Desarrollo y evaluación de una formulación oftálmica de atropina al 0,01%

  1. BRIZ MARTÍN, María Luisa 1
  2. ZARZUELO CASTAÑEDA, Aranzazú 2
  3. SANCHEZ AVILA, Adela 3
  1. 1 Facultad de Farmacia. Campus Miguel de Unamuno. Salamanca.
  2. 2 Área de Farmacia y Tecnología Farmacéutica. Facultad de Farmacia. Campus Miguel de Unamuno. Salamanca.
  3. 3 Farmacia Ávila Bardají. Calle Gran Vía 24, 37001 Salamanca.
Montrer des affiliations +
Revue:
Farmajournal

ISSN: 2445-1355

Année de publication: 2018

Volumen: 3

Número: 1

Pages: 133-142

Type: Article

DIALNET GOOGLE SCHOLAR lock_openAccès ouvert editor

D'autres publications dans: Farmajournal

Résumé

Introduction: Topical use of low concentration atropine (0.01%) has proved to be the most effective treatment for controlling the progression of myopia in children. However, it is not commercialized as such and therefore the formulation of individualized drugs is an alternative to approach such treatment.Objectives: Galenic development of a 0.01% atropine sulfate formula, stability study and validation of the analytical method for the quantification of atropine sulfate in elaborated ophthalmic solutions.Material and Methods: Bibliographic study, development and elaboration of various formulas, controls and study of stability during two months at 25 ºC / 60 %RH and 5 ºC.Discussion and Results: The analytical method has proved to be selective, linear, accurate both inter and intraday. The pH and osmolarity of the proposed formulations were not modified after two months in any of them; no statistically significant differences were observed either in the richness of atropine or the preservative during the stability study.Conclusion: The results obtained recommend a formulation with phosphate buffer, since its pH is more similar to the physiological pH and, considering that it is a chronic use eye drops, it is advisable, and without preservative.

Références bibliographiques

  •  Aguirre L, Pérez JA, Pujol M. Validación de métodos analíticos. AEFI. Barcelona: 2001.
  •  Alonso JM. Preparación de medicamentos y formulación magistral para oftalmología. Madrid: Díaz de Santos; 2003.
  •  Bell N, Rosin L. Preservative toxicity in glaucoma medication: clinical evaluation of benzalkonium chloride-free 0.5% timolol eye drops. Clin. Ophthalmol. 2013;7:2131-2135.
  •  Chia A, Chua W, Wen L, Fong A, Goon Y, Tan D. Atropine for the Treatment of Childhood Myopina: Changes after Stopping Atropine 0.01%, 0,1% and 0.5%. Am J Ophthalmol. 2014;157(2):451-457.
  •  Formulación magistral de medicamentos. 5º ed. Bizkaia: Colegio Oficial de Farmacéuticos de Bizkaia, 2004.
  •  Formulario nacional. 2º ed. Agencia Española de Medicamentos y Productos Sanitarios, 2015.
  •  Herrero R. Generalidades de los conservantes en las formulaciones oftálmicas. Archivos de la Sociedad Española de Oftalmología. 2007;82:531-532.
  •  Huang J, Wen D, Wang Q, McAlinden C, Flitcroft I, Chen H Et al. Efficacy Comparison of 16 Interventions for Myopia Control in Children. Ophthalmology. 2016;123(4):697-708.
  •  Lee C, Sun C, Lin Y, Lin K. Effects of topical atropine on intraocular pressure and myopia progression: a prospective comparative study. BMC Ophtalmol. 2016;16(1):1-7.
  •  Polling J, Kok R, Tideman J, Meskat B, Klaver C. Effectiveness study of atropine for progressive myopia in Europeans. Eye. 2016;30(7):998-1004.
  •  Real Farmacopea Española. 5º ed. Agencia Española de Medicamentos y Productos Sanitarios, 2015. p. 600-602.
  •  Tan D, Tay S, Loh K, Chia A. Topical Atropine in the Control of Myopia. Asia Pac J Ophthalmol. 2016;5(6):424-428.
  •  Williams K, Bertelsen G, Cumberland P, Wolfram C, Verhoeven V, Anastasopoulos E Et al. Increasing Prevalence of Myopia in Europe and the Impact of Education. Ophtalmology. 2015;122(7):1489-1498.
La source de données: Dialnet