Zobrazeno 1 - 10
of 19
pro vyhledávání: '"M J, Pikal"'
Publikováno v:
Pharmaceutical research. 18(1)
This study aims to assess the pH changes induced by salt precipitation during far-from-equilibrium freezing of sodium phosphate buffers as a function of buffer composition, under experimental conditions relevant to pharmaceutical applications-sample
Publikováno v:
Journal of pharmaceutical sciences. 89(3)
The molecular mobility of amorphous pharmaceutical materials is known to be a key factor in determining their stability, reactivity, and physicochemical properties. Usually such molecular mobility is quantified using relaxation time constants. Typica
Publikováno v:
Pharmaceutical research. 15(5)
To evaluate a simple calorimetric method for estimating the fragility of amorphous pharmaceutical materials from the width of the glass transition region.The glass transition temperature regions of eleven amorphous pharmaceutical materials were chara
Autor:
M J, Pikal, D R, Rigsbee
Publikováno v:
Pharmaceutical research. 14(10)
Generalizations based upon behavior of small molecules have established that a crystalline solid is generally much more stable toward chemical degradation than is the amorphous solid. This study examines the validity of this generalization for protei
Publikováno v:
Pharmaceutical research. 14(8)
Publikováno v:
PDA journal of pharmaceutical science and technology. 51(1)
The objective of this study was to evaluate manometric temperature measurement as a non-invasive method of monitoring product temperature during the primary drying phase of lyophilization. This method is based on analysis of the transient response of
Autor:
M J, Pikal, S, Shah
Publikováno v:
PDA journal of pharmaceutical science and technology. 51(1)
Particularly for proteins that may be damaged by overdrying, the distribution of residual moisture in the dried product may be as important as the mean water content. Protein at the top of the cake could be "overdried" even though the mean water cont
Autor:
M J, Pikal, S, Shah
Publikováno v:
Developments in biological standardization. 74
Since the stability of a freeze-dried product is often sensitive to the level of moisture, control of residual moisture by attention to the secondary drying phase of the freeze-drying process is of considerable importance. However, several reports in
Publikováno v:
Developments in biological standardization. 74
This research presents the results of a series of stability studies on freeze-dried formulations of human growth hormone (hGH). Chemical decomposition via methionine oxidation and asparagine deamidation as well as irreversible aggregation are charact
Publikováno v:
Developments in biological standardization. 74
Deacetylvinblastine (DAVLB) hydrazide, a cytotoxic vinca alkaloid, has been linked to the monoclonal antibody, KS1/4, via aldehyde residues of the oxidized carbohydrate groups on the antibody. The resulting KS1/4-DAVLB hydrazide conjugate is unstable