Enteric Capsule Technologies

At Capsugel, we believe that robust product design is key to successfully advancing compounds, and results in overall speed-to-market. Having formulated over 4,000 compounds, we routinely develop custom approaches that improve bioavailability and positively influence the behavior of drug candidates in the body.

Science and Engineering Expertise

Our unique combination of science and engineering expertise is core to our offering at each stage of a product’s development and manufacturing cycle. Working closely with clients from design onwards, we can create optimized formulations with the greatest chances of therapeutic and commercial success.

Capsugel has multiple technologies and approaches for modifying the behavior of drug compounds within the body to achieve:

  • Effective targeted drug delivery in the upper gastro-intestinal tract
  • Protection of acid-sensitive drugs from acidic stomach conditions
  • Protection of the stomach lining from irritating drug actives
  • Effective drug delivery to the colon

Breakthrough Capsule Technology

Intrinsically enteric capsule technologies represent a significant breakthrough in providing enteric protection and targeted delivery. Capsules are designed for gastric protection, stomach protection against gastric-irritating compounds, and/or protection of the API from stomach acidity.   By incorporating biopharmaceutically-approved enteric polymers into the hard capsule shell, the technologies eliminate the need for enteric / delayed release coatings, and offer a number of benefits:

  • Product development functionality for rapid prototype development and testing of performance in patients
  • Speed to clinic – by minimizing the amount of work needed during process development, scale-up and validation programs
  • Branding and life cycle management opportunities due to the uniqueness of the capsule functionality

Enabling Technologies for Targeted Delivery

In addition to our intrinsically enteric capsule technologies, we have an extensive track record using various polymers and polymer combinations to achieve enteric protection, delayed release, and targeted delivery in the GI tract. The technologies used for targeted delivery are often employed in conjunction with other enabling technologies – such as solubility enhancement – in the development of complex dosage forms:

  • Timed-release technologies – using erodible polymer coatings for multiparticulates, tablet matrices and capsules; diffusion / erosion approaches using matrices; or osmotic approaches for zero order release
  • pH-controlled-release technologies– using polymer coatings that degrade at specific pH levels for multiparticulates and capsules
  • Combination of pH-triggered and enzyme-triggered coatings for reaching the colon

Targeted Release Finish Dosage Forms

Capsugel offers a full range of finished dosage forms focused on delayed, controlled and targeted release. These can range from single or multi-layer tablets, osmotic tablets, drug-layered or matrixed multiparticulates, capsules-in-capsules, and coated or uncoated capsules including liquid filled hard capsules (LFHC). LFHCs using either pH 6.8-7.2-triggered coatings or a combination of high pH-triggered and enzymatic-triggered coatings are typically used for effective colonic delivery.