Xi'an DELI Biochemical Industry Co., Ltd. was established in July, 1999. This company is a high-tech enterprise specialized in R&D of new pharmaceutical excipients, productions and sales. In 1997, the core technology was identified by the Scientific Committee of Shanxi Province, and it was considered to fill critical technological gaps in China and reach the international advanced level. In 2000, the company received free financing of 700 thousand Yuan RMB as innovation fund for technology SMEs from Ministry of Science; in 2001, the main products of the company—HP─β─CD project has been included into the Torch Plan of Xi’an, and HP─β─CD has passed the technical review of the State Drug Administration (SDA) as the first class I pharmaceutical excipients at the same year. HP─β─CD was approved for clinical trial on 14th September, 2002 (Approval NO. 2002FL0001). We applied to SFDA for declaration for production on 23rd July, 2007. Center for Drug Evaluation of the State Food and Drug Administration finished technological review on 23rd January, 2009, and submitted for approval from the State Food and Drug Administration. New drug certificate (certificate NO.: Chinese medicine certificate F20090001) and drug registration approval documents (Approval No. 2009S00608) were issued, and drug approval number was obtained (Chinese medicine certificate F20090001). The production area of the company is 2620m2, and the area of production site is approximately 400m2. Currently, the company possesses a production line and related devices with annual (HP-β-CD) yield of 100 tons. No source of pollution around the production area, and the workshop is featured with 100,000 purification area and general production area depends on the requirement of the production process.
Hydroxypropyl-β-cyclodextrin (HP-β-CD) is the hydroxyalkylated derivatives of β- cyclodextrin (β-CD). HP-β-CD is non-toxic and has no side effect, and it can significantly improve the solubility of insoluble drugs to dissolve insoluble or poorly water-soluble drugs due to its structural particularity. Therefore, it can effectively increase bioavailability of drugs; it can also improve drug quality and variety of dosage forms, thereby being applied in development and production of new drugs. Globally, in-depth studies of the properties, preparation technology, stability, pharmacology, toxicology, teratogenic, mutagenic, carcinogenic, hemolysis, irritation and other aspects of HP-β-CD have already been performed; the safety of this drug has been evaluated accurately. Among all the derivatives of β-CD, HP-β-CD is considered as a type of pharmaceutical excipients with most complete research data and highest medicinal value, and it has been studied in-width and in-depth mostly.
Medical use of hydroxypropyl β-cyclodextrin
Due to the low surface activity, low hemolytic activity and non-irritation to muscles, Hydroxypropyl β-cyclodextrin is considered an ideal pharmaceutical excipient and solubilizer in injections in pharmaceutical industry. It works to solubilize water-insoluble drugs, enhance drug stability, improve drug bio-availability (improve efficacy or lower dosage of drugs), moderate and control drug release, and can also help to diminish the toxicity and side effects of drugs. Further, Hydroxypropyl β-cyclodextrin can be applied as a drug carrier in oral medications, injections, mucosal drug delivery system, transdermal drug delivery system, and targeted lipophilic drugs. Also, it is suitable as a protectant and stabilizer for proteins.
Non-medical use of hydroxypropyl β-cyclodextrin
As a stabilizer, emulsifier and scent masking agent, hydroxypropyl β-cyclodextrin can minimize the irritation to skin and mucous membranes resulting from the organic molecules in cosmetics. Additionally, it enhances the stability of active ingredients, protects nutrients against vaporization and oxidation, solubilizes insoluble fragrance and sustains the release of the fragrance to keep it long-lasting.
Hydroxypropyl β-cyclodextrin can improve the stability and long-acting efficacy of food nutrients while covering or counteracting the unpleasant smells and tastes. By using hydroxypropyl β-cyclodextrin, the manufacturing process and product quality can be improved and the shelf period can be prolonged.
Hydroxypropyl β-cyclodextrin has been widely used in many sectors including coating and painting products, tobacco products, pesticide excipients, plant growth regulators for agricultural use, paper industry, textile industry, et al. As people are gaining great awareness of hydroxypropyl β-cyclodextrin, it shows great promise and is used in more and more fields.
Our company is a manufacturer of EP and USP qualified hydroxypropyl β-cyclodextrin. We are glad to provide customized products and service for clients according to different customer requirements.
HP-β-CD has a wide scope of applications and very huge demand. After years of the company’s efforts, our products have been utilized by hundreds of new drug research and development institutions and large pharmaceutical companies. With the raising of demands, the company invested over 20 million Yuan to construct a HP-β-CD production base with annual yield of 1000 tons in Daixin Industrial Park, Lintong Region, Xi’an in 2014, and it is expected to be completed and put into production in 2017.