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The Effects of Excipients on Freeze-dried Monoclonal Antibody Formulation Degradation and Sub-Visible Particle Formation during Shaking
Springer Science and Business Media LLC - - 2024
Jin Mei, Xin-Zhe Ge, Qiong Huang, Jiawei Liu, Rahul G. Ingle, Guang‐Hui Dong, Wei-Jie Fang
Controlled Gastric Emptying. II. In Vitro Erosion and Gastric Residence Times of an Erodible Device in Beagle Dogs
Springer Science and Business Media LLC - Tập 6 - Trang 506-509 - 1989
Robyn Cargill, Karen Engle, Colin R. Gardner, Patricia Porter, Randall V. Sparer, Joseph A. Fix
An erodible gastric retention device fabricated from various polymeric blends was examined in vitro for its dissolution properties and in vivo in fasting dogs for assessment of its gastric retention potential. Dissolution studies were conducted with extruded rods of polymer blends to assess their potential as candidates for the erodible component of a gastrically retained device. Based on results ... hiện toàn bộ
A Theoretical Basis for a Biopharmaceutic Drug Classification: The Correlation of in Vitro Drug Product Dissolution and in Vivo Bioavailability
Springer Science and Business Media LLC - Tập 12 - Trang 413-420 - 1995
Gordon L. Amidon, Hans Lennernäs, Vinod P. Shah, John R. Crison
A biopharmaceutics drug classification scheme for correlating in vitro drug product dissolution and in vivo bioavailability is proposed based on recognizing that drug dissolution and gastrointestinal permeability are the fundamental parameters controlling rate and extent of drug absorption. This analysis uses a transport model and human permeability results for estimating in vivo drug absorption t... hiện toàn bộ
Excipient Interaction with Cetylpyridinium Chloride Activity in Tablet Based Lozenges
Springer Science and Business Media LLC - - 1996
R. Michael E. Richards, James Z. Xing, Kirsty M. B. Mackay
Purpose. The purpose of the investigation was to determine the effect of tablet excipients on the activity of cetylpyridinium chloride (CPC) and the relative interaction between excipients and CPC. Methods. An analytical assay was developed to evaluate the interaction between CPC and the excipients. In vivo activity was investigated using six volunteers by determining the reduction in colony formi... hiện toàn bộ
Physiology-Based IVIVE Predictions of Tramadol from in Vitro Metabolism Data
Springer Science and Business Media LLC - Tập 32 - Trang 260-274 - 2014
Huybrecht T’jollyn, Jan Snoeys, Pieter Colin, Jan Van Bocxlaer, Pieter Annaert, Filip Cuyckens, An Vermeulen, Achiel Van Peer, Karel Allegaert, Geert Mannens, Koen Boussery
To predict the tramadol in vivo pharmacokinetics in adults by using in vitro metabolism data and an in vitro-in vivo extrapolation (IVIVE)-linked physiologically-based pharmacokinetic (PBPK) modeling and simulation approach (Simcyp®). Tramadol metabolism data was gathered using metabolite formation in human liver microsomes (HLM) and recombinant enzyme systems (rCYP). Hepatic intrinsic clearance (... hiện toàn bộ
Diffusion of lonizable Solutes Across Planar Lipid Bilayer Membranes: Boundary-Layer pH Gradients and the Effect of Buffers
Springer Science and Business Media LLC - Tập 10 - Trang 1654-1661 - 1993
Tian-xiang Xiang, Bradley D. Anderson
The diffusion of weak acids or bases across planar lipid bilayer membranes results in aqueous boundary layer pH gradients. If not properly taken into account, such pH gradients will lead to errors in estimated membrane permeability coefficients, P m. The role of the permeant concentration, the buffer capacity, and the physicochemical properties of both permeant and buffer on the magnitude and impa... hiện toàn bộ
Determination of Solute–Polymer Interaction Properties via Two-Stage Extraction
Springer Science and Business Media LLC - Tập 11 - Trang 774-775 - 1994
Dennis R. Jenke
Mechanistic Modeling of the Effect of Recombinant Human Hyaluronidase (rHuPH20) on Subcutaneous Delivery of Cetuximab in Rats
Springer Science and Business Media LLC - Tập 39 - Trang 1867-1880 - 2022
Xizhe Gao, Jongbong Lee, Kiran Deshpande, David W. Kang, Anas M. Fathallah, Leonid Kagan
To evaluate the duration of effect of rHuPH20 on SC absorption of cetuximab and to develop a mechanistic pharmacokinetic model linking the kinetics of rHuPH20 action with hyaluronan (HA) homeostasis and absorption of cetuximab from the SC space. Serum pharmacokinetics of cetuximab was evaluated after IV and SC dosing at 0.4 and 10 mg/kg (control groups). In test groups, SC cetuximab was administer... hiện toàn bộ
Proton-Cotransport of Pravastatin Across Intestinal Brush-Border Membrane
Springer Science and Business Media LLC - Tập 12 - Trang 1727-1732 - 1995
Ikumi Tamai, Hitomi Takanaga, Hiroshi Maeda, Takuo Ogihara, Masaru Yoneda, Akira Tsuji
Purpose. The purpose of the present study is to clarify the intestinal brush-border transport mechanism of a weak organic acid, pravastatin, an HMG-CoA reductase inhibitor. Methods. The transport of pravastatin was studied by using intestinal brush-border membrane vesicles prepared from rabbit jejunum, and uptake by the membrane vesicles was measured using rapid filtration technique. Results. The ... hiện toàn bộ
New Safe Method for Preparation of Sarin-Exposed Human Erythrocytes Acetylcholinesterase Using Non-Toxic and Stable Sarin Analogue Isopropyl p-Nitrophenyl Methylphosphonate and its Application to Evaluation of Nerve Agent Antidotes
Springer Science and Business Media LLC - Tập 23 - Trang 2827-2833 - 2006
Hikoto Ohta, Takeshi Ohmori, Shinichi Suzuki, Hiroshi Ikegaya, Koichi Sakurada, Takehiko Takatori
A non-toxic and stable sarin analogue, isopropyl p-nitrophenyl methylphosphonate (INMP), was synthesized for safe preparation of sarin-exposed acetylcholinesterase (AChE). This agent was stable for years, able to be handled in an ordinary laboratory without special care, and its 50% inhibitory concentration (IC50) on 0.04 U/ml human erythrocytes AChE was 15 nM. This reagent was thought to be espec... hiện toàn bộ
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