The Chapter 11 Tachnology tablets.
Mixing. Granulating. Damp granulating. Dry
granulating. Pressing-tableting. Direct pressing.
Dedusting
Technology of tablets.
Three technological circuits of reception are most distributed
Tablets: with application damp or dry a granulating and
Direct pressing.
Preparation of initial materials to tabletirovaniju is reduced to them
To dissolution and razveshivaniju. Weighing of raw material is carried out in
Flueblocks with aspiratsiej. After weighing the raw material acts
On sifting with the help proseivatelej a vibrating principle
Action.
Mixing.
Making tablets a mix medicinal and auxiliary
Substances are necessary for mixing carefully for uniform
Their distributions in a lump. Reception homogeneous on structure
A tablet of a mix is very important and rather complex
Technological operation. In connection with that, that powders possess
Various physical and chemical properties: dispersiveness,
In bulk density, humidity, fluidity, etc. At this stage
Use amalgamators of periodic action lopastnogo type,
The form of blades can be various, but more often worm or
zetobraznoj.
Granulirovanie.
It is process of transformation poroshkoobraznogo a material in grains
The certain size that is necessary for improvement of flowability
tabletiruemoj mixes and prevention of its stratifying.
Granulirovanie can be "damp" and "dry". The first kind
A granulating it is connected to use of liquids - solutions
Auxiliary substances; at dry granulatings to the help
Moistening liquids either do not resort, or use them only
At one certain stage of preparation of a material to
tabletirovaniju.
Damp granulirovanie will consist of the following operations:
1) crushing of substances in a thin powder; 2) ovlazhnenie a powder
A solution of connecting substances; 3) wiping of the received weight
Through a sieve; 4) drying and processings granuljata.
Crushing. This operation usually spend in spherical mills.
A powder sift through a sieve ¹ 38.
Ovlazhnenie. As connecting substances recommend to apply
Water, spirit, a sugar syrup, a solution of gelatin and 5 % krahmalnyj
Paste. Necessary quantity of connecting substances
Establish by practical consideration for everyone tabletiruemoj weights. For
It that the powder in general was granulated, he should be
It is humidified up to the certain degree. About sufficiency of humidifying
Judge so: a small amount of weight (0,5 - 1ã) compress between
The big and index finger; formed "flat cake" not
Should stick to fingers (excessive humidifying) and to be scattered
At falling from height 15 - 20 sm (insufficient humidifying).
Ovlazhnenie spend in the amalgamator with S (sigma) - figurative
Blades which rotate with in the various speed: a lobby-
With a speed 17 - 24ob/mines, and back - 8 - 11ob/mines, the blade
Can rotate in the return party. For oporozhnenija the amalgamator
The case of it overturn also weight push out with the help of blades.
Wiping (actually granulirovanie). Granulirovanie
Make by wiping the received weight through a sieve 3 - 5ìì
(¹ 20, 40 and 50) Apply penetrative a sieve from stainless steel,
A brass or bronze. The use tkannyh is not supposed
Wire sit in order to prevent hit in tablets weight
obryvkov a wire. Wiping make with the help special
protirochnyh machines - granulators. In vertical punched
The cylinder fill the granulated weight and wipe through apertures
With the help of springing blades.
Drying and processing of granules. Received ranuly rassypajut
A thin layer on pallets also dry sometimes on air at
To a room temperature, but is $more often at òåìïåðàòóðå30 - 40? C in
Drying cases or drying premises. Residual humidity
In granules should not exceed 2 %.
It we have considered operations of a method damp a granulating by
Wipings or prodavlivanija. Usually operations of mixing and
Uniform humidifying poroshkoobraznoj mixes various
Granulating solutions combine and spend in one
Amalgamators. Sometimes in one device operations are combined
Mixing and a granulating (high-speed amalgamators-
granuljatory). Mixing is provided at the expense of vigorous
Compulsory circular hashing particles and their colliding
With each other. Process of hashing for reception homogeneous on
To structure of a mix lasts 3 - 5 '. Then to preliminary mixed
To a powder in the amalgamator the granulating liquid, and a mix moves
Mixs up 3-10 more '. After end of process
A granulating open the unloading valve, and at slow
Rotation of a scraper the ready product gets enough sleep. Other design
The device for overlapping operations of mixing and a granulating-
The centrifugal amalgamator - a granulator.
In comparison with drying in drying cases which are
Unproductive and in which duration of drying reaches
20 - 24 hours, more perspective considers drying of granules in
Boiling (psevdoozhizhenom) a layer. Its basic advantages
Are: high intensity of process; reduction specific
Power expenses; an opportunity of full automation
Process.
But top of technical perfection and the most perspective
The device in which operations of mixing are combined serves,
A granulating, dryings and dusting. These are well-known
Devices SG-30 and Ñã-60, developed Leningrad NPO
"Progress".
If operations damp a granulating are carried out in separate
Devices after drying granules operation dry follows
A granulating. After drying granuljat does not represent
Uniform weight and often contains komki from slipshihsja granules.
Therefore granuljat repeatedly acts in protirochnuju the machine. The ambassador
It from granuljata eliminate the formed dust.
As the granules received after dry granulation, have
A rough surface that complicates further them
vysypanie from loading voronki in process tabletirovanija, and
Besides granules can stick to a matrix and punches
tabletpressa, that causes, besides infringement of weight, defects in
Tablets, resort to operation of "dusting" granuljata. This
Operation is carried out by free drawing is thin crushed
Substances on a surface of granules. By dusting in tabletmassu
Enter sliding and loosening substances.
Dry granulirovanie.
In some cases if the medicinal substance decays in
Presence of water, resort to dry a granulating. For this purpose
From a powder press briquettes which then grind, receiving
krupku. After elimination from a dust krupku tabletirujut. In the present
Time under dry granulirovaniem understand a method, at which
poroshkoobraznyj a material subject to initial condensation
(Pressing) also receive granuljat, which then tabletirujut-
Secondary condensation. At initial condensation in weight
Enter dry sticking together substances (MTS, KMTS, PEO), providing
Under pressure coupling of particles as gidrofilnyh, and
Waterproof substances. It is proved suitability for dry
Granulating PEO in a combination to starch and talc. At
Use of one PEO the weight sticks to punches.
Pressing. (actually tabletirovanie). It is process
Educations of tablets from granulated or poroshkoobraznogo
A material under action of pressure. In modern pharmaceutical
Manufacture tabletirovanie it is carried out on special
Presses - rotornyh tablets machines (RTM). Pressing on
Tablets machines it is carried out press - by the tool,
Consisting of a matrix and two punches.
The work cycle tabletirovanija on RTM develops of lines
Consecutive operations: batching of a material, pressing
(education of a tablet), its pushing out and sbrasyvanie. All
The listed operations are carried out automatically one for
Another by means of corresponding executive mechanisms.
Direct pressing. It is process of pressing not granulated
Powders. Direct pressing allows to exclude 3 - 4
Technological operations and, advantage thus has
Before tabletirovaniem with preliminary granulirovaniem
Powders. However, despite of seeming advantages, direct
Pressing slowly takes root into manufacture. It speaks
That, that for productive work of tablets of machines
The pressed material should possess optimum
Technical characteristics (flowability, presuemostju,
Humidity, etc.) Such characteristics possesses only
A small number of not granulated powders - sodium chloride,
kalija jodid, sodium and ammonium bromide, geksometilentetramin,
bromkamfara, etc. the substances having isometric forms of particles
Approximately identical granulometricheskogo structure, not
Fine fractions containing a plenty. They it is good
Are pressed.
One of methods of preparation of medicinal substances to direct
To pressing the directed crystallization is - achieve
Receptions tabletiruemogo substances in crystals set
Flowability, pressuemosti and humidity by special conditions
Crystallization. This method receive atsetilsalitsilovuju an acid
And an ascorbic acid.
Wide use of direct pressing can be provided
Increase of flowability of not granulated powders, qualitative
Mixing of dry medicinal and auxiliary substances,
Reduction of propensity of substances to stratification.
Obespylivanie. For removal from a surface of the tablets leaving from
Press, dust fractions are applied obespylivateli. Tablets
Pass through the rotating punched drum and are cleared
From a dust which is sucked away by a vacuum cleaner.