Softgel VS Hard Gelatin Capsule
Capsules are the most popular form of oral medication due to their ease of swallowing. Over the years, many alterations have been made in the manufacturing process and form of capsules.
Gelatin capsules are manufactured by pharmaceutical industry more as production of these capsules is less expensive than their vegetarian counterparts.
Gelatin capsules are of two types that are softgel and hard gelatin. You have been reading about different types of capsules, but do you know about the difference between both these types of capsules?
Let’s have a look at the major differences between hard gelatin and softgel capsules!
1.What is softgel and hard gelatin capsule?
Softgel capsules or softgel: are single-piece capsules, hermetically sealed. These are soft and elastic and natural, resistant to leakage or breakage. Softgel capsules are commonly filled with oils, vitamin E, facial serums, etc. The softgel capsule also has enough capability to dissolve in the stomach within a few minutes after oral administration.
Hard Gelatin Capsule: is composed of a hard shell- body and a cap. This hard-shell firmly binds and locks the filling material. The dosage form, which is normally filled in hard gelatin capsules are powders, that can easily be dissolved when reach in the stomach.
2.What are the advantages of softgel and hard gelatin capsules?
The basic advantages of softgel capsules and hard gelatin capsules are as followed:
Softgel Capsules
The main advantages of soft gel capsules are:
Easy Dissolution
Softgel capsules are ingested without any difficulty. These capsules are absorbed within minutes of their disintegration.
Airtight Sealing
Softgel capsules are hermetically and fully sealed. They are airtight and tamper-proof which makes them resistant to light and oxidizing environments.
Bioavailability
Softgel capsules are very useful in increasing the bioavailability of nutrients and materials which are otherwise are difficult to absorb.
Safety and Dosage
Softgel capsules are used for the delivery of precise dosage, they can deliver an extremely small amount of dosage with high accuracy.
Dusting
The manufacturing process of these capsules does not produce much drug dust.
Hard Gelatin Capsules
Some of the advantages of hard gelatin capsules are given below:
Easy Manufacturing
These hard gel capsules are very easy to fabricate. The filling of hard gel capsules does not necessitate large amount of money and time. Also, this manufacturing operation does not need a lot of labor.
Shelf Life
Hard gel capsules have a large shelf life in comparison with other capsules that are available in the market. Hard gel capsules are easily placed in the humidity control environment for a longer time without needing a complicated maintenance process.
Multiple Filling
Hard gelatin capsules can have multiple fillings of many materials such as beads, granules, powders, and semi-solids in a single capsule.
Flexibility of Formulation
Hard gelatin capsules can be effortlessly formulated as there is no need to compress the powder in order to fill the capsules, unlike the tablets.
Suited for Clinical Trials
Hard gelatin capsules are the best capsules for clinical trials as they are used to compare bioequivalence of various tablets, which can be placed inside the hard gel capsule.
3.Can you tell about raw material from which softgel and hard gelatin capsules made of?
Softgel Capsules
Softgel are made as single capsules which sealed hermetically. Softgel are also called soft elastic or soluble elastic capsules as they are made up of plasticizers. The shell of softgel capsules is made up of gelatin, plasticizer, water, and opacifier.
This plasticizer is either glycerol or sorbitol. The plasticizer imparts elasticity to the softgel capsules. These capsules are also composed of preservatives and coloring agents. The ratio of gelatin and plasticizer in softgel capsules is 1:0:8.
Different kinds of flavoring agents like vanillin, essential oils, and sugars are also used to manufacture softgel capsules. These flavoring agents hide the unpleasant taste of the drugs.
Hard Gelatin Capsules
Hard gel capsules are formed of two parts (cap and body) which are interlocked. The hard gel capsules are formed of gelatin, sugar, and water. These capsules can also have coloring agents, but the addition of these agents is optional.
These capsules also contain titanium oxide and plasticizer. The ratio between gelatin and plasticizer is about 1:0:4.
Glycerin is also added in hard gel capsules to decrease the hardness of gelatin.
4.What kind of fill materials are encapsulated in softgel and hard gel capsules?
Softgel Capsules
Fill materials inside softgel capsules are solutions or suspensions made up of oil-based material. These solutions are not of water as it dissolves the gelatin. Softgel capsules are usually composed of liquids or semi-solids.
The fill materials in softgel capsules are classified into three categories.
I) Oily Solutions
These are the oily mixture formed completely by oily ingredients.
II) Solutions Fill
These are the solution of active ingredients which are dissolved in appropriate solvents like soyabean oil and polyethylene glycols.
III) Suspension Fill
These types of filling material are suspensions of active ingredients that are dispersed in the carrier liquid.
Hard Gelatin Capsules
Hard gelatin capsules can either fill excipients of liquid state or of solid-state.
Liquid state excipients include:
- Lipophilic Liquids (oils, esters)
- Semi-solid liquids (hydrogenated oils)
- Emulsifiers
Hard gelatin capsules encapsulate dry ingredients which can be
- Beads
- Powder
- Pellets
- Granules
- Tablets
5.What are the various shapes and appearances of softgel and hard gelatin capsules?
Softgel Capsules
Softgel are more attractive in their appearance. They have variety of colors like yellow, blue, red, green, etc. They also have different unique shapes such as
Round
This shape of softgel capsules is like a circle. Mostly, softgel capsules are available in this form. These capsules are used as a nutritional supplement.
Oval
The oval-shaped softgel capsules have a shape like that of an egg. These are utilized as vitamin E, D, and biotin supplements.
Oblong
These capsules are like an eclipse with rectangular ends. These capsules encapsulate different oils like coconut, fish, and DHA oil that are used as nutritional supplements.
Tube
These softgel capsules are oblong with one end pointed. These tube softgel are used for tropical paste encapsulation.
Suppository
Suppository drugs are shaped like a bullet. These suppository softgel are used for rectal, vaginal, and urethral administration of drugs.
Fish or Twisted-off
These capsules are twisted off to apply tropical drugs or for oral drugs. They have different shapes like fish or teardrop shapes.
Special Shapes
These capsules have appealing shapes like of different animals and fruits. These softgel capsules are very popular in the cosmetic industry.
Hard Gelatin Capsules
Hardgel is mostly transparent or colorless. They can have one color or can be of two colors. These capsules are also half transparent and half colored. They have a rigid and cylindrical shape.
6.What do you know about the stability and moisture content of softgel and hard gelatin capsules?
Softgel Capsules
Softgel are unstable but can be kept at room temperature. These capsules do not disintegrate upon contacting oxidative conditions. These capsules are able to withstand direct light.
As these capsules have a high amount of plasticizer so they are unable to endure humid and warm conditions. These capsules contain 5 to 14% water content.
The shell of softgel contains more water than hard gelatin capsules, so they are not suitable for water-sensitive drugs.
Hard Gelatin Capsules
Hard gel capsules are more vigorous and stable than softgel capsules. These capsules have low permeability to the oxygen. These capsules are able to resist high temperature and humidity.
These capsules have more moisture content than softgel capsules which is around 12% to 15%.
7.What are the differences in sizes of softgel and hard gelatin capsules?
Softgel Capsules
Softgel capsules come in various shapes. Every shape has different sizes. Sizes of various shapes along with the volume of fill material are as follows:
Round Shape Softgel Capsules
The round shape comes in different sizes which are 1, 2, 3, 4, 5, 6, 7, 9, 15, 20, 28, 80, and 90. The volume enclosed inside them is 0.75 minims to 83.4 minims (0.046-4.95 cc),
Oval Shape Softgel Capsules
Oval softgel capsules have many sizes like 1, 2, 3, 4, 5, 6, 7, 7.5, 8, 8.5, 10, 11, 12, 13, 14, 16, 18, 20, 22, 24, 30, 40, 60, 65, and, 80. The volume of fill material in these capsules is about 1.5 minims to 65 minims (0.05-4.4 cc).
Tube Shape Softgel Capsules
Tube shape capsules have range of sizes from 5 to 120. These sizes are 5, 6, 8, 10, 17.5, 20, 30, 45, 55, and 120. The dosage of drug in these tubes is about 2.5 minims to 120 minims (0.25- 6.6 cc)
Suppository Shape Softgel Capsules
Suppository capsules have limited sizes that are 6, 10, 12, 40, and, 80. The dosage of filling material present inside the suppository capsule is 5 minims to 80 minims (0.03-4.4 cc).
Oblong Shape Softgel Capsules
These capsules have different sizes like 3, 4, 5, 6, 8, 9, 9.5, 10, 11, 12, 14, 16, 17, 18, 20, 22, 24, 25, and 26. The oily drugs present in these capsules have volume of 2.3 minims to 26 minims (0.15-1.4 cc)
Fish or Twisted Softgel Capsules
Fish or twisted softgel capsules are available in small number of sizes ranging from 5-20. The volume of fill material in these capsules is 2.5 minims to 20 minims (0.154-1.1 cc).
Special Shaped Softgel Capsules
Special shaped capsules also have diversity in their sizes. The size of these softgel capsules depends upon the volume of drug encapsulated inside them.
Hard Gelatin Capsules
Hard gelatin capsules have limited sizes. These sizes are 000, 00, 0, 1, 2, 3, 4, and 5. Unlike softgel capsules, the smaller number of hard gelatin capsules indicates the bigger size of the capsules and vice versa.
In softgel capsules, it is the opposite. The smaller numbers indicate small size.
Hard gel capsules can hold about 20 mg to 1600 mg of the drug.
| SIZES | 000 | 00 | 0 | 1 | 2 | 3 | 4 | |
| SPECIFI CATIONS |
CAP Length (mm) |
12.01- 12.95 | 11.4-12.0 | 10.7-11.3 | 9.50- 10.1 | 8.60-9.20 | 7.80-8.40 | 6.90-7.50 |
| CAP Diameter (mm) |
9.91 | 7.63-7.77 | 7.57-7.71 | 6.83-6.97 | 6.28-6.42 | 5.76-5.90 | 5.25-5.39 | |
| BODY Length (mm) |
20.5-22.20 | 19.8-20.4 | 18.2-18.8 | 16.2- 16.8 | 15.1-15.7 | 13.3-13.9 | 11.9-12.5 | |
| BODY Diameter (mm) |
9.55 | 7.31-7.45 | 7.26-7.40 | 6.56-6.70 | 6.00-6.14 | 5.50-5.64 | 4.98-5.12 | |
| COVERING Length (mm) | 25.4 | 22.2-23.2 | 20.7-21.7 | 18.5- 19.5 | 17.0-17.8 | 15.0-15.8 | 13.4-14.3 | |
| WEIGHT (mg) |
165土7 | 120士7 | 97土6 | 76土6 | 62土5 | 50土5 | 39土5 | |
| WEIGHT (GAP) |
土6% | 土6% | 土6% | 土6% | 土6% | 土8% | 土8% | |
8.What do you know about the absorption rate of softgel and hard gelatin capsules?
Softgel Capsules
Softgel are easily broken down on exposure to stomach acidic environment as their shell is made up of soft materials. It takes about 5 to 10 minutes for the shell of softgel capsules to disintegrate. Then they are easily absorbed. These capsules are best for rapid pain relief.
These capsules can be alter for sustain released of drug or they can be enteric coated for preventing the disintegration of capsules in stomach.
Hard Gelatin Capsules
Hard gelatin capsules remain in the stomach for a longer time. The amount of time hard gelatin capsules takes to dissolve in the stomach usually depends upon the amount of plasticizer used in making their shells.
These capsules usually take 30 to 40 minutes for their shell to break so that is why the drugs encapsulated inside them, take more time to absorb by the blood.
9.Which type of capsules is more costly to manufacture hard gel or softgel?
Softgel Capsules
Softgel are more costly to produce than hard gelatin capsules.
It is due to the filling and manufacturing procedure being more complicated than the hard gelatin capsules. The shell of softgel capsules is composed of more material than hard gelatin capsules.
It is difficult to optimize the manufacturing process of softgel capsules. If a problem arises in the coating of the drug in the softgel capsules, it cost more money as the error in the coating of one capsule damage the coating of all other capsules.
Hard Gelatin Capsules
Hard gelatin capsules are affordable as they are less expensive to manufacture. This filling of hard gelatin capsules is less taxing. Manufacturing of these capsules does not require complicated machinery.
Production of shell of hard gelatin capsules does not involve many ingredients and tiresome process so these capsules are the least expensive capsules to fabricate than all other capsules.
Description:
AIPAK is China’s number 1 packaging solution provider who has been in the packaging industry for nearly two decades. AIPAK has a number of machinery and products that deals with tablet and capsule manufacturing, blister and strip packaging, coating and cartoning machines, dryers and mixers and the list goes on. AIPAK is also the largest hard gelatin capsule manufacturer and has won a number of national awards.
10.What do you know about limitations of softgel vs hard gelatin capsules?
Softgel and hard gel capsules have some disadvantages as well.
Softgel Capsules
Moisture Prone Drugs
As the softgel capsules shells have more moisture content (20-30% w/w) than hard gelatin capsules so they are not suitable for encapsulating moisture sensitive drugs.
Growth of Microorganisms
Due to high moisture content used in the coating of softgel capsules, they are more likely to promote the growth of bacteria and fungi.
Interaction between Drug and Shell
The contact between the shell of softgel capsules and its encapsulated drug is far greater than hard gelatin capsules, which leads to interactions between the shell material and drug.
Drug Formulations
Softgel can only encapsulate a number of drug formulations like oily drugs. These capsules can only fill liquid or semi-solids.
Tedious Manufacturing
The production process of softgel capsules is difficult and hard to optimize. Different steps of ribbon thickness and fill weight are difficult to handle. If a coating of even a single capsule gets peeled, then it leads to mis-coating of many other capsules.
Hard Gelatin Capsules
Gastric Irritation
Hard gelatin capsules should not be filled with salts that are highly soluble such as bromide, chlorides, and iodides. The immediate release of these salts will cause high drug concentration in the stomach which causes gastric irritation.
Shell Moisture Content
Proper shell moisture of hard gelatin capsules must be maintained otherwise the material will get cracked and affect the performance of the drug.
Cross-linking
Gelatin of hard gel capsules can get hard due to cross-linking of material in the shell. This will result in slow disintegration of the shell which has an impact on the absorption of the drug.
Shape
Hard gelatin capsules come only in one standard shape (cylindrical) so the variation in the volume of dosage drug is small in case of hard gelatin capsules. That is why they are unable to meet customer requirements of variations in the volume of drug.
11.Which kind of capsule is more preferred by the consumer- softgel or hard gelatin capsules?
Softgel Capsules
Softgel are more preferred by the consumers than their hard gel counterparts as
- They are available in various colors which is appealing to the consumers.
- Softgel are easily swallowed, the shell of these capsules easily dissolves which increases the chances of absorption.
- They are tamper-proof which does not cause leakage of the drug.
- They are high in demand because they can mask the taste and smell of the drugs that are otherwise be unpleasant to take.
Hard Gelatin Capsules
Hard gelatin capsules are not preferred by the customers as they have limited shapes and sizes which are not pleasing to customers. Furthermore, these capsules are difficult to ingest as they have a bitter taste and smell.
Conclusion
Softgel and hard gelatin capsules are formulated to release active ingredients safely and rapidly after oral administration to obtain a complete systemic response without causing physiological disturbance such as GIT irritation. Whether it's softgel or hard gelatin, both induce maximum therapeutic response upon ingestion. That’s the reason both are high in demand in healthcare, cosmetics, or agricultural sectors across the globe.
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