Zhuhai Topchain Pharmaceutical Co., Ltd, established in 2012, specializes in research and manufacture of pharmaceutical excipients. MCC serial products are the main field of development of the company. The company has adequate technical resources and manufacturing capacities to satisfy individualized and differentiated demands of customers.
Manufacturing processes of the products are all independently developed by the company and possess independent intellectual property rights. Manufacturing workshops are designed and constructed as per EU API GMP standards following the quality by design (QbD) philosophy; clean manufacturing areas are of class D cleanliness. Established by reference to EU GMP standards, the quality management systems is sound and has been granted the Drug Manufacturing License and food production license（food additives） by CFDA. Product quality can satisfy requirements in NF, Ph.Eur, JP and CP specifications. MCC serial have also been registered by FDA's DMF.
TC Series are the optimal choice as filling diluents of solid preparations. With outstanding drug absorption performance, TC series can be uniformly mixed with drug and other powders so that the problem of non-uniform mixing of drug ingredients can be solved. Additionally, that good flowability plays a vital role in realizing minimal tablet weight variations. Their porous structures have strengthened their forming compressibility so that compression can be performed under low pressures while other conditions are kept unchanged; this can also reduce wearing of tablet press machines and filling dies.
The TF series is a new series of MCC ，with the ultimate ultra-high formability developed by TOPCHAIN PHARMA to solve the issues about the compression of low-formability API powders, API high-dose prescription, reducing the size of tablets and abrasion between tablets. Satisfactory tablet hardness can be obtained with relatively less pressure;and TF series can meet the requirements of API powder’s properties, customer's individualized customization and differentiated demands.
Flowablity of MCC powders has been maximized using specific technologies but not by increasing sizes and altering shapes of MCC particles so as to provide assistance in solving such problems as non-uniform mixing and greater tablet weight variations in manufacture of tablets with strongly sticky and adhesive API powders or high-dose formulations.
TLF Series products are the latest development achievements of TOPCHAIN PHARMA, which are high-end individualized MCC products with high formability and high compressibility. They are optimal diluents and fillers for compression and also the optimal choices for realizing compression of low-formability API powders and high-dose formulation of APIs and reducing tablet sizes and between-tablet abrasion. The flowability of any MCC product is not greater than TLF935. TLF525 has not only good flowability but also a formability that is much greater than that of TC101, a general MCC model.
TP Series products refer to pellets manufactured from 100% microcrystalline cellulose using a specific technology. With high sphericity, mechanical strength and controllable water absorption rate, they can be used for pellet core compression as the carrier of drug coatings and blank cores of sustained-release, controlled-release and other micropellet preparations.
TM Series products are high-quality suspending agents with a good lubrication texture. They are mixtures of micrycrystalline cellulose and carboxymethyl cellulose sodium manufactured using special technologies and mostly used in suspensions and preparations for oral suspension of indissolvable drugs.
TMS Series products are polyfunctional excipients and dried products of microcrystalline cellulose and silicon dioxide mixed using special technologies. The products have good flowability, compressibility and dispersity in the formulas. When used for direct compression, while saving the granulation procedure, the products can also greatly reduce the categories and dosages of excipients. The TOMOSIL ™ formulas can be adopted to prepare extraordinary tablets with extremely high cost performance.
TMT series products are mixed-type excipients prepared with microcrystalline cellulose and mannitol. The products can change the flowability, compressibility and disintegration of products and have an extremely low sensitivity to lubricants.
TOP Series products are high-efficacy functional excipients suitable for use in dry granulation. They are prepared with microcrystalline cellulose and anhydrous calcium phosphate as raw materials mixed using special technologies followed by drying