Lemus RMZ, Chong QA, Bosch EJ

Language: Spanish
References: 15
Page: 556-563
PDF size: 760.66 Kb.

ABSTRACT

The development of a chewable pill of soy phosphatidylcholilne was undertaken in "Oriente" Pharmaceutical Laboratory from Santiago de Cuba with registration ends and subsequent production, that was carried out during the biennium 2011-2013. Excipients of pharmaceutical quality, the analytic methods of the United States Pharmacopoeia, edition 35/National Form, 2012 30th edition, as well as the technology of humid granulation and direct compression were used. Phosphatidylcholine was characterized as pharmaceutical raw material and the developed pill fulfilled the established quality attributes, reason why it was registered with 2 years proven stability. Added value was given to this substance, with potential risk of accumulation for the environment, as new pharmaceutical product in Cuba.

REFERENCES

1. Convención farmacopea de los Estados Unidos. Farmacopea de los Estados Unidos de América: USP 35, Formulario nacional: NF 30. 35 rev (USP35) 30 ed (NF30). Rockville: Pharm Convention; 2012. p. 2047-8.

2. Rowe R, Sheskey P, Quinn M. Handbook of Pharmaceutical Excipients. Lecithin. 6th ed. USA: Pharmaceutical Press and American Pharmacists Association; 2009. p.385-7.

3. Pià Casas J. Lecitina de Soja 1.200 mg. [citado 20 Jun 2012].

4. Pià Casas J. Lecitina de Soja -250 perlas. [citado 20 Jun 2012].

5. Hankintatukku Oy. Tablets, capsules, extracts, tonics and cosmetics. Finlandia: Finis Hankintatukku Oy. [citado 20 de Junio 2012].

6. Sanct Bernhard K. El renacimiento de los remedios tradicionales. España: Herboristería Sanct Bernhard. [citado 20 Jun 2012].

7. Naturnet. Colombia: Naturnet sede administrativa. [citado 20 Jun 2012].

8. CebaNatural. Lecitina de Soja granulado. España: CebaNatural. [citado 20 Jun 2012].

9. Medicamentos similares y genéricos intercambiables. [citado 20 Jun 2012].

10. Plantas medicinales y para qué sirven. [citado 10 Ago 2012].

11. List of German Commission E Monographs (Phytotherapy). Soy Lecithin (Lecithinum ex soya). 1988 [citado 30 Jun 2012].

12. Mourad AM, de Carvalho Pincinato E, Gava Mazzola P, Sabha M, Moriel P. Influence of soy lecithin administration on hypercholesterolemia. Cholesterol. 2010[citado 17 Feb 2011]; 2010 (2010).

13. Higgins JPT, Flicker L. Lecitina para la demencia y los trastornos cognitivos En: Biblioteca Cochrane Plus. 2009.

14. Seventeenth Report of the Joint FAO/WHO Expert Committee on Food Additives. Toxicological evaluation of certain food additives with a review of general principles and of specifications. Geneva: World Health Organization;1974.

15. 15.Cuba. Empresa Laboratorio Farmacéutico “Oriente”. Expediente de Registro de Formas Terminadas LECISAN, tabletas. Santiago de Cuba: Empresa Laboratorio Farmacéutico “Oriente”; 2013.