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30 Sep 2013

Capsugel's Scintigraphic In Vivo Study of DRcaps Capsules Tracks Successful Delayed Release

Capsugel, a global leader in innovative dosage forms and solutions for the healthcare industry, has announced that the results of its 2013 scintigraphic in vivo study of its DRcaps capsules definitively documents that the specially formulated acid-resistant hydroxypropyl methylcellulose (HPMC) capsules are an “excellent choice” for delayed delivery of acid-sensitive ingredients such as probiotics and enzymes.

Data and images empirically demonstrate the capsules’ effective protection from early activation caused by stomach acids and, for a majority of study subjects, complete release in intestines where products such as probiotics and enzymes work best. More specifically, the capsules began release in a mean time of 52 min after ingestion and completely released the ingredients in a mean time of 72 min after ingestion.   

“The results from this human clinical study provide scientific evidence of DRcaps capsules’ acid-resistant and delayed-release performance to give confidence that DRcaps capsules are an excellent choice for delivery of acid-sensitive ingredients,” said Dr Keith Hutchison, Senior Vice President of R&D at Capsugel.

The study was designed to investigate the in vivo behavior of DRcaps using a scintigraphic method to assess the gastrointestinal transit and release of the contents from capsules based on the images obtained. Gamma scintigraphy is an established technique in which a radio label is swallowed and the disposition in the gut is photographed externally over time.

The scintigraphic study revealed that the capsules actually began releasing at 52 min when they were about to leave the stomach. “That is 45 min later than an immediate release capsule and means that the contents of the capsules would often be released in the intestines — where probiotics and enzyme ingredients are most effective,” Dr Hutchison elaborated.

DRcaps capsules are designed with unique polymer properties to slow down capsule opening after swallowing without adding synthetic chemicals, solvents or other coating ingredients. “The special release properties built into the capsules provide the choice of a vegetarian product for fast product launches, and still provide acid-protection and delayed release,” Dr Hutchison concluded.

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