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Enteric Coated Capsules: The Ultimate FAQ Guide

Whether you want to buy or learn more about enteric coated capsules, all information you’ve been looking for is right here.

From benefits, uses, sizes, quality standards to capsule filling process – this guide will help you choose the best enteric coated capsules.

Keep reading.

What are Enteric Coated Capsules?

Enteric coated capsules are types of capsules that have an extra acid resistant coating to protect them from dissolution.

The acid resistant coating will protect the capsules from dissolution as it passes through the acidic environment in the stomach.

Drug desintegration

 Drug disintegration

What are the Advantages of Enteric Coating of Capsules?

Enteric coated capsules come with numerous benefits that will make your health better.

Apart from improving our health, other benefits of enteric coated capsules include:

· Delayed Release Properties

Enteric coated capsules have delayed release properties that allows them to target specific areas of the body.

It has special ingredients that will protect it from dissolution in unfavorable conditions.

It, therefore, makes the enteric coated capsules the best choice for medications that are time sensitive.

· Easy to Swallow

You may not require a glass of water to wash down the enteric coated capsules because they are easy to swallow.

They have a very soft coating that will easily glide past your throat towards the target point.

· Gastric Acid Resistance

Enteric coated capsules are also resistant to the acidic conditions within the stomach.

It prevents the capsules from dissolving when it passes through such conditions.

· Low in Moisture Content

The enteric coated capsules have higher stability and durability levels due to the low levels of moisture content.

This is the reason why enteric coated capsules often have a longer shelf life than other types of capsules.

· Protects the Stomach Lining

It will also protect your stomach from irritation whenever you ingest the capsules.

You will not experience any form of irritation within your stomach when you ingest enteric coated capsules.

· Proper Regulatory Acceptance

Enteric coated capsules also pass through proper regulations thus making them safe for consumption.

It uses ingredients that go through proper testing to declare their safety for human consumption.

· Cross-Linking Resistant

Enteric coated capsules are also resistant to gelatin coat alteration thus preventing them from disintegration before time.

As soon as it reaches the right environment, the enteric coated capsules will disintegrate automatically.

· High Stability Levels Over Wide Environmental Conditions

You can store enteric coated capsules in different environmental conditions without fear of losing its stability.

Enteric coated tablets will survive varying temperature and humid conditions thus maintaining its stability.

Do Enteric Coated Capsules Exhibit Any Disadvantages?

Well, enteric coated capsules have some limitations that you should have knowledge of.

Here are some of the limitations of using the enteric coated capsules.

· Delayed Action

You will have to wait for a while longer to get proper relief from pain after swallowing enteric coated capsules.

This is because they have delayed release properties that will prevent them from disintegrating before reaching target point.

· Increases risk to Patients

You may also have serious complications such as heart attacks due to the delayed properties of the enteric coated capsules.

It will take time for it to release the active ingredients thus exposing you to other risk factors such as heart attacks.

Why Should You Coat a Capsule with an Enteric Coating?

Enteric coated capsules are very important in delivering different types of active ingredients to the right point.

Some of the active ingredients in medicine are sensitive to the acidic stomach conditions.

So, the only way to ensure that they reach the target point is by coating them with enteric coats.

You can use the enteric coated capsules to deliver insulin to the right point of the body thus avoiding early dissolution.

What are the main Uses of the Enteric Coated Capsules?

There are quite a number of applications that require the use of the enteric coated capsules.

Here are some of the main applications of the enteric coated capsules.

Enteric coated capsules

Enteric coated capsules

· Protection of the Stomach

You will use the enteric coated tablets to protect the linings of your stomach from irritative active ingredients.

It will protect you from side effects of consuming these types of drugs such as nausea, vomiting and potential injury.

· Reaching the Target Point

You will also make sure that the active ingredients reach the target point by using the enteric coated tablets.

As soon as it reaches the target environment, the enteric coated capsules will disintegrate and release the active ingredients.

For example, you can use the enteric coated capsules to treat infections in the intestines.

The enteric coat on the intestinal drugs will protect it from disintegrating within the acidic environment of the stomach.

As soon as it reaches the intestines, it will disintegrate and release the active ingredients that will treat the infection.

Which Part of the Body Absorbs the Enteric Coated Capsules?

In many cases, the enteric coated capsules often dissolve at the beginning of the small intestines or duodenum.

The duodenum has the perfect alkaline environment that is suitable for the disintegration of the enteric coated tablets.

How Does the Enteric Coated Capsule Work?

You might be a victim of serious stomach irritations whenever you swallow different types of capsules.

The irritation on your stomach is as a result of the acid in the stomach acting to the active ingredients in the capsule.

In such as case, the only remedy to such reactions is taking enteric coated tablets.

Just from the name, “Enteric”, you will note that the enteric coated tablets are bound for the intestines.

Enteric coated tablets work in such a way that they keep the active ingredients within the capsule from the stomach.

The enteric coating will make the capsule walls resistant to the acidic conditions in the stomach.

Once the enteric coated tablets reach the beginning of the small intestines, it will detect the alkaline environment.

Once in this environment, it will disintegrate and release the active ingredients in the small intestines.

At that point, it will cure you of the irritations or infections within the small intestines.

What are the Benefits of Breakthrough Technology Used in Enteric Coated Capsules?

Break through technology is the leading contributor to the incorporation of biopharmaceutical enteric polymers in capsules.

The new technology often eliminates the need of having enteric coatings on different types of capsules.

Here are the benefits of using the technologically advanced biopharmaceutical enteric polymers.

  • Proper functionality for capsule development of prototypes and tests in different patients.
  • Increasing the speed of developing the enteric coated capsules so that patients can have proper access.
  • Proper branding and management of the new technology, creating more opportunities.

What are the Enabling Technologies to Use in Making Enteric Coated Capsules?

There are numerous technological advancements that arise in a bid to achieve enteric protection, target delivery and delayed release.

Technologies that target proper delivery of active ingredients often involve other technologies such as:

  • Timed-Release Advancements
  • pH Control Release Advancements
  • Enzyme Triggered and pH Triggered Advancements

How Many Sizes of Enteric Coated Capsules are There?

There are different sizes of enteric coated capsules that you will choose from according to your requirements.

You will determine the size of the enteric coated capsules by looking at the height and volumetric capacity.

In that case, there is a specific size limit that you should not exceed when in comes to making enteric coated capsules.

Here is a table showing the different sizes of enteric coated capsules in the market.

Sizes of capsules

Sizes of capsules

You will notice that the enteric coated capsule sizes range from 0 to 5.

Here, 0 represents the capsules with the greatest capacity while 5 represents the capsule with lowest capacity.

You can categorize the enteric coated capsules into the following sizes:

· Largest Enteric Coated Capsule Size

The largest enteric coated capsules is 000 which holds about 1000mg of active ingredients.

· Average Enteric Coated Capsule Size

Average capsule sizes will range between 00 to 0 holding 750mg and 500mg of active ingredients respectively.

· Smallest Enteric Coated Capsule Size

The enteric coated capsules become smaller as the number becomes bigger.

Implying that the smallest enteric coated capsules range from 1 to 5.

How Do Veggie and Gelatin Enteric Coated Capsules Compare?

There are different types of gelatin capsules that you can choose from depending on your diet requirements.

In case you do not have diet limitations and you can consume animal products; you can use gelatin enteric coated tablets.

Gelatin is an animal product that manufacturers use to make the outer shell of gelatin enteric capsules.

On the other hand, if you have diet restrictions, then the you should opt for the veggie enteric coated capsules.

You will use veggie enteric coated capsules especially when you do not consume animal products.

The outer shell of the veggie capsule, is a product of different vegetables or plants such as tapioca.

Veggie enteric coated capsule is the best option for people following kosha or halal diets.

What are the Main Ingredients for making Enteric Coated Capsules?

You will use different types of ingredients in making different types of enteric coated tablets.

In case of veggie enteric coated capsules, you will use the plant products.

On the other hand, in case you are making gelatin enteric coated tablets, you will use animal products.

Despite the slight difference that makes the different types of capsules, there are common ingredients.

The main ingredients that you will use in formulating the delayed release properties in capsules are:

  • Zein
  • Hypromellose
  • Shellac
  • Proprietary Polymers
  • Cellulose acetate succinate
  • Cellulose acetate phthalate
  • Sodium Alginate
  • Polyvinyl acetate phthalate (PVAP)
  • Cellulose acetate trimellitate
  • Hydroxypropyl methyl cellulose phthalate

These ingredients will resist capsule disintegration in acidic conditions and allow proper disintegration in alkaline conditions.

Apart from that, you will also need other ingredients that will make up the outer shell.

Here are the main ingredients that you will use in making the outer shell of the enteric coated capsules.

  • Gelatin or Tapioca depending on the type of enteric coated capsules
  • Water as the main solution
  • Plasticizers
  • Proprietary polymers
  • Opacifying agents
  • Color
  • Sweeteners

Which Kind of Materials can you Fill in Enteric Coated Capsules?

While gelatin and enteric coating ingredients make up the external part of the enteric coated tablets.

There are other ingredients containing the active ingredients that you will fill inside the capsules such as:

  • Powder
  • Pellets
  • Tablets
  • Suspensions
  • Solutions

Content of capsules

Content of capsules

Are Enteric Coated Capsule Resistant to Acidic Conditions?

Absolutely, enteric coated tablets are resistant to low pH or acidic conditions.

The word enteric means that the capsule is bound for the intestines.

Implying that it will have to pass through the low pH conditions within the stomach.

The only way the enteric coated capsules pass the acidic stomach conditions is by being resistant to acidic conditions.

How Do Hard and Softgel Enteric Coated Capsules Compare?

Well, you can also choose to use the hard or soft gelatin enteric coated capsules.

Soft gelatin enteric coated tablets often have a very soft and hermetically sealed gelatin coating.

Apart from that, you can fill solutions and suspensions within the soft gelatin enteric coated capsules.

On the other hand, hard gelatin enteric coated capsules, have different inner fill ingredients such as powders, tablets, and pellets.

The outer covering or shell is often harder than that of softgel capsules thus the name hard gelatin capsules.

How Does Pullulan Enteric Coated Capsule Compare to HPMC Enteric Coated Capsules?

The main difference between the pullulan and HPMC enteric coated capsules is in the main ingredients.

HMPC capsules

 HMPC Capsules

Pullulan enteric coated capsules often have capsule caps from ingredients of fungi growing off starch substrates.

You can consume the pullulan enteric coated capsules if you follow a strict vegetarian diet that does not involve animal products.

They also have the special ingredients which will make them resistant to low pH conditions.

On the other hand, HPMC enteric coated capsules are also plant derivative capsules that disintegrate in a different ph.

This type of enteric coated capsule will disintegrate in a pH that is slightly higher than 5.5.

It is, therefore, capable of going through lower pH conditions ranging between 1.5 to 3.5.

It is the best ingredient for encapsulation of oil and hygroscopic inner fill materials.

Which Quality Standards Must Enteric Coated Capsules Adhere To?

Safety is paramount in the process of making enteric coated capsules.

On that note, you have to ensure that the enteric coated capsules adhere to the following quality standards.

  • Pharmacopeia Quality Standards (such as EP, NF, USP, and JP)
  • Food and Drug Administration Quality Standards
  • CE Quality Standards
  • Kosher or Halal Quality Standards
  • International Standards Organization Quality Standards
  • Current Good Manufacturing Practices Quality Standards

Which Machines Do You Use in the Manufacturing Process of Enteric Coated Capsules?

You will use different type of machine in making the enteric coated capsules.

Your choice for machines will depend on the type of enteric coated capsules that you will be making.

Here are the main types of machines that you must have when making enteric coated capsules.

  • Softgel Encapsulation Machine
  • Tamping Ping or Dosator Capsule Fillers
  • Hammer Mills
  • Pharma Ovens
  • Drums and Bins
  • Fluid Bed Processors

How Do You Manufacture Enteric Coated Capsules?

You can manufacture enteric coated capsules using different types of ingredients depending on the purpose.

Despite the type of ingredients, the method of making the enteric coated capsules will depend on the type of capsule.

Here is a step by step process that you can use in making of both types of enteric coated capsules.

1) Making the Outer Cap

Using the softgel encapsulation machine, you will begin by mixing all the ingredients of the softgel enteric coated capsules.

The process involves mixing, heating and melting all the ingredients in the gelatin mixing tank for almost 3 hours.

You must also remember to include the ingredients that make up the enteric coating properties of the capsules. s

After that, you will allow the warm and molten gelatin to flow on to the spreader box and revolving cooling drums.

This will lead to the formation of gelatin ribbons from the right as well as the left side of the encapsulation machine.

After that, the two gelatin ribbons will move to the tooling system at the same time for encapsulation.

2) Formulation of the Inner Fill Materials

Here, you will prepare the inner fill materials which are often in liquid, semi-solid or suspension forms.

You will mix all the ingredients in different machines to mix all the ingredients together thus forming a homogenous mixture.

In this case you have to ensure that the inner fill materials have the following properties:

i. Perfect stability on all the ingredients ensuring increased durability

ii. Increased bioavailability and ease of encapsulation

  • Step Three: Encapsulation Process

At the third step, the ribbon from the right and left side moves steadily on to the die roller system.

As that happens the die cavity will also receive the inner fill materials from the wedge.

You will also program the machine to determine the size of the softgel enteric coated capsules at this point.

The final process will involve cutting and hermetically sealing the inner fill ingredients within the ribbons.

3) Drying the Softgel Enteric Coated Capsules

Finally, you will pass the softgel enteric coated capsules through different drying conditions to get rid of excess moisture.

Let us have a look at how you will manufacture the hard gelatin enteric coated capsules.

4) Preparation of All the Ingredients

First, you will prepare all the ingredients that you need in making the hard gelatin capsules.

Here, you will use the same ingredients such as the ones you need for making softgel capsules.

The only exception is on the plasticizer which is not required as we are making hard gelatin capsules.

Apart from the omission, you will include the hypromellose which maintains low moisture content in the capsules.

You will use a jacketed pressure vessel to mix, heat, and melt all the ingredients.

After that, you must remove all the air bubbles by applying a vacuum in the mixture.

5) Molding the Hard Gelatin Capsule

You will transfer the homogenous mixture to the gelatin molding machine with numerous mold pins.

In a typical machine, you will have about 50,000 pins that will make the upper and lower caps.

With the molten mixture in the hopper or holding container, the machine will dip the pins inside the molten mixture.

It will lift the pins from the mixture after some time where the cool temperatures solidify the gelatin cover on the pins.

You will remove them from the pins and size them according to the size of enteric coated capsules you need.

6) Filling and Covering the Hard Gelatin Enteric Coated Capsules

Finally, you will use a tamping pin or dosator hard gelatin capsule filling machine to fill the body of the capsules.

After that, you will cover the body of the capsules with the cap and seal them permanently.

What are the Auxiliary Processes that Enteric Coated Capsules Pass Through?

After a successful process if manufacturing different types of enteric coated capsules.

You will proceed to auxiliary processes that will ensure that you have high quality products.

Here are the main auxiliary processes that the enteric coated capsules must pass through:

Acid resistant vegetable capsules

Acid resistant vegetable capsules

· Quality Control Process

Quality control involves inspection of all the capsules and removal of all the capsules that have defects.

With the help of the capsule sorting machine, you can eliminate all the capsules that have defects.

Here, you will maintain high quality enteric coated capsules by:

i. Eliminating damaged, broken, and mis-shaped capsules

ii. Conducting different microbiological tests that will ensure safety

iii. Verifying uniformity in weight, content as well as sizes of enteric coated tablets

iv. Determining moisture content in different enteric coated capsules

· Polishing and Proper Packaging of the Enteric Coated Capsules

Here, you will clean and remove all the debris from the surface of the enteric coated capsules.

Apart from that, you will print the enteric coated capsules for proper identification.

Finally, you will package all the enteric coated capsules accordingly before storage and distribution.

Is Acid Resistant Capsules same as Enteric Coated Capsules?

Yes, you may refer to the acid resistant capsules as the enteric coated tablets.

Enteric coated tablets are resistant to acidic conditions just like the acid resist capsules.

The only difference between the two types maybe on the target point.

Enteric coated tablets often target the small intestines where the conditions are favorable for dissolution.

On the other hand, acid resistant capsules may target other areas of the body which do not have acidic conditions.

At SaintyCo, we manufacture vegetable and gelatin enteric capsules of different sizes.

Besides, we also offer capsules machines that can boost your capsule filling business.

Contact us today for best prices on enteric capsules, capsule filling machines and support equipment.