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Capsugel Dosage Form Solutions has multiple technology approaches with which to:
We have an extensive track record in the applications of various polymers and combinations used to achieve enteric protection, delayed release, or targeted release in the GI tract:
enTRinsic™ drug delivery technology is an industry-first: the only technology providing full enteric protection without the use of functional coatings. This technology can enable the oral delivery of sensitive molecules requiring enteric protection but unable to withstand the high temperatures associated with conventional pan or fluidized bed coating application, e.g. nucleotides and peptides, biological products such as vaccines, and live biotherapeutic products (LBP). enTRinsic technology can also offer accelerated product development of acid-labile or gastric-irritating compounds by eliminating the preparation, application, scale-up and process validation steps associated with functional coating. The specialized capsules utilized in enTRinsic technology are manufactured with pharmaceutically approved enteric polymers, and have been demonstrated to meet pharmacopeia standards for both in-vitro and in-vivo performance. enTRinsic drug delivery technology is being used to develop specialized finished dosage forms for clients under a Services Agreement.
In additional to enTRinsic drug delivery technology, we offer a full range of finished dosage forms in achieving delayed or targeted release. Delivery presentations can range from single or multi-layer tablets, drug-layered multiparticulates,capsules-in-capsules and coated or uncoated capsules.
A range of fluidized-bed equipment is used to produce drug-layered multiparticulates with either timed or pH controlled release. Capsules are coated using a range of functional coatings using either perforated coating pans or fluidized-bed equipment. A full range of coating equipment is in place for finished dosage form production at laboratory, clinical and production scales.