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358 results on '"Hoag, Stephen W."'

57. L-Tetrahydropalmatine, a Novel Dopamine Antagonist, Fails to Improve Psychiatric Symptoms as Adjunctive Treatment for Schizophrenia

Author

Ponomareva, Olga Y, primary, Redman, Brianne, primary, Sayer, MacKenzie A, primary, Wehring, Heidi J, primary, Vyas, Gopal, primary, Richardson, Charles M, primary, Gold, James M, primary, Gorelick, David A, primary, Cihakova, Daniela, primary, Talor, Monica V, primary, Hoag, Stephen W, primary, Buchanan, Robert W, primary, Wang, Jingtao, primary, Chen, Shuo, primary, Liu, Fang, primary, Wang, Jia Bei, primary, and Kelly, Deanna L, primary

Published
2020
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60. Comparison of authentic and suspect pharmaceuticals

Author

Polli, James E., Hoag, Stephen W., and Flank, Sharon

Subjects
Government regulation, Near infrared spectroscopy -- Usage -- Comparative analysis -- Laws, regulations and rules, Drug counterfeiting -- Identification and classification -- Spectra -- Laws, regulations and rules -- Comparative analysis -- Usage
Abstract

Near-infrared (NIR) spectrophotometry is an important tool for process analytical technology and it shows promise for the rapid, nondestructive identification of counterfeit pharmaceuticals. The authors applied NIR to assess whether [...]

Published
2009

65. Open-label dose-extending placebos for opioid use disorder: a protocol for a randomised controlled clinical trial with methadone treatment

Author

Belcher, Annabelle M, primary, Cole, Thomas O, additional, Greenblatt, Aaron D, additional, Hoag, Stephen W, additional, Epstein, David H, additional, Wagner, Michael, additional, Billing, Amy S, additional, Massey, Ebonie, additional, Hamilton, Kristen R, additional, Kozak, Zofia K, additional, Welsh, Christopher J, additional, Weintraub, Eric, additional, Wickwire, Emerson M, additional, Wish, Eric D, additional, Kaptchuk, Ted J, additional, and Colloca, Luana, additional

Published
2019
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70. Contributors

Author

Agrawal, Satish, Atef, Eman, Chauhan, Harsh, Dash, Alekha K., Dave, Vivek S., Derba, Megan, Desu, Hari R., Govindarajan, Ramprakash, Gu, Chong-Hui, Hasanzad, Mandana, Hedaya, Mohsen A., Hepburn, Seon, Hoag, Stephen W., Jambhekar, Sunil S., Kuldipkumar, Anuj, Kumar, Virender, Lambros, Maria P., Mahato, Ram I., Medi, Babu, Mohapatra, Sarat K., Narang, Ajit S., North, E. Jeffrey, Sarrami, Behnaz, Shukla, Surabhi, Singh, Somnath, Thoma, Laura A., and Tolman, Justin A.

Published
2024
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72. A Multiparticulate Delivery System for Potential Colonic Targeting Using Bovine Serum Albumin as a Model Protein

Author

Jiang, Bowen, Yu, Hua, Zhang, Yongrong, Feng, Hanping, and Hoag, Stephen W.

Subjects
Drug Liberation, Protein Aggregates, Drug Delivery Systems, Polymethacrylic Acids, Colon, Protein Conformation, Protein Stability, Drug Compounding, Animals, Cattle, Serum Albumin, Bovine, Tablets, Enteric-Coated, Article
Abstract

There are many important diseases whose treatment could be improved by delivering a therapeutic protein to the colon, for example, Clostridium difficile infection, ulcerative colitis and Crohn's Disease. The goal of this project was to investigate the feasibility of colonic delivery of proteins using multiparticulate beads.In this work, bovine serum albumin (BSA) was adopted as a model protein. BSA was spray layered onto beads, followed by coating of an enteric polymer EUDRAGIT® FS 30 D to develop a colonic delivery system. The secondary and tertiary structure change and aggregation of BSA during spray layering process was examined. The BSA layered beads were then challenged in an accelerated stability study using International Council for Harmonization (ICH) conditions. The in vitro release of BSA from enteric coated beads was examined using United States Pharmacopeia (USP) dissolution apparatus 1.No significant changes in the secondary and tertiary structure or aggregation profile of BSA were observed after the spray layering process. Degradation of BSA to different extents was detected after storing at 25°C and 40°C for 38 days. Enteric coated BSA beads were intact in acidic media while released BSA in pH 7.4 phosphate buffer.We showed the feasibility of delivering proteins to colon in vitro using multiparticulate system.

Published
2017

73. Understanding the impact of magnesium stearate variability on tableting performance using a multivariate modeling approach.

Author

Wang, Ting, Ibrahim, Ahmed, and Hoag, Stephen W.

Subjects
RAMAN effect, MAGNESIUM, PARTICLE size distribution, RAMAN spectroscopy, MESOPOROUS materials
Abstract

The objective of this research is to understand how the properties of magnesium stearate (MgSt) affect product performance in a quantitative manner using a multivariate modeling approach. In addition, we explored the feasibility of using NIR and Raman spectra as a surrogate measurement of physiochemical properties in prediction of performance in tablet direct compression. Partial least square models to predict performance attributes (PAs) from MgSt properties or spectra were developed and validated. The model input variables are MgSt physiochemical properties, spectra, key formulation and process parameters. Material physiochemical properties include fatty acid composition, loss on drying, densities, particle size distribution, specific surface area, and solid state properties. The key formulation and process parameters include MgSt concentration, filler type and compression force. The output variables are PAs including tablet ejection force, breaking force and disintegration time. It was found that the prediction of MgSt performance from its properties greatly depends on filler type and PAs of interest. NIR spectra successfully predicted lubricant performance in lactose tablet; however, predictions from Raman spectra were not acceptable. In the cases that the contributing physiochemical properties in performance prediction are sufficiently captured in the spectra, the spectra can be used as an alternative tool to predict excipient performance. [ABSTRACT FROM AUTHOR]

Published
2020
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79. Understanding Pharmaceutical Quality by Design

Author

Massachusetts Institute of Technology. Center for Biomedical Innovation, Raju, Gokaraju K, Amidon, Gregory, Polli, James, Woodcock, Janet, Yu, Lawrence X., Khan, Mansoor A., Hoag, Stephen W., Massachusetts Institute of Technology. Center for Biomedical Innovation, Raju, Gokaraju K, Amidon, Gregory, Polli, James, Woodcock, Janet, Yu, Lawrence X., Khan, Mansoor A., and Hoag, Stephen W.

Abstract

This review further clarifies the concept of pharmaceutical quality by design (QbD) and describes its objectives. QbD elements include the following: (1) a quality target product profile (QTPP) that identifies the critical quality attributes (CQAs) of the drug product; (2) product design and understanding including identification of critical material attributes (CMAs); (3) process design and understanding including identification of critical process parameters (CPPs), linking CMAs and CPPs to CQAs; (4) a control strategy that includes specifications for the drug substance(s), excipient(s), and drug product as well as controls for each step of the manufacturing process; and (5) process capability and continual improvement. QbD tools and studies include prior knowledge, risk assessment, mechanistic models, design of experiments (DoE) and data analysis, and process analytical technology (PAT). As the pharmaceutical industry moves toward the implementation of pharmaceutical QbD, a common terminology, understanding of concepts and expectations are necessary. This understanding will facilitate better communication between those involved in risk-based drug development and drug application review.

Published
2017

82. Investigation of Polymer/Surfactant Interactions and Their Impact on Itraconazole Solubility and Precipitation Kinetics for Developing Spray-Dried Amorphous Solid Dispersions

Author

Deshpande, Tanvi M., Shi, Helen, Pietryka, John, Hoag, Stephen W., and Medek, Ales

Abstract

Methods were developed to systematically screen different polymer–surfactant combinations for the purpose of enhancing amorphous active pharmaceutical ingredient (API) solubility while maintaining its physical stability. Itraconazole (ITZ) was chosen as the model API mostly due to its low aqueous solubility. Special attention was paid to determine the effect of a reduction in the critical micelle concentration (CMC) by specific polymer/surfactant combinations on the ITZ solubility and physical stability. However, only a slight correlation was actually found. Only the polymer/surfactant combinations with the smallest effect on CMC improved solubility and stability of ITZ in simulated intestinal fluids (SIF). Surfactants were found to negate the stabilizing effects of polymers. ITZ crystallization tendency generally depended on the degree of supersaturation and the type of polymer/surfactant combinations used. In general, we found that instead of focusing solely on reducing the CMC, a systematic screening of systems that maintain high ITZ supersaturation proved to be a successful approach.

Published
2024
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83. Formulation and Characterization of Orally Dissolving Thin Films containing the German cockroach Blatella germanica (Bla g 2) Allergen

Author

Chen, Qingqing, Martin, Russell, Hoag, Stephen W., Wood, Robert A., Mao, Hai-Quan, and Keet, Corinne

Subjects
immune system diseases, Article, respiratory tract diseases
Abstract

Allergy and asthma are among the most common chronic diseases of childhood. Cockroach allergy is an important contributor to asthma morbidity, with a prevalence of 17 to 41%. Immunotherapy has been shown to be an effective treatment for other allergies that contribute to asthma, but several factors have limited its use for cockroach allergy. In this work, a sublingual immunotherapy (SLIT) formulation of orally dissolving thin film has been developed for the treatment of hypersensitivity to the German cockroach Bla g 2 allergen. The formulation allows for the incorporation of up to 25 μg/film of the allergen protein, and the film's mucoadhesiveness prolongs the effect of the allergen with the potential for enhanced efficacy. The potency and dose uniformity of the SLIT formulation were characterized by enzyme-linked immunosorbent assay (ELISA), and other physicochemical properties were evaluated by spectroscopic or mechanistic methods. The films were uniform in weight and thickness, and demonstrated substantial physical strength to allow easy manipulation during manufacturing and dosing. The dosage uniformity, in vitro disintegration and in vitro dissolution profiles of the films were within the acceptance criteria in the United States Pharmacopeia. The developed SLIT methodology possesses the potential to significantly improve immunotherapy for both food and inhalant allergies in adults and children.

Published
2014

84. A Systematic Approach of Employing Quality by Design Principles: Risk Assessment and Design of Experiments to Demonstrate Process Understanding and Identify the Critical Process Parameters for Coating of the Ethylcellulose Pseudolatex Dispersion Using Non-Conventional Fluid Bed Process

Author

Kothari, Bhaveshkumar H., primary, Fahmy, Raafat, additional, Claycamp, H. Gregg, additional, Moore, Christine M. V., additional, Chatterjee, Sharmista, additional, and Hoag, Stephen W., additional

Published
2016
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86. <italic>In Vitro</italic> Assessment of Nasal Insufflation of Comminuted Drug Products Designed as Abuse Deterrent Using the Vertical Diffusion Cell.

Author

Boyce, Heather, Smith, Dan, Byrn, Steve, Saluja, Bhawana, Qu, Wen, Gurvich, Vadim J., and Hoag, Stephen W.

Abstract

In vitro evaluation of abuse deterrent formulations (ADFs) is a challenge since real abuse situations are variable and ADF technology is evolving. Specifically, an assessment of an ADF to deter nasal insufflation would be valuable. In this study, a vertical diffusion cell (VDC) was used to evaluate polyethylene oxide (PEO)-based tablets manipulated by three different forces. The commercially available products Oxycontin®, an ADF, Opana®, and metoprolol tartrate tablet formulations made in our laboratory were studied. Particle size distribution and percent recovery of manipulated tablets were measured. Grinding produced the lowest recovery and the smallest particle size distribution. Drug release was examined using a VDC by placing the dry comminuted particles on an enclosed wetted cellulose membrane. Dispensing dry particles on a VDC is atypical but includes some key features associated with an abuse situation where once the particles are snorted, the moisture in the nasal mucosa activates hydration and swelling of the polymers in the formulation, retarding drug release. Drug release from OxyContin®, Opana®, and metoprolol tablets were analyzed for the cutting, grinding, and milling modes of abuse. The analysis showed that in most cases, the mode of abuse produced different particle sizes with different release rates. Statistically different release rates were observed for metoprolol tablets made with different molecular weight PEO and with different porosities. These results indicate that within detection limits, the VDC can be used to quantitate release differences due to various modes of abuse used in this study. [ABSTRACT FROM AUTHOR]

Published
2018
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98. To investigate the influence of machine operating variables on formulations derived from lactose types in capsule filling: part 2.

Author

Moolchandani, Vikas, Augsburger, Larry L., Gupta, Abhay, Khan, Mansoor A., Langridge, John, and Hoag, Stephen W.

Subjects
EXCIPIENTS, PHARMACEUTICAL encapsulation, LACTOSE, ACETAMINOPHEN, RISK assessment, DRUG solubility testing
Abstract

This study is the second in a series that examines the characterizing and selection of suitable grades of lactose for capsule formulation development. Based upon the previous study, four grades were selected for further study. The effects of drug load and operational variables on formulations derived from these four lactose types were evaluated for physicochemical and mechanical attributes of plugs and their capsules on an instrumented dosing-disc capsule filling machine (H&H KFM/3) using acetaminophen as a model, highly soluble and poorly compressible drug. The results obtained were as follows: (1) flowability reduced upon increasing drug load; (2) powder bed height (PBH) and compression force (CF) had positive significant effect on plug weight (p < 0.05); (3) ejection force was positively and significantly correlated with increasing speed and CF (p < 0.05); (4) AL capsule plugs had the highest plug crushing force which was followed by DCL15; (5) the crushing strength of plugs made from DCL11 increased with increasing acetaminophen concentration; (6) higher CF had a significant negative impact on acetaminophen release at 15 min time point (p < 0.05); (7) at 10% and 40% drug load, formulations containing AL showed the quickest drug release; and (8) increased drug load had a significant negative impact on the release rate at 15 and 45 min time points (p < 0.05). Overall, the results from this study provides information on risk based assessment of filler selection based on drug load and the range of machine operating variables which will help in defining criteria for meeting key quality attributes for capsule formulation development. [ABSTRACT FROM PUBLISHER]

Published
2016
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