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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
Good afternoon, we received the PR-15 powder dispenser in plastic vials, scheduled in the interval from 14:00-16:00 to open the box and test. 24/06/2026 18:34
Riley, good afternoon. Great news, please send a photo and video report to WhatsApp +79853643808. 24/06/2026 18:35
Run through the order. V-shaped mixer for powders VM-50 and Mechanical tablet press PP-28 are waiting. 24/06/2026 18:44
Bella, Checking delivery status. The shipment is already in Granada warehouse. Please arrange for pickup. 24/06/2026 18:45
Please inform me about the status of the order Rotary tablet press RZ-10A in D.C. ? 24/06/2026 18:54
Good afternoon, Scarlett. We have contacted the carrier, delivery is scheduled tomorrow until 18: 30. Please let us know when you receive it. Thank you. 24/06/2026 18:57
PU-420 flow-pack packaging machine along with 500 kg packaging , delivery to Phoenix. Please confirm the delivery time. 24/06/2026 19:04
Good afternoon Elijah, your shipment has left. Arrival time tomorrow until 13:30. The driver will call you back later. Please organize prompt unloading. 24/06/2026 19:06
When purchasing the RY-200 centrifugal type powder granulator, I asked for tests on our powder 24/06/2026 19:14
Hello Oliver, Please send 2 kg of your raw material to the address given to you by Natalia. After the test, the engineer will inform you about the results. 24/06/2026 19:15
Dear Roman, good afternoon, vacuum powder conveyors QV-05 in quantity of 4 pieces, already on their way to Cluj-Napoca ? 24/06/2026 19:24
Good afternoon, Benjamin! Our manager has sent a scan of the bill of lading to your email. The shipment is on its way. 24/06/2026 19:27
Contract #12, the deadline for delivery has already passed. Take action at last. Accelerate Tsibulsky R.G. 24/06/2026 19:34
Hello Owen, we are on vacation on weekends and are not able to respond to messages. Raise the contract, delivery time of equipment to your warehouse in Granada to 50 working ( not calendar) days. Action taken. 24/06/2026 19:36
Vacuum lyophilic freeze dryer LG-30, can we get faster than the contract ? 24/06/2026 19:44
Hello Elijah, Shipments go through several time stages. Manufacturing, delivery from the factory to the warehouse in Beijing or Shanghai, waiting for batch collection, customs clearance and delivery. It's hard to predict. 24/06/2026 19:46
PU-250 flow-pack packaging machine, please advise delivery status. 24/06/2026 19:54
Hello Zoey, your equipment is undergoing customs clearance. Your manager Natalia will contact you tomorrow until 17:30 24/06/2026 19:54
Please advise the delivery status of the order. Desktop ampoule sealing machine RF-01 delivery to Tucson. Thank you. 24/06/2026 20:04
Amelia, Checked delivery status , your shipment is in transit warehouse in Shanghai. Delivery to Tucson is scheduled for as agreed. Please notify us upon receipt. 24/06/2026 20:07
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- MANUAL EQUIPMENT FOR FILLING GELATIN CAPSULES WITH POWDER
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