Gel-Caps Gelatin Capsule 100% bovine hide gelatin

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Gel-Caps Gelatin Capsule 100% bovine hide gelatin

Gelatin Capsules: The Ultimate FAQ Guide

Before you import gelatin capsules for your capsule filling business read this guide.

It explores everything about empty capsules – from material, quality, manufacturing to filling process.

So, if you want to be an expert in gelatin capsules, here is a guide you have been looking for.

What are Gelatin Capsules?

Gelatin capsules are types of consumables that have the outer shell manufactured from gelatin ingredients.

You will use collagen of animal bones or skin to make the gelatin responsible for manufacturing gelatin capsules.

Gelatin capsules

Gelatin capsules

What are the Advantages of Using Gelatin Capsules?

You should consider using gelatin capsules as the main source of your medication and supplements.

It is because gelatin capsules have numerous benefits such as:

· Easy to Swallow

Gelatin capsules have a soft outer layer that will easily go through your throat without the help of water.

It has a comfortable shape and very smooth texture that will glide easily through your mouth, throat and into the stomach.

· High Absorption Rate

Gelatin capsules will quickly disintegrate and dissolve in the right conditions thus releasing the active ingredients.

The body will, therefore, absorb the inner active ingredients thus providing sufficient relief to pain.

This makes it the best option for the administration of drugs that have very poor solubility rates.

· Improves Drug Bioavailability

Gelatin capsules often help in availing the drugs at the right point for proper action such as pain relief.

For instance, enteric gelatin caps will ensure that the active ingredients reach the intestines before releasing the drug.

· Suitable for Delivery of Low Component Dosages

You will use the gelatin capsules to deliver the low component drugs to the right point.

For instance, you will use gelatin capsules to deliver potent drugs thus decreasing the variability of plasma.

It is the most suitable capsules that you will use in the delivery of doses that are less than 100 micrograms.

· Masks Nasty Taste and Odor

Gelatin capsules often include sweet scented and tasting ingredients that mask the nasty smell and taste of active ingredients.

These properties enhance the overall oral intake of the gelatin capsules.

· Increased Variability

Gelatin capsules are available in different variables that include numerous shapes and colors that improve its appearance.

· Allows for Customization

You have the freedom of customizing your gelatin capsules to suit the size, shape and color that you desire.

Due to ease of manufacturing and filling, you can use high speed machines to produce numerous quantities in a short period.

· High Durability Levels

It has very high levels of stability thus keeping the active ingredients viable and durable for a very long time.

In addition to that, the outer gelatin capsule is also highly durable and will not decay fast under normal conditions.

· Suitable for Different Formulations

You can fill different types of gelatin capsules with different types of formulations or active ingredients.

For instance, soft gelatin capsules are suitable for filling liquids, semisolids and suspensions.

On the other hand, hard gelatin capsules can hold, powders, pellets, granules and even tablets.

Are there Disadvantages of Using the Gelatin Capsules?

Well, you may also experience a few disadvantages of using the gelatin capsules.

Here are some of the limitations for using gelatin capsules.

· Not Suitable for Vegetarians

As a vegetarian or a person who follows strict religious or vegetarian diet, you are not eligible to swallow gelatin capsules.

It is because the gelatin capsules have animal ingredients that vegetarians do not consume.

· Disintegrates in Digestive Fluids

Gelatin capsules will only disintegrate where there are digestive fluids.

This property makes it extremely difficult to target areas where there are no digestive fluids.

How Do Gelatin Capsules Compare to Veggie Capsules?

Basically, you will differentiate veggie capsules and gelatin capsules by looking at ingredients.

HMPC capsules

HMPC Capsules

Apart from that, the consumer will also make the difference as vegetarians will not consume gelatin capsules.

The main ingredient in making gelatin capsules is gelatin which comes from collagen, an animal product.

On the other hand, vegetable capsules use vegetable ingredients such as Tapioca plants to make the capsules.

You can fill gelatin capsules different formulations with the most suitable formulation being the powdered formulation.

Veggie capsules are also the most suitable type of capsules for filling semi-solid and gel formulations.

Gelatin capsules often cost less in comparison to vegetable capsules which cost more.

What are Soft Gelatin Capsules?

Soft gelatin capsules comprise of a very smooth and soft outer shell that is easy to swallow hence the name.

The soft gelatin shell often encloses the active ingredients thus protecting them from the effects of the external environment.

What are the Advantages of Using Soft Gelatin Capsules?

Soft gelatin capsules have numerous benefits including:

Softgel capsules

Softgel capsules

· Easy to Swallow

Due to the soft shell, sweet scent, and taste, softgel capsules will easily glide through your throat to the stomach.

· Available in Wide Varieties

Soft gelatin capsules are obtainable in different sizes, colors, and shapes thus making them very attractive to patients.

· High Levels of Safety and Durability

The softgel capsules have an outer shell that will not break easily, thus making the inner active ingredients safe.

In addition to that, the softgel capsule shell maintains high stability levels, thus increasing its durability levels.

It usually provides complete encapsulation of the active ingredients thus making them tamper proof.

· Best for Administering Particular Drugs

You will use soft gelatin capsules to administer particular types of active ingredients.

It is suitable for the administration of dosages that are less the 100 micrograms.

Apart from that, you can use it to administer special types of active ingredients to the right target area.

In addition to that, you can use softgel capsules to administer drugs that have very poor solubility levels.

Which Substance can you Fill in Soft Gelatin Capsules?

You will use soft gelatin capsules to fill various types of substances to the target point.

The substances which you will fill in the soft gelatin capsules include:

  • Oily liquids or neat components
  • Different types of solutions
  • Semisolid substances
  • Suspensions

What are the Formulation Techniques for Soft Gelatin Capsules?

There are two main formulation techniques for making softgel capsules.

Here are the main formulation techniques for softgel capsules.

Inside softgel capsules

Inside softgel capsules

· Chemical Reaction Formulation Technique

This involves numerous reactions that usually occur within the fill matrix against the plasticizer and gelatin.

Some of the chemical reaction formulations that can occur include:

i. Crosslinking between the active ingredients and the outer shell

ii. Transesterification and esterification of different medicine containing polyol elements

· Physical Interaction Formulation Technique

This formulation technique often occurs as a result of constant movement of fill materials in the outer shell.

The degree of physical interaction will depend on the following:

i. Suitability and type of chemical composition of the fill materials and outer covers

ii. Quantity of particular components within the outer shell and fill matrix

What are Chemical Reactions in the Formulation of Soft Gelatin Capsules?

The main chemical reactions that will occur on formulating the softgel capsules are:

i. Crosslinking between the active ingredients and the outer shell

ii. Transesterification and esterification of different medicine containing polyol elements

What are the Physical Interactions in the Formulation of Soft Gelatin Capsules?

The main physical interactions often occur as a result of fill materials enclosed in the outer shell.

Apart from that the physical action can occur through the outer shell or cover or in the fill matrix alone.

The degree of interaction between the above-mentioned parts will depend on the following:

i. Suitability and type of chemical composition of the fill materials and outer covers

ii. Quantity of particular components within the outer shell and fill matrix

For instance, the most common physical interaction formulation is water which should never exceed 5%.

Which Equipment do you need for Soft Gelatin Capsules Formulation?

When making the softgel capsules, there are different equipment that you will use.

Your choice for equipment will depend on the type of softgel formulation process of choice.

In this case, we will look at the equipment you will use in the rotary die process of softgel formulation.

These include:

  • Softgel Encapsulation Machine
  • Gelatin Mixing and Melting Tank
  • Softgel Capsule Sorting machine
  • Softgel Capsule Counting Machine
  • Softgel Capsules Printing Machine
  • Softgel Capsule Drying Trays and Tunnels
  • Softgel Capsule Polishing Machine

How Do Type A and Type B Soft Gelatin Capsules Compare?

You can categorize soft gelatin capsules into two broad groups which as Type A and Type B.

Here is a comparison of Type Asoftgel capsules against Type B soft gelatin capsules.

· Type A Soft Gelatin Capsules

You can achieve type A Soft gelatin capsules through acidic hydrolysis process in the precursor of hydroelectric point.

It will occur at a constant pH of 9 with pork skin being the primary source of the type A softgel capsules.

· Type B Soft Gelatin Capsules

You will manufacture type B gelatin capsules through alkali hydrolysis on precursors that display isoelectric points of -4.7 pH value.

The main source of the type B gelatin capsules are the bones from different animals.

How do you Manufacture Soft Gelatin Capsules?

With the help of the above equipment, you can easily manufacture soft gelatin capsule.

Here is a step by step procedure to follow when making softgel capsules.

Step One: Mixing Ingredients

First. mix the ingredients in a heating and mixing gelatin tank.

After that you will allow it to heat and mix for about 3 hours to form a molten homogenous mixture.

Step Two: Making the Gelatin Ribbon

With the homogenous mixture at hand, you will pour it into the hopper of the gelatin encapsulating machine.

The hopper will maintain it at a particular temperature and lead it to the spreader box to make the ribbons.

After that, the ribbons from the right and the left side will move to the tooling system which will determine the shape.

It is at the same point where the machine will encapsulate the filling material thus forming a whole gelatin capsule.

How Does the Soft Gelatin Capsule Compare to the Hard Gelatin Capsule?

The main ingredient for making hard and softgel capsules is gelatin.

The softgel capsules and hard gel capsules differ in the texture, shape, and manufacturing technology.

You will make hard gel capsules using hard gelatin and the soft gel capsules using soft gelatin.

Hard gel capsules consist of two parts which are the body containing the active ingredients and covering cap.

On the other hand, softgel capsules consist of one unit which encapsulates the active inner fill materials.

You will use different machine to make the shell of the hard gelatin capsules and another for filling.

In contrast to that, you need one machine that makes the softgel capsules through softgel encapsulation process.

Hard gelatin capsules come in one cylindrical shape while softgel capsules are available in numerous shapes.

Hard gelatin capsules

Hard gelatin capsule

Softgel capsules have a size limitation which is not available in the hard gel capsules.

What are Hard Gelatin Capsules?

Hard gel capsules are cylindrically shaped coats made from gelatin ingredients with a separate body and cap.

How Many Sizes of Hard Gelatin Capsules are in the Market?

Well, there are varying sizes of hard gel capsules on the market ranging from 000 to 5.

Size 000 hard gelatin capsules are often the biggest gelatin capsules while size 5 are smaller.

Capsules capacity also ranges between 0.13 mils to 28 mils.

Here is a table that will give you more details on specific sizes of hard gelatin capsules.

Hard gelatin capsules sizes

Hard gelatin capsules sizes

Which Ingredients Do You Use in making Hard Gelatin Capsule Shells?

There are particular ingredients that you will use in the process of making hard gelatin capsules.

Here are the ingredients that you must have when making the hard gelatin capsules.

  • Gelatin from animal products such as hide skin and bones
  • Dye and edible colorings that will give the desired color
  • Preservatives that will maintain the freshness
  • Opacifiers preferable titanium dioxide
  • Sugar to improve the taste
  • Plasticizers that will make them more flexible and elastic
  • Glycerin that will decrease the hardness of the capsules
  • Demineralized water that helps in proper formulation of the mixture

Why use Hard Gelatin Capsules?

You should consider using hard gel capsules due to various benefits that you will enjoy.

Some of the benefits of using hard gel capsules are:

· Cheapest Option for Capsules

Process of production as well as the ingredients of hard gelatin capsules is less costly.

It is the reason why hard gelatin capsules are often cheaper than the softgel capsules.

· Ease of Filling

You will also enjoy the ease of filling hard gelatin capsules as per the dosages that you need.

It requires minimal work force and very few machines to successfully complete.

· Long Shelf Life

Hard gelatin capsules will last longer on the shelf than the soft gelatin capsules.

It also requires very little maintenance under different humid conditions without affecting the efficacy.

· Easy to Digest

Hard gelatin capsules are often very easy to digest once they reach the stomach with increased levels of bioavailability.

It will take a few seconds for the hard gelatin capsules to dissolve as soon as they get the perfect dissolution environment.

What are the Disadvantages of Hard Gelatin Capsules?

Unfortunately, hard gelatin capsules also come with a few limitations such as:

  • It has very high-water contents thus making it impossible to fill liquid inner fill materials
  • Unsuitable for the market with varying demands as it has one cylindrical shape.
  • The speed at which hard gelatin capsules produces the active ingredients may lead to stomach irritation.
  • It will dissolve when it reaches the right dissolution environment which comprises of fluids in the digestive system.
  • The capsule usually cracks if the water content goes below or above the 12 to 15% water content.
  • Not the best option for hygroscopic and soluble substances including ammonium chloride.

How Long Does It Take for the Hard Gelatin Capsules to Disintegrate?

Hard gelatin capsule will break in minutes after reaching the right disintegration environment.

The average time of disintegration usually ranges from 3 to 13 minutes depending on the capsule sizes.

Apart from that, the concentration of plasticizer in the hard gelatin capsule will determine the dissolution time.

How do you Manufacture Hard Gelatin Capsules?

You will manufacture hard gel capsules by going through these steps.

Capsules manufacturing process

Capsules manufacturing process

· Preparing the Ingredients

Mix gelatin and other ingredients with hot demineralized water under a tight vacuum.

After that, you will mix all the other ingredients such as color until you get a uniform gelatin mixture.

· Dipping the Pins

As soon as you achieve the right viscosity of making the hard gelatin capsules, you will dip the pins.

In this case, the machine will deep the pins in the gelatin solution and stay in the solution for a while.

The longer the pins stay in the solution, the thicker the coating of the hard gelatin capsules.

· Drying, Stripping and Trimming the Hard Gelatin Capsules

After that, you will remove the pins and dry them using industrial cooling furnaces.

As soon as it is dry, you will bring it to the table section of the machine where you will divide it into two parts.

The machine will strip them pins and then trim them into the right shape and size.

Finally, the machine will join the two parts thus forming the cap and the body of the hard gelatin capsules.

How Do You Fill the Hard Gelatin Capsules?

You will fill the hard gel capsules either manually or automatically.

In case you are filling the capsules automatically, you can use the dosatorcapsule filling or tamping pin capsule filling machines.

In general, the entire process often begins with placement of empty hard gelatin capsules on a tray.

After that, the loader on the machine will load the capsules into the filling unit and remove the caps.

It will expose the empty body of the hard gel capsules which you can fill with the right quantity of active ingredients.

Finally, replace the cap and fit it perfectly on the body of hard gel capsules.

What is the Quality Control Process of Hard Gelatin Capsules?

You must ensure that the hard gelatin capsules are safe for consumption by checking out the quality from the start.

Implying that the process of controlling the quality of hard gelatin capsules will begin right from selection of raw materials.

After that, you must also make sure that you take care of the quality of the manufacturing process.

It includes looking at the quality of the equipment and mixing ratios of different ingredients in the manufacturing process.

In addition to that, you will look at the quality of the filling process by ensuring you have the right quantities.

Finally, you must check on the quality of weight determination as well the quality of the packaging process.

You must also ensure that the hard gelatin capsule you purchase go through the requisite control procedures.

It will ensure that the hard gelatin capsule is safe and free of contamination from other sources.

How Does the Clear Gelatin Capsule and Opaque Gelatin Capsule Compare?

Well, there are different types of hard gelatin capsules that you can choose from.

Here is a comparison between the clear hard gelatin capsules and opaque hard gelatin capsules.

· Clear Hard Gelatin Capsules

Clear hard gelatin capsules are the types of capsules that you can actually see through.

They are transparent and enables you to see the inner fill content or materials.

You can use the clear hard gelatin capsules to show off the color and texture of the inner fill materials.

In many cases, the content that you will fill in the clear hard gelatin capsules must not be sensitive to light.

· Opaque Hard Gelatin Capsules

On the other hand, the opaque hard gelatin capsules have opacifiers that blocks the entry of light into the capsules.

Here, you will fill active ingredients that are light sensitive hence blocking them from light degradation.

How Do Colored Transparent and Opaque Hard Gelatin Capsules Compare?

Among the types of hard gelatin capsules, you can opt for opaque or colored transparent hard gelatin capsules.

Here is a comparison between the two types of hard gelatin capsules.

· Opaque Hard Gelatin Capsules

Opaque hard gelatin capsules contain opacifiers which makes them loose their transparency.

You will use the opaque hard gelatin capsules to fill active ingredients that are sensitive to light.

It will block the light from degrading the efficacy of the active ingredients thus remaining stable for long.

· Colored Transparent Capsules

On the other hand, colored transparent capsules are clear capsules that have a bit of color on the coat.

You can easily view the content inside these capsules due to the clarity of the outer shell.

Apart from that, the colors on the outer shell will also help in improving the aesthetic appeal of the capsules.

What are the Common Hard Gelatin Capsules Defects?

When manufacturing the hard gelatin capsules, you might experience a few defects in the outcome of the capsules.

Here are some of the most common defects that you are likely to come across.

Hard gelatin capsules defects

Hard gelatin capsules defects

· Defects of the Shape

You might have hard gelatin capsules with dents, short or long lengths, mashed or bent parts or even double caps.

· Defects in Color

You might experience defects such as discoloration and variations of different colors among others.

· Defects in Appearance

There might be defects in appearance including scrape, holes, splits, debris, dirt, telescoped or cracked surfaces.

· Defects on the Print Marks

Here, you might see improper marks on the capsule or missed marks on the hard gelatin capsules.

At SaintyCo, we manufacture empty capsules and filling equipment.

In case you plan to start capsules filling business, SaintyCo is the manufacturer you can trust.