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meltback

Spanish translation: sublimación incompleta

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02:13 Jul 3, 2008
English to Spanish translations [PRO]
Medical - Medical: Pharmaceuticals
English term or phrase: meltback
Hello,

I am mot sure about the translation of this word. I believe it is "refusión". Do you have any idea? This is the context.

Extensive sampling was performed during drug product validation to demonstrate equivalent performance of the two lyophilizers and robustness of the lyophilization cycle. Samples were taken from various locations in the lyophilizer for potency, pH, product tests, moisture, weight variation, particulate matter, and visual appearance (meltback).
María José Comuñez
Argentina
Local time: 05:23
Spanish translation:sublimación incompleta
Explanation:
No sé si existe algún término específico, pero yo siempre he óido hablar de sublimación incompleta. Se trata de un fallo de la liofilización por remanencia de solventes residuales, que quedan atrapados, por ejemplo, en el tapón del vial de liofilización y humedecen el liofilizado al cerrar el vial.

En esta foto se ve el resultado:

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=11...

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Note added at 2 días22 horas (2008-07-06 00:49:19 GMT)
--------------------------------------------------

Copio de la "Guide to inspections of lyophilization of parenterals" de la FDA (http://www.fda.gov/ora/inspect_ref/igs/lyophi.html):

«Meltback is a form of cake collapse and is caused by the change from the solid to liquid state. That is, there is incomplete sublimation (change from the solid to vapor state) in the vial. Associated with this problem is a change in the physical form of the drug substance and/or a pocket of moisture. These may result in greater instability and increased product degradation.
(…)
Manufacturers should be aware of the stability of lyophilized products which exhibit partial or complete meltback. Literature shows that for some products, such as the cephalosporins, that the crystalline form is more stable than the amorphous form of lyophilized product. The amorphous form may exist in the "meltback" portion of the cake where there is incomplete sublimation.»

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Note added at 2 días23 horas (2008-07-06 01:22:13 GMT)
--------------------------------------------------

Otra explicación del fenómeno:

«A final but important caveat for primary drying is that one must never allow the product temperature to exceed its eutectic or glass transition temperature. If this temperature is exceeded, ice in the vial will begin to liquefy, a condition known as meltback. The liquefied solvent will form a skin over the product and trap moisture within it. The end result will be not only an unattractive product, but an unstable product.»
(En: http://www.internationalbiotechnologylaboratory.com/articles...

Por eso se habla de sublimación incompleta: no todo el agua sublima, una parte permanece en estado líquido.
Selected response from:

M. C. Filgueira
Local time: 10:23
Grading comment
Thank you very much!
4 KudoZ points were awarded for this answer

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Summary of answers provided
4colapso
RNAtranslator
3sublimación incompletaM. C. Filgueira
2 -2[tecnica de] refusion
Sp-EnTranslator


  

Answers


48 mins   confidence: Answerer confidence 2/5Answerer confidence 2/5 peer agreement (net): -2
[tecnica de] refusion


Explanation:
Me apoyo en tu suposion y en la referencia adjunta.


HTH


    Reference: http://www.websters-online-dictionary.org/definition/meltbac...
Sp-EnTranslator
United States
Local time: 04:23
Works in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 34

Peer comments on this answer (and responses from the answerer)
disagree  RNAtranslator: no es una técnica, sino un defecto de la liofilización. La referencia que aportas se refiere a otra cosa. Es el peligro que tienen los diccionarios bilingües.
2 days15 hrs

disagree  M. C. Filgueira: Por las mismas razones que RNAtranslator.
2 days21 hrs
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2 days16 hrs   confidence: Answerer confidence 4/5Answerer confidence 4/5
colapso


Explanation:
Es el colapso del liofilizado, quedando éste sin la estructura en esponja propia de una sustancia liofilizada correctamente. Es el resultado de que al someterlo a vacío todavía quedan puntos en los que el solvente no está congelado.

"An extreme case of collapse or meltback of cake is illustrate by Figure 1.3d. Meltback is a result of the presence of liquid states in the ice-product matrix"
http://books.google.es/books?id=Zjuu-pB5kWYC&pg=PA10&lr=&sou...

"These coffee granules are then dried under conditions that generate partial collapse or controlled meltdown"
http://books.google.es/books?id=Zjuu-pB5kWYC&pg=PA12&vq=melt...

"The interstitial melting temperature is determined as a means of characterizing the thermal properties of the formulation and is the temperature at which severe collapse or meltdown would occur during the primary drying process"
http://books.google.es/books?id=Zjuu-pB5kWYC&pg=PA103&vq=mel...


RNAtranslator
Local time: 10:23
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 107

Peer comments on this answer (and responses from the answerer)
neutral  M. C. Filgueira: El "meltback" es una causa de colapso del liofilizado debido a sublimación incompleta. El caso de humedad atrapada en los tapones es, como dije, un ejemplo, pero la humedad puede quedar directamente atrapada entre los cristales. Mirá la ref. que copié.
6 hrs
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8 hrs   confidence: Answerer confidence 3/5Answerer confidence 3/5
sublimación incompleta


Explanation:
No sé si existe algún término específico, pero yo siempre he óido hablar de sublimación incompleta. Se trata de un fallo de la liofilización por remanencia de solventes residuales, que quedan atrapados, por ejemplo, en el tapón del vial de liofilización y humedecen el liofilizado al cerrar el vial.

En esta foto se ve el resultado:

http://www.pubmedcentral.nih.gov/articlerender.fcgi?artid=11...

--------------------------------------------------
Note added at 2 días22 horas (2008-07-06 00:49:19 GMT)
--------------------------------------------------

Copio de la "Guide to inspections of lyophilization of parenterals" de la FDA (http://www.fda.gov/ora/inspect_ref/igs/lyophi.html):

«Meltback is a form of cake collapse and is caused by the change from the solid to liquid state. That is, there is incomplete sublimation (change from the solid to vapor state) in the vial. Associated with this problem is a change in the physical form of the drug substance and/or a pocket of moisture. These may result in greater instability and increased product degradation.
(…)
Manufacturers should be aware of the stability of lyophilized products which exhibit partial or complete meltback. Literature shows that for some products, such as the cephalosporins, that the crystalline form is more stable than the amorphous form of lyophilized product. The amorphous form may exist in the "meltback" portion of the cake where there is incomplete sublimation.»

--------------------------------------------------
Note added at 2 días23 horas (2008-07-06 01:22:13 GMT)
--------------------------------------------------

Otra explicación del fenómeno:

«A final but important caveat for primary drying is that one must never allow the product temperature to exceed its eutectic or glass transition temperature. If this temperature is exceeded, ice in the vial will begin to liquefy, a condition known as meltback. The liquefied solvent will form a skin over the product and trap moisture within it. The end result will be not only an unattractive product, but an unstable product.»
(En: http://www.internationalbiotechnologylaboratory.com/articles...

Por eso se habla de sublimación incompleta: no todo el agua sublima, una parte permanece en estado líquido.

M. C. Filgueira
Local time: 10:23
Specializes in field
Native speaker of: Native in SpanishSpanish
PRO pts in category: 1279
Grading comment
Thank you very much!

Peer comments on this answer (and responses from the answerer)
neutral  RNAtranslator: Según mi referencia, la sublimación no es incompleta ni es el rsultado de la humidificación posterior, sino la no formación de la estructura en esponja de una liofilización correcta, con lo que el volumen aparente es menor, es decir, un colapso.
2 days8 hrs
  -> La liofilización es un proceso de secado por sublimación. La remanencia de solvente residual --y eso es lo que ocurre cuando se produce "meltback"-- se debe a una sublimación incompleta. Por supuesto, la consecuencia es la alteración del liofilizado.
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