The influence of product brand-to-brand variability on superdisintegrant performance: A case study with croscarmellose sodium

Pharmaceutical Development and Technology

Volumn 11, Issue 2, 2006, Pages 179-185

  Zhao, Na ^a   Augsburger, L L ^a  

^a UNIVERSITY OF MARYLAND SCHOOL OF PHARMACY   (United States)

Author keywords

Croscarmellose sodium; Discriminating model tablet formulation; Performance consistency; Product brand variability

Indexed keywords

CALCIUM PHOSPHATE DIBASIC; CARBOXYMETHYL SODIUM; CHLORIDE; CROSCARMELLOSE SODIUM; DISINTEGRATING AGENT; LACTOSE; NYMCEL ZSX; PRIMELLOSE; SODIUM DERIVATIVE; SOLUTAB; UNCLASSIFIED DRUG; VIVASOL; WATER;

ACIDITY; ARTICLE; PARTICLE SIZE; PH; PHYSICAL CHEMISTRY; POWDER; PRIORITY JOURNAL; TABLET DISINTEGRATION TIME; TABLET FORMULATION; TABLET MANUFACTURE; TABLET MATRIX; TABLET PROPERTY; TEMPERATURE SENSITIVITY; WATER TRANSPORT;

CALCIUM PHOSPHATES; CARBOXYMETHYLCELLULOSE; DRUG COMPOUNDING; EXCIPIENTS; HYDROGEN-ION CONCENTRATION; LACTOSE; MODELS, STATISTICAL; NANOSTRUCTURES; PARTICLE SIZE; QUALITY CONTROL; SOLUBILITY; TABLETS; WATER;

EID: 33745069348     PISSN: 10837450     EISSN: 10979867     Source Type: Journal    
DOI: 10.1080/10837450600561281     Document Type: Article

References (9)

1. Zhao, N.; Augsburger, L.L. The influence of swelling capacity of super disintegrants in different pH media on the dissolution of hydrochlorothiazide from directly compressed tablet. AAPS PharmaSciTech 2005, 7 (1), In Press.
2. Chen, C.R.; Lin, Y.H.; Cho, S.L.; Yen, S.Y.; Wu, H.L. Investigation of the dissolution difference between acidic and neutral media of acetaminophen tablets containing a super disintegrant and a soluble excipient. Chem. Pharm. Bull. 1997, 45 (Mar), 509-512.
3. Caramella, C.; Colombo, P.; Conte, U.; Gazzaniga, A.; La Manna, A. The role of swelling in the disintegration process. Int. J. Pharm. Tech. Prod. Mfr. 1984, 5, 1-5.
4. Caramella, C.; Colombo, P.; Conte, U.; Manna, A.L. Swelling of disintegrant particles and disintegrating force of tablets. In Proceedings of Third International Conference on Pharmaceutical Technology, Paris, 1983.
5. Caramella, C.; Colombo, P.; Conte, U.; La Manna, A. Tablet disintegration update: dynamic approach. Drug Dev. Ind. Pharm. 1987, 13 (12), 2111-2145.
6. Shah, U.; Augsburger, L.L. Multiple sources of sodium starch glycolate, NF: evaluation of functional equivalence and development of standard performance tests. Pharm. Dev. Technol. 2002, 7 (3), 345-359.
7. Shah, U.; Augsburger, L.L. Evaluation of the functional equivalence of crospovidone, NF, from difference sources. Part I. Physical characterization. Pharm. Dev. Technol. 2001, 6 (1), 1-15.
8. Shah, U.; Augsburger, L.L. Evaluation of the functional equivalence of crospovidone NF from different sources. Part 2. Standard performance test. Pharm. Dev. Technol. 2001, 6 (3), 419-430.
9. USP 27/NF 22, The United States Pharmacopeial Convention, Inc., Rockville, MD 2003, p. 2856.