Niosomes are non-ionic surfactant-based vesicles that can be used for drug delivery. They consist of a nonionic surfactant bilayer enclosing an aqueous core. This document discusses the definition, structure, advantages, preparation methods and evaluation of niosomes. Niosomes can be prepared using methods like ether injection, film hydration, sonication, heating and extrusion. Their stability and ability to encapsulate and release drugs can be evaluated by measuring vesicle size, drug content, entrapment efficiency and in vitro drug release over time. Niosomes offer targeted drug delivery and improved oral absorption compared to other formulations.
Factors affecting TRANSDERMAL DRUG DELIVERY SYSTEMSiddu K M
This document discusses factors that affect transdermal drug delivery systems (TDDS). It identifies three classes of factors: biological, physicochemical, and formulation factors. Biological factors include skin pH, hydration, the application site, and age/health of the user. Physicochemical factors include the drug's partition coefficient, molecular size/shape, concentration, and stability. Formulation factors incorporate release characteristics, vehicle pH, and permeation enhancers. The document also outlines ideal properties for drugs used in TDDS and references used.
In this presentation I have mentioned whatever the possible relevant content/guidelines require for biowaiver application.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
1. Dissolution and drug release tests measure the rate and extent of drug release from a product under specified conditions. They are important quality control tests linked to in vivo performance.
2. Many factors can affect drug dissolution, including drug properties, formulation excipients, test medium conditions, temperature, and apparatus type and settings.
3. Common apparatuses include baskets, paddles, cylinders and flow cells suited for different drug products like tablets, capsules, suspensions or films. Test conditions are selected based on the product type to simulate gastrointestinal conditions.
Optimal design & Population mod pyn.pptxPawanDhamala1
This document discusses optimal design and population modeling. It begins with an introduction to optimal design, noting that it allows parameters to be estimated without bias and with minimum variance. The advantages of optimal design are that it reduces experimentation costs by allowing statistical models to be estimated with fewer runs. It then describes different types of optimal designs such as A, C, D, and E optimality. The document next discusses population modeling, explaining that it is a tool for integrating data to aid drug development decisions. It notes the key components of population models are structural models, stochastic models, and covariate models. Structural models describe the response over time using algebraic or differential equations, while stochastic models describe variability and covariate models influence factors like dem
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
Niosomes are non-ionic surfactant-based vesicles that can be used for drug delivery. They consist of a nonionic surfactant bilayer enclosing an aqueous core. This document discusses the definition, structure, advantages, preparation methods and evaluation of niosomes. Niosomes can be prepared using methods like ether injection, film hydration, sonication, heating and extrusion. Their stability and ability to encapsulate and release drugs can be evaluated by measuring vesicle size, drug content, entrapment efficiency and in vitro drug release over time. Niosomes offer targeted drug delivery and improved oral absorption compared to other formulations.
Factors affecting TRANSDERMAL DRUG DELIVERY SYSTEMSiddu K M
This document discusses factors that affect transdermal drug delivery systems (TDDS). It identifies three classes of factors: biological, physicochemical, and formulation factors. Biological factors include skin pH, hydration, the application site, and age/health of the user. Physicochemical factors include the drug's partition coefficient, molecular size/shape, concentration, and stability. Formulation factors incorporate release characteristics, vehicle pH, and permeation enhancers. The document also outlines ideal properties for drugs used in TDDS and references used.
In this presentation I have mentioned whatever the possible relevant content/guidelines require for biowaiver application.
Citation Is done at the end of slide.
Content is up to date & true to my belief.
Thanks & Best Regards.
Anurag Pandey
B.Pharm (FACULTY OF PHARMACY, INVERTIS UNIVERSITY)
M.Pharm (INSTITUTE OF PHARMACY, NIRMA UNIVERSITY)
Email :- anurag.dmk05@gmail.com
1. Dissolution and drug release tests measure the rate and extent of drug release from a product under specified conditions. They are important quality control tests linked to in vivo performance.
2. Many factors can affect drug dissolution, including drug properties, formulation excipients, test medium conditions, temperature, and apparatus type and settings.
3. Common apparatuses include baskets, paddles, cylinders and flow cells suited for different drug products like tablets, capsules, suspensions or films. Test conditions are selected based on the product type to simulate gastrointestinal conditions.
Optimal design & Population mod pyn.pptxPawanDhamala1
This document discusses optimal design and population modeling. It begins with an introduction to optimal design, noting that it allows parameters to be estimated without bias and with minimum variance. The advantages of optimal design are that it reduces experimentation costs by allowing statistical models to be estimated with fewer runs. It then describes different types of optimal designs such as A, C, D, and E optimality. The document next discusses population modeling, explaining that it is a tool for integrating data to aid drug development decisions. It notes the key components of population models are structural models, stochastic models, and covariate models. Structural models describe the response over time using algebraic or differential equations, while stochastic models describe variability and covariate models influence factors like dem
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
This document discusses biopharmaceutical factors that can affect the bioavailability of drugs. It focuses on pharmaceutical factors including physicochemical properties of drug molecules and dosage form characteristics. Physicochemical properties like solubility, dissolution rate, particle size, polymorphism, salt form, and ionization state can impact drug absorption. The pH-partition hypothesis explains how a drug's pKa and lipid solubility relate to absorption based on gastrointestinal pH. Dosage form properties such as disintegration time, manufacturing methods, and ingredients are also discussed as formulation factors influencing bioavailability.
MICROBALLOONS: A NOVEL APPROACH IN GASTRO-RETENTION FLOATING DRUG DELIVERY SY...Snehal Patel
ABSTRACT
Oral controlled release dosage forms face several physiological restriction like inability to retain
and position the controlled drug delivery system within the targeted region of the gastrointestinal
tract (GIT) due to fluctuation in gastric emptying. This results in non uniform absorption
pattern, inadequate medication release and shorter residence time of the dosage form in the
stomach. As the fallout of this episode there is inadequate absorption of the drug having
absorption window predominantly, in the upper area of GIT. These contemplations have
provoked to the development of oral controlled release dosage forms with gastroretentive
properties. Microballoons (Hollow microspheres) hold certification as one of the potential
approaches for gastric retention. Microballoons are spherical empty particles without core and
can remain in the gastric region for delayed periods. They significantly increase the gastric
residence time of medication, thereby enhance bioavailability, improves patient compliance by
reducing dosing frequency, lessen the medication waste, enhance retention of medication which
solubilize only in stomach, enhance solubility for medications that are less soluble at a higher pH
environment. The present review preparation methods, characterization, advantages,
disadvantages, mechanism of drug release from microballoons, applications and list of the drugs
formulated as microballoons are discussed.
KEYWORDS: Microballoons, Gastro-retention, Floating drug delivery system (FDDS).
This document discusses various optimization techniques used in pharmaceutical product development including EVOP method, statistical designs like simplex method and response surface methodology, contour design, and factorial designs. It provides details on each technique such as the basic concepts, advantages, disadvantages and examples. EVOP method involves making small repeated changes to a formulation to optimize it but requires more time. Statistical designs help optimize formulations with 1-3 variables. Contour design uses constraints to optimize multiple response variables. Response surface methodology uses statistical techniques to build empirical models and optimize responses influenced by several variables. Factorial designs study the effects of individual and interacting input parameters on experimental outcomes.
The document discusses various drug delivery systems including niosomes, aquasomes, and phytosomes. Niosomes are vesicles composed of non-ionic surfactants that can encapsulate medications and offer advantages over liposomes such as lower cost and greater stability. Aquasomes are three-layered nanoparticle structures consisting of a ceramic core coated with an oligosaccharide film that can deliver fragile molecules while maintaining their integrity. Phytosomes utilize phospholipids to surround active herbal constituents, improving their absorption and bioavailability compared to traditional herbal extracts.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
This document compares different methods for comparing dissolution profiles of drug products. It defines dissolution profile comparison and its objectives such as developing bioequivalent products and in vitro-in vivo correlations. Graphical, statistical, model-dependent and model-independent methods are described. The most common model-independent method is the f2 similarity factor test recommended by the FDA, which provides a single value to determine if two dissolution profiles are similar based on the percent dissolved over time. Proper selection of time points and criteria for coefficient of variation are important for f2 testing.
Virtual clinical trials offer advantages over traditional trials such as improved patient comfort, convenience and confidentiality. They utilize technologies like apps and online platforms to remotely collect data from trial participants from start to finish. While offering benefits, virtual trials also carry risks regarding patient privacy, operational challenges, and technical or cultural barriers. Ideal virtual trials would generate necessary data with minimal burden, foster ongoing relationships to better understand conditions, and engage providers in a complementary way. Emerging technologies like social media, mobile devices, remote monitoring, and electronic patient reporting can help promote virtual trials by automating data collection and enabling remote participation. Physiologically-based modeling using software like GastroPlus can help predict food effects on drug absorption by simulating gastrointestinal conditions
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
Drug absorption from the gastrointestinal tract can be influenced by many factors. The drug must first disintegrate, dissolve, and permeate the gastrointestinal membranes before being absorbed into systemic circulation. The rate of absorption is determined by the slowest of these steps. Factors that can affect absorption include the drug's physicochemical properties, dosage form characteristics, and patient factors like gastrointestinal pH, transit time, and presence of food or enzymes. Understanding these biopharmaceutical factors is important for optimizing drug product design and therapeutic efficacy.
This document provides information on pulmonary drug delivery systems and aerosols. It discusses the advantages of pulmonary drug delivery such as localized drug deposition reducing systemic exposure and avoidance of first-pass metabolism. Aerosols are defined as colloidal systems containing liquid/solid particles suspended in a propellant. The document outlines the manufacturing process, components, and quality control tests of aerosols including pressure filling, cold filling, and compressed gas filling apparatuses. Evaluation tests like flash point and flame projection are also mentioned.
This document discusses drug targeting and various drug delivery systems for targeted drug delivery. It describes how drug targeting aims to selectively deliver drugs to the site of action and not to non-target tissues. Various polymer-based particulate carriers for targeted drug delivery are then discussed, including liposomes, microspheres, nanoparticles, and polymeric micelles. The document provides details on the composition, preparation techniques and applications of these particulate carriers. Key advantages and challenges of different targeted drug delivery approaches are also summarized.
postmarketing surviellance,,outsourcing of BA ,BE , CRO. supriyawable1
This document provides an overview of post-marketing surveillance, outsourcing of bioavailability and bioequivalence studies to contract research organizations. It discusses the need for post-marketing surveillance to identify rare or long-term adverse drug reactions not seen in clinical trials. Methods for post-marketing surveillance include controlled trials, spontaneous reporting, cohort and case-control studies. Outsourcing bioavailability and bioequivalence studies to CROs can help reduce costs and improve resource efficiency for pharmaceutical companies.
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
The document discusses several key concepts related to drug transport and absorption:
1) The pH partition hypothesis states that acidic drugs are absorbed from acidic solutions and basic drugs from alkaline solutions, though some exceptions exist due to the microclimate pH near the membrane surface.
2) Tight junctions form a virtually impermeable barrier between cells, composed of sealing strands that prevent fluid passage.
3) According to Fick's first law, passive diffusion of solutes is determined by concentration gradients and membrane permeability. For ionizable drugs, the uncharged form is more permeable. The pH partition hypothesis relates permeability to pH and the fraction of uncharged molecules.
Virtual trial, Fed vs fasted state, In vitro dissolution & IVIC correlation ,...PawanDhamala1
The document discusses virtual clinical trials and their advantages over conventional clinical trials. It describes how emerging technologies like mobile apps, remote monitoring devices, and electronic data capture can enable various stages of clinical trials to be conducted virtually with participants' comfort and convenience in mind. Several case studies are presented, including one conducted by Sanofi using Facebook to recruit diabetes patients for a virtual trial testing a wireless glucose meter. The document also covers other topics like predicting food effects on drug absorption using physiologically-based modeling, and using such models to establish in vitro-in vivo correlations.
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
Self micro-emulsifying drug delivery system (SMEDDS)Himal Barakoti
This document discusses self-microemulsifying drug delivery systems (SMEDDS), including their background, mechanism of action, formulations, stability testing, advantages, and applications. SMEDDS are isotropic mixtures of oils, surfactants, and co-surfactants that form fine oil-in-water emulsions upon mild agitation followed by dilution in gastrointestinal fluids. They can improve the oral absorption of poorly water-soluble drugs and enhance their bioavailability. SMEDDS formulations typically contain an oil, surfactant, co-surfactant, and drug. Their small particle size allows efficient drug release in the GI tract. Stability testing evaluates factors like temperature effects and in vitro drug release. SMEDDS
This document discusses common oral health problems and their causes, prevention, and treatment. It covers dental issues like dental plaque, calculus, tooth decay, dental hypersensitivity, dry mouth, as well as cosmetic concerns like dental staining and oral malodor. For each problem, it explains the causes such as bacteria, acid production, and dietary factors. Prevention methods include proper brushing, flossing, fluoride use, and limiting sugary foods. Treatment involves removing plaque and bacteria mechanically or chemically, using desensitizing toothpastes, artificial saliva, whitening agents, and masking odors. Maintaining good oral hygiene is key to preventing most oral health issues.
1) The document discusses the use of design of experiments (DoE) in pharmaceutical development and formulation. It covers topics like one variable at a time experimental design, factorial design, screening designs like Plackett-Burman design, and applications of DoE in quality assurance and process optimization.
2) A case study demonstrates the use of a Plackett-Burman design to screen influencing variables in a drug release formulation. Crosspovidone was found to be the most influencing variable based on this screening design.
3) DoE allows formulation scientists to systematically evaluate all formulation factors to optimize the formulation and manufacturing process in a timely manner. This leads to more robust and efficient processes.
This document discusses design of experiments (DoE) and its application in formulation development. It defines key terms like independent variables, dependent variables, levels, quality target product profile, critical process parameters, and critical quality attributes. It describes different types of DoE like factorial designs, response surface designs, central composite design, and Box-Behnken design. It provides an example of using a three-factor, three-level Box-Behnken design to investigate formulation variables affecting droplet size, drug release, and solubility of a fenofibrate SMEDDS formulation. Statistical software was used to fit the experimental results to a quadratic mathematical model.
This document discusses biopharmaceutical factors that can affect the bioavailability of drugs. It focuses on pharmaceutical factors including physicochemical properties of drug molecules and dosage form characteristics. Physicochemical properties like solubility, dissolution rate, particle size, polymorphism, salt form, and ionization state can impact drug absorption. The pH-partition hypothesis explains how a drug's pKa and lipid solubility relate to absorption based on gastrointestinal pH. Dosage form properties such as disintegration time, manufacturing methods, and ingredients are also discussed as formulation factors influencing bioavailability.
MICROBALLOONS: A NOVEL APPROACH IN GASTRO-RETENTION FLOATING DRUG DELIVERY SY...Snehal Patel
ABSTRACT
Oral controlled release dosage forms face several physiological restriction like inability to retain
and position the controlled drug delivery system within the targeted region of the gastrointestinal
tract (GIT) due to fluctuation in gastric emptying. This results in non uniform absorption
pattern, inadequate medication release and shorter residence time of the dosage form in the
stomach. As the fallout of this episode there is inadequate absorption of the drug having
absorption window predominantly, in the upper area of GIT. These contemplations have
provoked to the development of oral controlled release dosage forms with gastroretentive
properties. Microballoons (Hollow microspheres) hold certification as one of the potential
approaches for gastric retention. Microballoons are spherical empty particles without core and
can remain in the gastric region for delayed periods. They significantly increase the gastric
residence time of medication, thereby enhance bioavailability, improves patient compliance by
reducing dosing frequency, lessen the medication waste, enhance retention of medication which
solubilize only in stomach, enhance solubility for medications that are less soluble at a higher pH
environment. The present review preparation methods, characterization, advantages,
disadvantages, mechanism of drug release from microballoons, applications and list of the drugs
formulated as microballoons are discussed.
KEYWORDS: Microballoons, Gastro-retention, Floating drug delivery system (FDDS).
This document discusses various optimization techniques used in pharmaceutical product development including EVOP method, statistical designs like simplex method and response surface methodology, contour design, and factorial designs. It provides details on each technique such as the basic concepts, advantages, disadvantages and examples. EVOP method involves making small repeated changes to a formulation to optimize it but requires more time. Statistical designs help optimize formulations with 1-3 variables. Contour design uses constraints to optimize multiple response variables. Response surface methodology uses statistical techniques to build empirical models and optimize responses influenced by several variables. Factorial designs study the effects of individual and interacting input parameters on experimental outcomes.
The document discusses various drug delivery systems including niosomes, aquasomes, and phytosomes. Niosomes are vesicles composed of non-ionic surfactants that can encapsulate medications and offer advantages over liposomes such as lower cost and greater stability. Aquasomes are three-layered nanoparticle structures consisting of a ceramic core coated with an oligosaccharide film that can deliver fragile molecules while maintaining their integrity. Phytosomes utilize phospholipids to surround active herbal constituents, improving their absorption and bioavailability compared to traditional herbal extracts.
The release of the drug substance from the drug product leading to the bioavailability of the drug substance. The assessment of drug product performance is imp. Since bioavailability is related both to the pharmacodynamic responses and the adverse events. The performance tests relate the quality of a drug product to clinical safety and efficacy.
Bioavailability studies are drug product performance studies used to define
the effect of changes in the physicochemical properties of the drug substance, the formulation of the drug, and the manufacturing process of the drug product.
This document compares different methods for comparing dissolution profiles of drug products. It defines dissolution profile comparison and its objectives such as developing bioequivalent products and in vitro-in vivo correlations. Graphical, statistical, model-dependent and model-independent methods are described. The most common model-independent method is the f2 similarity factor test recommended by the FDA, which provides a single value to determine if two dissolution profiles are similar based on the percent dissolved over time. Proper selection of time points and criteria for coefficient of variation are important for f2 testing.
Virtual clinical trials offer advantages over traditional trials such as improved patient comfort, convenience and confidentiality. They utilize technologies like apps and online platforms to remotely collect data from trial participants from start to finish. While offering benefits, virtual trials also carry risks regarding patient privacy, operational challenges, and technical or cultural barriers. Ideal virtual trials would generate necessary data with minimal burden, foster ongoing relationships to better understand conditions, and engage providers in a complementary way. Emerging technologies like social media, mobile devices, remote monitoring, and electronic patient reporting can help promote virtual trials by automating data collection and enabling remote participation. Physiologically-based modeling using software like GastroPlus can help predict food effects on drug absorption by simulating gastrointestinal conditions
The document provides guidelines on validation of analytical procedures from the International Conference on Harmonisation (ICH) and the World Health Organization (WHO). It discusses validation characteristics like accuracy, precision, specificity, linearity, range, detection limit and quantitation limit that should be considered when validating identification tests, assays, and tests for impurities. It provides definitions for key terms and recommendations on how validation of these characteristics should be performed.
Drug absorption from the gastrointestinal tract can be influenced by many factors. The drug must first disintegrate, dissolve, and permeate the gastrointestinal membranes before being absorbed into systemic circulation. The rate of absorption is determined by the slowest of these steps. Factors that can affect absorption include the drug's physicochemical properties, dosage form characteristics, and patient factors like gastrointestinal pH, transit time, and presence of food or enzymes. Understanding these biopharmaceutical factors is important for optimizing drug product design and therapeutic efficacy.
This document provides information on pulmonary drug delivery systems and aerosols. It discusses the advantages of pulmonary drug delivery such as localized drug deposition reducing systemic exposure and avoidance of first-pass metabolism. Aerosols are defined as colloidal systems containing liquid/solid particles suspended in a propellant. The document outlines the manufacturing process, components, and quality control tests of aerosols including pressure filling, cold filling, and compressed gas filling apparatuses. Evaluation tests like flash point and flame projection are also mentioned.
This document discusses drug targeting and various drug delivery systems for targeted drug delivery. It describes how drug targeting aims to selectively deliver drugs to the site of action and not to non-target tissues. Various polymer-based particulate carriers for targeted drug delivery are then discussed, including liposomes, microspheres, nanoparticles, and polymeric micelles. The document provides details on the composition, preparation techniques and applications of these particulate carriers. Key advantages and challenges of different targeted drug delivery approaches are also summarized.
postmarketing surviellance,,outsourcing of BA ,BE , CRO. supriyawable1
This document provides an overview of post-marketing surveillance, outsourcing of bioavailability and bioequivalence studies to contract research organizations. It discusses the need for post-marketing surveillance to identify rare or long-term adverse drug reactions not seen in clinical trials. Methods for post-marketing surveillance include controlled trials, spontaneous reporting, cohort and case-control studies. Outsourcing bioavailability and bioequivalence studies to CROs can help reduce costs and improve resource efficiency for pharmaceutical companies.
NIOSOMES , GENERAL CHARACTERISTICS OF NIOSOME , TYPES OF NIOSOMES , OTHERS TYPES OF NIOSOMES , NIOSOMES VS LIPOSOMES , COMPONENTS OF NIOSOMES , Non-ionic surfactant , Cholesterol , Charge inducing molecule , METHOD OF PREPARATION , preparation of small unilamellar vesicles , Sonication , Micro fluidization , preparation of large unilamellar vesicles , Reverse Phase Evaporation , Ether Injection , preparation of Multilamellar vesicles , Hand shaking method , Trans membrane pH gradient drug uptake process (remote loading) , Miscellaneous method :Multiple membrane extrusion method , The “Bubble” Method , Formation of Niosomes From Proniosomes , SEPARATION OF UNENTRAPPED DRUGS , Gel Filtration , Dialysis , Centrifugation , FACTORS AFFECTING THE PHYSICOCHEMICAL PROPERTIES OF NIOSOMES , Membrane Additives , Temperature of Hydration , PROPERTIES OF DRUGS , AMOUNT AND TYPE OF SURFACTANT
Structure of Surfactants , Resistance to Osmotic Stress , Characterization of niosomes ,Therapeutic applications of Niosomes , For Controlled Release of Drugs , To Improve the Stability and Physical Properties of the Drugs , For Targeting and Retention of Drug in Blood Circulation , Proniosomes , Aspasomes , Vesicles in Water and Oil System (v/w/o) ,Bola - niosomes , Discomes , Deformable niosomes or elastic niosomes , According to the nature of lamellarity ,Small Unilamellar vesicles (SUV) 25 – 500 nm in size.,Large Unilamellar vesicles (LUV) 0.1 – 1μm in size , Multilamellar vesicles (MLV) 1-5 μm in size , According to the size:Small Niosomes (100 nm – 200 nm) , Large Niosomes (800 nm – 900 nm),Big Niosomes (2 μm – 4 μm)
The document discusses several key concepts related to drug transport and absorption:
1) The pH partition hypothesis states that acidic drugs are absorbed from acidic solutions and basic drugs from alkaline solutions, though some exceptions exist due to the microclimate pH near the membrane surface.
2) Tight junctions form a virtually impermeable barrier between cells, composed of sealing strands that prevent fluid passage.
3) According to Fick's first law, passive diffusion of solutes is determined by concentration gradients and membrane permeability. For ionizable drugs, the uncharged form is more permeable. The pH partition hypothesis relates permeability to pH and the fraction of uncharged molecules.
Virtual trial, Fed vs fasted state, In vitro dissolution & IVIC correlation ,...PawanDhamala1
The document discusses virtual clinical trials and their advantages over conventional clinical trials. It describes how emerging technologies like mobile apps, remote monitoring devices, and electronic data capture can enable various stages of clinical trials to be conducted virtually with participants' comfort and convenience in mind. Several case studies are presented, including one conducted by Sanofi using Facebook to recruit diabetes patients for a virtual trial testing a wireless glucose meter. The document also covers other topics like predicting food effects on drug absorption using physiologically-based modeling, and using such models to establish in vitro-in vivo correlations.
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
Self micro-emulsifying drug delivery system (SMEDDS)Himal Barakoti
This document discusses self-microemulsifying drug delivery systems (SMEDDS), including their background, mechanism of action, formulations, stability testing, advantages, and applications. SMEDDS are isotropic mixtures of oils, surfactants, and co-surfactants that form fine oil-in-water emulsions upon mild agitation followed by dilution in gastrointestinal fluids. They can improve the oral absorption of poorly water-soluble drugs and enhance their bioavailability. SMEDDS formulations typically contain an oil, surfactant, co-surfactant, and drug. Their small particle size allows efficient drug release in the GI tract. Stability testing evaluates factors like temperature effects and in vitro drug release. SMEDDS
This document discusses common oral health problems and their causes, prevention, and treatment. It covers dental issues like dental plaque, calculus, tooth decay, dental hypersensitivity, dry mouth, as well as cosmetic concerns like dental staining and oral malodor. For each problem, it explains the causes such as bacteria, acid production, and dietary factors. Prevention methods include proper brushing, flossing, fluoride use, and limiting sugary foods. Treatment involves removing plaque and bacteria mechanically or chemically, using desensitizing toothpastes, artificial saliva, whitening agents, and masking odors. Maintaining good oral hygiene is key to preventing most oral health issues.
1) The document discusses the use of design of experiments (DoE) in pharmaceutical development and formulation. It covers topics like one variable at a time experimental design, factorial design, screening designs like Plackett-Burman design, and applications of DoE in quality assurance and process optimization.
2) A case study demonstrates the use of a Plackett-Burman design to screen influencing variables in a drug release formulation. Crosspovidone was found to be the most influencing variable based on this screening design.
3) DoE allows formulation scientists to systematically evaluate all formulation factors to optimize the formulation and manufacturing process in a timely manner. This leads to more robust and efficient processes.
This document discusses design of experiments (DoE) and its application in formulation development. It defines key terms like independent variables, dependent variables, levels, quality target product profile, critical process parameters, and critical quality attributes. It describes different types of DoE like factorial designs, response surface designs, central composite design, and Box-Behnken design. It provides an example of using a three-factor, three-level Box-Behnken design to investigate formulation variables affecting droplet size, drug release, and solubility of a fenofibrate SMEDDS formulation. Statistical software was used to fit the experimental results to a quadratic mathematical model.
Tema 4. Diseño experimental para un factorKimberlyMtz
This document provides an overview of experimental design for a single factor. It begins by defining experimental design and its importance in empirical research. It then classifies experimental designs based on factors, variables, sample sizes, and their ability to control for extraneous variables. Examples are given of different experimental designs including completely randomized designs and randomized block designs. Key terms are defined related to experimental design methodology.
Computer-aided formulation development involves using computers to optimize drug products and processes. It involves several variables that are optimized using experimental designs like factorial designs. Computers are used at every step of optimization including design selection, data analysis, and result interpretation. Common software used include Design Expert, MINITAB, and JMP. Reports have optimized various liquid dosage forms like emulsions and suspensions. Computers also play a role in intellectual property protection of innovative research. Ethical issues involving privacy and codes of conduct must also be considered with computational research in pharmaceuticals. Computers can analyze market data to inform business decisions.
computer aided formulation developmentSUJITHA MARY
The document discusses optimization techniques used in computer aided formulation development. It defines optimization as choosing the best alternative while considering all influencing factors. Optimization techniques help minimize experimental trials, reduce costs and save time compared to traditional trial and error methods. The document describes various experimental design approaches like factorial designs, response surface methodology and mixture designs that are used to optimize formulations. It also discusses simultaneous techniques like evolutionary operations and simplex method as well as sequential techniques like mathematical modeling and search methods. Optimization is important for developing formulations with desired performance and ensuring reproducible, large-scale manufacturing.
Design of Experiment ppt by Ganesh AsabeGanesh355057
This document provides an overview of different types of design of experiments (DoE) approaches that can be used in pharmaceutical development and analysis, including factorial designs, central composite designs, mixture designs, and response surface methodology. It discusses key DoE terminology and how each approach works. Examples are given of applications for optimizing formulations, such as using a 23 factorial design to optimize an olmesartan tablet formulation to improve dissolution.
This document provides an overview of design of experiments (DOE). It defines DOE as a set of statistical tools used to plan, execute, analyze, and interpret controlled tests to determine which factors impact process outcomes. The document discusses different types of experimental designs like full factorial and fractional factorial designs. It provides an example to illustrate how a two-factor factorial design can be used to study the effects of driver type and ball type on golf score. The benefits of DOE are identified as being able to determine main effects, interactions, and optimal variable settings. The importance of understanding DOE is explained as it allows choosing between alternatives, identifying key factors, and modeling processes.
Optimization techniques are used to improve pharmaceutical formulations and processing methods. The primary goal may not be absolute optimization but rather an effective compromise that produces the best formulation given certain restrictions. Optimization involves systematically varying factors like concentration, temperature, and polymer grade to determine their effects on responses such as dissolution time, hardness, and reproducibility. Statistical experimental designs are commonly used for optimization and include factorial, response surface, and block designs. These designs help establish relationships between independent variables and dependent responses to find the ideal formulation parameters.
Optimization techniques in formulation Development Response surface methodol...D.R. Chandravanshi
The term “optimize” is “to make as perfect”. It is defined as follows: choosing the best element from some set of variable alternatives.
An art ,process ,or methodology of making something (a design system or decision ) as perfect ,as functional, as effective as possible .
Design of experiments formulation development exploring the best practices ...Maher Al absi
Now days computer tools used in the formulation and development of pharmaceutical product. Various technique such as design of experiment are implemented for optimization of formulation and processing parameter.
Optimization technique is a rational approach for selecting the excipients, their concentrations and process conditions for obtaining the best possible product satisfying the quality characteristics.
Optimization is an act, process or methodology of making design, system or decisions as fully perfect, functional or as effective as possible.
Six Sigma Methods and Formulas for Successful Quality ManagementRSIS International
This paper is about the five phases of Six Sigma which are Define, Measure, Analyze, Improve& Control. The methods used in each phase are discussed in detail and the various tests used in Analyze Phase of Six Sigma are given; Six Sigma can be implemented in an organization by using the methods and formulas used in each phase combined with the help of Statistical Software Minitab 18.
Chetan dhal-Optimization techniques in pharmaceutics, formulation and processingChetan Dhal
This document provides an overview of optimization techniques used in pharmaceutical formulation and processing. It discusses key optimization parameters like variables (independent and dependent) and problem types (constrained and unconstrained). Classical optimization methods like response surface methodology are described. The document focuses on experimental design techniques like factorial designs (full and fractional), response surface methodology using central composite design and Box-Behnken design, and adding center points. It provides examples of different types of experimental designs and how they are used to optimize pharmaceutical processes and formulations.
This document provides an overview of Design of Experiments (DOE). It discusses the key components of experimental design including factors, levels, and responses. Various purposes of experimentation are outlined such as comparing alternatives and identifying significant inputs. Guidelines for experimental design are presented, including minimizing sources of error. Common types of experiments like one-factor and multi-factor experiments are described. Advanced topics like Taguchi methods are also briefly introduced.
This document provides an overview of operational excellence and design of experiments (DOE). It defines key DOE terms and concepts, including factors, levels, interactions, resolution, coding/decoding variables. It discusses the objectives of different DOE designs (screening, modeling, optimizing) and considerations for choosing a design based on factors, levels, and resources. Guidelines are given for planning, executing, and analyzing a DOE. Examples are provided to illustrate DOE concepts like resolution, coding variables, and a full factorial design. The overall purpose is to introduce the reader to the technique of DOE for improving processes.
Optimization technology and screening design sathish h tSatishHT1
This document discusses various design of experiment methodologies including screening designs and optimization designs. It provides examples of factorial designs, response surface designs like central composite designs and Box-Behnken designs, and three-level full factorial designs. It also gives an example of using a fractional factorial design to screen critical processing parameters in a wet granulation coating process and selecting a three-level full factorial design to optimize two factors, blending speed and time, in a dry mixing process to investigate their interactive and quadratic effects on the response.
Six Sigma Methods and Formulas for Successful Quality ManagementIJERA Editor
This document discusses Six Sigma methods and formulas for quality management. It begins by introducing Six Sigma and defining key terms like defects per million opportunities and standard deviation. It then presents the Six Sigma implementation process (DMAIC), outlining the Define, Measure, Analyze, Improve, and Control phases. In the Define phase, projects are chartered and teams assembled. The Measure phase involves collecting data and doing capability analyses. The Analyze phase uses statistical tests like t-tests and ANOVA to find sources of variation. Formulas for measures of central tendency, dispersion, hypothesis testing, and process capability are also provided.
Optimizationinpharmaceuticsprocessing SIDDANNA M BALAPGOLSiddanna Balapgol
Optimization techniques are used to improve pharmaceutical formulations and processing methods. The goal is to make the formulation or process as effective as possible given existing constraints. Modern optimization uses systematic experimental design (DoE) to understand the effects of multiple variables and their interactions on a response. Key aspects of optimization include identifying independent variables that can be modified, dependent response variables to measure effects, and using statistical techniques like factorial designs to efficiently gather information on variable effects and optimize the system. Optimization aims to find the best settings for variables to achieve a desired response.
The facial nerve, also known as cranial nerve VII, is one of the 12 cranial nerves originating from the brain. It's a mixed nerve, meaning it contains both sensory and motor fibres, and it plays a crucial role in controlling various facial muscles, as well as conveying sensory information from the taste buds on the anterior two-thirds of the tongue.
Unlocking the Secrets to Safe Patient Handling.pdfLift Ability
Furthermore, the time constraints and workload in healthcare settings can make it challenging for caregivers to prioritise safe patient handling Australia practices, leading to shortcuts and increased risks.
About this webinar: This talk will introduce what cancer rehabilitation is, where it fits into the cancer trajectory, and who can benefit from it. In addition, the current landscape of cancer rehabilitation in Canada will be discussed and the need for advocacy to increase access to this essential component of cancer care.
Gemma Wean- Nutritional solution for Artemiasmuskaan0008
GEMMA Wean is a high end larval co-feeding and weaning diet aimed at Artemia optimisation and is fortified with a high level of proteins and phospholipids. GEMMA Wean provides the early weaned juveniles with dedicated fish nutrition and is an ideal follow on from GEMMA Micro or Artemia.
GEMMA Wean has an optimised nutritional balance and physical quality so that it flows more freely and spreads readily on the water surface. The balance of phospholipid classes to- gether with the production technology based on a low temperature extrusion process improve the physical aspect of the pellets while still retaining the high phospholipid content.
GEMMA Wean is available in 0.1mm, 0.2mm and 0.3mm. There is also a 0.5mm micro-pellet, GEMMA Wean Diamond, which covers the early nursery stage from post-weaning to pre-growing.
At Apollo Hospital, Lucknow, U.P., we provide specialized care for children experiencing dehydration and other symptoms. We also offer NICU & PICU Ambulance Facility Services. Consult our expert today for the best pediatric emergency care.
For More Details:
Map: https://cutt.ly/BwCeflYo
Name: Apollo Hospital
Address: Singar Nagar, LDA Colony, Lucknow, Uttar Pradesh 226012
Phone: 08429021957
Opening Hours: 24X7
As Mumbai's premier kidney transplant and donation center, L H Hiranandani Hospital Powai is not just a medical facility; it's a beacon of hope where cutting-edge science meets compassionate care, transforming lives and redefining the standards of kidney health in India.
Get Covid Testing at Fit to Fly PCR TestNX Healthcare
A Fit-to-Fly PCR Test is a crucial service for travelers needing to meet the entry requirements of various countries or airlines. This test involves a polymerase chain reaction (PCR) test for COVID-19, which is considered the gold standard for detecting active infections. At our travel clinic in Leeds, we offer fast and reliable Fit to Fly PCR testing, providing you with an official certificate verifying your negative COVID-19 status. Our process is designed for convenience and accuracy, with quick turnaround times to ensure you receive your results and certificate in time for your departure. Trust our professional and experienced medical team to help you travel safely and compliantly, giving you peace of mind for your journey.
The best massage spa Ajman is Chandrima Spa Ajman, which was founded in 2023 and is exclusively for men 24 hours a day. As of right now, our parent firm has been providing massage services to over 50,000+ clients in Ajman for the past 10 years. It has about 8+ branches. This demonstrates that Chandrima Spa Ajman is among the most reasonably priced spas in Ajman and the ideal place to unwind and rejuvenate. We provide a wide range of Spa massage treatments, including Indian, Pakistani, Kerala, Malayali, and body-to-body massages. Numerous massage techniques are available, including deep tissue, Swedish, Thai, Russian, and hot stone massages. Our massage therapists produce genuinely unique treatments that generate a revitalized sense of inner serenely by fusing modern techniques, the cleanest natural substances, and traditional holistic therapists.
Chandrima Spa Ajman is one of the leading Massage Center in Ajman, which is open 24 hours exclusively for men. Being one of the most affordable Spa in Ajman, we offer Body to Body massage, Kerala Massage, Malayali Massage, Indian Massage, Pakistani Massage Russian massage, Thai massage, Swedish massage, Hot Stone Massage, Deep Tissue Massage, and many more. Indulge in the ultimate massage experience and book your appointment today. We are confident that you will leave our Massage spa feeling refreshed, rejuvenated, and ready to take on the world.
Visit : https://massagespaajman.com/
Call : 052 987 1315
This particular slides consist of- what is hypotension,what are it's causes and it's effect on body, risk factors, symptoms,complications, diagnosis and role of physiotherapy in it.
This slide is very helpful for physiotherapy students and also for other medical and healthcare students.
Here is the summary of hypotension:
Hypotension, or low blood pressure, is when the pressure of blood circulating in the body is lower than normal or expected. It's only a problem if it negatively impacts the body and causes symptoms. Normal blood pressure is usually between 90/60 mmHg and 120/80 mmHg, but pressures below 90/60 are generally considered hypotensive.
At Malayali Kerala Spa Ajman, Full Service includes individualized care for every client. We specifically design each massage session for the individual needs of the client. Our therapists are always willing to adjust the treatments based on the client's instruction and feedback. This guarantees that every client receives the treatment they expect.
By offering a variety of massage services, our Ajman Spa Massage Center can tackle physical, mental, and emotional illnesses. In addition, efficient identification of specific health conditions and designing treatment plans accordingly can significantly enhance the quality of massaging.
At Malayali Kerala Spa Ajman, we firmly believe that everyone should have the option to experience top-quality massage services regularly. To achieve that goal we offer cheap massage services in Ajman.
If you are interested in experiencing transformative massage treatment at Malayali Kerala Spa Ajman, you can use our Ajman Massage Center WhatsApp Number to schedule your next massage session.
Contact @ +971 529818279
Visit @ https://malayalikeralaspaajman.com/
Healthy Eating Habits:
Understanding Nutrition Labels: Teaches how to read and interpret food labels, focusing on serving sizes, calorie intake, and nutrients to limit or include.
Tips for Healthy Eating: Offers practical advice such as incorporating a variety of foods, practicing moderation, staying hydrated, and eating mindfully.
Benefits of Regular Exercise:
Physical Benefits: Discusses how exercise aids in weight management, muscle and bone health, cardiovascular health, and flexibility.
Mental Benefits: Explains the psychological advantages, including stress reduction, improved mood, and better sleep.
Tips for Staying Active:
Encourages consistency, variety in exercises, setting realistic goals, and finding enjoyable activities to maintain motivation.
Maintaining a Balanced Lifestyle:
Integrating Nutrition and Exercise: Suggests meal planning and incorporating physical activity into daily routines.
Monitoring Progress: Recommends tracking food intake and exercise, regular health check-ups, and provides tips for achieving balance, such as getting sufficient sleep, managing stress, and staying socially active.
COPD Treatment in Ghatkopar,Mumbai. Dr Kumar DoshiDr Kumar Doshi
Are you or a loved one affected by Chronic Obstructive Pulmonary Disease (COPD)? Discover comprehensive and advanced treatment options with Dr. Kumar Doshi, a preeminent COPD specialist based in Ghatkopar, Mumbai.
Dr. Kumar Doshi is dedicated to delivering the highest standard of care for COPD patients. Whether you are seeking a diagnosis, a second opinion, or exploring new treatment avenues, this presentation will guide you through the exceptional services available at his practice in Ghatkopar, Mumbai.
2. CONTENTS LIST
Introduction / Summary of Factorial Designs
What are Factorial Designs?
Process and Strategies Of using Factorial
Designs
Design Of Experiments
Experimental Runs
Design Space
Final Polynomial Equation
Glance about Quadratic Equation
3. INTRODUCTION
3
Factorial Design is an approach that is used to
minimize the following:-
Experimental Runs
Minimize Manpower
Money
And helps in:-
Optimization of batches &
Saves Time
4. WHAT ARE FACTORIAL
DESIGNS
FACTORIAL DESIGNS:-
These are the designs of choice for the simultaneous determination of the
effects of several factors and their interactions.
Symbols to denote levels are:-
When both variables are in low concentration
a- one low variable and second high variable
b- one high variable and second low variable
ab- both variables are high
Eg: Factorial designs are optimal to determine the effect of pressure
and lubricant on the hardness of a tablet
Eg: Effect of disintegrant & lubricant conc. On tablet dissolution
Eg: It is based on the theory of probability and test of significance.
5. PROCESSES AND STRATEGIES USED IN
FACTORIAL DESIGN
1. Problem
Defination
2. Selectiion of
factor and levels
3. Design of
experiment
protocol
4. Conduct
Experiment and
collect data
5. Analyse Data
6. Interpret
Data
7. Prediction
of optimum
formula
8. Validation of
optimisation
6. DESIGN OF EXPERIMENTS
3² FACTORIAL DESIGNS
6
Example:- How the effect of Dispersion Time and Disintegration Time impacts on the
Dispersion and Disintegration Rate of ORO DISPERSIBLE TABLET (At 3 Levels and 2 Factors)
FACTORS COMPOUNDS LEVEL (-1) LEVEL (0) LEVEL (+1)
Concentration of
Diluent
Cross Carme lose
Sodium
150mg 175mg 200mg
Super Disintegrant Micro Crystalline
Cellulose
25 mg 50 mg 75 mg
8. DESIGN SPACE
8
Design space of 3 ² FULL FACTORIAL DESIGN
D
I
S
P
E
R
S
I
O
N
T
I
M
E
DISINTEGRATION TIME
-1,+1 +1,+1
+1,-1
-1,-1
-1,0 +1,0
0,+1
0,0
0,-1
9. POLYNOMIAL EQUATION
9
Y= Ƀo+ B₁X₁+B₂X₂+B₃X₃+B₁₂X ₁₂+B ₁ ₃X ₁ ₃ +B ₂₃ X ₂₃+ B ₁₁X ₁²+ B ₂₂X ₂²
Y= Results/Responses
B ₀= Intercept
B₁ = Coefficient of variable X₁
B₂= Coefficient of variable X₂
B₃= Coefficient of variable X₃
B₁₂X ₁₂= Interaction Effects between variables X₁ & X₂
B ₁₃ x ₁₃ = Interaction Effects between variables X ₁ & X ₃
B ₁₁X ₁²+ B ₂₂X ₂²= Quadratic Equation