Excipients for Parenteral Use
The parenteral application requires excipients of highest quality standards. Solubilizers and co-solvents are the most widely employed excipients in the formulation of parenterals. BASF offers a wide range of high-quality solubilization excipients and has unparalleled experience in quality and regulatory affairs, as well as solubility enhancement strategies.
We offer a range of highly effective solubilization excipients for parenterals. Our experts have access to industry-leading tools and analytics such as our in-house developed high throughput formulation robot, comprehensive solubilization screening, supersaturation and crystallization precipitation kinetics, as well as biorelevant analysis. Coupled with a deepand profound understanding of our excipients, we are in anexcellent position to enable our customers to tackle their solubilization challenges rapidly and efficiently.
Our excipients for parenterals are produced in Germany by qualified and experienced employees in line with the appropriate high-quality standards including documentation, equipment, utilities and personnel.
The quality & regulatory benchmark BASF applies to its excipients for parenterals comprises of:
- Manufacturing according to IPEC-PQG GMP
- Compendial compliance covering current and proposed major global pharmacopoeia standards
- Endotoxin & microbial testing
- Elemental impurity limits as per ICH Q3D, stability studies as per ICH guidelines
- Regulatory documentation, registration & submission support
- Non-clinical safety data
|Product||Functionality||Monograph title / Chemical category||FDA IID listing|
|Kollidon® 12 PF||Solubilizer by complexation||Povidone (Ph.Eur. and USP/NF) / Synthetic polymer||Yes|
|Kollidon® 17 PF||Solubilizer by complexation||Povidone (Ph.Eur., USP/NF and JP/JPE) / Synthetic polymer||Yes|
|Kolliphor® ELP||Nonionic solubilizer and emulsifier (surfactant; HLB = 12-14)||Macrogolglycerol ricinoleate (Ph.Eur.) and Polyoxyl-35-castor oil (USP/NF) / Polyethoxylated castor oil||Yes|
|Kolliphor® HS 15||Nonionic solubilizer and emulsifier (surfactant; HLB = 15)||Macrogol 15 Hydroxystearate (Ph.Eur.) and Polyoxyl 15 Hydroxystearate (USP/NF) / Polyethoxylated 12-hydroxystearic acid||Yes 1|
|1 Kolliphor® HS 15 is used in a recently FDA approved parenteral drug. For over ten years Kolliphor® HS 15 has been used in injectable drugs in both Canada and Europe.
Discover our Excipients for Parenteral Use
More excipients for parenteral use to come