Evaluation of cellulose II powders as a potential multifunctional excipient in tablet formulations.
The use of UICEL-A/102 and UICEL-XL, the cellulose II powders, as a multifunctional direct compression excipient in the design of tablets containing hydrochlorothiazide (HCTZ) or ibuprofen (IBU), the model low and high dose drugs, respectively, has been reported. Commercial Oretic and Advil tablets containing HCTZ and IBU, respectively, and tablets made using Avicel PH-102 - the most commonly and widely used commercial direct compression excipient, were used in the study for comparison purposes. Tablets were made by first blending drug with the excipient and then with stearic acid, a lubricant, in a V-blender, followed by compressing into a tablet on a hydraulic press using 105 MPa of compression pressure and a dwell time of 30 s. The crushing strengths of HCTZ tablets decreased in the order Avicel PH-102>UICEL-XL, UICEL-A/102>Oretic and of IBU tablets in the order Avicel PH-102 > or = UICEL-XL approximately UICEL-A/102>Advil. The friability values for all tablets were well below the maximum 1% USP tolerance limit. UICEL-A/102 and UICEL-XL tablets containing HCTZ disintegrated rapidly (<25 s). Oretic tablets disintegrated in about 60 s, while Avicel PH-102 tablets remained intact during 1 h test period. The IBU tablets made using UICEL-A/102 disintegrated the fastest, UICEL-XL and Advil tablets the next, and Avicel PH-102 tablets remained intact. All tablets, except for those of Avicel PH-102, conformed to the USP drug release requirements. These results conclusively show that UICEL-A/102 and UICEL-XL have the potential to be used as filler, binder, and disintegrant, all-in-one, in the design of tablets containing either a low dose or high dose drug by the direct compression method.
de la Luz Reus Medina
Maria
M
Division of Pharmaceutics, College of Pharmacy, The University of Iowa, Iowa City, IA 52242, USA.
Kumar
Vijay
V
D002482:Cellulose / Q000737:chemistry*; D019245:Compressive Strength; D004339:Drug Compounding; D005079:Excipients / Q000737:chemistry*; D006852:Hydrochlorothiazide / Q000032:analysis / Q000737:chemistry; D007052:Ibuprofen / Q000032:analysis / Q000737:chemistry; D011208:Powders; D012995:Solubility; D013607:Tablets / Q000737:chemistry*
D005079:Excipients; D011208:Powders; D013607:Tablets; D006852:Hydrochlorothiazide; D002482:Cellulose; D007052:Ibuprofen