Today’s parenteral formulations industry is growing rapidly. In the vaccines segment, for instance, government organizations are launching increasing numbers of programs around the world to combat the rising prevalence of (infectious) diseases. Trends like this are pushing up demand for excipients offering patients maximum safety.
Rousselot offers you a new excipient for parenteral formulations that is purer than all acid gelatin alternatives available on today’s market: X-Pure® 10 HGP. Because we purify it following a validated process, product developers also benefit from consistent quality.
X-Pure® 10 HGP is a highly purified, hydrolyzed gelatin of porcine origin that offers many benefits over alternative excipients for parenteral formulations, both for patients and developers.
- Unrivalled safety as the first hydrolyzed acid porcine gelatin on the market with endotoxin levels below 10 Endotoxin Units per gram (EU/g), or even below LAL analysis detection limits(1) if required
- Biodegradable and therefore absorbable
- A substance of natural origin, well tolerated by the human body and biocompatible
- Purified by Rousselot, following a validated process
- Maximum quality consistency
- Generally Recognized As Safe (GRAS) by the USA’s Food and Drug Administration (FDA) and compliant with the US, and European pharmacopeia
- Suitable for both human and veterinary applications
One of the challenges in applying parenteral formulations, such as vaccine injections, is to avoid exposing the patient’s body to harmful endotoxins. When used in-body, these toxins can cause severe and sometimes fatal immune responses. As gelatin is widely used as an excipient, X-Pure gelatins significantly increase patient safety.
X-Pure® 10 HGP is a highly purified acid treated gelatin of porcine origin, offering endotoxin levels that are unrivalled in the market. Check the table below for details.
(1) These levels are determined by means of the Charles River LAL (Limulus Amebocyte lysate) assay, an FDA-compliant method