An excipient of considerable interest to the pharmaceutical industry is microcrystalline cellulose (MCC). MCC plays a critical and almost indispensable role in the production of spheroids containing drugs. Spheroids are highly desirable as they have defined surface areas and are best suited for the development of controlled release products. Besides, they possess excellent bulk handling and processing properties because of good flow properties and low friability.It is not fully understood how or why MCC possesses such unique qualities to facilitate the process of spheronisation. However, it is widely believed that it acts like a molecular sponge or water repository that helps to distribute water during spheronisation and, in turn, enable the extrudates to be rounded off into spheroids.
1)Inter-grade variability of MCC has been well-documented and much of this was attributed to the differences in the source, composition of plant material and processing conditions employed in its manufacture. [2][3][4][5][6] This variability is subsequently reflected as differences in their fundamental physical properties, such as particle size and size distribution, crystallinity, micromeritic properties and compressibility parameters such as bulk and tapped densities. The resultant inconsistencies in quality of starting materials compromised control of process parameters during pharmaceutical manufacture, causing considerable loss of time and resources due to products that fail to meet specifications. The importance of pre-formulation studies could not be over-emphasized.Common thermal analytical techniques include differential thermo-gravimetry (DTG), differential thermal analysis (DTA) and differential scanning calorimetry (DSC). DTG provides quantitative analysis of the reactions by measuring the change in weight while DTA measures the temperature difference between the reference and the test sample. DSC on the other hand measures the heat flow in and out of the sample. Pharmaceutical applications of thermal analysis and coupled techniques were studied by Giron.7) The important uses of techniques such as DSC, DTG and DTA included identification, purity determination and study of polymorphism in bioactive and excipients. The study of water-MCC interaction has been pursued with great interest over the years.8-10) Thermal behavior of MCC, MCC/water or MCC/lactose/water blends using DTG has been reported by a few researchers.11,12) It was found that particle size influenced the degree of water binding ability between the different MCC grades. Particle morphology such as particle size and shape, surface area and surface roughness can also be critical in influencing the strength of cohesive forces acting on the powder particles.
13)Water was believed to associate with celluloses in a triphasic process. Firstly, water binds to adjacent anhydroglucose units of the MCCs, forming 2 hydrogen bonds in the process. As the water content increases, some of the initial bonds between water and the cellulose molecules would be broken, vacating...