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Most often titanium dioxide is used as a clouding agent, less often aluminum hydroxide or calcium carbonate. In addition, the composition of gelatin capsule shells may include: water-absorbing agents – substances” allowing to prevent moisture retraction from the capsule shell by hygroscopic substances, which can be used when filling capsules. For this purpose, it is recommended to use polypeptides, oligosaccharides, starch and its derivatives, as well as some other substances; disintegrants – substances that contribute to maintaining a constant level of capsule disintegrability during long-term storage (since gelatin, being a product of collagen processing, has the property of “aging”), as well as achieving a rapid release of the contents of the dosage form. Amino acids, proteins, casein, croscarmellose, tweens, sodium hydrogen carbonate can be used in this capacity. To achieve rapid disintegration of capsule shells, the technology of dispersing some gases (oxygen, nitrogen, carbon monoxide, argon, etc.) into the gelatin mass can also be applied, which, among other things, allows saving the shell material. Also noteworthy is the original method of treatment of gelatin itself with amber anhydride proposed by Japanese scientists; sliding agents – substances that prevent possible sticking of capsules. Usually D-mannite, D-sorbitol, xylitol are used (relevant primarily for soft capsules sold in countries with hot climates, and when it is impossible to comply with the rules of storage of this dosage form).
Other additives may be added to the composition of gelatin capsule shells. As already noted, hard capsules are designed for dosing loose powdery, granular and microgranular substances. They have the shape of a cylinder with hemispherical ends and consist of two parts: the body (body) and the cap; which should freely enter one into the other. General information on capsules was given in section 3.4. In this section, the technology of production of hard gelatin capsules and the equipment used to produce them will be discussed. The steps in the production of hard gelatin capsules are as follows: preparation of the gelatin mass; manufacture of hard gelatin capsule shells; and filling of hard gelatin capsules.
Pharmaceutical Glossary
Technical specifications
There are two types of gelatin: acid gelatin A and alkaline gelatin B, which differ in some physical and chemical properties. Usually in the manufacture of pharmaceutical capsules use mixtures of gelatin A and B, as it allows to obtain masses for the manufacture of capsule shells with the most optimal rheological characteristics (in particular, in terms of strength, viscosity, pH, iron content, etc.). Gelatin is easily and quickly digested by the human body even with severe gastrointestinal disorders, non-toxic and has no adverse reactions. A characteristic property of gelatin (from Latin gelare – to solidify) is the ability of its solutions to gel when cooled, forming a solid gel. Production of gelatin capsules is based on this property of gelatin. To obtain a stable capsule shell, the composition of the gelatin base may include various auxiliary substances approved for use: plasticizers, film formers, stabilizers, preservatives, correcting agents, dyes and pigments. In order to improve structural and mechanical properties and to ensure appropriate elasticity, increase strength and reduce brittleness of shells, plasticizers are introduced into the composition of gelatin mass. The most popular plasticizers are glycerin, sorbitol, PEO-400, polyethylene glycol, polypropylene, polyethylene sorbitol (3-15%) with oxyethylene (4-40%), hexanthropol and others. For the manufacture of hard capsules gelatin mass should contain a small amount of plasticizers (0.3-1.0 %), for soft – their amount increases to 20-45 %.
In some cases, gelatin capsules become more stable with partial or complete replacement of glycerol in the shell with sorbitol, PEO-400 or other plasticizers.
Among the disadvantages of gelatin capsules can be noted their high sensitivity to moisture, which requires compliance with certain conditions of storage of capsules. Therefore, sometimes gelatin capsules are coated with special coatings – film formers, which reliably protect the shells from moisture, while not preventing their rapid destruction in the stomach.
Additional information
Such film formers include para-aminobenzoate sugars and cellulose amino derivatives, which improve the moisture resistance of gelatin capsules. Another way to overcome the moisture sensitivity of gelatin capsules is to use zein or other moisture-resistant film-forming agents instead of gelatin. For encapsulation of complex compositions of vitamins Japanese researchers proposed a method of obtaining “double” capsules: water-soluble vitamins are covered with a film of wax-like substances, and then a hydrophilic film of gelatin. The gelatin mass is a favorable environment for the reproduction of microorganisms. To ensure antimicrobial resistance of shells in the composition of the mass introduced preservatives: a mixture of salicylic acid (up to 0.12%) with potassium (sodium) metabisulfite (up to 0.2%), benzoic acid and sodium benzoate (0.05-0.1%), nipagin (0.1-0.5%)” To give capsules an attractive commercial appearance or protect the active substances from photochemical reactions, the composition of the gelatin mass introduced corrective auxiliary substances. Sometimes aromatizing substances (essential oils, essences, ethyl-vanillin 0.1%) are added to the gelatin base to give capsules a pleasant smell. The addition of sweet substances (sugar syrup, sucrose, glucose, etc.) improves the taste of capsules and reduces the unpleasant sensation when swallowing. Currently, all capsules (with rare exceptions) are colored to give them a more aesthetic appearance. For this purpose, coloring agents are introduced into the gelatin mass. Different coloring is also convenient for the release of different names of drugs in the form of capsules, as it allows you to distinguish products by color. As dyes can be used substances of natural origin (carminic acid, chlorophyll, beta-carotene, etc.), the low toxicity of which allows their use without restrictions in most countries, inorganic pigments (yellow, red and black iron oxide, titanium dioxide), as well as organic dyes approved for medical use. The amount of dyes in one capsule, as a rule, does not exceed 50 mcg. Capsules intended to be filled with photosensitive substances should be opaque. For this purpose, obscuring agents are used – substances that make it possible to obtain opaque capsules due to their ability to form a stable fine suspension in the gelatin mass.
Order status tracking
Today we were promised delivery of a blister machine for MN-14 tablets and capsules, remember us ? No one's called us back. 29/12/2025 22:28
Hello John, Our manager Natalya tomorrow until 12:30 will dial the driver, also we ask you yourself to the transportation company. 29/12/2025 22:31
Hello, I will quickly ask, what about BG-80 film coating boiler and HX-7 ultrasonic machine for sealing plastic tubes, contract No. 11 ???? 29/12/2025 22:38
Daniel, good afternoon! Your positions are produced by different factories, for HX-7 the factory reported that it is 90% ready, for BG-80 we are waiting for an answer tomorrow until 14:30. We will report back immediately. 29/12/2025 22:39
Dear Roman. Deadline (time) I am waiting for your quotation for a machine for removing tablets and capsules from blister packs MB-10 with delivery. 29/12/2025 22:48
Hello Alexander, By the specified time we will send the offer to your e-mail. Now we are waiting for an answer from the transportation company on the delivery time to San Antonio . 29/12/2025 22:50
PU-250 flow-pack packaging machine, please advise delivery status. 29/12/2025 22:58
Hello Benjamin, your equipment is undergoing customs clearance. Your manager Natalia will contact you tomorrow by lunchtime 29/12/2025 23:01
Good afternoon, please confirm that closer to evening we will receive our shipment in Ljubljana? Contact the transportation company. 29/12/2025 23:08
Hello Ellie ! Representatives of the transportation company on the delivery status of your shipment said that it will be in Ljubljana in a few days. Please expect it. 29/12/2025 23:10
YR-90 dry and wet powder granulator YR-90 month has already passed. Hurry up the factory. 29/12/2025 23:18
Owen, good afternoon. The factory has shipped your equipment to our representative, now is forming a consolidated shipment for shipment to customs. We will keep you informed. 29/12/2025 23:18
Dear Roman. Deadline (time) I am waiting for your quotation for a machine for removing tablets and capsules from blister packs MB-10 with delivery. 29/12/2025 23:28
Hello Jayden, By the specified time we will send the offer to your e-mail. Now we are waiting for an answer from the transportation company on the delivery time to San Jose . 29/12/2025 23:32
Please advise the delivery status of the order. Desktop ampoule sealing machine RF-01 delivery to Memphis. Thank you. 29/12/2025 23:38
Lucas, Checked delivery status , your shipment is in transit warehouse in Shanghai. Delivery to Memphis is scheduled for the day after tomorrow. Please notify us upon receipt. 29/12/2025 23:42
We received our order (BG-150 film coating boiler) in the box there was no spraying nozzle !!! 29/12/2025 23:48
Hello Matthew, we checked with the factory. Your nozzle was not received in time for the shipment of the main machine. We will now deliver it to you by DHL express mail. 29/12/2025 23:50
LW-35 automatic PVC+cardboard blister packaging machine has been on the road for 30 days. What news ? 29/12/2025 23:58
Hello Savannah, We are on time, tomorrow until 13:30 a driver will contact you about unloading. 30/12/2025 00:00
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- EQUIPMENT FOR FILLING LIQUIDS IN PLASTIC AND METAL BARRELS
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- EQUIPMENT FOR INDUCTION SEALING OF ALU FOIL BOTTLES
- AUTOMATIC EQUIPMENT FOR BLISTER PACKAGING
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- EQUIPMENT FOR VIBRATING SIEVING OF POWDERS
- EQUIPMENT FOR LABORATORY TESTING OF MEDICINES
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- SEMI-AUTOMATIC EQUIPMENT FOR BLISTER PACKAGING
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