Rodríguez LEA, González CVL, Sierra PRC, Vicente MR, Morales RCL, Marrero DD

Language: Spanish
References: 16
Page: 351-359
PDF size: 125.65 Kb.

ABSTRACT

Introduction: D—004 is a pharmaceutical active ingredient obtained from the Cuban royal palm fruits (Roystonea regia), mainly composed by a mixture of free fatty acids between 8 and 18 carbon atoms, potentially useful to treat benign prostatic hyperplasia.
Objective: to determine the shelf life of D—004 in high-density polyethylene flasks in climatic zones IV and II.
Methods: samples of three pilot batches of D—004, packed in white high-density polyethylene flasks and protected by cardboard boxes, were placed under conditions of the climatic zones IV (30 ºC/70 % RH) and II (25 ºC / 60 % RH). Organoleptic characteristics and unsaponifiable matter, fatty acids and microbiological contents were determined from the initial time till 36 months, and shelf lives were graphically determined in both zones.
Results: in the two climatic zones, the D—004 fulfilled the tested stability parameters during the first 33 months, but at the month 36th, the acid content in several samples was lower than the set limit. The regression analyses allowed determining the shelf lives of D—004 in climatic zones IV and II.
Conclusions: it was demonstrated that the active ingredient D—004, obtained at pilot scale, packed in high density polyethylene flasks and protected by a secondary container (cardboard box), exhibits a shelf life of 30 and 32 months in the climatic zones IV and II, respectively.

REFERENCES

1. Rodríguez EA. Determinaciones analíticas realizadas como contribución al desarrollo de un nuevo ingrediente farmacéutico activo obtenido a partir de la palma real. Reseña tesis doctoral. Rev CENIC Ciencias Quim. 2013;44:29-32.

2. Carbajal D, Arruzazabala ML, Más R, Molina V, Rodríguez E, González V. Effects of D-004, a lipid extract from Cuban royal palm fruit, on inhibiting prostatic hyperplasia induced with testosterone or dihydrotestosterone in a rat model: A randomized, controlled study. Curr Ther Res. 2004;65(6):505-14.

3. Carbajal D, Molina V, Más R, Arruzazabala ML. Therapeutic effect of D-004, a lipid extract from Rostoynea regia fruits, on prostate hyperplasia induced in rats. Drugs Exp Clin Res. 2005; 31(5-6):193-7.

4. Guzmán R, Illnait J, Mas R, Pérez Y, Fernández L, Mendoza S, et al. Comparative effects of Roystonea regia (D‒004) and Saw palmetto lipid extracts on blood oxidative variables in men with benign prostate hyperplasia (BPH). IOSR PHR. 2013;3(7):1-8.

5. Guzmán R, Fragas R, Illnait J, Mas R, Fernández L, Pedroso M, Mena J, et al. Effects of Roystonea regia (D-004) and saw palmetto lipid extracts in men with symptomatic benign prostatic hiperplasia. IOSR PHR. 2013;3(6):7-14.

6. Bhargava S, Canda AE, Chapple CR. A rational approach to benign prostatic hyperplasia evaluation: recent advances. Curr Opin Urol. 2004;14(1):1-6.

7. Sierra R, Rodríguez E, González V, Marrero D, Vicente R. Estudios preliminares de estabilidad de un extracto lipídico de los frutos de Roystonea regia en frascos de vidrio ámbar. Rev Cubana Farm. 2010;44(3):360-6.

8. Rodríguez E, Sierra R, González V, Marreo D, Vicente R. Estudio de estabilidad acelerada del ingrediente activo D-004 en diferentes envases. Rev Cubana Plant Med. 2009;14(3):54-60.

9. United States Pharmacopoeial Convention. USP XXXIII. The United States Pharmacopoeia Convention. Rockville: Mack Printing; 2010.

10. Rodríguez E, Marrero D, González V, Sierra R, Adames Y. Validación de un método por CG para la determinación de los ácidos grasos que componen el D-004 ingrediente activo. Rev CENIC Ciencias Quím. 2009;40(1):17-22.

11. International Conference of Harmonization. Guidance for Industry Q1E Evaluation of Stability Data. September 25, 2003.

12. Litwinienko G, Kasprzycka-G T. Study on the autoxidation kinetics of fats components by differential scanning calorimetric. 2. Unsaturated fatty acids and their esters. Ind Eng Chem Res. 2000;39(1):13-7.

13. Vekiari S, Papadopoulou P, Kiritsakis A. Effects of processing methods and commercial storage conditions on extra virgin olive oil quality indexes. Grasas y aceites. 2007;58(3):237-42.

14. Bruneton J. Farmacognosia y Fitoquímica de Plantas Medicinales. 2da ed. Zaragoza: ACRIBIA S.A., 2001:160-1.

15. CECMED. Regulación 24 del Centro para el Control Estatal de la Calidad de los Medicamentos. Requerimientos de los estudios de estabilidad para el registro de nuevos ingredientes farmacéuticos activos. La Habana: Minsap; 2000.

16. International Conference of Harmonization. Guidance for industry Q1A Stability Testing of New Drug Substances and Products. September 25, 2003.