| | Document Type | : | Latin Dissertation | Language of Document | : | English | Record Number | : | 54088 | Doc. No | : | TL24042 | Call number | : | 3184747 | Main Entry | : | Maria de la Luz Reus Medina | Title & Author | : | Preparation, characterization and tableting properties of cellulose II powdersMaria de la Luz Reus Medina | College | : | The University of Iowa | Date | : | 2005 | Degree | : | Ph.D. | student score | : | 2005 | Page No | : | 334 | Abstract | : | A new direct compression excipient, referred to as UICEL, was prepared from cotton linter or cellulose powders by treatment with an aqueous sodium hydroxide solution (≥5N), followed by precipitation with ethanol and subsequent washing with water and drying in air. A new direct compression excipient, referred to as UICEL-XL, was prepared from UICEL by crosslinking with glutaraldehyde in dilute hydrochloric acid at 100°C for 8 hours and subsequent washing with water and acetone and drying in air. Physicochemical characterization of UICEL and UICEL-XL materials was performed, and compared to those of commercially available cellulose excipients, microcrystalline cellulose (Avicel® PH-102) and powdered cellulose (Solka Floc® 40 NF). UICEL powders, in general, had lower degrees of crystallinity but comparable degrees of polymerization than the respective starting cellulose I material. UICEL-XL had a lower DP and higher crystallinity compared to UICEL-powders. Both UICEL and UICEL-XL powders were denser, showed improved flow properties, and had higher water uptake than Avicel® PH-102. UICEL powders typically showed higher yield pressure (>96 MPa), lower compressibility (<156 MPa) and compactability (∼159–365 MPa) values compared to those of UICEL-XL (85 MPa, 409 MPa and 327 MPa, respectively) and Avicel® PH-102 (69 MPa, 189 MPa and 619 MPa, respectively). UICEL displayed higher elasticity than UICEL-XL or Avicel® PH-102. The elasticity of Avicel® PH-102 and UICEL-XL was comparable. The rapid disintegration time for UICEL (<15 seconds) and UICEL-XL (<400 seconds) suggest the high affinity of these materials to water. Avicel ® PH-102 tablets showed long disintegration times (>1 hour). The tablet formulations containing hydrochlorothiazide (a low dose drug) or ibuprofen (a high dose drug), prepared by direct compression using UICEL and UICEL-XL, separately, met all the USP specifications and showed comparable performance to Oretic® and Advil®, the commercial hydrochlorothiazide and ibuprofen tablet products, respectively, suggesting that these materials have a high potential to be used as a filler-binder-disintegrant in tablet formulations. The formulations containing Avicel® PH-102 failed to meet the USP dissolution specifications for both drugs. | Subject | : | Pure sciences; Cellulose II; Direct compression; Powders; Tableting; Pharmacology; 0491:Pharmacology | Added Entry | : | V. Kumar | Added Entry | : | The University of Iowa |
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