Rodríguez CJE, López HOD, Palmeiro CM, Nogueira MA, López AM

Language: Spanish
References: 17
Page: 108-117
PDF size: 261.58 Kb.

ABSTRACT

Introduction: since the 60's, the Cuban pharmaceutical industry has as one basic production line the obtaining of the bile acids and its saline derivatives from bovine bile. This process consists of bile saponification and further precipitation of the cholic acid that changed into magnesium salt through a reaction process with magnesium hydroxide. The final active substance is used as active pharmaceutical ingredient to produce tablets for treatment of gastrointestinal disorders and of malfunctioning of the gallbladder.
Objective: to change the drying process currently in use by a spray drying variant.
Methods: a technological drying process was set. Bench scale studies were conducted. The results were then compared to those of the traditional process. Chemical, physical and technological evaluations were carried out, for example electronic microscopy and infrared spectroscopy.
Results: the results showed that the product obtained by spray drying was similar to that of the traditional process but with better physical and chemical characteristics. This helped in the further process of production of the finished form.
Conclusions: based on the results, one may state that the technological process of spray drying for production of magnesium bile salts assures the quality of the final product and improves the work and environmental conditions.

REFERENCES

1. Theisen J, Nehra D, Citron D. Suppression of Gastric Acid Secretions in Patients with Gastroesophageal Reflux Diseases Results in Gastric Bacterial Overgrowths and Deconjugation of Bile Acids. J Gasterointest Surg. 2000;4(1):50-4.

2. Gotley D, Morgan A, Cooper M. Bile-acid concentration in the Refluxate of Patients with Reflux Esophagitis. Br J Surg. 19887;5:587-90.

3. Moo Shin J, Sachs G. Restoration of Acid Secretion Following Treatment with Proton Pump Inhibitors. Gastroenterology. 2002;123:1588-97.

4. González Castellano RA. Principios básicos de escalado. La Habana: Ed. Universitaria; 2000. p. 9-18.

5. Granges Brown G. Operaciones básicas de Ingeniería Química. La Habana: Edición Revolucionaria; 1967. p. 592-5.

6. Bonaldi A. Process for pharmaceutical grade high purity hyodeoxycholic acid preparation. United States Patent US 5,349,074. 1994.

7. Dollmann J, Fritsch R, Gotzmann A, Nassauer J. Spray drying of acid whey, acid permeate and mixtures thereof. United States Patent US 5580592. 1996.

8. Rodríguez Chanfrau JE, López Hernández OD. Estudio del tiempo de filtración del citrato de calcio y magnesio obtenido a partir de dolomitas cubanas. Rev Cubana Farm. 2011;45(3):449-53.

9. Rodríguez Chanfrau JE, López Hernández OD, Nogueira Mendoza A. Secado del Citrato de Calcio y Magnesio a escala de banco. Rev Cubana Farm 2009 [citado 6 Dic 2012];43(1). Disponible en: http://scielo.sld.cu/scielo.php?script=sci_abstract&pid=S0034- 75152009000100004&lng=es&nrm=iso&tlng=es

10. United States Pharmacopoeia. USP 31. Washington DC: United States Pharmacopoeia Convention; 2008.

11. Iraizoz A, Bilbao O, Barrios MA. Conferencias de Tecnología Farmacéutica. La Habana: Ed. ENPES; 1990. p. 111-241.

12. PNO. Sales Biliares de Magnesio. Método de ensayo. ESP 2.03.012. La Habana: CIDEM; 2005.

13. United States Pharmacopoeia. USP 33. Washington DC: United Pharmacopoeia Convention; 2010.

14. Masters K. Spray Drying Handbook. 5th ed. New York: Longman Scientific and Technical; 1991.

15. Abatzoglou N, Simard J. Prediction of segregation tendency occurrence in dry particulate pharmaceutical mixtures: development of a mathematical tool adapted for granular systems application. Pharm Develop Technol. 2005;1:59-70.

16. Där A. Tecnología Farmacéutica. Madrid: Ed. Arcibia; 1979. p. 22-4.

17. Drusch S, Serfert Y, Schwarz K. Microencapsulation of fish oil with n-octenylsuccinate- -derivatised starch: Flow properties and oxidative stability. Eur J Lipid Sci Technol. 2006;108:501-12.