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, a suspension or a semisolid; referred to as a fill. The soft gel shell is usually comprised of a film-forming material such as gelatin, and a water-dispersible or watersoluble plasticizer (to impart flexibility). The soft gel shell could also include minor additives such as coloring agents, flavors, sweeteners, opacifying agent, medicaments, acid and preservatives. Soft gel capsules can also be enteric coated for certain applications. Soft gelatin capsules or also known as soft gels are becoming a popular dosage form for the administration of liquids, suspensions, pastes, and dry powders in the dietary supplement industry. Softgels can be an effective delivery system for oral drugs, especially poorly soluble drugs. This is because the fill can contain liquid ingredients that help increase solubility or permeability of the drug across the membranes in the body. Liquid ingredients are difficult to include in any other solid dosage form such as a tablet. Here are the complete review of advantage and disadvantage of soft gelatin capsule The advantages of soft gelatin capsule :
• • • • • •
Soft gels are easy to swallow, once swallowed, release their contents very quickly. have the ability to mask odors and unpleasant tastes have an elegant appearance readily dissolve in the gastric juices of the digestive tract they may enhance the bioavailability of the active ingredient In specialized dosage form, soft gel can be made into chewable, extended release, captabs, etc. It can also be used for ophthalmic preparations, e.g. aplicaps, vaginal/rectal suppositories. Dosage Accuracy. Uniformity and precision dosage Product Security. Dosage and formulation are tamper-resistant (a punctured or tampered softgels will leak or become discoloured). Protection against counterfeit Product Stability. Sealed container, Protection from light for photosensitive formulations, Protects drug from oxidation and degradation
Soft gel also had some disadvantages point :
water soluble material are difficult to incorporate Highly moisture sensitive. Gelatin is extremely water soluble, which helps it dissolve in the body. The downside is that soft gelatin capsules are very sensitive to heat and humidity. In hot or humid climates, soft gel caps may stick together or even break open before you have a chance to use them. Keeping your soft capsules in the bathroom may also decrease their life expectancy, since showers create a hot, humid climate that may not dissipate quickly. Efflorescent material can not be incorporated, they may cause softening/leaching
They may cause hardening or brittle capsule. stainless-steel mixing tanks 2. the only purchases other than the machinery would be the gelatin itself.• • • Deliquescent materials cannot be incorporated. Kathabar system for drying dehumidification 6. but they are generally more expensive and harder to find. In most cases. and evacuation for the removal of air in multivitamin products 3. the manufacturer can then very easily convert to a two. This cost can increase the price the consumer pays. standard polishing pan or a converted Pelligrini machine for the removal of the mineral oil residue that remains on the sof tgel 9. Gelatin is traditionally made out of the bones and skins of pigs and cows. This would be efficient for a one. Soft gel caps violate the religious dietary restrictions of observant Jews. Dietary Restrictions. Once the equipment is purchased for a one-machine operation. Muslims. about four tanks approximately 600 to 800 kilos each 5. inspection tables 8. come in liquid and soft gel cap form. many vegetarians also opt not to use them. Many groups.and under-fills prior to packaging.to nine-inch encapsulation machine is approximately 87. Because soft capsules are made out of animal parts. EQUIPMENT AND FACILITIES A company would have a minimum of 24. There are animal-free substitute gelatin capsules made out of seaweed extract or other sources. Many pharmaceutical companies do not have the equipment necessary to fill soft gelatin capsules and have to transport the drugs to have them processed. a cold-milling operation. such as cod liver oil. ingredient-fill holding tanks.600 soft gels per hour. however.or two-encapsulation machine operation.000-square feet of space to house the soft gel manufacturing operation. a sizing unit for the removal of any slugs and gel particles and for the removal of any over. . stainless-steel gelatin heating tanks. Buddhists and Hindus. adding to the cost. Following this. Most manufacturers run the machines an average of 21 to 22 hours daily for such products such as vitamin E and fish oils. trays for spreading the soft gels 7. The typical output of an eight. about three tanks 4.or three-machine operation. More Costly. Certain health supplements. Used for particle reducing. Equipment needs to produce soft gelatin capsule include: 1. the price is greater for the soft capsules than for the liquid. have dietary proscriptions that prevent them from consuming animal products found in soft gelatin capsules.
Drying 5. For instance the gelatin recipe may need to be adjusted to account for acidity. the mixture is placed into a reactor called as gelatin melter. The proportions of each ingredient involved in the mixture should be considered carefully because the shell material needs to be adapted to formulation and/or environmental requirements. Other plasticizers can also be used either alone or in combination with glycerine. Polishing 7. Gelatin Preparation 2. Inspection 6. MANUFACTURING PROCESS Manufacturing process of soft gelatin process divided into some steps. there are: 1. Glycerine acts as a plasticizer in the gelatine compound. Encapsulation 4. Packaging Gelatin Preparation Raw granular gelatin is mixed with glycerine and water. water content of the fill material or high humidity environmental conditions. At this stage. If a company is running machinery under strict cGMP guidelines to produce OTC products. Gelatin Melting Tank After the ingredients are combined. . Coloring agent can also be added at this stage. The reactor surrounded by a thermal jacket heats the mixture while a very high torque tribune mixer stirs it under vacuum. Material (Fill) Preparation 3. approximately 20% of gelatin mixture consists of water. the machinery needs to be shut down for taking full sets of weights and verifying adjustments of ribbons for correct thickness.Downtime includes changing gelatin and changing fill materials. such as sorbitol.
It is really important to keep the liquid gelatin warm before or during the encapsulation process.. homogenizer and variety of mills is use. sweeteners and fragrances are commonly used to make chewable softgels or to mask the unpleasant taste and odor of the fill material such as fish oils. 2. If the mixture is not thin enough. viscosity of the mixture.Heated Tank This process takes around 3 hours until the gelatin turns into a molten liquid mass. In order to allow homogeneous mixture. Pastes are oils or polyethylene glycols added with powders. Two important factors that affect the homogeneity and flow of the paste should be considered: 1. Because the only way to keep the gelatin mixture as liquid is to keep it warm otherwise it will solidify like jelly. The oils are mixed. particular size of powder. Various equipment should be available. vitamin E. high-shear mixer. These can go into fill or gelatin material. As soon as the liquid gelatin mass is ready for encapsulation process.e. it requires 2 shift operational time. At least. Oil mixtures are very easy to formulate. It is really important to plan and schedule the gelatin production in terms of time and quantity. Material (Fill) Preparation A homogeneous fill material plays a vital role to ensure the uniformity of each Softgel dose. fish oils). There are two types of fill materials: oil mixtures or pastes. it will not flow correctly through the machine injections. . powder particles must not be thicker than 80 mesh. such as processing tanks. deposited into a ground material tank and moved into the hopper of the encapsulation machine (i. Natural or artificial flavours. it is transferred to ground heated tanks which are wheeled into the clean room where the main encapsulation machine is.
dry air congeals the gelatin as the drum rotates so that a tacky. Thus. Simultaneously. the soft. and dropped into a tray. vitamins or other products. The process is basically performed as described. moist capsules are transferred to drying drums or chambers for rapid drying. sealed. From the capsulating machines. filled with medicine. This thin band is then automatically formed into capsules. The revolving stainless steel drum is about 24” in diameter and exposed to 400 CFM of 57-59°F air at 20% RH. The left and right ribbons pass over rollers which feed them through two die rolls. Too high of an air velocity will disturb the consistent thickness of the gelatin ribbon being formed. The gelatin shell and fill material are brought together simultaneously in the encapsulation machine. The extent of moisture to be removed . It takes place in a closed environment called clean room where the relative humidity is around 20%. or the air velocity is too low. This wedge injects the fill material into the die cavities between ribbons just right before the die rolls cut the ribbons and seal the two halves together. The cool. the gelatin will set too rapidly and become brittle which can cause the manufacturing process to grind to a halt. a sensitive and high accuracy positive displacement pump delivers the fill material into a heated wedge which sits between rotary dies. These die rolls determine the shape and size of softgels and cut the Softgel shell from the ribbons as they turn around. a pump delivers the warm gelatin over two chilled drums which are located at both opposite sides of the machine.Encapsulation Encapsulation is the manufacturing process that brings the gelatin shell and the fill material together to form Softgel capsules. The warm liquid gelatin flows over the drums and this transforms the liquid gelatin into two solid ribbons of gel. elastic band rolls off of the other end. through a spreader box that sits over each drum. If the air blowing against the drum has too low a temperature. the gelatin will not solidify into a ribbon. If the air temperature and humidity are too high. the need for constant control of the air being introduced to the drum is critical in the process.
By using a fully automatic Softgel drying machine. This amount of water content is needed to keep the gel flexible enough to form the capsules. they contain around 20 percent water. this long drying process time can be reduced to a few hours which enables you to save time and money. This process divided into two stages : Fluid Bed Tumble Drier for Softgel 1. This equipment tumbles the softgels around 30 to 40 minutes and removes approximately 25 percent of the water content in the softgel capsules. First stage : performed by a tumble dryer consists of sections. This process is called natural manual drying.during drying depends upon the size of the capsule. 2. Soft Gelatin Capsule Drying Machine . After the softgels are formed through the die rolls. Drying process requires an environment with low relative humidity in the air but not hot air. and the period of time over which this moisture can be removed. Drying Drying process purpose is to decrease the moister content to create a hard and durable finished softgel capsules ready for packaging. the number of capsules. Second stage : softgel capsules are spread on stackable trays and transferred to the drying room or tunnel where high air flow exists and they stay around 24 to 48 hours or until the softgels become hard enough.
Inspection. On the other hand desiccant type dehumidifiers combined with refrigeration can offer a simple and economical solution to controlling both temperature and humidity levels as low as necessary Bry-Air desiccant dehumidifiers have been utilized in many capsulating and soft gel manufacturing applications all over the world resulting in millions of dollars saved annually. operate and maintain. damaged and/or not fully filled capsules are removed manually by using an inspection table. impractical and cumbersome to design. broken etc. Any misshaped. Manual inspection will be time consuming process which leads to accuracy problems. Manual inspection process can be preferred if you have small batch size production but if you intend to manufacture softgel capsules in mass quantities. Finished product testing: • • • • • Capsule appearance Active ingredient assay & related substances assay Fill weight Content uniformity Microbiological testing/ Polishing The final step before packaging is to clean and polish the Softgel capsules to remove any mineral oil or glycerine that the capsules may have on their exterior skin. refrigeration equipment alone becomes uneconomical. fully automatic softgel sorting machine equipped with electronic sensors can be used to sort and remove the damaged. In Process Control and Finished Product Testing Due to air pockets in the gelatin and fill material and district production tolerances. In-process testing During the encapsulation process the four most important test are : • • • • the gel ribbon thickness soft gel seal thickness at the time of encapsulation fill matrix weight & capsule shell weight soft gel shell moisture level and soft gel hardness at the end of the drying stage. Tumbling is the most used production method to clean the Softgel capsules among others such as . In order to reduce process time and increase the accuracy. misshaped.Typically the environment to be maintained for effective and rapid drying corresponds to a dew point of 25° F or an absolute humidity level of 20 grains per pound of air. The following are typical design conditions: Temperature Humidity 78°F 15% RH 68°F 20% RH In order to achieve the controlled air requirement listed above. gelatin capsules. Two to three percent is an acceptable reject rate. the Softgel capsules may vary in size and need to be inspected visually.
eters. Pudin hara) Vegetable oils like arachis oil or aromatic or aliphatic hydrocarbons. yellow beeswax (as a suspension and thickening agent). Powdered extracts are usually combined with soybean oil (as a carrier). But. and lecithin (as a lubricant) for formulation in soft gels. solids that are not sufficiently soluble in liquids are capsulated as suspensions. . Capsulation of liquids that are immiscible with water and non-volatile. Capsule content: • • • • • • May be liquid or a combination of miscible liquids Solution of a solid in a liquid or a suspension of a solid in a liquid It can be a liquid like a volatile oil composition (e. Yellow wax. and polyethylene glycols in a non-oil-base. Such materials should have a particle size of 80 mesh or finer. Capsulation of suspensions is the most common form for a large group of dietary products. The most widely used suspending agent for oil-based formulation is wax (e. The relative amounts of the extract and the other ingredients depend upon the desired extract dose to be administered.washing with solvent.g beeswax). Soybean oil. such as vegetable oils and vitamin E. Thus aqueous solutions would not be appropriate. are easy and require little or no formulation. Some Limitations in Formulating Soft Gelatin Capsule Filling of soft gel capsules with liquid and semi-solid materials is possible if the "fillings" selected do not dissolve the gelatin. Packaging There is no difference between packaging softgels and traditional tablets or hard capsules.g. Suspension formulation requires a suspending agent to prevent the settling of the solids and to maintain homogeneity throughout capsulation. Solid that are not Sufficiently soluble in liquids or in combination of liquids are capsulated as suspension Suspending agents used are Lecithin. FORMULATION OF CAPSULE FILL The formulation of capsule fill can be developed to fulfill the specifications and end-use requirements of the product. substances in which gelatin is not soluble are suitable. Any finished Softgel product should be stored in an environment with temperature around 20-24 oC and relative humidity 35%. or alcohols. However. ethers.
may be added to produce an opaque shell. Chelating agents.The following types of compounds may not be suitable candidates for soft gel encapsulation: • • • • liquids that can easily migrate through the gelatin shell. Plasticizer usually used : Glycerin and sorbitol. The ratio by weight of water to dry gelatin can vary depending from 0. Ration used is between 0. Opacifier. Color may be natural or synthetic. Gelatin .3. adjusted to become neutral.5%. acids and alkalis can cause hydrolysis and leakage of the gelatin shell water-soluble solid compounds that may affect the gelatin shell unless they are minor constituents of a formula or combined with a carrier that reduces their effect on the shell.1. Coloring Agent. unless they are pictures on a blackboard. Usually used is titanium dioxide. which have the ability to harden the shell and hence affect its dissolution property acidic or alkaline solutions should be avoided.7-1. Additionally chelating agent may be used for preventing the reaction of iron with materials or colors. such as water (more than 5 percent of the fill).8 for soft to hard shell on dry basis. FORMULATION OF CAPSULE SHELL Capsule shell composition: • • • • • • Water : 45% w/w.3 (water) to 1. Iron is always present in raw gelatin & should not contain iron more than 15 ppm. Colour used in shell has to be darker than color of encapsulating material. when the fill formulation is a suspension or to prevent photo degradation of light sensitive fill ingredients.0 (dry gelatin) depending on the viscosity of the gelatin being used. Used to make the soft gel shell elastic & pliable. and hygroscopic and volatile compounds aldehydes. Concentration of oacifier may be up to 0. Plasticizer.
up to five to 10 times its weight. glutamic acid. alanine. which is found in the skin and bones of animals such as deep-water fish. and forms a gel upon cooling. colorless. and water (8-15 percent). which is derived from seaweed and grows off the coast of Ireland.512 0. or used individually. proline. Gelatin swells and absorbs roomtemperature water. Typical Formula of Soft Gelatin Capsule Shell for 1 batch = 120 L Ingredients/Materials Glycerin Propylmethyl Paraben Methyl Parabe Gelatin 120 Bloom Briliant Blue Ponceau Sunset Yellow Titanium Dioxide Water Sorbitol Liquid Amount (kg) 52 0. arginine. bovine or porcine. Gelatin contains a mixture of water-soluble proteins (84-90 percent). diluted acids and alkalis.128 152 0. There are two types of gelatins: 1. Gelatin is odorless. Gelatin used in soft gels is a blend of both types. These proteins contain a significant amount of the amino acids: glycine. lysine. in addition to other amino acids in smaller amounts. hydroxyproline. is available but is costlier than the animal-sourced gelatins. but soluble in glycerin. The brand name called Vegicap soft capsule. There are non-animal based forms of gelatin to meet the needs of those wishing alternatives to meat products for vegetarian. ethical or religious reasons. and insoluble in most organic solvents. type B : derived from bones and animal skin by hydrolysis with an alkaline solution. The main source of gelatin is collagen. mineral salts (1-2 percent). tasteless. type A : derived from pork skin by hydrolysis with an acid 2. Most of the soft gel capsules on the market are made from an animal source.3 0.3 16 120 L 16 Plasticizer Preservative Preservative Function Basis of gelatin Coloring agent Coloring agent Opacifier Solvent Plasticizer . It dissolves in hot water. aspartic acid. A vegetarian gelatin made from Irish moss.Soft Capsule’s Gelatin Gelatin is derived mostly from collagen by thermal denaturing with the aid of diluted acid or alkali.
3. decanted into 200 kg mobile vessels.vinensia. This mass is kept at a constant temperature until it is needed for the next stage of the process http://formulation. 2. then heat and stir it. After the molten gelatin mass is formed. It ensure consistency of gelatin mass 5.com/2011/06/soft-gelatin-capsule-shell-composition. 4. Mix the molten gelatin mass using turbine mixer then add color and flavors agent.html . Gelatin Powder is mixed with water and glycerin.Preparation of Soft Gelation Capsule Solution: The gel is prepared in a 100 liter stainless steel vessel: 1.
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