Plenity is a porcine gelatin capsule that contains a hydrogel powder (0.75 grams per capsule). Plenity is non-systemic and works directly in the gastrointestinal tract. Plenity hydrogel is…
Plenity is a porcine gelatin capsule that contains a hydrogel powder (0.75 grams per capsule). Plenity is non-systemic and works directly in the gastrointestinal tract. Plenity hydrogel is made from two naturally derived ingredients, cellulose and citric acid, that form a three-dimensional matrix designed to occupy volume in the stomach and small intestine, to create a sensation of fullness. Plenity is provided non-sterile. The capsules disintegrate in the stomach and release the Plenity particles, which can hydrate up to 100 times their original weight. When fully hydrated, the individual non-clustering Plenity particles from the 2.25 g/dose occupy about a quarter of the average stomach volume. The gel particles mix with ingested foods, creating a larger volume with higher elasticity and viscosity in the stomach and small intestine. Plenity passes through the digestive system, maintaining its three-dimensional structure in the stomach and small intestine before breaking down in the colon. The water is then released and reabsorbed by the body. Plenity particles are eliminated through normal bowel movements; they are not absorbed by the body. Patients consume a dose of three (3) capsules supplied in a single peelable pod. Patients take daily two doses with water, before both lunch and dinner. Plenity pods are supplied in a monthly kit for 28 days (4 weeks) of treatment.
Who Else Makes It
Registered in Guangdong.
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Single use | Yes |
| Prescription | Prescription only |
| Over the counter | Yes |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 5 to 30 °C |
| Packaging | Monthly kit of 4 |
| Distribution end date | 2025-01-20 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.