Overall, the tablet is a substance composed of two types, one is to play the role of drug therapy (ie primary drug), the other is not a number of physiologically active substances, and their role include: filling action, adhesion, lubrication and disintegration, sometimes, also play a role in coloring, flavoring and aesthetic effect of the role, in pharmaceutics, these materials are typically referred to as excipients (or excipients & Adjuvants). According to them the role of different, often the materials into four categories.
The main role of the diluent (or filler, Fil1ers) is used to fill the volume or weight of the tablet, thereby facilitating tabletting; commonly used fillers are starch, sugars, celluloses, and inorganic salts; determined by the tabletting process, preparation equipment and other factors, the tablet diameter generally not be less than 6mm, weighing more than 100mg or more, if the tablet is the main drug only a few milligrams or tens of milligrams, without the addition of a suitable filler , will not be made into tablets, therefore, diluents here played more important, to help increase the volume of its shaping role.
More commonly used corn starch, it is very stable, and most drugs do not work, the price is relatively cheap, moisture absorption, good appearance and color, in the actual production, often with better compressibility of powdered sugar, dextrin mixed use, because the starch compressibility is poor, if used alone, it will press out the tablet is too loose.
2, powdered sugar
Powdered sugar means crystalline sugar after low-temperature drying and crushing of a white powder, the advantage of strong adhesion, can be used to increase the hardness of the tablet, and the tablet surface is smooth and beautiful, the drawback is that hygroscopic long-term storage, make the tablet hardness is too large, difficult to disintegration or dissolution, except for buccal tablets or soluble tablets, it is generally not used alone, often with dextrin, starch used in conjunction.
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Dextrin starch hydrolyzate is a generic term of intermediate products, and its chemical formula (C6H10O5) n • XH2O, which was about 80% soluble in cold water to dissolve slowly, easily soluble in water, soluble in ethanol. Traditionally known as a high paste (high viscosity dextrin), which has strong adhesion, improper use will make one-sided pitting, watermarks or cause slow tablet disintegration or dissolution; Similarly, the content of If the determination is not sufficiently pulverized extraction will affect the measurement accuracy and reproducibility of the results, so rarely used alone as a filler dextrin heavy use, often associated with powdered sugar, starch used in conjunction.
Lactose is an excellent tablet fillers from bovine whey is extracted in the system, is widely used in foreign countries, but more expensive, not much use in the country. Common crystalline lactose containing a molecule of water (ie α- lactose hydrous), non-hygroscopic, compressible good, stable, and most drugs can not afford chemical reaction, pressed into pills bright and clean; the spray-drying method were lactose amorphous lactose, flowability, good compressibility, powder for direct compression to use.
5, compressible starch
Also known as pre-gelatinized starch (Pregelatinized starch), is a new pharmaceutical excipients, Britain, the United States, Japan and China have switched Pharmacopoeia reproduces, the successful development of our country in 1988, a lot has been supplied to the market. Domestic compressible starch is partially pregelatinized products (whole pre-gelatinized starch, also known as α- starch), with foreign Colorcon’s Starch RX1500 fairly. This product is a multi-functional materials, can be used as a filler, has good flowability, compressibility, self-lubricating and dry adhesion and a better disintegration. If used for direct tableting powder, magnesium stearate amount should not exceed 0.5%, in order to avoid softening effect.
6, microcrystalline cellulose
Microcrystalline cellulose (Microcrystalline cellulose, MCC) is obtained by partial hydrolysis of cellulose and the degree of polymerization of smaller crystalline cellulose, has good pressure, there is a strong binding force, a more compressed into tablets great hardness, as a powder directly compressible “dry adhesive” use. Foreign products under the trade name Avicel, and according to the size of about a number of different specifications. Domestic microcrystalline cellulose has been widely used in China, but the quality needs to be improved, the product range also need to be rich. Further, when the tablets containing microcrystalline cellulose disintegrant is preferably 20%.
7, inorganic salts
Mainly because some inorganic calcium salts such as calcium sulfate, calcium carbonate, calcium hydrogen phosphate and pharmaceutically acceptable (by the legal settlement was also called precipitated calcium carbonate) and the like. Wherein the calcium sulfate is more commonly used, the nature of its stable, odorless and tasteless, water-soluble, and can be compatible with a variety of drugs, tablets made of smooth appearance, hardness, disintegration are good, no adsorption of the drug. Use of calcium sulfate dihydrate in the tablet excipients often. It should be noted calcium sulphate on some major drugs (tetracyclines) absorption interference, this time should not be used.
Mannitol in granular or powder form, dissolved in the mouth absorbs heat, so there is a sense of cool, while both a certain sweetness in the mouth no gravel sense, it is more suitable for the preparation of a chewable tablet, but the price is a little expensive, often associated with sucrose With the use of.
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