Development and validation of in vitro release tests for semisolid dosage forms—case study

Dissolution Technologies

Volumn 10, Issue 2, 2003, Pages 10-15

  Thakker, Kailas D ^a   Chern, Wendy H ^b  

^a Analytical Solutions   (United States)

^b Aventis Pharmaceuticals Inc   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ALCOHOL; RETINOIC ACID;

ACCURACY; ANALYTICAL EQUIPMENT; DISSOLUTION MEDIUM; DISSOLUTION TESTING APPARATUS; DRUG DIFFUSION; DRUG DOSAGE FORM; DRUG FORMULATION; DRUG RELEASE; DRUG SOLUBILITY; IN VITRO STUDY; MEMBRANE FILTER; NOTE; PH; PHYSICAL PARAMETERS; REPRODUCIBILITY; SAMPLING INTERVAL; SAMPLING VOLUME; SCALE UP; TEMPERATURE; VALIDATION PROCESS; VISCOSITY;

EID: 84962076195     PISSN: 1521298X     EISSN: None     Source Type: Journal    
DOI: 10.14227/DT100203P10     Document Type: Note

References (4)

1. FDA Guidance for Industry: SUPAC-SS Nonsterile Semisolid Dosage Forms. Scale-Up and Postappraoval Changes: Chemistry, Manufacturing, and Controls; In Vitro Release Testing and In Vivo Bioequivalence Documentation, May 1997.
2. M Siewert, J Dressman, C Brown and VP Shah, FIP/AAPS Guidelines for Dissolution/ In Vitro Release Testing of Novel/Special Dosage Forms. Dissolution Technologies Volume 10 Issue 1 February 2003
3. M. Corbo, R. Partak, J. Marvel, S. Ng, T. Schultz, G. Van Buskirk, Utility of in Vitro Release Testing Methods for Semi-solid Formulations in which the active is fully solubalized. In Vitro Release of Tretinoin from an O/W Cream. Pharmaceutical Research (1994) Vol. 11, No 10 Suppl, pp S12
4. T. Higuchi, Physical Chemical Analysis of Percutaneous Absorption Process from Creams and Ointments. J. Soc. Cosmetic Chemistry, Vol 11, 85 (1960)