Evaluation of pancreatin stability through enzyme activity determination.
Acta Pharm
; 66(3): 423-31, 2016 Sep 01.
Article
en En
| MEDLINE
| ID: mdl-27383890
Pancreatin is a biotechnological product containing an enzyme complex, obtained from porcine pancreas, that is employed in treating pancreatic diseases. Experiments regarding the stability of the pharmaceutical formulation containing pancreatin were performed using standard binary mixtures with 6 excipients in a 1:1 ratio (m/m) and a commercial formulation. To accomplish these goals, samples were stored for 1, 3 and 6 months at 40 ± 1 °C and 75 ± 5 % relative humidity (RH) and 40 ± 1 °C and 0 % RH. Stress testing was also performed. All samples were analyzed to evaluate the α-amylase, lipase and protease activities through UV/Vis spectrophotometry. The results revealed that the excipient proprieties and the storage conditions affected enzyme stability. Humidity was a strong influencing factor in the reduction of α-amylase and protease activities. Stress testing indicated that pH 9.0 and UV light did not induce substantial alterations in enzyme activity.
Texto completo:
1
Colección:
01-internacional
Base de datos:
MEDLINE
Asunto principal:
Fármacos Gastrointestinales
/
Pancreatina
/
Excipientes
Tipo de estudio:
Guideline
Límite:
Animals
País/Región como asunto:
America do sul
/
Brasil
Idioma:
En
Revista:
Acta Pharm
Asunto de la revista:
FARMACIA
/
FARMACOLOGIA
Año:
2016
Tipo del documento:
Article
Pais de publicación:
Polonia