White Papers

Healthcare Documents

White Papers		Languages	Available as Request
METOLOSE® SR
	METOLOSE® SR using QbD Sample Kit A sample kit of Hypromellose having different viscosity levels, hydroxypropoxy (HPO) content and particle size was applied to a robustness study of a hydrophylic matrix tablet of dipyridamole. There was a difference in dissolution between the different viscosity grades of Hypromellose. However, there was no significant difference in the release profile when parameters were carried over the upper and lower limit of each specification. The only exception was a difference in release profile with the lowest viscosity grade containing lower end of HPO. Overall the data suggested that the formulation used in this study was highly robust with respect to the properties of Hypromellose.
	Robustness Study for Hydrophilic Matrix Tablets of METOLOSE® SR using QbD Sample Kit A sample kit of Hypromellose having different viscosity levels, hydroxypropoxy (HPO) content and particle size was applied to a robustness study of a hydrophylic matrix tablet of dipyridamole.
	Strategies to Reduce Nitrosamine Contamination of Drug Products Nitrosamines contamination of drug products is a concern for pharmaceutical companies and patients. From the 2018 report of N-Nitrosodimethylamine (NDMA) in various Sartan-type drug products, the regulatory bodies imposed a strict limit of acceptable intake of 96 ng/day for this specific nitrosamine. In the recent years, more drug products have been found to be contaminated with nitrosamine impurities leading to recalls and shortages of medicines world-wide, that includes Metformin HCl, Ranitidine, Nizatidine, Rifampin and Rifapentine. The risk of nitrosamines formation may vary depending on API and the drug product formulation. The nitrite test results indicate that Shin-Etsu hypromellose could be a solution to reduce risk of nitrosamine formation in drug products.
Shin-Etsu AQOAT®
	A New Developmental Grade of HPMCAS Hypromellose Acetate Succinate (HPMCAS) is known as an enteric polymer and used in coating for the last 30 years. HPMCAS also has excellent properties to use as a carrier in solid dispersion, a method to improve the solubility of poorly water-soluble drugs, due to its high solubilizing capability and high performance to maintain super-saturation. As a method to prepare solid dispersion, Hot Melt Extrusion (HME) is becoming attractive because of freedom from organic-solvents and high productivity. In HME, the polymer should be extruded at relatively low temperature as it can decompose at high temperature. In this study, Shin-Etsu has developed a new grade of HPMCAS that has better workability in the HME process. This new grade can be easily extruded at lower temperature than the conventional grades, while it keeps the original performance of heat stability, water adsorption and maintaining super saturation of APIs.
	Application to Solubility Enhancement Using Melt Extrusion Technology The development of bioavailable solid dispersions requires the use of secondary materials for stabilizing the amorphous dispersion while also enhancing dissolution and solubility of the new chemical entity. With the increased use of amorphous dispersions, HPMCAS (Hypromellose Acetate Succinate) has emerged as a commonly used excipient for formulary design. This white paper details the properties of HPMCAS that make it a beneficial material for use in solid dispersion formulation, with a specific focus on relevant properties for melt extrusion.
	Development of a user friendly coating formulation containing HPMCAS. Presented at AAPS 2014
	Trust the Originator: HPMCAS Technology The development of bioavailable solid dispersions requires the use of secondary materials for stabilizing the amorphous dispersion while also enhancing dissolution and solubility of the new chemical entity. With the increased use of amorphous dispersions, HPMCAS (Hypromellose Acetate Succinate) has emerged as a commonly used excipient for formulary design. This white paper details theproperties of HPMCAS that make it a beneficial material for use in solid dispersion formulation, with a specific focus on relevant properties for melt extrusion.
L-HPC
	Try L-HPC to Formulate Solid Dosage Forms with Good Stability. L-HPC (Low-substituted Hydroxypropyl Cellulose) was first approved in 1987 as a disintegrant/binder for pharmaceutical solid dosage forms in Japan. A recent survey shows that L-HPC is ranked as the first choice for tablet disintegrant by Japanese pharmaceutical companies. Not only a disintegrant, L-HPC also functions as binder due to its good compressibility. There are many cases that L-HPC solved problems of interactions with APIs other issues such as capping.