ソフトジェルカプセル (sometimes called soft capsules or soft gelatin capsules) are one-piece gelatin shells filled with liquid or semi-solid medicine or nutrients. Unlike hard (two-piece) カプセル, softgels are formed and filled in one continuous process. They are widely used for dietary supplements, ビタミン, and pharmaceuticals because they are easy to swallow and can seal oils or sensitive ingredients tightly. このガイドでは, we’ll walk through exactly how softgel capsules are made, from raw ingredients to the finished pill, in a friendly, easy-to-read way.
A softgel (softgelatin capsule) is essentially a flexible gelatin shell (sometimes called a gelatin softgel capsule) that encases a liquid or semi-solid fill. You may also hear them called ソフトカプセル, especially when referring to the gelatin cover. Softgels were invented in the 1930s and have become very common in pharmaceuticals and supplements. 例えば, many fish oil or vitamin D supplements are delivered as softgel capsules.
Softgels differ from hard capsules in that two softgel ribbons are sealed together around the fill in one go, creating a watertight seal. 対照的に, a hard capsule has a separate cap and body that are filled with dry powder and then closed. This continuous encapsulation process lets softgels hold oils and liquids without leaking. According to industry sources, softgel manufacturing “involves meticulous attention to detail and a deep understanding of the materials and processes.” It’s a precise, multi-step procedure that requires specialized equipment.
Softgel production starts with selecting the right materials for both the shell and the fill.
要約すれば, a softgel (soft gelatin) capsule is made from gelatin, glycerin, water, and optional colors in the shell, with a carefully prepared liquid or semi-solid fill inside. All raw materials must meet strict quality standards.
The softgel manufacturing process has several key steps. Below is a simplified, friendly overview of each major step, from shell to finished capsule.
A large stainless-steel melter (mixing tank) heats and mixes the shell ingredients. 初め, water and glycerin are heated to about 70–80 °C. Then gelatin powder is slowly added while stirring. This can be done by a hot melt or cold melt process, but in both cases a vacuum is applied to pull out air bubbles. After mixing, the molten gelatin syrup is very viscous and should be clear of any clumps. Operators often check viscosity in a simple way (例えば, dipping a finger and seeing if the gel “strings” about 4–5 inches). Once mixed, the gelatin mass is transferred to a heated receiver tank to “season” for several hours (頻繁 3 に 24+ 時間). This holding period at around 65–70 °C lets trapped air escape and ensures a uniform, stable temperature. この時点で, a color solution (if used) may be added through a fine filter to evenly tint the mass. After seasoning, the gelatin shell mixture is ready to form the capsule walls.
Key equipment: stainless-steel melter with agitator and vacuum pump, heaters, and insulated holding tanks.
While the shell is being prepared, the fill material is also made in parallel. In dedicated mixing tanks (often stainless steel), all active ingredients, 油, and solvents are blended. Powders (like vitamins or APIs) are milled and sieved to avoid large particles. Liquids and liquids/solids are mixed using high-shear mixers, homogenizers, or magnetic agitators to achieve a uniform suspension or solution. During mixing, care is taken to avoid trapping air (using slow, smooth stirring or even vacuum). Some sensitive oils (like fish oils) may be blanketed with nitrogen gas to prevent oxidation during processing. The goal is a smooth, lump-free fill. Once complete, the final fill mixture is pumped into the encapsulation machine’s hopper.
Key equipment: stainless steel fill tanks (with lids/valves), high-shear mixers, mills/colloid mills, transfer pumps, and filtering screens.
Now comes the heart of the process. A rotary die softgel machine simultaneously forms, 埋める, and seals capsules in one continuous motion. Here’s what happens inside the machine:
In simpler terms, the machine works like this: Two gelatin ribbons come together, liquid is pumped in between, and rotating dies seal and cut out individual softgel capsules all in one step. Because it’s all one continuous operation, softgel production is very efficient and produces uniform capsules.
Key equipment: rotary die encapsulator with casting drums, spreader boxes, injection wedge, rotary dies, lubrication system, cooling fans, and control panel. (Major manufacturers include Technophar, がある, Jinlupacking, 等, and they all use this basic rotary die method.)
The freshly made softgel capsules are still warm and soft, with high moisture (often 30–40% water in the shell). They must be dried and hardened. This is typically done in two stages:
After drying, the capsules are solid, glossy, and no longer tacky. They often receive a light polishing or coating (with edible oils or beeswax) to give a shiny finish and prevent sticking. Any slug or scrap capsules are removed (例えば, via a sieve or destoner).
Key equipment: tumble dryer, drying tunnel or cabinet, cooling trays, and finishing machines. (Dryers often have humidistat control – industry sources suggest drying chambers may be kept at ~20–25% RH during capsule drying.)
Common production issues (like air trapped in fill or uneven capsules) are addressed by adjusting mixing or machine settings. 一般的に, strict controls during mixing and encapsulation (例えば, milling powders fine and degassing liquids) help avoid problems like leaks or non-uniform fills.
注記: Softgel lines require a clean, climate-controlled environment. Manufacturing rooms are usually kept around 20–22 °C and 25–30% humidity to keep the gelatin flexible. Drying rooms are drier (often ~20% RH) to cure the capsules.
要約すれば, making soft gelatin capsules is a careful, multi-step process. You mix a gelatin/plasticizer solution, prepare a uniform fill, then feed both into a specialized encapsulation machine. That machine casts gelatin ribbons, injects the liquid fill, seals and cuts each capsule, and produces softgels at high speed. The new capsules are then dried to the correct moisture level and inspected.
By following each step precisely and using the right equipment, manufacturers produce high-quality softgels that meet pharma standards. With this knowledge, you (or your production team) can better understand softgel lines, troubleshoot any issues, and ensure your softgel capsules come out consistent and effective every time.
If you’re interested in exploring softgel capsule manufacturing — whether you want to discuss production capacity, machine customization, or get a detailed equipment quote — we’re here to help. Contact us today to request a free quote or learn more about our softgel encapsulation machines.
ソフトジェルカプセル (also called soft gelatin capsules or simply soft capsules) are one-piece gelatin shells filled with oils or semi-solid solutions. They’ve become a staple in pharmaceuticals and supplements because they’re easy to swallow and improve bioavailability.
The shell of a softgel capsule typically includes gelatin (from animal collagen) または, in some cases, plant-derived/non-gelatin alternatives. 加えて, 可塑剤 (like glycerin or sorbitol), water, and often additives such as colorants, opacifiers (例えば. titanium dioxide), 防腐剤, and sometimes flavorings or sweeteners (for chewable softgels) are used.
Typically the shell is made from gelatin (animal-derived) mixed with a plasticizer (like glycerin or sorbitol) and purified water, to achieve the right flexibility and viscosity. Some formulations may also include colorants, opacifiers, preservatives or other additives depending on requirements.
はい. Although traditional softgel capsules rely on gelatin, there are non-gelatin alternatives (例えば. plant-derived polymers or cellulose-based) for manufacturers targeting vegan/vegetarian or other special requirements.
Fillings are usually liquid or semi-liquid: common are oils (例えば. vitamin oils, MCT oil, plant oils), emulsions, or suspensions (finely milled powders dispersed in liquid). These formulations must be compatible with the shell — for example, viscosity must allow smooth injection, and the fill should not react negatively with gelatin or plasticizers.
The most common method is the “rotary-die process”. The process consists of: preparing gelatin shell mass; preparing the fill material; forming two continuous gelatin ribbons; injecting the fill between ribbons; sealing and cutting the capsules via rotating dies; followed by drying, 検査, polishing and packaging.
Because the gelatin shell and process depend heavily on moisture and temperature: during ribbon formation, 封印, and especially drying — improper humidity or temperature can cause poor ribbon quality, weak seals, 変形, こだわり, or other defects. A well-controlled environment ensures consistent ribbon formation, 適切なシール, and a stable final capsule.
Common defects include leaking or broken capsules, discoloration or cloudiness, abnormal shape/size, presence of air pockets/voids, or residual shell fragments. Causes can be poor raw material (gelatin quality), incompatible fill materials, incorrect ribbon thickness, improper sealing, humidity/temperature issues, or poor machine maintenance/calibration.
Essential equipment includes: gelatin melting/preparation tanks, filling material mixing tanks (with filtration), a rotary-die encapsulation machine (with spreader boxes, drums for ribbons, die rollers, injection wedge, 潤滑), tumble dryers or drying tunnels/trays, inspection/sorting equipment, and polishing/packaging machines.
After encapsulation, softgels are soft and moisture-rich. 乾燥 (via tumble drying + controlled drying tunnels/trays) typically takes from 24 に 72 時間, depending on capsule size, shell formulation, and environmental conditions. Proper drying ensures shell stability, prevents sticking or deformation, and helps reach final desired moisture content.
You should verify raw-material quality (gelatin or alternative shell) and fill-material compatibility, ensure the manufacturer uses validated rotary-die machines and proper environmental (temperature/humidity) コントロール, inspect their quality-control procedures (seal integrity, fill uniformity, defect removal), and confirm they follow good manufacturing practices (GMP) or relevant standards. Also check for flexibility in shell/fill customization (サイズ, 形, color, fill type) if needed.
参考文献：
1.ソフトジェル — Wikipedia
2.The manufacturing process of softgel capsules — Softcaps.science
3. IJCRT (International Journal / Creative Research Thoughts) — “Manufacturing of soft gelatin capsules” (IJCRT2306100)
4.PharmaTutor — “ソフトゼラチンカプセル (ソフトジェル)”
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