According to the form characteristics, physical and chemical properties and stability of drugs, we conduct process research to determine the preliminarily preparation process of laboratory samples and set corresponding process control indicators.
Our CMC Department has worked successfully with well-known large and medium-sized companies . With more than 10 years' experience in the research and filing of innovative drugs and generic drugs, the department is continuing to develop its capabilities.
We have extensive equipment commonly used in preparation process and quality assessment for preparations including tablets, injections, capsules, granules, ointments, creams, sprays, gels, syrups, tinctures and oral liquid preparations, as well as GMP-based pilot-scale test workshops for oral solid preparations. We are also capable of developing new technologies such as sustained-release preparations, nano preparations and fat emulsions.
Development of generic drugs and corresponding strategies
election and analysisRLDsAnalytical method developmentKey ingredient selectionComparison with RLD quality index comparison to determine formulationOptimization of production process parameters based on QbDPackaging materials and container selectionProcess scale-up and technology transfer Analytical methods verificationQuality standards verificationProduct stability investigation
Development of innovative drugs and corresponding strategies
Suspensions (micro-suspensions and nano-suspensions)Bottled active pharmaceutical ingredientsMicro-filling of active pharmaceutical ingredientsDry mixing and pottingLiquid capsule filling Spray dryingDry/wet granulating and capsule filling/tabletingDirect tabletingPouch filling
New technology for preparation
Development of single-layer or double-layer sustained-release tabletsSkeleton and coating technology Filled capsules with sustained- or delayed-release pelletsSustained-r or delayed-release pellets, granules, and tablets filled with hollow capsules to enable slow release in vivo. Microsphere preparation Dissolves or disperses the drug in a polymer material, and then employs the solvent evaporation method to obtain skeleton-type tiny spherical subjects with a diameter of 1-25 μm (which has a sustained-release effect). Microcapsule preparationUses natural or synthetic polymer materials to wrap the drug into a warehouse-like structure, and then uses a carrier with slow-release properties to facilitate a sustained release from the capsule. LiposomeEncapsulate the drug in vesicles composed of lipid bilayers by film dispersion and reversed-phase evaporation.
Technical support for preparation
Micronization by airflow grindingGranulating after nano suspension or micro suspensionPreparation of solid dispersion by spray dryingHot melt extrusionLiquid capsule filling
In the development of pharmaceutic preparation, more drugs with low solubility have been identified recently, and about 70% of new drug candidate compounds are insoluble drugs. Our Preparation Department has professional platforms for insoluble innovative drugs and high-end preparations, with a focus on R&D services.
With our advanced technologies, solubility and permeability problems are easily resolved to improve the success rate of drug development, shorten R&D time, and promote compounds through new drug development. At present, technical platforms for solid dispersion (hot melt extrusion), micronization, solubilization, clathrate compounds, in vitro dissolution/in vivo PK comprehensive evaluation have been established and finely honed. Medicilon's Preparation Department not only features outstanding performance in the R&D of traditional forms, but also has established technical platforms for high-end preparations such as those for inhalation, ophthalmic, transdermal, sustained- and controlled-release, and new particulate system administration. We have established a complete GMP-based workshop for oral solid preparations, a GMP-based analysis laboratory and a QA system. We have an experienced R&D team that boasts a wealth of success in innovative drug R&D, consistency evaluation, optimzed innovative drug R&D, IND services and project management. The Preparation Department R&D team is highly professional, with rich experience in preparation process research and analysis. Through their efforts, the preparation process and quality research can be guaranteed to be completed in a standardized, high-quality, and efficient manner, corresponding control indicators can be established and the industrial manufacturing of products finalized.Our one-stop preparation R&D service includes complete preparation research (R&D + clinical sample production), safety evaluation, package compatibility, filter membrane verification, package sealing inspection, pre-BE and BE research.
Service scope
Relevant laboratories
Relevant articles
marketing@medicilon.com
ABOUT
