Pharmaceutical excipient, this product serves as a thickener, hardener, and sustained-release agent in formulations, hence it is used as a thickening agent, hardening agent, and sustained-release agent for preparing semisolid and solid dosage forms, such as ointments, suppositories, pills, tablets, etc.
Usage Concentration (%)
Coating agent (delayed release) 5.0-20.0
Delayed-release substrate 5.0-10.0
Lubricant 0.5-2.0
Stamping lubricant 0.1-2.0
Others 1-10
This product primarily serves as a hardening agent for pastes in ointments, creams, and suppositories, used to adjust the consistency of formulations. In oral preparations, it is mainly employed for the production of sustained-release tablets and capsules, where it can function as a coating film or form a solid matrix to achieve sustained or controlled release. It can also act as a lubricant for tablets and capsules, improving the flowability of granules.
Hydrogenated castor oil manufacturers in China have not yet supplied pharmaceutical excipient-grade products domestically. Prior to 2013, common foreign hydrogenated castor oil brands in the domestic market included Sterotex K, Castwax MP-70/MP-80, Catina, and Cerit 3H.
Sterotex K is a product of an American company, a mixture of hydrogenated castor oil and hydrogenated tea seed oil. Castwax MP-70 and MP-80 are the primary imported varieties in China, produced and supplied by Vertellus Specialities Inc. MP-70 (with a normal melting point around 75°C) is more commonly used in daily chemical products, while MP-80 (with a normal melting point around 85°C) is primarily employed in pharmaceutical formulations.
The quality of hydrogenated castor oil primarily depends on the source of castor oil and the hydrogenation and post-processing procedures. China is a major producer and exporter of castor oil, with fatty acid compositions identical to those of European varieties but differing from those of countries like the U.S. and India. Consequently, the CP2010 standard for hydrogenated castor oil is nearly equivalent to the EP7.0 standard. Therefore, our company's product quality standards are equivalent to those of European hydrogenated castor oil products, surpassing the quality standards required by the U.S. Pharmacopeia.
The manufacturing process of our company's products differs from that of other enterprises. The key feature of our production process lies in the bleaching and deodorization steps following crude oil refining, which enhance the purity of raw materials before hydrogenation and reduce the generation of uncertain impurities. Other common processes involve deodorization after hydrogenation.
