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Sanjay Garg - One of the best experts on this subject based on the ideXlab platform.

  • selection of Excipients for extended release formulations of glipizide through drug Excipient compatibility testing
    Journal of Pharmaceutical and Biomedical Analysis, 2005
    Co-Authors: Rajan K Verma, Sanjay Garg
    Abstract:

    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.

  • selection of Excipients for extended release formulations of glipizide through drug Excipient compatibility testing
    Journal of Pharmaceutical and Biomedical Analysis, 2005
    Co-Authors: Rajan K Verma, Sanjay Garg
    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 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.

  • Selection of Excipients for extended release formulations of glipizide through drug–Excipient compatibility testing
    Journal of Pharmaceutical and Biomedical Analysis, 2005
    Co-Authors: Rajan K Verma, Sanjay Garg
    Abstract:

    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.

  • Selection of Excipients for extended release formulations of glipizide through drug–Excipient compatibility testing
    Journal of pharmaceutical and biomedical analysis, 2005
    Co-Authors: Rajan K Verma, Sanjay Garg
    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 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.

Kathiresan Krishnasamy - One of the best experts on this subject based on the ideXlab platform.

  • Drug-Drug/Drug-Excipient Compatibility Studies on Curcumin using Non-Thermal Methods.
    Advanced Pharmaceutical Bulletin, 2014
    Co-Authors: Moorthi Chidambaram, Kathiresan Krishnasamy
    Abstract:

    Purpose: Curcumin is a hydrophobic polyphenol isolated from dried rhizome of turmeric. Clinical usefulness of curcumin in the treatment of cancer is limited due to poor aqueous solubility, hydrolytic degradation, metabolism, and poor oral bioavailability. To overcome these limitations, we proposed to fabricate curcuminpiperine, curcumin-quercetin and curcumin-silibinin loaded polymeric nanoformulation. However, unfavourable combinations of drug-drug and drug-Excipient may result in interaction and rises the safety concern. Hence, the present study was aimed to assess the interaction of curcumin with Excipients used in nanoformulations. Methods: Isothermal stress testing method was used to assess the compatibility of drugdrug/drug-Excipient. Results: The combination of curcumin-piperine, curcumin-quercetin, curcumin-silibinin and the combination of other Excipients with curcumin, piperine, quercetin and silibinin have not shown any significant physical and chemical instability. Conclusion: The study concludes that the curcumin, piperine, quercetin and silibinin is compatible with each other and with other Excipients.

  • drug drug drug Excipient compatibility studies on curcumin using non thermal methods
    Advanced Pharmaceutical Bulletin, 2014
    Co-Authors: Moorthi Chidambaram, Kathiresan Krishnasamy
    Abstract:

    Purpose: Curcumin is a hydrophobic polyphenol isolated from dried rhizome of turmeric. Clinical usefulness of curcumin in the treatment of cancer is limited due to poor aqueous solubility, hydrolytic degradation, metabolism, and poor oral bioavailability. To overcome these limitations, we proposed to fabricate curcuminpiperine, curcumin-quercetin and curcumin-silibinin loaded polymeric nanoformulation. However, unfavourable combinations of drug-drug and drug-Excipient may result in interaction and rises the safety concern. Hence, the present study was aimed to assess the interaction of curcumin with Excipients used in nanoformulations. Methods: Isothermal stress testing method was used to assess the compatibility of drugdrug/drug-Excipient. Results: The combination of curcumin-piperine, curcumin-quercetin, curcumin-silibinin and the combination of other Excipients with curcumin, piperine, quercetin and silibinin have not shown any significant physical and chemical instability. Conclusion: The study concludes that the curcumin, piperine, quercetin and silibinin is compatible with each other and with other Excipients.

Rajan K Verma - One of the best experts on this subject based on the ideXlab platform.

  • selection of Excipients for extended release formulations of glipizide through drug Excipient compatibility testing
    Journal of Pharmaceutical and Biomedical Analysis, 2005
    Co-Authors: Rajan K Verma, Sanjay Garg
    Abstract:

    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.

  • selection of Excipients for extended release formulations of glipizide through drug Excipient compatibility testing
    Journal of Pharmaceutical and Biomedical Analysis, 2005
    Co-Authors: Rajan K Verma, Sanjay Garg
    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 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.

  • Selection of Excipients for extended release formulations of glipizide through drug–Excipient compatibility testing
    Journal of Pharmaceutical and Biomedical Analysis, 2005
    Co-Authors: Rajan K Verma, Sanjay Garg
    Abstract:

    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.

  • Selection of Excipients for extended release formulations of glipizide through drug–Excipient compatibility testing
    Journal of pharmaceutical and biomedical analysis, 2005
    Co-Authors: Rajan K Verma, Sanjay Garg
    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 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.

Moorthi Chidambaram - One of the best experts on this subject based on the ideXlab platform.

  • Drug-Drug/Drug-Excipient Compatibility Studies on Curcumin using Non-Thermal Methods.
    Advanced Pharmaceutical Bulletin, 2014
    Co-Authors: Moorthi Chidambaram, Kathiresan Krishnasamy
    Abstract:

    Purpose: Curcumin is a hydrophobic polyphenol isolated from dried rhizome of turmeric. Clinical usefulness of curcumin in the treatment of cancer is limited due to poor aqueous solubility, hydrolytic degradation, metabolism, and poor oral bioavailability. To overcome these limitations, we proposed to fabricate curcuminpiperine, curcumin-quercetin and curcumin-silibinin loaded polymeric nanoformulation. However, unfavourable combinations of drug-drug and drug-Excipient may result in interaction and rises the safety concern. Hence, the present study was aimed to assess the interaction of curcumin with Excipients used in nanoformulations. Methods: Isothermal stress testing method was used to assess the compatibility of drugdrug/drug-Excipient. Results: The combination of curcumin-piperine, curcumin-quercetin, curcumin-silibinin and the combination of other Excipients with curcumin, piperine, quercetin and silibinin have not shown any significant physical and chemical instability. Conclusion: The study concludes that the curcumin, piperine, quercetin and silibinin is compatible with each other and with other Excipients.

  • drug drug drug Excipient compatibility studies on curcumin using non thermal methods
    Advanced Pharmaceutical Bulletin, 2014
    Co-Authors: Moorthi Chidambaram, Kathiresan Krishnasamy
    Abstract:

    Purpose: Curcumin is a hydrophobic polyphenol isolated from dried rhizome of turmeric. Clinical usefulness of curcumin in the treatment of cancer is limited due to poor aqueous solubility, hydrolytic degradation, metabolism, and poor oral bioavailability. To overcome these limitations, we proposed to fabricate curcuminpiperine, curcumin-quercetin and curcumin-silibinin loaded polymeric nanoformulation. However, unfavourable combinations of drug-drug and drug-Excipient may result in interaction and rises the safety concern. Hence, the present study was aimed to assess the interaction of curcumin with Excipients used in nanoformulations. Methods: Isothermal stress testing method was used to assess the compatibility of drugdrug/drug-Excipient. Results: The combination of curcumin-piperine, curcumin-quercetin, curcumin-silibinin and the combination of other Excipients with curcumin, piperine, quercetin and silibinin have not shown any significant physical and chemical instability. Conclusion: The study concludes that the curcumin, piperine, quercetin and silibinin is compatible with each other and with other Excipients.

Sarrate Arjona Rocío - One of the best experts on this subject based on the ideXlab platform.

  • Obtención por atomización y evaluación de agregados esféricos. Un nuevo Excipiente co-procesado para compresión directa
    'Edicions de la Universitat de Barcelona', 2017
    Co-Authors: Sarrate Arjona Rocío
    Abstract:

    La aparición de los Excipientes co-procesados se debe principalmente a la creciente apreciación del rol que desempeñan los Excipientes en los comprimidos y a la mayor tendencia a su fabricación, especialmente por compresión directa, por las ventajas que aporta, tanto económicas como de proceso. Los Excipientes co-procesados son combinaciones de dos o más Excipientes establecidos que, a nivel particular son diseñados para modificar físicamente alguna de sus propiedades de una forma inalcanzable por la mezcla física simple, sin realizar cambio químico significativo. En este estudio se ha desarrollado y evaluado un prototipo de Excipiente co-procesado para compresión directa compuesto por maltosa tipo II (75 %) y almidón de maíz (25 %), utilizando como técnica para su obtención la atomización por nebulización neumática de doble fluido y comparándolo finalmente con la mezcla física simple entre los Excipientes que lo componen. La selección de los Excipientes iniciales se ha realizado en base a su interés como diluyentes/aglutinantes en la formulación de comprimidos y se han agrupado en función de su solubilidad en agua (solubles, parcialmente solubles y prácticamente insolubles). Mediante la evaluación de las partículas después de la atomización de estos Excipientes individualmente, se han establecido una serie de combinaciones binarias entre ellos. La co-atomización de los 40 ensayos resultantes de las combinaciones binarias establecidas, se ha realizado determinando las propiedades y características de las suspensiones y ajustando las condiciones de co-atomización. Como respuestas de proceso se ha estudiado la temperatura de salida, el tiempo de proceso, el rendimiento, la velocidad de atomización, la eficiencia de secado y el contenido en agua. La evaluación de las propiedades de las partículas ha consistido en la determinación del tamaño y distribución del tamaño de partícula y la observación de la morfología de las partículas para conocer el grado de integración de éstas (particle engineering), además de estudiar la compactación de las muestras obtenidas. Tras establecer la composición final del prototipo de Excipiente co-procesado (75 % de maltosa tipo II y 25 % de almidón de maíz) se ha evaluado la robustez del proceso para su obtención. En primer lugar, el estudio comparativo entre el prototipo de Excipiente co-procesado y la mezcla física simple ha consistido en realizar una caracterización estructural, utilizando las técnicas de microscopía electrónica de barrido, calorimetría diferencial de barrido, difracción de rayos X, espectroscopia de infrarrojos, resonancia magnética nuclear de protón, picnometría de helio y difracción láser. Y en segundo lugar se ha efectuado un estudio físico-mecánico, realizando el diagrama SeDeM para conocer la viabilidad de las muestras para compresión directa, analizando los parámetros farmacotécnicos de los comprimidos, caracterizando las propiedades de compactación y evaluando la compactación mediante la aplicación del modelo de Heckel.With the advancement of tablet manufacturing process, the demand of Excipients with improved functionalities, mainly in terms of flow and compression properties, has increased. Moreover, due to the growing appreciation of the role of the Excipients in tablets and the greater tendency to manufacture them, especially by direct compression, due to the advantages it brings, both in economic and process terms. Coprocessed Excipients are a mixture of two or more existing Excipients at subparticle level, that offer substantial benefits of the incorporated Excipients and minimize their drawbacks. They are designed to physically modify some of their properties in a manner unattainable by simple physical mixing without significant chemical change. The objective of this study was to prepare and evaluate a novel spray dried co-processed Excipient using a mixture of maltose and maize starch to be used as a directly compressible Excipient. To achieve this purpose, the selection of the starting materials has been made according to their ability as filler/binder in tableting and according to their solubility in water. After the study of the modification of the morphology and particle size of the starting pharmaceutical Excipients by spray drying, 40 binary powder mixtures were prepared by co-spray drying according to the obtained results. In terms of particle level, particles were evaluated for particle size, particle size distribution and morphology, to analyze the incorporation of one Excipient into the particle structure of the other. And in terms of bulk level, it was evaluated the compaction ability of the powders. With these results, the final composition was established: 75 % of maltose type II and 25 % of maize starch. With an experimental design of the process of co-spray drying, it was evaluated the significant factors with the studied responses. The prototype of the co-processed Excipient was compared with the physical mixture of both starting materials. Relevant analytical methods, such X ray diffraction, IR spectroscopy, DSC and H1 NMR among others, showed the absence of chemical change. Moreover, the study of the rheological and compaction properties proved that the prototype of the co-processed Excipient was able to improve the desired properties for a direct compression Excipient, resulting in performance enhancement about this

  • Obtención por atomización y evaluación de agregados esféricos. Un nuevo Excipiente co-procesado para compresión directa
    'Edicions de la Universitat de Barcelona', 2017
    Co-Authors: Sarrate Arjona Rocío
    Abstract:

    [spa] La aparición de los Excipientes co-procesados se debe principalmente a la creciente apreciación del rol que desempeñan los Excipientes en los comprimidos y a la mayor tendencia a su fabricación, especialmente por compresión directa, por las ventajas que aporta, tanto económicas como de proceso. Los Excipientes co-procesados son combinaciones de dos o más Excipientes establecidos que, a nivel particular son diseñados para modificar físicamente alguna de sus propiedades de una forma inalcanzable por la mezcla física simple, sin realizar cambio químico significativo. En este estudio se ha desarrollado y evaluado un prototipo de Excipiente co-procesado para compresión directa compuesto por maltosa tipo II (75 %) y almidón de maíz (25 %), utilizando como técnica para su obtención la atomización por nebulización neumática de doble fluido y comparándolo finalmente con la mezcla física simple entre los Excipientes que lo componen. La selección de los Excipientes iniciales se ha realizado en base a su interés como diluyentes/aglutinantes en la formulación de comprimidos y se han agrupado en función de su solubilidad en agua (solubles, parcialmente solubles y prácticamente insolubles). Mediante la evaluación de las partículas después de la atomización de estos Excipientes individualmente, se han establecido una serie de combinaciones binarias entre ellos. La co-atomización de los 40 ensayos resultantes de las combinaciones binarias establecidas, se ha realizado determinando las propiedades y características de las suspensiones y ajustando las condiciones de co-atomización. Como respuestas de proceso se ha estudiado la temperatura de salida, el tiempo de proceso, el rendimiento, la velocidad de atomización, la eficiencia de secado y el contenido en agua. La evaluación de las propiedades de las partículas ha consistido en la determinación del tamaño y distribución del tamaño de partícula y la observación de la morfología de las partículas para conocer el grado de integración de éstas (particle engineering), además de estudiar la compactación de las muestras obtenidas. Tras establecer la composición final del prototipo de Excipiente co-procesado (75 % de maltosa tipo II y 25 % de almidón de maíz) se ha evaluado la robustez del proceso para su obtención. En primer lugar, el estudio comparativo entre el prototipo de Excipiente co-procesado y la mezcla física simple ha consistido en realizar una caracterización estructural, utilizando las técnicas de microscopía electrónica de barrido, calorimetría diferencial de barrido, difracción de rayos X, espectroscopia de infrarrojos, resonancia magnética nuclear de protón, picnometría de helio y difracción láser. Y en segundo lugar se ha efectuado un estudio físico-mecánico, realizando el diagrama SeDeM para conocer la viabilidad de las muestras para compresión directa, analizando los parámetros farmacotécnicos de los comprimidos, caracterizando las propiedades de compactación y evaluando la compactación mediante la aplicación del modelo de Heckel.[eng] With the advancement of tablet manufacturing process, the demand of Excipients with improved functionalities, mainly in terms of flow and compression properties, has increased. Moreover, due to the growing appreciation of the role of the Excipients in tablets and the greater tendency to manufacture them, especially by direct compression, due to the advantages it brings, both in economic and process terms. Coprocessed Excipients are a mixture of two or more existing Excipients at subparticle level, that offer substantial benefits of the incorporated Excipients and minimize their drawbacks. They are designed to physically modify some of their properties in a manner unattainable by simple physical mixing without significant chemical change. The objective of this study was to prepare and evaluate a novel spray dried co-processed Excipient using a mixture of maltose and maize starch to be used as a directly compressible Excipient. To achieve this purpose, the selection of the starting materials has been made according to their ability as filler/binder in tableting and according to their solubility in water. After the study of the modification of the morphology and particle size of the starting pharmaceutical Excipients by spray drying, 40 binary powder mixtures were prepared by co-spray drying according to the obtained results. In terms of particle level, particles were evaluated for particle size, particle size distribution and morphology, to analyze the incorporation of one Excipient into the particle structure of the other. And in terms of bulk level, it was evaluated the compaction ability of the powders. With these results, the final composition was established: 75 % of maltose type II and 25 % of maize starch. With an experimental design of the process of co-spray drying, it was evaluated the significant factors with the studied responses. The prototype of the co-processed Excipient was compared with the physical mixture of both starting materials. Relevant analytical methods, such X ray diffraction, IR spectroscopy, DSC and H1 NMR among others, showed the absence of chemical change. Moreover, the study of the rheological and compaction properties proved that the prototype of the co-processed Excipient was able to improve the desired properties for a direct compression Excipient, resulting in performance enhancement about this