Medicilon has the professional formulation technical platform and the most experienced team, which could offer fully integrated pharmaceutical services to meet different requirements of our clients. We focus on the development of solid dosage forms, semisolid dosage forms, liquid dosage forms and sterile dosage forms. Our formulation group is also highly experienced in developing sustained release dosage forms, micro-particle dosage forms, protein and peptide drugs, etc.
Medicilon CMC department is a team with well-known large and medium-sized enterprises at home and abroad successful cooperation in innovative drugs and generic drugs research, declaration accumulated more than 10 years of experience, and is still growing with the times.
We have tablets, injections, capsules, granules, ointments, creams, sprays, gels, syrups, tinctures, oral liquid preparations and other preparation technology research and quality research commonly used equipment and instruments and oral solid preparations GMP pilot plant. We also have the development of slow release preparations, Nano preparations, fat emulsion and other new technology research and development capabilities. R & D team personnel have a strong professional level and a wealth of preparation process research, analysis of experience, to ensure that the norms, high quality and efficient preparation of prescription technology research, quality research, and the establishment of the corresponding process control indicators, and ultimately industrial production.
The practical review of the established process route not only examines the yield, product quality and economic efficiency, but also examines the labor intensity of the workers.
The workshop layout, workshop area, safety production, equipment investment, production costs, etc. must also be carefully analyzed and compared, the final validation process operation methods, process division and arrangement.
The requirements of the pilot process:
i) The process is clear, the operating conditions to determine the product yield stability, quality and reliable.
ii) The establishment of the products, intermediates and raw materials standards and analytical methods.
iii) To provide the required general equipment and the performance of certain special equipment and pipe materials.
iv) There are preliminary waste disposal programs and safety requirements.
The Requirements for the device:
i) According to the type of reaction, operating conditions and other options and design, taking into account the material and form requirements (especially corrosive materials), according to the process to install.
ii) It can also be in a highly adaptable multi-function workshop.
iii) With a variety of medium and small reactor and post-processing separation and purification equipment.
iv) The reactor has a stirrer, and the mixer is preferably equipped with step less speed regulation.
v) The reactor has a variety of piping, can be steam, cooling water or ice salt water, etc., also attached to the distillation device can be reflux or fractionation, and decompression and other fractions.
vi) Some reactors are also equipped with medium and small centrifuges, etc., solid-liquid mixture filtration is generally a small mobile filter press.