The document describes validation of a UV spectroscopic assay method for quantifying Albendazole in three different brand tablet formulations used in Bangladesh. Key points:
- The method was validated according to ICH guidelines and found to be accurate, precise, specific, linear, robust and suitable for its intended use of routine analysis of Albendazole tablets.
- Accuracy, precision, specificity, linearity, range, limit of detection and quantification were within acceptable limits for all three brands according to validation parameters.
- The proposed UV spectroscopic method is simple, rapid, sensitive, reproducible and cost-effective for quality control testing of Albendazole tablets.
Bioavailability and Bioequivalence StudiesPranav Sopory
BA and BE studies.
Seminar presented in All India Institute of Medical Sciences (AIIMS - New Delhi).
Focus in Pharmacokinetic parameters (Cmax, AUC)
Single dose PK study, Steady state PK study, Modified drug release PK study, In vivo mechanisms, invitro mechanisms, Pharmacodynamic Study, Comparatice Clinical Trials. Biowavers and Biosimilimars.
Reference: CDSCO guideline, USFDA guideline, ICH guidelines
burnBurn Cool Cream Which Gives A soft Glow on Skin, Anti Coagulant, Cut Skin, Rashes, Swelling, Psoriasis, Urticaria, Cellulitis, Herpes, Protect from Burns, All Kinds of Injuries, Healing effect on wound. etc...,
For external use only cool by almoherbalhealthcare
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
The first generation of biological drugs, which
have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.
Bioavailability and Bioequivalence StudiesPranav Sopory
BA and BE studies.
Seminar presented in All India Institute of Medical Sciences (AIIMS - New Delhi).
Focus in Pharmacokinetic parameters (Cmax, AUC)
Single dose PK study, Steady state PK study, Modified drug release PK study, In vivo mechanisms, invitro mechanisms, Pharmacodynamic Study, Comparatice Clinical Trials. Biowavers and Biosimilimars.
Reference: CDSCO guideline, USFDA guideline, ICH guidelines
burnBurn Cool Cream Which Gives A soft Glow on Skin, Anti Coagulant, Cut Skin, Rashes, Swelling, Psoriasis, Urticaria, Cellulitis, Herpes, Protect from Burns, All Kinds of Injuries, Healing effect on wound. etc...,
For external use only cool by almoherbalhealthcare
Bioequivalence is a term in pharmacokinetics used to assess the expected in vivo biological equivalence of two proprietary preparations of a drug. If two products are said to be bioequivalent it means that they would be expected to be, for all intents and purposes, the same.
The first generation of biological drugs, which
have introduced many revolutionary treatments to life threatening and rare illnesses, is currently facing patent expiration. As a result, research-based and generics pharmaceutical companies alike are pursuing the opportunity to develop “generic” substitutes to original biologics, which are also known as biosimilars.
A simple visible spectrophotometric method is proposed for the determination
of ulipristal acetate present in bulk and tablet formulation. The currently
proposed method is established based on MBTH oxidation by ferric ions to
form an active coupling species (electrophile), followed by its coupling with
the ulipristal in acidic medium to form high intensiϑied green colored chromophore
having max at 609 nm. Validated the method as per the current
guidelines of ICH. Beer’s law was obeyed in the concentration range of 6.25 –
37.50 g mL 1 with a high regression coefϑicient (r > 0.999). Reproducibility,
accuracy, and precision of the method are evident from the low values of R.S.D.
This method can be used in quality control laboratories for routine analysis of
ulipristal acetate in bulk drug and pharmaceutical dosage forms.
The objective of the present study was to develop asimple, precise and accurate reversed-phase HPLC method and subsequent validation of the
same as per the ICH guidelines. The present study deals with the estimation by RP HPLC of two different drug components pseudoephedrine
hydrochloride (PSE) and cetirizine hydrochloride (CET) present in a tablet formulation.
The chromatographic separation of PSE and CET was done using phosphate buffer al
NOVEL SIMULTANEOUS SEPARATION AND QUANTITATIVE DETERMINATION OF FOUR SARTANS...Dr. Ravi Sankar
The core AIM of the present study is to develop a novel, rapid, precise and accurate RP-HPLC method for simultaneous separation and quantification of Hydrochlorothiazide along with four sartans Telmisartan(TELM), Losartan(LOSA), Olmesartan(OLME) and Valsartan(VALS).
To develop Novel methods for separation and quantification of all the above said drugs on single chromatographic system without any minor changes in detection wavelength and mobile phase composition.
Design expert software assisted development and evaluation of cefpodoxime pro...Makrani Shaharukh
Cefpodoxime Proxetil is third generation, broad-spectrum Cephalosporin Antibiotic & it has an oral bioavailability of only 50% and biological half life 2 h so to improve it’s bioavailability sustain release matrix formulation was designed. Sustained release matrix tablets of Cefpodoxime Proxetil prepared by direct compression method based on combination of natural Acacia gum & Karaya gum polymers. 32 full factorial designs optimization study was carried out by using Design Expert Software to find the effect of independent variables, i.e., Acacia gum (X1) and Karaya gum (X2) concentration on dependent variables i.e., Hardness & % CDR. The drug excipient mixtures were subjected to preformulation studies. The tablets were subjected to physicochemical studies, in-vitro drug release, kinetic studies and stability studies. FTIR and DSC studies shown there was no interaction between drug and polymers. Matrix tablet of Cefpodoxime Proxetil were formulated well in term of hardness 5.07 ± 0. 5.93 ± 0.03 kg/cm2, thickness 2.25 ± 0.1 mm to 3.33 ± 0.3 mm, weight variation were within limits. In-vitro release studies show that almost 90 % of drug was release from all the formulation were within 12 h. Formulation F5 selected as a optimized one since it showed optimum hardness & sustained drug release within 12 h in comparison to other formulation. The F5 optimized formulations were subjected to stability studies and shown there were no significant changes in drug content, physicochemical parameters and release pattern. 32 full factorial design optimization technique was successfully used in this research work. Developed matrix tablets of Cefpodoxime Proxetil produced a sustained and effective drug release over a prolonged time frame that led to greater therapeutic efficacy.
The goal of reverse pharmacology is to utilize disease pathology in order to identify specific and targetable elements that novel compounds can be modeled from.
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
ABSTRACT The purpose of this study was to prepare and evaluate immediate release itraconazole pellets and comprehensive studies of the same. The itraconazole pellets is prepared using fluid bed processer with different concentration of HPMC (Hydroxy Propyl Methyl Cellulose). The physicochemical compatibility of the drug and the excipient studied by differential scanning calorimetry. The prepared pellets were physically evaluated with size, shape, bulk density, tapped density, compressibility index, hausners ratio, angle of repose, sieve analysis, surface roughness, density, moisture content, assay and drug release etc. The in vitro drug release profile from pellets shows that all the formulation release more than 75% drug within 90min. Optimized formulations were found to have HPMC concentration 2-5% of total weight of pellets to maximize high-quality surface, desired release, and size distribution within the range. These results indicate that pellets containing 10 % HPMC of total weight of pellets give better quality of itraconazole pellets for immediate release. Key Words: Itraconazole, Hydroxyl propyl methyl cellulose and Immediate release.
A simple visible spectrophotometric method is proposed for the determination
of ulipristal acetate present in bulk and tablet formulation. The currently
proposed method is established based on MBTH oxidation by ferric ions to
form an active coupling species (electrophile), followed by its coupling with
the ulipristal in acidic medium to form high intensiϑied green colored chromophore
having max at 609 nm. Validated the method as per the current
guidelines of ICH. Beer’s law was obeyed in the concentration range of 6.25 –
37.50 g mL 1 with a high regression coefϑicient (r > 0.999). Reproducibility,
accuracy, and precision of the method are evident from the low values of R.S.D.
This method can be used in quality control laboratories for routine analysis of
ulipristal acetate in bulk drug and pharmaceutical dosage forms.
The objective of the present study was to develop asimple, precise and accurate reversed-phase HPLC method and subsequent validation of the
same as per the ICH guidelines. The present study deals with the estimation by RP HPLC of two different drug components pseudoephedrine
hydrochloride (PSE) and cetirizine hydrochloride (CET) present in a tablet formulation.
The chromatographic separation of PSE and CET was done using phosphate buffer al
NOVEL SIMULTANEOUS SEPARATION AND QUANTITATIVE DETERMINATION OF FOUR SARTANS...Dr. Ravi Sankar
The core AIM of the present study is to develop a novel, rapid, precise and accurate RP-HPLC method for simultaneous separation and quantification of Hydrochlorothiazide along with four sartans Telmisartan(TELM), Losartan(LOSA), Olmesartan(OLME) and Valsartan(VALS).
To develop Novel methods for separation and quantification of all the above said drugs on single chromatographic system without any minor changes in detection wavelength and mobile phase composition.
Design expert software assisted development and evaluation of cefpodoxime pro...Makrani Shaharukh
Cefpodoxime Proxetil is third generation, broad-spectrum Cephalosporin Antibiotic & it has an oral bioavailability of only 50% and biological half life 2 h so to improve it’s bioavailability sustain release matrix formulation was designed. Sustained release matrix tablets of Cefpodoxime Proxetil prepared by direct compression method based on combination of natural Acacia gum & Karaya gum polymers. 32 full factorial designs optimization study was carried out by using Design Expert Software to find the effect of independent variables, i.e., Acacia gum (X1) and Karaya gum (X2) concentration on dependent variables i.e., Hardness & % CDR. The drug excipient mixtures were subjected to preformulation studies. The tablets were subjected to physicochemical studies, in-vitro drug release, kinetic studies and stability studies. FTIR and DSC studies shown there was no interaction between drug and polymers. Matrix tablet of Cefpodoxime Proxetil were formulated well in term of hardness 5.07 ± 0. 5.93 ± 0.03 kg/cm2, thickness 2.25 ± 0.1 mm to 3.33 ± 0.3 mm, weight variation were within limits. In-vitro release studies show that almost 90 % of drug was release from all the formulation were within 12 h. Formulation F5 selected as a optimized one since it showed optimum hardness & sustained drug release within 12 h in comparison to other formulation. The F5 optimized formulations were subjected to stability studies and shown there were no significant changes in drug content, physicochemical parameters and release pattern. 32 full factorial design optimization technique was successfully used in this research work. Developed matrix tablets of Cefpodoxime Proxetil produced a sustained and effective drug release over a prolonged time frame that led to greater therapeutic efficacy.
The goal of reverse pharmacology is to utilize disease pathology in order to identify specific and targetable elements that novel compounds can be modeled from.
Preclinical Development, Introduction
Definition, Stages of development of a new drug, Objectives of Preclinical studies, Several steps in preclinical trials, Types of studies in Preclinical trials, Importance of preclinical trials
By
Ms. I. Sai Reddemma.
Department of Pharmacology
ABSTRACT The purpose of this study was to prepare and evaluate immediate release itraconazole pellets and comprehensive studies of the same. The itraconazole pellets is prepared using fluid bed processer with different concentration of HPMC (Hydroxy Propyl Methyl Cellulose). The physicochemical compatibility of the drug and the excipient studied by differential scanning calorimetry. The prepared pellets were physically evaluated with size, shape, bulk density, tapped density, compressibility index, hausners ratio, angle of repose, sieve analysis, surface roughness, density, moisture content, assay and drug release etc. The in vitro drug release profile from pellets shows that all the formulation release more than 75% drug within 90min. Optimized formulations were found to have HPMC concentration 2-5% of total weight of pellets to maximize high-quality surface, desired release, and size distribution within the range. These results indicate that pellets containing 10 % HPMC of total weight of pellets give better quality of itraconazole pellets for immediate release. Key Words: Itraconazole, Hydroxyl propyl methyl cellulose and Immediate release.
a substance can absorb any visible light or external radiation and then again emit it. this called fluorescence and the process of reduction in fluorescence intensity is called quenching. this presentation is all about quenching of fluorescence.
Method validation for drug substances and drug product _remodified_2014Ramalingam Badmanaban
Method validation is the process of proving that an analytical method is acceptable for its intended purposes.
METHOD VALIDATION = ERROR ASSESSMENT
Method validation is the process of demonstrating that analytical procedures are suitable for their intended use and that they support the identity, strength, quality, purity and potency of the drug substances and drug products
Validation: Prior ConsiderationsSuitability of Instrument Status of Qualification and Calibration Suitability of Materials Status of Reference Standards, Reagents, Placebo Lots Suitability of Analyst Status of Training and Qualification Records Suitability of Documentation Written and approved standard test procedure and proper approved protocol with pre-established acceptance criteria
Compendial vs. Non-compendial Methods
Compendial methods-Verification
Regulatory analytical procedure in USP/NF
Non- compendial methods-Validation
Alternative analytical procedure proposed by the applicant for use instead of the regulatory analytical procedure
Chromatographic Methods
Demonstrate Resolution
Impurities/Degradants Available
Spike with impurities/degradants
Show resolution and a lack of interference
Impurities/Degradants Not Available
Stress SamplesFor assay, Stressed and Unstressed Samples should be compared.
Ability of an analytical method to measure the analyte free from interference due to other components.
Selectivity describes the ability of an analytical method to differentiate various substances in a sample
Original term used in USP
Also Preferred by IUPAC and AOAC
Also used to characterize chromatographic columns
Degree of Bias (Used in USP)
The difference in assay results between the two groups
the sample containing added impurities, degradation products, related chemical compounds, placebo ingredients
Selectivity: For impurity test, impurity profiles should be compared.
Temperature (50-60℃)
Humidity (70-80%)
Acid Hydrolysis (0.1 N HCl)
Base Hydrolysis (0.1 N NaOH)
Oxidation (3-30%)
Light (UV/Vis/Fl)
Intent is to create 10 to 30 % Degradation
Change in the analytical procedure, drug substance, drug product, the changes, may necessitate revalidation of the analytical procedures.
“The degree of revalidation depends on the nature of the change.”
“FDA intends to provide guidance in the future on post-approval changes in analytical procedures.”
By Visual Inspection of plot of signals vs. analyte concentration
By Appropriate statistical methods
Linear Regression (y = mx + b)
Correlation Coefficient, y-intercept (b), slope (m)
Acceptance criteria: Linear regression r2 > 0.999
Requires a minimum of 6 concentration levels
Normally derived from Linearity studies.
Established by confirming that the method provides acceptable degree of linearity, accuracy, and precision.
Specific range dependent upon intended application of the procedure.
Validation of Analytical and Bioanalytical methodssarikakkadam
Guidelines for Validation of Analytical and Bioanalytical methods as per ICH (Q2R1) and USFDA respectively with an example of Bioanalytical method validation.
An Analysis on the UV-Visible Spectrophotometry MethodAI Publications
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.
ABSTRACT
Overactive bladder (OAB) is a prevalent condition which has an adverse effect on quality of life. The presence
of urgency incontinence confers significant morbidity above and beyond that of OAB sufferers who are
continent. The primary treatment for OAB and urgency incontinence is a combination of behavioral measures
and antimuscarinic drug therapy. The ideal antimuscarinic agent should effectively relieve the symptoms of
OAB, with the minimum of side effects; it should be available as a once-daily sustained release formulation
and in dosage strength that allows easy dose titration for the majority of sufferers. Solifenacin succinate was
launched in 2005 and has been shown in both short and long term clinical trials to fulfill these requirements.
Solifenacin is a competitive M3 receptor antagonist with a long half-life (45-68 hours). It is available in two
dosage strengths namely a 5 or 10 mg once-daily tablet. The efficacy and tolerability of solifenacin for the
treatment of all symptoms of OAB has been evaluated in a number of large, placebo controlled, randomized
trials. Long-term safety, efficacy, tolerability and persistence with treatment have been established in an open
label 40 week continuation study.
KEYWORDS
Solifenacin, Urinary incontinence, Overactive bladder and Wet granulation method.
Analytical Method Development and Validation of Prednisolone Sodium Phosphate...iosrjce
IOSR Journal of Pharmacy and Biological Sciences(IOSR-JPBS) is a double blind peer reviewed International Journal that provides rapid publication (within a month) of articles in all areas of Pharmacy and Biological Science. The journal welcomes publications of high quality papers on theoretical developments and practical applications in Pharmacy and Biological Science. Original research papers, state-of-the-art reviews, and high quality technical notes are invited for publications.
Stability indicating analytical method development and validation for estimat...SriramNagarajan18
Stability indicating analytical method development and validation for estimation of Ceftazidime and Avibactam in bulk and pharmaceutical dosage form using RP-HPLC
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).
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.
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
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
NVBDCP.pptx Nation vector borne disease control programSapna Thakur
NVBDCP was launched in 2003-2004 . Vector-Borne Disease: Disease that results from an infection transmitted to humans and other animals by blood-feeding arthropods, such as mosquitoes, ticks, and fleas. Examples of vector-borne diseases include Dengue fever, West Nile Virus, Lyme disease, and malaria.
Here is the updated list of Top Best Ayurvedic medicine for Gas and Indigestion and those are Gas-O-Go Syp for Dyspepsia | Lavizyme Syrup for Acidity | Yumzyme Hepatoprotective Capsules etc
ABDOMINAL TRAUMA in pediatrics part one.drhasanrajab
Abdominal trauma in pediatrics refers to injuries or damage to the abdominal organs in children. It can occur due to various causes such as falls, motor vehicle accidents, sports-related injuries, and physical abuse. Children are more vulnerable to abdominal trauma due to their unique anatomical and physiological characteristics. Signs and symptoms include abdominal pain, tenderness, distension, vomiting, and signs of shock. Diagnosis involves physical examination, imaging studies, and laboratory tests. Management depends on the severity and may involve conservative treatment or surgical intervention. Prevention is crucial in reducing the incidence of abdominal trauma in children.
These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
- Video recording of this lecture in English language: https://youtu.be/kqbnxVAZs-0
- Video recording of this lecture in Arabic language: https://youtu.be/SINlygW1Mpc
- Link to download the book free: https://nephrotube.blogspot.com/p/nephrotube-nephrology-books.html
- Link to NephroTube website: www.NephroTube.com
- Link to NephroTube social media accounts: https://nephrotube.blogspot.com/p/join-nephrotube-on-social-media.html
Recomendações da OMS sobre cuidados maternos e neonatais para uma experiência pós-natal positiva.
Em consonância com os ODS – Objetivos do Desenvolvimento Sustentável e a Estratégia Global para a Saúde das Mulheres, Crianças e Adolescentes, e aplicando uma abordagem baseada nos direitos humanos, os esforços de cuidados pós-natais devem expandir-se para além da cobertura e da simples sobrevivência, de modo a incluir cuidados de qualidade.
Estas diretrizes visam melhorar a qualidade dos cuidados pós-natais essenciais e de rotina prestados às mulheres e aos recém-nascidos, com o objetivo final de melhorar a saúde e o bem-estar materno e neonatal.
Uma “experiência pós-natal positiva” é um resultado importante para todas as mulheres que dão à luz e para os seus recém-nascidos, estabelecendo as bases para a melhoria da saúde e do bem-estar a curto e longo prazo. Uma experiência pós-natal positiva é definida como aquela em que as mulheres, pessoas que gestam, os recém-nascidos, os casais, os pais, os cuidadores e as famílias recebem informação consistente, garantia e apoio de profissionais de saúde motivados; e onde um sistema de saúde flexível e com recursos reconheça as necessidades das mulheres e dos bebês e respeite o seu contexto cultural.
Estas diretrizes consolidadas apresentam algumas recomendações novas e já bem fundamentadas sobre cuidados pós-natais de rotina para mulheres e neonatos que recebem cuidados no pós-parto em unidades de saúde ou na comunidade, independentemente dos recursos disponíveis.
É fornecido um conjunto abrangente de recomendações para cuidados durante o período puerperal, com ênfase nos cuidados essenciais que todas as mulheres e recém-nascidos devem receber, e com a devida atenção à qualidade dos cuidados; isto é, a entrega e a experiência do cuidado recebido. Estas diretrizes atualizam e ampliam as recomendações da OMS de 2014 sobre cuidados pós-natais da mãe e do recém-nascido e complementam as atuais diretrizes da OMS sobre a gestão de complicações pós-natais.
O estabelecimento da amamentação e o manejo das principais intercorrências é contemplada.
Recomendamos muito.
Vamos discutir essas recomendações no nosso curso de pós-graduação em Aleitamento no Instituto Ciclos.
Esta publicação só está disponível em inglês até o momento.
Prof. Marcus Renato de Carvalho
www.agostodourado.com
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
1. UV Spectroscopic assay method Validation of
Albendazole in three different brand tablet
formulations used in Bangladesh.
Presented by
Al Imran (B.Pharm)
Department of Pharmacy
Dhaka International University
3. Introduction
In most general sense, a drug may be defined as any substance that brings about a
change in biological function through its chemical actions. A drug is any substance
other than food, that when inhaled, injected, smoked, consumed, absorbed via a
patch on the skin or dissolved under the tongue causes a physiological change in the
body.
Medicine is a drug that can help people if the amount of medicine is right. People
take medicine because they want to get better if they have illness they want to feel
relieved of their pain even for temporary.
4. Objective
Numerous novel drugs are being introduced and are constantly growing
day by day. Therefore it is absolutely imperative to evolve novel
methods and introduced them for controlling their quality. The
objective of the study is the UV Spectroscopic assay method
development and Validation of Albendazole in three different brand
tablet formulations used in Bangladesh.
5. Method Validation
Method validation is the process used to confirm that the analytical procedure employed
for a specific test is suitable for its intended use. Results from method validation can be
used to judge the quality, reliability and consistency of analytical results; it is an integral
part of any good analytical practice.
Why Method Validation is Important?
1.The purpose of analytical measurement is to get consistent, reliable and accurate data.
Incorrect measurement results can lead to tremendous costs.
2. Equal importance for those working in a regulated and in an accredited environment.
U.S. FDA, EMEA, EPA, AOAC, ISO
8. Drug Profile ALBEndazole
Albendazole (methyl N-(6-propylsulfanyl-1H-benzimidazol-2-yl) carbamate)
marketed as Albenza among others, is a medication used for the treatment of a variety of
parasitic worm infestations. It is useful for giardiasis, trichuriasis, filariasis,
neurocysticercosis, hydatid disease, pinworm disease, and ascariasis, among others. It is
taken by mouth. Albendazole developed in 1975. It is on the World Health
Organization's List of Essential Medicines, the most important medications needed in a
basic health system.
9. Drug profile
albendazole
Mechanism of Action
Albendazole binds to the colchicine-sensitive site of β-tubulin inhibiting their
polymerization into microtubules. The decrease in microtubules in the intestinal
cells of the parasites decreases their absorptive function, especially the uptake of
glucose by the adult and larval forms of the parasites, and also depletes glycogen
storage. Insufficient glucose results in insufficient energy for the production of
adenosine triphosphate (ATP) and the parasite eventually dies.
10. Drug profile
albendazole
Dosage
A single dose of 400 mg is recommended for clearance of gastrointestinal nematode
infection of both adults and children over 2 years of age. Additional or more
frequent dosage may be advised in certain conditions, including systemic disease.
Side effects
Albendazole may cause
abdominal pain
Dizziness
Headache
fever, nausea
Vomiting or
temporary hair loss.
11. Drug profile
albendazole
Drug Interactions
Taking albendazole with a fatty meal increases its absorption by two to six- folds.
The concentration of albendazole sulphoxide in blood is increased by 50% when
administered concurrently with dexamethasone and by 4.5 fold when administered
concurrently with praziquantel. Administration of albendazole with grapefruit juice
results in a 3-fold increase in Cmax of albendazole sulphoxide.
Contraindications
Hypersensitivity
Liver disease
Pregnancy & lactation
Children less than two years
12. result
λ max: 308 nm
Solvent: Ethanolic HCl
Machine: Single cell UV-vis
spectroscopy (Shimadzu)
Sample 01: Alba, Navana Pharma
Sample 02: Estazol, Ibn Sina
Pharma
Sample 03: Almex, Square Pharma
Sl no. Parameters Normal Range Result
1 Linearity
Alba
0.999
0.9998
Estazol 0.9997
0.9997Almex
2 Accuracy
Standard
% RSD <2%
0.0116
Alba 0.0092
Estazol 0.8456
Almex 0.1531
13. result
3 Precision
Repeatability
Standard 2.3904
Alba 2.2797
Estazol 2.7469
Almex 2.2573
Intraday
Standard 1.1108
0.5154
Alba
2.4551Estazol
Almex 1.2051
Inter day
Standard 1.2839
Alba 0.4876
Estazol 0.3933
Almex 0.8131
14. result
4 LOD
Alba 0.5746 µg/ml
Estazol 0.591 µg/ml
Almex 0.5838 µg/ml
5 LOQ
Alba 1.7412 µg/ml
Estazol 1.791 µg/ml
Almex 1.7693 µg/ml
6
Robustness (%
RSD)
Alba
% Assay
127.4
121.8Estazol
Almex 111.6
15. Comparison of validation parameters
Linearity and Accuracy
0.9998 0.9997 0.9997
0.0116 0.0092
0.8456
0.1531
0
0.2
0.4
0.6
0.8
1
1.2
Standard Alba Estazol Almex
Linearity
Accuracy
16. Comparison of validation parameters
Repeatability; Intraday and Interday
2.3904 2.2797
2.7469
2.2573
1.1108
0.5154
2.4551
1.20511.2839
0.48 0.39
5
0
1
2
3
4
5
6
Standard Alba Estazol Almex
Repeatability
Intraday
Interday
24. Discussion
The proposed method for estimation of Albendazole dosage form was found to be accurate,
simple and rapid without repeatability precision parameter. The assay results were shown in
above table. The % RSD of accuracy, intraday, interday, LOD and LOQ is found to be less
than 2, which indicates the validity of method. But repeatability result are not follows ICH
guidelines; this cause may be environment effect, solvent effect or are not qualified sterility
of apparatus.
Linearity was observed by regression equation for Albendazole in different concentration
range. The assay results obtained by proposed method were precise; hence it can be used for
routine analysis of Albendazole dosage form. The method is accurate, simple, rapid, precise,
reliable, sensitive, reproducible and economic and is validated as per ICH guidelines.
25. conclusion
The reagents utilized in the proposed method are cheap, readily available, and quite stable in solution unlike
many reagents. The procedures do not involve any critical reaction conditions such as rigid pH control,
tedious and time-consuming extraction or heating step. The methods are more sensitive than many of the
reported spectrophotometric methods and applicable over wide linear dynamic ranges. The methods are free
from interferences from the common excipients. The statistical parameters and the recovery data reveal good
accuracy and precision of the methods. The methods have many other advantages such as reduced cost,
simplicity, and speed. Hence, the methods can be used in routine analysis of the drug in quality control
laboratories and pharmaceutical analysis.
26. references
Davidson AG (2002) Ultraviolet-visible absorption spectrophotometry. In BeckettAH, Stenlake JB, (4thedn), Practical
Pharmaceutical chemistry. CBS Publishers and distributors, New Delhi, 275-278.
CITAC/EURACHEM, Working Group, International guide to quality in analytical chemistry: An aid to accreditation, 2002.
International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for
Human Use, Validation of analytical procedures: Methodology, adopted in 1996, Geneva
SPECTROPHOTOMETRIC DETERMINATION OF ALBENDAZOLE IN PURE FORM AND TABLET FORM, Mohamed M. Baraka et al.
/ Asian Journal of Pharmaceutical Analysis and Medicinal Chemistry. 2(4), 2014, 276-294.
WHO Model List of Essential Medicines" (PDF). World Health Organization. October 2013. Retrieved 22 April 2014.
Neonatal Formulary: Drug Use in Pregnancy and the First Year of Life. John Wiley & Sons. 2014. p. 64. ISBN
9781118819593.
International Conference on Harmonization (ICH) of Technical Requirements for the Registration of Pharmaceuticals for
Human Use, Validation of analytical procedures: definitions and terminology, Geneva (1996)
Guideline on general principles of process validation". U.S. Food and Drug Administration. Archived from the original on 6
June 2009. Retrieved 12 July 2008.
Validation definition and FDA, Regulatory agencies guidelines requirement. Accessed 27 Feb 2014.
DEVELOPMENT AND VALIDATED UV SPECTROPHOTOMETRIC METHOD FOR ESTIMATION OF ALBENDAZOLE IN TABLET
DOSAGE FORM, Sandhya Bhimrao Lahane, Dr.U.A.Deokate, World Journal of Pharmaceutical Research, Volume 3, Issue 4,
1461-1467