The document discusses preformulation studies for a new drug. It aims to characterize the physical and chemical properties of the drug substance and determine its stability. The objectives are outlined as determining solubility, kinetics, physical characteristics and compatibility with excipients. Key areas covered include analyzing the physicochemical properties, bulk characterization, solubility and stability of the drug. Analytical techniques discussed for characterization include microscopy, thermal analysis, powder X-ray diffraction and particle size determination methods. The importance of preformulation studies to develop a stable dosage form is highlighted.
Preformulation involves determining the physicochemical properties of new drug substances to establish parameters that may impact drug performance and dosage form development. Some key goals of preformulation testing include establishing a drug's physical characteristics, solubility, stability, and compatibility with excipients. Understanding properties like solubility, hygroscopicity, and powder flow help determine how a drug should be processed, stored, and formulated to ensure quality. Preformulation is an important first step in rational dosage form design.
The document discusses key concepts and steps in preformulation testing. Preformulation involves investigating the physical and chemical properties of a drug substance alone and when combined with excipients. This generates useful information for formulating stable and safe dosage forms with good bioavailability. Some important properties discussed include solubility, particle size and shape, melting point, thermal analysis profile, hygroscopicity, and polymorphism potential. Determining these properties of a new drug substance is an important first step before developing drug formulations.
The document provides an overview of preformulation studies. It discusses the importance of characterizing the physical and chemical properties of new drug molecules during preformulation to aid in the development of stable dosage forms. Some of the key areas covered include drug-excipient compatibility studies, stability kinetics testing, and determining properties like solubility, partition coefficient, and polymorphism that can help dictate the suitable dosage form. The goal of preformulation is to gather necessary data to rationally develop safe and efficacious dosage forms.
1.preformulation concept in Modern pharmaceutics.pptxPNMallikarjun
Preformulation is defined as the investigation of physical and chemical properties of a drug substance alone and when combined with excipients. The goal is to generate information to help formulators develop stable and safe dosage forms with good bioavailability. Some key tests include determining the drug's solubility, stability, and compatibility with various excipients using techniques like DSC, TLC, and HPLC. This provides critical data to guide the rational selection of dosage form and formulation components.
The document discusses preformulation studies for solids. The objectives are to develop a stable, safe and effective dosage form with maximum bioavailability. Preformulation testing characterizes the physical, chemical and other properties of a new drug to aid in dosage form development. Studies include analyzing the drug's crystallinity, polymorphism, particle size, solubility, stability and compatibility with excipients. Analytical techniques used include microscopy, spectroscopy, chromatography and thermal analysis to understand the drug's properties and develop an optimal dosage form.
This document discusses preformulation, which involves studying the physical and chemical properties of a drug prior to developing a dosage form. The goals of preformulation are to establish the drug's physicochemical parameters, physical characteristics, compatibility with excipients, and provide data to support dosage form design and evaluation. The major areas of preformulation study include physical description and bulk characterization, solubility analysis, and stability analysis. Specific tests described include assessing crystallinity, polymorphism, hygroscopicity, particle size, thermal effects, and powder flow properties.
This document presents information on preformulation studies, which involve characterizing the physicochemical properties of new drug molecules. The objectives are to generate stability and bioavailability data for formulation development. Key studies discussed include analyzing bulk properties, solubility, partitioning, hygroscopicity, ionization, dissolution, stability, and compatibility. Analytical techniques like spectroscopy, microscopy, thermal analysis, and chromatography are used to investigate properties and purity. Thorough preformulation provides critical information for designing dosage forms that are stable, safe, and effective.
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.
Preformulation involves determining the physicochemical properties of new drug substances to establish parameters that may impact drug performance and dosage form development. Some key goals of preformulation testing include establishing a drug's physical characteristics, solubility, stability, and compatibility with excipients. Understanding properties like solubility, hygroscopicity, and powder flow help determine how a drug should be processed, stored, and formulated to ensure quality. Preformulation is an important first step in rational dosage form design.
The document discusses key concepts and steps in preformulation testing. Preformulation involves investigating the physical and chemical properties of a drug substance alone and when combined with excipients. This generates useful information for formulating stable and safe dosage forms with good bioavailability. Some important properties discussed include solubility, particle size and shape, melting point, thermal analysis profile, hygroscopicity, and polymorphism potential. Determining these properties of a new drug substance is an important first step before developing drug formulations.
The document provides an overview of preformulation studies. It discusses the importance of characterizing the physical and chemical properties of new drug molecules during preformulation to aid in the development of stable dosage forms. Some of the key areas covered include drug-excipient compatibility studies, stability kinetics testing, and determining properties like solubility, partition coefficient, and polymorphism that can help dictate the suitable dosage form. The goal of preformulation is to gather necessary data to rationally develop safe and efficacious dosage forms.
1.preformulation concept in Modern pharmaceutics.pptxPNMallikarjun
Preformulation is defined as the investigation of physical and chemical properties of a drug substance alone and when combined with excipients. The goal is to generate information to help formulators develop stable and safe dosage forms with good bioavailability. Some key tests include determining the drug's solubility, stability, and compatibility with various excipients using techniques like DSC, TLC, and HPLC. This provides critical data to guide the rational selection of dosage form and formulation components.
The document discusses preformulation studies for solids. The objectives are to develop a stable, safe and effective dosage form with maximum bioavailability. Preformulation testing characterizes the physical, chemical and other properties of a new drug to aid in dosage form development. Studies include analyzing the drug's crystallinity, polymorphism, particle size, solubility, stability and compatibility with excipients. Analytical techniques used include microscopy, spectroscopy, chromatography and thermal analysis to understand the drug's properties and develop an optimal dosage form.
This document discusses preformulation, which involves studying the physical and chemical properties of a drug prior to developing a dosage form. The goals of preformulation are to establish the drug's physicochemical parameters, physical characteristics, compatibility with excipients, and provide data to support dosage form design and evaluation. The major areas of preformulation study include physical description and bulk characterization, solubility analysis, and stability analysis. Specific tests described include assessing crystallinity, polymorphism, hygroscopicity, particle size, thermal effects, and powder flow properties.
This document presents information on preformulation studies, which involve characterizing the physicochemical properties of new drug molecules. The objectives are to generate stability and bioavailability data for formulation development. Key studies discussed include analyzing bulk properties, solubility, partitioning, hygroscopicity, ionization, dissolution, stability, and compatibility. Analytical techniques like spectroscopy, microscopy, thermal analysis, and chromatography are used to investigate properties and purity. Thorough preformulation provides critical information for designing dosage forms that are stable, safe, and effective.
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.
This document discusses the importance of preformulation studies, which involve characterizing the physical and chemical properties of a drug prior to formulation development. The major areas covered in preformulation include physical characterization of the drug's solid state, solubility analysis, and stability studies. Understanding properties like crystallinity, hygroscopicity, and solubility is crucial for developing a stable, safe, and effective dosage form. Key tests described are used to determine the drug's particle size, surface morphology, thermal behavior, polymorphism, and compatibility with excipients. The results of preformulation studies provide critical guidance for dosage form design and regulatory approval.
Preformulation and physicochemical property of the drugSHIVANEE VYAS
“It is the study of the physical and chemical properties of the
drug prior to compounding process”.
Preformulation commences when a newly synthesized drug shows sufficient pharmacologic promise in animal models towarrant evaluation in man.
These studies should focus on physicochemical properties of new compound that affect drug performance & development of efficaciouss dosage form.
This properties may provide;
A rationale for formulation design
Support the need for molecular modification.
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.
Preformulation studies characterize the physical and chemical properties of new drug molecules to aid in developing safe, effective, and stable dosage forms. The objectives are to establish physico-chemical parameters, determine kinetics and stability, and establish compatibility with excipients. Major areas of investigation include organoleptic properties, bulk characterization like crystallinity and polymorphism, solubility analysis including pH effects, and stability analysis of solutions and solids. Understanding these properties provides insights for processing and storage to ensure drug quality.
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.
This document discusses preformulation for new drug development. A change in formulation, dosage, route of administration, or dosage form of an existing drug causes it to be considered "new" and requires safety and efficacy evaluation. Preformulation aims to optimize a drug's physical and chemical properties for a stable, effective dosage form. It involves characterizing the drug molecule and developing the dosage form. Some goals of preformulation include establishing the drug's physicochemical parameters, kinetic profile, physical characteristics, and compatibility with excipients. Polymorphism, or the ability of a drug to exist in different crystal forms, is also evaluated as it can impact properties like solubility, dissolution rate, and bioavailability.
Separation techniques play a key role in various fields of science and technology. The document discusses the significance of separation techniques in pharmaceutical analysis. It covers various classical and instrumental separation methods like chromatography, spectroscopy, centrifugation etc. and their applications in qualitative analysis, quantitative analysis and purification of substances. The conclusion emphasizes that separation techniques are important as they allow obtaining pure materials from complex mixtures.
Microspheres are spherical & free flowing particles ranging in average particle size from 1 to 50 microns which consist of proteins or synthetic polymers. Some of the problems of overcome by producing control drug delivery system which enhances the therapeutic efficacy of a given drug. One such approach is using microspheres as carriers for drugs. The target site drug deliver with Specificity & maintain the concentration at site of interest without untoward effects. It will find the central place in novel drug delivery. Drugs can be targeted to specific sites in the body using microspheres. Degree of targeting can be achieved by localization of the drug to a specific area in body (for example in lungs), to a particular group of cells and even to the intracellular structures. The rate of drug release from the microspheres dictates their therapeutic action.
This document discusses preformulation in pharmaceutical research and development. It defines preformulation as characterizing the physical and chemical properties of a new drug substance to develop a stable, safe and effective dosage form. The goals are to establish the physicochemical parameters, physical characteristics, kinetic rate profile, and excipient compatibility of a new drug. The objectives are to develop elegant, stable, and safe dosage forms and have an understanding of the drug substance before dosage form development. The document outlines various physicochemical characteristics that are evaluated during preformulation including physical properties like solubility, partition coefficient, stability, and chemical properties like hydrolysis, oxidation, reduction, racemization, and polymerization.
Stability Indicating HPLC Method Development A Reviewijtsrd
High performance liquid chromatography is most powerful tools in analytical chemistry which assessing drug product stability. It is most accurate method for determining the qualitative and quantitative analysis of drug product. Forced degradation plays an important role in development of stability indicating analytical methodology. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacture of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. Forced degradation studies establish degradation pathways of drug substances and drug products. Forced degradation elucidate the possible degradation pathway of the drug substance or the active pharmaceutical ingredient in the drug product. At every stage of drug development practical recommendations are provided which will help to avoid failure. Rushikesh S Mulay | Rishikesh S Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46342.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46342/stability-indicating-hplc-method-development--a-review/rushikesh-s-mulay
This document discusses pre-formulation studies, which involve investigating the physical and chemical properties of drug substances alone and when combined with excipients. Some key areas covered include polymorphism, hygroscopicity, particle size characterization, and solubility analysis. Thermal analysis techniques like DSC and XRD are described as useful for characterizing polymorphs. The importance of solubility studies at various pH levels and temperatures is highlighted for developing oral dosage forms with appropriate dissolution profiles.
This document provides an overview of preformulation studies for developing drug formulations. It discusses the importance of studying the physical and chemical properties of drug substances alone and when combined with excipients. The summary is:
1) Preformulation studies investigate the physical and chemical properties of drugs and how they interact with excipients. This helps formulators develop stable, bioavailable drug products.
2) Key properties studied include solubility, particle size, solid state properties, and how the drug behaves under different conditions like temperature, light and pH.
3) The results of preformulation studies guide formulation development and ensure the final product has the desired quality, performance and safety.
This document provides an overview of preformulation studies for liposomes and microspheres. It defines preformulation and describes various characterization tests conducted during preformulation including bulk characterization, solubility characterization, stability characterization, assessment of lamellarity, trapped volume, flow properties, and in vitro drug release for liposomes. For microspheres, it discusses techniques to determine particle size and distribution, surface charge, thermal analysis, stability studies, and in vitro drug release. The goal of preformulation is to generate useful information for developing stable and bioavailable dosage forms.
Evaluation of protein and peptide formulations.pptxDivya Pushp
This document discusses stability testing and evaluation methods for protein formulations. Stability testing ensures products maintain specifications over shelf life under various storage conditions. Evaluations include bioassays to assess potency, which can be in vitro by monitoring cell responses to proteins or in vivo by monitoring animal pharmacological responses. Common evaluation methods are UV spectroscopy, Bradford assay, thermal analysis like DSC and TGA, and chromatography techniques like HPLC, ion exchange, and chromatofocusing.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
This document discusses the importance of preformulation studies, which involve characterizing the physical and chemical properties of a drug prior to formulation development. The major areas covered in preformulation include physical characterization of the drug's solid state, solubility analysis, and stability studies. Understanding properties like crystallinity, hygroscopicity, and solubility is crucial for developing a stable, safe, and effective dosage form. Key tests described are used to determine the drug's particle size, surface morphology, thermal behavior, polymorphism, and compatibility with excipients. The results of preformulation studies provide critical guidance for dosage form design and regulatory approval.
Preformulation and physicochemical property of the drugSHIVANEE VYAS
“It is the study of the physical and chemical properties of the
drug prior to compounding process”.
Preformulation commences when a newly synthesized drug shows sufficient pharmacologic promise in animal models towarrant evaluation in man.
These studies should focus on physicochemical properties of new compound that affect drug performance & development of efficaciouss dosage form.
This properties may provide;
A rationale for formulation design
Support the need for molecular modification.
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.
Preformulation studies characterize the physical and chemical properties of new drug molecules to aid in developing safe, effective, and stable dosage forms. The objectives are to establish physico-chemical parameters, determine kinetics and stability, and establish compatibility with excipients. Major areas of investigation include organoleptic properties, bulk characterization like crystallinity and polymorphism, solubility analysis including pH effects, and stability analysis of solutions and solids. Understanding these properties provides insights for processing and storage to ensure drug quality.
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.
This document discusses preformulation for new drug development. A change in formulation, dosage, route of administration, or dosage form of an existing drug causes it to be considered "new" and requires safety and efficacy evaluation. Preformulation aims to optimize a drug's physical and chemical properties for a stable, effective dosage form. It involves characterizing the drug molecule and developing the dosage form. Some goals of preformulation include establishing the drug's physicochemical parameters, kinetic profile, physical characteristics, and compatibility with excipients. Polymorphism, or the ability of a drug to exist in different crystal forms, is also evaluated as it can impact properties like solubility, dissolution rate, and bioavailability.
Separation techniques play a key role in various fields of science and technology. The document discusses the significance of separation techniques in pharmaceutical analysis. It covers various classical and instrumental separation methods like chromatography, spectroscopy, centrifugation etc. and their applications in qualitative analysis, quantitative analysis and purification of substances. The conclusion emphasizes that separation techniques are important as they allow obtaining pure materials from complex mixtures.
Microspheres are spherical & free flowing particles ranging in average particle size from 1 to 50 microns which consist of proteins or synthetic polymers. Some of the problems of overcome by producing control drug delivery system which enhances the therapeutic efficacy of a given drug. One such approach is using microspheres as carriers for drugs. The target site drug deliver with Specificity & maintain the concentration at site of interest without untoward effects. It will find the central place in novel drug delivery. Drugs can be targeted to specific sites in the body using microspheres. Degree of targeting can be achieved by localization of the drug to a specific area in body (for example in lungs), to a particular group of cells and even to the intracellular structures. The rate of drug release from the microspheres dictates their therapeutic action.
This document discusses preformulation in pharmaceutical research and development. It defines preformulation as characterizing the physical and chemical properties of a new drug substance to develop a stable, safe and effective dosage form. The goals are to establish the physicochemical parameters, physical characteristics, kinetic rate profile, and excipient compatibility of a new drug. The objectives are to develop elegant, stable, and safe dosage forms and have an understanding of the drug substance before dosage form development. The document outlines various physicochemical characteristics that are evaluated during preformulation including physical properties like solubility, partition coefficient, stability, and chemical properties like hydrolysis, oxidation, reduction, racemization, and polymerization.
Stability Indicating HPLC Method Development A Reviewijtsrd
High performance liquid chromatography is most powerful tools in analytical chemistry which assessing drug product stability. It is most accurate method for determining the qualitative and quantitative analysis of drug product. Forced degradation plays an important role in development of stability indicating analytical methodology. Stability indicating HPLC methods are used to separate various drug related impurities that are formed during the synthesis or manufacture of drug product. This article discusses the strategies and issues regarding the development of stability indicating HPLC system for drug substance. Forced degradation studies establish degradation pathways of drug substances and drug products. Forced degradation elucidate the possible degradation pathway of the drug substance or the active pharmaceutical ingredient in the drug product. At every stage of drug development practical recommendations are provided which will help to avoid failure. Rushikesh S Mulay | Rishikesh S Bachhav "Stability Indicating HPLC Method Development - A Review" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-5 | Issue-6 , October 2021, URL: https://www.ijtsrd.com/papers/ijtsrd46342.pdf Paper URL : https://www.ijtsrd.com/pharmacy/analytical-chemistry/46342/stability-indicating-hplc-method-development--a-review/rushikesh-s-mulay
This document discusses pre-formulation studies, which involve investigating the physical and chemical properties of drug substances alone and when combined with excipients. Some key areas covered include polymorphism, hygroscopicity, particle size characterization, and solubility analysis. Thermal analysis techniques like DSC and XRD are described as useful for characterizing polymorphs. The importance of solubility studies at various pH levels and temperatures is highlighted for developing oral dosage forms with appropriate dissolution profiles.
This document provides an overview of preformulation studies for developing drug formulations. It discusses the importance of studying the physical and chemical properties of drug substances alone and when combined with excipients. The summary is:
1) Preformulation studies investigate the physical and chemical properties of drugs and how they interact with excipients. This helps formulators develop stable, bioavailable drug products.
2) Key properties studied include solubility, particle size, solid state properties, and how the drug behaves under different conditions like temperature, light and pH.
3) The results of preformulation studies guide formulation development and ensure the final product has the desired quality, performance and safety.
This document provides an overview of preformulation studies for liposomes and microspheres. It defines preformulation and describes various characterization tests conducted during preformulation including bulk characterization, solubility characterization, stability characterization, assessment of lamellarity, trapped volume, flow properties, and in vitro drug release for liposomes. For microspheres, it discusses techniques to determine particle size and distribution, surface charge, thermal analysis, stability studies, and in vitro drug release. The goal of preformulation is to generate useful information for developing stable and bioavailable dosage forms.
Evaluation of protein and peptide formulations.pptxDivya Pushp
This document discusses stability testing and evaluation methods for protein formulations. Stability testing ensures products maintain specifications over shelf life under various storage conditions. Evaluations include bioassays to assess potency, which can be in vitro by monitoring cell responses to proteins or in vivo by monitoring animal pharmacological responses. Common evaluation methods are UV spectroscopy, Bradford assay, thermal analysis like DSC and TGA, and chromatography techniques like HPLC, ion exchange, and chromatofocusing.
8 Surprising Reasons To Meditate 40 Minutes A Day That Can Change Your Life.pptxHolistified Wellness
We’re talking about Vedic Meditation, a form of meditation that has been around for at least 5,000 years. Back then, the people who lived in the Indus Valley, now known as India and Pakistan, practised meditation as a fundamental part of daily life. This knowledge that has given us yoga and Ayurveda, was known as Veda, hence the name Vedic. And though there are some written records, the practice has been passed down verbally from generation to generation.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
Osteoporosis - Definition , Evaluation and Management .pdfJim Jacob Roy
Osteoporosis is an increasing cause of morbidity among the elderly.
In this document , a brief outline of osteoporosis is given , including the risk factors of osteoporosis fractures , the indications for testing bone mineral density and the management of osteoporosis
Promoting Wellbeing - Applied Social Psychology - Psychology SuperNotesPsychoTech Services
A proprietary approach developed by bringing together the best of learning theories from Psychology, design principles from the world of visualization, and pedagogical methods from over a decade of training experience, that enables you to: Learn better, faster!
These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
TEST BANK For Community Health Nursing A Canadian Perspective, 5th Edition by...Donc Test
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NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Histololgy of Female Reproductive System.pptxAyeshaZaid1
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Tests for analysis of different pharmaceutical.pptx
PREFORMULATION.pptx
1. PREFORMULATION STUDIES
7/26/2023 1
SUBMITTED TO:
Dr. Sajeev KB
Professor, Department of Pharmaceutics
ABMRCP, Bengaluru
SUBMITTED BY:
S Kishor kumar Singha
ACP22PHCE005
M.Pharm(1ST sem)
Department of Pharmaceutics
ABMRCP, Bengaluru
4. OBJECTIVES OF PREFORMULATION
1. To find the necessary physicochemical properties like solubility, crystal form of new drug
substance.
2. To determine kinetic release of drug from dosage form.
3. To establish physical characteristics.
4. To establish compatibility with common excipients.
7/26/2023 4
5. PRINCIPALAREAS FOR
PREFORMULATION RESEARCH :
7/26/2023 5
PHYSICO-CHEMICAL
PROPERTIES
BULK
CHARACTERISATION
SOLUBILITY
ANALYSIS
STABILITY
ANALYSIS
• ORGANOLEPTIC
PROPERTIES.
• PARTICLE
SHAPE AND
SIZE.
• PURITY.
• SURFACE AREA.
• CRYSTALLINITY
AND
POLYMORPHISM.
• HYGROSCOPICITY.
• PARTICLE SIZE
CHARACTERIZATI
ON.
• BULK DENSITY.
• POWDER FLOW
PROPERTIES.
• IONISATION
CONSTANT, pKa.
• pH SOLUBILITY
PROFILE.
• COMMON ION
EFFECT.
• PARTITION
COEFFICIENT.
• DISSOLUTION.
• SOLID STATE
STABILITY.
• SOLUTION STATE
STABILTY.
• DRUG-EXCIPIENT
COMPATIBILITY.
• ACCELERATED
STABILITY
STUDIES.
• LONG TERM
STABILITY
STUDIES.
6. ORGANOLEPTIC PROPERTIES
7/26/2023 6
• Colour, odour, taste of the new drug must be recorded.
COLOUR ODOUR TASTE
• OFF-WHITE. • PUNGENT. • ACIDIC.
• CREAM YELLOW. • SULPUROUS. • BITTER.
• TAN. • FRUITY. • BLAND.
• SHINY. • AROMATIC. • SWEET.
• ODOURLESS
7. BULK CHARACTERISATION:
Crystallinity:
Crystal habit and internal structure of drug can affect bulk and physicochemical property of the
drug.
Crystal habit is description of the outer appearance of crystal.
Internal structure is molecular arrangement within the solid.
7/26/2023 7
9. DIFFERENT SHAPES OF CRYSTALS:
Depending on internal structure compounds is classified as
1. Crystalline.
2. Amorphous.
Crystalline compounds are characterized by repetitious spacing of constituent
atom or molecule in 3-dimensional array.
In amorphous form atom or molecule are randomly placed.
Dissolution rates and solubility are greater for amorphous form.
7/26/2023 9
10. POLYMORPHISM
Ability of the compound to crystallize to more than one distinct crystalline
species with different internal lattice.
Polymorph are of 2 types:
1. Enantiotropic.
2. Monotropic.
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11. ANALYTICAL METHODS FOR THE
CHARACTERIZATION OF SOLID FORMS
METHOD MATERIAL REQUIRED PER SAMPLE
MICROSCOPY 1mg
HOT STAGE MICROSCOPY 1mg
DIFFERENTIAL SCANNING CALIROMETRY 2-5mg
INFRARED SPECTROSCOPY 2-20mg
X-RAY POWDER DIFFRACTION 500mg
SCANNING ELECTRON MICROSCOPY 2mg
DISSOLUTION/ SOLUBILITY ANALYSIS mg to g
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12. MICROSOPY:
Advantage :
By this method we can study crystal morphology and difference between polymorphic form.
Disadvantage:
This require a well trained optical crystallographer, as there are many possible crystal habit and
their appearance at different orientation.
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13. HOT STAGE MICROSCOPY:
The polarizing microscope fitted with hot stage is useful for investigating
polymorphism, melting point, transition temperatures.
Disadvantage:
Organic molecules can degrade during the melting process.
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14. THERMALANALYSIS
Differential Scanning Calorimetry (DSC) & differential thermal analysis.
Measures heat loss and heat gain from physical or chemical changes within a
sample.
To find out the purity of the sample.
To find out the number of polymorph and to find the ratio of each polymorph.
To find out the thermal degradation of a drug or excipients.
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15. X-RAY DIFFRACTION:
Random orientation of crystal lattice in the powder causes the x-ray to scatter in
a reproducible pattern of peak intensities.
The diffraction pattern is characteristic of a specific crystalline lattice for a given
compound.
The peaks are observed which indicates crystalline powder.
No peaks are observed indicates the amorphous forms.
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17. HYGROSCOPICITY (Cont.)
Significance of hygroscopy test:
To decide the storage condition.
Special packaging, e.g. With desiccant.
Moisture level of powder sample may affect the flowability.
Analytical methods used are :
Gravimetry.
Karl fischer titration.
Gas chromatography.
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18. PARTICLE SIZE:
Particle size is characterized using these terms:
Very coarse, coarse, moderately coarse, fine, very fine, microfine, superfine.
Particle size can influence:
Dissolution rate.
Uniform distribution.
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20. POWDER FLOW PROPERTIES:
Powder flow properties can be affected by change in particle size, shape & density.
The flow properties depend upon the following:
1. Force of friction.
2. Cohesion between one particle to another.
Powder flow can be determined by:
1. Angle of repose.
2. Carr’s compressibility index.
3. Hausner’s ratio.
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21. ANGLE OF REPOSE
It is determined by the equation, tan Ꝋ = h/ r, where, Ꝋ = angle of repose, h = height of the pile,
r = radius.
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ANGLE OF REPOSE (Ꝋ) TYPE OF FLOW (AS PER USP)
25-30 EXCELLENT
31-35 GOOD
36-40 FAIR
41-45 PASSABLE
46-55 POOR
56-65 VERY POOR
≥65 VERY, VERY POOR
22. COMPRESSIBILITY INDEX AND
HAUSNER RATIO:
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CARR’S INDEX(%) =(TAPPED DENSITY – POURED DENSITY) *100
TAPPED DENSITY
HAUSNER RATIO = TAPPED DENSITY/ BULK DENSITY
23. COMPRESSIBILITY INDEX HAUSNER RATIO FLOW CHARACTER
≤10 1.00-1.11 EXCELLENT
11-15 1.12-1.18 GOOD
16-20 1.19-1.25 FAIR
21-25 1.26-1.34 PASSABLE
26-31 1.35-1.45 POOR
32-37 1.46-1.59 VERY POOR
>38 >1.60 VERY VERY POOR
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COMPRESSIBILITY INDEX AND
HAUSNER RATIO:
SCALE OF FLOWABILITY (AS PER USP)
24. SOLUBILITY STUDIES
Preformulation solubility studies include :
1. pKa Determination
2. pH Solubility profile
3. Solubilization mechanism
4. Rate of dissolution
Analytical methods useful for solubility measurements include hplc, uv spectroscopy, gas
chromatography, fluorescence spectroscopy.
Solubility depends on ph, temperature, ionic strength and buffer concentrations.
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25. pKa DETERMINATIONS:
It is the dissociation constant of a drug.
The unionised is lipid soluble thus permeates through lipid membrane.
The ionised substance is lipid insoluble therefore permeation is slow.
Degree of ionisation depends on pH.
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27. METHODS FOR DETERMINING pKa
OF A DRUG:
Detection of spectral change by uv spectroscopy at a range of pH.
Potentiometric titrations:
1. Maximum sensitivity for compounds with pKa In the range of 3 to 10.
Effect of temperature on solubility:
1. The solubility process is endothermic. Increasing the solution temperature increases the drug solubility.
2. Solutes that are ionised when dissolved, the process is exothermic thus supressing the solubility.
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28. SOLUBILISATION:
1. For drug candidates with poor water solubility, preformulation studies should
include limited experiments to identify the possible mechanisms for solubilisation.
2. Means of increasing the solubility are:
(I) Addition of a cosolvent to the aqueous system e.g. Ethanol, propylene glycol and
glycerin.
(II) pH change method.
(III) Reduction of particle size.
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30. PARTITION COEFFICIENT:
1. Partition coefficient is defined, as the ratio of un-ionized drug concentrations between the
organic and aqueous phases, at equilibrium.
2. It is a measurement of drug liphophilicity , the ability to cross the cell membrane.
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31. STABILITYANALYSIS:
Quantitative assessment of chemical stability of new drug. This
involves:
1. Stability study in toxicology formulation.
2. Stability in solution state.
3. Stability in solid state.
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32. STABILITY STUDY IN
TOXICOLOGY FORMULATION:
A new drug is administered to animals through oral route either by
(i) Mixing the drug in the feed
(ii) In the form of solution
(iii) In the form of suspension in aqueous vehicle
Feed may contain water, vitamin, minerals (metal ions), enzymes and different functional groups that may severely reduce the
stability of the new drug. So stability study should be carried out in the feed and at laboratory temperature.
For solution and suspension, the chemical stability at different temperature and pH should be checked.
For suspension-state the drug suspension is occasionally shaken to check dispersibility.
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33. SOLUTION STABILITY:
Identification of condition to form a stable solution.
Stability of a new drug may depend on:
(I) pH,
(II) IONIC STRENGTH,
(III) CO-SOLVENT,
(IV) LIGHT,
(V) TEMPERATURE,
(VI) OXYGEN.
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34. pH STABILITY STUDY :
A. Experiments to confirm decay at the extremes of ph and temperature. Three stability studies are
carried out at the following conditions:
0.1 N HCL SOLUTION AT 90⁰C.
SOLUTION IN WATER AT 90⁰C.
0.1 N NAOH SOLUTION AT 90⁰C.
B. Now aq. Buffers are used to produce solutions with wide range of pH values but with constant
level of drug concentration, co solvent and ionic strength.
C. All the rate constant at a single temperature are plotted as a function of pH.
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35. IONIC STRENGTH :
The pH-stability studies should be carried out at a constant ionic strength that is compatible with body
fluids.
Ionic strength of a buffer can be calculated by
Where, mi = Molar concentration of the ion, Zi = Valency of that ion.
For computing, μ all the ionic species of the buffer solution and drugs are also taken into calculation.
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36. TEMPERATURE :
The rate constant (k) of degradation reaction of a drug varies with temperature according to arrhenius equation.
where, k = Rate constant, A = Frequency factor, Ea = Energy of activation, R = Ideal gas constant
T = Absolute temperature
Shelf life of the drug may be calculated.
If the drug is sufficiently stable, liquid formulation development may be started at once. If the drug is unstable,
further investigations may be necessary.
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37. SOLID STATE STABILITY :
Identification of stable storage conditions for drug in the solid state and identification of compatible excipients
for a formulation.
Solid state reactions are much slower, so the rate of appearance of decay product is measured (not the amount of
drug remaining unchanged).
To determine the mechanism of degradation thin layer chromatography (tlc), fluorescence or uv / visible
spectroscopy may be required.
To study polymorphic changes dsc or ir-spectroscopy is required.
In case of surface discoloration due to oxidation or reaction with excipients, surface reflectance equipment may
be used.
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38. ROLE OF EXCIPIENTS IN DOSAGE
FORM DESIGN:
BINDERS
GLIDANTS
COLORING AGENTS
PRESERVATIVES
FLAVOURING AGENT
FILM FORMERS
DILUENTS
DISINTEGRANTS
LUBRICANTS
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39. IDEAL PROPERTIES OF EXCIPIENT:
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EXCIPIENTS
FEASIBLE
NO INTERACTION WITH
DRUG
STABLE FOR HANDLING
COST
EFFECTIVE
40. TYPES OF DRUG EXCIPIENT
INTERACTION:
1. PHYSICAL DRUG EXCIPIENT INTERACTIONS.
2. CHEMICAL DRUG EXCIPIENT INTERACTIONS.
3. BIOPHARMACEUTICAL/ PHYSIOLOGICAL DRUG EXCIPIENT
INTERACTIONS.
4. EXCIPIENT-EXCIPIENT INTERACTIONS.
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41. PHYSICAL DRUG-EXCIPIENT
INTERACTION:
Physical interactions alter the rate of dissolution, dosage uniformity, colour,
flow properties etc.
Do not involve chemical changes.
They are difficult to detect.
Physical interaction can be either beneficial or detrimental to the product
performance depending on its application.
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42. BENEFITS OF PHYSICAL DRUG-
EXCIPIENT INTERACTION :
1. Improves bioavailability of sparingly water soluble drugs. E.G: complexation.
2. Increase surface area of drugs available for dissoution. Adsorption of drugs on
excipient surface can increase the surface area of the drug .
3. Improves dissolution rate and bioavailability of hydrophobic drugs.
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43. CHEMICAL DRUG-EXCIPIENT
INTERACTION:
1. It involves the interaction of drug substance and excipient through chemical degradation
pathway.
2. Chemical interaction have delirious effect on formulation, hence they must be avoided.
3. Hydrolysis.
4. Oxidation.
5. Photolysis.
6. Polymerization.
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44. BIOPHARMACEUTICAL/ PHYSIOLOGICAL
DRUG-EXCIPIENT INTERACTION:
1. The interaction occurs between the medicine( drug and excipient) with the
body fluid.
2. The interaction have the tendency to influence the rate of absorption of drug.
3. Examples of such interaction include :
a. Premature breakdown of enteric coat.
b. Interactions due to adjunct therapy.
c. Increasein gastrointestinal motility.
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45. CONCLUSION:
1. Drug excipient compatibility study is a necessary prerequisite to the
development of drug products that are safe and stable for use.
2. Proper selection and assessment of incompatibilities between drug and
excipient during preformulation studies is of utmost importance to accomplish
the target product profile and critical quality attributes.
3. In order to avoid stability problems encountered during drug development
and post commercialisation.
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46. REFERENCE :
1. Theory and practice of industrial pharmacy, leon lachman, herbert a. Leiberman, joseph l.
Kanig.
2. Drug-Excipient Interactions: An Overview on Mechanisms and Effects on Drug Stability and
Bioavailability, Derar M. Omari, Yazan Akkam, Assayed sallam.
3. Drug-excipient interactions, Patrick Crowley, Dr Luigi G Martini.
4. www.slideshare.com
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