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Effect of excipients on Recombinant Interleukin-2 Stability in Aqueous Buffers

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American Journal of Analytical Chemistry 2021年第10期12卷 347-372页

作者： A. S. Prakasha Gowda Andrew D. Schaefer Terry K. Schuck Department of Raw Materials Eurofins BioPharma Product Testing Lancaster USA

In order to retain structural and functional integrity, protein medicines are frequently stabilized with excipients in aqueous solutions. The goal of this investigation was to see how stable IL-2 is with excipients that are acceptable for cell therapy. We investigated the time-dependent stability of commercially available recombinant IL-2 in aqueous solutions (CTS, RPMI, PBS, and water) at different temperatures [2°C - 8°C, room temperature (20°C ± 2°C) and 37°C] in the presence of excipients (EDTA, methionine, histidine, and glycine) over a period of up to 30 days. To detect and quantify IL-2, reversed phase high performance liquid chromatography was employed. Electrophoresis on a sodium dodecyl sulfate polyacrylamide gel was used to assess conformational stability. We discovered that IL-2 stability was improved in aqueous solutions including excipients, and that it may have retained its biological activity and sterility in these conditions.

关键词： Interleukin-2 excipients Stability RP-HPLC SDS-PAGE

Challenges and trends in apomorphine drug delivery systems for the treatment of Parkinson's disease

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Asian Journal of Pharmaceutical Sciences 2018年第6期13卷 507-517页

作者： Nrupa Borkar Huiling Mu René Holm Department of Pharmacy Faculty of Health and Medical Sciences University of Copenhagen Drug Product Development Janssen Research and Development Johnson & Johnson

Parkinson's disease(PD) is a chronic debilitating disease affecting approximately 1% of the population over the age of 60. The severity of PD is correlated to the degree of dopaminergic neuronal loss. Apomorphine has a similar chemical structure as the neurotransmitter dopamine and has been used for the treatment of advanced PD patients. In PD patients,apomorphine is normally administered subcutaneously with frequent injections because of the compound's extensive hepatic first-pass metabolism. There is, hence, a large unmet need for alternative administrative routes for apomorphine to improve patient compliance.The present review focuses on the research and development of alternative delivery of apomorphine, aiming to highlight the potential of non-invasive apomorphine therapy in PD,such as sublingual delivery and transdermal delivery.

关键词： Apomorphine Drug delivery Parkinson’s disease Alternative apomorphine therapy Non-invasive delivery excipients

Investigation of the potential application of sodium bentonite as an excipient in formulation of sustained release tablets

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Asian Journal of Pharmaceutical Sciences 2017年第3期12卷 259-265页

作者： Jamal Alyoussef Alkrad Reham Abu Shmeis Iyad Alshwabkeh Husam Abazid Mohammad Amin Mohammad Faculty of Pharmacy Isra UniversityPO Box 22 and 23AmmanJordan School of Pharmacy University of BradfordBradford BD7 1DPUK

In this study, the application of sodium bentonite(SB) in formulation of tablets prepared by direct compression for oral administration was tested. Three different model drugs with different solubilities: paracetamol, diclofenac sodium and metformin HCl were tested. Each drug was mixed with SB at ratio of 50% and the mixtures were subsequently compressed.Compatibility studies were conducted using both Deferential Scanning Calorimeter(DSC)and Fourier Transform Infrared Spectroscopy(FTIR). The dissolution profile for each drug was determined in USP-buffers at different time intervals. Diclofenac sodium in pH 6.8 buffer and paracetamol in both pH 6.8 and pH 4.5 buffers showed extended release. However,metformin HCl showed immediate release at the different pH values. The study showed that using SB was possible to prepare tablets with different release profiles. However, these profiles differ depending on dissolution media and drug type.

关键词： Direct compression Sustained release excipients Sodium bentonite

Dose-dependent and Synergistic Effects of excipients Commonly used in the Self-emulsifying Drug Delivery System(SEDDS) on Human Multidrug Resistance Related Protein 2(MRP2)

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Dose-dependent and Synergistic Effects of Excipients Commonl...

Formulation strategies in immunotherapeutic pharmaceutical products

“好医生杯”中药制剂创新与发展论坛

作者：易涛李良林伟基澳门科技大学澳门药物及健康应用研究院中药质量研究国家重点实验室

本研究以灯盏乙素为模型药,研究自乳化给药系统(SEDDS)的常用辅料对多药耐药相关蛋白2(MRP2)抑制作用的剂量依赖性和协同效应。基于以前的研究结果,选取10种具有降低灯盏乙素外排作用的辅料和6种对MRP2有抑制作用的辅料,分别进行了Caco-... 详细信息

本研究以灯盏乙素为模型药,研究自乳化给药系统(SEDDS)的常用辅料对多药耐药相关蛋白2(MRP2)抑制作用的剂量依赖性和协同效应。基于以前的研究结果,选取10种具有降低灯盏乙素外排作用的辅料和6种对MRP2有抑制作用的辅料,分别进行了Caco-2细胞模型研究、MRP2膜囊转运研究和ATP酶活性评价研究。同时,以对MRP2抑制作用最强的CremophorEL为中心,研究比较其它辅料与其联合使用后抑制MRP2的协同效应。研究结果显示,CremophorEL和CremophorRH降低灯盏乙素在Caco-2细胞模型中的外排具有剂量依赖性,机理是它们通过剂量依赖性地抑制ATP酶的活性从而抑制了MRP2的作用。PEG 2000和PluronicF127分别与CremophorEL联用时,对MRP2的抑制作用具有协同效应。而其它没有剂量依赖性的辅料,在使用浓度超过某个临界浓度时,对灯盏乙素外排的抑制作用显著提高。因此研究辅料对MRP2抑制作用的剂量依赖性和协同效应,对于筛选灯盏乙素SEDDS的处方具有重要意义。

关键词： dose dependent synergistic effect excipients MRP2 self-emulsifying drug delivery systems scutellarin

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World Journal of Clinical Oncology 2020年第5期11卷 275-282页

作者： Yajie Zhang Robert O Williams Ⅲ Haley Oana Tucker Division of Molecular Pharmaceutics and Drug Delivery College of PharmacyThe University of Texas at AustinAustinTX 78712United States Departments of Bioengineering and Molecular Biosciences The University of Texas at AustinAustinTX 78712United States

Development of immunologic-based biopharmaceutical products have strikingly increased in recent years and have made evident contributions to human health.Antibodies are the leading entity in immunotherapy,while chimeric antigen receptor T cells therapies are the advent of a novel strategy in this area.In order to enable antibody candidates or cells available as products,formulation is critical in terms of stabilize molecules or cells to achieve practical shelf life,storage and handling conditions.Here we provide a concise and contemporary review of ongoing formulation strategies and excipients used in approved antibodies and cellular therapeutic products.excipients are categorized,and their function in formulations are discussed.

关键词： Immunotherapeutic Pharmaceutical products Formulation excipients Cell therapy Antibody

Stress Degradation Studies on Lisinopril Dihydrate Using Modified Reverse Phase High Performance Liquid Chromatography

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American Journal of Analytical Chemistry 2014年第5期5卷 316-322页

作者： Elsadig H. K. Adam Department of Pharmaceutical Chemistry College of Pharmacy Salman bin Abdulaziz University Al-Kharj KSA

A simple, precise, accurate and sensitive reverse phase high performance liquid chromatographic method for simultaneous estimation of lisinopril dihydrate and its degradation products occuring under different ICH prescribed stress conditions has been modified. Drug was resolved on a C18 column, utilizing modified mobile phase of tetra butyl ammonium hydroxide solution and acetonitrile. Ultra violet detection was carried out at 210 nm. The method was modified with respect to linearity, precision, accuracy, selectivity, specificity and ruggedness. The results obtained revealed that lisinopril dihydrate was an active product slightly changed under stress conditions.

关键词： Lisinopril Dihydrate Stability UV Light Sun Light High Temperature Pharmaceutical excipients High Performance Liquid Chromatography

Drug-Excipient Interactions: Case Studies and Overview of Drug Degradation Pathways

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American Journal of Analytical Chemistry 2016年第1期7卷 107-140页

作者： Kishore Kumar Hotha Swapan Roychowdhury Veerappan Subramanian Novel Laboratories Inc. Somerset NJ USA

The objective of the current research article is to provide a comprehensive review of excipients impact on the stability of the drug product and their implications during the product development. Recent developments in the understanding of the degradation pathways further impact methodologies used in the pharmaceutical industry for potential stability assessment. The formation of drug excipient adducts was very common based on the sensitive chemical moieties in the drugs and the excipients. The formation of the impurities was not limited to drug related impurities but there were several possibilities of the drug-excipient adduct formations as well as excipient impurities reaction with Active Pharmaceutical Ingredients. Identification of drug degradation in presence of excipients/excipient impurities requires extensive knowledge and adequate analytical characterization data. Systematic literature review and understanding about the drug formulation process, give you a smooth platform in establishing the finished product in the drug market. This paper discusses mechanistic basis of known drug-excipient interactions with case studies and provides an overview of common underlying themes in solid, semisolid and parenteral dosage forms.

关键词： Drug excipients Forced Degradation Impurities Adducts Degradation Pathways HPLC LC-MS/MS Synthesis Chemistry Characterization