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" Preparation, characterization and tableting properties of cellulose II powders "
Maria de la Luz Reus Medina
V. Kumar
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Latin Dissertation
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| Language of Document
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English
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| Record Number
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54088
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| Doc. No
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TL24042
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| Call number
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3184747
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| Main Entry
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Maria de la Luz Reus Medina
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| Title & Author
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Preparation, characterization and tableting properties of cellulose II powders\ Maria de la Luz Reus Medina
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| College
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The University of Iowa
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| Date
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2005
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| Degree
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Ph.D.
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2005
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| Page No
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334
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| Abstract
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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.
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| Subject
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Pure sciences; Cellulose II; Direct compression; Powders; Tableting; Pharmacology; 0491:Pharmacology
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V. Kumar
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The University of Iowa
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