Search Results - "Pikal, Michael J."

Role of thermodynamic, molecular, and kinetic factors in crystallization from the amorphous state by Bhugra, Chandan, Pikal, Michael J

“…Though there is an advantage in using the higher solubility amorphous state in cases where low solubility limits absorption, physical instability poses a…”
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Lyophilized Drug Product Cake Appearance: What Is Acceptable? by Patel, Sajal Manubhai, Nail, Steven L, Pikal, Michael J, Geidobler, Raimund, Winter, Gerhard, Hawe, Andrea, Davagnino, Juan, Rambhatla Gupta, Shailaja

“…Cake appearance is an important attribute of freeze-dried products, which may or may not be critical with respect to product quality (i.e., safety and…”
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Mechanisms of protein stabilization in the solid state by Chang, Liuquan Lucy, Pikal, Michael J

“…The solid state is preferred for many proteins due to their marginal stability in solution. However, even in the solid state, chemical and physical degradation…”
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Solubility advantage of amorphous pharmaceuticals: I. A thermodynamic analysis by Murdande, Sharad B, Pikal, Michael J, Shanker, Ravi M, Bogner, Robin H

“…In recent years there has been growing interest in advancing amorphous pharmaceuticals as an approach for achieving adequate solubility. Due to difficulties in…”
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Freeze-Drying Process Development and Scale-Up: Scale-Up of Edge Vial Versus Center Vial Heat Transfer Coefficients, K v by Pikal, Michael J, Bogner, Robin, Mudhivarthi, Vamsi, Sharma, Puneet, Sane, Pooja

“…This report presents calculations of the difference between the vial heat transfer coefficient of the "edge vial" and the "center vial" at all scales. The only…”
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Solubility Advantage of Amorphous Pharmaceuticals: II. Application of Quantitative Thermodynamic Relationships for Prediction of Solubility Enhancement in Structurally Diverse Insoluble Pharmaceuticals by Murdande, Sharad B, Pikal, Michael J, Shanker, Ravi M, Bogner, Robin H

“…Purpose To quantitatively assess the solubility advantage of amorphous forms of nine insoluble drugs with a wide range of physico-chemical properties utilizing…”
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Design of freeze-drying processes for pharmaceuticals: practical advice by Tang, Xiaolin, Pikal, Michael J

“…Design of freeze-drying processes is often approached with a "trial and error" experimental plan or, worse yet, the protocol used in the first laboratory run…”
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Determination of End Point of Primary Drying in Freeze-Drying Process Control by Patel, Sajal M., Doen, Takayuki, Pikal, Michael J.

“…Freeze-drying is a relatively expensive process requiring long processing time, and hence one of the key objectives during freeze-drying process development is…”
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Modeling the Secondary Drying Stage of Freeze Drying: Development and Validation of an Excel-Based Model by Sahni, Ekneet K, Pikal, Michael J

“…Although several mathematical models of primary drying have been developed over the years, with significant impact on the efficiency of process design, models…”
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Protein Stability During Freezing: Separation of Stresses and Mechanisms of Protein Stabilization by Bhatnagar, Bakul S., Bogner, Robin H., Pikal, Michael J.

“…Although proteins are often frozen during processing or freeze-dried after formulation to improve their stability, they can undergo degradation leading to…”
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The role of electroosmotic flow in transdermal iontophoresis by Pikal, Michael J.

“…Iontophoresis enhances transdermal drug delivery by three mechanisms: (a) the ion-electric field interaction provides an additional force which drives ions…”
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Calorimetric investigation of the structural relaxation of amorphous materials: evaluating validity of the methodologies by Kawakami, Kohsaku, Pikal, Michael J

“…Although the potential advantages of the amorphous solid state is widely recognized among pharmaceutical researchers, its industrial applications have been…”
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Mechanism of protein stabilization by sugars during freeze-drying and storage: native structure preservation, specific interaction, and/or immobilization in a glassy matrix? by Chang, Liuquan Lucy, Shepherd, Deanna, Sun, Joanna, Ouellette, David, Grant, Kathleen L, Tang, Xiaolin Charlie, Pikal, Michael J

“…The purpose of this study is to investigate the mechanism of protein stabilization by sugars in the solid state. That is, explore whether the stabilization is…”
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Study of the individual contributions of ice formation and freeze-concentration on isothermal stability of lactate dehydrogenase during freezing by Bhatnagar, Bakul S, Pikal, Michael J, Bogner, Robin H

“…The objective of this study was to determine the individual contributions of ice formation, solute concentration, temperature, and time, to irreversible…”
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The challenge of drying method selection for protein pharmaceuticals: product quality implications by Abdul-Fattah, Ahmad M, Kalonia, Devendra S, Pikal, Michael J

“…Numerous drying methods are used to dry solutions of proteins in the laboratory and/or in pharmaceutical manufacturing. In this review article, we will discuss…”
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Role of mechanical stress in crystallization and relaxation behavior of amorphous indomethacin by Bhugra, Chandan, Shmeis, Rama, Pikal, Michael J

“…Even within an amorphous state, high energy sites can be generated due to sample handling and variations in preparation techniques can result in variation in…”
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Use of manometric temperature measurement (MTM) and SMART freeze dryer technology for development of an optimized freeze-drying cycle by Gieseler, Henning, Kramer, Tony, Pikal, Michael J

“…This report provides, for the first time, a summary of experiments using SMART Freeze Dryer technology during a 9 month testing period. A minimum ice…”
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Prediction of onset of crystallization from experimental relaxation times. II. Comparison between predicted and experimental onset times by Bhugra, Chandan, Shmeis, Rama, Krill, Steven L, Pikal, Michael J

“…Given a good correlation between onsets of crystallization and mobility above T(g), one might be able to predict crystallization onsets at a temperature of…”
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Heat and mass transfer scale-up issues during freeze drying: II. Control and characterization of the degree of supercooling by Rambhatla, Shailaja, Ramot, Roee, Bhugra, Chandan, Pikal, Michael J

“…This study aims to investigate the effect of the ice nucleation temperature on the primary drying process using an ice fog technique for temperature-controlled…”
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The effect of dryer load on freeze drying process design by Patel, Sajal M, Jameel, Feroz, Pikal, Michael J

“…Freeze-drying using a partial load is a common occurrence during the early manufacturing stages when insufficient amounts of active pharmaceutical ingredient…”
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