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 and the demand for excipients as safe carriers in vaccines and other injectables is higher than ever before (Kaddar, 2013). As gelatin is widely used as stabilizing excipient, Rousselot Biomedical’s X-Pure range significantly increases patient safety.
As a biomaterial of choice, gelatin is widely recognized for its use in parenteral applications.
Highly biocompatible, purified pharmaceutical gelatin helps provide drug protection, offers superior drug loading rates, and great flexibility in the control of drug release. It helps stabilize vaccines and other formulations and minimizes side reactions while ensuring patient safety. These are just few examples of the many benefits provided by purified gelatins.
Read our white paper which explores these various advantages and describes how X-Pure® extra purified GMP quality gelatins can help realize superior parenteral formulations.
Pharmaceutical gelatin is a key excipient used in many vaccine formulations. It generally offers an effective strategy to improve stability of lyophilized products and is a preferred stabilizer in many vaccines. Well-known examples include Fluenz Tetra (Astra Zeneca), MMR-II and MMR VaxPro (Merck), VariVax (Merck), YF-Vax (Sanofi) and Zostavax (Merck). In the case of Fluenz, the formulation using hydrolyzed gelatin achieved significantly superior stability over a large number of alternative stabilizers evaluated.
X-Pure is ideally suited for use in such applications where lyophilization stability is required as it is also available in a hydrolyzed and non-gelling form, has well controlled endotoxin levels below 10 EU/g, and ensured batch to batch consistency.
We can help you in your vaccine development, also for COVID-19.
X-Pure® 10 HGP: safer than ever
Our excipient for parenteral formulations, X-Pure® 10 HGP (a hydrolyzed gelatin of porcine origin), is one of the purest acid gelatin alternatives available on today’s market. Purified by means of a validated process, it also offers the benefit of consistent quality.
X-PURE PHARMACEUTICAL GRADE GELATIN improves patient safety
- 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 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
Find out more our validation method under Quality first