Capsugel® Enprotect® Capsule – First of its kind enteric technology

The microbiome market

In a rapidly growing market, microbiome-based therapies are in high demand, yet many are abandoned due to challenges in the drug development pipeline.

Quality and batch compliance

of the microbiome drug candidates that were in the drug development pipeline between 2018 and 2021, failed due to inadequate delivery of the API1

 

market value of the global human microbiome market, including drugs, probiotics, prebiotics, foods, and diagnostic tests in 20282,3,4 Expanding from $894 million in 2025

Today’s microbiome market by the numbers

The majority of microbiome-based therapies under development today target, amongst others, diseases of the gastrointestinal tract, psoriasis and diseases that involve the gut–brain axis, such as Parkinson’s disease and other neurological disorders, cancer and infectious disease, such as Clostridium difficile infections.

Currently over 3000 studies on the microbiome4

Delivering new drug modalities

Gastrointestinal delivery of acid-sensitive pancrelipase* was evaluated with Capsugel® Enprotect® capsule using an exocrine pancreatic insufficiency disease model. Proof of enzymatic activity was determined by measuring conversion of tributyrin to butyrate.†5

*Pancrelipase is a product containing a mixture of digestive enzymes (lipases, proteases and amylases) used to treat patients whose pancreas do not produce sufficient enzymes to properly digest dietary proteins, carbohydrate and fats, a condition called “exocrine pancreatic insufficiency”6

†SHIME®, Simulator of the Human Intestinal Microbial Ecosystem5

• The pancrelipase activity has been fully protected by the Capsugel® Enprotect® capsule, as the butyrate conversion rate of 66% is the maximum achievable for this enzyme
• Capsugel® Enprotect® capsule had a similar release profile, enzyme protection and efficiency as the Creon® (pancrelipase) 10,000 U capsule

Oral solid dosage form with first of its kind enteric technology

Building on the Capsugel® legacy of developing and launching innovative oral solid dosage forms, Lonza has developed a unique manufacturing process to build a bi-layered capsule to assist in enteric delivery.

Partner with us to meet compendial enteric delivery requirements and enable accelerated development processes.

Coni-Snap® secure closure capsule design

Locking system provides leak-free containment enabling maximum delivery of API. Proprietary two-ring closure system facilitating high-speed filling processing and secure locking of capsule body and cap.

HPMC and HPMC-AS polymers

Protects acid-sensitive APIs, preventing gastric irritation and allows for intestinal delivery. Provides acid resistance up to pH 6.0 with no need for banding or sealing. Rapid disintegration profile release (within 30 minutes) in the buffer stage (pH 6.8).

Bi-layered technology

Ensures targeted delivery of APIs to the distal small intestine without the need for post-filling coating excipients7,8. No post-filling coating or additional excipient helps to accelerate drug development processes, inducing fast first-in-human timelines.

Create your ideal capsule/get support

Customize your capsule to meet the specific needs of your molecule and your brand. Lonza now offers our new TiO2-free. Swedish Orange-colored Capsugel® Enprotect® capsule for even more customization.

With fewer manufacturing steps than alternative technologies on the market today, Lonza’s enteric technology accelerates time to human and time to market

See the full brochure Capsugel® Enprotect® here:

(click the picture to download the brochure)

Source: Capsugel®/Lonza, brochure: Capsugel® Enprotect®

Interested in more information about Capsugel®/Lonza capsules?