Presentation on review article published on high performance liquid chromatography (HPLC) including Abstract, Introduction, Types, Instrumentation, Parameters, Applications, Conclusion & References.
This document summarizes a study that formulated and tested rapidly dissolving nanofibers of the anti-diabetic drug Glibenclamide (GLB) using electrospinning and Polyvinylpyrrolidone (PVP) polymer. Scanning electron microscopy showed the nanofibers were 370-553nm in diameter. Fourier-transform infrared spectroscopy and differential scanning calorimetry indicated good drug-polymer compatibility. In vitro drug release studies found the nanofibers had enhanced dissolution rates compared to pure GLB, with release dependent on pH. The nanofibers showed potential as a fast dissolving oral formulation to improve GLB solubility and bioavailability.
A seminar on applications of various analytical techniquePatel Parth
This document provides information on preformulation studies for new drug development. It discusses:
1. The purpose of preformulation studies is to understand the characteristics of drug components and optimize dosage form manufacturing.
2. Preformulation studies establish the identity, properties, and compatibility of new drug substances to support formulation development and regulatory filings.
3. A variety of analytical techniques are used in preformulation studies including spectroscopy, chromatography, and thermal analysis to characterize drug substances and excipients.
Analytical tech in pre formulation 112070804009Patel Parth
This document provides an overview of preformulation studies for new drug development. It discusses the need for preformulation to understand drug properties and design stable dosage forms. The stages of preformulation studies are outlined. A wide range of analytical techniques and instruments used in preformulation are described, including spectroscopic, separation, and thermal methods. Regulatory requirements for preformulation related to IND/NDA submissions and cGMP are also reviewed.
This document summarizes an article that examines how different ionization source designs in LC-ESI-MS/MS systems can influence matrix effects during analysis. The article analyzes acamprosate (ACM) using two different LC-ESI-MS/MS instruments with different ionization source designs (a Z-spray source and an orthogonal spray source) coupled to UPLC/HPLC systems under the same chromatographic conditions. It finds that ACM showed almost complete ion suppression in the Z-spray source coupled to UPLC/HPLC, but only minor ion enhancement in the orthogonal spray source coupled to HPLC. Different phospholipids were responsible for the matrix effects in each case. The study demonstrates how
A Systematic Approach to Overcome the Matrix Effect during LC-ESI-MS/MS AnalysisBhaswat Chakraborty
This document discusses matrix effects (MEs) that can occur during LC-MS/MS bioanalytical methods and presents a systematic approach to overcome MEs through different sample extraction techniques. It finds that solid phase extraction produces the cleanest samples with the lowest MEs, while protein precipitation using methanol produces the dirtiest samples with the highest MEs. Different phospholipids are identified as contributing to MEs, with longer-retained phospholipids playing a more significant role. Among extraction methods, solid phase extraction is most effective at removing phospholipids and minimizing MEs, while protein precipitation is least effective.
This document discusses the importance of preformulation studies in designing sustained release dosage forms. Preformulation studies provide important information about the drug substance that can be used to develop stable and bioavailable sustained release formulations. Key aspects of preformulation include determining solubility, pKa, partition coefficient, crystal properties, and compatibility with excipients. This information helps select appropriate formulation components, manufacturing processes, container closure systems and more. The overall goal of preformulation is to generate data to support the development of sustained release dosage forms that can be mass produced and provide a prolonged therapeutic effect.
This document discusses structure-activity relationships (SAR) and how medicinal chemistry uses SAR to develop new drugs. It defines SAR as the relationship between a molecule's structure and its biological activity. Medicinal chemists analyze how structural modifications affect biological properties in order to determine which parts of a molecule are responsible for its effects. The goal is to optimize desired effects and minimize unwanted side effects by making targeted changes to a lead compound's structure. The document provides several examples of drugs that were developed through systematic SAR studies of existing compounds.
This document discusses preformulation studies, which examine the physicochemical properties of drugs and excipients before formulation to optimize the dosage form design. It covers fundamental properties like spectroscopy, solubility, melting point and assay. Derived properties include microscopy, flow properties, drug-excipient compatibility and drug stability studies. Preformulation helps ensure quality, uniformity and minimize costs and errors in product development and regulatory filings.
This document summarizes a study that formulated and tested rapidly dissolving nanofibers of the anti-diabetic drug Glibenclamide (GLB) using electrospinning and Polyvinylpyrrolidone (PVP) polymer. Scanning electron microscopy showed the nanofibers were 370-553nm in diameter. Fourier-transform infrared spectroscopy and differential scanning calorimetry indicated good drug-polymer compatibility. In vitro drug release studies found the nanofibers had enhanced dissolution rates compared to pure GLB, with release dependent on pH. The nanofibers showed potential as a fast dissolving oral formulation to improve GLB solubility and bioavailability.
A seminar on applications of various analytical techniquePatel Parth
This document provides information on preformulation studies for new drug development. It discusses:
1. The purpose of preformulation studies is to understand the characteristics of drug components and optimize dosage form manufacturing.
2. Preformulation studies establish the identity, properties, and compatibility of new drug substances to support formulation development and regulatory filings.
3. A variety of analytical techniques are used in preformulation studies including spectroscopy, chromatography, and thermal analysis to characterize drug substances and excipients.
Analytical tech in pre formulation 112070804009Patel Parth
This document provides an overview of preformulation studies for new drug development. It discusses the need for preformulation to understand drug properties and design stable dosage forms. The stages of preformulation studies are outlined. A wide range of analytical techniques and instruments used in preformulation are described, including spectroscopic, separation, and thermal methods. Regulatory requirements for preformulation related to IND/NDA submissions and cGMP are also reviewed.
This document summarizes an article that examines how different ionization source designs in LC-ESI-MS/MS systems can influence matrix effects during analysis. The article analyzes acamprosate (ACM) using two different LC-ESI-MS/MS instruments with different ionization source designs (a Z-spray source and an orthogonal spray source) coupled to UPLC/HPLC systems under the same chromatographic conditions. It finds that ACM showed almost complete ion suppression in the Z-spray source coupled to UPLC/HPLC, but only minor ion enhancement in the orthogonal spray source coupled to HPLC. Different phospholipids were responsible for the matrix effects in each case. The study demonstrates how
A Systematic Approach to Overcome the Matrix Effect during LC-ESI-MS/MS AnalysisBhaswat Chakraborty
This document discusses matrix effects (MEs) that can occur during LC-MS/MS bioanalytical methods and presents a systematic approach to overcome MEs through different sample extraction techniques. It finds that solid phase extraction produces the cleanest samples with the lowest MEs, while protein precipitation using methanol produces the dirtiest samples with the highest MEs. Different phospholipids are identified as contributing to MEs, with longer-retained phospholipids playing a more significant role. Among extraction methods, solid phase extraction is most effective at removing phospholipids and minimizing MEs, while protein precipitation is least effective.
This document discusses the importance of preformulation studies in designing sustained release dosage forms. Preformulation studies provide important information about the drug substance that can be used to develop stable and bioavailable sustained release formulations. Key aspects of preformulation include determining solubility, pKa, partition coefficient, crystal properties, and compatibility with excipients. This information helps select appropriate formulation components, manufacturing processes, container closure systems and more. The overall goal of preformulation is to generate data to support the development of sustained release dosage forms that can be mass produced and provide a prolonged therapeutic effect.
This document discusses structure-activity relationships (SAR) and how medicinal chemistry uses SAR to develop new drugs. It defines SAR as the relationship between a molecule's structure and its biological activity. Medicinal chemists analyze how structural modifications affect biological properties in order to determine which parts of a molecule are responsible for its effects. The goal is to optimize desired effects and minimize unwanted side effects by making targeted changes to a lead compound's structure. The document provides several examples of drugs that were developed through systematic SAR studies of existing compounds.
This document discusses preformulation studies, which examine the physicochemical properties of drugs and excipients before formulation to optimize the dosage form design. It covers fundamental properties like spectroscopy, solubility, melting point and assay. Derived properties include microscopy, flow properties, drug-excipient compatibility and drug stability studies. Preformulation helps ensure quality, uniformity and minimize costs and errors in product development and regulatory filings.
Preformulation involves characterizing the physicochemical properties of a new drug substance. This includes determining properties like solubility, melting point, particle size, and powder flow. Understanding these properties helps formulators design an optimal dosage form. Key goals of preformulation are generating useful data for formulators and establishing properties that may impact drug performance or development.
This document summarizes literature on cocrystal systems published in 2011 that are of interest to pharmaceutical scientists. It begins with an introduction to cocrystal systems and relevant review articles. It then discusses general articles on cocrystal engineering principles and characterization methods. The majority of the document summarizes literature on preparation methods for cocrystal systems and specific pharmaceutical cocrystal systems that were reported. It concludes with a discussion of regulatory guidance on pharmaceutical cocrystals.
The document provides an outline for lectures on pharmaceutical dosage form processing. It will cover general introduction to manufacturing processes, formulation assessment, analytical method development, formulation development, good manufacturing practices, and drug product stability. Key aspects of preformulation are also summarized, including characterizing organoleptic properties, purity, particle size and shape, solubilization using surfactants, and preformulation stability studies. Manufacturing processes involve transforming raw materials into finished products through various treatment, machining, and reshaping steps while ensuring quality.
This document outlines the course content, units, and recommended books for a Pharmacognosy and Phytochemistry II course. The 5 units cover topics like metabolic pathways in plants and biosynthesis of secondary metabolites, classes of secondary metabolites like alkaloids and terpenoids, isolation and analysis of phytoconstituents, industrial production of selected phytoconstituents, and modern extraction and analytical techniques. The practical sessions involve morphology, histology, extraction and detection of selected plants, isolation of active principles like caffeine and diosgenin, and analysis of crude drugs. Recommended textbooks cover latest editions on pharmacognosy, phytochemistry, herbal drug industry, and plant biotechnology.
Preformulation studies are important to develop a safe, effective, and stable dosage form. The goals are to establish physicochemical parameters of the drug substance for stability and compatibility with excipients. Key preformulation considerations include physical properties like polymorphism, particle size and shape, and chemical properties like hydrolysis and oxidation. These factors impact the drug's solubility, dissolution, and stability in a dosage form. Understanding preformulation is essential for optimizing the drug development process and producing dosage forms with consistent therapeutic effects.
This document discusses preformulation and various analytical techniques used for drug-excipient compatibility studies. It describes types of incompatibilities like physical and chemical incompatibilities. Techniques discussed include thermal analysis methods like thermogravimetry (TG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). Other techniques mentioned are X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR). The document also covers limitations of thermal analysis and applications of these techniques in preformulation studies like characterization of hydrates/solvates, detection of impurities, and compatibility studies.
IRJET- Insilico Studies of Molecular Property and Bioactivity of Organic ...IRJET Journal
This document summarizes an insilico study of the molecular properties and bioactivity of 10 organic crystalline compounds using the Molinspiration software. The key findings are:
1) All 10 compounds obeyed Lipinski's rule of five and had good drug-likeness scores based on parameters like miLogP, TPSA, molecular weight, etc.
2) Compounds I, II, IV, V, VI, VII, VIII and IX had bioactivity scores between -1.20 to 0.31, suggesting they could moderately act as GPCR ligands, ion channel modulators, nuclear receptor ligands, kinase inhibitors, protease inhibitors or enzyme inhibitors.
3) Compounds III, V
Supercritical fluid (CO2) chromatography for quantitative determination of se...Ratnakaram Venkata Nadh
In the present study, two cancer therapeutic drugs (docetaxel and bortezomib) were separated from their
potential impurities on a chromatographic platform by utilizing CO2 gas (supercritical state) and quantified.
The chromatographic separations were achieved on two short columns BEH-2EP (100mm 3mm, 1.7 mm)
and CHIRALPAK AD-3 (100 mm 4.6 mm, 3 mm) for docetaxel and bortezomib, respectively. The present
work describes the role of organic modifiers in the separation of polar compounds by supercritical fluid
chromatography. The two new methods were fully validated in accordance with the current ICH
(International Council for Harmonization of technical requirements for pharmaceuticals for human use)
guidelines. The stability indicating power of the methods was demonstrated from the stress studies
conducted on the injection formulations of the two compounds. The methods are precise with % RSD of
0.4, linear with the correlation coefficient of r2 $ 0.999 and accurate in the range of 50–150% of the
target assay concentration. The two methods can be equally employed for the assay determination of
docetaxel and bortezomib APIs as well.
This document provides guidance on preformulation studies for new drug substances. It outlines the key steps in preclinical testing including pharmacology, toxicology, and preformulation. Preformulation involves characterizing the physicochemical properties of the drug, including solubility, pKa, partition coefficient, stability, and crystal properties. The goal is to design an optimal drug delivery system through understanding the physical and chemical attributes of the new molecule.
This document summarizes various physicochemical characterization techniques used to analyze solid oral dosage forms, including microscopy, X-ray powder diffraction, thermal analysis, FTIR microspectroscopy, NMR imaging and spectroscopy, mass spectrometry, and Raman spectroscopy. Specific examples are provided to illustrate how each technique can provide insight into the drug substance distribution, solid state properties, and release characteristics. Near infrared analysis is also discussed for applications in qualitative analysis like raw material identification and blend homogeneity assessment and quantitative analysis for assaying finished drug products.
Physical and Structural Characterization of Biofield Treated Imidazole Deriva...albertdivis
The Aim of present study was to evaluate the impact of biofield treatment on two imidazole derivatives (i.e., imidazole and 2-methylimidazole) by various analytical methods.
This document provides an overview of preformulation studies, which characterize the physical and chemical properties of new drug molecules to aid in the development of safe, effective, and stable dosage forms. Some key points covered include:
- Preformulation studies give direction for dosage form selection, excipient choice, composition, and process development.
- Important physicochemical properties to determine include solubility, partition coefficient, pKa, stability, and interactions with excipients.
- Methods are described for evaluating properties like solubility, dissolution, oxidation, hydrolysis, and polymorphism which can impact stability and bioavailability.
- Understanding these properties aids in developing robust formulations and setting appropriate storage conditions for drug products
This document discusses modern pharmaceutics and preformulation concepts. It begins with an introduction to preformulation, which involves investigating a drug's physical and chemical properties alone and with excipients. This information guides dosage form development. The document then discusses drug-excipient interactions and compatibility testing methods. It also covers topics like solid dispersions, emulsions, suspensions, and parenteral product formulation and testing requirements.
The document discusses preformulation and summarizes some of its key aspects. Preformulation involves determining the physicochemical properties of new drug substances to aid in developing effective dosage forms. It covers topics like organoleptic properties, purity, particle size and shape, solubilization using surfactants, and the effect of temperature, pH and co-solvents on solubility. It also mentions the importance of preformulation stability studies and considering drug characteristics for different dosage forms. The goals of preformulation are establishing parameters, kinetic profiles, physical characteristics and compatibility with excipients.
Mohan Vivekanandan has 5 years of experience in bioanalytical assay development and quality control for biotherapeutics and vaccines. He has a PhD in Biochemistry and expertise in protein characterization, stability testing, method development and validation. His most recent role was as a Research Scientist at Theragen Biologics where he developed ELISA and other assays to characterize a novel Fab protein. He is looking for a challenging career in a progressive organization.
This document contains the resume of Dr. Abhishek Gupta. It summarizes his educational qualifications including an M.Sc. in Biotechnology, Ph.D. in Zoology, and research experience including six years as Director of two institutes. It also lists 16 research publications, training experiences, seminars and conferences attended, and skills including familiarity with analytical instruments and scientific writing. The resume is signed and dated by Dr. Gupta and includes two references.
Preformulation involves characterizing the physicochemical properties of a new drug substance. This includes determining properties like solubility, melting point, particle size, and powder flow. Understanding these properties helps formulators design an optimal dosage form. Key goals of preformulation are generating useful data for formulators and establishing properties that may impact drug performance or development.
This document summarizes literature on cocrystal systems published in 2011 that are of interest to pharmaceutical scientists. It begins with an introduction to cocrystal systems and relevant review articles. It then discusses general articles on cocrystal engineering principles and characterization methods. The majority of the document summarizes literature on preparation methods for cocrystal systems and specific pharmaceutical cocrystal systems that were reported. It concludes with a discussion of regulatory guidance on pharmaceutical cocrystals.
The document provides an outline for lectures on pharmaceutical dosage form processing. It will cover general introduction to manufacturing processes, formulation assessment, analytical method development, formulation development, good manufacturing practices, and drug product stability. Key aspects of preformulation are also summarized, including characterizing organoleptic properties, purity, particle size and shape, solubilization using surfactants, and preformulation stability studies. Manufacturing processes involve transforming raw materials into finished products through various treatment, machining, and reshaping steps while ensuring quality.
This document outlines the course content, units, and recommended books for a Pharmacognosy and Phytochemistry II course. The 5 units cover topics like metabolic pathways in plants and biosynthesis of secondary metabolites, classes of secondary metabolites like alkaloids and terpenoids, isolation and analysis of phytoconstituents, industrial production of selected phytoconstituents, and modern extraction and analytical techniques. The practical sessions involve morphology, histology, extraction and detection of selected plants, isolation of active principles like caffeine and diosgenin, and analysis of crude drugs. Recommended textbooks cover latest editions on pharmacognosy, phytochemistry, herbal drug industry, and plant biotechnology.
Preformulation studies are important to develop a safe, effective, and stable dosage form. The goals are to establish physicochemical parameters of the drug substance for stability and compatibility with excipients. Key preformulation considerations include physical properties like polymorphism, particle size and shape, and chemical properties like hydrolysis and oxidation. These factors impact the drug's solubility, dissolution, and stability in a dosage form. Understanding preformulation is essential for optimizing the drug development process and producing dosage forms with consistent therapeutic effects.
This document discusses preformulation and various analytical techniques used for drug-excipient compatibility studies. It describes types of incompatibilities like physical and chemical incompatibilities. Techniques discussed include thermal analysis methods like thermogravimetry (TG), differential thermal analysis (DTA), and differential scanning calorimetry (DSC). Other techniques mentioned are X-ray diffraction (XRD) and Fourier transform infrared spectroscopy (FTIR). The document also covers limitations of thermal analysis and applications of these techniques in preformulation studies like characterization of hydrates/solvates, detection of impurities, and compatibility studies.
IRJET- Insilico Studies of Molecular Property and Bioactivity of Organic ...IRJET Journal
This document summarizes an insilico study of the molecular properties and bioactivity of 10 organic crystalline compounds using the Molinspiration software. The key findings are:
1) All 10 compounds obeyed Lipinski's rule of five and had good drug-likeness scores based on parameters like miLogP, TPSA, molecular weight, etc.
2) Compounds I, II, IV, V, VI, VII, VIII and IX had bioactivity scores between -1.20 to 0.31, suggesting they could moderately act as GPCR ligands, ion channel modulators, nuclear receptor ligands, kinase inhibitors, protease inhibitors or enzyme inhibitors.
3) Compounds III, V
Supercritical fluid (CO2) chromatography for quantitative determination of se...Ratnakaram Venkata Nadh
In the present study, two cancer therapeutic drugs (docetaxel and bortezomib) were separated from their
potential impurities on a chromatographic platform by utilizing CO2 gas (supercritical state) and quantified.
The chromatographic separations were achieved on two short columns BEH-2EP (100mm 3mm, 1.7 mm)
and CHIRALPAK AD-3 (100 mm 4.6 mm, 3 mm) for docetaxel and bortezomib, respectively. The present
work describes the role of organic modifiers in the separation of polar compounds by supercritical fluid
chromatography. The two new methods were fully validated in accordance with the current ICH
(International Council for Harmonization of technical requirements for pharmaceuticals for human use)
guidelines. The stability indicating power of the methods was demonstrated from the stress studies
conducted on the injection formulations of the two compounds. The methods are precise with % RSD of
0.4, linear with the correlation coefficient of r2 $ 0.999 and accurate in the range of 50–150% of the
target assay concentration. The two methods can be equally employed for the assay determination of
docetaxel and bortezomib APIs as well.
This document provides guidance on preformulation studies for new drug substances. It outlines the key steps in preclinical testing including pharmacology, toxicology, and preformulation. Preformulation involves characterizing the physicochemical properties of the drug, including solubility, pKa, partition coefficient, stability, and crystal properties. The goal is to design an optimal drug delivery system through understanding the physical and chemical attributes of the new molecule.
This document summarizes various physicochemical characterization techniques used to analyze solid oral dosage forms, including microscopy, X-ray powder diffraction, thermal analysis, FTIR microspectroscopy, NMR imaging and spectroscopy, mass spectrometry, and Raman spectroscopy. Specific examples are provided to illustrate how each technique can provide insight into the drug substance distribution, solid state properties, and release characteristics. Near infrared analysis is also discussed for applications in qualitative analysis like raw material identification and blend homogeneity assessment and quantitative analysis for assaying finished drug products.
Physical and Structural Characterization of Biofield Treated Imidazole Deriva...albertdivis
The Aim of present study was to evaluate the impact of biofield treatment on two imidazole derivatives (i.e., imidazole and 2-methylimidazole) by various analytical methods.
This document provides an overview of preformulation studies, which characterize the physical and chemical properties of new drug molecules to aid in the development of safe, effective, and stable dosage forms. Some key points covered include:
- Preformulation studies give direction for dosage form selection, excipient choice, composition, and process development.
- Important physicochemical properties to determine include solubility, partition coefficient, pKa, stability, and interactions with excipients.
- Methods are described for evaluating properties like solubility, dissolution, oxidation, hydrolysis, and polymorphism which can impact stability and bioavailability.
- Understanding these properties aids in developing robust formulations and setting appropriate storage conditions for drug products
This document discusses modern pharmaceutics and preformulation concepts. It begins with an introduction to preformulation, which involves investigating a drug's physical and chemical properties alone and with excipients. This information guides dosage form development. The document then discusses drug-excipient interactions and compatibility testing methods. It also covers topics like solid dispersions, emulsions, suspensions, and parenteral product formulation and testing requirements.
The document discusses preformulation and summarizes some of its key aspects. Preformulation involves determining the physicochemical properties of new drug substances to aid in developing effective dosage forms. It covers topics like organoleptic properties, purity, particle size and shape, solubilization using surfactants, and the effect of temperature, pH and co-solvents on solubility. It also mentions the importance of preformulation stability studies and considering drug characteristics for different dosage forms. The goals of preformulation are establishing parameters, kinetic profiles, physical characteristics and compatibility with excipients.
Mohan Vivekanandan has 5 years of experience in bioanalytical assay development and quality control for biotherapeutics and vaccines. He has a PhD in Biochemistry and expertise in protein characterization, stability testing, method development and validation. His most recent role was as a Research Scientist at Theragen Biologics where he developed ELISA and other assays to characterize a novel Fab protein. He is looking for a challenging career in a progressive organization.
This document contains the resume of Dr. Abhishek Gupta. It summarizes his educational qualifications including an M.Sc. in Biotechnology, Ph.D. in Zoology, and research experience including six years as Director of two institutes. It also lists 16 research publications, training experiences, seminars and conferences attended, and skills including familiarity with analytical instruments and scientific writing. The resume is signed and dated by Dr. Gupta and includes two references.
Research paper description dr. mcd may 2021aissmsblogs
This research article is about analytical method development and validation for estimation of drug combination used for the treatment of Hepatitis C. This combination is claimed to have an advantage of being highly potent, well tolerated and used once a day. The analytical method is based on use of HPTLC (High Performance Thin Layer Chromatography). The stress degradation studies of Sofosbuvir and Velpatasvir were carried out under the conditions of hydrolysis at various pH, photolysis, thermal and oxidative degradation. Both these APIs were found to be sensitive to stress degradation conditions. The peak purity was monitored to ensure “stability indicating” nature of the developed method. The method was validated as per ICH Q2 (R1) guidelines.
This document outlines a research proposal on investigating the ethnobotany and ethnomedicine of plants in Goa. The proposal discusses the need to study indigenous medicinal plant knowledge and potential plant-based treatments for diseases like diabetes, viral infections, and cancer. The aims are to study pharmacologically active local wild plants, isolate bioactive compounds, and culture plants with bioactivities. The methodology proposed includes collecting plant samples, preparing extracts using different solvents, and testing extracts for activities like antidiabetic, anti-inflammatory, antioxidant, anticancer, and antiviral effects. Characterization of bioactive compounds using chromatography and spectroscopy is also proposed. A timeline outlines the activities over 5 years including literature review, screening plants,
This document discusses the importance of preformulation studies in designing sustained release dosage forms. Preformulation studies provide important information about the drug substance including solubility, pH effects, partitioning, stability and compatibility with excipients. This information guides the selection of appropriate formulation components, manufacturing processes and container closure systems. Key preformulation tests described include determining intrinsic solubility, dissociation constant (pKa), partition coefficient, crystal properties, and dissolution rate. The results of preformulation studies help develop stable, bioavailable sustained release dosage forms that can be mass produced.
1. Biosimilars are not generics because they have a different manufacturing process and excipients compared to the innovator product.
2. Hypothesis testing is not adequate for demonstrating biosimilarity because it is difficult to detect a difference with small subject numbers.
3. An "intended copy" is a biologic product that is attempting to demonstrate biosimilarity but has not fully done so yet.
This document provides a summary of Hari Narayan Kushwaha's career and qualifications. It outlines his educational background including a PhD in Pharmacy, M.Pharm with a gold medal, and B.Pharm. It details his work experience as a research scientist and postdoctoral research associate studying pharmacokinetics, metabolism, and photoprotection. It also lists his technical expertise, publications, patents, awards, and professional affiliations.
Dr.Lavanya.S.A - standardization of herbal drugsDr.Lavanya .S.A
The document discusses the standardization of herbal drugs. It begins by introducing the growth of herbal medicine and the need for standardization. It then defines herbs, herbal drugs, and what standardization of herbal drugs refers to. The document outlines some of the key procedures for standardizing herbal drugs, including authentication, physical and chemical analysis, and microbiological and residue testing. It also discusses identifying crude drugs through systematic study, microscopic identification of features like stomata and veins, and various quantitative studies that can be done on crude drugs. Overall, the document provides an overview of the importance and processes involved in standardizing herbal medicines.
The document describes a method development and validation project for the analysis of drugs using UV spectrophotometry and HPLC. It provides an introduction, objectives, literature review, and plan of work. The literature review summarizes 15 research papers on method development and validation using these techniques. The instruments available for the project are also listed. The conclusion states that the project aims to develop analytical methods for quality assessment of drug products to ensure therapeutic effectiveness.
Ultra performance liquid chromatographic method for simultaneous quantificati...Ratnakaram Venkata Nadh
Plerixafor (PLX) injections are administered to patients with cancers of lymphocytes
(non-Hodgkin’s lymphoma) and plasma cells (multiple myeloma). The main
objective of the current study was to develop a short reverse phase chromatographic
method for the simultaneous quantification of PLX and its impurities, in an injection
formulation, to reduce the time required for these quality tests. Furthermore, the
present work describes the role of nonalkyl branched nonquaternary ion pair reagent
in improving the peak shape and reducing column equilibration time. The separation
of PLX and its related substances is pH dependent (optimum pH = 2.50) and was
achieved on an octadecylsilyl (C18) column. The method was validated for its intended
purpose in accordance with the current regulatory guidelines for validation. The
proposed method can be applied for quality control, release, and stability analyses of
active pharmaceutical ingredient, PLX, as well as finished products, PLX injections
This document outlines the course content for a Pharmaceutical Technology course. It discusses topics like pre-formulation, dosage forms, liquid dosage forms, suspensions, emulsions, semisolids, suppositories, transdermal drug delivery systems, and case studies. Pre-formulation is described as investigating the physical and chemical properties of drug substances alone or with excipients to generate information for developing stable and bioavailable dosage forms. Key areas of pre-formulation research include solubility analysis, particle characterization, and stability analysis.
This document discusses improving the solubility and stability of drug molecules through solid state chemistry approaches. It notes that 80% of drugs have solubility issues and 40% have stability problems. Common approaches to address this include polymorphs, amorphous forms, and salts, but each has limitations. Cocrystal technology is presented as a newer approach to modulate properties for drugs lacking ionizable groups. The document summarizes recent studies using this approach with curcumin and temozolomide to yield forms with better solubility and stability. It concludes these solid state approaches can optimize properties critical for a drug's pharmacological effects.
The document summarizes procedures for evaluating ophthalmic drug preparations. It discusses that evaluation includes sterility testing, clarity testing, leak testing, and testing for metal particles in ointments. It also describes that drug product quality tests assess attributes like identification, potency, purity, sterility and particulate matter, while performance tests evaluate drug release. Key quality tests discussed are identification, assay, pH, osmolarity, bacterial endotoxins, and uniformity of dosage units. Specific tests covered include viscosity and drop size.
IOSRPHR(www.iosrphr.org) IOSR Journal of Pharmacyiosrphr_editor
The document summarizes a workshop on experimental techniques organized by the Indian Pharmacological Society's local branch in Belgaum. The workshop consisted of two interactive sessions - the first involved hands-on demonstrations of screening methods like blood pressure measurement, endothelial studies, and models to screen drugs. The second session demonstrated sophisticated instruments like FTIR, HPLC, UV spectrophotometry, HPTLC, and gas chromatography. Over 50 delegates from medical colleges participated in the workshop and provided positive feedback in the valedictory function. The workshop aimed to provide hands-on training to help practitioners and researchers cope with recent advances in experimental methods.
IOSRPHR(www.iosrphr.org) IOSR Journal of Pharmacyiosrphr_editor
The document summarizes a workshop on experimental techniques organized by the Indian Pharmacological Society's local branch in Belgaum. The workshop consisted of two interactive sessions - the first involved hands-on demonstrations of screening methods like blood pressure measurement, endothelial studies, and models to screen drugs. The second session demonstrated sophisticated instruments like FTIR, HPLC, UV spectrophotometry, HPTLC, and gas chromatography. Over 50 delegates from medical colleges participated in the workshop and provided positive feedback in the valedictory function. The workshop aimed to provide hands-on training to help practitioners and researchers cope with recent advances in experimental methods.
Gregg Kamilar is an experienced drug discovery chemist with over 20 years of experience in medicinal chemistry, small molecule design and synthesis. He has worked at major pharmaceutical companies including Pfizer, Vertex, and NPS Pharmaceuticals designing and synthesizing novel compounds for drug development. He has experience across many areas of medicinal chemistry including structure based drug design, heterocyclic and nucleotide synthesis, compound purification and characterization.
Bioanalytical method development and validation .Shubham Bora
1) A bioanalytical method was developed and validated for the quantification of levodopa and carbidopa in rat plasma using LC-MS/MS. Derivatization and ion-pairing chromatography were used to improve the chromatographic retention of the polar analytes.
2) The method was fully validated as per FDA guidelines and demonstrated selectivity, linearity, accuracy, precision, recovery, matrix effects and stability in accordance with acceptance criteria.
3) The validated method was successfully applied to support toxicokinetic studies of levodopa and carbidopa in rats.
This document contains the resume of Akanksha Palial summarizing her work experience and qualifications. She has over 5 years of experience in microbiological research and quality control. She has worked at Nestle India Ltd. testing food products for pathogens. She also worked at the Institute of Microbial Technology studying biodegradation of pesticides. Additionally, she worked at the Veterinary College of Palampur researching the antimicrobial properties of herbal extracts. Her work includes published research papers and she has experience with various laboratory techniques and equipment. She is currently seeking a growth-oriented role that utilizes her knowledge and experience in healthcare, research and quality control.
This document lists 100 papers published by Averineni Ravi Kumar in national and international journals from 2006 to 2014. The papers cover a wide range of topics including phytochemical screening and analysis of various plant species, evaluation of anti-inflammatory, antibacterial, and antidiabetic properties of plants, development and validation of analytical methods for pharmaceutical compounds, and toxicity studies of herbal formulations in animal models. Many of the papers involve collaboration with other authors and were published in reputed journals in the fields of pharmacology, toxicology, pharmaceutical sciences, and chemistry.
Mathew Pucuta - Official Research Project PresentationMateus Púcuta
The document describes the design and synthesis of isatin analogues by Mateus A. da C. Púcuta for their Master's thesis. The objectives were to design isatin analogues, synthesize them, and characterize the synthesized analogues. Isatin was selected as the natural product scaffold due to its wide range of biological activities. Various isatin analogues were designed and synthesized involving steps such as N-alkylation, O-alkylation, aldol condensation, and click reactions. The analogues and intermediates were characterized by melting point, TLC, NMR, and mass spectrometry. Further testing of the analogues for inhibitory activity against HIV protease and reverse transcriptase is proposed. The objectives were partially
Similar to Presentation_on_a_complete_review_on_high_performance_liquid_chromatography_pramod_ghule (20)
LAND USE LAND COVER AND NDVI OF MIRZAPUR DISTRICT, UPRAHUL
This Dissertation explores the particular circumstances of Mirzapur, a region located in the
core of India. Mirzapur, with its varied terrains and abundant biodiversity, offers an optimal
environment for investigating the changes in vegetation cover dynamics. Our study utilizes
advanced technologies such as GIS (Geographic Information Systems) and Remote sensing to
analyze the transformations that have taken place over the course of a decade.
The complex relationship between human activities and the environment has been the focus
of extensive research and worry. As the global community grapples with swift urbanization,
population expansion, and economic progress, the effects on natural ecosystems are becoming
more evident. A crucial element of this impact is the alteration of vegetation cover, which plays a
significant role in maintaining the ecological equilibrium of our planet.Land serves as the foundation for all human activities and provides the necessary materials for
these activities. As the most crucial natural resource, its utilization by humans results in different
'Land uses,' which are determined by both human activities and the physical characteristics of the
land.
The utilization of land is impacted by human needs and environmental factors. In countries
like India, rapid population growth and the emphasis on extensive resource exploitation can lead
to significant land degradation, adversely affecting the region's land cover.
Therefore, human intervention has significantly influenced land use patterns over many
centuries, evolving its structure over time and space. In the present era, these changes have
accelerated due to factors such as agriculture and urbanization. Information regarding land use and
cover is essential for various planning and management tasks related to the Earth's surface,
providing crucial environmental data for scientific, resource management, policy purposes, and
diverse human activities.
Accurate understanding of land use and cover is imperative for the development planning
of any area. Consequently, a wide range of professionals, including earth system scientists, land
and water managers, and urban planners, are interested in obtaining data on land use and cover
changes, conversion trends, and other related patterns. The spatial dimensions of land use and
cover support policymakers and scientists in making well-informed decisions, as alterations in
these patterns indicate shifts in economic and social conditions. Monitoring such changes with the
help of Advanced technologies like Remote Sensing and Geographic Information Systems is
crucial for coordinated efforts across different administrative levels. Advanced technologies like
Remote Sensing and Geographic Information Systems
9
Changes in vegetation cover refer to variations in the distribution, composition, and overall
structure of plant communities across different temporal and spatial scales. These changes can
occur natural.
This slide is special for master students (MIBS & MIFB) in UUM. Also useful for readers who are interested in the topic of contemporary Islamic banking.
Chapter wise All Notes of First year Basic Civil Engineering.pptxDenish Jangid
Chapter wise All Notes of First year Basic Civil Engineering
Syllabus
Chapter-1
Introduction to objective, scope and outcome the subject
Chapter 2
Introduction: Scope and Specialization of Civil Engineering, Role of civil Engineer in Society, Impact of infrastructural development on economy of country.
Chapter 3
Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
How to Manage Your Lost Opportunities in Odoo 17 CRMCeline George
Odoo 17 CRM allows us to track why we lose sales opportunities with "Lost Reasons." This helps analyze our sales process and identify areas for improvement. Here's how to configure lost reasons in Odoo 17 CRM
A workshop hosted by the South African Journal of Science aimed at postgraduate students and early career researchers with little or no experience in writing and publishing journal articles.
This presentation includes basic of PCOS their pathology and treatment and also Ayurveda correlation of PCOS and Ayurvedic line of treatment mentioned in classics.
1. Presented By: Mr. Ghule Pramod Babasaheb
Final Year M.Pharm (Pharmaceutical Quality Assurance)
Guided By: Dr. Vishal Bharat Babar
M.Pharm, PhD (PG Coordinator)
Dattakala College of Pharmacy, Daund, Pune (Savitribai Phule Pune University)
Date: 20th – Jan - 2022
3. HPLC is a qualitative & quantitative technique which is employed for
the evaluation of the medicine & biological samples.
This article was published to explore various aspects of HPLC,
including principles, types, equipment & applications.
From the perspective of qualitative & quantitative estimation of active
molecules, it has a wide range of applications in various fields in terms
of quantitative & qualitative estimation of active molecules.
4. HPLC is generally used in biochemistry & analysis to separate, identify
& quantify the active compound.
Includes:
Stationary Phase (Packing Material)
Mobile Phase
Column
5. Principle: Analyzing the interaction of the compound in mobile phase
through stationary phase.
Types:
Normal Phase Chromatography
Reversed Phase Chromatography
Size Exclusion Chromatography
Ion Exchange Chromatography
Bio-affinity Chromatography
Bio-specific elution
Aspecific elution
7. 1) Chemical Separation
2) Purification
3) Identification generally assay of compounds are carried using
HPLC
4) Environmental Applications
5) Forensic Medicine
6) Clinical
7) Food & Flavour
8. Through a comprehensive complete review, we conclude, HPLC is a
chromatographic technique for the assessment of a drug’s generic and
reproducible.
From the perspective of qualitative & quantitative estimation of active
molecules, it has a wide range of applications in various fields in terms
of quantitative & qualitative estimation of active molecules.
9. 1. Martin M., Guiochon, G. Effects of high pressures in liquid chromatography. J. Chromatogr. A, 2005; (1-2)7: 16-38.
2. Liu Y., Lee M.L. Ultrahigh pressure liquid chromatography using elevated temperature. Journal of Chromatography. 2006; 1104 (1-2): 198–202.
3. Abidi,S.L. High-performance liquid chromatography of phosphatidic acids and related polar lipids. J. Chromatogr. 1991; 587: 193-203.
4. Hearn M.T.W. Ion-pair chromatography on normal and reversed-phase systems. Adv. Chromatogr. 1980; 18: 59–100.
5. Bergh J. J., Breytenbach, J. C. Stability-indicating High-performance Liquid- chromatographic Analysis of Trimethoprim in Pharmaceuticals. J. Chromatogr.
1987; 387: 528-531.
6. Stubbs C., Kanfer, I. Stability-indi- cating High-performance Liquid-chromato- graphic Assay of Erythromycin Estolate in Pharmaceutical Dosage Forms.
Int. J. Pharm. 1990; 3(2): 113-119.
7. MacNeil L., Rice J. J., Muhammad N. Lauback R. G. Stability-indicating Liquid-chromatographic Determination of Cefapirin, Desacetylcefapirin and
Cefapirin Lactone in Sodium Cefapirin Bulk and Injectable Formulations. J. Chromatogr. 1986; 361: 285-290.
8. Bounine J. P., Tardif B., Beltran P. Mazzo D. J. High-performance Liquid-
Bansal V. et al., Journal of Global Pharma Technology. 2010; 2(5): 22-26
chromatographic Stability-indicating Determination of Zopiclone in Tablets. J. Chromatogr. 1994; 677(1): 87-93.
9. Lauback R. G., Rice J. J., Bleiberg B., Muhammad N., Hanna, S. A. 1984. Specific High-performance Liquid-chromato- graphic Determination of Ampicillin
in Bulks, Injectables, Capsules and Oral Suspensions by Reversed-phase Ion-pair Chromatography. J. Liq. Chromatogr. 1984; 7(6): 1243-1265.
10. Wiklund A E., Dag B., Brita S. Toxicity evaluation by using intact sediments and sediment extracts. Marine Pollution Bulletin (2005); 50(6): 660-667.
11. Kwok Y. C., Hsieh D. P. H., Wong P. K. Toxicity identification evaluation (TIE) of pore water of contaminated marine sediments collected from Hong
Kong waters. Marine Pollution Bulletin. 2005; 51(8-12): 1085-1091.
12. Hongxia Yu., Jing C., Cui Y., Shang H., Ding Z., Jin H. Application of toxicity identification evaluation procedures on wastewaters and sludge from a
municipal sewage treatment works with industrial inputs. Ecotoxicology and Environmental Safety. 2004; 57(3): 426-430.
13. Ayerton J. Assay of ceftazidime in biological fluids using high-pressure liquid chromatography. J. Antimicrob. Chemother. 1981; 8: 227-231.
14. Bowden R.E., Madsen P.O. High- pressure liquid chromatographic assay of sulbactam in plasma, urine and tissue. Antimicrob. Agents Chemother. 1986;
30: 31-233.
15. Haginaka J., Yasuda H., Uno T., Nkagawa T. Alkaline degradation and determination by high-performance by high-performance liquid chromatography.
Chem. Pharm. Bull. 1984; 32: 2752-2758