Evaluation of the test system used for in vitro release of drugs for topical dermatological drug products

Pharmaceutical Development and Technology

Volumn 4, Issue 3, 1999, Pages 377-385

  Shah, Vinod P ^a   Elkins, Jerome S ^b   Williams, Roger L ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b Dallas Independent School District   (United States)

Author keywords

Dermatological products; In vitro release; Topical products

Indexed keywords

ALCOHOL; BETAMETHASONE DIPROPIONATE; GLUCOCORTICOID; MYRISTIC ACID ISOPROPYL ESTER; POLYSULFONE; TRIAMCINOLONE ACETONIDE;

AGITATION; ARTICLE; CONTROLLED STUDY; CREAM; DERMATOLOGY; DIFFUSION; DRUG FORMULATION; DRUG RELEASE; GEL; IN VITRO STUDY; MEMBRANE; OINTMENT; PRIORITY JOURNAL; TOPICAL DRUG ADMINISTRATION;

ADMINISTRATION, TOPICAL; ADRENAL CORTEX HORMONES; ANTI-INFLAMMATORY AGENTS; BETAMETHASONE; CHEMISTRY, PHARMACEUTICAL; CHROMATOGRAPHY, HIGH PRESSURE LIQUID; DERMATOLOGIC AGENTS; DIFFUSION; EVALUATION STUDIES; EXCIPIENTS; GLUCOCORTICOIDS; INDICATORS AND REAGENTS; OINTMENTS; PHARMACEUTICAL PREPARATIONS; UNITED STATES; UNITED STATES FOOD AND DRUG ADMINISTRATION;

EID: 0032792016     PISSN: 10837450     EISSN: None     Source Type: Journal    
DOI: 10.1081/PDT-100101373     Document Type: Article

References (12)

1. R. H. Guy, A. H. Guy, H. I. Maibach, and V. P. Shah, The bioavailability of dermatological and other topically administered drugs, Pharm. Res., 3, 253-262 (1986).
2. V. P. Shah, J. Elkins, S. Y. Lam, and J. P. Skelly, Determination of in vitro drug release from hydrocortisone creams, Int. J. Pharm., 53, 53-59 (1989).
3. R. Guy and J. Hadgraft, On the determination of drug release rates from topical dosage forms, Int. J. Pharm., 60, R1-R3 (1990).
4. G. A. Van Buskirk, V. P. Shah, D. Adair, et al., Workshop Report: Scale-up of liquid and semi-solid disperse systems, Pharm. Res., 11, 1216-1220 (1994).
5. AAPS/FDA Workshop: Assessment of value and applications of in vitro testing of topical dermatological drug products, Arlington, VA, September 1997.
6. Guidance for Industry: SUPAC-SS Nonsterile Dosage Forms, #CMC 7; CDER, Food and Drug Administration, Rockville, MD, May 1997.
7. J. L. Zatz, Drug release from semisolids: effect of membrane permeability on sensitivity to product parameters, Pharm. Res., 12, 787-789 (1995).
8. V. P. Shah and J. Elkins, In vitro release from glucocorticosteroid ointments, J. Pharm. Sci., 84, 1139-1140 (1995).
9. W. I. Higuchi, Analysis of data on the medicament release from ointments, J. Pharm. Sci., 51, 802-804 (1962).
10. V. P. Shah, J. S. Elkins, and J. P. Skelly, Relationship between in vivo skin blanching and in vitro release rate for betamethesone valerate creams, J. Pharm. Sci., 81, 104-106 (1992).
11. V. P. Shah, J. S. Elkins, and R. L. Williams, In vitro drug release measurements of topical glucocorticoid creams, Pharm. Forum, 19, 5048-5060 (1993).
12. FDA Research Contract 223-93-3016 with Professor Gordon L. Flynn, Ph.D., University of Michigan, Ann Arbor, Ml, manuscripts in preparation.