How are quality medicines and pills produced? Materials Raw materials for the pharmaceutical industry.
Such a familiar thing as a tablet became widespread relatively recently - at the end of the 19th century. Prior to this, the usual dosage forms that the pharmacy sold were: potions, drops, powders and pills. The latter can be considered the closest relatives of the modern tablet, the production of which is a complex automated process.
Just like in the pharmacy
Any tablet consists of several components that must be combined in a certain proportion into a homogeneous mass. Each of the tablet starting materials is weighed to the nearest milligram per drug lot, then dissolved, sieved and mixed.
In fact, mixing various ingredients, creating a homogeneous mass, is not at all easy, since they may differ in density, dispersion, moisture content, etc. In pharmaceutical industries, several types of mixing devices are used. Sometimes this is possible in the process of vigorously moving the particles of the future tablet in a circle and pushing them against each other. And sometimes mixing is achieved due to the principle of centrifugal force
Birth of a granule
The second stage of production is granulation of the resulting homogeneous mass. This is necessary in order, on the one hand, to prevent delamination of the future tablet, on the other hand, to make it easily soluble in the human body.
Granulation is carried out in two ways: "wet" and "dry". At the first, moisturizers are used: water, syrups, solutions of starch, gelatin. After that, the mixture is sent to an apparatus that acts like a sieve with tiny holes. The mashed mass - new granules, is dried.
The "dry" principle of granulation is used in cases where the composition of the future tablet preparation includes substances that lose their properties when moistened. This type of granulation can be carried out both by crushing and by clotting pre-compacted powders. As a result, dry granules are again tested for shape and size on the "sieve" of the pharmaceutical production line.
In the process of granulation, the tablet mass is converted into tiny grains (granules) of the same size, which ultimately simplifies the next production process - tableting (or pressing).
Taking shape
There are tablets that bypass the granulation process, they are made by direct compression, which significantly reduces the cost of the drug, but unfortunately, it is suitable for a very small number of constituent tablets.
The tablet receives its shape and size on a special machine - a press. Usually a biconvex "round" has a groove in the center, which helps to determine half the dose. Some firms print their logo or its patented name on the tablets.
About what is put in tablets and why excipients are needed
All modern medicines are multicomponent and contain active and excipients. The active substance reduces the symptoms of the disease or completely cures it, being the basis of the drug. Excipients do not have a therapeutic effect on the body, but play an important role in determining taste, color, size (tablets), solubility and many other properties.
Security
Excipients have proven safety, do not cause harm to health and usually do not cause side effects. The exception is people who are hypersensitive to a particular excipient (lactose, nut butter, some sugars). As a rule, manufacturers of original drugs and generics (analogues) use the same additional components.
Filling agent
by the most simple example excipient may serve as a filler substance. It is used in the manufacture of tablets with a very small content active ingredient. The filler gives the drug hardness, maintains mechanical stability so that the tablet does not crumble while still in the package.
disintegrants
In order for the drug to start acting faster, disintegrants are added to it. These substances provide rapid disintegration of solid dosage forms upon contact with water. Tubules are formed that destroy strong bonds between the particles: the tablet swells and crumbles, dissolving in the liquid. One of the latest developments is disintegrants and binders based on microcrystalline cellulose. The new component alone performs two functions at once: it binds particles, helping to form a tablet, and promotes disintegration - disintegration after it enters the body.
Binders (binders)
The purpose of binders is to firmly bind small and unstable particles of powders, granules or tablets to each other in order to ensure sufficient mechanical strength of the drug.
lubricants
Lubricants (usually magnesium stearate) are water-repellent. They are used at the stage of pressing and molding tablets so that the powder or granules do not remain in the factory forms, there is no loss of the active substance at the production stage.
Glidants
The shape of the finished tablet is supported by glidants, substances necessary for the tight contact of the particles of the medicinal substance. Previously, talc was used for these purposes, today it is a colloidal form of silicon oxide. The concentration of excipients of this type usually does not exceed 0.2%.
Solvents or solvents
Water is the best solvent for medicines. It has excellent physiological compatibility with the human body, high dissolving power. But sometimes these properties can lead to instability medicinal product Moreover, water is a favorable substrate for the growth of bacteria. Sorbitol and dextrose, which are also used as solvents and sweeteners, have the same properties. These unpleasant properties are deprived of co-solvents - propylene glycol, glycerol, ethyl alcohol. Co-solvents provide antimicrobial properties, improve taste, so they are added to preparations intended for resorption. Also, these substances allow you to reduce the dose of the drug, better dissolving the drug.
Medicines for children
Medicines intended for children are subject to special requirements for safety and external characteristics. Of course, they must have good taste and a pleasant color. It is recognized that not all children are able to swallow solid drugs, so for many drugs it is necessary to develop liquid or other forms (for example, in the form of chewing gums). The single dose should be small, and the dosage accuracy should be high. Special requirements are also imposed on the size of the injection needle and the volume of the injected drug. Children are often afraid of one type of syringe.
Oleg Kucheryavenko - doctor, head of the European branch of the International working group in Evidence-Based Medicine, Master's Degree (MPH), London School of Hygiene and Tropical Medicine.Comment on the article "Homeopathy - benefit or quackery?"
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2. For some customers, it is easier, but more expensive, to buy the most powerful press model. Other customers want to save money on equipment and are engaged in the technological preparation of the powder. In any case, my recommendations are a preliminary check of the powder and subsequent (if necessary) preparation. The maximum load in terms of pressing force should not exceed 70% of the indicator specified in the technical specifications. Powder additives that improve pressing are indicated in the articles on this site.
3. The next problem that usually occurs with tablet presses is poor powder flow. If your powder has a fine fraction, such as flour, and visually there is a lot of air in this powder, then such a powder will simply hang in the tablet press hopper. Thereby preventing uniform doses from entering the matrices. There are two solutions - adding additives in the form of larger crystals to the fine powder, which will ensure the movement of the powder in the hopper, the second solution is granulating your powder, the choice of method - dry or wet, you will determine based on the composition of your powder. Working with granular powder gives more uniform weight and quality tablets.
4. Sticking of the powder to the punches and the inner walls of the dies. This unfortunate trend is stopping many pill productions. The solution may be to dry the powder (check the moisture level of your pellets or feedstock). Dry if necessary. It can also affect this factor and the humidity in the room. The best way to deal with sticking on punches is calcium stearate and magnesium stearate powders. When they are added to any powder, the sticking problem goes away. You need to add gradually from the minimum dose until the effect occurs. Some get 0.5% by weight. There are cases and applications of 5% sterat. In any case, when mixing powders, you need to understand that a certain powder will give a sticking effect, and this should be taken into account at the stage of preparing the mixture. Polishing the punches also helps.
5. Some powders have high abrasive properties, as well as aggressive destructive actions. Conventional tablet press models come with standard molds. I recommend everyone to treat all parts in contact with the powder with hardening compounds. There are various electro-chemical methods of hardening steels. This will increase the resource of the tablet press by several times.
Questions about pills
You will find answers to all questions related to the production of tablets on the pages of the resource www.site
- How to mix powders correctly? Mixing powders, especially in unequal proportions, is a very complex process. It is impossible to visually determine the quality of powder mixing. When buying any powder mixer you should know some powder mixing secrets from our website.
- How to coat a tablet? Coating of tablets - covering the surface of the tablet with a protective or decorative shell. We choose the shell material, study the technology of panning tablets and the principles of operation of panning boilers.
- How to remove dust from tablets? In the process of pressing tablets, a layer of powder is formed on them, as well as on the working surface of the press. In the future, if this layer of dust is not removed from the tablets, this leads to incorrect operation of counting and filling machines, the dusty tablet makes it difficult to apply a strong shell. We share with you what means to remove dust, remove dust from tablets..
- How to distinguish tablets from briquettes? Square tablets, oval tablets, round tablets, salt tablets, charcoal tablets, tablets with a logo, tablets for washing machines - which of them are tablets and which are already briquettes. Sizes and shapes of tablets.
- How to pack tablets in a blister? The most popular type of packaging for tablets is a blister pack. The blister pack of tablets is a PVC film and a layer of heat-sealed aluminum foil. Cells are formed by temperature desired shape, after filling, sealed with aluminum foil on top.
Today, every person uses pills, whether it is for the temperature of an adult, or in order to stop childhood illnesses.
The most common are three technological schemes for obtaining tablets: using wet or dry granulation and direct compression. Preparation of raw materials for tableting is reduced to their dissolution and hanging. Weighing of raw materials is carried out in fume hoods with aspiration. After weighing, the raw material is sent for sifting with the help of vibrating sieves.
Mixing
The medicinal and excipients that make up the tablet mixture must be thoroughly mixed to evenly distribute them in the total mass. Obtaining a tablet mixture homogeneous in composition is a very important and rather complex technological operation. Due to the fact that the powders have different physical and chemical properties: dispersion, bulk density, moisture content, fluidity, etc. At this stage, paddle-type batch mixers are used, the shape of the blades can be different, but most often worm or z-shaped. Often also mixing is carried out in a granulator.
Granulation
This is the process of converting a powdered material into grains of a certain size, which is necessary to improve the flowability of the tablet mixture and prevent its delamination. Granulation can be "wet" and "dry". The first type of granulation is associated with the use of liquids - solutions of excipients; in dry granulation, wetting liquids are either not used, or they are used only at one specific stage in preparing the material for tableting.
Wet granulation consists of the following operations:
1) grinding substances into a fine powder; 2) moistening the powder with a solution of binders; 3) rubbing the resulting mass through a sieve; 4) drying and processing of the granulate.
Usually, the operations of mixing and uniform moistening of a powder mixture with various granulating solutions are combined and carried out in one mixer. Sometimes mixing and granulation operations are combined in one apparatus (high-speed mixers - granulators). Mixing is provided by vigorously forced circular mixing of the particles and pushing them against each other. The process of mixing to obtain a homogeneous mixture lasts 3-5". Then, granulating liquid is supplied to the pre-mixed powder in the mixer, and the mixture is mixed for another 3-10". After the granulation process is completed, the unloading valve is opened, and with the scraper slowly rotating, the finished product is poured out. Another design of the apparatus for combining mixing and granulating operations is a centrifugal mixer - granulator.
Compared with drying in drying cabinets, which are inefficient and in which the duration of drying reaches 20 - 24 hours, drying of granules in a fluidized (fluidized) bed is considered more promising. Its main advantages are: high intensity of the process; reduction of specific energy costs; full automation of the process.
But the pinnacle of technical excellence and the most promising is the apparatus in which the operations of mixing, granulating, drying and dusting are combined. If the wet granulation operations are carried out in separate apparatuses, the drying of the granules is followed by the dry granulation operation. After drying, the granulate is not a uniform mass and often contains lumps of sticky granules. Therefore, the granulate is re-entered into the masher. After that, the resulting dust is sifted from the granulate.
Since the granules obtained after dry granulation have a rough surface, which makes it difficult to spill them out of the hopper during tableting, and besides, the granules can stick to the matrix and punches of the tablet press, which causes, in addition to weight loss, flaws in the tablets, resorted to to the operation of "dusting" the granulate. This operation is carried out by free application of finely divided substances on the surface of the granules. Gliding and disintegrating agents are introduced into the tablet mass by dusting.