All you need to know about Gelatin Capsules

Gelatin capsules – two-piece hardcaps – are produced from high-grade gelatin, a protein derived from animal hides. They are a predominant drug delivery system and are safe for your health.

Introduction

Gelatin Capsules

Part of our medications and supplements are formulated as capsules, having different shapes, colors, and textures. They are made as such for various reasons. On one side, capsules afford the manufacturers of pharmaceuticals the flexibility to package varieties of fills and deliver them for desired actions in the body. Consumers also prefer the softness and smoothness of capsules; their lack of taste, odor, and appearance make them inviting and easy to use for kids and adults alike.

As a popular empty capsule product in the market, gelatin capsules are of great interest to consumers and regulatory bodies alike.

Keep reading to find our answers to the top FAQs we have received about gelatin capsules: their source, uses, available types, and safety for health.

What are gelatin capsules?

Gelatin capsules have been used for almost 200 years in the pharmaceutical industry. They are an easy and effective delivery system for holding active pharmaceutical fills intended for oral use. Capsules provide an alternative to tablets, granules, and powders as oral dosage forms. They help increase the acceptance and ease of use of medications and work with a wide range of pharmaceutical ingredients, including liquids and solids. Gelatin is a pure, non-reactive, safe, and non-GMO material that allows for diverse applications. Gelatin capsules have dominated the empty capsules market, holding 88.5% of the $2.8 Bn global market share in 2021.

What are gelatin capsules made of?

Bovine Hide
Gelatin is a derivative of collagen, a protein found in the skins and connective tissues of cattle, pigs, and fish. This gelatin is used extensively in the food and pharmaceutical industries. The most preferable source of gelatin capsules comes from the cattle due to mass production requirements and safety of precedence.


Gel caps are made via a process called "dip-coating"; which involves molding and cooling off a hot concentrated gelatin solution.

Apart from gelatin, this type of capsule may also contain opacifiers, colorants, preservatives, and other additives to enhance the capsule's formation and function.

The principal component – gelatin – has some unique characteristics that make it an early preference for capsule production. These characteristics include its good gelling, stabilizing, and emulsifying properties, plus its glossy appearance, which is flexible at the print.

What are gelatin capsules used for?

Gelatin capsules are used mainly for oral medication drug delivery; and occasionally for other routes (for example, suppositories for rectal use). The advantages of gel caps include:

  • Allowing accurate and convenient unit dosing of drugs, vitamins, and nutraceuticals.
  • Capsules help to mask the unpleasant taste and smell of drugs, ease swallowing, and deliver by mouth drugs that are not formulable as tablets.
  • They help enhance medication acceptance, identification, and adherence for the patient and, thus, improve therapeutic outcomes.
  • Manufacturers have higher branding flexibility with gelatin capsules through shape and color variation, which helps promote brand identity and recognition.
  • Capsule aids modern drug delivery, capable of housing beads, mini-tablets, and even mini-capsules.
  • In clinical studies, gelatin capsules are often used to present test drugs for administration to volunteers.
  • Capsules enable individuals to develop personal supplement formulas at home to meet specific needs.
  • For veterinary care, using home-filled PetCaps is a more convenient way to pill your cat or dog without making a mess, losing the medicine, or risking a bite.
    Empty Gelatin Capsules by Capsuline

    What are the two types of gelatin capsules?

    Gelatin capsules are generally of two types: hard two-piece gelatin capsules (also called hard capsules or hardcaps) and soft gelatin capsules (or softgels). Hard capsules make up about 75 percent of gelatin capsules on the market. Softgels have also gained popularity over the years because they help attain specific manufacturers' and patients' needs. The two types also differ in the nature and volume of their fills. Further distinctions between these two types of gelatin capsules are: 

    • Hard capsules: these got their name from their stiff appearance when filled. They are a two-piece capsule system consisting of separable cylindrical gelatin shells– a shorter cap and a longer body, each closed at one end. The capsule has a slightly wider diameter, allowing the body to fit into it, forming a tight seal. Hard capsules are usually prefabricated and can be used to formulate solid, semisolid, and liquid pharmaceuticals.
    • Softgels: are often one-piece hermetically sealed gelatin capsules used exclusively for formulating liquid and semisolid actives. There are various sizes, designs, and shapes of softgels that may be used for any of the above-listed reasons. In addition, twist-off and suckable softgels are made to give direct access to their content, as found in some vitamin products.

    Are gelatin capsules good for health?

    Pharmaceutical-grade gelatin is subjected to rigorous quality testing for physical, chemical, and microbiological integrity before being supplied to industries for capsule production. Reputable suppliers also ensure compliance with global and local standards and specific consumer requirements in making raw gelatin available for use.

    In addition, trusted capsule manufacturers produce their capsules in cGMP-certified facilities applying rigorous quality control processes. They also adapt their manufacturing and marketing operations to meet regulatory updates. Hence, gelatin capsules have excellent safety profiles when used for drug formulation.

    Furthermore, the FDA has repeatedly confirmed that standard gelatin does not suffer the risk of contamination with bovine spongiform encephalopathy (BSE) agents. Also, many suppliers get consumers' preference certifications from recognized bodies such as Halal and Kosher to assure safety and acceptability.

    Conclusion

    Empty gelatin capsules are of great value to the pharmaceutical industry, supporting a wide application as a drug delivery system. Also, they are non-toxic, and multiple studies have shown that taking gelatin, especially as a supplement, offers significant health benefits to joint, bone, skin, hair, gut, and liver functioning.

    Are you interested in getting empty gelatin capsules? Check out our collections here.

    Resources:

    https://www.fda.gov/food/cfsan-constituent-updates/fda-announces-final-rule-bovine-spongiform-encephalopathy
    https://www.healthline.com/nutrition/gelatin-benefits#TOC_TITLE_HDR_9