Gelatin capsules are one of the most used forms of oral dosage in the pharmaceutical and nutraceutical industry. CapsCanada wants you to know all the information related to this important form of drug delivery and answer all the questions you might have.

What are Gelatin Capsules?

Gelatin capsules are a way of drug delivery made of materials derived from pork or bovine. Depending on the product, they can be filled with powders, liquid, or pastes:

  • Vegetable and aromatic oils.
  • Nonionic surface-active agents.
  • Aromatic and aliphatic hydrocarbons.
  • Propylene glycol and isopropyl alcohol.
  • Ethers

These capsules act as a coating shell that protects the formulation from external components, allowing the release of the API according to the product needs.

These convenient packages enable reliable dosing, portability, and high consumer compliance.

Gelatin Capsule Structure

Structure of Gelatin Capsules

 

History of Gelatin Capsules

In the 19th century, raw collagen-sourced gelatin evolved from a simple glue to a transformed process for other applications. Industrialized gelatin for glue was produced for the first time in Lyon, central eastern France, in 1818.


The first patented use of gelatin for capsule making took place in France, in 1834. The chemist François Mothes created a gelatin outer shell to mask the commonly bitter tastes and odors in medicines. This shell also offered some instant protection against product degradation.

This revolutionary product evolved rapidly. In 1847, Londoner James Murdock developed a hard-divided gelatin capsule. But it was not until the first decade of the 1900s that gelatin capsules were mass-produced.

Eli Lilly, a US drug marketer, was the creator of the first automated production line for hard gelatin capsules, in 1913.

By 1930, the market of gelatin capsules had evolved considerably. Soft gelatin capsules were produced in filling machines and the technology evolved steadily until this day.

Two-piece gelatin capsules, which are now widely available, offer an optimal combination of in vivo performance, excellent handling in high-speed filling machines, and shelf-life stability.

What Are the Benefits of Using Gelatin Capsules?

Their composition, adaptability to different formulations, diverse applications, customization opportunities, and the trends that are yet to come makes gelatin capsules the best option for your product development, consider these features:

Flexible

Being a flexible option which works for a wide range of formulations and applications.

Flavors

The addition of custom flavors, which can mask the unpleasant smell and taste of the encapsulated drug.

GRAS

Being Generally Recognized as Safe (GRAS) for human consumption by most of the world's regulatory authorities.

Cost

Have remarkable cost efficiency. The production cost of gelatin capsules is at least 30% lower than other alternatives.

Natural and allergen-free

Do not contain GMOs. They are completely natural and allergen-free.

Gelatin Capsule Materials

Main Component: Gelatin Capsules

Main Component: Gelatin

Protein made from animal products, used historically by the pharmaceutical industry, food preparations, and cosmetic industry.

 

Amino Acids in Gelatin Capsules

Amino Acids in Gelatin

Amino acids are absorbed by the human body to form building blocks of proteins, so they're vital for several processes within the human body, such as synthesizing hormones and neurotransmitters.

When Choosing a Gelatin source or provider You Should Consider…

  • Gelatin is not made from GMO livestock.

  • Preservative-free

  • Free of prions

    A prion is an infectious agent responsible for several neurodegenerative diseases, one of the most prevalent found in humans is Creutzfeldt-Jakob disease (CJD). A prion-free certification is a must for your brand.

  • BSE-free

    BSE stands for Bovine Spongiform Encephalopathy, also known as mad cow disease. To prevent BSE presence in gelatin capsules, as ACMA cites, they must not be "manufactured from, processed with, or otherwise containing, prohibited cattle materials. These materials include specified risk materials, material from non-ambulatory cattle, material from cattle not inspected and passed, or mechanically separated beef."

    Therefore, it is very important that the gelatin capsules you choose for your product development are BSE-free certified.

 

The process of making gelatin capsules.

Testing:

  • First of all, the raw materials need to be tested to ensure safeness.

    They go to a special oven, in which they’re submitted to the adequate temperature in order to stimulate the growth of organisms to see if they develop bacteria which can affect both the consumer and the formula of the product.

  • Next, the materials go to a spectrometer, which burns the gelatin to create a gas. This substance needs to be analyzed to assure that there are no impurities.

  • Once the gelatin passes the quality test, it is mixed and subjected to a heating process in which the gelatin will set. The heating temperature rises up to 80° C, while the storage tanks will keep the gelatin at 60° C.

  • During the filling process, capsule-shaped pens are dipped into the gelatin solution. Then they rise to where cool air blows over them to spread the solution evenly and the solution will stay in the pen until it dries.

The making:

  • Once the process is completed, the capsules are removed from the n. Using a special lever, the capsules are removed from the pans and placed in forceps, or holding grids, where they would be clipped to remove gelatin excess. The remaining pieces will be vacuumed where they will then be recycled.

  • Once trimmed, the batch will go to a classifier to establish if there are any defects in the capsules. The batch will also go through an automatic machine, which checks the capsules for holes, dents or pinches. Defective parts are thrown into the recycling bin.