MX2008003374A - Oral vehicle for systemic pharmaceuticals - Google Patents

Abstract

Systemic drug delivery means comprises boluses of a semi-solid agar gel, each containing active ingredients, packed singly or in co-operating sets in blister packs, or loose in a container. When placed in the mouth the bolus is disrupted, comes apart, and releases the active ingredients. Sialogogues, flavours, and other additives assist in swallowing. Grains of the active ingredients may be encapsulated inside harder gel capsules.Active ingredients include over-the-counter medications and prescription medications. Applications include self-medication particularly in water-free situations such as public transport, medication for children, stroke victims or the aged.

Description

ORAL VLE FOR PHARMACEUTICAL PRODUCTS SYSTEMS FIELD OF THE INVENTION The invention relates to means of supplying systemic drugs; a carrier of the drug for use with the drugs to be administered by an oral route.

DEFINITIONS The term "BSSG" is used herein to refer to a bolus indefinitely comprising a semi-solid gel; each bolus includes an effective amount of at least one pharmacist or alternatively of an "agent that hides the taste" to continue the administration of an unpleasant-tasting medicine that itself has been through a BSSG bolus. (BSSG = bolus: semi-solid gel). The term "agent that hides the taste" is used to refer to any substance that can help the act of taking a pharmaceutical substance, greatly reducing the perceived bad taste when some particular substances come into contact with taste buds in the mouth Also included are light beverages such as water, concealing agents such as seasoning agents or sweetening agents and coating agents such as finely divided inert substances, or honey (see US 6998139 below). 190844 BACKGROUND OF THE INVENTION The invention relates to means for delivering systemic drugs orally or to intraoral drug delivery. Most drugs are distributed for sale and used as dry tablets, pills, boluses or the like; these are found in single dose units and those in dry state are relatively stable. Some medications are distributed as syrups, suspensions or other medicines in liquid state. For oral medications, the main route of absorption in the stomach and intestine is by blood. A common demand requirement is that it is necessary to ingest a dry tablet under circumstances in which the usual rinse is not available with a glass of water to do so. A headache can for example, arise at any time, away from home or in the absence of a sink; or when you do not bring bottled water with you; for example, when one is traveling on the bus or the train, or when one is driving in traffic, in a theater, in an important meeting, or when walking, or perhaps when a headache is perceived or some another disorder. Certain emergency medications, such as those to mitigate an anaphylactic response or for use in obstetrician's may involve taking an oral systemic treatment, if no parenteral administration is available or is feasible. Another is one in which "treatment fails" in children. Another problem comes from the risks associated with swallowing hard and large objects such as pills or capsules in certain patients, such as the elderly or neurologically impaired people with a deformed swallow reflex. An additional requirement refers to the dosage of pets or domestic animals; It is an art to supply a tablet to a cat with a successful and scratch-free result. Another requirement is emergency medication when parenteral administration can not be provided or may not be advisable. The oral cavity has been an acceptable route for pain-free drug delivery for many years. The mucosa is relatively permeable, has a rich blood supply, is robust, and recovers quickly if damaged. It has almost no Langerhans cells, and is tolerant to possible allergens. Since the venous secretion does not cross the liver, the elimination of the absorbed drugs is slower. Three possible sites within the oral cavity include: sublingual, oral and local sites. There is a possibility of accelerating absorption by iontophoresis or local massage. However, it is not used by universal means. A patent search EP 0651997 from Yamanouchi reveals that the bolus preparation for the administration of medication through the oral cavity includes 0.1-1.2 per a hundred weight agar, made in capsule-free boluses that are distributed in the bubbles inside the blister packs. In contrast to the present invention, these boluses comprise mainly 50-99% of specific sugars - lactose and / or mannitol - and an additional procedure is used for external drying in each bolus starting immediately after the agar set for a prolonged period of typically a few hours or days, while bowling becomes hard enough to resist pushing through the back of a bubble-like package ("blister pack"). This is described as "sufficient force for its management". Hardness measurements are provided (interpreted as resistance to crushing) with an average of about 2 or 2.45 kg (19.6 - 24 N). Raising the temperature of the agar solution, when done first, to almost 100 ° C is considered important by the present inventor for the improved properties of the bolus. EP 0651997 does not mention that aspect. WO2004 / 037231 is an example of a group using capsules for medicinal use - in this case, broadly comprising gum arabic and a water soluble polymer within a capsule. The present invention does not use gum arabic, and any capsule is non-essential. EP 0389700 discloses capsules that include a plurality of micro soft capsules with an agar layer, considering that the present invention describes homogeneous boluses, not capsules covered. EP 0950402 describes a chewable pharmaceutical with a specific gelatin matrix, capable of being swallowed in less than 20 seconds - considering that the present invention uses agar, a different material with differing properties, and normally expects to retain the material in the mouth for a longer period of time. EP 1444975 for the present application discloses a variety of formulations for releasing the toothpaste in the mouth and rapidly separating under the application of a force, so that the toothpaste can serve a mechanical function, considering that the present application claims that The formulations release their active ingredients more slowly for diffusion to occur via the oral mucosa. US6998139 describes a method for reducing the bitterness of a bitter-tasting drug taken as oral tablets, which comprises pre-coating the tongue immediately with a finely divided inert material (such as titanium dioxide) which has the apparent effect of blocking the receptors of flavor in the tongue. Dry tablets are claimed which rapidly disintegrate into multiple parts. The nuts of the areca tree (betel nuts) are usually chewed by the South East Asians along with the betel leaf and ed lime, and is described as having a very bitter taste and raspy taste. It is suspected that ed lime can serve the same hiding function as the titanium dioxide of the U.S. 6998139 although it is known for its use as an agent that extracts alkaloids (include arecholine) from the walnut.

BRIEF DESCRIPTION OF THE INVENTION It is an object of this invention to provide an alternative vehicle for the administration of pharmaceuticals, or at least to provide a useful option to the public. In a first broad aspect of the invention provides an oral vehicle for bringing an effective amount of one or more desired ingredients (herein called "active agents") into the systemic circulation of a human or animal orally; the oral vehicle comprising at least one bolus of the unit (in the present so-called BSSG (= bolus: semisolid gel for its acronym in English)), wherein the or each BSSG includes a matrix of a semi-solid gel comprised of agar or a functional equivalent thereof and carrying an effective amount of one or more active agents; The semi-solid gel has a hardness of about 15 Newtons per mm under test conditions defined herein and ranging from about 0.1% to more than 5% by weight of agar. "Active agents" include without limitation, pharmaceuticals, antibiotics, medicines, vaccines, mineral and dietary supplements, health food supplements, plant extracts, placebos, alternative medicines, and materials taken voluntarily by a person. Preferred or pharmaceutical medications include (without limitation) medicines, antibiotics, oral vaccines, plant extracts, peptides pharmacologically active agents, vitamins, mineral and nutritional supplements (such as trace elements, including iodine), and placebos . Example of pharmaceuticals include (without limitation) known compounds such as ampicillin, cloxacillin, tetracycline, codeine phosphate, dextromethorphan, morphine, paracetamol (acetaminophen), nicotine, diclofenac, pholcodine, piperazine, pseudoephedrine, quinine, contraceptives, tadalafil, sildenafil, and substances that serve as placebos; also antihistamines and / or adrenaline analogues for anaphylactic shock caused by bee stings. More particularly, preferred pharmacists include those materials available over the counter (without prescription) for pain suppression, for overcoming headache or migraine, such as remedies, for colds and influenza, for suppressing nausea, and inhibiting or kills protozoan parasites such as Plasmodium species. (malaria); also vitamins, mixtures of vitamins, trace elements and other health supplements; also oral sprays, decongestants and suppressants for allergic reactions such as remedies for fever hay. Preferably, the mass of a single BSSG is approximately 0.6-1.2 grams, while the larger sizes particularly those for intraoral absorption can include from about 2 grams of medication and up to about 3 grams of excipients, gels, flavorings and the like. Preferably the semi-solid gel is homogeneous and includes agar or a functional equivalent thereof in an amount from about 0.6% to 0.9% by weight of agar. Alternatively, the semi-solid gel is homogeneous but encapsulated and the homogeneous portion includes agar or a functional equivalent thereof in an amount of about 0.1% to 0.9% by weight of agar. Preferably, the oral carrier comprises a set of at least two BSSGs each having a different set of active agents; wherein a first BSSG is formulated to complement the sustained formulation within a second BSSG and therefore promotes the systemic absorption of one or more active agents sustained within the second BSSG when both BSSGs are taken at or about the same time. In a related aspect, at least two BSSG are used to separately hold active agents over a period of time; said active agents are unstable if they are stored in the same BSSG during the period of time.

In a main option, the route or intentional route of supply is mainly one whose gastrointestinal absorption after swallowing, facilitated by. the bolus delivery with at least one medium capable of being used to make the or each BSSG easier to swallow in the absence of water. Preferably, the promotion of systemic absorption is facilitated by means of at least one medium selected from a range which includes: promotion of salivation, at least partial concealment of adverse taste, which provides a uniform exterior, and which allows the each BSSG is dissociated in the mouth before swallowing, so that an effective course of treatment would have to be maintained. In a second major option, the intended oral route of supply is mainly that of intra-oral absorption for a period of time independent of swallowing, and the promotion of systemic absorption is facilitated by means of at least one ingredient capable of obtaining at least a process selected from a range that includes: the promotion of salivation, at least the partial concealment of adverse taste, the supply of an active surface agent, the promotion of circulation within the oral submucosa, facilitating, by means of the properties of the semi-solid gel, the or each BSSG to be physically dissociated within the mouth, allowing diffusion to occur within or each BSSG and / or providing a pleasant perception sensitive to the mouth (which includes providing an external smoothing) so that an effective course of treatment will tend to be maintained, c) dissociating forces applied within the mouth (between the tongue and the teeth for example) . An optional supplemental physical medium capable of promoting circulation within the oral submucosa comprises a toothbrush or the like. Preferably, at least the partial concealment of adverse taste is caused by a process that includes at least one of: blocking taste buds that include at least one coating substance, submerging the budding flavor with a sweetness that includes less a sugar or sweetener, or providing a flavoring that includes an effective amount of at least one flavoring agent, thus dominating, the olfactory receptors. In a subsidiary aspect, the agent that hides the flavor is provided in a BSSG. individual so that the person can manipulate the time of ingestion of the respective BSSG to minimize an adverse taste of at least one active agent. Alternatively, the flavor-hiding agent is supplied within the BSSG that contains the active agents. In addition, at least some BSSGs also include, at least one of: distinctive coloring agent, an agent of distinctive opacity, and a distinctive form so that each of a range of BSSG types is supplied and allows the identification of at least one sustained active agent. Optionally, the BSSG further include a distinctive coloring agent in an amount sufficient to dye the interior of the mouth during and after use, such that the absorption of at least one active agent is confirmed.

Alternatively, a water container for a BSSG is replaced; which has an effect when the oral vehicle is in use, which helps to swallow and / or dilute a remaining bad taste, such that a course of treatment will be maintained. Optionally, each BSSG is immersed in a substance capable of forming a relatively impenetrable seal on any exposed surface after cooling; the substance provides a less permeable material capable of serving as a cover that is less likely to allow the passage of active ingredients from the center during storage. In a second broad aspect, the invention provides a blister pack for maintaining an oral vehicle comprising a set of one or more BSSG as claimed in any preceding claim, wherein the materials of the blister pack seal are provided with frangible lines and labels so that a person can take off a selected vial, open it and recover the content without applying force to the content. In a third broad aspect, the invention provides a method for making a BSSG comprising the steps of assembling the raw materials in advised quantities; dissolving completely the agar, salt, sucrose, and glycerol in the hot water; dissolving or suspending at least one active agent in the solution prepared in (b); optionally when cooled: at least optionally dissolving an additive projected to facilitate swallowing in the solution prepared in (c); optionally dissolving or suspending at least one dye in the solution prepared in (c); distributing the solution prepared in (e) in molds, which each maintain a recommended quantity; allowing the solution to solidify in a semi-solid gel and packing the resulting BSSG in a container. A method as claimed in claim 18 further includes substances within the gel that are selected from a range that includes polyethylene glycols having a selected range of molecular weights, and polypropylene glycols having a selected range of molecular weights. A method as claimed in claim 19 in wherein the method is adapted to include the mechanical dosage of the fused material prepared in (e) in a plurality of blister packs to congregate in a package of blister packs. A method as claimed in claim 20 wherein the method is adapted to include the mechanical dosing of different molten materials having different compositions in each of a plurality of blister pack assemblies to congregate in a blister pack package: each set contains more than one distinctive BSSG. Alternatively the method ends with the extrusion of an almost ready mass in a fresh environment and then cutting the extruded material into pieces of a predetermined mass. A method as claimed in claim 18, characterized in that the method includes the steps of preparation and inclusion of microencapsulated ingredients that maintain at least one flavor and / or active agent color. In a related aspect, the invention provides a kit of raw materials for use in a low volume, in which a kit is provided with an empty and sealed blister pack package, granular raw materials, colorants and flavors in bottles, and instructions so that a pharmacist can add a prescribed medication and complete the process of creating boluses from a semi-solid gel, create a specific course of medication to be administered in the form of BSSG for a specific prescription. In a fourth broad aspect, the invention provides a method for dispensing a BSSG to an animal, wherein the BSSG is smeared into the mouth of the animal, adjacent to the teeth of the animal's cheek (molars) so that the active agent or the active agents within the BSSG are absorbed into the mouth of the animal. The description of the invention to be provided herein is given entirely by way of example and will not be taken in any way as limiting the scope or magnitude of the invention. The terms "including" and "comprising" are both taken as non-restrictive in the appended data list to identify only the data appended to the list.

BRIEF DESCRIPTION OF THE FIGURES Figure 1: is a diagram showing a section through some typical BSSG. Figure 2: is a diagram showing a BSSG and an agent that hides the flavor in a bubble type package. Figure 3: shows how a blister-type package is provided with a rear part that opens.

Figure: shows the deformation and fracture of a semisolid gel according to the invention by the application of a force.

DETAILED DESCRIPTION OF THE INVENTION It would be desirable to have an easily administered form of a broad range of "over the counter" drugs or nonprescription medications, and prescription medications. Applications include particularly self-medication in adverse situations such as public transportation, medication for children, physically or mentally damaged, victims of a stroke or is an elderly person. As will be explained below, the invention demonstrates the utility in recent tests without still using the most sophisticated techniques such as the microencapsulation of ingredients that have a bad taste or require a controlled discharge, or on the contrary, require an additional packaging . The drug delivery means comprise pieces or boluses of a semi-solid gel, each containing (a BSSG) a dose of an amount comparable to that of a simple solid tablet, which includes one or more active ingredients (or sometimes a flavor) , packaged simply in such a way as a sheet, or in blister packs, or loose in a container. When they are placed in the mouth, the BSSG falls apart or dissolves over a period of time and discharges the active ingredients. Sialogogues, flavorings and other additives help to swallow or swallow. The grains of the active ingredients can be encapsulated within hard gel envelopes using well known microencapsulation methods. The active ingredients include "over the counter" medications and prescription medications. Applications include self-medication (particularly in adverse situations such as being outdoors or on public transport), medication in children, in physically or mentally damaged people, being victims of a stroke or due to age.

EXAMPLE 1 The bolus (BSSG). Each "increment" of medication includes a pharmaceutically effective amount of a specific medication within a mass. Preferably, but of course not essentially, the amount in each BSSG is comparable to that of a single tablet of a pre-existing formulation, which prevents people from making mistakes; There is always a possibility when a headache or other pain is activated. The mass is a matrix of a semi-solid gel that retains its integrity during storage for an adequate period, and what is able to be fragmented in the mouth when the bolus is administered. The bolus can include at least one additive that has the effect, when swallowed of improving the swallowing, although the additives of that group are not essential components of the bolus. A single bolus can be made by a pharmacist to maintain more than one active agent ingredient, as long as the ingredients are mutually compatible during storage. Although most of the compositions will be mainly aqueous, an anhydrous formula that has storage and / or discharge benefits can only have approximately 2% water with the remainder being made from glycerol (glycerin), polyethylene glycol (PEG) from a range of selected average molecular weight, or polypropylene glycol (PPG) also from a selected average molecular weight range. The gel of BSSG. The semi-solid gel depends on the properties of the agar, the gel is of a resistance of approximately 0.8% agar in a bolus. The amount can be varied to make the bolus harder (with an increased concentration, or softer as required) In addition, other materials included will affect the hardness and some can prevent hardening.The gel at 0.8% agar retains its shape if remains free and will fragment if suffers a superior effort. The shape is retained because the material is a soft or "semi-solid" solid. (The following paragraph assesses what "semi-solid" means.) In contrast, many products sold to the public as "gels" are semi-liquids instead of semi-solids, and are based on polymethoxycelluloses and the like, and will flow without fracturing like viscous liquids. The BSSG material has a "soft fusion" property in the mouth, when exposed to mouth temperature, saliva, and interruption by chewing, direct pressure, or other applied forces. When using agar, true fusion is unlikely at body temperatures because of the well-known hysteresis property of agar, which means that it melts at a temperature higher than that of solidification. Preferably, the hardness and softening point are selected so that the probable "soft fusion" property is improved. Agar is currently preferred over other gels that occur naturally. Artificial gels or combinations of gels can be used. See the detailed recipe below. The type of agar used in the assays is food-grade agar from Coast Biologicals (NZ) seaweed.

Quantification of "softness / hardness" This experiment allows the term "semi-solid" as used herein is approximately quantified. The hardness of the tablet (for example by Dr K Schleuninger AG of Zurich) is measured by applying an increasing force to the point at which the disintegration of the solid tablet is reached. The present test method measures the compression ratio: force before the gel under the test provides any form. Five representative samples were tested at room temperature, using a controlled force to gather two parallel surfaces that span the test sample at the same time. The force was measured using an electronic balance in the air at approximately 35 ° C and the compression caused was measured with a Vernier scale at 0.05 mm. The reduced force / distance ratio to Newtons results in a 1mm flattening that was measured after waiting for a drag that ceases almost after each of the 7 or 8 ladder increments, within an upper instrumental limit of 2.94 N. Results are provided in the following Table. Sample 4 had a partial drying after it was stored for several years. Sample 5 was from a previous day.

TABLE 1- Measurements of the smoothness of some semisolid BSSG. Sample Dimensions of the Softness Sample description (N / mm) A (0.787 g) Disk 14 mm of 2.94 Semi-soft, diameter, 5 mm of malleable, easily removable height apart in the mouth or pressed by the tongue B (0.756 g) Disk 12 mm of 2.55 Like top diameter, 6 mm of height C (1.085 g) Disc of 1.13 Soft for approximately 14 mm handle; in diameter, 4 mm fast height absorption. Continuous drag when it is at a pressure of > 2.35 N D (1.080 g) Disc 14 mm of 7.7 Relatively diameter, 5 mm hard although it is fragile height when used. A slower absorption could be expected E (0.701 g) Dome 14 mm of 2.65 (0- Composition diameter, 14. 4 mm of 1.6 N) is that of the height example 1 C. fracture to 1.6 Newtons There is a middle range instead of the extremes in terms of a range of the appropriate hardness or smoothness. All samples included around the same percentage (0.8%) of agar. The hardness or smoothness of a given BSSG can be varied in a very wide range other than the previous one by making vary the proportion of agar in the mixture from about 0.1 to 10%. Figure 4 shows a typical measurement sequence for sample E, such as a graph 400 (where the linear portion of the plotted traces have been traced by line 401, used to extract an average hardness value). At about 1.6 N, the agar mass under one test developed a radial crack just at 2 N, the mass disintegrated into small cubes. Figure 1 shows a section 100 through the BSSG of approximately rectangular shape. This example has no capsule or material included: the whole mass 101 is substantially homogeneous and lacks a capsule although the particles of a suspension, precipitate or suspended crystals may exist in some versions. Figure 1 also shows a spherical version 102 of a BSSG. This version includes an optional separate capsule 104 as described below, a mass 105 of semi-solid gel, and one or more optional inclusions of even another material 103 which may be another active agent pharmaceutical material such as in the capsules, or a gel mass with a rich flavor. Figure 2 is a section cut of a blister pack 200 having a cover 201 typically of a sheet material detailed as in Figure 3 and adhering in the usual way to that of the sheets of formed plastics including sources or blister packs 202, each containing a material placed in the place that was poured into the liquid; such as or a pharmaceutically active agent material 203 blended in a solid gel or an active inert gel including flavorings - the "flavor-hiding agent" mentioned below. The agent that conceals the taste may be a more solid mass such as a piece of chewing gum, or the good may instead be filled with a second gel containing the same or another pharmaceutically active agent material. Modifications. A tendency has been noted for some BSSG tests performed according to the general principle of a BSSG to "exude" an ingredient that covers the outside propitiating the possibility that the first taste after ingestion will be particularly bitter. This effect is a form of syneresis and is believed to be a result of the BSSG that becomes supersaturated for the ingredient when cooled after the formation. One solution is to add a stage to the industrial process by submerging the BSSG in a less permeable layer; this may be another gel mixture, a calcium salt of one or more alginate type gels, a gelatin coating, a wax layer, or a waterproof foil wrapper or a waterproof pocket. A further solution is to use an ionic charge or the like to bind the pharmacist to the gel macromolecules or a modified gel or an added gel. 0, the concentration can simply be made lower. Identification by appearance. Although there is a limited number of variants that can be applied to the account itself, it would be desirable to individually identify at least each type of medication commonly used for appearance. It may be that only a small number of over-the-counter pharmaceutical products normally consumed will be included in BSSG according to the invention. The options available either alone or in combination (if not mutually exclusive in the account of adverse drug reactions for example if they were imprudently mixed) include: 1. color - with up to approximately 10 color options: a) the entire account is the same color; one or both ends with the same or different dyes or a pigment; Inner granules are in one or more colors within a substantially clean water account. 2. and / or opacity - a) transparent; translucent; opalescent (pearly); opaque; inadvertently, a gleaming surface that is due, for example, to syneresis and crystallization with acetaminophen. 3. and / or form-a) round; elliptical; rod type (a form that particularly lends itself to being divided if the person wants only a small dose); Various forms dictated by the packaging blister type that include cylindrical, oval, triangular, square, hexagon, star-shaped or pentagon-shaped or donut-shaped. Any manufactured blister pack or portion thereof must of course be labeled by name, brand, lot and date in accordance with normal GMP practice. Vehicle destinations. At this point, a distinction will be made between BSSG as projected vehicles to facilitate swallowing and the gastrointestinal absorption site, against BSSG as vehicles designed for trans-mucosal absorption within the mouth, although some BSSG formulations can be satisfied on both routes. Any form falls within the scope of the invention. It is likely that both ways reveal the taste of the drug to the user. In addition BSSG include drugs, pharmaceuticals, pharmaceuticals, nutritional supplements, and the like (hereinafter referred to as "active agents") are supplied either (a) alone or (b) together with complementary BSSGs that lack active agents but include substances which help the absorption, transport of the vehicle, or (c) together with different BSSG that include different and perhaps active agents incompatible with storage.

Compositions; The BSSG suitable for both routes include: 1. Water: up to more than 90%. The long-term stability of specific active agents in an effectively aqueous solution within the BSSG should be considered, although water, being highly polar and physiologically compatible, has many advantages, a) minimum water versions exist as in Example ID; II / 122G that confers benefits regarding storage and discharge. 2. Agar: 0.1 - 2%. At this point no other similar material seems to be so effective. 3. Active agents, see Table 2 for exemplary supply pharmacists, and note that peptides, hormones, Chinese medicines, food supplements, vitamins and even placebos are additional classes of active agents not included in Table 2. 4. Materials which support particular active agents such as salts for the osmotic effect and pH control, sugars, polymers such as polyethylene glycols and polypropylene glycols with suitable molecular weight ranges, excipients, including humectants (such as glycerol), salts for flavor, sugars, saccharin, carboxymethyl cellulose or other cellulose derivatives to improve tackiness and adhesion to gums, and the like. 5. The optional dyes and materials that create opacity together with the shape (see above) serve to identify the particular compositions. 6. Non-toxic dyes or an optional pigment (additional to that required for identification) such as a food-grade dye temporarily stains a person's mouth to indicate that a particular BSSG has been properly ingested. This is useful in some situations, such as in disaster medicine, when it is important to clearly show that a dose has been given to an unconscious patient or one that is unable to speak in a compatible language, or when the patient's administration is not trivial, such as in a mental health room. 7. The optional flavors for at least the partial obstruction of a flavor possessed by the or each substance of the active agent product comprising the medication. These tend to be bitter in flavor. A partial obscuration may be enough. It is widely known that strong medicines might taste bad and completely hiding that taste could have a psychologically adverse effect on their effectiveness. Flavors are preferred that include menthol, essence or peppermint oil, orange oil and aniseed essence. For example, the essence of anise seems very adequate to hide the bitter taste of acetaminophen. PEG (polyethylene glycol) can hide the adverse flavors. In addition, BSSGs as vehicles designed to facilitate swallowing may include: Sialogogues, flavorings and other additives that help the swallowing that according to the application must be "swallowed without water or other drinkable inert liquid". Most sialogogues operate through taste and odor buds, and many suitable examples may be the flavoring itself, or the salt (NaCl) or equivalent. The physical presence of the BSSG or fragments thereof in the mouth also act to promote salivation via reflexes that include mechanoreceptors. Combinations of "sub-vehicles" such as the use of encapsulation as well as the use of harder agar granules within the full soft agar bolus can aid in the slow transport and release of the active ingredient ingredient in the stomach. In addition, the BSSG as vehicles mainly aim to facilitate trans-oral absorption that may include: 1. The class of pharmaceutical products relatively capable of being absorbed through diffusion through the mucous membranes of the mouth and pharynx, and especially those that would be easily broken by the acidity of the stomach when swallowed. Low MW peptides such as oxytocin and perhaps insulin are included in this group of diffusible substances. An increasing amount of products developed by the biotechnology industry is in the form of peptides. Oral vaccines can be included in this section. 2. Detergents and the like (as they are commonly found in toothpastes) for which one application is to reinforce access through possibly thick saliva to the buccal epithelium. 3. Chemicals that enhance absorption such as those that include dimethyl sulfoxide (DMSO). Ideally these could be provided within the fragile microcapsules, but it is likely that they would have to be quickly mixed in the BSSG before use. 4. Moderately inflammatory local substances (by increasing oral blood flow); sialogogues such as flavorings or salt (NaCl) or equivalents. The physical presence of the BSSG or fragments thereof in the mouth also act to promote salivation via reflexes that include mechanoreceptors and the presence of saliva will carry the active agents around the mouth and reach a larger area of the buccal epithelium, and start swallowing 5. Substances to delay the discharge of active agents. Some active agent materials can diffuse out of the gel too quickly and for example reduce their absorption and that predominantly the sprouted flavor or their hiding means (flavors, etc.). An ionic charge to the gel of each BSSG can be provided by means (for example) of addition of a chemical material capable of in one part joining the gel and in another part of presenting the appropriately charged portions, so that the pharmacist transported with the BSSG is indirectly linked to the interior of the gel. 6. Physical delay (Encapsulation). The invention is suitable for using a "wrapping" step wherein the particles of the active medications are covered in a gel before being mixed with the matrix, so that they are less likely to be tested by the patient. The "particle" can include solids, drops, or oils. Two optional procedures are described below that will have the effect of reducing the patient's taste. The cover gel can be a non-medicinal material, a more concentrated agar, one treated to cause hardening, or it can be a alginate hardened with calcium. Each particle of cover gel can be approximately 0.1-1 mm in diameter. The inventor believes that one way to overcome or at least to render a bad taste tolerable is to provide another element such as a second BSSG which maintains some other substance or substances, hereby called "taste concealing agents" so that the person can ingest in the mouth a BSSG that includes the agent that conceals the previous taste, or with, or shortly after taking the BSSG pharmacist loaded (what would be identified clearly differently due to color or shape, or by the design of the bubble-type packaging ) and the agent of the concealment of the flavor would hide any excess bad flavor. The or all the agent that hides the taste can be provided individually (not within the medicinal BSSG itself) so that the person can defer ingestion until the active agent ingredient can be clearly savored. Examples of taste concealing agents include: water that serves as a diluent and as a "chaser", a flavoring agent to dominate the olfactory receptors, a sweet material, or a taste bud that covers the material such as titanium dioxide finely divided (which does not seem to bind irreversibly to the pharmaceutical product). The accompanying bolus is not a necessary component of the invention but its presence aids in the intake of medicines in situations in which some that overcome a bad taste included are involved, as in the case in which water is not available for ingestion. The alternative term for an agent that hides the taste - a "light drink" would involve swallowing sequentially but it may be that the agent that hides the taste remains in the mouth afterwards and / or while the primary BSSG is kept in the mouth, so that a possible bad taste is neutralized after tolerating the flavor for a limited period. Alternatively the agent that hides the flavor can be taken first. The best order would be the one that depended on the particular compounds ingested. Preferably, the agent that hides the taste is a second BSSG made of different constituents; such as one that includes a flavoring or other agents that hide the flavor or water supplies or a sialogogo, but (usually) lacking pharmaceutical products. (Sometimes a medication can support storage if it is divided into two parts). It is easy to manufacture mixed blister packs, depositing a different BSSG material in different rows along the length of a bubble-type pack, like a hot liquid that is put in place like a gel. This is technically simpler than putting a solid element in a bubble type package. In some variations, the agent that hides the taste may include a second pharmaceutical product; one that would not survive storage if mixed directly with an incompatible first pharmacist. In fact, there may be an agent that hides extra flavor to help, to actually aid in fact, to help you include a mouthwash that is not chemically antagonistic to active pharmaceutical agents. Preferably, the BSSG active agent and the agent that hides the taste are clearly distinctive in appearance, so that a person who is bewildered or sick does not confuse both. An agent that hides the alternative flavor to a BSSG is for example, a gelatinous bean; a boiled sweet, a piece of liquor, a breath freshener, a specially made product or chewing gum that is kept in a blister pack along with a blister pack that preserves the BSSG. 7. More detailed active ingredients and medications that include examples. It is expected that most of those medications accepted for storage and delivery in syrups and other aqueous media such as suspensions will be sufficiently stable for inclusion in an aqueous gel as a BSSG. It is difficult to list all the specific materials that are now or will be suitable for future use. In general, it can be seen that it is easier to manufacture according to this recipe if the active ingredients are water soluble, although versions of the BSSG reduced in water are described herein. The conditions for the proposal of a saturated solution can cause syneresis, and / or crystallization during manufacture. Finely ground suspensions are acceptable if they are kept in suspension during their manufacture by recirculation (as is known in the art) to the deposit in the BSSG. Preferred or pharmaceutical medications include (without limitation) medicines, antibiotics, oral vaccines, plant extracts, pharmacologically active peptides, vitamins, minerals and food supplements, (such as trace elements, including iodine), and placebos. Some specific examples are shown in the non-limiting Table.

Table 2. Some examples of pharmacists that can be supplied with CAS numbers and point to their reapplicability.

(OTC = available at counter, drug without prescription.) Precautions and Security. Each pharmacist has its own problems regarding storage and its possible degradation. The interactions of the drug, and overconsumption should be saved against, especially if the person who ingests some drug is a little dehydrated and does not excrete much urine. Since the invention is projected for a situation where ingestion also requires the availability of water, the package may in some cases probably include the warning of drinking water or other liquid after ingestion of a bolus of BSSG, wherein the water or another drink is available. Repeated doses of acetaminophen would warrant recommending water suction, just like when people take the drug in the form of gel capsules or tablets. The wet nature of a BSSG is compared to a tablet that would not have exceeded the water requirement. An example of a more complicated substance is diclofenac (Voltaren ™) which is relatively toxic / irritable and which has not been evaluated here. It is reported that it "burns" the oral mucosa and, like aspirin, will cause ulcers in the stomach. This invention provides the use of how the synthetic prostaglandins in the gel of the BSSG protects the stomach, and the microencapsulation of diclofenac in 1-2 mm of granules having a variety of thicknesses in its wall retard its discharge for a period after its ingestion. and also after that the prostaglandin has been released. Such techniques must overcome these problems if market demand justifies their development and testing. A suppository (a common administration route for diclofenac) is not very easy to self-administer in a public place. Children. One should keep the visually attractive container of flavored semisolid gel within reach before the possibility that it could be tested by a child who believes it is a sweet and presents a toxicity. The method is not completely effective to reduce the risk. Active agent control by the father and the use of a locked locker is the safest protection. Some steps to minimize this form of risk include: 1. Distributing BSSG in sets, perhaps in a bubble-type package - typically with a neutral or pleasant flavor, for the purpose of being used as an "agent that hides the taste" (see below) It has no active pharmaceutical agents, and probably try other unpleasant flavors that include the active ingredients. The children would ingest only the BSSG with a pleasant flavor, rejecting the unpleasant flavors, and the game or set stolen alert the adult responsible for their finding. 2. Colors and appearances that are not related to pleasant flavors such as candy in the form of rubber. 3. Opaque packing (due to the use of a filling of titanium dioxide in the plastic material itself); also the packaging is resistant to children because it is difficult to open for small children and hardly they could remove their contents. The use of blister packs tends to make ingestion more difficult for a child. 4. Clearly one has to keep them in such a way that a child or unconscious person consumes sweets or treats that by their pleasant taste accidentally ingested a dangerous amount of a pharmacist. For this reason, the supply of BSSG is preferred within a blister-type package than in a bottle. Few sweets are sold in blister packs. Blister-type packaging for teenagers is an obstacle. Any consumption is visible in empty blister packs. Protection of the contents of light (especially UV light) may also be required as long as dyes are provided on its surface or foil wrapping. 5. Minimizes the use of sugar or sweeteners in the BSSG in relation to the active ingredients. 6. Late concealment of an unpleasant taste for a limited period in the mouth so that a child spits the BSSG off before any flavor becomes active agent. The flavor could be microencapsulated or on the contrary integrated to delay its discharge. 7. Coloration of the mouth, if colorants are included orally, it will be shown that a child has been potentially poisoned. The following Examples show the methods for the preparation of BSSG according to the invention. Storage. In accordance with the invention, the pharmacist is in contact with or dissolved in water; usually sometimes considered to accelerate degradation in a dry state. Factors that have the ability to extend the shelf life include (a) cooling or freezing, (b) the inherently immobile nature of the water in the gel, (c) the use of excipients such as buffers and humectants. , and (d) light protection. The usual prudent storage of medications in blister packs should be recommended to keep them in cool places.

Example 1. The method for the preparation of BSSG includes acetaminophen [103-90-2]. 430 a) Agar 0.8% (all are% by weight) b) Glycerol 15% c) V41 (one type of sodium chloride) 1% d) sodium sucrose 0.2% e) boiling water 42% (all mixed) f) Acetaminophen 40% g) Essence of anise 1% (Add at a lower temperature) = 100%. 2. The mixture is cooled and mechanically divided or distributed in preferably one gram BSSG (any weight is possible: 100 mg to 2.5 g for example) preferably in separate sources of a bubble-type package. Note that once the agar dissolves at 100 ° C other components can be added to the liquid mixture at considerably lower temperatures (such as 35-45 degrees) which are useful in the case of volatile flavors or thermally or easily dissociated peptides. 3. Results: Color: White. The essence of anise provides a surprisingly effective mask for the bitter taste of Acetaminophen. Each of the grams of BSSG carries 0.4 of acetaminophen Maximum dose = approximately 2 g / day for an adult. 4. Notes: Some difficulty was experienced as a result of acetaminophen which tends to form large crystals while the solution is carried out and cooled while being distributed in blister packs. This can be overcome "mechanically, by using a centrifugal cutting type from a recirculation and temperature maintenance pump, or by using an anti-crystallization compound capable of inhibiting the formation of crystals.

Mix can be thrown in temporary molds and then transferred to blister packs. Alternatively, acetaminophen can be added to raw materials just before distribution.

Example Ib 1. The preparation of BSSG includes acetaminophen and ascorbic acid - to treat them cold, a) Agar 0.8% (all percentages are by weight) b) Glycerol 15% c) V41 (a type of sodium chloride) 1% d ) sodium sucrose 0.2% e) boiling water 41% (mixes and dissolves everything at this point) f) Acetaminophen 40% g) Tartrazine (or coloring lake) 0.4% h) orange oil 1% i) acid ascorbic 0.2% j) Menthol 0.4% = 100% 2. The mixture is cooled and mechanically divided or distributed in 0.5 to one gram of the BSSG weight, preferably in separate wells of a blister type packaging. 3. The results: Color: Yellow. Orange oil and ascorbic acid provide some benefits for those who suffer from cold. Each gram of BSSG carries 0.4 g of acetaminophen. 4. Perceived taste: One half of the BSSG of paracetamol made according to the previous recipe includes a flavoring that was ingested without water. The material was broken into small pieces in approximately 30 seconds and the combination of the foreign material and the taste caused sufficient salivation for swallowing or swallowing. It showed a better taste after a few minutes but not at an unacceptable level, and was of a little intensity compared to that of a typical headache. Notes: Some initial difficulty was experienced as a result of acetaminophen tending to crystallize when the solution cools while being distributed in blister packs. This can be overcome mechanically, by using a type of centrifugal cutting by means of a pump for recirculation and maintenance of the temperature, or by using an anti-crystallization compound capable of inhibiting the formation of the crystals. Acetaminophen can be added later. The mixture can be emptied in temporary molds and then transferred in blister packs. Since the active ingredients that are available for faster absorption as is the case with the compressed or encapsulated dry formulations, advise the person taking BSSG to delay the BSSG for a few seconds for 10 minutes instead of taking two at once, so that the concentration of serum that rises quickly will stay much longer at an effective level. Then, the second BSSG can be discovered not necessary. Instead of being emptied into blister packs or other molds, the agar mixture can be allowed to flow in a fresh oil such that the agar beads of about the desired volume are formed while suspended, and then filtered. The BSSG can eject outward and can be formed as a long rod or tape and then cut into pieces.

Example Formulation made by stability tests of a recently made formulation 11 / 17ID: lkg white / translucent Agar 0.8 (all% w / w) Glycerin 15.0 Texapon OCN 1.0 Salt V41 1.5 Sodium saccharine 0.1 Boiling water 32.4 Víctor DF 45.0 Citric acid monohydrate 0.5 sodium phosphate monofluoro 0.7 Synthecol CAB 2.0 mint B &J 684 1.0 TOTAL = 100.0 Specification: Crisp-looking white gel with an oily surface. PH of a 10% aqueous mixture in deionized water = 5.5-6.0 Manufacturing: 1. Add agar, glycerin, Texapon OCN, salt, and saccharin in a casserole dish with the capacity to boil water and mix. 2. Add boiling water to the pan and mix while raising the temperature to 95 - 100 ° C. The achievement of this temperature is critical to structure the final product, verifying that the mixture is completely clear and without opalescence. Decrease the heat. (Although the inventor prefers such a high temperature, he realizes that the agar can dissolve at very low temperatures, although imperfectly). 3. Add Víctor DF and citric acid and mix to a smooth white liquid. 4. In a separate non-hot beaker mix the CAB Synthecol and the flavoring and add to the hot mix when the temperature has been reduced to less than 50 ° C.

(Some components of a bolus may be unable to withstand temperatures of more than about 45-55 ° C, such as the peptides or organisms within the vaccines).

Example ID (as 3 versions) These variations include the exploration of high sucrose versions (II / 122F), and high glycerol versions reduced in water (11 / 122G) both represent the ways of affecting shelf life and the proportion of the solubilization of particular pharmaceutical products.

Medicinal Bases represented as: Manufacture of samples produced with the following Properties: 11/122 D - Good structuring, clear gel curl. Also probably to work with polyethylene glycols, monopropylene glycols and polypropylene glycols. 11/122 F - The set inhibited due to sugar, the sets are correct if the sugar content was further reduced. 530 11/122 G - The whole improves because the water content rises above this level.

Example 1E With granules prepared separately. Example IE may include a series of steps for preparing the encapsulated ingredients, and materials dealing with these aspects should ensure that the granules formed remain uniformly mixed and evenly distributed. a) Select a first gelling material. Because of the syneresis that is a property of the agar, the first gelling material may not have the characteristics of a melting point superior to that of the gel used to form the volume structure of the beads. In other words, the same agar composition can be used at least twice. However, it is preferable that the resulting pieces do not release the unpleasant taste in the mouth at least immediately afterwards, so that additional treatment is possible, see example IB b) Suspend the medication and mix it with the first gelling material after heating and liquefying. c) Cool the resulting gel until it is placed. d) Fragment the mechanically solidified gel into small pieces. (Here, techniques such as that of air mattresses to fluidize are known). Freezing and screening can be useful; controlling the size of the particles that will confer some control over the proportion of the discharge. e) Dissolve and liquefy a second gel that may include flavorings and dyes f) Mix small pieces with the second gel and do not raise the temperature of the mixture above the softening level of the second gel, so that it remains intact during and after the process . g) The mixture is cooled and mechanically divided or distributed in BSSG each of a predetermined mass, as of 0.5 for one gram of the bolus. Larger boluses may be used since it is not difficult in most circumstances to swallow 2 g or more, although some people who have difficulty swallowing would present problems.

Example 1F As Example IE, with the encapsulation of separate granules. Example IA can be modified by adding more stages between stages d and e as follows: di) As a third gelling material, select one that can harden; for example sodium alginate. d2) Dissolve and blend a sodium alginate gel. d3) Submerge the pieces of either (a) the ingredients, or (b) gel containing the gel in the sodium alginate gel, cover and remove them again, d4) Harden the layer by converting it into the alginate gel of Calcium, immersing the gel in a calcium chloride brine, so that the layer remains intact for a prolonged period when kept in the mouth.

Example 2 Packaging. The inventor considers that the packaging of BSSG in an ordinary blister pack is a clean, convenient and safe way to prepare the product for retail presentation, also convenient for the user who carries appropriate amounts of their medication that are always ready to be used. . It is easier to handle materials that are manufactured as liquids to be poured in hot state instead of adding solid elements (tablets) individually in blister packs. A technology for carrying out a hot-pour process of ground agar in a blister package includes the steps of: (1) mixing the active ingredients in a tub and keeping them hot. The mixture will be made with an adequate accuracy and a usual standard (GMP) required by a pharmaceutical company. (2) distribute the mixture from a volumetric accurate dosing device in blister packs. (3) cool and seal the blister packs afterwards. (The foil wrapping can also be included). (4) Pack blister packs as in the appropriate cardboard boxes for retail sale. A blister pack protects the BSSG until it is taken for ingestion, carries an appropriate label, and an empty blister pack indicates that a BSSG has been used. A production of up to one hundred thousand blister packs can be obtained in one hour in a production line, without thereby directly involving the human being. The loose BSSGs in an approximately globular form can be made by distributing them as large globules in an oil and screening the boluses out when they are cooled and converted to a solid state. BSSGs can be done in a variety of ways that They include round, square, triangular, star-shaped, disc, rod, plate, and these shapes can be determined by the forms of blister-type packaging in blister packs. Note that the BSSG according to currently preferred formulations is too soft to act as its own device when fracturing when pushed from a sealed blister pack. For that reason, the inventor prefers to provide blister packs that can be rotated, having adhesive free ends on their back surface (flat, without blister packs) that can be pulled open by the user at the time of use, and / or perforations to help remove one or more BSSG as required without destroying its structure. Figure 3 shows an example of a pocket 7x2 blister pack 300 on its back (flat) side and the incubation portion 303 of the diagram indicates that part of the back sheet which is usually a sheet of metal, which is Coats selectively with an adhesive. Pockets such as 301 and 302 may contain different types of BSSG. In order to open the 585 blister pack without pressing through the front side, this pack is provided with (a) relatively sticky removable adhesive, (b) perforations or functional equivalents (such as 304) that allow removing the spare to be removed in the strips, and (c) an angle 305 that the person would throw first, to start taking off the back out along a row. The arrow 306 is printed on the backing sheet to indicate the direction in which the contents are removed. The deformed plastic sheet includes a blister pack 300 which can also be provided with a depression that is pressed down under each label 305 in such a way that the user can more easily grasp the free end. The cutting notch 306 on the side of the deformed plastic sheet illustrates an extensive way of preparing an easy-to-open portion of a sealed blister pack. Other modifications of the sheet that facilitate the opening and recovery of the interior of the soft gel can also be used. The inventor prefers that the deformed plastic sheet be made of a relatively strong material (0.5 mm polyvinyl chloride or PVC) to provide mechanical protection to the BSSG during long-term transport in a pocket or the like. This material is supplied with a coating of polyvinylidino (PVDC) in different thicknesses as an effective barrier for water. For example, 0.25 mm PVC plus 40 grams per square meter (gsm) of PVDC for storage within a box, or 0.5 mm of PCV plus 80 gsm of PVDC for durable storage in a loose assembly, to be selected in accordance with the requirements effective shelf life and the thickness of the plastic base. The deformed leaf can also be made from sheet, as for military use.

Example 2a Packaging without blister packs. Despite the numerous benefits of a bubble-type packaging, the BSSG can be manufactured in a loose form, without a bubble-type packaging. For example, they could be pushed from a hole in a controlled manner in cold air or cold oil, and cut from the hole to a convenient length. They could be given a dry knock of oil, or allowed to drip, and then packaged in a box or sealable glass or other container along with a powder such as cornmeal to prevent their adhesion.

Example 2b Packaging for prescription by a pharmacy. A BSSG batching kit is provided as raw materials lacking only specific pharmaceuticals so that a pharmaceutical product can create a specific course of medication to be administered as BSSG written in prescription for a specific case. The equipment would include one or more sets of: an empty and sealed blister pack, a plastic squeeze bottle, agar powders, dyes and bottles and instructions. The apparatus required is a device jacket to heat with hot water maintained at approximately 95-98 ° C so that the agar can be heated sufficiently during melting.

Application Example 1. The administration of the medication to overcome an immediate problem is a useful application. For example, the treatment of the most severe allergic reactions, classic anaphylactic shock or an accident such as a sting of a wasp in the mouth, especially when the pharynx becomes inflamed but no one has or has the ability to administer parenteral medication ( for example intravenously) using a BSSG containing a suitable antihistamine in an affective amount. The BSSG is pressed against the inside of the mouth and the absorption can be encouraged through the use of an available toothbrush provided in the kit to rub the oral mucosa or gums so that the surface is fresh and the blood circulation. After all, there is still a squamous epithelium that has to be crossed before the drug gains access to the blood supply. An antihistamine plus an agent that hides the taste plus a toothbrush kit would help many classes of emergency workers (such as first aid workers, shore guards, police, teachers, ambulance personnel and the like respond to a medical emergency and reduce the requirement for appropriate urgent medical treatment by a doctor who must bring in injectable adrenaline (epinephrine). It is also likely to carry injectable adrenaline for people prone to allergic reactions.

Application Example 2. Nicotine replacement therapy for smokers can be provided by means of a BSSG containing an effective amount from 2 to 8 mg of nicotine, such that the (ex) smoker can experience the effects of the therapy of nicotine but that others are not subject to the adverse effects of smoke. In this example, a variety of BSSGs containing a convenient amount of nicotine are supplied, probably as relatively hard plates in a bubble-like package. The user takes one and carries it between the rubber and the cheek for approximately 20 minutes, at which time the BSSG slowly melts. This slowness helps a limit repetition of self-dosing with nicotine.

Variations The invention can be used when treating domestic animals with oral medications. A common problem that is found is the difficulty to treat a cat (in particular) with tablets, usually the treatment cycle fails when a cat is sent to a doctor's house veterinarian with a treatment based on tablets. A soft bolus, which can be broken with the animal's fangs inside the snout in the molars - (and optionally provide the bolus with an active, appealing taste such as fish) may be easier to administer to most cats than a dry tablet or hard capsule.

Industrial Applicability and Advantages 1. A BSSG can be cut for example in parts with a pair of scissors, if a person does not require a full dose, because the body of the preferred type of BSSG is homogeneous. (A capsule can not be cut in the parts, although a solid tablet can bite along the fold line). 2. The means of supply are advantageous for some pharmaceutical products and some diseases. For example, the upper limit of an acetaminophen serum concentration is expected to be faster compared to the ingestion of a tablet or capsule. This rapid lifting is an advantage for a person who wants quick relief for example, from a headache. 1. Lower doses can be effective if taken by BSSG, reducing the risk of cumulative toxicity. A dose could work on its own. 2. A BSSG that contains a finely solid material divided will allow the material to be absorbed and become available more quickly than one ingested inside a capsule such as one of gelatin that first has to be dissolved in the stomach. An elevation in blood levels of the ingested pharmaceutical product should be administered via a needle if administered within a BSSG. 3. In an emergency situation, where a patient requires a systemic drug and can not move or stand up to ingest ordinary tablets, and in particular, when the auxiliaries can not or are not specialized in the administration of injection materials , the medication of the BSSG type could be administered by breaking either by the assistant or inside the patient's mouth and ingested slowly absorbing at a moment with a minimum risk of suffocation on the part of the patient. 4. It is thought that the invention helps when there is a need to swallow a treatment contained in solid form under circumstances in which a glass vessel is not available- it is outdoors (walking or sailing), it is traveled on a bus or train, when driving in traffic, is in the theater, at an important meeting, or while walking, and perhaps a headache from some other disorder is perceived or suddenly presents itself. Take precautions if you want to avoid adverse effects such as a risk increased toxicity because if the BSSG is taken without water, the kidney and / or the liver reduce its function. The same effects would occur with a dry tablet, but the nature of the BSSG or the manner in which it is promoted may inadvertently suggest to a user that water is not necessary. 5. Another application is that "treatment fails" in regard to children. Another is based on the risks associated with reduced swallowing in the elderly or neurologically impaired people. 6. The invention is also convenient for giving the medication to domestic animals or birds, and also for farm animals. 7. The invention complements other forms of drug delivery such as oral, rectal, pulmonary, or parenteral methods. Finally, it will be understood that the scope of this invention as described and / or illustrated herein is not limited to the specified embodiments. Those skilled in the art will appreciate that various modifications, additions, known equivalents, and substitutions are possible without departing from the scope and spirit of the invention as set forth in the following claims. It is noted that in relation to this date, the best method known to the applicant to carry out the aforementioned invention, is that which is clear from the present description of the invention.

Claims (25)

1. CLAIMS Having described the invention as above, the content of the following claims is claimed as property: 1. An oral vehicle for transporting an effective amount of one or more active ingredients (herein referred to as "active agents") in the systemic circulation of a human or animal orally; the oral vehicle comprising at least one bolus unit (in the present call a BSSG (= the bolus: semi-solid gel)), characterized in that the or each BSSG includes a semi-solid gel matrix comprising agar or a functional equivalent thereof and carries an effective amount of one or more active agents; the semi-solid gel has a hardness of about 1 to about 15 Newtons per. mm under test conditions defined herein and including from about 0.1% to about 10% by weight agar. The BSSG according to claim 1, characterized in that the semi-solid gel is homogeneous and includes agar or a functional equivalent thereof in an amount from about 0.6% to 0.9% by weight of agar. The BSSG according to claim 1, characterized in that the semi-solid gel is homogeneous but encapsulated and the homogeneous portion includes agar or a functional equivalent thereof in an amount of about 0.1% up to 0.9% by weight of agar. 4. The oral vehicle using BSSG according to claim 1, characterized in that it comprises a set of at least two BSSG each containing a different set of active agents; wherein a first BSSG is formulated to complement the formulation maintained within a second BSSG and therefore, promote the systemic absorption of one or more active agents maintained within the second BSSG when both BSSGs are taken at about the same time. The oral vehicle using BSSG according to claim 4, characterized in that at least two BSSG are used to separately keep active agents for a period of time; the active agents are unstable if they are stored in the same BSSG during the period of time. The oral vehicle using BSSG according to claim 2, claim 3, claim 4 or claim 5, characterized in that the intended route of delivery is mainly by means of gastrointestinal absorption after it is swallowed, by supplying the bolus with at least one means capable of providing the provision of each BSSG to make swallowing easier in the absence of water. 7. The oral vehicle using BSSG according to claim 6, characterized in that the promotion of Systemic absorption is facilitated by means of at least one medium selected from a range that includes: the promotion of salivation, at least a partial concealment of an adverse taste, which provides a uniform exterior, and which allows the or each BSSG to be dissociated in the mouth before swallowing, so that an effective course of treatment will tend to be maintained. 8. An oral vehicle using at least one BSSG according to claim 2, claim 3, claim 4 or claim 5, characterized in that the intentional oral route of delivery is mainly that in which the intra oral absorption during a period of time independent of swallowing, and the promotion of systemic absorption is facilitated by at least one ingredient capable of producing a selected process from a range that includes: the promotion of salivation, at least the partial concealment of adverse taste , providing an active surface agent, promoting circulation within the oral submucosa, facilitating, by means of the properties of the semi-solid gel, the or each BSSG to be physically dissociated within the mouth, allowing diffusion to occur within the or each BSSG and / or providing a pleasant mouthfeel (which includes providing a uniform exterior) in such a way that an effective course of treatment will tend to be maintained, c) apply forces dissociators inside the mouth (for example, between the tongue and the teeth). 9. The oral vehicle using at least one BSSG according to claim 8, characterized in that a supplementary physical means capable of promoting circulation within the oral submucosa comprises a toothbrush. 10. An oral vehicle using at least one BSSG according to claim 7 or claim 8, characterized in that at least the partial concealment of adverse taste is caused by a process that includes at least one of: blocking the flavors of the flavor including at least one coating substance, submerging the sweetness-flavored flavor that includes at least one sugar or sweetener, or providing a flavor including an effective amount of at least one flavoring agent, thus dominating the receptors Olfactory 11. The oral vehicle that includes at least one BSSG according to claim 10, characterized in that the taste concealing agent is provided in a separate BSSG in such a way that the person can manipulate the time of ingestion of the respective BSSG to minimize the adverse taste of at least one active agent. 12. The oral vehicle that includes at least one BSSG according to claim 11, characterized in that the agent that hides the taste is provided within the BSSG that contains the active agents. The BSSG according to any of the previous claims, characterized in that the BSSG further includes at least one: a distinctive coloring agent, a distinctive opacifying agent, and a distinctive form for each of a range of types of BSSG are provided differently to allow the identification of at least one active agent that is kept inside. The BSSG according to any of the previous claims, characterized in that it also includes a distinctive coloring agent in an amount sufficient to dye the inside of the mouth during and after its use, in such a way that the absorption of at least one active agent. The oral vehicle based on BSSG according to claim 9, characterized in that a water container is replaced by a BSSG; which has an effect, when the oral vehicle is in use, which helps to swallow and / or dilute an unpleasant taste remaining, so that a course of treatment will be maintained. 16. A blister package for maintaining an oral vehicle comprising assemblies of one or more BSSGs according to any of the previous claims, characterized in that the bubble packing seal materials are provided with lines and fragile labels of such so that a person can strip a selected blister-type package, open it and remove its contents without applying force to the contents. The BSSG according to any of the previous claims, characterized in that each BSSG is immersed in a substance capable of forming a relatively impenetrable seal on any exposed surface after cooling; The substance provides a less permeable material that has the ability to serve as a layer that probably allows the passage of active ingredients from the center during storage. 18. A method for making an SVG, characterized in that it comprises the steps of a) assembling the raw materials in advised quantities; b) dissolve the agar, salt, saccharine, and glycerol completely in hot water; c) dissolving or suspending at least one active agent in the solution prepared in (b); optionally at a lower temperature: d) at least optionally dissolving an additive designed to facilitate swallowing in the solution prepared in (c); e) optionally dissolving or suspending a dye at least in the solution prepared in (c); f) distribute the solution prepared in (e) in each of the molds that maintain a recommended quantity; g) allow the solution to solidify in a semi-solid gel and pack the resulting BSSG into a container. The method according to claim 18, characterized in that it includes substances within the gel that are selected from a range that includes polyethylene glycols having a selected range of molecular weights, and polypropylene glycols having a selected range of molecular weights. The method according to claim 19, characterized in that it is adapted to include the mechanical dosage of the molten material prepared in (e) in a plurality of blister packs to be assembled in blister packs. The method according to claim 20, characterized in that it is adapted to include mechanical dosing of different molten materials having different compositions in each of a plurality of blister pack assemblies to be assembled in a bubble-type package: each set contains more than one distinctive BSSG. 22. The method according to claim 18, characterized in that it includes the stages of preparation and the inclusion of microencapsulated ingredients that maintain at least one active agent and / or flavors and / or colors. 23. The method according to claim 18, characterized in that it ends with the extrusion of an almost fixed mass in a cool environment and then the extruded material is fragmented into pieces of a predetermined mass. 24. A kit of raw materials for low volume use, characterized in that it is provided with an empty and sealed blister pack, granular raw materials, dyes and flavors in jars, and instructions so that a pharmacist can add a prescribed medication and complete the process of creating boluses of a semisolid gel, constitute a specific course of medication to be administered in the form of BSSG for a specific prescription. 25. A method for distributing a BSSG to an animal, characterized in that the BSSG is smeared into the mouth of the animal, adjacent to the teeth of the animal's cheek (molars) so that the active agent or the active agents within the BSSG are absorbed within from the mouth of the animal.