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Are Generic Formulations Equivalent to Trade Name Topical Glucocorticoids?

Are Generic Formulations Equivalent to Trade Name Topical Glucocorticoids? Abstract • Trade name glucocorticoid formulations triamcinolone acetonide, fluocinolone acetonide, and betamethasone valerate were compared with their generic equivalents because of increasing substitution of generic formulations for trade name formulations. The vasoconstrictor assay was the method used for these comparisons. Large differences were found between generic and trade name formulations containing the same steroid in the same concentration in both cream and ointment vehicles. If generic substitutions are to be used for trade name formulations, the physician must be aware that significant differences in therapeutic effectiveness may be expected. (Arch Dermatol 1987;123:1312-1314) References 1. Cornell RC, Stoughton RB: Correlation of the vasoconstrictor assay and clinical activity in psoriasis . Arch Dermatol 1985;121:63-67.Crossref 2. Gibson JR, Kirsch JM, Darley ER, et al: An assessment of the relationship between vasoconstrictor assay findings, clinical efficacy, and skin thinning effects of a variety of undiluted and diluted corticosteroid preparations . Br J Dermatol 1984;111( (suppl 27) ):204-212.Crossref 3. Burdick KH: Various vagaries of vasoconstriction . Arch Dermatol 1974;110:238.Crossref 4. McKenzie AW, Atkinson RM: Topical activities of betamethasone esters in man . Arch Dermatol 1964;89:741-744.Crossref 5. McKenzie AW: Percutaneous absorption of steroids . Arch Dermatol 1962;86:611-614.Crossref 6. McKenzie AW, Stoughton RB: Method for comparing percutaneous absorption of steroids . Arch Dermatol 1962;86:608-610.Crossref 7. Stoughton RB: Bioassay system for formulations of topically applied glucocorticosteroids . Arch Dermatol 1972;106:825-827.Crossref 8. Glantz SA: Primer of Biostatistics . New York, McGraw-Hill International Book Co, 1981. http://www.deepdyve.com/assets/images/DeepDyve-Logo-lg.png Archives of Dermatology American Medical Association

Are Generic Formulations Equivalent to Trade Name Topical Glucocorticoids?

Archives of Dermatology , Volume 123 (10) – Oct 1, 1987

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Publisher
American Medical Association
Copyright
Copyright © 1987 American Medical Association. All Rights Reserved.
ISSN
0003-987X
eISSN
1538-3652
DOI
10.1001/archderm.1987.01660340074023
Publisher site
See Article on Publisher Site

Abstract

Abstract • Trade name glucocorticoid formulations triamcinolone acetonide, fluocinolone acetonide, and betamethasone valerate were compared with their generic equivalents because of increasing substitution of generic formulations for trade name formulations. The vasoconstrictor assay was the method used for these comparisons. Large differences were found between generic and trade name formulations containing the same steroid in the same concentration in both cream and ointment vehicles. If generic substitutions are to be used for trade name formulations, the physician must be aware that significant differences in therapeutic effectiveness may be expected. (Arch Dermatol 1987;123:1312-1314) References 1. Cornell RC, Stoughton RB: Correlation of the vasoconstrictor assay and clinical activity in psoriasis . Arch Dermatol 1985;121:63-67.Crossref 2. Gibson JR, Kirsch JM, Darley ER, et al: An assessment of the relationship between vasoconstrictor assay findings, clinical efficacy, and skin thinning effects of a variety of undiluted and diluted corticosteroid preparations . Br J Dermatol 1984;111( (suppl 27) ):204-212.Crossref 3. Burdick KH: Various vagaries of vasoconstriction . Arch Dermatol 1974;110:238.Crossref 4. McKenzie AW, Atkinson RM: Topical activities of betamethasone esters in man . Arch Dermatol 1964;89:741-744.Crossref 5. McKenzie AW: Percutaneous absorption of steroids . Arch Dermatol 1962;86:611-614.Crossref 6. McKenzie AW, Stoughton RB: Method for comparing percutaneous absorption of steroids . Arch Dermatol 1962;86:608-610.Crossref 7. Stoughton RB: Bioassay system for formulations of topically applied glucocorticosteroids . Arch Dermatol 1972;106:825-827.Crossref 8. Glantz SA: Primer of Biostatistics . New York, McGraw-Hill International Book Co, 1981.

Journal

Archives of DermatologyAmerican Medical Association

Published: Oct 1, 1987

References