Enteric coating and controlled-release strategies

Delayed release and prolonged release describe different objectives. Gastro-resistant formulations are designed to resist release under acidic gastric conditions. Prolonged-release formulations are designed to release drug over a longer period than a conventional-release formulation.

Sources: EMA: oral modified-release quality

Coating development considers excipient compatibility with the active ingredient and manufacturing conditions. Performance is established through testing the finished formulation.

Sources: ICH Q8(R2): pharmaceutical development

For modified-release products, dissolution testing generally uses several sampling times. Gastro-resistant formulations are tested through an acid stage followed by a suitable buffer stage. The method and acceptance criteria should reflect the particular product and be justified with development data.

Sources: ICH Q6A: specifications and testing · EMA: oral modified-release quality

A discriminating dissolution method helps reveal changes caused by formulation or processing. Similar laboratory profiles alone do not establish bioequivalence between products from different marketing-authorisation applicants.

Sources: EMA: oral modified-release quality

• The intended release profile and final dosage form.
• The proposed apparatus, media, sampling schedule and acceptance criteria.
• The evidence needed for the target market and any later manufacturing changes.

Sources: ICH Q6A: specifications and testing

Discuss the specifications, supporting data and target-market requirements for your formulation with our technical team.