In the pharmaceutical industry, quality control is a necessary process. Pharmaceutical medicinal products must be advertised as safe, therapeutically active formulations with predictable qualities and performance. The main aim of the study is an analysis on the UV-Visible Spectrophotometry Method. UV spectroscopy was performed on Shimadzu 1700 uv spectrometer, 1cm cell quartz cuvette. Mode was set as UV mode and Detector wavelength was kept at 231 nm and 276 nm. A simple, rapid, accurate, sensitive and cost economical methodology for simultaneous estimation and precise ultraviolet radiation methodology has been developed and valid as per ICH guidelines for simultaneous Estimation of MET and AGP in Their Combined dose form.
A Review on Step-by-Step Analytical Method Validationiosrphr_editor
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
Impurity profiling and degradent characterization {presented by shameer m.pha...ShameerAbid
these slides discuss
Impurity profiling
Degradation characterization
Stability testing & Accelerated stability testing (ICH)
Evaluation of the test (shelf life)
analytical method development
ICH vs USP definition
methods for identification
method for the isolation of the impurity
factors affecting the degradation of formulation
What is degradation characterization
general protocol of degradation conditions used for drug substance and drug product
Degradation conditions
Stress testing
Container closure system
Review on Bioanalytical Method Development in Human Plasmaijtsrd
Bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and this method are applied to study in the areas of human clinical and nonhuman study. Bioanalytical methods employed for the quantitative estimation of drugs and their metabolites plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. The major bioanalytical role is method development, method validation, and sample analysis. Techniques such as high pressure liquid chromatography HPLC and liquid chromatography coupled with double mass spectrometry LCMS MS can be used for bioanalytical studies. Mayuri Gavhane | Dr. Ravindra Patil | Tejaswini Kande "Review on Bioanalytical Method Development in Human Plasma" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-7 , December 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52578.pdf Paper URL: https://www.ijtsrd.com/chemistry/analytical-chemistry/52578/review-on-bioanalytical-method-development-in-human-plasma/mayuri-gavhane
Analytical method development and validation for simultaneous estimationProfessor Beubenz
Brief about analytical method development and validation
Subscribe to the YouTube Channel #Professor_Beubenz
https://www.youtube.com/channel/UC84jGf2iRN5VjwnQqi6qmXg?view_as=subscriber
A Review on Step-by-Step Analytical Method Validationiosrphr_editor
When analytical method is utilized to generate results about the characteristics of drug related samples it is essential that the results are trustworthy. They may be utilized as the basis for decisions relating to administering the drug to patients. Analytical method validation required during drug development and manufacturing and these analytical methods are fit for their intended purpose. To comply with the requirements of GMP pharmaceutical industries should have an overall validation policy which documents how validation will be performed. The purpose of this validation is to show that processes involved in the development and manufacture of drug, production and analytical testing can be performed in an effective and reproducible manner. This review article provides guidance on how to perform validation characteristics for the analytical method which are utilized in pharmaceutical analysis.
Impurity profiling and degradent characterization {presented by shameer m.pha...ShameerAbid
these slides discuss
Impurity profiling
Degradation characterization
Stability testing & Accelerated stability testing (ICH)
Evaluation of the test (shelf life)
analytical method development
ICH vs USP definition
methods for identification
method for the isolation of the impurity
factors affecting the degradation of formulation
What is degradation characterization
general protocol of degradation conditions used for drug substance and drug product
Degradation conditions
Stress testing
Container closure system
Review on Bioanalytical Method Development in Human Plasmaijtsrd
Bioanalytical methods are widely used to quantitate drugs and their metabolites in plasma matrices and this method are applied to study in the areas of human clinical and nonhuman study. Bioanalytical methods employed for the quantitative estimation of drugs and their metabolites plays an important role in estimation and interpretation of bioequivalence, pharmacokinetic, and toxicokinetic studies. The major bioanalytical role is method development, method validation, and sample analysis. Techniques such as high pressure liquid chromatography HPLC and liquid chromatography coupled with double mass spectrometry LCMS MS can be used for bioanalytical studies. Mayuri Gavhane | Dr. Ravindra Patil | Tejaswini Kande "Review on Bioanalytical Method Development in Human Plasma" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-6 | Issue-7 , December 2022, URL: https://www.ijtsrd.com/papers/ijtsrd52578.pdf Paper URL: https://www.ijtsrd.com/chemistry/analytical-chemistry/52578/review-on-bioanalytical-method-development-in-human-plasma/mayuri-gavhane
Analytical method development and validation for simultaneous estimationProfessor Beubenz
Brief about analytical method development and validation
Subscribe to the YouTube Channel #Professor_Beubenz
https://www.youtube.com/channel/UC84jGf2iRN5VjwnQqi6qmXg?view_as=subscriber
Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Review Article: PROCESS ANALYTICAL TECHNOLOGY- Innovative pharmaceutical deve...Vignan University
Process Analytical Technology in pharmaceutical production checks the quality of the raw material attributes
both physically and chemically, that too off-line, in-line or on-line. Process analytical technologies have been
applied to manufacturing processes for decades. PAT is a system for design, analysis, and control of
manufacturing processes, 1
based on continuous monitoring/rapid measurements of critical quality and
performance attributes of raw material, intermediates and products. PAT involves measurement science by
using conventional process sensors such as pressure, temperature and probes. The PAT initiative was initially
intended for traditional pharmaceutical manufacturers, but the FDA.s, PAT guidance now clearly states that it
applies to all manufacturers of human and veterinary drug products. PAT involves shift from testing the quality
to building quality into products by testing at several intermediate steps. It specifically requires that
quantifiable, causal, and predictive relationships be established among the raw materials. There by decreasing
the chances of contamination and cross contamination. It also saves a huge amount of time and money required
for sampling and analysis of the products. Overall PAT paves a way for producing a quality product thus
satisfying the customer needs and creating a good brand image for the organization. PAT that will encourage
the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and
quality assurance as well as novel analyzer technologies.
Assessment of Good Pharmacy Practice (GPP) in Pharmacies of Community Setting...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
A General Review on Bioanalytical Method Development & Validation for LC-MS/MSijtsrd
Rapid growth in the use of LC-MS/MS for the analysis of drugs in biological matrices has been compelled by the need for timely and high-quality data at every stages in drug discovery and development process: from throughput screening of drug candidates and rapid data generation for pre-clinical studies to almost 'real-time' analysis of clinical samples. A well developed bioanalytical development and its validation plays a pivotal role in achieving the goals. . The aim behind this review is to enlighten the need of validation which provide a practical approach for determining the different parameters like selectivity, specifity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness to help the perfect studies of pharmacokinetic, toxic kinetic, bioavailability and bioequivalence. Bio-analysis study is for the quantitative determination of drug and their metabolites in biological fluids. Accurate and robust methods for quantitative analysis of drug and their metabolites are important for the successful conduct of pre-clinical, bio-pharmaceutics and clinical pharmacology. Ashutosh Badola | Preeti Joshi | Preeti Kothiyal"A General Review on Bioanalytical Method Development & Validation for LC-MS/MS" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-2 | Issue-4 , June 2018, URL: http://www.ijtsrd.com/papers/ijtsrd14203.pdf http://www.ijtsrd.com/pharmacy/pharmaceutics/14203/a-general-review-on-bioanalytical-method-development-and-validation-for-lc-msms/ashutosh-badola
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
The Statutory Interpretation of Renewable Energy Based on Syllogism of Britis...AI Publications
The current production for energy consumption generates harmful impacts of carbon dioxide to the environment causing instability to sustainable development goals. The constitutional reforms of British Government serve to be an important means of resolving any encountered incompatibilities to political environment. This study aims to evaluate green economy using developed equation for renewable energy towards political polarization of corporate governance. The Kano Model Assessment is used to measure the equivalency of 1970 Patents Act to UK Intellectual Property tabulating the criteria for the fulfillment of sustainable development goals in respect to the environment, artificial intelligence, and dynamic dichotomy of administrative agencies and presidential restriction, as statutory interpretation development to renewable energy. The constitutional forms of British government satisfy the sustainable development goals needed to fight climate change, advocate healthy ecosystem, promote leadership of magnates, and delegate responsibilities towards green economy. The presidential partisanship must be observed to delineate parties of concerns and execute the government prescriptions in equivalence to the dichotomous relationship of technology and the environment in fulfilling the rights and privileges of all citizens. Hence, the political elites can execute corporate governance towards sustainable development of renewable energy promoting environmental parks and zero emission target of carbon dioxide discharges. The economic theory developed in statutory interpretation for renewable energy serves as a tool to reduce detrimental impacts of carbon dioxide to the environment, mitigate climate change, and produce artefacts of bioenergy and artificial intelligence promoting sustainable development. It is suggested to explore other vulnerabilities of artificial intelligence to prosper economic success.
Enhancement of Aqueous Solubility of Piroxicam Using Solvent Deposition SystemAI Publications
Piroxicam is a non-steroidal anti-inflammatory drug that is characterized by low solubility-high permeability. The present study was designed to improve the dissolution rate of piroxicam at the physiological pH's through its increased solubility by using solvent deposition system.
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Quality management systems - INDUSTRIAL PHARMACY llJafarali Masi
syllabus
Quality management & Certifications: Concept of Quality, Total Quality Management, Quality by Design (QbD), Six Sigma concept, Out of Specifications (OOS), Change control, Introduction to ISO 9000 series of quality systems standards, ISO 14000, NABL, GLP
Review Article: PROCESS ANALYTICAL TECHNOLOGY- Innovative pharmaceutical deve...Vignan University
Process Analytical Technology in pharmaceutical production checks the quality of the raw material attributes
both physically and chemically, that too off-line, in-line or on-line. Process analytical technologies have been
applied to manufacturing processes for decades. PAT is a system for design, analysis, and control of
manufacturing processes, 1
based on continuous monitoring/rapid measurements of critical quality and
performance attributes of raw material, intermediates and products. PAT involves measurement science by
using conventional process sensors such as pressure, temperature and probes. The PAT initiative was initially
intended for traditional pharmaceutical manufacturers, but the FDA.s, PAT guidance now clearly states that it
applies to all manufacturers of human and veterinary drug products. PAT involves shift from testing the quality
to building quality into products by testing at several intermediate steps. It specifically requires that
quantifiable, causal, and predictive relationships be established among the raw materials. There by decreasing
the chances of contamination and cross contamination. It also saves a huge amount of time and money required
for sampling and analysis of the products. Overall PAT paves a way for producing a quality product thus
satisfying the customer needs and creating a good brand image for the organization. PAT that will encourage
the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and
quality assurance as well as novel analyzer technologies.
Assessment of Good Pharmacy Practice (GPP) in Pharmacies of Community Setting...iosrphr_editor
The IOSR Journal of Pharmacy (IOSRPHR) is an open access online & offline peer reviewed international journal, which publishes innovative research papers, reviews, mini-reviews, short communications and notes dealing with Pharmaceutical Sciences( Pharmaceutical Technology, Pharmaceutics, Biopharmaceutics, Pharmacokinetics, Pharmaceutical/Medicinal Chemistry, Computational Chemistry and Molecular Drug Design, Pharmacognosy & Phytochemistry, Pharmacology, Pharmaceutical Analysis, Pharmacy Practice, Clinical and Hospital Pharmacy, Cell Biology, Genomics and Proteomics, Pharmacogenomics, Bioinformatics and Biotechnology of Pharmaceutical Interest........more details on Aim & Scope).
A General Review on Bioanalytical Method Development & Validation for LC-MS/MSijtsrd
Rapid growth in the use of LC-MS/MS for the analysis of drugs in biological matrices has been compelled by the need for timely and high-quality data at every stages in drug discovery and development process: from throughput screening of drug candidates and rapid data generation for pre-clinical studies to almost 'real-time' analysis of clinical samples. A well developed bioanalytical development and its validation plays a pivotal role in achieving the goals. . The aim behind this review is to enlighten the need of validation which provide a practical approach for determining the different parameters like selectivity, specifity, limit of detection, lower limit of quantitation, linearity, range, accuracy, precision, recovery, stability, ruggedness, and robustness to help the perfect studies of pharmacokinetic, toxic kinetic, bioavailability and bioequivalence. Bio-analysis study is for the quantitative determination of drug and their metabolites in biological fluids. Accurate and robust methods for quantitative analysis of drug and their metabolites are important for the successful conduct of pre-clinical, bio-pharmaceutics and clinical pharmacology. Ashutosh Badola | Preeti Joshi | Preeti Kothiyal"A General Review on Bioanalytical Method Development & Validation for LC-MS/MS" Published in International Journal of Trend in Scientific Research and Development (ijtsrd), ISSN: 2456-6470, Volume-2 | Issue-4 , June 2018, URL: http://www.ijtsrd.com/papers/ijtsrd14203.pdf http://www.ijtsrd.com/pharmacy/pharmaceutics/14203/a-general-review-on-bioanalytical-method-development-and-validation-for-lc-msms/ashutosh-badola
CMC, post approval regulatory affairs, etcJayeshRajput7
this document covers points such as CMC, post approval regulatory affairs, regulation for combination products, and medical devices, common technical document (CTD) and electronic common technical document (eCTD) format, industry and FDA liasion, ICH guidelines of ICH Q,S,E,M, regulatory requirements of EU, MHRA, TGA and ROW countries.
Regulatory guidelines for conducting toxicity studies by ichAnimatedWorld
ICH is the “International Conference on Harmonization of
Technical Requirements for Registration of Pharmaceuticals for
Human Use”
ICH is a joint initiative involving both regulators and research based industry representatives of the EU, Japan and the US in
scientific and technical discussions of the testing procedures required
to assess and ensure the safety, quality and efficacy of medicines
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In the current digital landscape, cybercriminals continually evolve their techniques to execute successful attacks on businesses, thus posing a great challenge to information technology (IT) professionals. While traditional cybersecurity approaches like layered defense and reactive security have helped IT professionals cope with traditional threats, they are ineffective in dealing with evolving cyberattacks. This paper focuses on the need for a proactive cybersecurity culture among IT professionals to enable them combat evolving threats. The paper emphasis that building a proactive security approach and culture can help among IT professionals anticipate, identify, and mitigate latent threats prior to them exploiting existing vulnerabilities. This paper also points out that as IT professionals use reactive security when dealing with traditional attacks, they can use it collaboratively with proactive security to effectively protect their networks, data, and systems and avoid heavy costs of dealing with cyberattack’s aftermaths and business recovery.
The Impacts of Viral Hepatitis on Liver Enzymes and BilrubinAI Publications
Viral hepatitis is an infection that causes liver inflammation and damage. Several different viruses cause hepatitis, including hepatitis A, B, C, D, and E. The hepatitis A and E viruses typically cause acute infections. The hepatitis B, C, and D viruses can cause acute and chronic infections. Hepatitis A causes only acute infection and typically gets better without treatment after a few weeks. The hepatitis A virus spreads through contact with an infected person’s stool. Protection by getting the hepatitis A vaccine. Hepatitis E is typically an acute infection that gets better without treatment after several weeks. Some types of hepatitis E virus are spread by drinking water contaminated by an infected person’s stool. Other types are spread by eating undercooked pork or wild game. Hepatitis B can cause acute or chronic infection. Recommendation for screening for hepatitis B in pregnant women or in those with a high chance of being infected. Protection from hepatitis B by getting the hepatitis B vaccine. Hepatitis C can cause acute or chronic infection. Doctors usually recommend one-time screening of all adults ages 18 to 79 for hepatitis C. Early diagnosis and treatment can prevent liver damage. The hepatitis D virus is unusual because it can only infect those who have a hepatitis B virus infection. A coinfection occurs when both hepatitis D and hepatitis B infections at the same time. A superinfection occurs already have chronic hepatitis B and then become infected with hepatitis D. The aim of this study is to find the effect of each type of viral hepatitis on the bilirubin (TB , DSB) , and liver enzymes; AST, ALT, ALP,GGT among viral hepatitis patients. 200 patients were selected from the viral hepatitis units in the central public health laboratory in Baghdad city, all the chosen cases were confirmed as a positive samples , they are classified into four equal group each with fifty individual and with a single serological viral hepatitis type either; anti-HAV( IgM ) , HBs Ag , anti-HCV ,or anti-HEV(IgM ). All patients were tested for; serum bilirubin ( TB ,D.SB ) , AST , ALT , ALP , GGT. Another fifty quite healthy and normal person was selected as a control group for comparison. . Liver enzymes and bilirubin changes are more pronounced in HAV, HEV than HCV and HBVAST and ALT lack some sensitivity in detecting HCV ,HBV and mild elevations of ALT or AST in asymptomatic patients can be evaluated efficiently by considering ,hepatitis B, hepatitis C. ALT is generally a more sensitive indicator of acute liver cell damage than AST, It is relatively specific for hepatocyte necrosis with a marked elevations in viral hepatitis. Liver enzymes and bilirubin changes are more pronounced in HAV, HEV than HCV and HBV.AST and ALT lack some sensitivity in detecting HCV ,HBV and mild elevations of ALT or AST in asymptomatic patients can be evaluated efficiently by considering ,hepatitis B, hepatitis C. ALT is generally a more sensitive indicator of acute liver
Determinants of Women Empowerment in Bishoftu Town; Oromia Regional State of ...AI Publications
The purpose of this study was to determine the status of women's empowerment and its determinants using women's asset endowment and decision-making potential as indicators. To determine representative sample size, this study used a two-stage sampling technique, and 122 sample respondents were selected at random. To analyze the data in this study, descriptive statistics and a probit model were used. The average women's empowerment index was 0.41, indicating a relatively lower status of women's empowerment in the study area. According to the study's findings, only 40.9% of women were empowered, while the remaining 59.1% were not. The probit model results show that women's access to the media, women's income, and their husbands' education status have a significant and positive impact on the status of women's empowerment, while the family size of households has a negative impact. As a result, it is important to enhance women's access to the media and income, promote family planning and contraception, and improve men's educational status in order to improve the status of women's empowerment.
Knee anatomy and clinical tests 2024.pdfvimalpl1234
This includes all relevant anatomy and clinical tests compiled from standard textbooks, Campbell,netter etc..It is comprehensive and best suited for orthopaedicians and orthopaedic residents.
Ozempic: Preoperative Management of Patients on GLP-1 Receptor Agonists Saeid Safari
Preoperative Management of Patients on GLP-1 Receptor Agonists like Ozempic and Semiglutide
ASA GUIDELINE
NYSORA Guideline
2 Case Reports of Gastric Ultrasound
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Ve...kevinkariuki227
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
TEST BANK for Operations Management, 14th Edition by William J. Stevenson, Verified Chapters 1 - 19, Complete Newest Version.pdf
Basavarajeeyam is a Sreshta Sangraha grantha (Compiled book ), written by Neelkanta kotturu Basavaraja Virachita. It contains 25 Prakaranas, First 24 Chapters related to Rogas& 25th to Rasadravyas.
Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
Adv. biopharm. APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMSAkankshaAshtankar
MIP 201T & MPH 202T
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS : UNIT 5
APPLICATION OF PHARMACOKINETICS : TARGETED DRUG DELIVERY SYSTEMS By - AKANKSHA ASHTANKAR
New Drug Discovery and Development .....NEHA GUPTA
The "New Drug Discovery and Development" process involves the identification, design, testing, and manufacturing of novel pharmaceutical compounds with the aim of introducing new and improved treatments for various medical conditions. This comprehensive endeavor encompasses various stages, including target identification, preclinical studies, clinical trials, regulatory approval, and post-market surveillance. It involves multidisciplinary collaboration among scientists, researchers, clinicians, regulatory experts, and pharmaceutical companies to bring innovative therapies to market and address unmet medical needs.
Basavarajeeyam is an important text for ayurvedic physician belonging to andhra pradehs. It is a popular compendium in various parts of our country as well as in andhra pradesh. The content of the text was presented in sanskrit and telugu language (Bilingual). One of the most famous book in ayurvedic pharmaceutics and therapeutics. This book contains 25 chapters called as prakaranas. Many rasaoushadis were explained, pioneer of dhatu druti, nadi pareeksha, mutra pareeksha etc. Belongs to the period of 15-16 century. New diseases like upadamsha, phiranga rogas are explained.
2. Singh et al./ An Analysis on the UV-Visible Spectrophotometry Method
Int. J. Med. Phar. Drug Re., 7(4), 2023
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liquid chromatography (HPLC), and high-
performance thin layer chromatography (HPTLC)].
Quality control laboratories use the official test
procedures that result from these processes to assure
the identification, purity, potency, and performance of
medicinal items.
Every year, a greater number of medications are
added to the market. These medications could be
brand-new or structurally modified versions of
existing ones. There is frequently a time lag between
the release of a medicine to the market and its
inclusion in pharmacopoeias. This is owing to the risk
of ongoing and extended use of these medicines,
reports of additional toxicities (leading to their
removal from the market), the development of patient
resistance, and the release of superior medications by
rivals. In certain cases, pharmacopoeias may not have
standards or analytical techniques for these
compounds. As a result, newer analytical
methodologies for such drugs are required.
The therapeutic advantage of complex medication
combinations should take precedence above any
potential analytical challenge, which is ultimately the
responsibility of the analyst. As a result, novel
analytical methodologies for such drugs are critical.
1.2.3 Some reasons for the development of newer
methods of drugs analysis are:
• Existing analytical procedures may need expensive
reagents and solvents. It could also entail time-
consuming extraction and separation methods that
aren't always reliable.
• Any pharmaceutical development programme must
include the creation, validation, and transfer of
analytical methods. Method development that works
ensures that laboratory resources are optimized, while
methods meet the objectives required at each stage of
drug development.
II. LITERATURE REVIEW
Aravind A et al (2021) developed simultaneous
measurement of Metformin Hydrochloride and
Pioglitazone in tablet dose form, a UV
Spectrophotometric approach was devised. Methanol
was used to make the stock solutions. 231 nm and 269
nm were discovered to be the maximum wavelengths
for Metformin Hydrochloride and Pioglitazone,
respectively. In concentration ranges of 5-30g/ml and
2-12g/ml, Metformin Hydrochloride and
Pioglitazone followed Beer's law. The accuracy,
precision, linearity, robustness, LOD, and LOQ of the
absorbance ratio method were evaluated and
validated according to ICH guidelines for various
parameters. Because the proposed method is
extremely sensitive, exact, and accurate, it can be
employed for the intended purpose.
Habash IW et al (2020) reported that for analysing
Alogliptin, Pioglitazone, and Metformin inside the
bulk medication and tablet pharmaceutical dosage
form, an RP-HPLC method has been developed and
validated. The drug was separated using an ACE C18
(250 mm 4.6 mm), 5 m column with a flow rate of 1.0
mL/min at 25°C and detection at 230 nm. The
detector's linearity was tested in concentrations
ranging from 20 to 250 ppm, with a regression
coefficient of 0.9998. When the API was stressed by
acid, base, neutral, oxidation, and sunshine, the ICH
guidelines were followed to determine stability.
Linearity, precision, accuracy, the limit of detection,
and the limit of quantification were all used in the
validation process. According to ICH criteria, the
results were satisfactory. The method's robustness
was tested using variations in the mobile phase's pH,
detector wavelength, mobile phase composition, and
temperature. The method also yields a low relative
standard deviation and a good recovery value,
ensuring its suitability for regular analysis of tablets
containing Alogliptin, Pioglitazone, and Metformin.
Godge RK, et al (2020) develop Simple, accurate,
precise, and quick RP-HPLC technique validated
according to ICH recommendations for the
measurement of Alogliptin benzoate and
Glibenclamide hydrochloride employing mobile
phase [65:35 combination of Acetonitrile: Phosphate
buffer pH-3.6 The suggested approach entails
measuring Retention time at a certain analytical
wavelength. 240.0 nm. Alogliptin benzoate (ALO) and
Glibenclamide had retention times of 5.055 and 2.838,
respectively. The suggested approach was tested for
linearity in the ranges of 1-5 g/ml (r = 0.9998) for ALO
and 10-50 g/ml (r = 0.9999) for MET. The method's
linearity, accuracy, and precision were statistically
confirmed. Inter-day and intra-day variance were
found to have lower percent RSD (Relative Standard
Deviation) values, indicating a high level of accuracy.
3. Singh et al./ An Analysis on the UV-Visible Spectrophotometry Method
Int. J. Med. Phar. Drug Re., 7(4), 2023
Online Available at: https://www.aipublications.com/ijmpd/ 75
Mahrouse MA, et al (2019) approached in
chromatographic separation performance with the
least amount of labour and resources DOE was used
in the development of an ion pair RP-HPLC method
for the simultaneous determination of metformin
hydrochloride (MET), alogliptin benzoate (ALO), and
repaglinide (REP) in combined binary tablets because
combination therapy of oral hypoglycemic drugs was
generally recommended by Clinical Practice
Guidelines on hypoglycemic agent therapy for the
treatment of type 2 diabetes mellitus. Screening using
the Plackett-Burman design followed by the face-
centered composite design allowed for the calculation
of optimal parameters that provide the best resolution
and peak form within a reasonable amount of time.
The constructed models were statistically examined,
and the correlations between coefficients of the
generated polynomial equations were interpreted
using surface plots. The Models fit the data well and
may be used to predict responses. The mobile phase
was acetonitrile: phosphate buffer (0.01 M, adjusted to
pH 2.5 with o-phosphoric acid): 0.3 percent sodium
heptane sulfonate in water (60:20:20, v/v/v) at a flow
rate of 1 mL min1. At 220 nm, UV detection was
performed. The indicated medications produced
sharp and clearly spaced peaks. The mean %
recoveries of laboratoryprepared combinations
comprising MET, ALO, and REP were 99.66 0.468,
99.98 0.398, and 99.70 0.988, respectively. The
approach worked well for determining the medicines
in binary pills, with recoveries of 99.75 0.6 and 99.74
0.982 for MET and ALO tablets, respectively. Q2 of the
ICH guidelines were used to validate the method (R1).
The constructed models were used to assess
robustness. The analytical Eco-scale and the Green
Analytical Procedure Index were used to analyse the
developed method's greenness profile. The devised
method for determining the mentioned
pharmaceuticals in binary tablets proved to be an
accurate, selective, precise, and environmentally
friendly approach that may be used in quality control
laboratories for regular drug analysis.
KB P, et al (2018) designed Two novel techniques for
determining Alogliptin(ALG) and Metformin at the
same time have been developed (MTF). Principal
component regression (PCR) and partial least squares
are two chemometrically aided spectrophotometric
approaches (PLS). Alogliptin and Metformin spectra
were acquired at various concentrations within their
linear range, and the measurements were utilised to
calculate the calibration mixture in methanol between
wavelengths 200 and 400 nm at a 1 nm interval. Using
the absorption spectra of acceptable solutions, the two
approaches were effectively used to quantify each
individual medication in the combination. The
analytical responses of various chemometric
techniques were measured and evaluated using
relative prediction errors and recoveries (percent).
The two methods were found to be satisfactory and
successfully applied to a pharmaceutical dosage form
and the results were compared.
III. METHODOLOGY
Instrument Parameters and Spectroscopic
conditions
UV spectroscopy was performed on Shimadzu 1700
uv spectrometer, 1cm cell quartz cuvette. Mode was
set as UV mode and Detector wavelength was kept at
231 nm and 276 nm.
Preparation of AGP (5 ppm) and MET (10 ppm)
standard solution: Weighing 5 milligrammes of AGP
and transferring it to a 100 mL volumetric flask with
the diluent. Pipette 1 ml into a 10 ml volumetric flask
and dilute with diluents to 10 ml. Weighing 10
milligrammes of MET and transferring it to a 100 mL
volumetric flask with the diluent Pipette 1 ml into a 10
ml volumetric flask and dilute with diluents to 10 ml.
Analysis of Pharmaceutical dosage form-Tablet by
developed method Preparation of Sample solution:
Tablet powder weighing 10 mg MET and 5 mg AGP
was transferred to a 100 ml volumetric flask and
diluent was added to make up the capacity. Pipette 1
mL from the above resolution into a 10 mL
volumetrical flask and top up with diluent. Using a
UV Spectrometer, examine the above solution.
IV. RESULTS
The spectrum of MET and AGP show no interference
with the spectrum of MET and AGP blank, that the
developed method is found to be specific.
4. International Journal of Medical, Pharmacy and Drug Research (IJMPD)
Article DOI: https://dx.doi.org/10.22161/ijmpd.7.4.6
Peer-Reviewed Journal Int. J. Med. Phar. Drug Re., 7(4), 2023
ISSN: 2456-8015
Int. J. Med. Phar. Drug Re., 7(4), 2023
Online Available at: https://www.aipublications.com/ijmpd/ 76
Fig.4.1 UV Spectra of MET and AGP
4.1.1 Linearity
Appropriate volume from AGP and MET hydrochloride standard solution was transferred to volumetrical flask of
10 ml unit} capacity. The volume was adjusted with mobile phase to allow a solution containing 5–25 μg/ml μg/ml
AGP and 5–20 μg/ml MET hydrochloride. The correlation co-efficient of AGP and MET was achieved to be 0.998
and 0.999 severally.
Table 4.1 Linearity data for AGP
Concentration(µg/ml) Abs.
5 0.31
10 0.65
15 0.92
20 1.27
25 1.61
Table 4.2 Linearity data for MET
Concentration(µg/ml) Abs.
5 0.43
10 0.85
15 1.29
5. Singh et al./ An Analysis on the UV-Visible Spectrophotometry Method
Int. J. Med. Phar. Drug Re., 7(4), 2023
Online Available at: https://www.aipublications.com/ijmpd/ 77
20 1.71
25 2.17
Fig. 4.2 Linearity of AGP
Fig. 4.3 Linearity of MET
4.1.2 Precision
Six measurements of the same solution of AGP (5 μg/ml) and MET (10 μg/ml) were supported by the results for
technique precision of absorbance measurement for AGP (5 μg/ml) and MET (10 μg/ml). AGP and MET both had
a percent RSD of 1.46 and 1.43, respectively.
Table 4.3 Method Precision data for AGP
Conc. (μg/ml) Abs. Mean % R.S.D
6. Singh et al./ An Analysis on the UV-Visible Spectrophotometry Method
Int. J. Med. Phar. Drug Re., 7(4), 2023
Online Available at: https://www.aipublications.com/ijmpd/ 78
0.35
0.35
5
0.36
0.3533 1.46
0.35
0.37
0.35
Table 4.4 Method Precision data for MET
Conc. (μg/ml) Area
Response
Average % R.S.D
0.84
0.84
10
0.85
0.8466 1.43
0.85
0.85
0.85
Intraday and Interday precision
Intraday precision was assessed by analysing a standard solution containing (5, 10, 15 µg/ml) of MET and (5, 10,
15 µg/ml) of AGP three times on the same day and calculating two R.S.D. Interday precision was determined by
analysing a reference solution containing (5, 10, 15 µg/ml) MET and (5, 10, 15 µg/ml) AGP three times on separate
days and calculating two R.S.D.
Table 4.5 Intraday precision data for estimation of AGP
AGP
Conc.
(µg/ml)
Average Abs. % R.S.D
5 0.33 0.10
10 0.65 0.25
15 0.94 0.25
7. Singh et al./ An Analysis on the UV-Visible Spectrophotometry Method
Int. J. Med. Phar. Drug Re., 7(4), 2023
Online Available at: https://www.aipublications.com/ijmpd/ 79
Table 4.6 Intraday precision data for estimation of MET
MET
Conc.
(µg/ml)
Average Abs. % R.S.D
5 0.44 0.25
10 0.82 1.03
15 1.23 0.25
Table 4.7 Interday precision data for estimation of AGP
Conc.
(µg/ml)
Average Abs. % R.S.D
5 0.34 0.59
10 0.66 0.30
15 0.96 0.35
Table 4.8 Interday precision data for estimation of MET
Conc.
(µg/ml)
Average Abs. % R.S.D
5 0.43 1.32
10 0.84 0.96
15 1.25 0.54
V. CONCLUSION
A simple, rapid, accurate, sensitive and cost
economical methodology for simultaneous estimation
and precise ultraviolet radiation methodology has
been developed and valid as per ICH guidelines for
simultaneous Estimation of MET and AGP in Their
Combined dose form. Validation concludes that
developed UV methodology is linear, accurate,
precise, specific and sturdy. It may be successfully
acquired for routine quality control analysis of MET
and AGP in Combined dose form. This methodology
can currently transfer to utilize for routine laboratory
analysis and assay of MET and AGP in their combined
dose form.
REFERENCES
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Ratio Spectrophotometric Method For The
Simultaneous Estimation Of Metformin Hydrochloride
And Pioglitazone In Tablet Dosage Form.
[2] Habash IW, Al-Shdefat RI, Hailat MM, Dayyih WA. A
Stability Indicating RP-HPLC Method Development for
8. Singh et al./ An Analysis on the UV-Visible Spectrophotometry Method
Int. J. Med. Phar. Drug Re., 7(4), 2023
Online Available at: https://www.aipublications.com/ijmpd/ 80
Simultaneous Estimation of Alogliptin, Pioglitazone,
and
[3] Godge RK, Shinde GS, Bhosale MS. RP-HPLC Method
for estimation of Alogliptin and Glibenclamide in
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methodology for optimization and robustness
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Chemometrics Assisted Simultaneous
Spectrophotometric Determination of Alogliptin and
Metformin in Pharmaceutical Dosage Form.
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stabilty indicating RP-HPLC method for simultaneous
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[8] Rendell M, Drincic A, Andukuri R. Alogliptin benzoate
for the treatment of type 2 diabetes. Expert Opinion on
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