What if it was much easier to distribute, store and give antibiotics to sick children? In low resource settings where pediatric formulations of antibiotics are rare, this could mean the difference between life and death? Learn more about four promising innovations including: peanut-butter infused amoxicillin that is easy to swallow, tastes good and also treats malnutrition (from Sangwei Lu at U Cal Berkeley); an amoxicillin suppository (from Catherine Tuleu and Sara Hanning at UC London); oil-based amoxicillin (from Connie Louw at Gateway Health Institute); and amoxicillin that you squeeze out of a tube like toothpaste (from Chenjie Xu at Nanyang Technical University). Who said there was no innovation in antibiotics?
This document summarizes a presentation on decoding embryo culture. It discusses how in vitro culture aims to mimic the in vivo environment by balancing nutrients, temperature, pH, oxygen tension, and preventing contaminants. It describes the in vivo conditions in the oviduct and uterus and how culture media and protocols try to replicate these. Key aspects of embryo culture systems like media, gas phase, incubators, and embryologists are outlined. Different culture media compositions and the expectations and history of development are summarized. Various culture protocols like single step, sequential, group and individual culture are compared. Factors like pH, temperature, oxygen tension and their optimal levels are highlighted.
Solity 3PTM is Stabicon Life Sciences' proprietary technology platform that enables industry-specific solutions to improve productivity and create value. It transforms insoluble compounds into water-soluble formulations with enhanced bioavailability. This allows for improved products with novel properties like reduced toxicity and dose requirements while maintaining or improving efficacy. The technology has wide applications in pharmaceuticals, nutraceuticals, cosmeceuticals, agriculture and more. It provides benefits like increased solubility, bioavailability and stability while allowing for simplified manufacturing processes.
Emerging applications for food system sustainability. UVC shows potential for...Gail Barnes
UV light in the range of 200 - 280 nm (UVC) inactivates pathogens as a result of the absorption of the UV light by the nucleotides of DNA molecules.
The nucleotides are dimerized by UVC and the subsequent chemical modification prevents DNA replication and transcription.
This presentation explores the significance of the germicidal effect of UVC for processing liquid dairy products in both developing and developed markets, on its potential to improve raw milk quality, and address food safety issues around soft cheeses.
Manufacture of parenteral products and troubleshootingMostafaQalavand1
Parenteral administration of drugs by intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes is now an established and essential part of medical practice.
Many important drugs are available only as parenteral dosage forms. Notable among these are numerous biotechnology drugs, insulin, several cephalosporin antibiotic products, and drugs such as heparin, protamine, and glucagon. In addition, other drugs such as lidocaine hydrochloride and many anticancer products are used principally as parenterals.
Manufacture of Parenteral Products and Troubleshooting - Part AWang Lang
Parenteral administration of drugs through intravenous, intramuscular, or subcutaneous routes is now essential in medicine. It provides rapid onset, predictable effects, and avoids gastrointestinal issues. Many important drugs are only available as parenteral formulations. However, injections can be painful and discomforting for patients. Parenteral products must consider factors like drug solubility, particle size, pH, and excipients to ensure stability, sterility, and appropriate delivery of the drug. Careful formulation is required to develop safe and effective injectable medications.
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
The Essentials of USP chapter 51 antimicrobial effectiveness testingGuide_Consulting
Salah Satu Referensi Yang Digunakan Dalam One Day Seminar "Preservative Effectiveness Validation"
04 Desember 2014. Bogor
Detail : info@traininglaboratorium.com
Intra Vaginal Drug Delivery System was presented by Saloni Dalwadi, a 1st year M.Pharm student at Anand Pharmacy College under the guidance of Dr. Vaishali Thakkar. The presentation covered the epidemiology and anatomy of the vagina, advantages and disadvantages of intravaginal formulations, classification of marketed formulations, pharmaceutical aspects affecting formulations, evaluation parameters, and various intravaginal drug delivery systems including creams, gels, films, rings, tablets, and suppositories. The document provided details on the anatomy, physiology, and factors impacting drug delivery via the vaginal route.
This document summarizes a presentation on decoding embryo culture. It discusses how in vitro culture aims to mimic the in vivo environment by balancing nutrients, temperature, pH, oxygen tension, and preventing contaminants. It describes the in vivo conditions in the oviduct and uterus and how culture media and protocols try to replicate these. Key aspects of embryo culture systems like media, gas phase, incubators, and embryologists are outlined. Different culture media compositions and the expectations and history of development are summarized. Various culture protocols like single step, sequential, group and individual culture are compared. Factors like pH, temperature, oxygen tension and their optimal levels are highlighted.
Solity 3PTM is Stabicon Life Sciences' proprietary technology platform that enables industry-specific solutions to improve productivity and create value. It transforms insoluble compounds into water-soluble formulations with enhanced bioavailability. This allows for improved products with novel properties like reduced toxicity and dose requirements while maintaining or improving efficacy. The technology has wide applications in pharmaceuticals, nutraceuticals, cosmeceuticals, agriculture and more. It provides benefits like increased solubility, bioavailability and stability while allowing for simplified manufacturing processes.
Emerging applications for food system sustainability. UVC shows potential for...Gail Barnes
UV light in the range of 200 - 280 nm (UVC) inactivates pathogens as a result of the absorption of the UV light by the nucleotides of DNA molecules.
The nucleotides are dimerized by UVC and the subsequent chemical modification prevents DNA replication and transcription.
This presentation explores the significance of the germicidal effect of UVC for processing liquid dairy products in both developing and developed markets, on its potential to improve raw milk quality, and address food safety issues around soft cheeses.
Manufacture of parenteral products and troubleshootingMostafaQalavand1
Parenteral administration of drugs by intravenous (IV), intramuscular (IM), or subcutaneous (SC) routes is now an established and essential part of medical practice.
Many important drugs are available only as parenteral dosage forms. Notable among these are numerous biotechnology drugs, insulin, several cephalosporin antibiotic products, and drugs such as heparin, protamine, and glucagon. In addition, other drugs such as lidocaine hydrochloride and many anticancer products are used principally as parenterals.
Manufacture of Parenteral Products and Troubleshooting - Part AWang Lang
Parenteral administration of drugs through intravenous, intramuscular, or subcutaneous routes is now essential in medicine. It provides rapid onset, predictable effects, and avoids gastrointestinal issues. Many important drugs are only available as parenteral formulations. However, injections can be painful and discomforting for patients. Parenteral products must consider factors like drug solubility, particle size, pH, and excipients to ensure stability, sterility, and appropriate delivery of the drug. Careful formulation is required to develop safe and effective injectable medications.
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
The Essentials of USP chapter 51 antimicrobial effectiveness testingGuide_Consulting
Salah Satu Referensi Yang Digunakan Dalam One Day Seminar "Preservative Effectiveness Validation"
04 Desember 2014. Bogor
Detail : info@traininglaboratorium.com
Intra Vaginal Drug Delivery System was presented by Saloni Dalwadi, a 1st year M.Pharm student at Anand Pharmacy College under the guidance of Dr. Vaishali Thakkar. The presentation covered the epidemiology and anatomy of the vagina, advantages and disadvantages of intravaginal formulations, classification of marketed formulations, pharmaceutical aspects affecting formulations, evaluation parameters, and various intravaginal drug delivery systems including creams, gels, films, rings, tablets, and suppositories. The document provided details on the anatomy, physiology, and factors impacting drug delivery via the vaginal route.
This document discusses biowaivers, which allow waiving of clinical bioequivalence studies based on in vitro dissolution testing. It introduces the Biopharmaceutics Classification System (BCS), which categorizes drugs into four classes based on their solubility and permeability. BCS-based biowaivers can be granted for BCS Class 1 and 3 drugs that are highly soluble and highly permeable. The criteria for biowaivers include that the highest dose must dissolve within 15 minutes in pH ranges of 1-7.5. Requirements for biowaiver studies are specified, including dissolution testing in 3 media and establishing similarity between test and reference products. Data to support biowaiver requests must demonstrate high solubility, permeability, and
Mkt 1043 stability and efficiency testing-SPPT23DrMariani
Stability testing is performed on cosmetic formulations to ensure they maintain consistent physical, chemical, and performance characteristics over their shelf life under different storage conditions. Key aspects of stability testing covered in the document include:
- Testing formulations at different temperatures and light levels to simulate real-world conditions.
- Evaluating characteristics like color, odor, viscosity, and emulsion stability at intervals.
- Guidelines for when additional testing is needed, such as with new formulations, raw materials, or manufacturing processes.
- Common testing procedures include temperature cycling, centrifugation, and packaging tests.
- The goal is to predict a formulation's stability so consumers receive a consistent product.
Bioavailability and bioequivalence studyMcpl Moshi
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Kashikar V S
PES Modern College of Pharmacy ( for ladies), Moshi Pune
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Probiotic weaning food by monika keshavrao tambakheMonika Tambakhe
This document discusses probiotics in weaning food. It begins with definitions of weaning and an overview of the importance of weaning food when breast milk is no longer sufficient for nutritional requirements between 4-6 months. It then discusses desirable qualities of weaning foods including being rich in calories, protein, vitamins, and minerals while being easily digestible. The document outlines various techniques for preparing weaning foods commercially or traditionally, including spray drying, roller drying, extrusion cooking, malting, and using banana or popped grains. It provides guidelines for developing processed weaning foods and recommended standards. Finally, it discusses probiotics, defining them, listing common types, and criteria and sources for probiotic bacteria.
The document discusses key considerations for designing a parenteral production facility, including product characteristics like sterility, nonpyrogenicity, and stability. It covers personnel flow and requirements like hygiene, clothing, and training. It also compares batch and continuous manufacturing operations, noting advantages like continuous processes being more time and cost efficient.
Modified Atmospheric Packaging in Food SystemVikas Bansal
The document discusses combining modified atmosphere packaging (MAP) with other preservation techniques to extend the shelf life of foods. It describes how MAP is a mild preservation method that works best when combined with additional hurdles like heat treatment, reduced temperature, or adding preservatives. The document also examines integrating MAP with newer techniques like ultraviolet radiation and ozone treatment to further improve safety and inhibit microbial growth. It focuses on how these techniques can be applied using form-fill-seal packaging machines and appropriate packaging films while still maintaining high quality and detecting any package leaks.
Advancement in research for improving the ambient temperature stability of a ...Arup Nag
An overview of my research in a Centre of Research Excellence in New Zealand to develop novel technology which successfuly enabled probiotic strains remain stable for longer duration under ambient storage conditions.
Pilot Plant scale up techniques in Pharmaceutical industryShubham Sharma
1) Pilot plant scale up techniques are used to test pharmaceutical processes on a small scale before commercial production. This helps identify critical process parameters and ensures consistent product quality.
2) The objectives of pilot plant studies include defining the product and key process steps, conducting preliminary studies, and evaluating results. Steps involve defining production requirements, conducting lab and preliminary studies, and evaluating pilot plant results.
3) General considerations for pilot plants include having dedicated staff with pharmaceutical knowledge, defining space needs, reviewing the formula, selecting raw materials and equipment, and evaluating production rates and process parameters.
This document provides an overview of Hazard Analysis Critical Control Point (HACCP) and food safety management systems. It discusses the 7 principles of HACCP including conducting a hazard analysis, identifying critical control points, establishing critical limits, monitoring procedures, corrective actions, verification, and documentation. Key points covered include common food safety hazards, temperature danger zones for bacterial growth, Malaysian food regulations, and integrating HACCP with other systems like ISO 22000. The purpose of HACCP is to effectively manage food safety risks and prevent foodborne illnesses.
The document discusses the importance of stability studies for pharmaceutical products. It defines stability as the extent to which a drug substance or product retains its properties within specified limits throughout its shelf life. Stability studies are important for determining shelf life, identifying optimal storage conditions, and ensuring drug efficacy and safety. The key factors that can affect drug stability are temperature, moisture, light, pH, concentration, and drug interactions. The document also discusses the different types of stability, including physical, chemical, and microbiological stability. It outlines the various regulations and guidelines for conducting stability studies.
This document describes the formulation and evaluation of oral thin films containing the drug pitavastatin. Various oral thin film formulations were prepared using solvent casting method with polymers like PVP, HPMC and gelatin. The solubility studies showed pitavastatin has highest solubility in 0.1N HCl. Compatibility studies using FTIR showed no interactions between drug and excipients. The formulated films were evaluated for weight uniformity, thickness, folding endurance, drug content uniformity and in vitro drug release. The stable F8 formulation from 3 months stability studies will be subjected to bioavailability studies and commercialized if requirements are met.
FUROCYST is a proprietary and clinically evaluated product for management of Polycystic Ovarian Syndrome (PCOS). It is a single herb product extracted from Fenugreek seeds. It has been scientifically processed without affecting the chemical properties of the active ingredient to give maximum benefit.
Furocyst is supported by international patents and has been clinically evaluated on 150 patients of PCOS. It has been proven safe and effective for an effective management of PCOS. The clinical studies are also published in well-known international journals. A further study on 375 PCOS patients is underway at the reputed PGI, Chandigarh. Furocyst has also been accepted under the Prime Minister’s Fellowship Scheme for Doctoral Research.
Each batch of Furocyst is tested at our in-house Quality control lab to ensure the best quality.
This thesis work contributes new techniques for the development of more stable pharmaceutical dosage forms and probiotic foods through the microencapsulation of two probiotic strains, Lactobacillus fermentum CECT 5716 and Lactobacillus plantarum WCSF-1. Controlled-release tablets containing L. fermentum CECT 5716 were designed and shown to protect the probiotic under simulated gastric conditions. The microencapsulation and formulation techniques developed in this work could enable a wider range of probiotic products to reach consumers with higher viable cell counts.
Impact of non-processing technology in dairy products for microbial safety | ...FoodresearchLab
Dairy products, especially milk is highly perishable as it contains ample nutrition and high in moisture content for the microorganism to grow and multiply.
1.Pulsed electric Field (PEF)
2.High Pressure Processing (HPP)
3.Ultrasound (US)
4.Plasma and low plasma Technology (PT)
To Read More : https://bit.ly/2UX13af
The document discusses using pulsed electric fields (PEF) to extend the shelf life of pasteurized milk. PEF involves applying short electric pulses that kill bacteria through electroporation without heat, preserving sensory and nutritional properties. The document reports on an experiment that found applying PEF after high-temperature short-time (HTST) pasteurization extended milk's shelf life to 60 days, while applying PEF after 8 days of storage following HTST extended it to 78 days, significantly longer than commercial HTST milk without affecting quality. PEF is a promising non-thermal method for pasteurizing and preserving liquid foods like milk.
Stability studies are important to evaluate how the quality of drug products may change over time due to degradation. Key factors that can affect drug product stability include chemical degradation, physical changes, temperature, humidity, and light exposure. Stability studies are conducted according to regulatory guidelines and involve testing drug products for degradation over their proposed shelf life through methods that can detect changes in drug concentration, dissolution, or other quality attributes. Understanding the kinetics and factors that influence the rate of degradation allows for more accurate prediction of a drug product's shelf life.
What do we really know about the interaction between breastmilk and the infant microbiome? Research shows that the newborn gut microbiome — the trillions of bacteria that live within the intestinal tract of newborns — plays a critical role in proper immune and metabolic development as well as meeting the newborn’s nutritional needs. Disruption of the newborn gut microbiome can cause both acute and chronic health consequences. Based on novel discoveries of the unique partnership between mammalian milk and B. infantis, Evolve has pioneered a microbiome-based approach to solving newborn gut dysbiosis.
Introduction to the "Bridge" - a new breastfeeding support tool Leith Greenslade
The Bridge team introduces their new product, the Bridge, which is designed to simplify at-breast supplementation for parents struggling with breastfeeding. The Bridge allows milk or supplement to be delivered to the baby's mouth while at the breast, providing stimulation to increase milk supply and keeping the baby interested. The team believes the Bridge can help resolve many breastfeeding issues so parents can get their baby back to exclusively breastfeeding. They have already had success helping over 400 families and are looking to expand use of the Bridge through partnerships and further research.
This document discusses biowaivers, which allow waiving of clinical bioequivalence studies based on in vitro dissolution testing. It introduces the Biopharmaceutics Classification System (BCS), which categorizes drugs into four classes based on their solubility and permeability. BCS-based biowaivers can be granted for BCS Class 1 and 3 drugs that are highly soluble and highly permeable. The criteria for biowaivers include that the highest dose must dissolve within 15 minutes in pH ranges of 1-7.5. Requirements for biowaiver studies are specified, including dissolution testing in 3 media and establishing similarity between test and reference products. Data to support biowaiver requests must demonstrate high solubility, permeability, and
Mkt 1043 stability and efficiency testing-SPPT23DrMariani
Stability testing is performed on cosmetic formulations to ensure they maintain consistent physical, chemical, and performance characteristics over their shelf life under different storage conditions. Key aspects of stability testing covered in the document include:
- Testing formulations at different temperatures and light levels to simulate real-world conditions.
- Evaluating characteristics like color, odor, viscosity, and emulsion stability at intervals.
- Guidelines for when additional testing is needed, such as with new formulations, raw materials, or manufacturing processes.
- Common testing procedures include temperature cycling, centrifugation, and packaging tests.
- The goal is to predict a formulation's stability so consumers receive a consistent product.
Bioavailability and bioequivalence studyMcpl Moshi
BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Kashikar V S
PES Modern College of Pharmacy ( for ladies), Moshi Pune
Bioavailability and Bioequivalence studyMcpl Moshi
Bioavailability and Bioequivalence study, BCS is a scientific framework for classifying drug substances based on their aqueous solubility and intestinal permeability.
It is a drug development tool that allows estimation of solubility, dissolution and intestinal permeability affect that oral drug absorption.
Probiotic weaning food by monika keshavrao tambakheMonika Tambakhe
This document discusses probiotics in weaning food. It begins with definitions of weaning and an overview of the importance of weaning food when breast milk is no longer sufficient for nutritional requirements between 4-6 months. It then discusses desirable qualities of weaning foods including being rich in calories, protein, vitamins, and minerals while being easily digestible. The document outlines various techniques for preparing weaning foods commercially or traditionally, including spray drying, roller drying, extrusion cooking, malting, and using banana or popped grains. It provides guidelines for developing processed weaning foods and recommended standards. Finally, it discusses probiotics, defining them, listing common types, and criteria and sources for probiotic bacteria.
The document discusses key considerations for designing a parenteral production facility, including product characteristics like sterility, nonpyrogenicity, and stability. It covers personnel flow and requirements like hygiene, clothing, and training. It also compares batch and continuous manufacturing operations, noting advantages like continuous processes being more time and cost efficient.
Modified Atmospheric Packaging in Food SystemVikas Bansal
The document discusses combining modified atmosphere packaging (MAP) with other preservation techniques to extend the shelf life of foods. It describes how MAP is a mild preservation method that works best when combined with additional hurdles like heat treatment, reduced temperature, or adding preservatives. The document also examines integrating MAP with newer techniques like ultraviolet radiation and ozone treatment to further improve safety and inhibit microbial growth. It focuses on how these techniques can be applied using form-fill-seal packaging machines and appropriate packaging films while still maintaining high quality and detecting any package leaks.
Advancement in research for improving the ambient temperature stability of a ...Arup Nag
An overview of my research in a Centre of Research Excellence in New Zealand to develop novel technology which successfuly enabled probiotic strains remain stable for longer duration under ambient storage conditions.
Pilot Plant scale up techniques in Pharmaceutical industryShubham Sharma
1) Pilot plant scale up techniques are used to test pharmaceutical processes on a small scale before commercial production. This helps identify critical process parameters and ensures consistent product quality.
2) The objectives of pilot plant studies include defining the product and key process steps, conducting preliminary studies, and evaluating results. Steps involve defining production requirements, conducting lab and preliminary studies, and evaluating pilot plant results.
3) General considerations for pilot plants include having dedicated staff with pharmaceutical knowledge, defining space needs, reviewing the formula, selecting raw materials and equipment, and evaluating production rates and process parameters.
This document provides an overview of Hazard Analysis Critical Control Point (HACCP) and food safety management systems. It discusses the 7 principles of HACCP including conducting a hazard analysis, identifying critical control points, establishing critical limits, monitoring procedures, corrective actions, verification, and documentation. Key points covered include common food safety hazards, temperature danger zones for bacterial growth, Malaysian food regulations, and integrating HACCP with other systems like ISO 22000. The purpose of HACCP is to effectively manage food safety risks and prevent foodborne illnesses.
The document discusses the importance of stability studies for pharmaceutical products. It defines stability as the extent to which a drug substance or product retains its properties within specified limits throughout its shelf life. Stability studies are important for determining shelf life, identifying optimal storage conditions, and ensuring drug efficacy and safety. The key factors that can affect drug stability are temperature, moisture, light, pH, concentration, and drug interactions. The document also discusses the different types of stability, including physical, chemical, and microbiological stability. It outlines the various regulations and guidelines for conducting stability studies.
This document describes the formulation and evaluation of oral thin films containing the drug pitavastatin. Various oral thin film formulations were prepared using solvent casting method with polymers like PVP, HPMC and gelatin. The solubility studies showed pitavastatin has highest solubility in 0.1N HCl. Compatibility studies using FTIR showed no interactions between drug and excipients. The formulated films were evaluated for weight uniformity, thickness, folding endurance, drug content uniformity and in vitro drug release. The stable F8 formulation from 3 months stability studies will be subjected to bioavailability studies and commercialized if requirements are met.
FUROCYST is a proprietary and clinically evaluated product for management of Polycystic Ovarian Syndrome (PCOS). It is a single herb product extracted from Fenugreek seeds. It has been scientifically processed without affecting the chemical properties of the active ingredient to give maximum benefit.
Furocyst is supported by international patents and has been clinically evaluated on 150 patients of PCOS. It has been proven safe and effective for an effective management of PCOS. The clinical studies are also published in well-known international journals. A further study on 375 PCOS patients is underway at the reputed PGI, Chandigarh. Furocyst has also been accepted under the Prime Minister’s Fellowship Scheme for Doctoral Research.
Each batch of Furocyst is tested at our in-house Quality control lab to ensure the best quality.
This thesis work contributes new techniques for the development of more stable pharmaceutical dosage forms and probiotic foods through the microencapsulation of two probiotic strains, Lactobacillus fermentum CECT 5716 and Lactobacillus plantarum WCSF-1. Controlled-release tablets containing L. fermentum CECT 5716 were designed and shown to protect the probiotic under simulated gastric conditions. The microencapsulation and formulation techniques developed in this work could enable a wider range of probiotic products to reach consumers with higher viable cell counts.
Impact of non-processing technology in dairy products for microbial safety | ...FoodresearchLab
Dairy products, especially milk is highly perishable as it contains ample nutrition and high in moisture content for the microorganism to grow and multiply.
1.Pulsed electric Field (PEF)
2.High Pressure Processing (HPP)
3.Ultrasound (US)
4.Plasma and low plasma Technology (PT)
To Read More : https://bit.ly/2UX13af
The document discusses using pulsed electric fields (PEF) to extend the shelf life of pasteurized milk. PEF involves applying short electric pulses that kill bacteria through electroporation without heat, preserving sensory and nutritional properties. The document reports on an experiment that found applying PEF after high-temperature short-time (HTST) pasteurization extended milk's shelf life to 60 days, while applying PEF after 8 days of storage following HTST extended it to 78 days, significantly longer than commercial HTST milk without affecting quality. PEF is a promising non-thermal method for pasteurizing and preserving liquid foods like milk.
Stability studies are important to evaluate how the quality of drug products may change over time due to degradation. Key factors that can affect drug product stability include chemical degradation, physical changes, temperature, humidity, and light exposure. Stability studies are conducted according to regulatory guidelines and involve testing drug products for degradation over their proposed shelf life through methods that can detect changes in drug concentration, dissolution, or other quality attributes. Understanding the kinetics and factors that influence the rate of degradation allows for more accurate prediction of a drug product's shelf life.
What do we really know about the interaction between breastmilk and the infant microbiome? Research shows that the newborn gut microbiome — the trillions of bacteria that live within the intestinal tract of newborns — plays a critical role in proper immune and metabolic development as well as meeting the newborn’s nutritional needs. Disruption of the newborn gut microbiome can cause both acute and chronic health consequences. Based on novel discoveries of the unique partnership between mammalian milk and B. infantis, Evolve has pioneered a microbiome-based approach to solving newborn gut dysbiosis.
Introduction to the "Bridge" - a new breastfeeding support tool Leith Greenslade
The Bridge team introduces their new product, the Bridge, which is designed to simplify at-breast supplementation for parents struggling with breastfeeding. The Bridge allows milk or supplement to be delivered to the baby's mouth while at the breast, providing stimulation to increase milk supply and keeping the baby interested. The team believes the Bridge can help resolve many breastfeeding issues so parents can get their baby back to exclusively breastfeeding. They have already had success helping over 400 families and are looking to expand use of the Bridge through partnerships and further research.
"The Own Mother's Milk (OMM) Economic Value Calculator": A New Tool to Save L...Leith Greenslade
Tricia Johnson, Professor of Health Systems Management at Rush University and a health economist, shows how the
“Own Mother's Milk (OMM) Economic Value Calculator" can help hospitals calculate reductions in morbidities and associated cost savings from increasing the dose of mother’s milk among very low birth weight infants (<1,500g) in NICUs.
“Own Mother's Milk (OMM) Economic Value Calculator": increasing access to hum...Leith Greenslade
Paula Meier, a Professor of Pediatrics and Nursing at Rush University, is a clinician and researcher specializing in own mother's milk for vulnerable infants and optimal lactation care for their mothers, and an expert in the dose-response relationship of own mother's milk and various health outcomes. Here she presents a new tool, the “Own Mother's Milk (OMM) Economic Value Calculator", that enables hospitals to calculate the reductions in morbidities and associated cost savings by increasing the dose of mother’s milk among very low birth weight infants (<1,500g) in NICUs.
Launch of Resource Toolkit for Establishing and Integrating Human Milk BanksLeith Greenslade
Ensuring equitable access to human milk for all infants has the potential to save countless lives, especially vulnerable neonates, such as those born low-birthweight or premature. Yet many do not have access to their own mother’s milk in the first critical hours or days of life. PATH has developed “Strengthening Human Milk Banking: A Resource Toolkit for Establishing and Integrating Human Milk Banks” as a compendium of standards to advance access to human milk for all babies. This toolkit is comprised of 11 separate core documents and accompanying materials—including templates, standards, and tools—to guide critical steps for establishing human milk banking as an integrated component within breastfeeding support and neonatal care, with in-depth focus on readiness, quality assurance, operations, auditing, training, monitoring and evaluation, and communications. These tools are intended to be utilized as a cohesive package, with embedded links throughout to orient and guide users to relevant resources. This toolkit, in its entirety, is freely available and globally accessible. The content was developed to be adaptable to local context requirements to maximize effectiveness and reach. Click here to view the materials
https://www.path.org/programs/maternal-newborn-child-health-and-nutrition/strengthening-human-milk-banking-resource-toolkit/
Challenges in Breastfeeding and Breastmilk Feeding in NICUs in IndiaLeith Greenslade
Little is known about rates of breastfeeding and breastmilk feeding in NICUs in low and middle income settings. Access Health International has joined forces with three tertiary referral hospitals in the states of Maharashtra, Andhra Pradesh and Karnataka in India to document newborn nutrition in their NICUs. The results are important and make a strong case for more investment in this neglected area of child nutrition.
Innovations in Breastfeeding and Breastmilk Feeding in the NICULeith Greenslade
Can "Lactation Scorecards" drive up low rates of breastmilk feeding in NICUs? Low rates of breastfeeding and breastmilk feeding among sick and vulnerable newborns contribute to low survival rates and poor development outcomes. Medela has developed a new tool that enables NICUs to set new targets and measure their performance - The NICU Lactation Care Scorecard.
"Food for Thought: an Independent Assessment of the International Code of Mar...Leith Greenslade
Angela Evans, author of an independent assessment of the WHO Code of Marketing of Breast-milk Substitutes, presents her findings and major recommendations to the Breastfeeding Innovations Team, March 28th, 2018. The report suggests ways in which the Code can be strengthened as an effective public policy instrument in the service of the Sustainable Development Goals relating to child health and nutrition.
A New Tool for Collecting Colostrum: Jules ShermanLeith Greenslade
Colostrum is baby's critical first food, filled with highly-concentrated nutrients and antibodies to protect against disease.
For the babies who cannot breastfeed, new tools are needed to collect the colostrum from mother's breast and store it so it can be fed to baby. Jules Sherman has created a new two-part system for colostrum collection called the Primo-Lacto®, composed of a breast pump adapter and hand expression funnel. Learn more about how it works and the plans to make it available for wide use.
Breastfeeding & AI: could an Alexa Answer Bot increase breastfeeding rates?Leith Greenslade
AI is set to transform many healthcare experiences, but what about breastfeeding? Could AI be used to dramatically improve the breastfeeding support experience and reduce the costs of lactation support? The team at Breastfeeding Help@Home explores the potential development of an Alexa Answer Bot to provide 24/7 at-home access to lactation support at extremely low cost.
Why is it so hard to reduce household air pollution among the very poor?Leith Greenslade
What cooking technologies can deliver lasting reductions in exposure to household air pollution among the very poor? This is THE question. Learn more from four experts, including Neil Schluger and Darby Jack (Columbia University), Alison Lee (Icahn School of Medicine Mt Sinai) and Joshua Rosenthal (NIH), on the latest research and the most promising technologies, especially the new efforts to reroute government fuel subsidies from the middle class to the very poor (e.g. India Give it Up Campaign for LPG).
Economics of Human Milk in Very Low Birth Weight InfantsLeith Greenslade
The cost of providing support in US hospitals for mothers of very low birth weight newborns to initiate and maintain lactation are dwarfed by the benefits to babies and the hospitals, according to a growing body of research by Rush University academics. Their work also details the various costs to initiating and maintaining lactation in NICUs.
Making NICUs Breastfeeding-Friendly: Meena JoshiLeith Greenslade
India is home to the world's largest number of preterm births and deaths. Ensuring all sick and vulnerable babies have access to breastmilk in the days and weeks after they are born is critical to keeping these babies alive. But as leading research group AIIMS discovered in its own hospital, a minority of NICU babies were being fed breastmilk. Meena Joshi describes how they turned that situation around.
Growing the Number of Quality Human Milk Banks: Kimberly Amundson Leith Greenslade
Human milk banks should be as common as blood banks because they deliver a lifesaving "medicine" to sick and vulnerable newborns - breastmilk. But in high, middle and low income countries the opposite is too often the case. Kimberly Amundson is part of a team at PATH who are working hard to stimulate the development of quality human milk banks in low resource settings by releasing guidance to the groups who will build and operate them.
Breastfeeding Sick and Vulnerable Newborns, Why Invest in Research?: Mary Ren...Leith Greenslade
Leading expert Professor Mary Renfrew laments the lack of quality research to better understand the impact of breastfeeding on sick and vulnerable newborns in health facilities and proposes a way forward.
New Training Guide to Help Babies with Special Needs to Breastfeed: MAITSLeith Greenslade
Babies born with congenital anomalies, birth trauma complications, preterm and low birth weight can struggle to breastfeed. This new training guide aims to teach healthcare workers how to help mothers of special needs babies to breastfeed. Breastmilk can be vital for these more vulnerable babies but without extra support these babies too often miss out.
The Health & Economic Value of Breastmilk for Preterm Babies: MedelaLeith Greenslade
New research in the UK and Germany has found substantial health benefits and cost savings when more infants in NICUs are fed breastmilk. Health benefits include reductions in NEC, SIDS and ear infections which, in turn, save the health system tens of millions. The research, sponsored by Medela, finds that the benefits of breastmilk in the NICU have been "systematically underestimated".
The world's first public-private partnership to increase access to pulse oximetry and oxygen at scale was launched at the Clinton Global Initiative in September 2016. Fifteen organizations from representing government, business and civil society joined forces to support the Government of Ethiopia's national roadmap to scale-up access to pulse oximetry and oxygen in health facilities, with a special focus on reducing deaths in pregnancy, childbirth and childhood. The Ethiopian oxygen access model is a potential blueprint for other governments struggling with high burdens of maternal and child deaths.
Human Milk Bank Hazard Analysis Plan: Trainee WorkbookLeith Greenslade
In the absence of global guidelines and standards for human milk banking, the need for quality assurance planning is critical and needed at the local level. This new toolkit from PATH will help ensure that hazards are identified, eliminated, minimized, or monitored, and proactively checked for the optimal safe distribution of donor human milk. This training workbook will help local human milk bank teams at the national, regional, and hospital levels determine that their human milk banks are operating safely and effectively.
Human Milk Bank Hazard Analysis Plan, Trainer's GuideLeith Greenslade
In the absence of global guidelines and standards for human milk banking, the need for quality assurance planning is critical and needed at the local level. This new toolkit from PATH will help ensure that hazards are identified, eliminated, minimized, or monitored, and proactively checked for the optimal safe distribution of donor human milk. This training guide will help local facilitators lead trainings that allow human milk bank teams at the national, regional, and hospital levels determine that their human milk banks are operating safely and effectively.
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.
Cell Therapy Expansion and Challenges in Autoimmune DiseaseHealth Advances
There is increasing confidence that cell therapies will soon play a role in the treatment of autoimmune disorders, but the extent of this impact remains to be seen. Early readouts on autologous CAR-Ts in lupus are encouraging, but manufacturing and cost limitations are likely to restrict access to highly refractory patients. Allogeneic CAR-Ts have the potential to broaden access to earlier lines of treatment due to their inherent cost benefits, however they will need to demonstrate comparable or improved efficacy to established modalities.
In addition to infrastructure and capacity constraints, CAR-Ts face a very different risk-benefit dynamic in autoimmune compared to oncology, highlighting the need for tolerable therapies with low adverse event risk. CAR-NK and Treg-based therapies are also being developed in certain autoimmune disorders and may demonstrate favorable safety profiles. Several novel non-cell therapies such as bispecific antibodies, nanobodies, and RNAi drugs, may also offer future alternative competitive solutions with variable value propositions.
Widespread adoption of cell therapies will not only require strong efficacy and safety data, but also adapted pricing and access strategies. At oncology-based price points, CAR-Ts are unlikely to achieve broad market access in autoimmune disorders, with eligible patient populations that are potentially orders of magnitude greater than the number of currently addressable cancer patients. Developers have made strides towards reducing cell therapy COGS while improving manufacturing efficiency, but payors will inevitably restrict access until more sustainable pricing is achieved.
Despite these headwinds, industry leaders and investors remain confident that cell therapies are poised to address significant unmet need in patients suffering from autoimmune disorders. However, the extent of this impact on the treatment landscape remains to be seen, as the industry rapidly approaches an inflection point.
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Local Advanced Lung Cancer: Artificial Intelligence, Synergetics, Complex Sys...Oleg Kshivets
Overall life span (LS) was 1671.7±1721.6 days and cumulative 5YS reached 62.4%, 10 years – 50.4%, 20 years – 44.6%. 94 LCP lived more than 5 years without cancer (LS=2958.6±1723.6 days), 22 – more than 10 years (LS=5571±1841.8 days). 67 LCP died because of LC (LS=471.9±344 days). AT significantly improved 5YS (68% vs. 53.7%) (P=0.028 by log-rank test). Cox modeling displayed that 5YS of LCP significantly depended on: N0-N12, T3-4, blood cell circuit, cell ratio factors (ratio between cancer cells-CC and blood cells subpopulations), LC cell dynamics, recalcification time, heparin tolerance, prothrombin index, protein, AT, procedure type (P=0.000-0.031). Neural networks, genetic algorithm selection and bootstrap simulation revealed relationships between 5YS and N0-12 (rank=1), thrombocytes/CC (rank=2), segmented neutrophils/CC (3), eosinophils/CC (4), erythrocytes/CC (5), healthy cells/CC (6), lymphocytes/CC (7), stick neutrophils/CC (8), leucocytes/CC (9), monocytes/CC (10). Correct prediction of 5YS was 100% by neural networks computing (error=0.000; area under ROC curve=1.0).
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!
Muktapishti is a traditional Ayurvedic preparation made from Shoditha Mukta (Purified Pearl), is believed to help regulate thyroid function and reduce symptoms of hyperthyroidism due to its cooling and balancing properties. Clinical evidence on its efficacy remains limited, necessitating further research to validate its therapeutic benefits.
Rasamanikya is a excellent preparation in the field of Rasashastra, it is used in various Kushtha Roga, Shwasa, Vicharchika, Bhagandara, Vatarakta, and Phiranga Roga. In this article Preparation& Comparative analytical profile for both Formulationon i.e Rasamanikya prepared by Kushmanda swarasa & Churnodhaka Shodita Haratala. The study aims to provide insights into the comparative efficacy and analytical aspects of these formulations for enhanced therapeutic outcomes.
1. Sangwei Lu, Ph.D.
School of Public Health
University of California
Berkeley, California
U. S. A.
Email: sangwei@berkeley.edu
Phone: (510) 643-4986
Website: http://sph.berkeley.edu/sangwei-lu
Novel, Peanut Butter – Based
Formulation of Amoxicillin
- Toward a child–friendly formulation of amoxicillin
that is stable, ready to use and nutritious
2. The Need for a Child –Friendly
Formulation of Amoxicillin
• Young children cannot swallow pills.
• Needs clean water to reconstitute
• Needs refrigeration once reconstituted
• Heavy to transport once reconstituted
Peanut butter – based formulation of amoxicillin (NutMox)
• Child-friendly and nutritious
• Ready to use and light weight; no refrigeration
necessary
• Can be combined with RUTF therapy based on
updated WHO guidelines of management of
severe acute malnutrition in children
Sangwei Lu, PhD, sangwei@berkeley.edu Novel, Peanut Butter – Based Formulation of Amoxicillin
3. Design of Peanut Butter–Based
Formulation of Amoxicillin
packaged and distributed as a single course of antibiotic treatment
Advantages
• Easy to handle
• Easy to track
• Helps ensure completion of full course of treatment and
prevent emergence of drug resistance
Sangwei Lu, PhD, sangwei@berkeley.edu Novel, Peanut Butter – Based Formulation of Amoxicillin
4. Project Plan
• Formulate a suitable peanut butter base for amoxicillin
• Test the long term stability of amoxicillin in the peanut
butter base under various storage temperatures
• Determine the pharmacokinetics of NutMox in an
animal model
• Test the efficacy of NutMox in a mouse pneumonia
model.
Preliminary Results
• Amoxicillin is very stable in peanut butter base
with various ratios of peanut butter, sugar,
vegetable oil and dry milk.
• Peanut butter base does not prevent amoxicillin
from being released into mouse bloodstream.
Sangwei Lu, PhD, sangwei@berkeley.edu Novel, Peanut Butter – Based Formulation of Amoxicillin
5. • Prepare in vitro data for FDA Investigational New
Drug (IND) filing.
• Clinical trial – bioequivalence study
• FDA New Drug Application (NDA) filing
• Partner with pharmaceutical companies, NGOs and
non-profit organizations.
Future Directions - Path to Clinical Use
Community Input
• Requirements and feasibility of NutMox in the field
• Regulatory requirements of the countries NutMox is
most likely to be used
• Route of distribution
• Connection with clinicians and organizations
Sangwei Lu, PhD, sangwei@berkeley.edu Novel, Peanut Butter – Based Formulation of Amoxicillin
6. UCL SCHOOL OF PHARMACY
BRUNSWICK SQUARE
Child Friendly Formulations of Amoxicillin:
RAMOX
Dr Catherine Tuleu, Reader of Pharmaceutics
Dr Sara Hanning, Research Associate
UCL School of Pharmacy, London, UK
7. UCL SCHOOL OF PHARMACY
BRUNSWICK SQUARE
Paediatric Pharmacy R & D
Manipulation & Compounding
– Reformulation/repurposing of API for (ultra) rare diseases
– Palliative care
Excipients tolerability and safety
– STEP Database (www.eupfi.org)
Appropriateness of dosage forms (including acceptability)
– RAMOX
– Multiparticulates
– Flexible solid oral dosage forms
Palatability of formulations
– In vivo (human panels)/in vitro (BATA model) tools
– HME for TM of FDC TB drugs
– Cocrystals for TM for neglected infectious diseases
Drug delivery/administration devices
– Nipple shield 7
8. UCL SCHOOL OF PHARMACY
BRUNSWICK SQUARE
Child-friendly formulations of amoxicillin: Exploring the
rectal route
Jannin V, Lemagnen G, Gueroult P, Larrouture D, Tuleu C (2014). Advanced Drug Delivery Reviews 73(0):34-49.
8
9. UCL SCHOOL OF PHARMACY
BRUNSWICK SQUARE
Advantages
Low manufacture cost
Ease of administration (no
need for trained carers)
Avoidance of
taste/swallowability
concerns
Challenges
Ability to withstand high-
temperature environments
Offer immediate and
predictable drug release in
vivo
The rectal route
10. UCL SCHOOL OF PHARMACY
BRUNSWICK SQUARE
Screen potential excipients for irritability
Development, optimisation and characterisation of formulations
Physical and chemical data essential to ensure quality, stability
and an immediate drug release profile
PPI
…to bring forward to Phase II
Clinical efficacy
Paediatric Investigation Plan (PIP)/Paediatric Use Marketing
Authorisation (PUMA)
Educational material to promote and support rectal
administration
Phase I: Pharmaceutical development
10
Phase II: Translation of research
11. The Challenge
Beta-lactam bonds in amoxicillin are hydrolyzed (broken down) by water causing
reconstituted amoxicillin the degenerate within 2 weeks and faster if no cold chain
(refrigeration) is present. DOM (dissolved organic matter) also contribute to 48-74% of
amoxicillin loss if reconstituted with natural waters. Direct sunlight further contributes to
the photochemical degradation especially in the presence of DOM.
Problems encountered in low resource settings
No refrigeration
“Dirty” water – leading to contamination of the reconstituted antibiotic – also contains
DOM
High temperatures in some parts of the developing world – Africa, South East Asia etc
Hypothesis
If water hydrolyzes the Beta-lactam bonds it is acceptable to say oil will not. An oil based
suspension will lead to a suspension that will stay chemically stable with therapeutic
efficacy intact for periods of up to 2 years, without cold chain and at very high
temperatures as experienced in many parts of the world.
12. Water:
is a polar molecule with a dipole moment
can act as an acid or a base (Bronsted Lowry)
has strong hydrogen bonds
Amoxicillin:
is predominantly a polar molecule (polar dissolves in polar)
Oil :
is a non-polar molecule
Other issues with water in LMICs:
Water is mostly contaminated and contains dissolved organic matter
DOMs accelerate hydrolysis
PH also plays a role – should be between 3 and 6 (approximate)
Temperature – in water should be at between 4 and 8 Celsius
At temperatures above 37 Celsius – hydrolysis is accelerated
Direct sunight – accelerates photolysis
Benefits of an oil based suspension:
• Such a suspension will not require refrigeration,
• will eliminate contamination risks
• stay stable at very high temperatures of 40 to 50 degrees Celsius.
• Added benefit of using oil is that oil provides plus minus 9 calories per gram, giving more energy to the child to fight the
infection.
• Individualized dosing units clearly marked for populations of LMICs
13. • Mix amoxicillin with various non-volatile oils and triglycerides.
• Add silicon dioxide as adsorbent and anti-caking agent
• Any flavoring and colorant can be added
Testing conditions as per generic protocol (WHO) and USP
• Long term testing conditions for South Africa (Zone II) = 25°C/60%RH
• Long Term Testing conditions for Zone IVB countries (hot and very humid
conditions) + intermediate conditions for Zone II = 30°C/75%RH
• Accelerated stability testing conditions = 40°C/75%RH
• *%RH = Relative Humidity
.
14. Stability Testing Phase I
Method and Metrics Desired Outcome
Physical analysis: Description and
Appearance; odour, colour, palatability,
uniformity, dissolution
Original physical properties are retained
Chemical analysis: Ph, density, viscosity Original chemical properties are retained
Re-suspendability Suspendability is retained
Uniformity of dosing units: weight
variation
Chemical integrity and labelled potency
are retained
Chemical assay: Assay Amox Suitability of method must be proven
Sterility No contamination
Microbiological: resistance to
microbiological growth and no
contamination
Amoxicillin retains its antimicrobial
effectiveness
Photostability: direct sunlight Determine suitability of amber/clear
ampoules
15. Research Phase II
Method and Metrics Desired Outcome
Therapeutic efficacy Remains unchanged
Bioavailability Remains within specified limits
Safety Safety remains within current limits
Toxicological No increase in adverse events and side
effects
Our product will be safe with no added allergens and we expect no increase in
side effects and adverse events.
Conclusion
Amoxicillin is an existing API - all testing should remain within current limitations.
However, if we could include a comparative study our data will be more unbiased
and we will be able to accelerate phase I and II drastically – especially if we could
test both child formulations 125mg/5ml and 250mg/5ml.
THANK YOU
16. A Thixotropic System for Oral
Delivery of Amoxicillin in Treating
Pneumonia in Children
Chenjie Xu
Assistant Professor
School of Chemical and Biomedical Engineering
Nanyang Technological University
Singapore
16
17. Challenges of Amoxicillin Delivery to Children
(0-5 yrs) at High Burden Countries
http://www.envita.com/
Amoxicillin
17
18. Criteria of an Ideal Formulation
1. Taste-masked
2. Easy to swallow
3. No need of clean water
4. Improved shelf life without the need of refrigeration
5. Low cost
http://gcgh.grandchallenges.org/Explorations/Topics/Pages/ChildhoodPneumoniaTreatment_Round14.aspx
18
19. Birth of Idea
Images are adapted from Waker silicone electronic business. Co. Ltd
19
20. Components of a Thixotropic System
1. A coating that blocks the unappealing taste and odor of
Amoxicillin;
2. A water-containing matrix that disperses, stabilizes,
and delivers the drug.
20
21. Spray-drying Synthesis of Amoxicillin
Micro/nano-particles
• Poly(meth)acrylates polymer (trade name:
EUDRAGIT® E) seals taste and masks odor.
• Soluble in solution (pH <5.0)
Amoxicillin
• Poorly water-soluble (0.004g/ml)
• Insoluble in organic solvents like
chloroform.
• Its sodium salt is soluble in water
(0.05g/ml)
An acidic solution of
Amoxicillin sodium
and Eugragit E
Harsha S. Drug design, development and therapy 2013, 7, 1027
Khachane,P et al, Journal of biomedical nanotechnology 2001, 7, 590
21
22. Encapsulation of Amoxicillin Particles in Sodium
Carboxymethyl Cellulose Hydrogel
High and medium-viscosity types of sodium carboxymethyl cellulose
(SCC) solution exhibit thixotropic behavior and acts like liquid under
the pressure.
http://www.dow.com/; Lee, C.H., Moturi, V. & Lee, Y. Journal of Controlled Release 2009, 136, 88
+
SCCAmoxicillin Particles
Mechanical Stirring
22
Editor's Notes
Intro – rectal amoxicillin
Outline – background into research group, outline of our project, plan of attack
Former CPPR (center for paediatric pharmacy research since 2002) – long established relationship with ICH and GOSH
Formulation but also research capacity on PK PD PG + drug use and safety
Formulation team =
4 post doc
1RA
5 PhD
2 Msc
2 visiting students
(undergrad Mpahrm research students)
Formulations for developing countries
State aim: To address the paucity of age appropriate amoxicillin formulations by developing an innovative, child-friendly rectal dosage form of amoxicillin
Pneumonia is the leading cause of mortality in children < 5
First-line treatment: amoxicillin 250mg
Child-friendly dosage forms unavailable in many countries
Manipulation of adult dosage forms
Compromised efficacy, adherence, medicine stability
Phase 1
-Screen potential excipients for irritability using slug assay
-Development, optimisation and characterisation of formulations
-Generation of essential physical and chemical data to ensure quality, stability and an immediate drug release profile to bring forward to Phase II
Amoxicillin is an antibiotic useful for the treatment of a number of bacterial infections. it is better-absorbed, following oral administration, than other β-lactam antibiotics. Amoxicillin is one of the most common antibiotics prescribed for children.
Amoxicillin particles will be embedded in a gel-like sodium carboxymethyl cellulose solution to protect and stabilize the formulation for long-term storage.
Challenges: Recommended child oral dosage of amoxicillin for pneumococcus is ~50 mg/kg every 12 hours. For a 10-20kg child, 0.5-1g amoxicillin is to be delivered. As a child can usually swallow <5 ml solution at a time, the concentration of amoxicillin in the hydrogel would be ideally above 0.1g/ml.