title: To Evaluate the Effect of Solvents and Different Relative Humidity Conditions on Thermal and Rheological Properties of Microcrystalline Cellulose 101 Using METHOCEL™ E15LV as a Binder.
abstract: The solvent used for preparing the binder solution in wet granulation can affect the granulation end point and also impact the thermal, rheological, and flow properties of the granules. The present study investigates the effect of solvents and percentage relative humidity (RH) on the granules of microcrystalline cellulose (MCC) with hydroxypropyl methyl cellulose (HPMC) as the binder. MCC was granulated using 2.5% w/w binder solution in water and ethanol/water mixture (80:20 v/v). Prepared granules were dried until constant percentage loss on drying, sieved, and further analyzed. Dried granules were exposed to different percentage RH for 48 h at room temperature. Powder rheometer was used for the rheological and flow characterization, while thermal effusivity and differential scanning calorimeter were used for thermal analysis. The thermal effusivity values for the wet granules showed a sharp increase beginning 50% w/w binder solution in both cases, which reflected the over-wetting of granules. Ethanol/water solvent batches showed greater resistance to flow as compared to the water solvent batches in the wet granule stage, while the reverse was true for the dried granule stage, as evident from the basic flowability energy values. Although the solvents used affected the equilibration kinetics of moisture content, the RH-exposed granules remained unaffected in their flow properties in both cases. This study indicates that the solvents play a vital role on the rheology and flow properties of MCC granules, while the different RH conditions have little or no effect on them for the above combination of solvent and binder.
authors.affiliation: Division of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, New York, 11201, USA.
authors.forename: Moksh
authors.initials: M
authors.lastname: Jagia
authors.affiliation: Norwich Pharmaceuticals, Norwich, New York, 13815, USA.
authors.forename: Maitri
authors.initials: M
authors.lastname: Trivedi
authors.affiliation: Division of Pharmaceutical Sciences, Arnold & Marie Schwartz College of Pharmacy and Health Sciences, Long Island University, Brooklyn, New York, 11201, USA. rutesh.dave@liu.edu.
authors.forename: Rutesh H
authors.initials: RH
authors.lastname: Dave
mesh_terms: D002152:Calorimetry, Differential Scanning / Q000379:methods; D002482:Cellulose / Q000737:chemistry*; D002626:Chemistry, Pharmaceutical / Q000379:methods; D000431:Ethanol / Q000737:chemistry; D005079:Excipients / Q000737:chemistry; D006813:Humidity; D065347:Hypromellose Derivatives / Q000737:chemistry*; D007700:Kinetics; D010316:Particle Size; D011208:Powders / Q000737:chemistry; D012212:Rheology; D012997:Solvents / Q000737:chemistry*; D013678:Technology, Pharmaceutical / Q000379:methods; D014867:Water / Q000737:chemistry; D017155:Wettability
chemical_list: D005079:Excipients; D011208:Powders; D012997:Solvents; D014867:Water; C584703:hypromellose 2910 (15 MPA.S); D000431:Ethanol; D065347:Hypromellose Derivatives; D002482:Cellulose; C109691:microcrystalline cellulose
keywords: end point; granulation; powder rheology; relative humidity; thermal effusivity