Understanding the Physical Stability of Freeze Dried Dosage Forms rom the Glass Transition Temperature of the Amorphous Components

Fitzpatrick, Shaun; Saklatvala, Robert

doi:10.1002/jps.10474

Cited by 10 publications

(4 citation statements)

References 12 publications

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“…At the buffer concentrations of 20 mM used in this study, only minor perturbations to the glass transition behavior of the overall mixture are expected due to the presence of the buffer. 18,19,29…”

Section: Composition Of Formulationsmentioning

confidence: 99%

Mixing Properties of Lyophilized Protein Systems: A Spectroscopic and Calorimetric Study

Katayama

Carpenter

Menard

et al. 2009

Journal of Pharmaceutical Sciences

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Section: Composition Of Formulationsmentioning

confidence: 99%

Mixing Properties of Lyophilized Protein Systems: A Spectroscopic and Calorimetric Study

Katayama

Carpenter

Menard

et al. 2009

Journal of Pharmaceutical Sciences

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“…Additional ingredients like flavors and taste-masking agents may also be incorporated. The resulting mixture is dosed in the blister packs (as described in US patent 5729958), and then the freeze-drying process is performed to remove the water by sublimation (Fitzpatrick and Saklatvala, 2003). The dryers used for this production process enable rapid processing.…”

Section: Introductionmentioning

confidence: 99%

In-vitro and in-vivo evaluation of taste-masked cetirizine hydrochloride formulated in oral lyophilisates

Preis

Grother

Axe

et al. 2015

International Journal of Pharmaceutics

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“…Os produtos liofilizados possuem boa estabilidade durante o armazenamento, resultando em longo tempo de vida-de-prateleira (PITOMBO, 1989;FITZPATRICK;SAKLATVALA, 2003).…”

Section: Lista De Figurasunclassified

Otimização da liofilização do pericárdio bovino com o auxílio de ferramentas matemáticas

Borgognoni¹

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Freeze-drying is a method of preservation that provides high-quality dehydrated products. It is a process that requires time and energy and it may take days to finish. Freeze-drying optimization is used to minimize the process time keeping the high quality of the product. Mathematical models that predict the behavior of products during freeze-drying can drastically reduce the number of experiments and determine variables in a study that could not be experimentally measured. Biological tissues are sensitive to heat and might be irreversibly modified. The study of bovine pericardium freeze-drying improves its handling and storage. The purpose of this project was to determine key parameters which served to guide the development of a mathematical model able to describe the bovine pericardium freeze-drying process and achieve its validation. The study of the freezing step in the bovine pericardium freeze-drying was done by analyzing the time of the process and the residual moisture content of the dried product. Mathematical modeling of the process was shown from the determination of sublimation rates by freeze-drying microscopy under different chamber pressures and heating rates. The freeze-dried products were evaluated for the maintenance of their physical properties. The results revealed that slow freezing with thermal treatment had short process time and low residual moisture of the final product. The mathematical model demonstrated the bovine pericardium freeze-drying and the product indicated no change in their physical properties after the process. Thus, the freeze-drying microscopy analysis was validated in determining the sublimation rate during the bovine pericardium freeze-drying and the process was endorsed through mathematical modeling.

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Understanding the Physical Stability of Freeze Dried Dosage Forms rom the Glass Transition Temperature of the Amorphous Components

Cited by 10 publications

References 12 publications

Mixing Properties of Lyophilized Protein Systems: A Spectroscopic and Calorimetric Study

Mixing Properties of Lyophilized Protein Systems: A Spectroscopic and Calorimetric Study

In-vitro and in-vivo evaluation of taste-masked cetirizine hydrochloride formulated in oral lyophilisates

Otimização da liofilização do pericárdio bovino com o auxílio de ferramentas matemáticas

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