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Technologies of a covering of tablets shells.

Drawing of shells pursues the following purposes: to give to tablets beautiful Appearance to increase their mechanical durability, to hide unpleasant taste, A smell to protect from influence of an environment (light, a moisture, oxygen Air) to locate or prolong action of medicinal substance, To protect mucous membranes of a gullet and a stomach from destroying action Medicinal substance. The coverings rendered on tablets, it is possible to divide on 3 groups: drazhirovannye, film and pressed.

Drazhirovannye coverings - see. Technology of reception of drops.

Film coverings.

Are created on tablets by drawing a solution of film-forming substance with The subsequent removal of solvent. Thus on a surface of tablets It is formed thin (0,05 - 0,2мм) the shell. Film coverings in dependence From solubility divide into the following groups: water-soluble, soluble in Gastric juice, soluble in intestines and insoluble coverings. Water-soluble coverings protect from mechanical damages, but not Protect from influence of a moisture of air. Water-soluble shells form PVP, MTS, oksipropilenmetiltselljuloza, Na KMTS, etc. rendered as vodnoetanolnyh or water solutions. Coverings, soluble in gastric Juice. It is a film which protect tablets from action of a moisture, but not Interfere with fast their destruction in a stomach (during 10-30мин). The polymers having in a molecule assistants of the basic character concern, Mainly amino groups, for example dietilaminometiltselljuloza, benzilaminotselljuloza, paraaminobenzoaty sugars and atsetiltselljuloza, etc. For Coverings use solutions of the specified substances in organic solvents: Ethanol, izopropanole, acetone. Coverings, soluble in intestines. They Locate medicinal substance in intestines, prolonging his action. For Receptions of coverings use atsetilftalilTS, metaftalilTS, polivinilatsetatftalat, ftalaty dekstrina, lactoses, mannita, sorbite, shellac (natural Naval Forces) For reception of a film use the specified substances as Solutions in ethanol, izopropanole, etilatsetate, toluene, etc. solvents, HFI (. Sankt Petersburg) has developed technology of a covering of tablets A vodno-ammoniac solution of shellac and atsetilftalilTS. For improvement Mechanical properties plenok to them add softener.

Insoluble coverings - a film with microporous structure. Represent Itself solutions etilTS and atsetilTS in ethanol, izopropanole, acetone, toluene, Chloroform, etilatsetate, etc. With addition of softeners. The mechanism Liberation of medicinal substance: digestive juices will quickly penetrate In time of the insoluble shell also dissolve medicinal substance or Cause his swelling. In the first case medicinal substance diffundiruet Through a film in the opposite direction, in the second - occurs having dug shells, Then the medicinal substance is liberated by usual way.

Methods of drawing of film coverings.

Drawing film coverings is carried out in drageeing boilers, Installations of centrifugal action and in psevdoozhizhennom a layer. A method of drawing Coverings in psevdoozhzhennom a layer it is applied to drawing of water coverings, As drageeing boilers have low parameters warmly and massoperenosa And process of a covering proceeds slowly, that reduces productivity The device. Use of water coverings has a number of advantages: disappears Necessity of catching and regeneration of solvent; to prepare water Solutions it is easier, they it is better distributed on a surface of tablets. For Film water coverings use water solutions oksipropilmetplTS, ammonijnyh salts of shellac and atsetilftalilTS. Before drawing of water coverings Surfaces of tablets give water repellency at the expense of drawing a layer Vegetable oil. The device for drawing a water film covering It is developed by the Russian pharmaceutical firms.

At impossibility of use of a water film covering it is applied A covering on the basis of organic solvents. For drawing these coverings Use drageeing boilers. This method is simple, differs high Productivity at use of coverings on the basis of organic Solvents. For drawing a covering biconvex tablets are loaded in The drageeing boiler. Before the beginning of process of a covering from a surface of tablets The dust (with the help of an air jet or vacuum) leaves. A covering solution It is entered in the boiler by repeated razbryzgivanija (with the help established At an aperture of the boiler of an atomizer).

For drawing film coverings on the basis of organic solvents The special installation having closed system of catching and is applied Regenerations of solvent.

Installation works as follows: in the drageeing boiler rotating from A drive, tablets subject to a covering are loaded. The system is isolated. In The collection the covering solution prepares. The system of pipelines is filled Nitrogen. The fan nitrogen moves in a heater where it is heated up up to set Temperatures, then, entering into the boiler, washes mixed tablets, on Which covering solution with the help raspylivatelja is rendered. Nitrogen with pairs Solvent acts in the condenser where solvent is condensed and Is going to in the collection. The drained nitrogen again acts on the fan. This The cycle repeats repeatedly up to a full covering of tablets. After the termination Process it is made razgermetizatsija a casing of the drageeing boiler, for what Preliminary from system with the help of vacuum nitrogen with pairs leaves Solvent. The boiler opens, the rest parogazovoj knead leaves from the boiler The local pump. A covering of a tablet are unloaded by an inclination of the boiler. Weight The tablets loaded in the boiler, makes 25 kg. Duration of a cycle not More 4ч.

Napressovannye coverings. Napressovannye coverings are dry coverings, Rendered on tablets by pressing by special machines, which Represent a combination of two machines: rotational - usual type for Pressing tablets and special - for reception on them napressovannogo Coverings. On the first rotor tablets, which passing are pressed The device go on the second rotor in which matrix moves The covering solution and a tablet is pressed finally. Principal causes, Wide application of this method, lower are constraining Characteristics of coverings in comparison with plenkami and less attractive A packaging.

Trituratsionnye tablets. Trituratsionnymi the tablets formed from are called The humidified weight by her vtiranija in the special form with the subsequent drying. As against pressed, trituratsionnye tablets did not treat to action Pressure: coupling of particles of these tablets is carried out only in result autogezii at drying, therefore trituratsionnye tablets possess smaller Durability, than pressed. Trituratsionnye tablets make in those Cases when use of pressure is undesirable or it is impossible. It can To take place when a dosage of medicinal substance it is small, and Addition of a plenty of a plenty of auxiliary substances It is inexpedient. To make such tablets because of the small size (d = 1-2 mm) On tabletochnoj it is technically difficult for the machine. Trituratsionnye tablets Make and when action of addition can call to - l Change of medicinal substance. For example, at reception of tablets Nitroglycerine at use of addition there can be an explosion. And more trituratsionnye it is expedient to prepare for tablets when Tablets are necessary, it is fast and easy rastvorjajushchiesja in water. For them Manufacturing sliding substances which are insoluble are not necessary Connections. Trituratsionnye tablets are porous and fragile and Therefore they are quickly dissolved at contact to a liquid that is convenient at Manufacture of tablets for injections and eye drops.

As auxiliary substances for trituratsionnyh tablets use Lactose, saccharose, glucose, kaolin, СаСО3. At their reception poroshkoobraznuju The mix is humidified with 50-70 % spirit before reception of plastic weight, which then With the help shpatelja rub in a plate - a matrix placed on glass. Then With the help of pistons of punches damp tablets are pushed out from matrixes and Are dried on air or in a drying case at temperature 30-40ºC. On another To a way drying of tablets is carried out, is direct in plates and with The help of punches pushes out dried already up tablets.

Drops.

Drops - firm dosed out LF for the internal application, received in the way Repeated naslaivanija (drazhirovanija) medicinal and auxiliary Substances on sugar granules (krupku). The drops have the spherical form, weight 0,1 - 0,5г. As drops issue difficultly tabletiruemye medicinal Substances. The drops allow to hide unpleasant taste of medicinal substance, To reduce their irritating action, to protect from influence external Factors. However in this LF it is difficult to provide accuracy of batching, raspadaemost in required terms, fast liberation of medicinal substances. The drops are not recommended to children. Taking into account above stated, this LF does not concern To perspective.

Technology: industrial production of drops is carried out in Drageeing boilers (obduktorah). Process of reception of drops is similar Technologies of a covering of tablets drageeing shells. In quality Auxiliary substances apply sugar, starch, wheat flour, magnesium A carbonate, etilTS, atsetilTS, NaKМЦ, talc, gidrogenizirovannye fats, an acid Stearin, cocoa, chocolate, food dyes and varnishes.

Granules (sugar krupka) sift through a sieve so that in 1 g them Contained about 40, load into the rotating boiler and make Consecutive escalating until all materials will be spent.

Obduktor represents the rotating boiler of the oval form, ukreplennyj on Inclined to a shaft. Speed of rotation of the boiler from 20 up to 60 rev/min. Loading obduktora should make 1/5 - 1/6 volumes. At the greater loading a tablet Can collapse under weight of the rotating weight, at smaller to be used up for The bill of intensive hashing inside the boiler.

For drawing each subsequent layer a surface of drops humidify sugar A syrup and in regular intervals sprinkle all over again with a flour, and in some minutes- Magnesium a carbonate. After 25 - 30 ' in the boiler submit filtered air, podogretyj up to t = 40 - 50ºC. The weight dries up through 30 - 40 minutes. Operation Repeat 2 - 3 r.

Prepare testoobraznuju for the weight consisting of a flour and a syrup sugar (1 kg of a flour On 2 l a syrup), here add medicinal substances.

Water poslojno, sprinkle magic with a carbonate. Submit hot air on 30-40 Minutes. Operation repeat 2 - 3 times.

At the end of process the boiler rotate without escalating and receive drops with brilliant A smooth surface. For glossing add wax.

Prospects of development of technology of tablets.

1) Multilayered tablets allow to combine medicinal substances, Incompatible on physical and chemical properties to prolong action Medicinal substances to adjust their sequence vsasyvanija in The certain time intervals. To their manufacture apply cyclic tabletochnye of the machine. The medicinal substances intended for various Layers, move in a feeder of the machine from the separate bunker. In a matrix on Turns the new medicinal substance is filled, and the bottom punch falls All is lower. Each medicinal substance has the painting, and their action It is shown consistently, by way of dissolution of layers. For reception Layered tablets various foreign firms issue special models tabletochnyh pressov.

2) Frame tablets (or tablets with an insoluble skeleton) - for them Receptions use the auxiliary substances forming mesh structure (Matrix) in which the medicinal substance is switched on. Such tablet Reminds gubku which time are filled with soluble medicinal substance. Such tablet does not break up in a gastroenteric path. Depending on The nature of a matrix she can nabuhat and slowly be dissolved or save The geometrical form during all stay in an organism also it is deduced Constant as porous weight, in which time are filled with a liquid. Frame tablets concern to preparations of prolonged action. The medicinal substance from them is liberated by washing away. Thus Speed of his liberation does not depend on the maintenance of enzymes in To an environment, from its size rN also remains enough constant on To a measure of passage of a tablet through a gastroenteric path. Speed Liberation of medicinal substance, define such factors, as the nature Auxiliary and solubility of medicinal substances, a parity of medicines And forming a matrix of substances, porosity of a tablet and a way of its reception.

Auxiliary substances for education of matrixes subdivide on gidrofilnye, waterproof, inert and inorganic.

Gidrofilnye matrixes - from nabuhajushchih polymers (gidrokolloidov): gidroksipropilTS, gidroksipropilmetilTS, gidroksietilmetilTS, metilmetakrilata , etc.

Waterproof matrixes - (lipidnye) - from natural voskov or from Synthetic mono-, di-and triglitseridov, hydrogenated vegetable oils, Fat maximum spirits, etc.

Inert matrixes - from insoluble polymers: etilTS, polythene, polimetilmetakrilat, etc. For creation of channels in a layer of polymer, Insoluble in water, add water-soluble substances (PEG, PVP, Lactose, pectin, etc.). Being washed away from a skeleton of a tablet, they create conditions For gradual allocation of molecules of medicinal substance.

For reception of inorganic matrixes use nontoxical insoluble Substances: Са2НРО4, СаSO4, BaSO4, aeroforces, etc.

Frame tablets receive direct pressing of a mix medicinal and Auxiliary substances, whether pressing of microgranules of microcapsules Medicinal substances.

3) Tablets with ionitami - prolongation of action of medicinal substance is possible By increase in his molecule at the expense of sedimentation, on and - about pitch. Substances, Connected with and about pitch, become insoluble, and clearing Medicinal substance in a digestive path it is based only on an exchange Ions. Tablets with ionitami support a level of action medicinal Substances within 12 hours.

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