylindrical basic shape of the dosage form.According to the invention, the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer, may also be arranged in a stacked manner and / or consecutively and / or parallel to one another. Furthermore, the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer, may be in contact with one another, in particular directly or indirectly.

[0220] Furthermore, the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer, can form a composite, in particular for forming the dosage form, in particular the multilayer tablet. In particular, the respective phases or layers can form a solid composite. The connection of the layers can occur, for example, during compression to form the dosage form according to the invention.

[0221] In general, it can be provided within the scope of the present invention that the first phase, in particular the first layer, and / or the second phase, in particular the second layer, and / or optionally the third phase, in particular the third layer, in particular independently of one another, each have a cylindrical basic shape, in particular a cylindrical basic shape with oval or oblong base surfaces, in particular elliptical base surfaces. In this context, it is possible according to the invention that the base surfaces of the respective phases or layers that are on the outside in the dosage form, in particular in the multi-layer tablet, are each convex and / or curved outwards, in particular independently of one another. In particular, the base surfaces of the respective phases or layers that are on the inside in the dosage form, in particular in the multi-layer tablet, and / or that are opposite one another and / or that are adjacent to one another canLayers, in particular independently of one another, must each be at least substantially flat and / or level.

[0222] Furthermore, in the dosage form, in particular in the multilayer tablet, the inner and / or opposite and / or adjacent base surfaces of the respective phases or layers can be arranged, in particular independently of one another, at least substantially parallel to one another. Furthermore, the respective phases or layers can be firmly and / or at least substantially fully connected to one another via the inner and opposite base surfaces of the respective phases or layers, in particular independently of one another, and / or form a composite. This is in particular a solid composite for forming the dosage form.

[0223] According to the invention, it can specifically be provided that, in particular in the case of the dosage form being designed as a two-layer tablet, the first phase, in particular the first layer, and the second phase, in particular the second layer, are firmly and / or at least substantially fully connected to one another via the inner and mutually opposing base surfaces of the respective phases or layers, in particular independently of one another, and / or form a composite, and that the outer base surface of the first phase or layer and / or second phase or layer, in particular of the first phase or layer and the second phase or layer, independently of one another, is in each case convex and / or curved outwards.

[0224] In addition, it can preferably be provided according to the invention that, in particular when the dosage form is designed as a three-layer tablet, the second phase, in particular the second layer, is arranged between the first phase, in particular the first layer, on the one hand, and the third phase, in particular the third layer, on the other hand. Furthermore, it can be the case according to the invention that, in particular when the dosage form is designed as a three-layer tablet, the second phase, in particular the second layer, is firmly and / or at least substantially fully connected to the first phase, in particular the first layer, on the one hand, and to the third phase, in particular the third layer, on the other hand, via the inner and opposite base surfaces of the respective phases or layers, in particular independently of one another, and / or forms a composite.In addition, it can be provided according to the invention that, in particular in the case of the dosage form being designed as a three-layer tablet, the outer base surface of the first phase or layer and / or the third phase or layer, in particular of the first phase or layer and the third phase or layer, is independently of one another, each convex and / or curved outwards.

[0225] In addition, the geometric dimensions of the dosage form are also important, especially with regard to the application and usage properties:

[0226] In particular, the dosage form, in particular the multi-layer tablet, can have a (total) thickness (tablet thickness) or (total) cylinder height (maximum thickness or maximum cylinder height) in the range from 1.2 mm to 21 mm, in particular in the range from 1.5 mm to 15 mm, preferably in the range from 2 mm to 12 mm, preferably in the range from 3 mm to 9 mm.

[0227] In particular, the first phase, in particular the first layer, can have a thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) in the range from 0.3 mm to 15 mm, in particular in the range from 0.6 mm to 9 mm, preferably in the range from 1.2 mm to 6 mm.

[0228] In addition, the second phase, in particular the second layer, can have a thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) in the range from 0.3 mm to 15 mm, in particular in the range from 0.6 mm to 9 mm, preferably in the range from 1.2 mm to 6 mm.

[0229] Furthermore, the third phase, in particular the third layer, can have a thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) in the range from 0.6 mm to 18 mm, in particular in the range from 0.9 mm to 15 mm, preferably in the range from 1.5 mm to 9 mm.

[0230] In addition, the first phase, in particular the first layer, can have a thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) in the range from 0.3 mm to 15 mm, in particular in the range from 0.6 mm to 9 mm, preferably in the range from 1.2 mm to 6 mm. In addition, the second phase, in particular the second layer, can have a thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) in the range from 0.3 mm to 15 mm, in particular in the range from 0.6 mm to 9 mm, preferably in the range from 1.2 mm to 6 mm.

[0231] Furthermore, the third phase, in particular the third layer, can have a thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) in the range from 0.6 mm to 18 mm, in particular in the range from 0.9 mm to 15 mm, preferably in the range from 1.5 mm to 9 mm.

[0232] The above dimensions also lead to better application properties of the dosage form, particularly with regard to improved swallowability.

[0233] According to the invention, the ratio of the thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) of the first phase, in particular of the first layer, to the thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) of the second phase, in particular of the second layer, can be in the range from 5:1 to 1:5, in particular in the range from 3:1 to 1:3, preferably in the range from 2:1 to 1:2, preferably in the range from 1.5:1 to 1:1.5.

[0234] In addition, the ratio of the thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) of the first phase, in particular of the first layer, to the thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) of the third phase, in particular of the third layer, can be in the range from 4:1 to 1:5, in particular in the range from 2:1 to 1:3, preferably in the range from 1.5:1 to 1:2, preferably in the range from 1.1:1 to 1:1.5.

[0235] Furthermore, the ratio of the thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) of the second phase, in particular of the second layer, to the thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) of the third phase, in particular of the third layer, can be in the range from 4:1 to 1:5, in particular in the range from 2:1 to 1:3, preferably in the range from 1.5:1 to 1:2, more preferably in the range from 1.1:1 to 1:1.5. In addition, the ratio of the thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) of the first phase, in particular of the first layer, to the thickness (layer thickness) or cylinder height (maximum thickness or maximum cylinder height) of the second phase, in particular of the second layer, to the thickness (layer thickness) or cylinder height (maximum thickness ormaximum cylinder height) of the third phase, in particular of the third layer, in the range from 4:1:1 to 1:4:5, in particular in the range from 2:1:1 to 1:2:3, preferably in the range from 1.5:1:1 to 1:1.5:2, preferably in the range from 1.1:1:1.5 to 1:1.1:1.5.

[0236] In addition, the dosage form, in particular the multi-layer tablet, can have a width or a diameter, in particular maximum diameter and / or in particular with respect to the main axis in the case of oval or oblong or circular bases, preferably elliptical bases, in the range from 2 mm to 30 mm, in particular in the range from 4 mm to 25 mm, preferably in the range from 5 mm to 20 mm.

[0237] According to a specific embodiment of the present invention, the dosage form can be designed as a coated and / or film-coated multi-phase tablet, in particular a coated and / or film-coated multi-layer tablet, preferably a coated and / or film-coated two-layer tablet (two-layer film-coated tablet), preferably a coated and / or film-coated three-layer tablet (three-layer film-coated tablet).

[0238] Due to its special properties, particularly with regard to supporting or promoting healthy sleep or sleep behavior, as well as with regard to the treatment of sleep disorders, the dosage form according to the invention can be available in numerous application- or use-specific forms. Thus, according to the invention, the dosage form can be provided as a dietary supplement; medicament; pharmaceutical; pharmaceutical composition; medical device; homeopathic; dietary; cosmetic; consumer article or food, preferably as a dietary supplement.In particular, the dosage form according to the invention can be a dosage form for the non-therapeutic and / or non-medical support and / or promotion of restful sleep and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

[0239] In addition, the dosage form according to the invention can be a dosage form for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

[0240] Furthermore, the dosage form according to the invention can also be a dosage form for use in the prophylactic and / or therapeutic medical treatment of dyssomnia, in particular agrypnia, insomnia and / or hyposomnia.

[0241] In particular, sleep disorders or dysregulations of the natural day / night rhythm and / or the circadian rhythm can be accompanied by or caused by a reduced and / or inhibited production and / or a reduced and / or inhibited release of melatonin, particularly in the human body. In this context, the lack of melatonin can be compensated for, so to speak, by the inventive application of, in particular, exogenous melatonin, specifically with regard to the underlying sleep period, with a somewhat rapid initial phase of melatonin application through the rapid release from the first phase ("rapid increase in melatonin level"), followed by a sustained release of melatonin through the second phase ("maintenance of melatonin level").This provides optimal sleep promotion, which is further supported by the targeted use of special extracts, namely those based on Ashwagandha and, in particular, valerian or lavender.

[0242] Furthermore, the dosage form according to the invention can be a dosage form for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for the support and / or promotion of restful sleep and / or for the curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

[0243] According to the present aspect, the present invention also relates to the dosage form according to the invention, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, in particular a dosage form as defined above, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promotion and / or support, preferably for preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular sleep onset and / or sleep maintenance behavior, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular sleep onset and / or sleep maintenance disorders, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is designed as a three-layer tablet,wherein the dosage form and / or the three-layer tablet has or consists of three different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the three-layer tablet has: a) a first phase ("immediate phase"), in particular the first layer ("immediate layer"), with rapid and / or immediate (immediate) disintegration and / or active ingredient release in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer, (i, a ) Melatonin and

[0244] (ii a) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0245] (ib) Melatonin and

[0246] (üb) contains at least one extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably an extract of valerian (Valeriana officinalis) ("valerian extract"), c) a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer,

[0247] (i c) at least one (further) extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably at least two (further) extracts of different sleep-inducing and / or sedative drugs (plants orherbs), preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.

[0248] According to the present aspect, the present invention also relates to the dosage form according to the invention, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, in particular a dosage form as defined above, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promotion and / or support, preferably for preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulties falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is designed as a three-layer tablet,wherein the dosage form and / or the three-layer tablet has or consists of three different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the three-layer tablet has: a) a first phase ("immediate phase"), in particular a first layer ("immediate layer"), with rapid and / or immediate (immediate) disintegration and / or active ingredient release in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer,

[0249] (i a ) Melatonin and

[0250] (ii a) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0251] (ib) Melatonin and

[0252] (üb) contains at least one extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably an extract of valerian (Valeriana officinalis) ("valerian extract"), c) a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer,

[0253] (i c) at least one (further) extract of at least one sleep-promoting and / or sedative drug (plant or herb), preferably at least two (further) extracts of different sleep-promoting and / or sedative drugs (plants or herbs), preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains the extract of Ashwagandha in a total amount of at least 50 mg, in particular in a total amount in the range of 50 mg to 1,000 mg,contains; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range from 10 mg to 500 mg. According to the present aspect, the present invention further also relates to the dosage form according to the invention, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, in particular a dosage form as defined above, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promotion and / or support, preferably for preventive and / or curative promotion and / or support, sleep health and / or sleep behavior, in particular the ability to fall asleep and / or sleep through the night,and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is designed as a three-layer tablet, wherein the dosage form and / or the three-layer tablet has or consists of three different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the three-layer tablet has: a) a first phase ("immediate phase"), in particular the first layer ("immediate layer"),with rapid and / or immediate (immediate) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer,

[0254] (i a ) Melatonin and

[0255] (ii a ) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0256] (ib) Melatonin and

[0257] (üb) at least one extract of valerian (Valeriana officinalis) ("valerian extract"), c) a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer,

[0258] (i c) an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.

[0259] According to the present aspect, the present invention furthermore also relates to the dosage form according to the invention, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, in particular a dosage form as defined above, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promotion and / or support, preferably for preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulties falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is designed as a three-layer tablet,wherein the dosage form and / or the three-layer tablet has or consists of three different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the three-layer tablet has: a) a first phase ("immediate phase"), in particular a first layer ("immediate layer"), with rapid and / or immediate (immediate) disintegration and / or active ingredient release in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer,

[0260] (i a ) Melatonin and

[0261] (ii a) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0262] (ib) Melatonin and

[0263] (üb) an extract of valerian (Valeriana officinalis) ("valerian extract"), c) a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer, (i c) an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains the extract of Ashwagandha in a total amount of at least 50 mg, in particular in a total amount in the range of 50 mg to 1,000 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.

[0264] According to the present aspect, the present invention further relates to the dosage form according to the invention, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, in particular a dosage form as defined above, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promotion and / or support, preferably for preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulties falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is designed as a three-layer tablet,wherein the dosage form and / or the three-layer tablet has or consists of three different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the three-layer tablet has: a) a first phase ("immediate phase"), in particular a first layer ("immediate layer"), with rapid and / or immediate (immediate) disintegration and / or active ingredient release in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer,

[0265] (i a ) Melatonin and

[0266] (ii a) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0267] (ib) Melatonin and

[0268] (üb) at least one extract of valerian (Valeriana officinalis) ("valerian extract"), c) a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer,

[0269] (i c) an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg; wherein the first phase, in particular first layer, is in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1 , a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1 , in the range from 1 min to 30 min, in particular in the range from 2 min to 20 min, preferably in the range from 5 min to 10 min; and / or wherein the second phase, in particular second layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1 , a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1 , in the range from 2 h to 10 h, in particular in the range from 4 h to 9 h, preferably in the range from 6 h to 8 h; and / or wherein the third phase, in particular third layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10thEdition, Chapter 2.9.1 , in the range of 1 h to 6 h, in particular in the range of 3 h to 6 h, preferably in the range of 4 h to 6 h.

[0270] According to the present aspect, the present invention further relates to the dosage form according to the invention, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, in particular a dosage form as defined above, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promotion and / or support, preferably for preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulties falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is designed as a three-layer tablet,wherein the dosage form and / or the three-layer tablet has or consists of three different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the three-layer tablet has: a) a first phase ("immediate phase"), in particular a first layer ("immediate layer"), with rapid and / or immediate (immediate) disintegration and / or active ingredient release in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer,

[0271] (i a ) Melatonin and

[0272] (ii a) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredients in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0273] (ib) Melatonin and

[0274] (üb) an extract of valerian (Valeriana officinalis) ("valerian extract"), c) a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer, (i c) an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains the extract of Ashwagandha in a total amount of at least 50 mg, in particular in a total amount in the range of 50 mg to 1.000 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg; and / or wherein the first phase, in particular first layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range of 1 min to 30 min, in particular in the range of 2 min to 20 min, preferably in the range of 5 min to 10 min; and / or wherein the second phase, in particular second layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or- duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range from 2 h to 10 h, in particular in the range from 4 h to 9 h, preferably in the range from 6 h to 8 h; and / or wherein the third phase, in particular third layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range from 1 h to 6 h, in particular in the range from 3 h to 6 h, preferably in the range from 4 h to 6 h. For further details on the aspect of the invention described above, reference can also be made to the statements on the further aspects of the invention, these statements equally applying accordingly to the present aspect of the invention.

[0275] In addition, the subject of the present invention - according to a further aspect of the present invention - is the use of a dosage form according to the invention, as defined above, in the food supplement sector and / or as a food supplement, in particular for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for the support and / or promotion of restful sleep and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

[0276] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0277] Furthermore, the present invention - according to yet another aspect of the present invention - also relates to the use of a dosage form according to the invention, as defined above (for the manufacture of a medicament) for the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

[0278] For further details on this aspect of the invention, in particular also on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally and accordingly to the present aspect of the invention. Yet another subject of the present invention—according to a further aspect of the present invention—is the medicament, pharmaceutical, medical device, or homeopathic remedy containing or consisting of a dosage form as defined above, in particular for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

[0279] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0280] The present invention - according to yet another aspect of the present invention - also relates to the use of a medicament, pharmaceutical, medical device or homeopathic remedy, as defined above, (for the manufacture of a medicament or drug) for the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

[0281] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0282] Furthermore, the present invention - according to a further aspect of the present invention - also relates to the food according to the invention, wherein the food supplement contains or consists of a dosage form as defined above, in particular for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for supporting and / or promoting restful sleep and / or for supporting and / or promoting restful sleep and / or sleep behavior and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

[0283] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0284] Yet another subject matter of the present invention - according to a further aspect of the present invention - is also the use of a food supplement as defined above for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for the support and / or promotion of restful sleep and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

[0285] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0286] Yet another subject matter of the present invention - according to yet another aspect of the present invention - is also the method for the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein in the method a patient having and / or suffering from the sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm is administered a pharmaceutically effective and / or therapeutically effective amount of a dosage form as defined above or of a medicament, pharmaceutical, medical device or homeopathic remedy as defined above.

[0287] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0288] Yet another subject matter of the present invention is - according to a further aspect of the present invention - the method for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for supporting and / or promoting restful sleep and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm, wherein in the method a patient or person having the disorders and / or deficits and / or suffering from them is administered a nutritionally effective and / or nutritionally relevant amount of a dosage form, as defined above, or of a dietary supplement, as defined above.

[0289] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0290] Finally, the subject matter of the present invention - according to yet another aspect of the present invention - is a packaging unit containing at least one dosage form, preferably a plurality of dosage forms, according to the present invention or as defined above. In this context, the packaging unit can in particular be a blister pack or be designed as a blister pack, preferably as a push-through blister pack. In this regard, it has proven useful if the blister pack comprises a receiving mold, made in particular of plastic, with a plurality of cavities for receiving the dosage form(s) and / or the preparation(s) and / or the tablet(s), as well as a cover film, in particular blister film, preferably aluminum foil, which is sealingly connected to the receiving mold and closes the cavities.

[0291] For further details on this aspect of the invention, in particular on the associated advantages and special technical effects, reference can be made to the statements on the other aspects of the invention, whereby these statements apply equally to the present aspect of the invention.

[0292] The present invention, both according to the first aspect of the present invention and according to all other aspects of the present invention, is associated with a multitude of advantages and special features which make the application or therapy concept according to the invention unique and highly efficient.

[0293] The following invention is explained in more detail with reference to preferred embodiments and drawings or figures illustrating preferred embodiments. In connection with the explanation of these preferred embodiments or embodiments of the present invention, which, however, are in no way limiting with respect to the present invention, further advantages, properties, aspects, and features of the present invention are also presented.

[0294] In the figure representations, which will be discussed in more detail below, it shows:

[0295] Fig. 1 is a schematic representation with a perspective view of the dosage form 1 according to the invention in the form of a three-layer tablet, wherein the dosage form 1 has a first phase or layer 2 ("immediate phase", "immediate layer") (which contains melatonin and an extract of Ashwagandha), a second phase or layer 3 ("depot phase", "depot layer") (which contains melatonin and at least one extract of at least one sleep-promoting or sedative drug, preferably an extract of valerian), and a third phase or layer 4 ("chronophase", "chrono layer") (which contains at least one (further) extract of a sleep-promoting or sedative drug, preferably an extract of valerian and / or an extract of lavender);

[0296] Fig. 2 is a schematic cross-sectional view of the dosage form 1 according to the invention as shown in Fig. 1, illustrating a preferred arrangement of the first phase or layer 2, the second phase or layer 3 and the third phase or layer 4;

[0297] Fig. 3 is a schematic representation based on Fig. 2, wherein the dosage form 1 additionally has a coating or film coating 5;

[0298] Fig. 4A is a graphical representation in the form of a bar chart of the effect of an Ashwagandha extract used according to the invention on the time to fall asleep of subjects studied in this regard; the x-axis shows the underlying study period (with week 0 and week 6), and the y-axis shows the time to fall asleep (ET) in minutes.

[0299] Fig. 4B shows a further graphical representation in the form of a bar chart of the effect of an Ashwagandha extract used according to the invention on the prolonged total sleep duration of subjects studied in this regard; the x-axis shows the underlying study period (with WO = week 0 and W6 = week 6), and the y-axis shows sleep duration (SD) in minutes.

[0300] Fig. 4C is yet another graphic representation in the form of a bar chart showing the effect of an Ashwagandha extract used according to the invention with regard to improving sleep quality based on the relevant RSQ-W value (Restorative Sleep Questionnaire-Weekly) of test subjects; the X-axis shows the placebo group (P) and the group treated with the Ashwagandha extract (A); furthermore, the Y-axis shows the RSQ-W value in percent; Fig. 5 is a graphic representation in the form of a curve diagram showing the time-dependent disintegration and active ingredient release behavior of a dosage form according to the invention in the form of a coated three-layer tablet with melatonin in the first and second phases; the X-axis shows the time course (t) in minutes, and the Y-axis shows the disintegration (Z) in percent; the continuous line representation of the curve (up to 120 min) refers to the disintegration orthe release in a gastric juice simulating medium with a pH of 4.5, and the dashed line (from 120 min) shows the further degradation or release in an intestinal juice simulating medium with a pH of 6.8.

[0301] Fig. 1, Fig. 2 and Fig. 3 thus each illustrate a preferred embodiment according to the invention, according to which the dosage form 1 is designed as a three-layer tablet. In particular, Fig. 1, Fig. 2 and Fig. 3 show the dosage form 1 according to the invention, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promoting and / or supporting, preferably for preventive and / or curative promoting and / or supporting, sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulties falling asleep and / or staying asleep.and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form 1 is designed as a three-layer tablet, wherein the dosage form 1 has or consists of several, namely three, different phases 2, 3, 4, in particular layers, wherein the different phases 2, 3, 4, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration; wherein the dosage form 1 and / or the three-layer tablet has: a) a first phase 2 ("immediate phase"), in particular first layer ("immediate layer"), with rapid and / or immediate (instant) disintegration and / or active ingredient release in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the first phase 2, in particular the first layer,

[0302] (i a ) Melatonin and

[0303] (ii a ) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase 3 ("depot phase"), in particular second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer,

[0304] (ib) Melatonin and

[0305] (üb) contains at least one extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably an extract of valerian (Valeriana officinalis) ("valerian extract"), c) a third phase 4 ("chronophase"), in particular third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase 4, in particular the third layer,

[0306] (i c) at least one (further) extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably at least two (further) extracts of different sleep-inducing and / or sedative drugs (plants orherbs), preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein dosage form 1 contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein dosage form 1 contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.

[0307] In addition, Fig. 3 shows that the dosage form 1 in question can be provided with a coating 5 applied in particular over the entire surface.

[0308] Furthermore, Fig. 4A, Fig. 4B and Fig. 4C are based on an application study with standardized Ashwagandha extract, as used according to the invention. The Ashwagandha extract used has a withanolide glycoside content of approximately 35% w / w, based on the extract. The investigations are based on a randomized, placebo-controlled, double-blind study. The administration of 120 mg of a standardized Ashwagandha extract (from roots and leaves) per day or placebo over a period of six weeks was investigated. The Ashwagandha extract has a withanolide glycoside content of 35% w / w, based on the extract. The participants were 150 healthy individuals (22 men, 78 women) with non-restorative sleep (RSQ-W (Restorative Sleep Questionnaire-Weekly) of 50 or less). Fig. 4A shows the significant reduction in time to fall asleep after six weeks with Ashwagandha extract. Fig.Figure 4B further shows the significantly increased total sleep duration after six weeks of treatment with Ashwagandha extract. Finally, Figure 4C shows the significantly improved sleep quality after six weeks of treatment with Ashwagandha extract.

[0309] The curve diagram shown in Fig. 5 is based on a dosage form according to the invention in the form of a three-layer tablet (with coating), which contains melatonin in the first phase or layer and in the second phase or layer. To simulate the application with oral administration and the entry or passage of the dosage form into the gastrointestinal tract, the procedure with regard to Fig. 5 was such that the dosage form was first introduced into an artificial gastric juice medium (pH: 4.5) according to Ph. Eur., 10th edition, Chapter 5.17.1, for a period of 120 minutes (cf. continuous curve representation in Fig. 5 up to t = 120 minutes). The remaining dosage form was then brought into contact with an intestinal fluid medium (pH: 6.8) according to Ph. Eur., 10th edition, Chapter 5.17.1 (see dashed curve in Fig. 5 starting at t = 120 min). Fig. 5 illustrates the rapid and immediate disintegration.Active ingredient release, followed by or transitioning into a controlled, delayed, or continuous disintegration or active ingredient release. Fig. 5 thus illustrates the overall defined temporal disintegration or active ingredient release of a dosage form according to the invention with the specifically designed or coordinated disintegration or active ingredient release profile with a rapid or immediate disintegration or release of melatonin followed by a controlled, delayed, or continuous disintegration or release of melatonin.

[0310] Further embodiments, modifications and variations as well as advantages of the present invention will be readily apparent and achievable to a person skilled in the art upon reading the description, without departing from the scope of the present invention.

[0311] The following embodiments serve only to illustrate the present invention, without, however, limiting the present invention thereto.

[0312] EXAMPLES OF IMPLEMENTATION:

[0313] Production of a dosage form according to the invention in the form of a multi-phase tablet, in particular a multi-layer tablet, with coating or film coating

[0314] On the basis of the recipe specified below, a dosage form according to the invention for oral administration is produced in the form of a three-layer tablet provided with a coating (film) ("three-layer film-coated tablet"), wherein the dosage form according to the invention has three different phases or layers, wherein the different phases or layers have different disintegration times and active ingredient release rates in the gastrointestinal tract, in particular the stomach, after oral administration.

[0315] The dosage form produced according to the invention in the form of a film-coated three-layer tablet has the following phases / layers: a) first phase / layer ("immediate phase" / "immediate layer") with rapid or immediate (immediate) disintegration and release of active ingredient in the gastrointestinal tract, in particular the stomach, following oral administration, b) second phase / layer ("depot phase / depot layer") with controlled and delayed (retarded) disintegration and release of active ingredient in the gastrointestinal tract, in particular the stomach or intestine, following oral administration, c) third phase / layer ("chronophase" / "chrono layer") with continuous disintegration and release of active ingredient in the gastrointestinal tract, in particular the stomach or intestine, following oral administration.

[0316] The individual layers have the following composition: a) Composition of the first phase / layer ("Immediate phase'7"Immediate layer") b) Composition of the second phase / layer ("depot phase" "depot layer") c) Composition of the third phase / layer ("Chronophase'T'Chronolayer") d) Composition of the coating or film

[0317] The crushed and homogenized starting mixtures for the three phases or layers are filled into three different storage containers. From the storage container for the mixture of the first phase / layer, a suitable tablet matrix is ​​then partially filled to form the first phase / layer. In a conventional manner, by applying a suitable pressure in the range of 15 to 20 kgf / cm 2(1.5 to 2 MPa) a first tablet phase layer is created, resulting in the first phase / layer. The mixture for the second phase / layer is then introduced into the tablet die onto this first phase / layer and pressed into the second phase / layer with the same pressure. The starting mixture for the third phase / layer is then introduced into the tablet die onto the second phase / layer created in this way, followed by a conventional pressing process with the same pressure.

[0318] The result is a dosage form according to the invention in the form of a three-phase layered tablet (three-layer tablet), which is then coated or film-coated in a conventional manner based on the aforementioned coating composition. The coating or film-coating ensures better stability, in particular storage and long-term stability, and better oral administration, in particular swallowability upon application, and also prevents undesirable premature dissolution or dissolution in the mouth / throat.

[0319] The resulting tablet is formed according to the specified matrix shape, preferably as a so-called oblong tablet (i.e. tablet with an oblong or oblong-shaped basic shape).

[0320] The different optical and color characteristics of the individual tablet phase layers ensure effective process, processing, and quality control of both the manufacturing process and the final product. The different optical and color characteristics of the individual tablet phase layers also make the inventive multiphase or multilayer concept easily recognizable by the user.

[0321] The dosage form according to the invention produced in this way is shown schematically in the previously described figures according to Figs. 1, 2 and 3.

[0322] The resulting dosage form according to the invention contains the Ashwagandha root and leaf extract in an amount of 120 mg (of which: 42 mg withanolide glycosides), valerian root extract in an amount of 270 mg, lavender flower extract in an amount of 100 mg (of which 10 mg linalool) and approximately 1.9 mg melatonin.

[0323] The dosage form according to the invention is particularly suitable as a dietary supplement, in particular for the non-therapeutic or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, or also as a pharmaceutical dosage form (e.g. medicament or medical device) preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular disorders of falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

[0324] The dosage form according to the invention thus comprises an innovative 3-phase or 3-layer technology, combined with different disintegration times and active ingredient release rates of the individual phases or layers in the gastrointestinal tract, in particular the stomach and / or intestine, and this in a special combination of melatonin with ashwagandha extract and with other extracts of sleep-promoting and / or sedative drugs (plants or herbs) (here specifically based on valerian and lavender).

[0325] The special composition of the dosage form according to the invention in combination with the innovative 3-phase or 3-layer technology ensures a triple sleep-promoting effect throughout the night or in the various sleep phases, namely falling asleep faster, supporting restful sleep and enabling sleep through the night.

[0326] The Ashwagandha extract and its constituents, particularly the withanolide glycosides it contains, synergistically support the sleep-inducing effect of melatonin in the immediate phase, particularly due to its physiologically different mechanism of action. Likewise, the Ashwagandha extract and its constituents, particularly the withanolide glycosides it contains, also act synergistically as so-called adaptogens (i.e., biologically active plant substances that help the organism adapt to increased physical and emotional stress situations), and with prolonged use, even sustainably throughout the day.The immediate phase with melatonin and ashwagandha extract dissolves quickly. The melatonin in the immediate phase helps shorten the time it takes to fall asleep. The positive effect of melatonin is particularly evident when it is released immediately after ingestion, while the ashwagandha extract generally supports falling asleep. In the second phase (depot phase), the melatonin, together with the other sleep-promoting and / or sedative drug (here: valerian), synergistically promotes good sleep and deep relaxation. In particular, the depot phase with melatonin and valerian extract dissolves in a long-lasting, controlled, and delayed manner, with the valerian contributing to maintaining sleep and relaxation.

[0327] The chrono phase with valerian extract and lavender flower extract dissolves continuously, with the lavender extract supporting recovery and contributing to better sleep patterns, and the valerian extract further supporting sleep through the night.

[0328] Due to the fact that the dosage form according to the invention is based exclusively on a combination of a physiological or endogenous ingredient / active substance (melatonin) with herbal ingredients / active substances, excellent tolerability and, at the same time, high efficacy are guaranteed without the serious side effects of synthetic or pharmaceutical active substances.

[0329] For further details on the advantages and special features of the dosage form according to the invention, reference can also be made to the above statements in the general description.

[0330] With regard to the active ingredient release profile and the efficacy of the dosage form according to the invention, reference can also be made to the figures discussed in detail above in accordance with Figs. 4A, 4B, 4 and 5.

[0331] Results of applications and studies on effectiveness

[0332] Based on the dosage form described above according to the present invention with the high-dose Ashwagandha (dry) extract contained therein (i.e. Ashwagandha root and leaf extract with a drug / extract ratio (DEV) of 40:1 and a withanolide glycoside content of approximately 35% wt.% (HPLC-determined); standardized, Shoden® from Arjuna Natural Pvt. Ltd., India) and comparison extracts with a significantly lower withanolide glycoside content, a large number of applications and studies on efficacy were evaluated.

[0333] In a randomized, double-blind, placebo-controlled study, 150 healthy subjects suffering from non-restorative sleep received 120 mg of standardized Ashwagandha extract (Shoden®) once daily for six weeks. The outcome was assessed using a restorative sleep questionnaire and the WHOQOL (World Health Organization Quality of Life Scale). Sleep onset latency, sleep efficiency, total sleep time, and awakening after sleep onset were measured. A total of 144 subjects completed the study. A 72% improvement in self-rated sleep quality was observed in the treatment group, compared to 29% in the placebo group (significance level p < 0.001). The treatment group, on the other hand, showed a significant improvement in sleep efficiency (p < 0.01), total sleep time (p < 0.001), sleep latency (p < 0.01), and awakening after sleep onset (p < 0.05) compared to placebo after six weeks.In the treatment group (Ashwagandha group) there were also significant improvements in quality of life (QOL) in the areas of body (p < 0.001), psychology (p < 0.001) and environment (p < 0.01).

[0334] Another study explored the life experiences of college students participating in a randomized, double-blind, controlled trial investigating the effects of ashwagandha as an intervention to promote well-being. Participants were college students (N = 60) aged 18–50 years who were randomly assigned to either the intervention or placebo group and were asked to take one capsule of a full-spectrum ashwagandha extract (non-standardized full-spectrum ashwagandha extract containing only < 5 wt% withanolide glycosides) twice daily for 30 days. Participants in the intervention group took 700 mg of a full-spectrum ashwagandha root extract daily, while participants in the placebo group took glycerin capsules. Qualitative data included daily affect checks and focus groups.The data were analyzed using qualitative coding software and thematic analysis. Four themes emerged related to energy levels, mental clarity, sleep dynamics, and stress. The results demonstrate that Ashwagandha increases college students' perceived well-being by supporting sustained energy, increased mental clarity, and improved sleep quality. A moderate dose of Ashwagandha over a 30-day period showed no significant improvement compared to the standardized high-dose Ashwagandha (dry) extract (i.e., Ashwagandha root and leaf extract with a drug / extract ratio (DEV) of 40:1 and withanolide glycoside content of approximately 35% w / w).-% (HPLC-determined); standardized, Shoden®), significantly higher amounts of the full-spectrum extract of Ashwagandha root are required to achieve the desired effect. Consequently, this low-dose extract form tends to be unsuitable for the production of the multiphase or multilayer tablet according to the invention if an oral and compact tablet size is desired, especially given the multitude of other ingredients and active ingredients that also need to be incorporated.

[0335] Furthermore, a meta-study to determine the effect of Ashwagandha extract on sleep evaluated a large number of suitable randomized, controlled trials. These trials examined the effect of Ashwagandha extract compared to placebo on the sleep of people aged 18 years and older. The primary outcome measures were sleep quantity and quality; the secondary outcome measures were mental alertness upon waking, level of anxiety, and quality of life. A total of various randomized, controlled trials with a total of 400 participants were evaluated. Ashwagandha extract demonstrated a significant effect on overall sleep. The effects on sleep were more pronounced in the subgroup of adults diagnosed with insomnia, a treatment dose of more than 600 mg / day, and a treatment duration of more than 8 weeks.Ashwagandha extract was also found to improve mental alertness upon waking and anxiety levels, but had no significant effect on quality of life. No serious side effects were reported. Ashwagandha extract therefore has a positive effect in improving sleep in adults. In particular, Ashwagandha extract has both subjective and objective positive effects on sleep in adults. In the included studies, the two Ashwagandha extracts used were, on the one hand, a standardized high-dose Ashwagandha (dry) extract (i.e., Ashwagandha root and leaf extract with a drug / extract ratio (DEV) of 40:1 and a withanolide glycoside content of approximately 35% w / w (determined by HPLC); standardized, Shoden®) and, on the other hand, a full-spectrum Ashwagandha root extract with a significantly lower withanolide glycoside content (<5% w / w, KSM-66).The studies show that, compared to the standardized, high-dose Ashwagandha (dry) extract, significantly higher amounts of the full-spectrum Ashwagandha root extract are required to achieve the desired effect. List of reference symbols: Dosage form, in particular dietary supplement or pharmaceutical dosage form; first phase, in particular first layer; second phase, in particular second layer; third phase, in particular third layer; coating or film coating.

Claims

Patent claims:

1. Dosage form, in particular dietary supplement and / or pharmaceutical dosage form, in particular for oral application, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promoting and / or supporting, preferably for preventive and / or curative promoting and / or supporting, sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulties falling asleep and / or staying asleep, and / or Dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is designed as a multi-phase tablet, preferably a multi-layer tablet, in particular a two-layer tablet, preferably a three-layer tablet, wherein the dosage form and / or the multi-phase tablet has or consists of several, in particular at least two, preferably three, different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration;wherein the dosage form and / or the multi-phase tablet comprises: a) a first phase ("immediate phase"), in particular a first layer ("immediate layer"), with rapid and / or immediate (instant) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer; (i a ) Melatonin and (ii a ) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer, (ib) Melatonin and (üb) contains at least one extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably an extract of valerian (Valeriana officinalis) ("valerian extract"), c) optionally a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer, (i c) at least one (further) extract of at least one sleep-promoting and / or sedative drug (plant or herb), preferably at least two (further) extracts of different sleep-promoting and / or sedative drugs (plants or herbs), preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.

2. Dosage form, in particular a dietary supplement and / or pharmaceutical dosage form, in particular for oral administration, in particular a dosage form according to claim 1, preferably for promoting and / or supporting, in particular for non-therapeutic and / or non-medical promotion and / or support, preferably for preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular sleep onset and / or sleep maintenance behavior, and / or preferably for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular sleep onset and / or sleep maintenance disorders, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the dosage form is designed as a multi-phase tablet, preferably a multi-layer tablet, in particular a two-layer tablet, preferably a three-layer tablet,wherein the dosage form and / or the multi-phase tablet comprises or consists of several, in particular at least two, preferably three, different phases, in particular layers, wherein the different phases, in particular layers, have different disintegration times and / or active ingredient release rates in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration; wherein the dosage form and / or the multi-phase tablet comprises: a) a first phase ("immediate phase"), in particular the first layer ("immediate layer"), with rapid and / or immediate (immediate) disintegration and / or active ingredient release in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the first phase, in particular the first layer, (i a ) Melatonin and (ii a) contains an extract of Ashwagandha (Withania somnifera) ("Ashwagandha extract"), b) a second phase ("depot phase"), in particular a second layer ("depot layer"), with controlled and / or delayed (retarded) disintegration and / or release of active ingredient in the gastrointestinal tract, in particular the stomach and / or intestine, after oral administration, wherein the second phase, in particular the second layer, (ib) Melatonin and (üb) contains at least one extract of at least one sleep-inducing and / or sedative drug (plant or herb), preferably an extract of valerian (Valeriana officinalis) ("valerian extract"), c) optionally a third phase ("chronophase"), in particular a third layer ("chronolayer"), with continuous disintegration and / or release of active ingredient in the gastrointestinal tract, in particular stomach and / or intestine, after oral administration, wherein the third phase, in particular the third layer, (i c) at least one (further) extract of at least one sleep-promoting and / or sedative drug (plant or herb), preferably at least two (further) extracts of different sleep-promoting and / or sedative drugs (plants or herbs), preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and / or an extract of lavender (Lavandula angustifolia) ("lavender extract"), particularly preferably an extract of valerian (Valeriana officinalis) ("valerian extract") and an extract of lavender (Lavandula angustifolia) ("lavender extract"); in particular wherein the dosage form contains the melatonin in a total amount of at least 1.5 mg, in particular in a total amount in the range of 1.5 mg to 5 mg; and / or in particular wherein the dosage form contains the extract of Ashwagandha in a total amount of at least 50 mg, in particular in a total amount in the range of 50 mg to 1,000 mg; and / or in particular wherein the dosage form contains withanolide glycosides, in particular withanolide glycosides provided by the extract of Ashwagandha, in a total amount of at least 10 mg, in particular in a total amount in the range of 10 mg to 500 mg.

3. Dosage form according to claim 1 or 2, wherein the dosage form comprises the melatonin in an (absolute) amount, in particular total amount, of at least 1.6 mg, in particular at least 1.7 mg, preferably at least 1.8 mg, more preferably at least 1.9 mg; and / or wherein the dosage form comprises the melatonin in an (absolute) amount, in particular total amount, of at most 4 mg, in particular at most 3.5 mg, preferably at most 3 mg, more preferably at most 2.5 mg; and / or wherein the dosage form comprises the melatonin in an (absolute) amount, in particular total amount, in the range from 1.6 mg to 4 mg, in particular in the range from 1.7 mg to 3.5 mg, preferably in the range from 1.8 mg to 3 mg, more preferably in the range from 1.9 mg to 2.5 mg.

4. Dosage form according to one of the preceding claims, wherein the dosage form comprises the melatonin in a (relative) amount, in particular a total amount, of at least 0.02 wt.%, in particular at least 0.05 wt.%, preferably at least 0.1 wt.%, preferably at least 0.13 wt.%, particularly preferably at least 0.16 wt.%, based on the dosage form; and / or wherein the dosage form comprises the melatonin in a (relative) amount, in particular a total amount, of at most 0.9 wt.%, in particular at most 0.5 wt.%, preferably at most 0.3 wt.%, preferably at most 0.25 wt.%, particularly preferably at most 0.22 wt.%, based on the dosage form; and / or wherein the dosage form contains the melatonin in a (relative) amount, in particular total amount, in the range of 0.02 wt.% to 0.9 wt.%, in particular in the range of 0.05 wt.% to 0.5 wt.%, preferably in the range of 0.1 wt.% to 0.3 wt.%, preferably in the range of 0.13 wt.% to 0.25 wt.%, particularly preferably in the range of 0.16 wt% to 0.22 wt%, based on the dosage form.

5. Dosage form according to one of the preceding claims, wherein the first phase, in particular the first layer, comprises the melatonin in an (absolute) amount, in particular a total amount, of at least 0.8 mg, in particular at least 0.85 mg, preferably at least 0.9 mg, more preferably at least 0.95 mg, particularly preferably at least 1 mg; and / or wherein the first phase, in particular the first layer, comprises the melatonin in an (absolute) amount, in particular a total amount, of at most 2.7 mg, in particular at most 2.2 mg, preferably at most 1.9 mg, preferably at most 1.7 mg, particularly preferably at most 1.4 mg; and / or wherein the first phase, in particular first layer, comprises the melatonin in an (absolute) amount, in particular total amount, in the range from 0.8 mg to 2.7 mg, in particular in the range from 0.85 mg to 2.2 mg, preferably in the range from 0.9 mg to 1.9 mg, preferably in the range from 0.95 mg to 1.7 mg, particularly preferably in the range from 1 mg to 1.4 mg.

6. Dosage form according to one of the preceding claims, wherein the second phase, in particular second layer, comprises the melatonin in an (absolute) amount, in particular total amount, of at least 0.7 mg, in particular at least 0.75 mg, preferably at least 0.8 mg, preferably at least 0.85 mg, particularly preferably at least 0.9 mg; and / or wherein the second phase, in particular second layer, comprises the melatonin in an (absolute) amount, in particular total amount, of at most 2.3 mg, in particular at most 1.8 mg, preferably at most 1.6 mg, preferably at most 1.3 mg, particularly preferably at most 1.1 mg; and / or wherein the second phase, in particular second layer, contains the melatonin in an (absolute) amount, in particular total amount, in the range of 0.7 mg to 2.3 mg, in particular in the range of 0.8 mg to 1.8 mg, preferably in the range of 0.85 mg to 1.6 mg, preferably in the range of 0.85 mg to 1.3 mg, particularly preferably in the range of 0.9 mg to 1.1 mg.

7. Dosage form according to one of the preceding claims, wherein the (absolute) amount (weight amount) of melatonin in the first phase, in particular the first layer, is greater than the (absolute) amount (weight amount) of melatonin in the second phase, in particular the second layer.

8. Dosage form according to one of the preceding claims, wherein the weight ratio of melatonin in the first phase, in particular first layer, to melatonin in the second phase, in particular second layer, is in the range from 3:1 to 1:2, in particular in the range from 2:1 to 1:1.5, preferably in the range from 1.5:1 to 1:1.1, preferably in the range from 1.2:1 to 1:

1.

9. Dosage form according to one of the preceding claims, wherein the melatonin is present and / or used in pure form, in particular wherein the melatonin has a purity of at least 95% by weight, preferably at least 97% by weight, more preferably at least 99% by weight, based on the melatonin; and / or wherein the melatonin is present and / or used in the form of a derivative or precursor, in particular in the form of tryptophan, in particular L-tryptophan, and / or hydroxytryptophan.

10. Dosage form according to one of the preceding claims, wherein the third phase, in particular the third layer, contains at least substantially no melatonin and / or is substantially free of melatonin; and / or wherein only and / or exclusively the first phase, in particular the first layer, and the second phase, in particular the second layer, contain the melatonin.

11. Dosage form according to one of the preceding claims, wherein the dosage form comprises the extract of Ashwagandha in an (absolute) amount, in particular a total amount, of at least 10 mg, in particular at least 20 mg, preferably at least 50 mg, more preferably at least 100 mg; and / or wherein the dosage form comprises the extract of Ashwagandha in an (absolute) amount, in particular a total amount, of at most 1,000 mg, in particular a maximum of 600 mg, preferably a maximum of 400 mg, more preferably a maximum of 200 mg; and / or wherein the dosage form comprises the extract of Ashwagandha in an (absolute) amount, in particular a total amount, in the range from 10 mg to 1,000 mg, in particular in the range from 20 mg to 600 mg, preferably in the range from 50 mg to 400 mg, more preferably in the range from 100 mg to 200 mg.

12. Dosage form according to one of the preceding claims, wherein the dosage form comprises the extract of Ashwagandha in a (relative) amount, in particular a total amount, of at least 0.2% by weight, in particular at least 0.5% by weight, preferably at least 1% by weight, preferably at least 5% by weight, particularly preferably at least 8% by weight, based on the dosage form; and / or wherein the dosage form comprises the extract of Ashwagandha in a (relative) amount, in particular a total amount, of at most 50% by weight, in particular at most 40% by weight, preferably at most 30% by weight, preferably at most 20% by weight, particularly preferably at most 15% by weight, based on the dosage form; and / or wherein the dosage form contains the extract of Ashwagandha in a (relative) amount, in particular total amount, in the range of 0.2 wt.% to 50 wt.%, in particular in the range of 0.5 wt.% to 40 wt.%, preferably in the range of 1 wt.% to 30 wt.-%, preferably in the range of 5 wt.% to 20 wt.%, particularly preferably in the range of 8 wt.% to 15 wt.%, based on the dosage form.

13. Dosage form according to one of the preceding claims, wherein the first phase, in particular the first layer, comprises the extract of Ashwagandha in an (absolute) amount, in particular a total amount, of at least 10 mg, in particular at least 20 mg, preferably at least 50 mg, more preferably at least 100 mg; and / or wherein the first phase, in particular the first layer, comprises the extract of Ashwagandha in an (absolute) amount, in particular a total amount, of at most 1,000 mg, in particular at most 600 mg, preferably at most 400 mg, more preferably at most 200 mg; and / or wherein the first phase, in particular first layer, comprises the extract of Ashwagandha in an (absolute) amount, in particular total amount, in the range of 10 mg to 1,000 mg, in particular in the range of 20 mg to 600 mg, preferably in the range of 50 mg to 400 mg, preferably in the range of 100 mg to 200 mg.

14. Dosage form according to one of the preceding claims, wherein the second phase, in particular the second layer, contains at least substantially no extract of Ashwagandha and / or is substantially free of the extract of Ashwagandha; and / or wherein the third phase, in particular the third layer, contains at least substantially no extract of Ashwagandha and / or is substantially free of the extract of Ashwagandha; and / or wherein the second phase, in particular the second layer, and the third phase, in particular the third layer, contain at least substantially no extract of Ashwagandha and / or are substantially free of the extract of Ashwagandha; and / or wherein only and / or exclusively the first phase, in particular the first layer, contains the extract of Ashwagandha.

15. Dosage form according to one of the preceding claims, wherein the Ashwagandha extract is a dry extract and / or is formed as a dry extract; and / or wherein the Ashwagandha extract is a root and / or leaf extract, in particular a root and leaf extract.

16. Dosage form according to one of the preceding claims, wherein the extract of Ashwagandha has a drug / extract ratio (DEV) in the range of 10:1 to 80:1, in particular in the range of 20:1 to 60:1, preferably in the range of 30:1 to 40:1, more preferably in the range of 35:1 to 45:

1.

17. Dosage form according to one of the preceding claims, wherein the Ashwagandha extract comprises at least one carrier (excipient, matrix former) ("carrier Ashwagandha extract") and / or is formulated with at least one carrier (excipient, matrix former) ("carrier Ashwagandha extract"); in particular wherein the carrier is an inorganic or organic carrier; and / or in particular wherein the carrier is a gastric juice-soluble or gastric juice-dispersible and / or intestinal juice-soluble or intestinal juice-dispersible carrier; and / or in particular wherein the carrier is a carbohydrate-based and / or carbohydrate-containing, preferably oligo- and / or polysaccharide-based and / or carbohydrate-containing, carrier, preferably maltodextrin; or in particular wherein the carrier is a carrier in the form of an oxide of silicon, preferably silicon dioxide; and / or in particular wherein the extract of Ashwagandha contains the carrier(s) in an amount ranging from 1% to 75% by weight.-%, in particular in the range of 5 wt.% to 70 wt.%, preferably in the range of 10 wt.% to 60 wt.%, more preferably in the range of 20 wt.% to 50 wt.%, based on the extract.

18. Dosage form according to any one of the preceding claims, wherein the withanolide glycosides are provided by the extract of Ashwagandha; and / or wherein the withanolide glycosides are contained in the extract of Ashwagandha.

19. Dosage form according to one of the preceding claims, wherein the extract of Ashwagandha contains the withanolide glycosides in a (relative) amount of at least 10 wt.%, in particular at least 20 wt.%, preferably at least 30 wt.%, based on the extract; and / or wherein the extract of Ashwagandha contains the withanolide glycosides in a (relative) amount in the range of 10 wt.% to 60 wt.%, in particular in the range of 20 wt.% to 55 wt.%, preferably in the range of 30 wt.% to 50 wt.%, based on the extract.

20. Dosage form according to one of the preceding claims, wherein the dosage form, preferably the first phase, in particular first layer, contains the withanolide glycosides in an (absolute) amount in the range from 15 mg to 400 mg, in particular in the range from 20 mg to 200 mg, preferably in the range from 25 mg to 100 mg, more preferably in the range from 30 mg to 60 mg; and / or wherein the dosage form contains the withanolide glycosides in a (relative) amount in the range from 0.1 wt% to 50 wt%, in particular in the range from 1 wt% to 30 wt%, preferably in the range from 1.5 wt% to 10 wt%, more preferably in the range from 2 wt% to 7 wt%, based on the dosage form.

21. Dosage form according to one of the preceding claims, wherein the second phase, in particular the second layer, contains at least substantially no withanolide glycosides and / or is substantially free of withanolide glycosides; and / or wherein the third phase, in particular the third layer, contains at least substantially no withanolide glycosides and / or is substantially free of withanolide glycosides; and / or wherein the second phase, in particular the second layer, and the third phase, in particular the third layer, each contain at least substantially no withanolide glycosides and / or are substantially free of withanolide glycosides; and / or wherein only and / or exclusively the first phase, in particular the first layer, contains the withanolide glycosides.

22. Dosage form according to one of the preceding claims, wherein the sleep-promoting and / or sedative drug, in particular the sleep-promoting and / or sedative drug of the second and / or third phase, in particular the second and / or third layer, in particular each independently of one another, is selected from the group of valerian (Valeriana officinalis), lavender (Lavandula angustifolia), hops, St. John's wort, lavender, lemon balm, in particular lemon balm, kava-kava, passionflower, chamomile, cranberry, walnut, pistachio, golden poppy (herb), bitter orange (bitter orange leaves), orange (orange blossoms), linden (linden blossoms), bergamot, passionflower, Montmorency sour cherry, hawthorn, and combinations and mixtures thereof, preferably valerian (Valeriana officinalis) and / or lavender (Lavandula angustifolia).

23. Dosage form according to one of the preceding claims, wherein the dosage form comprises the extract(s) of at least one sleep-inducing and / or sedative drug, in particular the extract(s) of at least one sleep-inducing and / or sedative drug of the second and optionally present third phase, in particular the second and optionally present third layer, in an (absolute) amount, in particular total amount, in the range of 10 mg to 4,000 mg, in particular in the range of 50 mg to 3,000 mg, preferably in the range of 100 mg to 1,500 mg, preferably in the range of 200 mg to 1,000 mg; and / or wherein the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract(s) of at least one sleep-promoting and / or sedative drug of the second and optionally present third phase, in particular second and optionally present third layer, in a (relative) amount, in particular total amount, in the range from 0.5 wt.% to 80 wt.%, in particular in the range from 1 wt.% to 70 wt.%, preferably in the range from 5 wt.% to 60 wt.%, preferably in the range from 10 wt.% to 50 wt.%, particularly preferably in the range from 15 wt.% to 40 wt.%, based on the dosage form.

24. Dosage form according to one of the preceding claims, wherein the extract of at least one sleep-promoting and / or sedative drug, in particular the extract of at least one sleep-promoting and / or sedative drug of the second and / or third phase, in particular second and / or third layer, in particular each independently of one another, is a dry extract and / or is designed as a dry extract.

25. Dosage form according to one of the preceding claims, wherein the extract of at least one sleep-promoting and / or sedative drug, in particular the extract of at least one sleep-promoting and / or sedative drug of the second and / or third phase, in particular second and / or third layer, in particular in each case independently of one another, in each case has a drug / extract ratio (DEV) in the range from 1:1 to 100:1, in particular in the range from 2:1 to 80:1, preferably in the range from 3:1 to 50:1, preferably in the range from 4:1 to 40:

1.

26. Dosage form according to one of the preceding claims, wherein the extract of at least one sleep-promoting and / or sedative drug, in particular the extract of at least one sleep-promoting and / or sedative drug of the second and / or third phase, in particular second and / or third layer, in particular independently of one another, in each case comprises at least one carrier (excipient, matrix former) ("carrier drug-extract") and / or is in each case formulated with at least one carrier (excipient, matrix former) ("carrier drug-extract"); in particular wherein the carrier is an inorganic or organic carrier; and / or in particular wherein the carrier is a gastric juice-soluble or gastric juice-dispersible and / or intestinal juice-soluble or intestinal juice-dispersible carrier; and / or in particular wherein the carrier is a carbohydrate-based and / or carbohydrate-containing, preferably oligo- and / or polysaccharide-based and / or carbohydrate-containing, carrier, preferably maltodextrin; or in particular wherein the carrier is a carrier in the form of an oxide of silicon, preferably silicon dioxide.

27. Dosage form according to one of the preceding claims, wherein the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of valerian, in an (absolute) amount, in particular total amount, in the range from 10 mg to 1,200 mg, in particular in the range from 50 mg to 800 mg, preferably in the range from 100 mg to 600 mg, preferably in the range from 200 mg to 400 mg; and / or wherein the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of valerian, in a (relative) amount, in particular total amount, in the range from 0.5 wt.% to 60 wt.%, in particular in the range from 1 wt.% to 50 wt.%, preferably in the range from 5 wt.% to 45 wt.%, preferably in the range from 10 wt.% to 40 wt.%, particularly preferably in the range from 15 wt.% to 35 wt.%, based on the dosage form.

28. Dosage form according to one of the preceding claims, wherein in the second phase, in particular the second layer, the extract of at least one sleep-promoting and / or sedative drug comprises and / or is formed from an extract of valerian; and / or wherein the second phase, in particular the second layer, contains an extract of valerian; and / or wherein the second phase, in particular the second layer, contains no further and / or different extract of at least one sleep-inducing and / or sedative drug apart from the extract of valerian.

29. Dosage form according to one of the preceding claims, wherein the second phase, in particular second layer, comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of valerian, in an (absolute) amount, in particular total amount, in the range from 10 mg to 800 mg, in particular in the range from 20 mg to 600 mg, preferably in the range from 50 mg to 400 mg, preferably in the range from 80 mg to 200 mg.

30. Dosage form according to one of the preceding claims, wherein the first phase, in particular the first layer, contains at least substantially no valerian extract and / or is substantially free of the valerian extract; and / or wherein the second phase, in particular the second layer, and the third phase, in particular the third layer, contain the valerian extract; and / or wherein only and / or exclusively the second phase, in particular the second layer, and the third phase, in particular the third layer, contain the valerian extract.

31. Dosage form according to one of the preceding claims, wherein in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of valerian; and / or wherein the third phase, in particular the third layer, contains an extract of valerian.

32. Dosage form according to one of the preceding claims, wherein the third phase, in particular third layer, contains the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of valerian, in an (absolute) amount, in particular total amount, in the range of 15 mg to 900 mg, in particular in the range of 30 mg to 700 mg, preferably in the range from 60 mg to 500 mg, preferably in the range from 100 mg to 250 mg.

33. Dosage form according to one of the preceding claims, wherein the (absolute) amount (weight) of valerian extract in the third phase, in particular third layer, is greater than the (absolute) amount (weight) of valerian extract in the second phase, in particular second layer.

34. Dosage form according to one of the preceding claims, wherein the weight ratio of extract of valerian in the second phase, in particular second layer, to extract of valerian in the third phase, in particular third layer, is in the range from 2:1 to 1:3, in particular in the range from 1.5:1 to 1:2, preferably in the range from 1.1:1 to 1:1.5, preferably in the range from 1:1 to 1:1.

2.

35. Dosage form according to one of the preceding claims, wherein the valerian extract is a dry extract and / or is formed as a dry extract; and / or wherein the valerian extract is a root extract; and / or wherein the valerian extract has a drug / extract ratio (DEV) in the range of 1:1 to 30:1, in particular in the range of 2:1 to 20:1, preferably in the range of 3:1 to 10:

1.

36. Dosage form according to one of the preceding claims, wherein the valerian extract comprises at least one carrier (excipient, matrix former) ("carrier valerian extract") and / or is formulated with at least one carrier (excipient, matrix former) ("carrier valerian extract"); in particular wherein the carrier is an inorganic or organic carrier; and / or in particular wherein the carrier is a gastric juice-soluble or gastric juice-dispersible and / or an intestinal juice-soluble or intestinal juice-dispersible carrier; and / or in particular wherein the carrier is a carbohydrate-based and / or -containing, preferably oligo- and / or polysaccharide-based and / or -containing, carrier, preferably maltodextrin; and / or in particular wherein the valerian extract contains the carrier(s) in an amount in the range of 5 wt.% to 80 wt.%, in particular in the range of 10 wt.% to 60 wt.%, preferably in the range of 20 wt.% to 40 wt.%, based on the extract.

37. Dosage form according to one of the preceding claims, wherein the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of lavender, in an (absolute) amount, in particular total amount, in the range of 5 mg to 1,000 mg, in particular in the range of 10 mg to 600 mg, preferably in the range of 50 mg to 400 mg, preferably in the range of 75 mg to 200 mg.

38. Dosage form according to one of the preceding claims, wherein the dosage form comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of lavender, in a (relative) amount, in particular total amount, in the range from 0.2 wt.% to 55 wt.%, in particular in the range from 0.5 wt.% to 45 wt.%, preferably in the range from 1 wt.% to 40 wt.%, preferably in the range from 3 wt.% to 30 wt.%, particularly preferably in the range from 5 wt.% to 25 wt.%, based on the dosage form.

39. Dosage form according to one of the preceding claims, wherein in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from a lavender extract, preferably comprises; and / or wherein the third phase, in particular the third layer, contains a lavender extract, in particular in combination and / or together with a valerian extract, in particular as defined above.

40. Dosage form according to one of the preceding claims, wherein the third phase, in particular third layer, comprises the extract(s) of at least one sleep-promoting and / or sedative drug, in particular the extract of lavender, in an (absolute) amount, in particular total amount, in the range from 10 mg to 750 mg, in particular in the range from 20 mg to 550 mg, preferably in the range from 50 mg to 350 mg, preferably in the range from 70 mg to 175 mg.

41. Dosage form according to one of the preceding claims, wherein the lavender extract is a dry extract and / or is formed as a dry extract; and / or wherein the lavender extract is a flower extract.

42. Dosage form according to one of the preceding claims, wherein the extract of lavender has a drug / extract ratio (DEV) in the range of 1:1 to 50:1, in particular in the range of 3:1 to 25:1, preferably in the range of 5:1 to 15:

1.

43. Dosage form according to one of the preceding claims, wherein the lavender extract comprises at least one carrier (excipient, matrix former) ("carrier lavender extract") and / or is formulated with at least one carrier (excipient, matrix former) ("carrier lavender extract"); in particular wherein the carrier is an inorganic or organic carrier; and / or in particular wherein the carrier is a gastric juice-soluble or gastric juice-dispersible and / or intestinal juice-soluble or intestinal juice-dispersible carrier; and / or in particular wherein the carrier is a carbohydrate-based and / or -containing, preferably oligo- and / or polysaccharide-based and / or -containing, carrier, preferably maltodextrin; and / or in particular wherein the extract of lavender contains the carrier(s) in an amount in the range of 1 wt% to 60 wt%, in particular in the range of 2 wt% to 40 wt%, preferably in the range of 5 wt% to 20 wt%, based on the extract.

44. Dosage form according to one of the preceding claims, wherein the first phase, in particular first layer, and / or the second phase, in particular second layer, preferably the first phase, in particular first layer, and the second phase, in particular second layer, at least substantially contain(s) no extract of lavender and / or are substantially free of the extract of valerian; and / or wherein the third phase, in particular third layer, contains an extract of lavender; and / or wherein only and / or exclusively the third phase, in particular third layer, contains an extract of lavender.

45. Dosage form according to one of the preceding claims, wherein in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of valerian and / or an extract of lavender, in particular an extract of valerian and an extract of lavender; and / or wherein the third phase, in particular the third layer, contains an extract of valerian and / or an extract of lavender, in particular an extract of valerian and an extract of lavender; and / or wherein the third phase, in particular the third layer, contains no further and / or different extract of at least one sleep-promoting and / or sedative drug apart from the extract of valerian and / or the extract of lavender, in particular the extract of valerian and the extract of lavender.

46. Dosage form according to one of the preceding claims, wherein the (absolute) amount (weight) of lavender extract in the third phase, in particular third layer, is smaller than the (absolute) amount (weight) of valerian extract in the third phase, in particular third layer; and / or wherein the weight ratio of lavender extract in the third phase, in particular third layer, to valerian extract in the third phase, in particular third layer, is in the range from 1.5:1 to 1:5, in particular in the range from 1.2:1 to 1:3, preferably in the range from 1.1:1 to 1:2, more preferably in the range from 1:1 to 1:1.

5.

47. Dosage form according to one of the preceding claims, wherein the dosage form, preferably the third phase, in particular the third layer, contains linalool, in particular linalool provided by the extract of lavender, in particular in a total amount of at least 3 mg, in particular at least 5 mg, preferably at least 8 mg and / or in particular in a total amount in the range from 3 mg to 50 mg, in particular in the range from 5 mg to 40 mg, preferably in the range from 8 mg to 30 mg.

48. Dosage form according to one of the preceding claims, wherein in the second phase, in particular the second layer, the extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of valerian; and / or wherein the second phase, in particular the second layer, contains an extract of valerian, in particular wherein the second phase, in particular the second layer, comprises the extract of valerian in an (absolute) amount, in particular a total amount, in the range of 10 mg to 800 mg, in particular in the range of 20 mg to 600 mg, preferably in the range of 50 mg to 400 mg, preferably in the range of 80 mg to 200 mg; and wherein in the third phase, in particular the third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of valerian; and / or wherein the third phase, in particular the third layer, contains an extract of valerian, in particular wherein the third phase, in particular third layer, comprises the extract of valerian in an (absolute) amount, in particular total amount, in the range from 15 mg to 900 mg, in particular in the range from 30 mg to 700 mg, preferably in the range from 60 mg to 500 mg, preferably in the range from 100 mg to 250 mg; and wherein in the third phase, in particular third layer, the (further) extract of at least one sleep-promoting and / or sedative drug comprises or is formed from an extract of lavender;and / or wherein the third phase, in particular third layer, contains an extract of lavender, in particular wherein the third phase, in particular third layer, comprises the extract of lavender in an (absolute) amount, in particular total amount, in the range from 10 mg to 750 mg, in particular in the range from 20 mg to 550 mg, preferably in the range from 50 mg to 350 mg, preferably in the range from 70 mg to 175 mg, and / or in particular wherein the third phase, in particular the third layer, contains linalool, in particular linalool provided by the extract of lavender, in particular in a total amount of at least 3 mg, in particular at least 5 mg, preferably at least 8 mg and / or in particular in a total amount in the range from 3 mg to 50 mg, in particular in the range from 5 mg to 40 mg, preferably in the range from 8 mg to 30 mg.; 49. Dosage form according to one of the preceding claims, wherein the dosage form contains at least one vitamin, in particular selected from the group of vitamin A, vitamins of the B group, in particular vitamin B1, vitamin B6 and / or vitamin B12, vitamin C, vitamins of the D group, in particular vitamin D2 and / or vitamin D3, vitamin E, vitamins of the K group, in particular vitamin K1 and / or vitamin K2, and combinations and mixtures thereof, preferably selected from the group of vitamin A, vitamins of the B group, in particular vitamin B1, vitamin B9 and / or vitamin B12, vitamin C and vitamins of the D group, in particular vitamin D2 and / or vitamin D3, and combinations and mixtures thereof, preferably selected from the group of vitamins of the B group, in particular vitamin B1, vitamin B9 and / or vitamin B12, and vitamins of the D group, in particular vitamin D2 and / or vitamin D3, and combinations and mixtures thereof.

50. Dosage form according to one of the preceding claims, wherein the dosage form contains, in particular in respectively effective amounts, preferably in nutritionally and / or pharmaceutically effective amounts, at least one vitamin of the B group, in particular vitamin Be, vitamin Bg and / or vitamin B12, and / or at least one vitamin of the D group, in particular vitamin D2 and / or vitamin D3, preferably at least one vitamin of the D group, in particular vitamin D2 and / or vitamin D3.

51. Dosage form according to one of the preceding claims, wherein the dosage form contains, in particular in respectively effective amounts, preferably in nutritionally and / or pharmaceutically effective amounts, at least one immunostimulant, in particular selected from the group of: (i) immunostimulating drugs (plants orherbs) or their ingredients, preferably echinacea, ginseng, ginger, garlic, berries and / or rockrose, in particular in the form of the respective extracts; (ii) polyphenols; (iii) minerals and trace elements, in particular zinc, preferably zinc components and / or zinc compounds, and / or selenium, preferably selenium components and / or selenium compounds; (iv) vitamins, in particular vitamins of the D group, preferably vitamin D2 and / or vitamin D3, and / or vitamin C; (v) probiotics; (vi) prebiotics; (vii) microorganisms; (viii) physiological immunomodulators, in particular lymphokines, interleukins, thymus factors and interferons; as well as combinations and mixtures thereof.

52. Dosage form according to one of the preceding claims, wherein the first phase, in particular first layer, and the second phase, in particular second layer, and the optionally present third layer, in particular third phase, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, have different disintegration times (dissolution times or durations), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, and / or different active ingredient release rates, in particular determined according to Ph. Eur., 10th edition, chapter 2.9.

3.

53. Dosage form according to one of the preceding claims, wherein the first phase, in particular first layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, of at most 30 min, in particular at most 20 min, preferably at most 10 min; and / or wherein the first phase, in particular first layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range from 1 min to 30 min, in particular in the range from 2 min to 20 min, preferably in the range from 5 min to 10 min.

54. Dosage form according to one of the preceding claims, wherein the second phase, in particular second layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, of at most 10 h, in particular at most 9 h, preferably at most 8 h; and / or wherein the second phase, in particular second layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range of 2 h to 10 h, in particular in the range of 4 h to 9 h, preferably in the range of 6 h to 8 h.and / or wherein the disintegration of the second phase, in particular the second layer, begins and / or starts (only) with a time delay in the range of 0.5 min to 20 min, in particular in the range of 1 min to 15 min, preferably 2 min to 10 min, after contact with a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, Chapter 5.17.

1.

55. Dosage form according to one of the preceding claims, wherein the third phase, in particular third layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, of at most 6 h, in particular at most 5 h, preferably at most 4 h; and / or wherein the third phase, in particular third layer, in a medium of the gastrointestinal tract, in particular gastric juice and / or intestinal juice, preferably according to Ph. Eur., 10th edition, chapter 5.17.1, has a disintegration time (dissolution time or duration), in particular determined according to Ph. Eur., 10th edition, chapter 2.9.1, in the range of 1 h to 6 h, in particular in the range of 3 h to 6 h, preferably in the range of 4 h to 6 h.

56. Dosage form according to one of the preceding claims, wherein the disintegration time (dissolution time or duration) of the first phase, in particular the first layer, and / or the disintegration time (dissolution time or duration) of the second phase, in particular the second layer, and / or the disintegration time (dissolution time or duration) of the third phase, in particular the third layer, preferably the mutually different disintegration times (dissolution times or durations) of the respective phases, in particular layers, in particular independently of one another, is set and / or predetermined by at least one of the following measures.are: a) use and / or selection of the type and / or amount of at least one disintegrating and / or disintegrating additive, in particular disintegrating and / or disintegrating agent and / or disintegration-promoting filler and / or carrier; and / or at least one disintegration-retarding agent and / or at least one respective binder in the respective phases, in particular layers; b) selection and / or adjustment of the level of the pressing force and / or the pressing pressure when producing the dosage form, in particular when producing the respective phases, in particular layers; c) arrangement and / or shaping, in particular arrangement, of the respective phases, in particular layers, in the dosage form, in particular wherein in particular in the case of the formation of the. Dosage form as a three-layer tablet, the second phase, in particular the second layer, is arranged between the first phase, in particular the first layer, and the third phase, in particular the third layer; d) applying and / or forming a coating and / or film onto the dosage form; and / or c) adjusting the residual moisture in the respective phases, in particular layers.

57. Dosage form according to one of the preceding claims, wherein the first phase, in particular the first layer, comprises at least one disintegrant and / or disintegrating agent and optionally at least one binder, in particular at least one disintegrant and / or disintegrating agent and at least one binder, in particular in a weight ratio of disintegrant and / or disintegrating agent(s) to binder(s) of < 1:1, in particular < 0.8:1, preferably < 0.7:1; and / or in particular wherein the first phase, in particular the first layer, contains the disintegrant and / or disintegrating agent(s) in a (relative) amount in the range from 1 wt.% to 10 wt.%, in particular in the range from 1 wt.% to 5 wt.%, preferably in the range from 1 wt.% to 3 wt.%, based on the first phase, in particular the first layer; and / or in particular wherein the first phase, in particular the first layer, contains the binder in a (relative) amount in the range from 1 wt.% to 20 wt.- %, in particular in the range from 1 wt.% to 10 wt.%, preferably in the range from 1 wt.% to 5 wt.%, based on the first phase, in particular the first layer.

58. Dosage form according to one of the preceding claims, wherein the second phase, in particular second layer, comprises at least one disintegration-retarding agent and optionally at least one binder, in particular at least one disintegration-retarding agent and at least one binder, in particular wherein the second phase, in particular the second layer, contains the disintegration-retarding agent(s) in a (relative) amount in the range from 5 wt.% to 50 wt.%, in particular in the range from 10 wt.% to 40 wt.%, preferably in the range from 20 wt.% to 30 wt.%, based on the second phase, in particular the second layer; and / or in particular wherein the second phase, in particular the second layer, contains the binder in a (relative) amount in the range from 1 wt.% to 15 wt.%, in particular in the range from 1 wt.% to 10 wt.%, preferably in the range from 1 wt.% to 5 wt.%, based on the second phase, in particular the second layer; in particular wherein the second phase, in particular the second layer, has at least substantially no disintegrating and / or disintegrating additive, in particular at least substantially no disintegrating and / or disintegrating agent.

59. Dosage form according to one of the preceding claims, wherein the third phase, in particular the third layer, comprises at least one disintegration-slowing-release agent, in particular wherein the third phase, in particular the third layer, contains the disintegration-slowing-release agent(s) in a (relative) amount in the range from 5% to 25% by weight, in particular in the range from 7.5% to 15% by weight, preferably in the range from 8% to 12% by weight, based on the third phase, in particular the third layer; and / or in particular wherein the third phase, in particular the third layer, comprises at least substantially no disintegrating and / or disintegrating additive, in particular at least substantially no disintegrating and / or disintegrating agent.

60. Dosage form according to one of the preceding claims, wherein the first phase, in particular first layer, and the second phase, in particular second layer, and the optionally present third phase, in particular third layer, are optically and / or visually different from each other, namely different in color, in particular wherein the first phase, in particular first layer, and / or the second phase, in particular second layer, and / or the optionally present third phase, in particular third layer, independently of one another, each comprise a coloring ingredient (dye).

61. Dosage form according to one of the preceding claims, wherein the dosage form or the multi-phase tablet, in particular the two-layer tablet, preferably a three-layer tablet, has a coating (film coating), in particular a gastric juice-soluble or gastric juice-dispersible and / or intestinal juice-soluble or intestinal juice-dispersible coating, preferably a cellulose-based coating, preferably based on hydroxypropylcellulose, optionally in combination with polyethylene glycol, and / or wherein the dosage form orthe multi-phase tablet, in particular the two-layer tablet, preferably the three-layer tablet, is in coated form, in particular wherein the coating is a gastric juice-soluble or gastric juice-dispersible and / or intestinal juice-soluble or intestinal juice-dispersible coating, preferably a cellulose-based coating, preferably based on hydroxypropylcellulose, optionally in combination with polyethylene glycol; in particular wherein the dosage form orthe multi-phase tablet, in particular the two-layer tablet, preferably the three-layer tablet, is at least substantially completely coated and / or at least substantially completely enclosed by the coating; and / or in particular wherein the coating has a weight in the range from 1 mg to 100 mg, in particular in the range from 2 mg to 75 mg, preferably in the range from 5 mg to 50 mg, more preferably in the range from 8 mg to 20 mg; and / or in particular wherein the coating is present in a (relative) amount in the range from 0.1 wt% to 10 wt%, in particular in the range from 0.2 wt% to 5 wt%, preferably in the range from 0.5 wt% to 2 wt%, more preferably in the range from 0.7 wt% to 1 wt%, based on the dosage form or the multi-phase tablet, and / or. in particular wherein the coating is at least substantially colorless and / or at least substantially translucent and / or transparent.

62. Dosage form according to one of the preceding claims, wherein the dosage form, in particular the multi-layer tablet, is obtained by compression, preferably compression of the active ingredients and ingredients forming the dosage form, in particular the tablet, and / or wherein the dosage form, in particular the tablet, is designed and / or is present as a pressed article; and / or wherein the first phase, in particular the first layer, and the second phase, in particular the second layer, and the optionally present third phase, in particular the third layer, are produced in particular independently of one another and / or separately from one another and / or successively, in particular each individually by compression, preferably by compression of the active ingredients and ingredients forming the respective phase, in particular layer;and / or wherein the dosage form, in particular the multilayer tablet, is obtained by joint (final) compression of the previously produced and / or compressed first phase, in particular the first layer, the previously produced and / or compressed second phase, in particular the second layer, and the optionally present, previously produced and / or compressed third phase, in particular the third layer; and / or wherein the dosage form, in particular the multilayer tablet, is obtained by successive compression of the phases, in particular layers, forming the dosage form, in particular wherein the successive layers or phases are compressed onto or with one another, in particular so that the dosage form in the form of the multilayer tablet is obtained.; 63. Dosage form according to one of the preceding claims, wherein the dosage form, in particular the multi-layer tablet, has a (total) weight in the range of 200 mg to 8,000 mg, in particular in the range of 400 mg to 6,000 mg, preferably in the range of 600 mg to 4,000 mg, preferably in the range of 800 mg to 2,000 mg; and / or wherein the first phase, in particular the first layer, has a weight in the range of 60 mg to 2,500 mg, in particular in the range of 120 mg to 1,800 mg, preferably in the range of 180 mg to 1,000 mg, preferably in the range of 250 mg to 600 mg; and / or wherein the second phase, in particular the second layer, has a weight in the range of 60 mg to 2,500 mg, in particular in the range of 120 mg to 1,800 mg, preferably in the range of 180 mg to 1,000 mg, preferably in the range of 250 mg to 600 mg; and / or wherein the third phase, in particular the third layer, has a weight in the range of 80 mg to 3,000 mg, in particular in the range of 160 mg to 2,400 mg, preferably in the range of 240 mg to 2,000 mg, preferably in the range of 300 mg to 800 mg.

64. Dosage form according to one of the preceding claims, wherein the dosage form, in particular the multi-layer tablet, has a cylindrical basic shape, in particular a cylindrical basic shape with oblong or circular base surfaces, in particular oval, preferably elliptical, base surfaces, in particular wherein at least one of the base surfaces, preferably both base surfaces, in particular independently of one another, are each convex and / or curved outwards and / or in particular wherein the dosage form is present and / or designed as a multi-phase oblong tablet, in particular a multi-layer oblong tablet, preferably a two-layer oblong tablet, preferably a three-layer oblong tablet.

65. Dosage form according to one of the preceding claims, wherein the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer, are arranged in a stacked manner and / or successively and / or parallel to one another; and / or wherein the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer, are in contact with one another, in particular directly or indirectly in contact with one another; and / or and / or the first phase, in particular the first layer, and the second phase, in particular the second layer, and optionally the third phase, in particular the third layer, form a composite, in particular for forming the dosage form, in particular the multi-layer tablet.

66. Dosage form according to one of the preceding claims, wherein, in particular in the case of the dosage form being designed as a three-layer tablet, the second phase, in particular the second layer, is arranged between the first phase, in particular the first layer, on the one hand, and the third phase, in particular the third layer, on the other hand; and / or wherein, in particular in the case of the dosage form being designed as a three-layer tablet, the second phase, in particular the second layer, is connected to the first phase, in particular the first layer, on the one hand, and to the third phase, in particular the third layer, on the other hand, in each case via the inner and mutually opposite base surfaces of the respective phases, orLayers, in particular independently of one another, are firmly connected to one another and / or at least substantially over their entire surface and / or form a composite; and / or wherein, in particular in the case of the dosage form being designed as a three-layer tablet, the outer base surface of the first phase or layer and / or the third phase or layer, in particular of the first phase or layer and the third phase or layer, independently of one another, is each convex and / or curved outwards.

67. Dosage form according to one of the preceding claims, wherein the dosage form is designed as a coated and / or film-coated multi-phase tablet, in particular a coated and / or film-coated multi-layer tablet, preferably a coated and / or film-coated two-layer tablet (two-layer film-coated tablet), preferably a coated and / or film-coated three-layer tablet (three-layer film-coated tablet).

68. Dosage form according to one of the preceding claims, wherein the dosage form is present as a dietary supplement; medicament; pharmaceutical; pharmaceutical composition; medical device; homeopathic; dietary; cosmetic; consumer article or food, preferably as a dietary supplement.

69. Dosage form according to one of the preceding claims for the non-therapeutic and / or non-medical support and / or promotion of restful sleep and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm; and / or for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm; and / or for use in the prophylactic and / or therapeutic medical treatment of dyssomnia, in particular agrypnia, insomnia and / or hyposomnia.

70. Dosage form according to one of the preceding claims, wherein the sleep disorders and / or the dysregulation of the natural day / night rhythm and / or the circadian rhythm are accompanied by and / or caused by a reduced and / or inhibited production and / or a reduced and / or inhibited release of melatonin, in particular in the human body.

71. Dosage form according to one of the preceding claims for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for the support and / or promotion of restful sleep and / or for the curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

72. Use of a dosage form according to one of claims 1 to 71 in the food supplement sector and / or as a food supplement, in particular for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for the support and / or promotion of restful sleep and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

73. Use of a dosage form according to any one of claims 1 to 71 (for the manufacture of a medicament or drug) for the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

74. A medicinal product, pharmaceutical, medical device or homeopathic remedy, wherein the medicinal product, pharmaceutical, medical device or homeopathic remedy contains or consists of a dosage form as defined in any one of claims 1 to 71, in particular for use in the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

75. Use of a medicament, pharmaceutical, medical device or homeopathic remedy as defined in claim 74 (for the manufacture of a medicament or drug) for the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

76. A food supplement, wherein the food supplement contains or consists of a dosage form as defined in any one of claims 1 to 71, in particular for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for supporting and / or promoting restful sleep and / or for supporting and / or promoting restful sleep and / or sleep behavior and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

77. Use of a food supplement according to claim 76 for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for the support and / or promotion of restful sleep and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm.

78. A method for the prophylactic and / or therapeutic medical treatment of sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm, wherein the method comprises administering a pharmaceutically effective and / or therapeutically effective amount of a dosage form as defined in any one of claims 1 to 71 or of a medicament, pharmaceutical, medical device or homeopathic remedy as defined in claim 74 to a patient having and / or suffering from the sleep disorders, in particular difficulty falling asleep and / or staying asleep, and / or dysregulation of the natural day / night rhythm and / or the circadian rhythm.

79. A method for the non-therapeutic and / or non-medical promotion and / or support, preferably for the preventive and / or curative promotion and / or support, of sleep health and / or sleep behavior, in particular the behavior of falling asleep and / or staying asleep, and / or for supporting and / or promoting restful sleep and / or for the preventive and / or curative promotion and / or support of the natural day / night rhythm and / or the natural circadian rhythm, wherein in the method a patient or person having the disorders and / or deficits and / or suffering therefrom is administered a nutritionally effective and / or nutritionally relevant amount of a dosage form as defined in any one of claims 1 to 71 or of a food supplement as defined in claim 76.

80. Packaging unit containing at least one dosage form, preferably a plurality of dosage forms, as defined in one of claims 1 to 71; in particular wherein the packaging unit is a blister pack and / or is designed as a blister pack, preferably as a push-through blister pack; and / or in particular wherein the blister pack comprises a receiving form, made in particular of plastic, with a plurality of cavities for receiving the dosage form(s) and / or the preparation(s) and / or the tablet(s), as well as a cover film, in particular blister film, preferably aluminum foil, which is sealingly connected to the receiving form and closes the cavities.

81. Use of a dosage form according to claim 72 or 73; medicament, pharmaceutical, medical device, or homeopathic remedy according to claim 74; use of a medicament, pharmaceutical, medical device, or homeopathic remedy according to claim 74; food supplement according to claim 76; use of a food supplement according to claim 77; method according to claim 78 or 79 or packaging unit according to claim 80, each characterized by one or more of the features of claims 1 to 71.

Images