Composition and method with using stabilised sensitive ingredient

FIELD: medicine.

SUBSTANCE: invention describes a method for stabilising a sensitive ingredient for biological absorption in the oral intake in a therapeutic composition involving the stages of combining pregelatinised starch with at least one sensitive ingredient, and mixing the sensitive ingredient with pregelatinised starch. Pregelatinised starch is used in the amount of 5% to 80% of composition weight. The sensitive ingredient is specified in vitamin C, phenylephrine and their combinations. The sensitive ingredient is used in the amount of 0.1% to 20% of composition weight. Said sensitive ingredient is uniformly distributed in pregelatinised starch and adsorbed on pregelatinised starch.

EFFECT: stability of said sensitive ingredients and maintenance of their activity and availability for biological absorption in the oral intake of the therapeutic composition.

17 cl, 15 ex

 

The technical field

The present invention relates to a method of stabilizing ingredient in the composition, which includes stages of Association gelatinising starch with at least one sensitive ingredient; adsorption specified sensitive ingredient on gilotinirovaniya starch, wherein said sensitive ingredient uniformly distributed in the specified gilotinirovaniya starch.

Prior art

Many biologically important compounds lose activity when exposed to heat, water and/or oxygen. Such compounds include vitamins, medicinal herbs, antioxidants, carotenoids, polyphenols, minerals, fatty acids, amino acids, enzymes, probiotics, analgesics, anticholinergics, antihistamines, anti-inflammatories, antipyretics, antitussives, antiviral agents, decongestants, expectorants, mucolytics and prebiotics. There have been numerous attempts to stabilize these compounds, so that the activity of the compounds was preserved for longer periods of time when exposed to heat, water and/or oxygen. Some of these methods are focused on the application of the compounds of coatings sasanov the material, including gelatin and alginate. However, protecting the joints from degradation is not the only problem. Secure connection should also be available for biological absorption after oral ingestion. These two objectives are contradictory, since the known methods of protection compounds during processing and storage also limit or prevent the absorption of compounds, resulting in a smaller number of biologically important compounds effectively delivered took it orally to a mammal.

The only reliable option to ensure the delivery of compounds is the use of excessive quantities of labile components included in the composition. Such use of excess amounts leads to higher costs and does not guarantee the quality of the product. In the case of tablets or capsules with a low content of components in the weight of tablet is very large compared with the small amount of labile active ingredients. This creates a problem, which consists in the fact that it is difficult to uniformly dispersing a small amount of active substances in solid tablet or capsule.

Thus, the aim of the present invention is to provide a composition and method of stabilization of sensitive ingredients, preferably, by using gelatine is consistent starch, in which all sensitive ingredients of the composition are stable and retain activity sensitive ingredients in the presence of heat, water and/or oxygen, are available for biological absorption after oral ingestion and evenly distributed in gilotinirovaniya starch.

The invention

The present invention relates to a method of stabilizing ingredient in the composition, which includes stages of Association gelatinising starch with at least one sensitive ingredient; adsorption specified sensitive ingredient on gilotinirovaniya starch; wherein said sensitive ingredient uniformly distributed in the specified gilotinirovaniya starch.

The present invention further relates to compositions containing: gelatinising starch; at least one sensitive ingredient selected from the group consisting of a carotenoid, rosemary, rosemary extract, caffeic acid, coffee extract, turmeric extract, curcumin, blueberry extract, grape seed extract, rosmarinic acid, tea extract, antioxidant, amino acid, enzyme, prebiotic, probiotic, vitamin A, vitamin B, vitamin C, vitamin D, extract of Andrographis, 1-tryptophan, Allium sativum, analgesics, anticholinergics the ski means, antihistamine drugs, anti-inflammatory drugs, antipyretics, antitussives tools, antivirus tools, protivozastojnye means, means salt, mucolytic means and combinations thereof; in which the specified sensitive ingredient adsorbed on gilotinirovaniya starch and in which the specified sensitive ingredient uniformly distributed in the specified gilotinirovaniya starch.

A detailed description of the invention

The present invention relates to a method of stabilizing ingredient in the composition.

The term "sensitive ingredient" used here, the value applies to the ingredient, which is negotaitions decomposition reactions, accelerated water and/or present in small amounts of active substances, adsorbiruyuschimi on the surface gelatinising starch. Preferably, the sensitive ingredient is subjected to oxidation, thermal decomposition, rearrangement or other reactions, promoted by the presence of water.

The term "oral composition"used here, the value applies to the compositions in a form that can be delivered to the needy in the mammal. Non-limiting examples include liquid compositions, nasal compositions, drinks, water for dopisivanje, pills, soft is eaten, tablets, double-layer tablets, capsules, gel compositions, and combinations thereof. Nasal compositions, liquid compositions, the gel composition can be in a form suitable for direct introduction into the respiratory tract from the nose and mouth. Such compositions can be delivered using a pipette, spray guns, devices for irrigation, aerosol sprays, sprays, aerosol inhalation devices and other packages and devices.

All weights, sizes and concentrations herein are measured at 25°C from the total composition, unless otherwise indicated.

These and other characteristics of the compositions and methods of the present invention, as well as many optional ingredients suitable for use in the present invention, are described below.

All percentages, parts and ratios used here the value related to the weight of the total composition, unless otherwise indicated. All such weights related to the listed ingredients, based on the active substance and thus do not include solvents or by-products that may be present in commercially available materials, unless otherwise indicated.

The composition and methods of the present invention may contain, consist of or consist essentially of the essential elements and features of the invention, described is here as well as any additional or optional ingredients, components, or characteristics described here or otherwise suitable for compositions intended for use mammal, preferably for human use.

COMPOSITION

The present invention is a composition and methods for stabilization of sensitive ingredients, preferably, by using gelatinising starch, in which all sensitive ingredients in the composition are stable and retain activity sensitive ingredients in the presence of heat, water and/or oxygen, are available for biological absorption after oral ingestion and evenly distributed in gilotinirovaniya starch.

The preferred range of values of pH of the composition is from about 1 to about 7, from about 2 to 6.5, from about 2 to about 5 and from about 2.6 to about 4.5.

The composition of the present invention, preferably, is an oral composition, and may be liquid or semi-liquid, or gel or naselenie compositions, drinks, water for dopisivanje, pills, tablets, bilayer tablets, soft gels or capsules.

SENSITIVE INGREDIENTS

The composition according to the present invention contains chuvstvitelnyj, moreover, the sensitive ingredient is stabilized by combining gelatinising starch with at least one sensitive ingredient; adsorption specified sensitive ingredient on gilotinirovaniya starch; and specified sensitive ingredient uniformly distributed in the specified gilotinirovaniya starch.

The composition comprises from about 0.1% to about 20% sensitive ingredient by weight of the composition, alternatively from about 0.5% to about 15%, alternatively from about 1% to about 10%, alternatively, from about 1.5% to about 5%, alternatively, from about 2% to about 4% sensitive ingredient by weight of the composition.

Non-limiting examples of sensitive ingredients include vitamin C, vitamin B, vitamin D, a carotenoid, rosemary, rosemary extract, caffeic acid, coffee extract, turmeric extract, curcumin, blueberry extract, grape seed extract, rosmarinic acid, tea extract, antioxidant, amino acid, enzyme, prebiotic, probiotic, vitamin, extract of Andrographis, 1-tryptophan, Allium sativum, analgesics, anticholinergics, antihistamines, anti-inflammatories, antipyretics, antitussives, antiviral agents, decongestants, expectorants, mukoliticescoe and combinations thereof.

The preferred form of vitamin C for use in the composition is ascorbic acid or an equivalent salt of ascorbic acid or equivalent amount of a derivative of ascorbic acid. Vitamin C can be in the form immediate-release or forms with delayed release.

Vitamin A and carotene can be obtained from animal or vegetable sources. Vitamin A can be in the form of vitamin A, retinol, retinilpalmitat, retinella, retailpoint, beta-carotene, alpha-carotene, beta-cryptoxanthin and mixtures thereof.

Non-limiting examples of vitamin D suitable for the present invention include vitamin D3 (cholecalciferol), vitamin D2 (ergocalciferol) and their combinations. Additionally, non-limiting examples also include metabolites of vitamin D, including calcidiol, calcitriol, and combinations thereof. Vitamin D, including cholecalciferol, ergocalciferol, calcidiol and calcitriol may be derived from synthetic or natural sources. Vitamin D, including cholecalciferol and calcitriol may be obtained from an extract of Solanum glaucophyllum (malacoxylon), Trisetum flavescens (goldhafer) or Cestrum diurnum. Can be used as pure vitamin D and/or glycosides of vitamin D.

Examples protivozastojnye funds include Oxymetazoline, phenylephrine, Xylometazoline, nafazolina, 1-detoxif the Drina, ephedrine, propylhexedrine, pseudoephedrine and phenylpropanolamine. Examples of anticholinergics include ipratropium, chlorpheniramine, brompheniramine, diphenhydramine, doxylamine, clemastine and triprolidine. Conventional analgesics, anti-inflammatories, and antipyretics include: ibuprofen, Ketoprofen, diclofenac, naproxen, acetaminophen and aspirin. Examples of anti-virus programs include: amantadine, rimantadine, pleconaril, zanamivir and oseltamivir. Examples of the antitussive funds include codeine, dextromethorphan, chlophedianol and levodropropizine. Examples of face means include guaifenesin. Examples mucolytic funds include Ambroxol and N-acetylcysteine. Examples of antihistamines include diphenhydramine, doxylamine, triprolidine, clemastine, Pheniramine, chlorpheniramine, brompheniramine, loratadine, cetirizine, Fexofenadine.

The tea extract is a polyphenol. Non-limiting examples of extracts include Camellia sinensis. Non-limiting sources of tea extract for use in the present invention are black tea, white tea, Oolong tea and/or green tea.

In his presence the composition comprises from about 106up to 1012SOME of the probiotic, alternatively from about 106up to 1010SOME of the probiotic. Probiotic component can represent the manage a lactic acid bacteria. Preferably, the probiotic is selected from the group consisting of bacteria of the genera Bacillus, Bacteroides, Bifidobacterium, Enterococcus (e.g., Enterococcus faecium), Lactobacillus and Leuconostoc and combinations thereof. In another embodiment of the invention, the probiotic is selected from bacteria of the genera Bifidobacterium, Lactobacillus, and combinations thereof.

Non-limiting examples of lactic acid bacteria suitable for use in the present invention include strains of Streptococcus lactis, Streptococcus cremoris, Streptococcus diacetylactis, Streptococcus thermophilus, Lactobacillus bulgaricus, Lactobacillus acidophilus (for example, Lactobacillus acidophilus), Lactobacillus helveticus, Lactobacillus bifidus, Lactobacillus casei, Lactobacillus lactis, Lactobacillus plantarum, Lactobacillus rhamnosus, Lactobacillus delbruekii, Lactobacillus thermophilus, Lactobacillus fermentii, Lactobacillus salivarius, Lactobacillus reuteri, Bifidobacterium longum, Bifidobacterium infantis, Bifidobacterium bifidum, Bifidobacterium animalis, Bifidobacterium pseudolongum, and Pediococcus cerevisiae, or a mixture thereof, preferably Lactobacillus salivarius, Bifidobacterium infantis, or mixtures thereof.

Used here the value andrografis is a plant of the genus Andrographis, which includes a limited number of species distributed mainly in Asia. Only a few species are medicinal. In one embodiment, the plant belongs to the species of Andrographis paniculata, which in Ayurvedic medicine can be called calmag (kalmegh).

The coffee extract is a polyphenol. The main component of the extract of coffee coffee is acid. In the case of prisutstvie which I extract coffee non-limiting sources of coffee extract include coffee, coffee beans, coffee beans, and/or the fruit of the coffee tree. In the presence of caffeic acid non-limiting sources of caffeic acid include coffee beans, the fruit of the coffee tree, coffee, tea, berries, rosemary extract and/or grape extract.

The turmeric extract is a polyphenol. Extract turmeric is a spice that contains as a main active compound curcumin. Curcumin is a biologically active polyphenolic vegetable pigment. Non-limiting source of turmeric extract for use in the present invention is turmeric.

The blueberry extract is a polyphenol. The blueberry extract is rich in anthocyanins, which exhibit antioxidant activity.

Grape seed extract is a polyphenol. Grape seed extract is rich in procyanidins, which exhibit anti-oxidant activity. Non-limiting source of grape seed extract for use in the present invention are the seeds of grapes.

"Carotenoids are a class of pigments that are present in the tissues of higher plants, algae, bacteria and fungi. They usually have color from yellow to dark red. In the presence of the carotenoid carotenoid selected from the group, with the standing of beta-carotene, lutein, astaxanthin, zeaxanthin, bixin, lycopene and mixtures thereof.

Amino acids are the "building blocks" of the body. Besides building cells and regeneration of tissue, they form antibodies to combat Envirowise bacteria and viruses; they are part of the enzyme & hormonal system; they are polynucleotide acid (RNA & DNA); they carry oxygen throughout the body and participate in muscle activity. In the presence of amino acids amino acid selected from the group consisting of lysine, taurine, histidine, carnosine, alanine, cysteine, and mixtures thereof.

In the presence of an antioxidant, the antioxidant is chosen from the group consisting of vitamin E, CoQ10, and mixtures thereof. The main food sources of vitamin E are vegetable oils, margarine and cooking oil, nuts, seeds, whole grains and wheat germ provide additional sources. "Vitamin E includes eight different chemical forms: four Tocopherols and four tocotrienols. The most biologically active form of vitamin E is alpha-tocopherol.

In an additional embodiment, the sensitive ingredient is encapsulated in the coating, before sensitive ingredient combined with gelatinising starch. The coating helps to create an additional barrier for sensitive Jn is regienov, such as vitamin C and phenylephrine, and the coating helps to stabilize sensitive ingredients when exposed to heat, water and/or oxygen. Preferably, the coating does not contain reducing sugars, such as dextrose, fructose, sucrose, and combinations thereof. Additionally, the coating helps to prevent discoloration of the composition, caused by sensitive ingredients such as doxylamin. Non-limiting examples of coatings include derivatives of cellulose ethers, cellulose, methylcellulose, ethylcellulose, carboxymethylcellulose, carboximetilzellulozu, hydroxyethyl cellulose, hydroxypropylcellulose, hypromellose, low-viscosity hydroxypropylcellulose, the low-viscosity hypromellose, wax or wax-like substance, such as Carnauba wax, fatty alcohols, hydrogenated vegetable oils, Zein, shellac, sucrose, gum Arabic, polyethylene glycol, polyvinylpyrrolidone, gelatin, sodium alginate, dextrin powder, shell seeds psyllium, polymethacrylates, anionic polymethacrylates, poly(methacrylic acid, methyl methacrylate) 1:1 mixtures of poly(methacrylic acid, methyl methacrylate) 1:2 and poly(methacrylic acid, methyl methacrylate) 1:1, acetated cellulose, acetatetreated cellulose phthalate of hydroxypropylmethylcellulose (HPMCP), propio attalah cellulose, zetaclear cellulose phthalate polyvinyl alcohol, acetylsuccinate hydroxypropylmethylcellulose (HPMCAS), hexahydrophthalic hydroxypropylmethylcellulose, polyvinylacetate, poly(methacrylic acid, ethyl acrylate) 1:1 and a compatible mixture.

GELATINISING STARCH

The composition comprises gelatinising starch. It is believed that gelatinising starch provides beneficial effects in various ways. First, it is believed that gelatinising starch adsorbs moisture from the atmosphere or moisture, make other raw materials, and the starch binds the moisture and makes it inaccessible to unwanted chemical reactions. The starch molecule contains a lot of available hydroxyl functionality, which can easily form hydrogen bonds with water molecules, capturing these water molecules in the matrix polysaccharide strands of starch. Gelatinising starch is resistant to the blurring due to atmospheric moisture. This means that it can adsorb large amounts of water without dissolving in the water.

Secondly, it is believed that gelatinising starch, which is a fine material that sticks to sensitive ingredients and pharmaceutically active substances, which allows them to evenly dispergirujutsja in gilotinirovaniya starch.

Gelatinising starch combined with a sensitive ingredient and sensitive ingredient, adsorbed on gilotinirovaniya starch. Additionally, sensitive ingredient and gelatinising starch can be combined so that they form a premix (pre-blend). This premix can be geometrically diluted with other pharmaceutically active substances, more sensitive ingredients, excipients and mixtures thereof with formation of a homogeneous dispersion in gilotinirovaniya starch and/or composition. Gelatinising starch is particularly useful in tablets or capsules active ingredient unstable to moisture, because, in addition to binding moisture, gelatinising starch is a material suitable for direct compression, has good fluidity. Additionally, gelatinising starch quickly absorbs water and swells, thus destroying the matrix tablets and capsules and leading to its demise, which contributes to the disintegration of tablets and capsules and release of sensitive ingredients.

In one embodiment, the sensitive ingredient is ascorbic acid. It is believed that gelatinising starch strongly attracts and binds moisture from the environment, making it unavailable to participate in the process of degradation of ascorbic acid. Thanks to tablets or capsules containing relatively Brahma is, may have from zero to a low degradation of ascorbic acid for a certain period of time.

In an additional embodiment, the sensitive ingredient can be a phenylephrine. The response of phenylephrine with aldehydes is accelerated in the presence of water. It is believed that the ability gelatinising starch to bind water helps to inhibit this reaction.

The composition comprises from about 5% to about 80% gelatinising starch by weight of the composition, alternatively from about 8% to about 70% by weight of the composition, alternatively from about 10% to about 60%, alternatively from about 20% to about 50%, alternatively from about 30% to about 40% gelatinising starch by weight of the composition.

Non-limiting examples gelatinising starch include relatively potato, wheat or corn starch. Non-limiting examples of cornstarch include Starch®1500, supplied by the firm use, Instabind IC-820, the company supplied Ideal Cures PVT. Ltd. and Lycatab®PGS supplied by the company Roquette, as well as any regulatory gelatinising starch.

ADDITIONAL PHARMACEUTICAL ACTIVE SUBSTANCE

The compositions of the present invention can contain a wide range of additional pharmaceutically active substances. Non-limiting examples include PR is evocative means, antihistamines, nnegative antihistamines, decongestants, expectorants, analgesics, antipyretic anti-inflammatory agents, local anesthetics, anti-inflammatory agents, tools, relieving irritation of mucous membranes, medicinal herbs, vitamins, nutritional supplements, antioxidants, natural ingredients, minerals, high-energy ingredients, tools, improving sleep, and means activating the immune system, tea extract, antioxidants, amino acids, enzymes, prebiotics, probiotics, extract of Andrographis, 1-tryptophan, Allium sativum, anticholinergic agents, antiviral agents, mucolytic agents, and combinations thereof.

Examples protivozastojnye funds include Oxymetazoline, phenylephrine, Xylometazoline, nafazolina, 1-desoxyephedrine, ephedrine, propylhexedrine, pseudoephedrine and phenylpropanolamine. Examples of anticholinergics include ipratropium, chlorpheniramine, brompheniramine, diphenhydramine, doxylamine, clemastine and triprolidine. Conventional analgesics, anti-inflammatories, and antipyretics include: ibuprofen, Ketoprofen, diclofenac, naproxen, acetaminophen and aspirin. Examples of anti-virus programs include: amantadine, rimantadine, pleconaril, zanamivir and oseltamivir. Examples FR the contradictions vokashlevogo funds include codeine, dextromethorphan, chlophedianol and levodropropizine. Examples of face means include guaifenesin. Examples mucolytic funds include Ambroxol and N-acetylcysteine. Examples of antihistamines include diphenhydramine, doxylamine, triprolidine, clemastine, Pheniramine, chlorpheniramine, brompheniramine, loratadine, cetirizine, Fexofenadine.

Non-limiting examples of additional pharmaceutically active substances include, without limitation, pyrilamine, promethazine, oxycodone, hydrocodone, carbinoxamine, caffeine, benzonatate, Pheniramine, fentanyl, azetidin, desloratadin, carbamazepine, buprenorphine, hydromorphone, indomethacin, Oxymorphone, phenol, codeine, mesalamine, diclofenac, sulindac, beclometason, meloxicam, fenoprofen, mometasone, menthol, benzocaine, dipyridamole, methscopolamine, available forms and forms salts of accession, the medicinal chamomile, passion flower, vitamin C, vitamin D, b vitamins, Echinacea, melatonin, green tea, curcumin, zinc, selenium, calcium, guarana, probiotics, and mixtures thereof.

The compositions of the present invention may contain a quantity of at least one additional pharmaceutically active substance in the range from about zero (0) mg to about 1000 mg of each of the at least one additional pharmaceutically active substances, alternative from PR is about 2.5 mg to about 750 mg, and alternate from about 5 mg to about 650 mg of each of the at least one additional pharmaceutically active substance, all per dose of composition.

The compositions of the present invention can contain a number of additional pharmaceutically active substance in the range from about 0% to about 20%, alternatively of 0.0001% to about 15%, alternatively from about 0,001% to about 10% and an alternate from about 0.01% to about 5%, all by weight of the composition.

EXCIPIENTS

The composition may contain excipient. The composition may contain from about 0.1% to about 99% of excipient by weight of the composition, alternatively from about 0.25% to about 70%, alternatively from about 0.5% to about 70%, alternatively from about 2% to about 70%, alternatively from about 3% to about 40%, alternatively from about 5% to about 30%, alternatively from about 6% to about 25% of excipient, by weight of the composition. Non-limiting examples of excipients include microcrystalline cellulose, dicalcium phosphate, stearic acid, magnesium stearate, corn starch, lactose, sodium croscarmellose, sodium starch glycolate, polyvinylpyrrolidone, gelatin, and combinations thereof. In the case where excipient is the stearate, the contents present stearate is at least 0,1%, alternatively less than about 0.5%, alternatively less than about 0.25 per cent, by weight of the composition. Maintaining content stearate m is fester level, equal to at least about 0.1%, helps to prevent darkening of the composition caused by the presence of certain sensitive ingredients, such as doxylamine and/or phenylephrine.

CHELATING AGENT

The composition may contain a chelating agent. Non-limiting examples of chelating agents include, without limitation, the disodium salt and the calcium salt of ethylenediaminetetraacetic acid (EDTA), Terentieva salt EDTA, sodium hexametaphosphate (SHMP), citric acid, phosphoric acid, di(hydroxyethyl)glycine, 8-hydroxyquinoline and mixtures thereof. Can also be useful chelating agents for trivalent metals, such as complexes of galactomannans with iron.

If the composition of the present invention contain a chelating agent, the composition may optionally contain from about 0,0001% to about 1% chelating agent, alternatively from about 0,001% to about 0.5% and an alternate from about 0.01% to about 0.3% of a chelating agent, all by weight of the composition.

SWEETENERS

The composition of the present invention may contain a sweetener to provide sweets and assist in masking the taste of the pharmaceutically active substance (s) and/or sensitive ingredients. The sweeteners of the present invention can be artificial podcastalley/or natural sweeteners. Non-limiting examples of artificial sweeteners are selected from the group consisting of saccharin sodium, Acesulfame potassium, Sucralose, aspartame, monoamine of glycyrrhizinate, neohesperidin of dihydrochalcone, thaumatin, neotame, cyclamate and mixtures thereof. Non-limiting examples of natural sweeteners include sucrose, fructose, glucose, glycerin, sorbitol, ▫ maltitol, and mannitol, and combinations thereof.

OPTIONAL INGREDIENTS

The compositions of the present invention can contain a wide range of optional ingredients. Non-limiting examples of optional ingredients include antimicrobial metal salts, optional means of improving the softness, optional stabilizers, abrasives, antioxidants, additives, chemical additives, colorants, tools, creating a feeling of cold, complexing agents, denaturing tools, drug astringents, emulsifiers, external analgesics, film formers, aromatics, moisturizers, cloud emulsions, plasticizers, preservatives, property, reducing agents, solvents, foaming agents, girotropnye substances soljubilizatory, suspendresume agents (no surfactant), solvents, agents for increasing the viscosity of the (aqueous and nonaqueous), airing, vitamins, antioxidants, buffet is a, keratolytic tools, etc. and combinations thereof. Preferably, the optional ingredient selected from the group consisting of solvents, complexing agents, preservatives, flavorings, buffers, antimicrobial metal salts and combinations thereof.

Non-limiting examples of antimicrobial metal salts include zinc, iron, copper, silver, tin, bismuth, and combinations thereof.

Non-limiting examples of preservatives include, without limitation, benzalconi chloride, EDTA, benzyl alcohol, potassium sorbate, parabens and mixtures thereof.

If not stated otherwise, the compositions may optionally contain one or more of such optional ingredients in concentrations that constitute from about 0,001% to about 99%, alternatively from about 0.01% to about 80%, alternatively from about 0.01% to about 50%, alternatively from about 0.01% to about 10%, all by weight of the composition.

APPLICATIONS

Used here is the term "ingested" in relation to the mammal indicates that the mammal takes in or is instructed to ingest or take in or deliver one or more compositions of the present invention. In cases when a person is instructed to ingest the composition, this indication may be that which instructs and/or details mirouet, using songs can and/or will provide relief from respiratory diseases (e.g., symptomatic relief, whether temporary or permanent), such as relief from congestion. For example, such indication may be oral direction (e.g., through oral instruction, for example, doctor, pharmacist, or other specialist in the field of medicine), the message on radio or television (e.g., an advertisement) or work order (for example, by written order, for example, physician, pharmacist or other professional in the medical field (for example, prescription), seller, or trade organization (for example, promotional brochures, leaflets or other information materials), written materials (e.g., Internet, email, or other related computer equipment materials), and/or packaging associated with the composition (for example, the label on the container in which the composition). Used here is "written" means using words, images, symbols, and/or other visible or tangible identifiers, such as Braille. This information should not necessarily use the word specifically listed here, such as "respiratory", "disease" or "mammal", but instead it is about the scope of the present invention involves the use of words, images, characters, etc. that convey the same or similar value.

The introduction can be performed as needed or desired, for example once a month, once a week or daily, including several times a day, for example at least once a day, twice a day, three times a day or four times a day or more.

The number of input composition may depend on various factors including the General health of the mammal, the type of mammal, age, gender or severity of symptoms.

In one embodiment, the present invention is administered orally to a mammal a composition, which provides in General a dosed amount of from about 0.15 to about 180 μg/kg body weight of the mammal, alternatively from about 0.7 to about 40 μg/kg of body weight of the mammal, alternatively from about 3 to about 20 μg/kg body weight of the mammal, sensitive ingredient per dose.

In one embodiment, the present invention is administered orally to a mammal a composition, which provides in General a dosed amount of from about 10 to about 1500 μg/kg body weight of the mammal, alternatively, from about 50 to about 750 μg/kg body weight of the mammal, alternatively from about 100 to about 300 μg/kg of body weight of the mammal, sensitive and is of gradient per dose.

A METHOD of MANUFACTURING

The compositions of the present invention can be prepared by any known or otherwise effective methods suitable for obtaining a composition that provides a therapeutic benefit. In one embodiment, the composition is obtained by combining the sensitive ingredient with gelatinising starch. The combined ingredients pass through a sieve into a mixer (V-blender and mix until smooth. Optionally, you can add to a mixture of microcrystalline cellulose and continue stirring until obtaining a homogenous mixture. Then the composition is pressed tablet press.

In an alternative embodiment, the composition is obtained by combining the sensitive ingredient with gelatinising starch. The combined ingredients pass through a sieve into a mixer (V-blender and mix until smooth. Optionally, you can add to the mixture and continue mixing until a homogeneous state. Then the composition is pressed tablet press.

EXAMPLES

The following additional examples describe and demonstrate the options that are included in the scope of the invention. The examples are given solely for the purpose of illustration and should not be construed as limiting the present invention, by which they may be many ways without going beyond the nature and scope of the invention.

Example 1

Raw materialwt.%/wt.
Acetaminophen54,7
Phenylephrine HCl0,8
Dextromethorphan HBr1.5
Ascorbic acid9,5
Microcrystalline cellulose15,0
Gelatinising starch16,5
Stearic acid1,5
Magnesium stearate0,5

Example 1 can be prepared by passing phenylephrine HCl, dextromethorphan HBr and gelatinising starch through a sieve with apertures 14 mesh (1,41 mm) and stirring for 100 revolutions of the mixer, V-blender. Then miss ascorbic acid and microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Miss acetaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and mix in ECENA 100 rpm. Then pass the magnesium stearate through a sieve with openings 20 mesh (841 μm) in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press.

Example 2

Raw materialwt.%/wt.
Acetaminophen54,7
Doxologically0,9
Dextromethorphan HBr2,3
Ascorbic acid19,1
Microcrystalline cellulose9,8
Gelatinising starch11,2
Stearic acid1,5
Magnesium stearate0,5

Example 2 can be prepared by passing doxylamine, dextromethorphan HBr and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss ascorbic acid and microcrystalline cellulose through a sieve with a CTE is NSTEMI 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Miss acetaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and stirred for 100 revolutions. Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press.

Example 3

Raw materialwt.%/wt.
Bifidobacteria (lyophilized)5,0
Gelatinising starch25,0
Microcrystalline cellulose65,0
Stearic acid5,0

Example 3 can be prepared by passing lyophilized bifidobacteria and gelatinising starch through a sieve with openings 20 mesh in a mixer, V-blender and mixing for 100 revolutions. Then miss ascorbic acid and microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 rpm to obtain a composition. Fill composition hard gelatin capsules with the aid of the rd machine for filling capsules.

Example 4

Raw materialwt.%/wt.
Ibuprofen50,00
Phenylephrine HCl1,25
Gelatinising starch10,00
Microcrystalline cellulose38,25
Magnesium stearate0,50

Example 4 can be prepared by passing phenylephrine HCl and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss ibuprofen and microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press.

Example 5

Raw materialwt.%/wt.
Vitamin E3,75
Vitamin C25,00
Gelatinising starch20,00
Sorbitol48,25
Stearic acid3,0

Example 5 can be prepared by passing vitamin E and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then skip the vitamin C and sorbitol through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Then miss stearic acid through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press.

Example 6

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%53,1113
Phenylephrine hcl0,7781
Of of dextromethorphan hydrobromide1,4842
Ascorbic acid is direct pressing, 97%9,2843
Microcrystalline cellulose, NF14,6001
Gelatinising starch, NF16,0591
Stearic acid, USP1,4589
Magnesium stearate0,4863
Opadry II 57U93320 orange2,0173
Opadry FX62W32046 yellow0,7204

Example 6 can be prepared by passing phenylephrine HCl, dextromethorphan HBr and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss ascorbic acid and microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Miss acetaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and stirred for 100 revolutions. Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press. Applied to the composition of the film p is a regional Opadry II 57U93320 orange using water systems for coating. Then applied film coating Opadry FX62W32046 yellow using the water system for coating.

Example 7

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%53,1474
Doxologically, USP0,9006
Of of dextromethorphan hydrobromide2,2262
Ascorbic acid direct pressing, 97%18,5685
Microcrystalline cellulose, NF9,5077
Gelatinising starch, NF10,9667
Stearic acid, USP1,4589
Magnesium stearate0,4863
Opadry II 57U91251 green2,0173
Opadry FX62W8547 silver0,7204

Example 7 can be prepared by passing doxylamine, dextromethorphan HBr and gelatinising starch through a sieve with holes and 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss ascorbic acid and microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Miss acetaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and stirred for 100 revolutions. Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press. Applied to the composition of film coating Opadry II 57U91251 green with the use of the water system for coating. Then applied film coating Opadry FX62W8547 silver using the water system for coating.

Example 8

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%53,1113
Phenylephrine hcl0,7781
Of of dextromethorphan hydrobromide1,4842
Microcrystalline cellulose, NF14,6001
Relatively to Ajmal, NF25,3434
Stearic acid, USP1,4589
Magnesium stearate0,4863
Opadry II 57U93320 orange2,0173
Opadry FX62W32046 yellow0,7204

Example 8 can be prepared by passing phenylephrine HCl, dextromethorphan HBr and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Then miss acetaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and stirred for 100 revolutions. Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press. Applied to the composition of film coating Opadry II 57U93320 orange using water systems for coating. Then applied film coating Opadry FX62W32046 yellow using the water system for coating.

Example

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%53,1474
Doxologically, USP0,9006
Of of dextromethorphan hydrobromide2,2262
Microcrystalline cellulose, NF9,5077
Gelatinising starch, NF29.5352
Stearic acid, USP1,4589
Magnesium stearate0.4863
Opadry II 57U91251 green2,0173
Opadry FX62W8547 silver0,7204

Example 9 can be prepared by passing doxylamine, dextromethorphan HBr and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Miss and etaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and stirred for 100 revolutions. Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press. Applied to the composition of film coating Opadry II 57U91251 green with the use of the water system for the coating composition. Then applied film coating Opadry FX62W8547 silver using the water system for coating.

Example 10

Raw materialwt.%/wt.
Vitamin C25,00
Gelatinising starch42,00
Microcrystalline cellulose30,0
Stearic acid3,0

Example 10 can be prepared by passing vitamin C and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Then miss stearic acid through a sieve the openings 20 mesh in gelatinising mixture and stirred for 100 rpm to obtain a composition. Pressed composition in a tablet press.

Example 11

Raw materialwt.%/wt.
Phenylephrine HCl5,0
Gelatinising starch65,00
Microcrystalline cellulose27,0
Stearic acid3,0

Example 11 can be prepared by passing phenylephrine HCl and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Then miss stearic acid through a sieve with openings 20 mesh in gelatinising mixture and stirred for 100 rpm to obtain a composition. Pressed composition in a tablet press.

Example 12

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%52,7560/td>
Phenylephrine hcl0,7500*
Of of dextromethorphan hydrobromide1,4715**
Ascorbic acid direct pressing, 97%9,2047
Microcrystalline cellulose14,4750
Gelatinising starch15,6804
Stearic acid1,9286
Magnesium stearate0,2410
Opadry II 85F1398 orange2,8571
Opadry FX 63F92532 yellow0,7143

5% excess with regard to production losses*
3% excess with regard to production losses**

Example 12 can be prepared by passing phenylephrine HCl, dextromethorphan HBr and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss ascorbic KIS the GTC and microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Miss acetaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and stirred for 100 revolutions. Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press. Applied to the composition of film coating Opadry II 85F1398 orange using water systems for coating. Then applied film coating Opadry FX 63F92532 yellow using the water system for coating.

Example 13

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%52,7561
Doxologically0,8929
Of of dextromethorphan hydrobromide2,2071*
Ascorbic acid direct pressing, 97%18,4093
Microcrystalline cellulose9,4262
Gelatinising starch10,6315
Stearin is the first acid 1,9286
Magnesium stearate0,2411
Opadry II 85F1369 green2,8571
Opadry FX 63F97546 silver0,7143
3% excess with regard to production losses*

Example 13 can be prepared by passing doxylamine, dextromethorphan HBr and gelatinising starch through a sieve with apertures 14 mesh and mixing within 100 rpm of the mixer, V-blender. Then miss ascorbic acid and microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Miss acetaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and stirred for 100 revolutions. Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatinising mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press. Applied to the composition of film coating Opadry II 85F1369 green with the use of the water system for coating. Then applied film coating Opadry FX 63F97546 silver using the water system for the NAS is the basis of coverage.

Example 14

Layer 1

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%60,0649
Ascorbic acid direct pressing, 97%20,2922
Microcrystalline cellulose17,0455
Stearic acid2,2727
Magnesium stearate0,3247

Layer 2

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%59,1054
Gelatinising starch16,7732
Microcrystalline cellulose16,7732
Phenylephrine hcl1,5974
Of of dextromethorphan hydrobromide3,1949
Stearic acid2,2364
Magnesium stearate0,3195

Example 14 can be prepared using a tablet press designed for manufacturing two-layer tablets. Each layer is prepared separately using the process and stages described in Example 13. The individual layers of the composition is then loaded into separate bins double-layer media. Layer 1 is pressed first and the powder layer 2 then fall asleep on this pre-molded tablet, after which the layer 2 is pressed on top of the previously compacted layer 1.

Example 15

Raw materialwt.%/wt.
Acetaminophen direct pressing, 90%52,7560
Phenylephrine hcl0,7500*
Of of dextromethorphan hydrobromide1,4715**
Coated ascorbic acid/Eudragit9,2047
Microcrystalline cellulose14,4750
Gelatinising starch15,6804
Stearic key is lots 1,9286
Magnesium stearate0,2410
Opadry II 85F1398 orange2,8571
Opadry FX 63F92532 yellow0,7143
5% excess with regard to production losses*
3% excess with regard to production losses**

Example 15 can be carried out in a column of Wurster by spraying 3,0% Eudragit (Eudragit L-30 on a fluidized bed of suspended ascorbic acid. Suspended ascorbic acid encapsulate the coating of Eudragit L-30. After that, phenylephrine HCl, dextromethorphan HBr and gelatinising starch is passed through a sieve with apertures 14 mesh and stirred for 100 revolutions in the mixer, V-blender. Then miss ascorbic acid encapsulated in a coating of Eudragit, and microcrystalline cellulose through a sieve with apertures 14 mesh in the mixture gelatinising starch and stirred for 100 revolutions. Miss acetaminophen and stearic acid through a sieve with apertures 14 mesh in gelatinising mixture and stirred for 100 revolutions.

Then pass the magnesium stearate through a sieve with openings 20 mesh in gelatin is stimulated mixture and stirred for 30 turns before receiving the composition. Pressed composition in a tablet press. Applied to the composition of film coating Opadry II 85F1398 orange using water systems for coating. Then applied film coating Opadry FX 63F92532 yellow using the water system for coating.

The dimensions and values disclosed here should not be construed as strictly limited to the exact numerical values. Instead, unless otherwise specified, each such dimension shall be defined as the present value and a functionally equivalent range surrounding that value. For example, the size, disclosed as "40 mm"must mean "about 40 mm".

All the documents referred to in the detailed description of the invention, in relevant part included here as links; reference to any document shall be construed as an admission that it is prior art with respect to the present invention. To the extent that any meaning or definition of a term in this document contradicts any meaning or definition of the same term in a document incorporated by reference, the dominant should be a value or definition specified terms in this document.

Although there have been illustrated and described specific options to the present invention, qualified specialists in the art it will be obvious that various other changes and modifications can be made without going beyond the nature and scope of the invention. Therefore, it is assumed that it covers in the appended claims all such changes and modifications are included in the scope of the present invention.

1. The method of stabilization of sensitive ingredient for biological absorption after oral ingestion in pharmaceutical compositions, with a sensitive ingredient selected from vitamin C, phenylephrine, and combinations thereof; the said method comprises a stage on which:
a) combine gelatinising starch, in an amount of from about 5% to 80% by weight of the composition, with at least one sensitive ingredient, in an amount of from about 0.1% to about 20% by weight of the composition;
b) mix sensitive ingredient with gelatinising starch to achieve a uniform distribution of the sensitive ingredient in gilotinirovaniya the starch, so that the sensitive ingredient is adsorbed on gilotinirovaniya starch;
specified sensitive ingredient uniformly distributed in the specified gilotinirovaniya starch.

2. The method according to claim 1, characterized in that the said composition comprises from about 8% is about 70% gelatinising starch, by weight of the composition.

3. The method according to claim 1, characterized in that the said composition comprises from about 0.5% to about 15% sensitive ingredient, by weight of the composition.

4. The method according to claim 1, characterized in that said sensitive ingredient contains vitamin C.

5. The method according to claim 1, characterized in that said sensitive ingredient contains phenylephrine.

6. The method according to claim 1, characterized in that it further includes a step in which: encapsulate the specified sensitive ingredient in the coating.

7. The method according to claim 1, characterized in that it further includes a step in which: form the premix.

8. The method according to claim 7, characterized in that it further includes a step in which: dilute the specified premix at least one additional pharmaceutically active substance.

9. The method according to claim 8, characterized in that the said additional pharmaceutically active substance selected from the group consisting of antitussives funds, antihistamines, reseating antihistamines, protivozastojnye means, means salt, analgesics, antipyretic anti-inflammatory agents, local anesthetics, anti-inflammatory agents, tools, relieving irritation of mucous membranes, remedies from herbs, vitamins, supplements, EN is ioxidant, natural ingredients, minerals, high-energy ingredients, tools, improving sleep, and means activating the immune system, tea extract, antioxidant, amino acid, enzyme, prebiotic, probiotic, extract of Andrographis, 1-tryptophan, Allium sativum, anticholinergics, anti-virus tools, mucolytic means and their combinations.

10. The method according to claim 1, characterized in that the composition additionally contains excipient.

11. The method according to claim 10, characterized in that the specified excipient selected from the group consisting of microcrystalline cellulose, dicalcium phosphate, stearic acid, magnesium stearate, corn starch, lactose, sodium croscarmelose, of sodium glycolate, polyvinylpyrrolidone, gelatin and combinations thereof.

12. The method according to claim 1, characterized in that the specified composition selected from the group consisting of tablets, soft gels and capsules.

13. The method according to claim 1, characterized in that the composition further comprises a chelating agent.

14. Medicinal composition containing:
a) from about 5% to 80% by weight of the composition gelatinising starch;
b) from 0.1% to 20% by weight of the composition of at least one sensitive element for biological absorption after oral ingestion, selected from vitamin C, penile the ins and combinations thereof;
where specified sensitive ingredient uniformly distributed in the specified gilotinirovaniya starch.

15. The composition according to 14, characterized in that it further comprises excipient.

16. The composition according to 14,characterized in that it further contains a chelating agent.

17. The composition according to 14, characterized in that the said composition is selected from tablets, soft gels and capsules.



 

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16 cl, 4 dwg, 7 tbl, 55 ex

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4 cl, 4 dwg, 7 tbl, 6 ex

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16 cl, 7 dwg, 2 tbl, 9 ex

FIELD: medicine.

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8 cl, 1 dwg, 3 ex

FIELD: medicine, pharmaceutics.

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EFFECT: according to the invention, the medication is noted for a pronounced virus-inhibiting action, satisfactory organoleptic properties and pharmacological safety and extends the arsenal of antiviral medications.

12 cl, 3 dwg, 7 tbl, 3 ex

Forming of capsules // 2450798

FIELD: process engineering.

SUBSTANCE: invention relates to chemistry and pharmaceutics, particularly, to method and device for producing capsule with solid shell wherein capsule components are formed from material to be gelled after heating, for example, HPMC. Drying conditions after dipping are accurately controlled for controlling drying rate.

EFFECT: heater for multiple dies.

21 cl, 3 dwg

FIELD: medicine.

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EFFECT: preparation improvement.

2 cl, 5 ex

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