What Are Gelatin Capsules – The Ultimate Guide

Gelatin capsules are some of the most common packaging solutions in the industry today. Whether you wish to fill capsules with powder, pellets or liquid, there is a perfect gelatin capsule for your unique requirements.

In this guide, we will cover everything about gelatin capsules.

What Are Gelatin Capsules

When we talk about capsules, we can define them as an oral way of delivering drugs into our body’s digestive system. They contain active ingredients that reach our digestive system once the capsules dissolve inside our guts.

 

They are the best replacement for bitter tablets that prove to be hard to swallow and leave an unpleasant taste. The main component of these capsules is gelatin.

This same gelatin also assists in the gelling of the capsule. We have two main types of gelatin capsules; the two-piece hard caps capsules and the soft gel capsules that are in whole single units.

We can extract this gelatin ingredient from the hides and bones of animals. They are normally protein in nature.

Gelatin Capsules
Gelatin Capsules

Benefits Of Gelatin Capsules

When it comes to the benefits of these capsules, we can categorize them based on the two types available. Let us analyze them individually:

Soft Gelatin Capsules

i. They are tasteless and odorless

ii. They improve the bioavailability of the active pharmaceutical ingredients

iii. Their soft nature enables you to easily swallow them orally

iv. These capsules are sealed and therefore can protect the active ingredients from any form of UV radiation. Photosensitive ingredients are also protected from adverse light conditions using

v. They have an elegant appearance hence patient compliance with medication or supplements is improved

 Soft Gelatin Capsules
Soft Gelatin Capsules

Hard Gelatin Capsules

i. They are the best bet especially when you’re dealing with unstable ingredients or sensitive drugs

ii. They have a unique shape and you can customize the color to increase the product identity

iii. They dissolve inside the gut easily after ingestion

iv. Their hermetical tight seals offer protection for the ingredients inside from environmental impacts

Hard Gelatin Capsules
Hard Gelatin Capsules

Types Of Gelatin Capsules

We can categorize gelatin capsules into two major categories, soft or hard gelatin capsules. They may be the same in their composition but their structure and nature differ.

We can have a detailed look at some of their distinguishing features:

Hard Gelatin Capsules

As the name suggests, hard gelatin capsules have a stiff outer cover once they are filled. They normally have a cap and a body which are cylindrical.

The cap is designed in such a way that it is smaller than the body enabling it to fit into the body. The seal formed is usually very tight to prevent the spillage of the ingredients contained within them.

Soft Gelatin Capsule

These capsules are soft one-piece gelatins that have been sealed hermetically. Their contents are mostly liquid or semi-liquid with their shapes varying according to your specifications.

Process Of Manufacturing Gelatin Capsules

We have different processes for manufacturing both soft and hard gelatin capsules. We can have a look at each of the processes in detail:

Soft Gelatin Capsule

Preparation

You should first assemble all the ingredients you want to use and choose the tank that you are going to mix them in. Pour your ingredients into the tank and give them a thorough mix.

Heat the resultant mixture in a melting tank for about three hours. This will produce a liquid that is homogenous and in a molten state.

You will have to maintain a constant mixing temperature so that the molten mixture does not solidify.

Fill Material

You can have the fill materials in the form of either semi-solid, liquid, or in suspension form. This fill material has to be homogenous and you can achieve this using bins and drums, hammer mills, or a fluid bed processor.

Your fill material has to have stable elements to ensure the filling process is safe. The material also has to ensure that it improves the bioavailability of the soft gelatin capsule.

Encapsulation

This is the process that will bring together your fill material with the gelatin shell resulting in a complete capsule. The gelatin shell is first taken through the tooling system where it is taken to the spreader box.

The fill material is contained inside a product tank. It is transferred to the die cavities of the soft gelatin ribbon shell through positive displacement.

Once filled, the gelatin ribbon shell is then cut by the die system. The soft gelatin capsule is them hermetically sealed and processed to the next stage.

Drying The Capsules

This procedure heavily relies on the size of the capsules you have made, their quantity and amount of moisture in them. The soft gelatin capsules are placed on a conveyor belt from where they go through a tumble dryer.

The tumble dryer eliminates about 25% of the moisture available in the soft gelatin capsules. They are then placed in trays and taken to a drying tunnel.

This procedure takes about 24 hours. However, this will depend on how much moisture your soft gelatin capsules have.

Inspection

This process ensures that the quality of your soft gelatin capsule is ascertained. You can eliminate capsules that have deformities such as broken or misshaped capsules.

You can also carry out microbiological testing of the capsules. This inspection also enables you to verify how much moisture your capsules have, their weight, and how well you have sealed them.

Packaging

Before packaging, you have to polish your soft gel capsules to eliminate any foreign particles on their surface. This gives them the correct texture and the desired color.

You can achieve this using a soft gel polishing device. Afterward, you can package them for distribution and shipping.

Soft Gelatin Capsule Manufacturing Process
Soft Gelatin Capsule Manufacturing Process

Hard Gelatin Capsules

Here are the steps involved when you want to manufacture empty gelatin capsules:

Preparation

You will require demineralized water to make a gelatin solution. You can boil the solution in a bracketed pressure vessel at temperatures of around 60-70°C.

Once you achieve a homogenous mixture, pass it through a vacuum that will remove any trapped air bubbles inside it.

You can add your preferred coloring agent once you transfer the solution into a different container. Depending on the thickness of your hard gelatin capsules, you can add water to the mixture to get the right viscosity.

Place the solution in a heated hopper and mix it with a gelling agent. You can also add a co-gelling agent that will convert the Hypromellose ingredient to blend well with the solution.

Mold Preparation

Place the solution in a dip pan while maintaining its temperature between 45 to 55°C. The molding sets will momentarily be dipped into the solution at room temperature.

As the molds are dipped, a thin film forms on the surface of the molds with every dip.

Rotation

After the capsules are formed, they are removed from the solution and rotated to an upper deck at a very slow motion. The rotation facilitates the uniform distribution of the gelatin on the capsule.

Drying

You can place the formed molds inside kilns that will dry them. The kilns will blow gusts of air over the mods that help in solidifying the gelatin.

Make sure that you set all the drying parameters accordingly. This will ensure that the gelatin does not over-dry or the thin film does not melt.

Stripping

After drying, the gelatin pins on your gelatin molds are removed by the machine with the design cut based on your specifications.

The machine has bronze jaws that will strip the gelatin capsule into the body and cap parts.

Trimming

This procedure ensures that your capsule has the recommended size, shape, and configuration. This is made possible by the rotation of the trimming machine.

Hard Gelatin Manufacturing Parameters
Hard Gelatin Manufacturing Parameters

Fusion

This fusion takes place even before the ingredients have been placed inside the capsule. The machine fuses the capsules body and cap together before the filling process.

You should note that the sealing is not permanent. Your capsules cap and body should have different colors depending on your product specifications.

Quality Control

Once you’re done with the fusion and your capsules have dried, you pass the capsules through a sorting machine. Any capsule with a defect is eliminated through this process while the good ones pass through.

The capsules then go through a labelling machine that brands them with your custom-made details. The gelatin capsules are still empty but will be filled in the next processing stage.

At this stage, you will have high quality empty gelatin capsules ready for filling process.

Capsule Filling

In case, you wish to fill your empty gelatin capsules, you need the right machine and equipment.

In this stage, the machine aligns the capsules to face a single direction and separates the cap from the body. The active ingredient is then filled into the capsule.

After filling, the machine replaces the gelatin capsules cap. It then ejects it as a complete capsule for packaging and further distribution.

Remember, even if you wish to manufacture vegetable capsules such as HPMC capsule, the process remains the same.

What Are Gelatin Capsules Made Of

 

You may be asking yourself what empty gelatin capsules are made of. Let us have a look at the major components involved in its making:

Gelatin

Just as the name suggests, this is what we majorly use as the chief ingredient for these capsules. This protein component can be sourced from animal bones and skin.

Of course, these are unlike the HPMC capsules which are considered vegetarian capsules.

Water

Water is what we use to make the gelatin solution used to fabricate the gelatin capsules. The water content level is dictated by your application and you should use an average of 47% w/w of gelatin.

Opacifiers

These are elements such as titanium dioxide that are found in the gelatin. They produce an opaque shell that serves as a buffer to the capsules photodegradation.

Plasticizers

You will notice that your gelatin capsules have a soft feel and texture when you feel their surface. Plasticizers are what soften these capsules.

It is worth noting that the hard gelatin capsules lack this component. An example of such plasticizers includes sorbitol or glycerin.

Hypromellose

When you ingest the hard gelatin capsules, they are usually resistant to the acids found in your stomach. Hypromellose enhances this feature while at the same time giving the gelatin capsules their synthetic color.

In most cases, capsule manufacturers can add additives or customize capsules according to your unique requirements.

Limitations of Gelatin Capsules

When we analyze the disadvantages of these capsules, we will look at the soft and hard capsules individually. Here is a list of some of those disadvantages:

Soft Gelatin Capsules

i. They are extremely sensitive to moisture

ii. They have a very complex manufacturing process

iii. You cannot use them to contain water-soluble ingredients

iv. Since it contains animal products, it is not suitable for ingestion by vegetarians

vi. They may cause some form of allergic reaction in some users

Hard Gelatin Capsules

i. You cannot use them to dispense drugs with a big unit dose. This is because large capsules can prove to be hard to ingest

ii. You cannot use them with ingredient drugs that can dissolve the hard gelatin capsule

iii. After the dissolution of the capsule, you may encounter some gastric irritation due to instant drug release

iv. It is impossible for you to formulate hygroscopic ingredients inside a hard gelatin capsule

v. Since it contains animal products, it is not suitable for ingestion by vegetarians

Gelatin Capsules VS Vegetarian Capsules

The two general categories of capsules are either vegetarian or gelatin. You will get the same applicational function from both in as much as they have some similarities and differences.

They are similar in that you can get them in a variety of shapes, sizes, and colors depending on your specifications. When it comes to storage, you can preserve them for extended periods without running the risk of bacterial growth.

Once you ingest them, both of these capsules react very fast and can dissolve easily. However, for the hard gelatin capsules, their acid resistance makes them react a bit slowly.

When we come to the differences, gelatin capsules are purely made from animal products. As the name suggests, vegetarian capsules are made from vegetable products.

Comparing them with their collagen base, gelatin capsules have collagen as the main component. This is in contrast to cellulose found in.

Vegetarian Capsule
Vegetarian Capsule

Gelatin Capsule Defects

Gelatin capsules are prone to certain manufactural defects. We can analyze some of them and how best we can try to prevent them:

Separation Failure

You may experience a situation where the capsules cap and body don’t separate when filling. You can easily solve this problem by properly adjusting the machines parameters.

Ensure the timing of your filling process is correctly timed and the specifications are okay. You should also check your machines filter bags and make sure that they are properly cleaned.

Dented Capsules

Your gelatin capsules can have dents caused by excessive processing pressure or when you overfill them. Ensure that you have done proper calculations of your parameters and regulate them accordingly.

Brittleness

This scenario mostly occurs during the storage of your gelatin capsules. The storage conditions may result in your gelatin capsules drying up and losing their moisture content.

The allowable moisture content that your capsules should have during storage is about 12%. Anything below this will result in your capsule being brittle.

Weight Variation

You will experience this mostly with soft gelatin capsules. This mostly happens when you excessively fill the capsule.

The simple remedy is adjusting the parameters of your machine. This ensures that each capsule is filled uniformly with all other capsules uniformly.

Technical Considerations When Manufacturing Gelatin Capsules

Capsule manufacturers use a complex process that entails accurate calculations to produce high quality empty capsules. You may notice that there is a variation in the performance of various gelatin capsules after fabrication.

This may be due to some technical factors that may have been incorporated during the process. We can take a swipe at some of these technical considerations:

Mechanical Resistance

Gelatin capsules are designed in such a way that they are able to withstand any mechanical stress. Any weak points on the capsule will lead to various deformities.

Oxygen Permeability

You may find some capsule contents that are sensitive to oxidation due their chemical structure. Gelatin capsules can avert such scenarios by shielding the ingredients.

Gelatin capsules allow very little oxygen to pass through them. This means it is the best option when your formulations are oxygen-sensitive.

Active Pharmaceutical Ingredient (API)

Once you ingest gelatin capsules, the rate at which our stomach dissolves it is what we term as API. With one of the most commendable dissolution rates, gelatin capsules enable easy absorption of the active ingredients.

Inside our bodies, the dissolution process is normally seamless. However, crosslinking of the capsule may occur if it is exposed to unfavorable humid or hot conditions.

Water Permeability

It is important to consider how much water the gelatin capsule can allow to pass through it. The moisture affects various capsules differently depending on their type and material composition.

Machinability

It is widely known that the gelatin material has a high machinability. This means that it can efficiently handle any mechanical processes you subject it to.

This means that you will not need any additional machining or ingredients to the process. Additionally, you will not need to add any gelling agents or machine adaptation.

Applications Of Gelatin Capsules

 

When it comes to gelatin capsules, we can use it for various types of applications. Let us have a look at some of its notable uses:

  • It contains amino acids that can assist in detoxifying your liver and enhancing its function
  • If you have regular stomach irritations, it is the best way to take your medicine since it is acid-resistant. This means that the active ingredients in them will take some time in the stomach before being released.
  • For your normal fatigue, the gelatin in the capsules supplements the ones in your body. This ensures that you get enough quality sleep when tired.
  • Because gelatin capsules are low in calories and rich in protein, they can assist you with a healthy weight loss plan.
  • These capsules encourage the production of more collagen by our bodies. This results in an even skin tone and reduces wrinkles forming on our skin.
  • Gelatin capsules ensure that our bones remain healthy. It does so by inhibiting the cartilage deterioration.
  • It acts as a protein supplement to our bodies. The result is improved fingernails and enhanced protein functions in our bodies.
  • The gelatin capsules also serve a great role in regulating your body’s blood sugar levels.
  • By using the amino acids in them, these capsules support your muscle actions. In the process, any possible joint pain is reduced.

With the information in this guide, you can choose the perfect capsule size for your packaging requirements.

At Yasin Gelatin, we manufacture different empty capsules, depending on unique customer requirements. Whether you want special sizes or specific color options, Yasin Gelatin is your trusted empty gelatin capsule manufacturer – contact us now.

More Resources:

Gelatin vs Vegetarian Capsules – Source: YASIN GELATIN

Gelatin – Source: WEBMD

Capsules – Source: WIKIPEDIA

Empty Capsules – Source: YASIN GELATIN

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