González CA, García PCM, Gómez CM, Lagarto PA, Achón TO, Montes de Oca PY, Couret TM

Language: Spanish
References: 12
Page: 209-218
PDF size: 170.95 Kb.

ABSTRACT

Introduction: latanoprost, F2α prostaglandine analogue, is a selective FP receptor Prostanoide agonist that reduces the intraocular pressure due to increase of aqueous humor; it is classified as an anti-glaucoma drug and indicated for the treatment of open angle glaucoma and eye hypertension.
Objective: aformula for ophthalmic uses was designed, which contains latanoprost as active ingredient at concentration of 500 µg/mL and complies with the quality control indexes for this pharmaceutical form and provides the desired therapeutic effect.
Methods: the formulation studies were conducted and nine technological variants were tested; the most adequate composicion and technological procedure was selected for further industry scaling. The pH index and isotonicity were then adjusted using trometamin and manitol, respectively according to the demands of the eye formulation. A high resolution liquid chromatography-based analytical technique was developed and validated to study the stability, to determine the expiry date and to make the quality control of the formulation.
Results: the technological development proved to satisfactory since this formulation complies with all the specifications described in the manufacturer's technique for the quality control of the product. It was confirmed that this preparation keeps its physical, chemical and microbiological properties unchanged for 24 months if stored at 2-8 ºC and protected from light. Pilot scale-up did not show either technological problem or irritating effect according to the European Union criteria for eye irritability.
Conclusions: there was attained a latanoprost eye drop formulation for the treatment of glaucoma, which complies with all the quality specifications for this type of pharmaceutical form and could increase the therapeutic arsenal in Cuba.

REFERENCES

1. Faulí i Trillo. Tratado de Farmacia Galénica. 1ra Ed. Madrid: Luzan S.S.A.; 2000;329-347.

2. Reynolds JEF. Martindale. The Complete Drug Reference. 36 Ed. London: Pharmaceutical Press; 2009:1882.

3. Diccionario de Especialidades Farmacéuticas. 58 Ed. México DF: Ed. PLM, 2012 [citado 12 Sep 2014]. Disponible en: http://www.minsa.gob.pe/portalbiblioteca2/biblio/plm/index.htm

4. Latanoprost Solución oftálmica. Catálogo de Medicamentos Genéricos Intercambiables para farmacias y público. 2007. [citado 12 Sep 2014]. Disponible en http://www.facmed.unam.mx/bmnd/gi_2k8/prods/PRODS/Latanoprost.htm

5. The Merck Index. 13 Ed. [CD-ROM]. New Jersey: Merck; 2001:5391.

6. Rosenstein E. Diccionario de especialidades farmacéuticas. 47 ed. México, DF: Ed. PLM, SA de CV; 2001.

7. Xalatan 50 μg/mL colirio solución. Pfizer. 2001. [citado 12 Sep 2014]. Disponible en http://bvs.minsa.gob.pe/local/biblio/plm/src/productos/27427_333.htm

8. The United States Pharmacopeial. USP 35, NF 30. [CD-ROM]. Rockville: Mack Printing; 2012.

9. The United States Pharmacopeial, USP 30, NF 25. [CD-ROM]. Rockville: Mack Printing; 2007.

10. Centro Estatal para el Control de Medicamentos. Regulación 41/07. Validación de Métodos de analíticos. [citado 12 Sep 2014]. CECMED: La Habana; 2007. Disponible en: http://www.cecmed.sld.cu/Pages/Reg_EvalEL.htm

11. Organisation for Economic Co-operation and Development (OECD). Guideline for testing of chemical. Acute eye irritation/corrosion. No 405. Adopted 2002. Paris: OECD, 2002.

12. Rowe RC, Sheskly PJ, Quinn ME. Handbook of Pharmaceutical Excipients. 6th Ed. London: Pharmaceutical Press; 2009;68:335-6.