METOLOSE® SR (Hypromellose) is especially suitable for Hydrophilic matrix systems, and provides a genuine consistency in the final products.
Hydrophilic matrix systems designed with water-soluble polymers, such as Hypromellose, were first introduced in the early 1970s. Since then, development work has concentrated on controlled release technology, and many types of advanced polymers and techniques have become available. The hydrophilic matrix system is the simplest sustained release technology for oral dosage forms, consisting essentially of a drug and a water-soluble, highly viscous polymer. It does not require any other excipient.
Recent advances in this hydrophilic matrix system have allowed more controllable and reproducible drug release by controlling the chemical and physical properties of the polymer.
QbD sample kits
Quality by Design (QbD) principles have been used to advance product and process quality, and most recently have been adopted by the U.S. Food and Drug Administration (FDA) as a tool to discover new drugs, developed, and commercially manufactured. The focus of this concept is that quality should be built into a product with a thorough understanding of the product and process by which it is developed, and manufactured along with a knowledge of the risks involved in manufacturing the product and how best to mitigate those risks. For the ICH Q8 guidelines on Pharmaceutical Development, many customers are requesting samples of excipients which are having an impact on the batch to batch quality of the final product. Metolose SR is the simplest sustained release technology for oral dosage forms. The ICH Q8 guidelines may require our customers to evaluate samples that are on the edge of our specifications. Due to our strict quality control it is difficult to provide samples within the outer limits of the specification, therefore Shin-Etsu this year have produced Metolose SR QbD sample kits. Each kit contains our regular specification, high and low viscosity and Hydroxypropoxy (HPO) content and also large and small particle sizes. We have internally evaluated the sample kits and you can find this data in our new technical information sheet SR-009. Please ask one of your local Shin-Etsu representatives for further information on our technical data and sample kits.
METOLOSE® SR Applications
e.g. Technical Information,
Material Safety Data Sheet and Samples
need to be requested by e-mail
Phone: +49 611 962-6199