Physical mechanical and tablet formation properties of hydroxypropylcellulose: in pure form and in mixtures.
The aim of the study was to analyze hydroxypropylcellulose (HPC) in pure form and in excipient mixtures and to relate its physical and chemical properties to tablet binder functionality. The materials used were Klucel hydroxypropylcellulose grades ranging from low to high molecular weight (80-1000 kDa) of regular particle size (250 microm mean size) and fine particle size (80 microm mean size). These were compared with microcrystalline cellulose, spray-dried lactose, and dicalcium phosphate dihydrate. Thermal behavior of HPC was analyzed by modulated temperature differential scanning calorimetry (MTDSC). Tablets of the pure materials and of dry blends with 4% low viscosity, fine particle HPC and 30% high viscosity, fine particle HPC were produced on an instrumented eccentric tableting machine at 3 relative humidities. The 3-dimensional (3-D) model with the parameters time plasticity d, pressure plasticity e, and the twisting angle omega, the inverse of fast elastic decompression was compared with the Heckel method for characterization of compaction. Elastic recovery and compactibility were also studied. The results show that HPC tablet formation is characterized by high plastic deformation. The d, e, and omega values were markedly higher as compared with the reference materials. Plasticity was highest for the fine particle size HPC types. Maximum compactibility was observed for low molecular weight, fine particle size HPC. Tableting of the mixtures showed deformation, which was strongly influenced by HPC. Plasticity and crushing force of formed tablets was increased. In conclusion, HPC is characterized by strong plastic deformation properties, which are molecular weight and particle size dependent.
Picker-Freyer
Katharina M
KM
Martin-Luther-University Halle-Wittenberg, Institute of Pharmaceutics and Biopharmaceutics, Wolfgang-Langenbeck-Str 4, 06120 Halle/Saale, Germany. katharina.picker-freyer@pharmazie.uni-halle.de
Dürig
Thomas
T
D002130:Calcium Phosphates / Q000737:chemistry*; D002482:Cellulose / Q000031:analogs & derivatives* / Q000737:chemistry; D002626:Chemistry, Pharmaceutical; D019245:Compressive Strength; D004339:Drug Compounding; D004548:Elasticity; D005079:Excipients / Q000737:chemistry*; D006813:Humidity; D007785:Lactose / Q000737:chemistry*; D008956:Models, Chemical; D008970:Molecular Weight; D010316:Particle Size; D016062:Porosity; D011208:Powders; D011312:Pressure; D013607:Tablets; D013678:Technology, Pharmaceutical / Q000379:methods*; D013718:Tensile Strength; D013997:Time Factors; D044366:Transition Temperature; D014783:Viscosity; D014867:Water / Q000737:chemistry
D002130:Calcium Phosphates; D005079:Excipients; D011208:Powders; D013607:Tablets; D014867:Water; D002482:Cellulose; C008079:hydroxypropylcellulose; D007785:Lactose; C494366:calcium phosphate, dibasic, dihydrate; C109691:microcrystalline cellulose