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CMC

Committed to the development and innovation of first-class drugs

Formulation R&D Platform

Oral Drug Delivery Technology Platform

The Oral Drug Delivery Technology Platform of Leadingpharm has a research and development team of nearly 200 people. In addition to ordinary oral solid preparations and oral liquid preparations, it can carry out research on sublingual/mucosal absorption preparations, high-end controlled-release preparations, gastrointestinal targeted preparations, and provide solubilization technical services.


♦Gastrointestinal-Targeted Drug Delivery
The gastrointestinal drug delivery technology team has professional R&D personnel to fully understand the solubility of various enteric-coated materials at different pH values and achieve enteric-soluble characteristics. The extrusion rounding, centrifugal granulation, and fluidized bed pellet coating process has been developed to ensure the intrinsic quality of the product. The preparation scale covers 200-100000 preparation units, which has strong industrialization ability. Have mature R&D experience, such as Omeprazole Sodium, Essomeprazole, Pantoprazole And Pantoprazole Sodium.

♦Solubilization Technology
The solubilization technology platform is committed to the formulation development and industrialization research of poorly soluble drugs. Solid dispersion solubilization technology (hot melt extrusion, spray drying, hot melt spray, etc.), salt solubilization technology, transcrystallization and solubilization technology are used to improve the solubility. The platform has an experienced team of experts and a complete equipment platform. Equipped with core preparation equipment such as spray dryer, hot melt spray granulation, hot melt extrusion granulator, multi-functional fluidized bed and so on. The platform has completed the development and registration of a number of poorly soluble drugs,such as Repaglinide tablets prepared by spray drying technology; Cefoxin dry suspension prepared by hot melt spray dispersion technology; Enalapril maleate tablets prepared by salt solubilization technology, Ceftolam pills and Ceftolam pirate granules prepared by crystal transfer solubilization technology.


♦ Modified-Release Preparations
The modified-release preparation platform has in-depth research on the drug release mechanism and various issues of scale-up production of preparation. The platform own the slow-release preparation technologies such as extrusion rounding, centrifugal granulation, fluidized bed multi-layer drug coating, hot melt spray granulation, film-controlled release technology, positioning drug release technology, etc., and has in-depth research on the drug release mechanism of hydrophobic skeleton system, hydrophilic skeleton system, storage system, skeleton film control system and high-strength gel sustained controlled release technology, and has successfully developed varieties including sustained-release skeleton tablets, sustained-release skeleton controlled-release tablets, sustained-release pellet capsules, enteric-coated pellet capsules, enteric-coated pellet tablets, membrane controlled osmosis pumps and so on.

 

 

 

 

Parenteral Administration Technology Platform

The Parenteral Drug Delivery Technology Platform has a research and development team of nearly 200 people. In addition to conventional water injection, powder injection, infusion, oral liquid, peritoneal dialysis fluid and other liquid preparations, it can also carry out research projects such as microemulsion preparations for injection, micellar preparations for injection.
 

♦ Eye Drug Delivery Technology Platform
The Ophthalmic Drug Delivery Technology Platform focuses on the clinical needs of ophthalmic drug delivery, and cooperates with the industry's senior expert think tank to carry out research on ophthalmic semi-solid preparations including solution type and suspension type eye drops, creams, gel, etc.

 

 

 

 

Inhalation Dosing Delivery Technology Platform

The inhalation platform can carry out the development, industrialization technology transfer and registration services of generic drugs and improved innovative drugs for inhalation preparations, providing customers with complete solutions.
 

The dosage forms mainly involves inhalation aerosol (MDI), inhalation powder aerosol (DPI), inhalation liquid preparation (nebulized inhalation solution), nasal spray. At present, there are more than 20 varieties under research, many varieties have entered the industrialization stage or IND stage, can be approved transfer or in-depth cooperation, such as ipratropium bromide solution for inhalation, levosalbutamol solution for inhalation, raphenacin solution for inhalation, moxifloxacin hydrochloride solution for inhalation, etc., which can efficiently provide customers with services such as registration, approval document acquisition, and value conversion.
 

Equipped with international advanced equipment including liquid dispensing system (with heating and cooling function), bladder filter, high shear homogenizer, microjet nano homogenizer, ampoule melting and sealing machine, automatic autoclave, blow filling (BFS) integrated machine, etc. Equipped with good atomization characteristic detection equipment, respiratory simulator, pharmaceutical multistage impactor (NGI), laser diffraction particle size meter, etc., it has a stability research system and facilities that meet GMP conditions to ensure the integrity and reliability of R&D data.

 

 

Transdermal Drug Delivery Technology Platform for External Use

The Transdermal Drug Delivery Platform is committed to solving the technical barriers of transdermal drug delivery preparations, improving the quality and efficacy of products, and providing pharmaceutical and clinical services for transdermal drug delivery preparations at home and abroad.
 

At present, the R&D team has nearly 30 people, all from first-class universities at home and abroad, and has more than 10 years experience of pharmaceutical R&D. The instrument and equipment are equipped with vacuum homogenizing emulsification machine, full-automatic metal tube filling and sealing machine, transdermal diffusion meter, cone penetration tester, peeling force tester, cone plate viscometer, rotary rheometer, particle size analyzer, polarizing microscope, coating machine, emulsification machine, adhesion tester, initial adhesion tester, adhesion tester, etc., which can meet the requirements of preparation research and development. It can carry out the research on chemical external lotion, gel, paste, patch and other dosage forms. Besides, it can and provide clinical research, registration services, etc.
 

The platform has carried out the research and development of several chemical drugs for external use and two Class II new drugs for external use. The projects under research include Loxoprofen Sodium Patch, Amorofen Hydrochloride Liniment, Lidocaine Dicaine Cream, Lidocaine Tetracaine Cream, Pimecrolimus Cream, Criborol Ointment, Lidocaine Gel Patch, Fentanyl Transdermal Patch, Fusidic Acid Cream, Minoxidil Topical Solution, Metronidazole Gel, etc.