MCC difficult to choose? Not at all!
Microcrystalline cellulose (MCC) is widely used in tablet and capsule formulations, usually as a diluent or blinder. In addition, due to its certain lubricant and disintegrant properties, MCC is generally used as an adsorbent, suspending agent, tablet and capsule diluent and disintegrant in pharmaceutical preparations. It's suitable not only for wet granulation but also for direct compression processes. Now, there are many brands and models of MMC in the domestic market, either imported or domestically manufactured. At first glance, there are many choices, but this makes it more difficult to choose and inevitably fall into a dilemma of choice. For instance, choosing imported MCC may need to consider the prices, delivery period, supply stability, tariffs, compliance with regulations, etc.; while choosing domestically manufactured MCC may need to weigh the impact on consistency evaluation, quality stability, compatibility with imported models, risk of extended inspections required by regulations, etc. If there is a domestic brand whose products are comparable with or superior to imported ones in quality and complete in model and can be tailor made and produced by batches according to consumer needs; are rather compliant with regulations and have been granted with the registration number F20180000805 and DMF number 032755; with manufacturing workshops constructed and managed according to ICHQ7, Class D clean workshops covering an area of more than 1,000 square meters and the Drug Manufacturing License, Food Production License (Food Additives), are you willing to try it to solve your dilemma? (Click here to apply for samples) Features of MCC series products of Topchain Pharma are as follows.
Topchain Pharma's MCC
MCC is a linear polysaccharide substance bound by β-1,4 glucoside bonds, usually a white or nearly white powdery substance obtained from natural cellulose by physical or chemical means, with a large specific surface area and a low degree of polymerization (LODP: 15-375). MCC is odorless, tasteless, and insoluble in water, dilute acids, organic solvents and oils. It's highly flowable, dispersible in water and partially swellable in alkalescent solutions. It also has a high performance in carboxymethylation, acetylation and esterification reactions.
Raw materials of Topchain Pharma's MCC: same as imported high-quality brands
According to studies, the properties of MCC, as a hydrolysate of natural cellulose, are closely related to the source and quality of the raw materials. In China, cotton has a high yield and costs less than wood, so some domestic manufacturers use cotton or pulp to produce MCC, while imported brands mostly use wood as the starting material.
For manufacturing MCC, Topchain Pharma imports the raw materials from a foreign supplier, processed from 5 kinds of eucalyptus seedlings selected from more than 1,000 different genes and harvested after 6 years of cultivation. The optimal varieties, stable growth environment and growth cycle have ensured the stable and uniform quality of the raw materials. The supplier also supplies raw materials to other international high-quality MCC manufacturers and provides us with the raw materials of the same variety and quality.
Production technology of Topchain Pharma's MCC: ammonium-free + spray-drying process
MCC is generally obtained from plant cellulose through hydrolysis, and the process is roughly as follows: use dilute inorganic acid solutions to hydrolyze α-cellulose that can be obtained from the pulp of fibrous plants, and then filter and purify the hydrolyzed cellulose and spray dry the aqueous slurry to form porous particles with broad size distribution. Topchain Pharma has carried out a number of comparative tests pursuant to Chinese Pharmacopoeia 2015, confirming that different levels of ammonium ions are contained in both commercially available MCC products of some domestic brands and those imported from the United States/Japan, but not in those produced by Topchain Pharma. This is because ammonia is added to remove the residual dilute acids in products in the traditional production process, thus introducing ammonium ions. However, Topchain Pharma applies a special ammonia-free process for deacidification, which has perfectly avoided the risk.
With regard to the impact of residual ammonium ions in MCC, there is no clear control requirement in Chinese Pharmacopoeia 2015. However, we've collected some cases in the actual use by our clients, proving that ammonium ions can degrade certain APIs or has a relatively great impact on related substances. For example, a client from Hebei confirmed to us that they had replaced multiple imported/domestic MCC products due to the impact of related substances during product development, but the issues in related substances till have not been resolved. It is not until they used Topchain Pharma's MCC to conduct a comparative experiment that the issues have been resolved. During the manufacture of MCC by Topchain Pharma, the pH value of cellulose is adjusted by a special process after being hydrolyzed with a dilute acid solution, instead of adding ammonia or other weak bases, which has avoided the potential risk of residual ammonium or other impurities in the MCC. Besides, before spray drying, Topchain Pharma would use a special physical process to adjust some MCC indicators. After spray drying, MCC powders with more pores, flowability and compressibility can be obtained.
SEMs of Some MCC products of Tophchain Pharma
Models of Topchain Pharma's MCC
From the beginning of its establishment, Topchain Pharma has been taking providing tailor-made products to its clients as its mission, with the slogan "individualized customization meeting your differentiated demands". Topchain Pharma is capable of manufacturing MCC products with different particle sizes, densities and moistures as required to meet customers' individualized demands to the greatest extent.
The MCC series products manufactured by Topchain Pharma are comparable in quality with those imported from the United States. Besides, Topchain Pharma's MCC products are ammonium-free, less risky in terms of compatibility, and complete in models. It's worth trying.
In addition to providing customized products according to customer needs, Topchain Pharma also produces other mature MCC varieties and models, including but not limited to:
Toncellus® TC Series: TC101, TC102, TC112, TC200, TC301, TC302，TCD555 and low-moisture products;
Toncellus® TF Series: TF515, TF525 and low-moisture products;
Toncellus® TLF Series: TLF915 and TLF935;
Toncellus® TL Series: TL9365 and TL565.
CDE registration number:
Topchain Pharma was granted the U.S. DMF number 032755 for its MCC products in 2018, have been granted CDE's associated registration number F20200000586. Welcome to apply for free samples for trial.
Topchain Pharma's MCC product tree：