Vcaps® Enteric
Vcaps® Enteric is a fully compliant capsule technology that simplifies drug enteric delivery implementation from early stage development to commercial manufacturing. Vcaps Enteric capsules have been evaluated in-vitro and in-vivo across a number of compounds, and have proven full compliance with relevant EP, JP and US Pharmacopeia monographs. By removing the need for enteric coating, Vcaps® Enteric capsules offer tremendous potential in early stage product development, greatly simplifying formulation and process development as well as scale-up and validation. Intrinsically enteric capsule technologies provide product differentiation, life cycle management and potential intellectual property opportunities.
About Capsugel
Capsugel designs, develops and manufactures a wide range of innovative dosage forms for the biopharmaceutical and consumer health & nutrition industries. Our unique combination of science, engineering, formulation and capsule expertise enables our customers to optimize the bioavailability, targeted delivery and overall performance of their products. We partner with more than 4,000 customers in over 100 countries to create novel, high-quality and customized solutions that align with our customers' evolving needs and benefit patients and consumers. For more information, visit www.capsugel.com.
Contact Details:
Capsugel
Website: www.capsugel.com
E-mail: solutions@capsugel.com
Specification Equivalence—A Practical Approach
December 30th 2024In this first of a four-part series, the authors provide an introduction to a practical approach for establishing specification equivalence. The regulatory basis and compliance examples from FDA observations and warning letters are included to support the need for an effective process.
