Sustainable Solutions in Drug Delivery: The Evolution of Enteric-Coated Softgel Capsules

Highlights

• Introduction
• Growth of the Asia-Pacific enteric softgel capsules industry
• Impact of advanced materials on enteric softgel couples
• Innovative products in the landscape

Enteric-coated capsules are formulated to resist dissolution in the mouth to prevent activation by acid exposure, making them suitable for specific formulations. The flexible gelatin shell, often combined with glycerin and plasticizers, makes it easy to swallow. Enteric softgel capsules offer advantages such as improved drug absorption, fewer gastrointestinal side effects, and enhanced patient compliance, particularly for those with specific health needs. Hence, they are widely used in the pharmaceutical and nutraceutical industries.

The coating prevents the capsule from dissolving in the mouth and esophagus, ensuring it remains intact until it reaches the stomach. Many drugs cause stomach irritation if released there; however, enteric-coated capsules allow the formulation to pass through the stomach without affecting the stomach lining. Additionally, the enteric coating protects any enzymes within the capsule from dissolving in the stomach's acidic environment. These capsules take an hour or two to dissolve, making them suitable for time-sensitive medications. The enteric softgel capsules industry is gaining prominence due to the surge in the prevalence of nutritional deficiency diseases, technological advancements in manufacturing, and increasing focus on clinical trials for new technologies and formulations.

The rise of enteric softgel capsules in Asia-Pacific

The Asia-Pacific region faces significant challenges related to nutritional deficiencies. The demand for effective dietary supplements that provide essential nutrients is rising, and enteric softgel capsules are well-suited for this purpose due to their ability to enhance bioavailability and mask unpleasant tastes.

The pharmaceutical landscape in the Asia-Pacific region is experiencing rapid growth due to a strong emphasis on innovative drug delivery systems. Enteric softgel capsules are becoming increasingly popular for delivering medications sensitive to stomach acids, such as proton pump inhibitors and specific antibiotics, which is further boosting their adoption in the region.

Moreover, rapid urbanization in the region is experiencing lifestyle changes that lead to poor dietary habits. This shift has heightened the demand for dietary supplements to address nutritional deficiencies, thereby boosting the industry for enteric softgel capsules.

Among the developing economies of Asia-Pacific, China is projected to cite a noteworthy CAGR of 7.20% by 2032. Governments and regulatory bodies in the region are providing increasing support to the health and wellness industry, promoting a favorable environment for the growth of dietary supplements. Furthermore, rising investments in research and development by major players are supporting the introduction of new and innovative products into the landscape.

Enhanced drug stability and patient compliance with biodegradable and hydrogel coatings

A significant advancement is the creation of biodegradable enteric coatings, which enhance sustainability by reducing environmental impact. These coatings are designed to break down naturally, addressing concerns about polymer accumulation. Hydrogel-based enteric coatings have also been introduced, providing enhanced protection for sensitive drugs and improving their stability and bioavailability. Moreover, the developing combination capsules with multiple compartments allows for the simultaneous delivery of various drugs, which boosts patient compliance and treatment effectiveness.

Lonza introduced the Enprotect® Size 9 capsule in June 2024

Lonza, a leading global partner in the pharmaceutical, biotech, and nutraceutical industries, announced the launch of the Capsugel® Enprotect® capsule in a new, smaller size 9 format. This innovation is designed to streamline pre-clinical solutions for delivering acid-sensitive active pharmaceutical ingredients (APIs).

The capsule utilizes award-winning Capsugel® Enprotect® technology by Lonza, which safeguards the drug payload from stomach acid, prevents gastric irritation, and facilitates enteric release. This new capsule allows for the integration of acid-sensitive drugs in pre-clinical testing with rodents. Its versatile technology supports the entire development process, from clinical trials to commercial manufacturing, thereby accelerating clinical development and the timelines for first-in-human studies.

The capsules offer acid protection and targeted enteric delivery without additional coatings, streamlining the formulation and manufacturing processes. Testing active pharmaceutical ingredients (APIs) in their final dosage form benefits clinical testing and commercial launch.

Catalent introduced a new delayed release softgel technology

Catalent unveiled OptiGel DR technology in October 2020. The technique is designed to formulate and produce delayed/enteric release softgels. It integrates pectin, a naturally derived polysaccharide, with gelatin to form the softgel capsules, thereby eliminating the need for an additional coating step.

According to the company, the delayed release profile of this technology safeguards active ingredients from stomach acid degradation, allowing them to be released directly into the intestine where they can be absorbed. This approach potentially enhances the bioavailability of the active ingredients.

Wrapping up

Enteric-coated capsules, particularly softgels, are transforming drug delivery and dietary supplementation. Their ability to enhance bioavailability and patient compliance while protecting sensitive formulations is contributing to the growth of the industry. Moreover, innovations like biodegradable coatings further enhance their appeal by combining efficacy with environmental sustainability.

For more details regarding advanced manufacturing techniques of enteric softgel capsules, contact our experts today

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