Zobrazeno 1 - 10
of 167
pro vyhledávání: '"Michael J. Pikal"'
Autor:
Arnab Ganguly, Lisa Hardwick, Serguei Tchessalov, Steven L. Nail, Dan Dixon, Frank Kanka, Anthony Guidinas, T. N. Thompson, Cindy Reiter, Zakaria Yusoff, Ted Tharp, Joseph Azzarella, Prerona Sharma, Petr Kazarin, Alina Alexeenko, Michael J. Pikal
Publikováno v:
AAPS PharmSciTech. 24
Best practices for performing freeze dryer equipment qualification are recommended, focusing on identifying methods to quantify shelf thermal uniformity (also known as “shelf surface uniformity”), equipment capability, and performance metrics of
Autor:
Sajal Manubhai Patel, Steven L. Nail, Michael J. Pikal, Raimund Geidobler, Gerhard Winter, Andrea Hawe, Juan Davagnino, Shailaja Rambhatla Gupta
Publikováno v:
Principles and Practices of Lyophilization in Product Development and Manufacturing ISBN: 9783031126338
Externí odkaz:
https://explore.openaire.eu/search/publication?articleId=doi_________::4211d3809f2899d01a25df035f9847eb
https://doi.org/10.1007/978-3-031-12634-5_31
https://doi.org/10.1007/978-3-031-12634-5_31
Publikováno v:
Journal of Pharmaceutical Sciences. 108:416-430
The aim of this research was to evaluate the impact of variability in ice sublimation rate (dm/dt) measurement and vial heat transfer coefficient (Kv) on product temperature prediction during the primary drying phase of lyophilization. The mathematic
Publikováno v:
Pharmaceutical Research. 37
Hydrogen/deuterium (H/D) exchange over a range of temperatures suggests a protein structural/mobility transition in the solid state below the system glass transition temperature (Tg). The purpose of this study was to determine whether solid-state pro
Autor:
Robin H. Bogner, Michael J. Pikal, Vamsi K. Mudhivarthi, Paritosh Pande, Puneet Sharma, Pooja Sane
Publikováno v:
AAPS PharmSciTech. 19:2828-2842
Inter- and intra-batch variability in heat and mass transfer during the drying phase of lyophilization is well recognized. Heat transfer variability between individual vials in the same batch arise from both different positions in the vial array and
Publikováno v:
Pharmaceutical research. 37(9)
Hydrogen/deuterium (H/D) exchange over a range of temperatures suggests a protein structural/mobility transition in the solid state below the system glass transition temperature (TSolid-state H/D exchange was monitored by FTIR spectroscopy to study t
Publikováno v:
AAPS PharmSciTech. 19:599-609
The goal of the work described in this publication was to evaluate a new, small, material-sparing freeze dryer, denoted as the “mini-freeze dryer or mini-FD”, capable of reproducing the product temperature history of larger freeze dryers, thereby
Autor:
Ekneet Sahni, Michael J. Pikal
Publikováno v:
Journal of Pharmaceutical Sciences. 106:779-791
Although several mathematical models of primary drying have been developed over the years, with significant impact on the efficiency of process design, models of secondary drying have been confined to highly complex models. The simple-to-use Excel-ba
Publikováno v:
Journal of Pharmaceutical Sciences. 105:3304-3313
The aim of this study was to determine the heat transfer characteristics of an optimized flexible holder device, using Tunable Diode Laser Absorption Spectroscopy, the Pressure Rise Test, and the gravimetric procedure. Two different controlled nuclea
Publikováno v:
Journal of Pharmaceutical Sciences. 105:3290-3295
Lyophilized proteins are generally stored below their glass transition temperature (Tg) to maintain long-term stability. Some proteins in the (pure) solid state showed a distinct endotherm at a temperature well below the glass transition, designated