Functionality and performance of excipients in a quality-by-design world, Part IX: New excipients

American Pharmaceutical Review

Volumn 13, Issue 3, 2010, Pages 34-37

  Moreton, Chris ^a  

^a FinnBrit Consulting   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BETA CYCLODEXTRIN SULFOBUTYL ETHER; EXCIPIENT; MICROCRYSTALLINE CELLULOSE; POLYETHYLENE GLYCOL ESTER; SILICON DIOXIDE; UNCLASSIFIED DRUG;

DRUG FORMULATION; DRUG INDUSTRY; ECONOMIC ASPECT; FOOD AND DRUG ADMINISTRATION; MARKET; PERFORMANCE; PROCESSING; SAFETY; SHORT SURVEY;

EID: 77951990378     PISSN: 10998012     EISSN: None     Source Type: Journal    
DOI: None     Document Type: Short Survey

References (4)

1. Moreton, R.C., Tablet excipients to the year 2001: A look into the crystal ball, Drug Dev. Ind. Pharm., (1996), 22, (1), 11-23.
2. Steinberg, M., Borzelleca, J.F., Enters, E.K., Kinoshota, F.K., Loper, A, Mitchell, D.B., Tamulinas, C.B., and Weiner, M.L., A new approach to the safety of pharmaceutical excipients, Reg. Toxicol. Pharmacol., (1996), 24, 149-154. (Pubitemid 26400649)
3. Guidance for Industry: Nonclinical Studies for the Safety Evaluation of Pharmaceutical Excipients, U.S. Department of Health and Human Services, Food and Drug Administration, Center for Drug Evaluation and Research (CDER) and Center for Biologics Evaluation and Research (CBER), May 2005.
4. Tobyn M.J., McCarthy G.P., Staniforth J.M. and Edge S., Physicochemical comparison between microcrystalline cellulose and silicified microcrystalline cellulose, Int. J. Pharm., (1998), 269, 182-194. (Pubitemid 28345254)