2001, Number 4
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Gac Med Mex 2001; 137 (4)
Study of the Anti-Inflammatory Effect of Topical Corticosteroid: Recognized Brand Vs. Generics
Castanedo-Cázares JP, Quistián-Hemández J, Torres-Alvarez B, Torres-Ruvalcaba A, Moncada B
Language: Spanish
References: 21
Page: 311-314
PDF size: 49.97 Kb.
ABSTRACT
In Mexico, the generic drug market is growing. Regarding topical corticosteroids, there are several preparations on the local market but their clinical efficacy has not been assessed in relation with the original brand name. Using as a model the fluocinolone acetonide cream, the purpose of this study was to evaluate the antiinflammatory effect of different preparations. A double-blind, vehicle-control essay was conducted causing irritation on five sites of the volar aspect of the forearm in twenty healthy volunteers using 10% aqueous sodium lauryl sulfate. On the same part of the forearm, the formulations tested were applied for a period of 4 days with visual score irritation readings at days 2 and 4. The analysis of the results showed that although one of the generic drugs is 80% less expensive than the brand-name medication, the clinical response was not as good as the other preparations. This deserves consideration, as newer and more potent generic corticosteroids will be available on the Mexican market.
REFERENCES
Norma Oficial Mexicana de Emergencia NOM-EM-003-SSAI-1998, medicamentos genéricos intercambiables. Criterios y requisitos de las pruebas para demostrar la intercambiabilidad y requisitos a que deben sujetarse los terceros autorizados. Diario Oficial de la Federación, DXXXX 18, 25 sept. México. 1998. p. 75-94.
Palma-Aguirre JA. Medicamentos genéricos, biodisponibilidad y bioequivalencia. Gac Med Mex 1998;134:491-94.
Guzzo CA, Lazarus GS, Werth VP. Dermatological pharmacology. In: Hardman JG, Limbird LE, editors. Goodman & Gilhman's The Pharmacological basis of therapeutics. 9 th ed. New York, McGraw Hill; 1996. p. 1595.
Baumann LS, Kerdel F. Topical glucocorticoids. In: Fitzpatrick's dermatology in general medicine. 5th ed. New York: McGraw Hill; 1999. p. 2714.
Stoughton RB. The vasoconstrictor assay in bioequivalence testing: practical concerns and recent developments. Int J Dermatol 1992;31(Suppl 1):26-8.
Guin JD, Wallis MS, Walls R, Lehman PA, Franz TJ. Quantitative vasoconstrictor assay for topical corticosteroids: the puzzling case of fluocinolone acetonide. J Am Acad Dermatol 1993;29(2 Pt 1):197-202.
Cornell RC. Clinical trials of topical corticosteroids in psoriasis: correlations with the vasoconstrictor assay. Int J Dermatol 1992 Oct;31(Suppl 1):38-40.
Olsen EA. Human test models for bioequivalence of topical corticosteroids: a review. Int J Dermatol 1992;31 (Suppl 1):9-13.
Ramsing DW, Agner T. Efficacy of topical corticosteroids on irritant skin reactions. Contact Dermatitis 1995;32:293-97.
Green C. The effect of topically applied corticosteroid on irritant and allergic patch test reactions. Contact Dermatitis 1996;35:331-33.
Treffel P, Gabard B. Measurement of sodium lauryl sulfate-induced skin irritation. Acta Derm Venereol 1996;76:341-3.
Dahl MV, Roering MJ. Sodium lauryl sulfate irritant patch tests. III. Evaporation of aqueous vehicle influences inflammatory response. J Am Acad Dermatol 1984;11:477-9.
Agner T, Serup J. Skin reactions to irritants assessed by non-invasive bioengineering methods. Contact Dermatitis 1989;20:352-9.
Basketter DA, Miettinen J, Lahti A. Acute irritant reactivity to sodium lauryl sulfate in atopics and non-atopics. Contact Dermatitis 1998;38:253-7.
Brasch J, Becker D, Effendy I. Reproducibility of irritant patch test reactions to sodium lauryl sulfate in a double-blind placebo-controlled randomized study using clinical scoring. Results from a study group of the German Contact Dermatitis Research Group (Deutsche Kontaktallergie-Gruppe, DKG). Contact Dermatitis 1999;41:150-5.
Frosch PJ, Kligman AM. The soap chamber test. A new method for assessing the irritancy of soaps. J Am Acad Dermatol 1979;1:673 -682.
Van Neste D, de Brouwer B. Monitoring of skin response to sodium lauryl sulphate: clinical scores versus bioengineering methods. Contact Dermatitis 1992;27:151-6.
Siegel S, Castellan NJ. La prueba de Friedman. In: Estadística no paramétrica aplicada a las ciencias de la conducta. 4 th ed. México. D.F.: Editorial Trillas; 1995. p. 207.
Kligman LH. Rapid assay of the antiinflammatory activity of topical corticosteroids by inhibition of a UVA-induced neutrophil infiltration in hairless mouse skin. II. Assessment of name brand versus generic potency. Acta Derm Venereol 1994;74:18-19.
Stoughton RB. Are generic formulations equivalent to trade name topical glucocorticoids? Arch Dermatol 1987;123:1312-1314.
Stoughton RB. Are generic topical glucocorticoids equivalent to the brand name? J Am Acad Dermatol 1988;18:138-139.