Application of spray drying technology in the production of antibiotics

[technical article of China Pharmaceutical network] datomomycin and vancomycin are two of the most powerful members of the antibiotic family at present, with great market demand However, using traditional freeze-drying technology for production will bring many limitations, high equipment investment cost, and because of batch production, low production capacity, unable to meet the huge market demand What is the way to make more people use the "life-saving drugs" in time? (the application of spray drying technology in the production of antibiotics) vancomycin in antibiotics has been regarded as the last line of defense against drug resistant strains Until the emergence of superbugs (methicillin-resistant microorganisms), it also became hopeless In 2004, when datomycin came into the market, it quickly replaced vancomycin These two antibiotics have similar antibacterial spectrum activity, but datomomycin has strong antibacterial effect on Gram-positive cocci It can be used to treat right infective endocarditis caused by Staphylococcus aureus and Staphylococcus aureus bacteremia related to right infective endocarditis or complex skin and soft tissue infection In just two years after it was put into the market, daptomycin soon occupied more than 2000 hospitals and emergency center pharmacies in the United States, and became an effective means to deal with drug-resistant strains of diseases trusted by American doctors The problem is coming: at present, datomomycin and vancomycin are two powerful members of the antibiotic family, with great market demand However, using traditional freeze-drying technology for production will bring many limitations, high equipment investment cost, and because of batch production, low production capacity, unable to meet the huge market demand Who is the "Wulin expert" in the pharmaceutical industry who can overcome the difficulty of output + industry standard, so that more people can use "life-saving medicine"? A "mysterious great Xia" from the East has been searching for a good prescription in the world since 2013, and aspires to find a way for the birth of "life-saving medicine" Zhejiang Pharmaceutical Co., Ltd is a large-scale joint-stock comprehensive pharmaceutical enterprise established in May 1997 Founded in 1954, Xinchang pharmaceutical factory, the core holding enterprise, has more than 50 years of professional experience Since 2007, "Zhejiang medicine" has been allowed to export APIs to the United States Vancomycin and daptomycin have been the key projects of "Zhejiang medicine" in recent years After repeated process comparison and deliberation, "Zhejiang medicine" decided to adopt the same spray drying technology approved by FDA GMP in the United States instead of the traditional freeze drying technology The former has the characteristics of continuous production and low initial investment, which can solve the dual concerns of economy and efficiency Which "powerful artifact" should be chosen to carry out this innovation? Considering the strict standards of drug production, "Zhejiang medicine" is very careful SPX flow is a powerful tool for "Zhejiang medicine" to relieve worries and send "made in China" to the United States Among the many candidates, "Zhejiang medicine" understands SPX FLOW's Anhydro brand has nearly 80 years of experience in spray drying technology Its various types of mass production equipment are well known in the industry, and its professional small equipment is the winning weapon of many pharmaceutical plants in research and development projects So, in 2013, "Zhejiang medicine" came to SPX with vancomycin sample FLOW overseas laboratory uses Anhydro small aseptic spray drying equipment MicraSpray 35 for testing The "small sharp tool" is specially designed for the research and development of the pharmaceutical industry, and can also be used for small-scale and continuous actual production, which conforms to the pharmaceutical production management specifications The spray drying principle ensures the experimental results and is reliable, and can easily accomplish the functional transformation from experimental research to quantitative production Finally, the results of the experiment were satisfactory "Zhejiang medicine" was given the title of the book, and the MasterSpray 1250 of the town store of SPX FLOW was taken decisively to put into operation the "vancomycin" This "large size artifact" is the world's largest and successful sterile spray drying equipment certified by the US FDA GMP At the same time, FDA agreed to apply for NDA of vancomycin hydrochloride for injection of "Zhejiang Pharmaceutical" in the form of 505b2 The next year, Jiaxun arrived again, Zhejiang medicine successfully completed the experiment of daptomycin in the same way again, and FDA also agreed to apply for NDA of daptomycin products for injection of Zhejiang medicine in the way of 505b2 In 2017, "Zhejiang Pharmaceutical" vancomycin hydrochloride for injection product submitted NDA application to FDA In this regard, this low-key "great Xia of the East" with the help of a unique secret collection, accelerated his journey to the West The team of experts guarding the array and escorting SPX flow for "made in China" has not only "possessed unique skills", but also overcome many technical difficulties along the way, and finally gained win-win solutions with "Zhejiang medicine" In addition, it has also carefully purchased testing equipment to ensure the validity of the experimental results The service does not stop from the contract! After the project, SPX flow's expert team continues to "teach the truth" to provide a progressive technical support, including the analysis of technical problems in the production process and the provision of technical data to explain the technical problems to the drug regulatory authority (FDA), so as to clear up the obstacles and pave the way for "made in China" to expand in the international market! The secret has its origin The Anhydro technology is used to solve the technological problems of production cost and production capacity for "Zhejiang medicine" FDA is certified as vancomycin and datomycin's efficacy and safety endorsement, so that these two drugs are no longer remote for patients I hope that in the near future, the "Wulin secret collection" of different sects can make all kinds of "life-saving drugs" no longer in short supply or expensive, and people all over the world can benefit from the professional technology and technological progress in the pharmaceutical field Popular science time: FDA, anda, NDA FDA: the abbreviation of food and drug administration, authorized by the U.S Congress or the federal government, is a high-level law enforcement agency specialized in food and Drug Administration anda: application for generic new drug ）This kind of application does not need to provide preclinical (animal) and clinical (human) data to prove its safety and effectiveness Instead, evidence of the bioequivalence of the product must be provided NDA: short for new drug application When the sponsor has enough reasons to prove that the safety and effectiveness of the drug meet the FDA's requirements for listing, the sponsor can submit NDA to FDA All new drugs to be listed in the United States must go through the new drug review process Technical materials such as chemistry, pharmacology, biopharmaceutics and statistics must be included in the submission for review Original title: [production site] spray drying technology in the production of antibiotics in the application of the whole process to teach you to use APP (Pharmaceutical Tong), seize the opportunity of medicine machine