Development and evaluation of a novel dry-coated tablet technology for pellets as a substitute for the conventional encapsulation technology.
Pellet formulations as represented by multiparticulate systems are often contained in hard capsules. We examined the use of a different approach to the making of compressed tablets containing pellets, OSDRC-technology. OSDRC-technology employs a double-structure punch (center punch and outer punch) allowing for dry-coated tablets to be assembled in a single run. We examined the effects of the thickness of the outer punch, formability of pellets, and diameter of tablets on pellet filling. The results revealed that thinner outer punches are not always better for filling small tablets with large amounts of pellets. We considered that this was because the core pellets spread in a cone shape within the formulating tablets at filling, requiring a thickness of the outer punch and a particle density of the diluents at which pellets would not exude from the formulating tablets. It was suggested that the formability of core pellets affects the maximum number of layers of pellets, and higher formability would yield better results. However, we found that pellets with poor formability (tensile strength of < or =2 kPa) could be used in tablets. For the tablets, the larger the diameter, the greater the maximum number of layers. We considered this to be due to the friction between the pellets and punch wall. We concluded that OSDRC-technology could be applied to capsule-like forms containing pellets > or =50 wt% through an unconventional approach.
Ando
Masaki
M
Pharmaceutical Research & Technology Laboratory, Sanwa Kagaku Kenkysho Co. Ltd., 363 Shiosaki, Inabe City, Mie 511-0406, Japan. m_andoh@mb3.skk-net.com
Kojima
Sayaka
S
Ozeki
Yuichi
Y
Nakayama
Yukiharu
Y
Nabeshima
Toshitaka
T
D002482:Cellulose / Q000737:chemistry; D003692:Delayed-Action Preparations / Q000737:chemistry; D004339:Drug Compounding / Q000295:instrumentation / Q000379:methods*; D004548:Elasticity; D005505:Food Coloring Agents / Q000737:chemistry; D007785:Lactose / Q000737:chemistry; D010316:Particle Size; D011312:Pressure; D013229:Stearic Acids / Q000737:chemistry; D013449:Sulfonamides / Q000737:chemistry / Q000493:pharmacokinetics; D013608:Tablets, Enteric-Coated / Q000737:chemistry*; D000077409:Tamsulosin; D013678:Technology, Pharmaceutical / Q000379:methods*; D013718:Tensile Strength
D003692:Delayed-Action Preparations; D005505:Food Coloring Agents; D013229:Stearic Acids; D013449:Sulfonamides; D013608:Tablets, Enteric-Coated; C031183:stearic acid; D002482:Cellulose; D000077409:Tamsulosin; D007785:Lactose