The Experts below are selected from a list of 63849 Experts worldwide ranked by ideXlab platform
Bai-wang Sun - One of the best experts on this subject based on the ideXlab platform.
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Compatibility study of rivaroxaban and its pharmaceutical Excipients
Journal of Thermal Analysis and Calorimetry, 2017Co-Authors: Ting Ding, Lan Chen, Li-hai Zhai, Bai-wang SunAbstract:Rivaroxaban is an oral direct Factor Xa inhibitor to treat thrombus. The aim of this study is to investigate the drug–excipient compatibility between rivaroxaban tablet and pharmaceutical Excipients by a combination of thermal and spectroscopic methods. Differential scanning calorimetry (DSC) is the most important technique to evaluate the compatibility. In addition, X-ray powder diffraction (XRPD) is a complementary technique to explain the DSC result and exclude relevant interaction. On the basis of DSC curves about rivaroxaban and excipient and mixture (1:1, w/w), the rivaroxaban was considered to be compatible with the most Excipients (microcrystalline cellulose, lactose, hydroxyl propyl methyl cellulose, magnesium stearate). Meanwhile, the XRPD studies also showed the compatibility of rivaroxaban and pharmaceutical Excipients, especially for the sodium lauryl sulfate. Overall, the compatibility of the Excipients with rivaroxaban was assessed successfully by DSC and XRPD, and the formulations developed using the compatible excipient were found to be stable.
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Compatibility of medroxyprogesterone acetate and pharmaceutical Excipients through thermal and spectroscopy techniques
Journal of Thermal Analysis and Calorimetry, 2014Co-Authors: Rui Gao, Bai-wang Sun, Jun Lin, Xiao-li GaoAbstract:Studies of active drug-excipient compatibility represent an important phase in the preformulation stage of the development of all dosage forms. For the development of conjugation estrogens and medroxyprogesterone acetate (MPA) double-layer tablets, techniques of thermal, isothermal stress testing (IST), and molecular vibrational spectroscopy analysis were performed to access the compatibility. Differential scanning calorimetry (DSC) studies were used as an important and complementary tool during preformulation to determine drug-excipient compatibility. On the basis of DSC results, MPA was found to be compatible with polyethylene glycol 6000. However, the results of Raman and IST studies showed that all the Excipients defined in the prototype formula were found to be compatible with MPA. Overall, the compatibility of selected Excipients with MPA was successfully evaluated using a combination of thermal and IST methods, and the formulations developed using the compatible Excipients were found to be stable.
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Selection of Excipients for dispersible tablets of itraconazole through the application of thermal techniques and Raman spectroscopy
Journal of Thermal Analysis and Calorimetry, 2013Co-Authors: Yan Wang, Yang-hui Luo, Jing Zhao, Bai-wang SunAbstract:For the development of dispersible tablets of itraconazole (ITR), techniques of thermal, Raman spectroscopy, and isothermal stress testing (IST) were used to assess the compatibility of ITR with selected Excipients. Initially, differential scanning calorimeter (DSC) was used to evaluate the compatibility. Raman spectrum of drug–excipient mixture was also compared with that of pure drug and excipient. Compatibility of Excipients defined in the prototype formula was tested using IST. Based on the DSC results alone, PEG-4000 was found to exhibit interaction with ITR. However, the results of Raman and IST studies showed that all the Excipients used in the formula were compatible with ITR. Overall, compatibility of Excipients with ITR was successfully evaluated using the combination of DSC, Raman spectroscopy, and IST techniques.
G. Popa - One of the best experts on this subject based on the ideXlab platform.
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The influence of Excipients on physical and pharmaceutical properties of oral lyophilisates containing a pregabalin-acetaminophen combination
Expert Opinion on Drug Delivery, 2017Co-Authors: Aurica P. Chiriac, Alina Diaconu, Loredana E. Nita, Nita Tudorachi, Liliana Mititelu-tartau, Andreea Creteanu, Oana Maria Dragostin, Daniela Rusu, G. PopaAbstract:ABSTRACTObjectives: The purpose of the study was to investigate and characterize the oral lyophilisates containing the pregabalin-acetaminophen drug combination and as xcipients mannitol with microcrystalline cellulose or hydroxypropyl methylcellulose, in order to conclude upon drug-excipient interactions and their stability implications, impact of Excipients on drug release and on the physicochemical and mechanical properties of the pharmaceutical formulations.Methods: The oral tablets were made by using a Christ freeze-dryer alpha 2–4-LSC lyophilizer, and evaluated for stability, drug-excipient compatibility and homogeneity of the prepared pharmaceutical formulations. The formulations were evaluated for in vivo absorption in rabbits by histopathological exams.Results: FTIR and thermogravimetric analyses, DLS technique, SEM and NIR-CI studies confirmed the compatibility between compounds. From the determined physical and biochemical parameters of the formulations it was established that they are stable, ...
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The influence of Excipients on physical and pharmaceutical properties of oral lyophilisates containing a pregabalin-acetaminophen combination
2017Co-Authors: Aurica P. Chiriac, Alina Diaconu, Loredana E. Nita, Nita Tudorachi, Liliana Mititelu-tartau, Andreea Creteanu, Oana Maria Dragostin, Daniela Rusu, G. PopaAbstract:Objectives: The purpose of the study was to investigate and characterize the oral lyophilisates containing the pregabalin-acetaminophen drug combination and as xcipients mannitol with microcrystalline cellulose or hydroxypropyl methylcellulose, in order to conclude upon drug-excipient interactions and their stability implications, impact of Excipients on drug release and on the physicochemical and mechanical properties of the pharmaceutical formulations. Methods: The oral tablets were made by using a Christ freeze-dryer alpha 2–4-LSC lyophilizer, and evaluated for stability, drug-excipient compatibility and homogeneity of the prepared pharmaceutical formulations. The formulations were evaluated for in vivo absorption in rabbits by histopathological exams. Results: FTIR and thermogravimetric analyses, DLS technique, SEM and NIR-CI studies confirmed the compatibility between compounds. From the determined physical and biochemical parameters of the formulations it was established that they are stable, homogeneous, and meet the conditions for orally disintegrating tablets. Conclusion: In the case of the investigated pharmaceutical formulations the study evidenced the assembling through physical bonds between the Excipients and the ‘codrug’ complex, which do not affect the release of the bioactive compounds.
Aurica P. Chiriac - One of the best experts on this subject based on the ideXlab platform.
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The influence of Excipients on physical and pharmaceutical properties of oral lyophilisates containing a pregabalin-acetaminophen combination
Expert Opinion on Drug Delivery, 2017Co-Authors: Aurica P. Chiriac, Alina Diaconu, Loredana E. Nita, Nita Tudorachi, Liliana Mititelu-tartau, Andreea Creteanu, Oana Maria Dragostin, Daniela Rusu, G. PopaAbstract:ABSTRACTObjectives: The purpose of the study was to investigate and characterize the oral lyophilisates containing the pregabalin-acetaminophen drug combination and as xcipients mannitol with microcrystalline cellulose or hydroxypropyl methylcellulose, in order to conclude upon drug-excipient interactions and their stability implications, impact of Excipients on drug release and on the physicochemical and mechanical properties of the pharmaceutical formulations.Methods: The oral tablets were made by using a Christ freeze-dryer alpha 2–4-LSC lyophilizer, and evaluated for stability, drug-excipient compatibility and homogeneity of the prepared pharmaceutical formulations. The formulations were evaluated for in vivo absorption in rabbits by histopathological exams.Results: FTIR and thermogravimetric analyses, DLS technique, SEM and NIR-CI studies confirmed the compatibility between compounds. From the determined physical and biochemical parameters of the formulations it was established that they are stable, ...
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The influence of Excipients on physical and pharmaceutical properties of oral lyophilisates containing a pregabalin-acetaminophen combination
2017Co-Authors: Aurica P. Chiriac, Alina Diaconu, Loredana E. Nita, Nita Tudorachi, Liliana Mititelu-tartau, Andreea Creteanu, Oana Maria Dragostin, Daniela Rusu, G. PopaAbstract:Objectives: The purpose of the study was to investigate and characterize the oral lyophilisates containing the pregabalin-acetaminophen drug combination and as xcipients mannitol with microcrystalline cellulose or hydroxypropyl methylcellulose, in order to conclude upon drug-excipient interactions and their stability implications, impact of Excipients on drug release and on the physicochemical and mechanical properties of the pharmaceutical formulations. Methods: The oral tablets were made by using a Christ freeze-dryer alpha 2–4-LSC lyophilizer, and evaluated for stability, drug-excipient compatibility and homogeneity of the prepared pharmaceutical formulations. The formulations were evaluated for in vivo absorption in rabbits by histopathological exams. Results: FTIR and thermogravimetric analyses, DLS technique, SEM and NIR-CI studies confirmed the compatibility between compounds. From the determined physical and biochemical parameters of the formulations it was established that they are stable, homogeneous, and meet the conditions for orally disintegrating tablets. Conclusion: In the case of the investigated pharmaceutical formulations the study evidenced the assembling through physical bonds between the Excipients and the ‘codrug’ complex, which do not affect the release of the bioactive compounds.
Rahul V Haware - One of the best experts on this subject based on the ideXlab platform.
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excipient variability and its impact on dosage form functionality
Journal of Pharmaceutical Sciences, 2015Co-Authors: Vivek S Dave, Suprit D Saoji, Nishikant A Raut, Rahul V HawareAbstract:Pharmaceutical Excipients are essential components of most modern dosage forms. Although defined as pharmacologically inert, Excipients can be thought of as the true enablers of drug product performance. Unintentional variability in the properties of the Excipients may be unavoidable, albeit minimizable. The variability may originate from the source, the excipient-manufacturing process, or during the manufacturing of dosage forms. Excipient variability may have a range of influences on their functionality and performance in the dosage form. A better understanding of these influences on the critical quality attributes of the final product is of prime importance. Modern analytical tools provide a significant assistance in characterizing excipient variability to achieve this understanding. The principles and concepts of Quality-by-Design, process analytical technology, and design space, provide a holistic risk-based approach toward manufacture and application of Excipients in pharmaceutical formulations. The International Pharmaceutical Excipients Council (IPEC) has developed guidelines for proper selection, use, and evaluation of Excipients in pharmaceutical products.
Sanjay Garg - One of the best experts on this subject based on the ideXlab platform.
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selection of Excipients for extended release formulations of glipizide through drug excipient compatibility testing
Journal of Pharmaceutical and Biomedical Analysis, 2005Co-Authors: Rajan K Verma, Sanjay GargAbstract:Abstract For the development of extended release formulations of glipizide, techniques of thermal and isothermal stress testing (IST) were used to assess the compatibility of glipizide with selected Excipients. Initially, differential scanning calorimeter (DSC) was used to evaluate the compatibility. IR spectrum of drug–excipient mixture was also compared with that of pure drug and excipient. Compatibility of Excipients defined in the prototype formula was tested using IST. Based on the DSC results alone, magnesium stearate, meglumine, TRIS buffer, and lactose, were found to exhibit interaction with glipizide. Stressed binary mixtures (stored at 50 °C for 3 weeks) of glipizide and meglumine showed yellow coloration indicating potential incompatibility. Based on the results of DSC, IR, and/or HPLC, Excipients defined in the prototype formula were found to be compatible with glipizide. The optimized formulation developed using the compatible Excipients were found to be stable after 3 months of accelerated stability studies (40 °C and 75% RH). Overall, compatibility of Excipients with glipizide was successfully evaluated using the combination of thermal and IST methods and the formulations developed using the compatible Excipients was found to be stable.
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selection of Excipients for extended release formulations of glipizide through drug excipient compatibility testing
Journal of Pharmaceutical and Biomedical Analysis, 2005Co-Authors: Rajan K Verma, Sanjay GargAbstract:For the development of extended release formulations of glipizide, techniques of thermal and isothermal stress testing (IST) were used to assess the compatibility of glipizide with selected Excipients. Initially, differential scanning calorimeter (DSC) was used to evaluate the compatibility. IR spectrum of drug-excipient mixture was also compared with that of pure drug and excipient. Compatibility of Excipients defined in the prototype formula was tested using IST. Based on the DSC results alone, magnesium stearate, meglumine, TRIS buffer, and lactose, were found to exhibit interaction with glipizide. Stressed binary mixtures (stored at 50 degrees C for 3 weeks) of glipizide and meglumine showed yellow coloration indicating potential incompatibility. Based on the results of DSC, IR, and/or HPLC, Excipients defined in the prototype formula were found to be compatible with glipizide. The optimized formulation developed using the compatible Excipients were found to be stable after 3 months of accelerated stability studies (40 degrees C and 75% RH). Overall, compatibility of Excipients with glipizide was successfully evaluated using the combination of thermal and IST methods and the formulations developed using the compatible Excipients was found to be stable.
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Selection of Excipients for extended release formulations of glipizide through drug–excipient compatibility testing
Journal of Pharmaceutical and Biomedical Analysis, 2005Co-Authors: Rajan K Verma, Sanjay GargAbstract:Abstract For the development of extended release formulations of glipizide, techniques of thermal and isothermal stress testing (IST) were used to assess the compatibility of glipizide with selected Excipients. Initially, differential scanning calorimeter (DSC) was used to evaluate the compatibility. IR spectrum of drug–excipient mixture was also compared with that of pure drug and excipient. Compatibility of Excipients defined in the prototype formula was tested using IST. Based on the DSC results alone, magnesium stearate, meglumine, TRIS buffer, and lactose, were found to exhibit interaction with glipizide. Stressed binary mixtures (stored at 50 °C for 3 weeks) of glipizide and meglumine showed yellow coloration indicating potential incompatibility. Based on the results of DSC, IR, and/or HPLC, Excipients defined in the prototype formula were found to be compatible with glipizide. The optimized formulation developed using the compatible Excipients were found to be stable after 3 months of accelerated stability studies (40 °C and 75% RH). Overall, compatibility of Excipients with glipizide was successfully evaluated using the combination of thermal and IST methods and the formulations developed using the compatible Excipients was found to be stable.
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Selection of Excipients for extended release formulations of glipizide through drug–excipient compatibility testing
Journal of pharmaceutical and biomedical analysis, 2005Co-Authors: Rajan K Verma, Sanjay GargAbstract:For the development of extended release formulations of glipizide, techniques of thermal and isothermal stress testing (IST) were used to assess the compatibility of glipizide with selected Excipients. Initially, differential scanning calorimeter (DSC) was used to evaluate the compatibility. IR spectrum of drug-excipient mixture was also compared with that of pure drug and excipient. Compatibility of Excipients defined in the prototype formula was tested using IST. Based on the DSC results alone, magnesium stearate, meglumine, TRIS buffer, and lactose, were found to exhibit interaction with glipizide. Stressed binary mixtures (stored at 50 degrees C for 3 weeks) of glipizide and meglumine showed yellow coloration indicating potential incompatibility. Based on the results of DSC, IR, and/or HPLC, Excipients defined in the prototype formula were found to be compatible with glipizide. The optimized formulation developed using the compatible Excipients were found to be stable after 3 months of accelerated stability studies (40 degrees C and 75% RH). Overall, compatibility of Excipients with glipizide was successfully evaluated using the combination of thermal and IST methods and the formulations developed using the compatible Excipients was found to be stable.
