medigraphic.com
ISSN 1561-2988 (Print)

2011, Number 4

<< Back Next >>

Rev Cubana Farm 2011; 45 (4)

Stability of injectable pharmaceutical Compvit-B®

González GOT, Sordo ML, Canal RLJ, Francis TL, Vázquez BE

Language: Spanish
References: 25
Page: 505-514
PDF size: 72.38 Kb.


ABSTRACT

Compvit-B® is a lyophilized injectable polypharmaceutical made up of 100 mg of B1, 100 mg of B6 and 5 000 μg of B12. It is prescribed to treat all types of neuropathies and neurodegenerative diseases. The objective of this paper was the technological development of a stable formulation. For the evaluation of the quality of this drug, three pilot batches were scaled up and were subjected to physical, chemical and microbiological tests; the results were all satisfactory. The stability studies of lyophilized Compvit-B® were performed at room temperature. They showed that the pharmaceutical was stable for 3 years and the formulation was regenerated for 72 hours. This drug is registered at the Cuban regulating body called State Center for Drug Control and has been included in the Basic Group of Drugs in Cuba. It has been put on the market by the national drug industry. It is also widely used in the hospital services in Cuba.


REFERENCES

  1. Ordóñez-García PO, Nieto FJ, Espinosa-Brito AD, Caballero B. Cuban epidemic neuropathy 1991 to 1994; history repeats itself a century after the amblyopia of the blockade. An J Public Health. 1996;86(5);738-43.

  2. Krupa D. B-Vitamins: Prove Effective In Relieving Chronic Pain. San Diego: The American Physiological Society (APS); 2003. p. 1-9.

  3. Nigthtingale LM, Paviour D. Nutritional, optic and peripheral neuropathy a case report. J List Cases J. 2009;2:7762. Available from: http://www.mendeley.com/research/nutritional-optic-and-peripheral-neuropathy-acase-report/

  4. Lanyau YD, Macías CM. Deficiencia de vitaminas y enfermedad de Alzheimer. Rev Cubana Salud Pública. 2005:31(4). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_arttext&pid=S0864-34662005000400009&lng=es&nrm=iso&tlng=es

  5. Sherman HC, Burton GW. Effect of hydrogen ion concentration upon the rate of destruction of vitamin b upon heating. J Biol Chem. 1926;70:639.

  6. King J. Estabilidad de las vitaminas. Rev Chil Nutr. 1987;5(3):143-52.

  7. Buhler V. Vademecum for Vitamin formulations. 2001; 32-123. Available from: http://www.metricas.unam.mx/LibrUNAM/libro.php?rec=000943791

  8. Sánchez Rojas F, Boch Ojeda C, Cano Pavón JM. Espectrofotometría ultravioleta de derivadas. Talanta. 1988:35:753-61.

  9. Statgraphics Plus, versión 5.1 (Manugistics, USA). December, 2001.

  10. Sordo L. Estabilidad físico-química del producto farmacéutico inyectable Compvit-B. Tesis para optar por el título de Máster. IFAL, La Habana. 2001. p. 1-52.

  11. World Health Organization, Guidelines for stability testing of Pharmaceutical products containing well established drug substance in conventional dosage forms. Expert Committee on Specifications for Pharmaceutical Preparations. Thirty first Report. WHO Technical Report. Geneva, 1996.

  12. Morelli B. Determination of ternary mixtures of vitamins by ratio-spectra zerocrossing derivative spectrophotometry. Anal Lett. 1994 Nov.;27(14):2751-68.

  13. Morelli B. High Resolution/higher-order derivative spectrophotometry for determination of ternary mixtures of B-complex vitamins in pharmaceuticals. J Anal Chem. 1996;354:97-102.

  14. O'Haver TC, Green GL. Espectrofotometría de derivadas. Aplicación a penicilinas. Anal Chem. 1976(48);312-6.

  15. Sordo L, Soto L, González R, González OT. Determinación de vitamina B12 en una formulación multivitamínica por espectrofotometría de primer orden. Acta Farm Bonaerense 1999;18(2):135-9.

  16. British Pharmacopeia. Thiamine Chlorhidrate and Pyridoxine Chlorhidrate. Vol. III. London: The Stationary Office; 2007.

  17. United States Pharmacopoeial Convention and National Formulary 25st. USP XXX. United States Pharmacopoeia Convention. User Guide Cyanocobalamin United Pharmacopeial Convention. Rockville: Staff Liaison; 2007. [monographic in CD-ROM].

  18. Shepard GS, Labadarios D. Degradation of B6 vitamin in standard solution. Clin Chem Acta. 1986 Nov.;15:160(3);307-11.

  19. Barary M, Addel-Harrid M, Hassan E, Elsayed M. Simultaneous spectrofluorimetric determination of B1, B2 y B6 in pharmaceutical multivitamin preparation. Pharmazie. 1986 Jul.;41(7):483-5.

  20. Komaromy-Hiller G, Nutlal KL. Effect of storage on serum vitamin B12 and folate stability. Ann Clin Lab Sci. 1997;27(4)249-53.

  21. Thorpe SJ, Heat A, Blacmore S, Lee A, Hamilton M. International collaborative study to evaluate a bath of lyophilized serum for B12 and folate content. Clin Chem Lab Med. 2007;45(3):380-6.

  22. Okamoto H, Nakajima T. Stability-indicating HPLC method for determination of vitamins B1, B2 ,B3 y B6 in pharmaceutical liquid dosage form. J Chromatograph A. 2003;986;153-7.

  23. Shino T, Rakesh K, Ashutosh S, Roshan, I Badri P. A study of the heat stability of the vitamin B factors required. Indian J Chem Technol. 2008 Nov.;15:598-603.

  24. Konings EJ. Detection of 10 water soluble vitamins by Liquid chromatographydiode- array detection (LC-DAD) in pharmaceutical preparation. International Committee on Food Nutrition, 2006 Jan-Feb.;89(1):285-8.

  25. González R, Soto L. Métodos para el análisis simultáneo de vitaminas hidrosolubles. Rev Mex Cienc Farm. 1999 Jul-Sep.;30(2):9-14.




2020     |     www.medigraphic.com