This document discusses modern pharmaceutics and preformulation concepts. It begins with an introduction to preformulation, which involves investigating a drug's physical and chemical properties alone and with excipients. This information guides dosage form development. The document then discusses drug-excipient interactions and compatibility testing methods. It also covers topics like solid dispersions, emulsions, suspensions, and parenteral product formulation and testing requirements.
M.pharm (Pharmaceutics) modern pharmacy unit-5 Study of consolidation parameters; Diffusion parameters, Dissolution
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors – f2
and f1, Higuchi and Peppas plot, Linearity Concept of significance, Standard
deviation , Chi square test, students T-test , ANOVA test
Self micro-emulsifying drug delivery system (SMEDDS)Himal Barakoti
This document discusses self-microemulsifying drug delivery systems (SMEDDS), including their background, mechanism of action, formulations, stability testing, advantages, and applications. SMEDDS are isotropic mixtures of oils, surfactants, and co-surfactants that form fine oil-in-water emulsions upon mild agitation followed by dilution in gastrointestinal fluids. They can improve the oral absorption of poorly water-soluble drugs and enhance their bioavailability. SMEDDS formulations typically contain an oil, surfactant, co-surfactant, and drug. Their small particle size allows efficient drug release in the GI tract. Stability testing evaluates factors like temperature effects and in vitro drug release. SMEDDS
The document discusses the physics of tablet compression. It describes the processes of compaction, consolidation and compression that tablets undergo in their production. It outlines the main stages of compression including particle rearrangement, deformation, fragmentation and bonding. It also discusses the forces involved and common compaction profiles and equations used to describe the process, including the Heckel and Kawakita equations. The document provides an overview of the key concepts and stages in understanding the physics behind tablet production through compression.
This document provides an overview of protein and peptide drug delivery. It begins with definitions of proteins and peptides and descriptions of protein structure. It then discusses protein functions and challenges with delivering proteins and peptides. These challenges include low permeability, enzyme degradation, short half-life, and immunogenicity. The document outlines various barriers to protein delivery, including enzymatic barriers and barriers at the intestinal epithelium, capillary endothelium, and blood-brain barrier. It also discusses physicochemical properties of proteins and peptides that impact delivery. Finally, it reviews various routes of delivery such as parenteral, pulmonary, and transdermal routes and technologies used for delivery like liposomes, hydrogels, emulsions, and pumps.
This document provides an overview of preformulation studies for drug development. It discusses the importance of characterizing key physicochemical properties of drug substances such as solubility, ionization constants, melting point, and polymorphism. It also covers the role of excipients and how drug-excipient interactions can impact stability. The document concludes with sections on stability studies, factors that influence stability, and guidelines for stability testing procedures and frequencies.
This document discusses different types of controlled drug delivery systems. It classifies systems as rate preprogrammed, activation modulated, or feedback regulated. Rate preprogrammed systems are further broken down into polymer membrane permeation controlled systems, polymer matrix diffusion controlled systems, and microreservoir partition controlled systems. The key aspects and release kinetics of each system type are described through examples. Factors that influence drug release rates from these systems include membrane thickness, drug solubility, diffusivity, and partitioning coefficients.
DIffusion, Dissolution and Pharmacokinetic Parameters.pptxKailas Mali
This document discusses various parameters used to study drug release and dissolution from pharmaceutical dosage forms, including diffusion parameters, dissolution parameters, pharmacokinetic parameters, and models like Higuchi and Peppas plots. It defines key terms like diffusion, flux, Fick's first law, and discusses how factors like agitation, pH, surfactants, viscosity, and temperature can influence dissolution. Key drug release mechanisms and models are also summarized.
it provide a brief note on the drug excipient interaction and various technique to find it which is a part of preformulation studies. it gives help to mpharm(pharmaceutics) students. i.
Sustained and controlled release drug delivery systemParul Sharma
This document discusses sustained and controlled release drug delivery systems (SR and CRDDS). It defines SR and CRDDS and lists their advantages and disadvantages. It describes factors that influence the release rate from these systems, including physicochemical factors like solubility and biological factors like metabolism. The document outlines various physicochemical approaches to SR and CRDDS like matrix systems, reservoir systems, and ion exchange systems. It also discusses biological approaches using biopolymers and pulsatile release formulations. Finally, it briefly mentions applications and concludes with references.
This document discusses excipients and their role in drug formulations. It notes that excipients are ingredients other than the active pharmaceutical ingredient that are used to formulate dosage forms. Excipients can act as protective agents, bulking agents, and can improve drug bioavailability. The document then lists common types of excipients and potential interactions between drugs and excipients, such as physical, chemical, biopharmaceutical, and excipient-excipient interactions. It describes several analytical techniques used to detect drug-excipient interactions, including DSC, accelerated stability studies, FT-IR, DRS, chromatography methods, and others.
1) Tablet compression involves the application of force to reduce the volume of powder materials through three main processes: compression, compaction, and consolidation. Compression removes air, compaction rearranges particles, and consolidation increases strength through bonding.
2) Key forces involved in compression include inter-particulate and die wall friction, which can be reduced by adding glidants and lubricants, respectively. Distribution forces transmit pressure from the punches to the powder bed and die wall.
3) Compaction profiles examine the relationship between axial and radial pressure. They provide information on elastic versus plastic deformation and ejection forces.
This document summarizes key parameters studied in the consolidation of pharmaceutical formulations, including diffusion parameters described by Higuchi's equation, dissolution parameters like the effects of agitation and pH, and pharmacokinetic parameters like Cmax, Tmax, and AUC. It also discusses the Heckel plot and similarity factors f1 and f2 for comparing drug release profiles.
This document discusses various analytical techniques used to evaluate protein and peptide drug formulations, including stability testing, bioassays, UV spectroscopy, Bradford assay, differential scanning calorimetry, chromatography, and electrophoresis. Stability testing evaluates how environmental factors affect the quality of a drug over time. Bioassays assess potency by monitoring the in vitro or in vivo pharmacological response to the protein. UV spectroscopy, Bradford assay, and electrophoresis can be used to detect and quantify the amount of protein present in a sample. Chromatography and differential scanning calorimetry provide information about stability and conformational changes of proteins.
This document discusses sustained release and controlled release drug formulations. It begins with an introduction and overview of basic concepts. It then discusses the advantages and disadvantages of sustained release formulations. Several key factors that influence sustained release drug formulations are described, including drug properties, route of administration, target sites, and whether the therapy is for acute or chronic conditions. Different physical approaches related to drug solubility, partitioning, and stability are covered.
Current Goods Manufacturing Practice & Industrial ManagementLukman N Kerur
This document provides an overview of CGMP (Current Good Manufacturing Practice) and industrial management. It discusses key aspects of CGMP such as plant layout, services, equipment, production organization, materials management, handling and transportation, inventory management, production planning and control, sales forecasting, budgeting, quality management, and industrial relationships. The objectives of CGMP are to ensure product quality and consistency in manufacturing. Key elements outlined include facilities and equipment requirements, quality control of materials, production systems, and regulatory compliance.
Effect of friction, distribution of force, compaction and solubility suraj se...Suraj Pund
This document discusses the effects of friction, force distribution, compaction, and solubility in pharmaceutical manufacturing. It describes how interparticulate and die wall friction affect tablet production, and how lubricants can reduce friction. It also explains that compaction involves compressing and consolidating powders through applied force, and describes the different phases of elastic and plastic deformation that occur during compaction. Finally, it defines solubility and discusses its importance for drug bioavailability and therapeutic effectiveness since drugs must be soluble to be absorbed.
This document discusses the differences between sustained release and controlled release drug formulations and their mechanisms of drug delivery. Sustained release aims to slowly release drug over 8-12 hours, while controlled release delivers drug at a predetermined rate according to bodily needs. Mechanisms include dissolution control using matrix or encapsulation methods, diffusion control using reservoir or matrix devices, and combinations of dissolution and diffusion. Common polymers used for coatings include ethyl cellulose and acrylic resins to control drug release rate.
Optimization techniques in pharmaceutical formulation and processingReshma Fathima .K
This document discusses various optimization techniques used in pharmaceutical formulation and processing. It defines optimization as making something as perfect or effective as possible. The advantages of optimization include reducing costs, saving time, and improving safety, reproducibility, and efficacy. Key optimization parameters discussed include problem type (constrained or unconstrained), variables (independent and dependent), and applied optimization methods like evolutionary operation, simplex method, search method, Lagrangian method, and canonical analysis.
Kinetics of Stability & Stability Testing Sidharth Mehta
This document discusses kinetics of stability and stability testing. It defines drug kinetics as how a drug changes over time and explains zero and first order reaction kinetics. Factors affecting reaction rate and types of drug degradation are covered. Stability testing is defined and its importance, types, methods, guidelines and climatic zones are summarized. Methods for estimating shelf life and determining expiration dates are also presented.
This document discusses drug stability and stabilization techniques. It defines drug stability and outlines the various types of instability drugs may experience, including physical, chemical, and microbial changes. It also discusses techniques for assessing stability through studies of solid state stability, compatibility with excipients, and solution phase stability. Specific degradation pathways like hydrolysis, oxidation, and photolysis are examined. Methods for establishing shelf life through accelerated stability testing and the Arrhenius equation are also covered. The document emphasizes the importance of stability studies in ensuring drug quality throughout storage and use.
preformulation concepts, drug excipient interactions different methods slide...vamshipradeep
This document discusses preformulation concepts and drug-excipient interactions. Preformulation involves investigating a drug's physical and chemical properties alone and with excipients to generate information for developing stable and bioavailable dosage forms. Drug-excipient interactions can be physical, chemical, or physiological, and are studied using techniques like thermal analysis, spectroscopy, and chromatography. Thermal methods like DSC and microcalorimetry detect interactions by examining heat changes, while spectroscopy and chromatography analyze molecular structures and separation of drug components. Understanding these interactions is important for developing optimal drug delivery systems.
The document discusses preformulation studies for a new drug entity. It defines preformulation studies as investigations of a drug substance's physical and chemical properties alone and with excipients to develop a safe, effective, and stable dosage form. The objectives are to establish physico-chemical parameters, determine kinetics and stability, and establish compatibility with excipients. Key aspects discussed include stability studies, physicochemical properties, drug-excipient interactions, and analytical techniques to detect interactions like DSC and TLC.
Modern p'ceutics drug excipient interactionArjunDhawale
This document discusses drug excipient interactions and stability testing methods. It covers various methods to detect drug-excipient compatibility, including thermal methods like DSC and TGA, spectroscopic techniques like FT-IR and PXRD, chromatography methods like HPLC and TLC, and microscopic techniques like SEM. It also discusses kinetics of stability including zero-order kinetics and half-life calculations. The goal is to understand interactions between drugs and excipients that can impact stability and shelf life through accelerated stability studies and various analytical techniques.
The document discusses stability testing of pharmaceutical products. It defines the purpose of stability testing as providing evidence of how a product's quality varies over time under the influence of factors like temperature, humidity and light. There are two main types of stability studies: stability studies and accelerated stability studies. Stability studies involve testing products under various storage conditions like long term, intermediate and accelerated conditions over minimum time periods to establish a product's shelf life.
This document discusses the objectives, learning outcomes, and content of the Physical Pharmaceutics-II Module-V course. The key topics covered include:
- Chemical kinetics principles and their application to stability testing and determining drug expiration dates.
- Factors that influence chemical degradation of pharmaceutical products such as temperature, solvents, and catalysis.
- Techniques for stabilizing drugs against common degradation reactions like hydrolysis and oxidation.
- Accelerated stability testing and its use in expiration dating of pharmaceutical dosage forms.
This document discusses the objectives, learning outcomes, and content of the Physical Pharmaceutics –II Module -V course. The module focuses on drug stability and kinetics. It defines drug stability and outlines different types of stability that must be considered for drugs. It describes various chemical degradation pathways for drugs and techniques for stabilizing drugs, including preventing hydrolysis, oxidation, and photolysis. The document also discusses methods for determining reaction order, factors that influence reaction rates, predicting shelf-life using the Arrhenius equation, and techniques for storage of pharmaceutical products.
1.preformulation concept in Modern pharmaceutics.pptxPNMallikarjun
Preformulation is defined as the investigation of physical and chemical properties of a drug substance alone and when combined with excipients. The goal is to generate information to help formulators develop stable and safe dosage forms with good bioavailability. Some key tests include determining the drug's solubility, stability, and compatibility with various excipients using techniques like DSC, TLC, and HPLC. This provides critical data to guide the rational selection of dosage form and formulation components.
1. The document provides guidance on preformulation studies for new drug candidates. Preformulation involves characterizing the physical and chemical properties of a drug substance to aid in developing an optimal dosage form.
2. Key preformulation studies discussed include determining solubility, pKa, partition coefficient, chemical stability, and polymorphism. These studies provide important information on factors like bioavailability and dosage form design.
3. The guidance describes common techniques for conducting preformulation studies like equilibrium solubility methods and stresses the importance of stability testing under various conditions like temperature, pH and light exposure.
Stress testing involves subjecting drug substances and products to conditions beyond typical accelerated testing to induce degradation. This helps identify degradation products and establish degradation pathways. Stress testing is performed during development and manufacturing to validate stability-indicating analytical methods. Methods may involve exposure to heat, humidity, acids, bases, oxidation or light. Identification and characterization of degradation products is important for regulatory approval and safety evaluation.
Stability testing of natural products.docxKipaPape
Stability is defined as the capacity of drug to remain within established specification limits to maintain its identity, strength, quality and purity throughout the retest or expiration dating period.
It is the ability of formulations to retain its physical, chemical, microbiological and toxicological parameters same that time of manufacturer.
The document discusses drug kinetics and stability testing. It defines drug kinetics as how a drug changes over time, and explains that stability testing is used to determine a drug's shelf life and recommended storage conditions. The key points are:
1) Drug stability is important to ensure effectiveness and safety for patients over time. Kinetics studies the rate of chemical reactions, including degradation pathways like hydrolysis, oxidation, and photolysis.
2) The order of a reaction (zero-order or first-order) determines how the reaction rate depends on the concentration of reactants. Stability testing evaluates if drugs remain chemically, physically and microbiologically stable under different storage conditions.
3) Real time and accelerated stability testing
The document discusses key concepts and steps in preformulation testing. Preformulation involves investigating the physical and chemical properties of a drug substance alone and when combined with excipients. This generates useful information for formulating stable and safe dosage forms with good bioavailability. Some important properties discussed include solubility, particle size and shape, melting point, thermal analysis profile, hygroscopicity, and polymorphism potential. Determining these properties of a new drug substance is an important first step before developing drug formulations.
The document provides an overview of preformulation studies. It discusses the importance of characterizing the physical and chemical properties of new drug molecules during preformulation to aid in the development of stable dosage forms. Some of the key areas covered include drug-excipient compatibility studies, stability kinetics testing, and determining properties like solubility, partition coefficient, and polymorphism that can help dictate the suitable dosage form. The goal of preformulation is to gather necessary data to rationally develop safe and efficacious dosage forms.
Chapter of M pharm First semester, Which covers order and rate of reaction,first order and zero order kinetics , ICH guidelines for stability testing,Storage conditions,etc.
This document discusses drug excipient interactions and provides information on various types of interactions including physical, chemical, biopharmaceutical, and excipient-excipient interactions. It also describes analytical techniques used to detect interactions such as thermal methods, accelerated stability studies, chromatography, and others. Key factors that can affect drug stability are also covered such as temperature, moisture, and chemical interactions. Guidelines for stability testing from organizations like ICH are also summarized.
This document provides an overview of preformulation studies for developing drug formulations. It discusses the importance of studying the physical and chemical properties of drug substances alone and when combined with excipients. The summary is:
1) Preformulation studies investigate the physical and chemical properties of drugs and how they interact with excipients. This helps formulators develop stable, bioavailable drug products.
2) Key properties studied include solubility, particle size, solid state properties, and how the drug behaves under different conditions like temperature, light and pH.
3) The results of preformulation studies guide formulation development and ensure the final product has the desired quality, performance and safety.
Formulation development of pharmaceutical drugSriramPraveen5
The document discusses the importance of formulation development in the pharmaceutical industry. It outlines key steps in the formulation development process, including excipient compatibility studies, formulation optimization, evaluation, and stability testing. Proper formulation is crucial for ensuring patient safety and therapeutic efficacy. The summary discusses formulation development as a critical aspect of drug discovery that can enhance patient outcomes through improved drug delivery and compliance.
This document presents information on preformulation studies, which involve characterizing the physicochemical properties of new drug molecules. The objectives are to generate stability and bioavailability data for formulation development. Key studies discussed include analyzing bulk properties, solubility, partitioning, hygroscopicity, ionization, dissolution, stability, and compatibility. Analytical techniques like spectroscopy, microscopy, thermal analysis, and chromatography are used to investigate properties and purity. Thorough preformulation provides critical information for designing dosage forms that are stable, safe, and effective.
The nervous system is divided into the central nervous system (brain and spinal cord) and peripheral nervous system. It coordinates the body's activities and transmits signals via neurons, which are composed of a cell body, dendrites, and an axon. Neuroglia provide support and protection to the neurons. The nervous system consists of sensory neurons that receive information, interneurons that communicate within the central nervous system, and motor neurons that activate muscles and glands. A nerve impulse is transmitted through neurons via changes in electrical charges across the cell membrane.
The document provides information on the somatic and special senses. It discusses the different types of receptors including chemoreceptors, nociceptors, thermoreceptors, mechanoreceptors, and photoreceptors. It then describes the specific senses - touch, pain, temperature, taste, smell, hearing, equilibrium, sight. For each sense, it outlines the receptors involved, their location, and how sensory information is transmitted to the brain. The document also reviews the anatomy and physiology associated with smell, hearing, taste, equilibrium, and vision.
Novel drug delivery system, nanoparticles, resealed erythrocytes, niosomes, microspheres. It also contains information about virus, bacterias and their removal methods and sterility methods.
Nepal Pharmacy Council Model Questions with Answer keysBashant Kumar sah
MCQS, most probable questions compiled from the GPAT old exam questions, old council and LokSewa questions, pharmacology, jurisprudence, pharmaceutics, pharmacognosy, chemistry, hospital pharmacy.
its not my personal work presentation but taken from lecture ppt from university of San Diego, california.
Its about the drug discovery process, its development and its commercialization.
it is about ideas and tips on how to write scientific writings like review, research articles papers as well as grants writing. its the preliminary things to know before the start to publish article.
Formulation and evaluation of folding film in a capsule for gastroretentive d...Bashant Kumar sah
This document describes research into developing a gastroretentive drug delivery system for losartan potassium using folding films enclosed in capsules. Sustained release films were prepared using polymers like HPMC and ethyl cellulose with polyethylene glycol as a plasticizer, through a solvent casting method. The films were evaluated for parameters like weight variation, thickness, folding endurance, tensile strength, drug content uniformity, surface pH and dissolution. A 2^3 factorial design was used to optimize the formulations, evaluating the effects of polymer amount, plasticizer amount, and coating solution concentration on drug release. The optimized formulations showed sustained drug release and remained stable over 30 days in accelerated stability studies.
This document outlines the key details of a home sale located at 123 Main St from the seller John Doe to the buyer Jane Smith. The three bedroom, two bathroom home was sold for $250,000 with the transaction closing on May 15th, 2022. John and Jane both signed the contract agreeing to the terms of the sale for the property located at 123 Main St.
This document outlines the terms and conditions for a home loan agreement between a lender and borrower. It details the loan amount, interest rate, repayment schedule, late fees, prepayment rules, default conditions, and foreclosure process if the borrower fails to meet the obligations of the loan. The lender and borrower must sign and date the document to finalize the agreement.
This document outlines the terms and conditions for a rental agreement between John Doe and Jane Smith for the property located at 123 Main St. It specifies the monthly rental rate of $1,000 due on the 1st of each month, the security deposit of $500, allows for pets with an additional $100 fee, and holds both parties accountable for repairs and damages that may occur during the lease period.
This document outlines the terms and conditions for a rental agreement between John Doe and Jane Smith for the lease of an apartment located at 123 Main St from January 1, 2023 through December 31, 2023. Key details include the monthly rent amount, late fees, repairs and maintenance responsibilities, entry rules, and terms for lease renewal or termination.
The document discusses the history and current state of the COVID-19 pandemic. It notes that over 4 million cases have been reported worldwide so far in 2020, with the number of cases and deaths continuing to rise in many countries. The author urges readers to take necessary precautions like social distancing and hand washing to help slow the spread of the virus.
The document discusses a proposed settlement agreement between two parties, John Doe and Richard Roe, to resolve a legal dispute over an automobile accident. The agreement states that John Doe will pay Richard Roe $5,000 in damages and that both parties will dismiss all claims against each other to avoid further legal proceedings. In exchange for the payment and dismissal of claims, Richard Roe agrees to release John Doe from any liability related to the accident.
THE MANAGEMENT OF PENILE CANCER. PowerPointBright Chipili
This PowerPoint includes all the relevant information and science about penile cancer and its management. Information is based on Campbell 12th edition and EAU 2024 updated guidelines.
Lymphoma Made Easy , New Teaching LecturesMiadAlsulami
This lecture was presented today as part of our local Saudi Fellowship program. After three years of direct interaction with trainees and hematologists, I have started to develop an understanding of what needs to be covered. This lecture might serve as a roadmap for approaching and reporting lymphoma cases.
Introduction to Dental Implant for undergraduate studentShamsuddin Mahmud
Introduction to Dental Implant
Dr Shamsuddin Mahmud
Assistant Professor, Department of Prosthodontics
Nortth East Medical College (Dental Unit)
Definition of Dental Implant
A prosthetic device
made of alloplastic material(s)
implanted into the oral tissues beneath the mucosal and/or periosteal layer and
on or within the bone
to provide retention and support for a fixed or removable dental prosthesis.
Classification of Dental Implant
According to placement within the tissue
Blade/Plate form implant
According to Material Used
A) METALLIC IMPLANTS
Commercially pure Titanium
Cobalt chromium molybdenum
Titanium aluminum vanadium
Stainless steel
B) NON-METALLIC IMPLANT
Zirconium
Ceramic
Carbon
According to the ability of implant to stimulate bone formation
A) Bio active
Hydroxyapatite
Tri Calcium Phosphate
B) Bio inert
Metals
Parts of Dental Implant
Implant fixture
Implant mount
Cover screw
Gingival former/healing screw/healing abutment/permucosal extension
Impression post/impression transfer abutment
Implant analogue
Abutment
Fixation screw
Implant Fixture
Implant Mount
Connected to the fixture
Function: used to carry implant from its vital to the prepared osteotomy site either by hand or with a ratchet/ handpiece adaption
Cover Screw
component that is used to cover the implant connection during the submerged healing of the implant
Function: preserves the patency of the connection by preventing any soft tissue ingrowth in the connection
Gingival former/ Healing Abutment/ Healing screw
Screw/ abutment used to create the soft tissue emergence profile around the implant.
Time of placement:
During 1st surgery – One step surgery
After Osseointegration – Two step/stage surgery
Gingival former/ Healing Abutment/ Healing screw
Placed in the site 2-3 weeks for soft tissue healing
Function:
Create gingival emergence profile
Formation of biological width
Impression post/impression transfer abutment
component that is used to trans- fer the implant Hex position and orientation from the mouth to the working cast.
Types
Closed tray
Open tray
Implant analogue/
component which has a different body but its platform and connection are exactly similar to the implant. The analogue is used to replicate the implant platform and connection in the laboratory mode.
Abutment
Abutments
Advantages of Dental Implant Retained Prosthesis
Maintain bone height and width by preventing bone resorption
Maintain facial esthetics
Improve masticatory performance
Improve stability and retention of prosthesis
More esthetics
Increase survival times of prostheses
There is no need to alter adjacent teeth
Improve psychological health
Disadvantages of Dental Implant Retained Prosthesis
Very expensive.
Cannot be used in medically compromised patients who cannot undergo surgery.
Longer duration of treatment
Requires a lot of patient co-operation because of repeated recall visits are essential
INDICATION OF DENTAL IMPLANT
Dental implants can successfully restore all
Are you ready to reap the benefits of this best magnesium supplement now? Visit us today to learn more about its health and vitality benefits.
Visit: https://wintersbiotechnology.com/magion/
Co-Chairs, Stephen Salloway, MD, MS, and Sharon J. Sha, MD, MS, prepared useful Practice Aids pertaining to Alzheimer's disease for this CME/MOC/NCPD/AAPA activity titled “Preparing Your Practice for the New Era of Amyloid-Targeting Therapies in Alzheimer's Disease: Expert Insights on Key Evidence, Administrative and Clinical Considerations, and Best Practices for Individualized, Patient-Centered Care.” For the full presentation, downloadable Practice Aids, and complete CME/MOC/NCPD/AAPA information, and to apply for credit, please visit us at https://bit.ly/3twjpAt. CME/MOC/NCPD/AAPA credit will be available until June 19, 2025.
Introduction of mental health nursing, Perspective of mental health and mental health nursing, Evolution of mental health services, treatment and nursing practices Mental health team, Nature and scope of mental health nursing, Role & function of mental health nurse inn various settings and factors affecting the level of nursing practice, concept of normal and abnormal behavior
Factors influencing growth & development:
Growth & development depend upon multiple factors or determinants. They influence directly or indirectly by promoting or hindering the process.
The determinants can be grouped as Heredity & environment..
Heredity or genetic factors are also related to sex, race, & nationality. Environment includes both pre natal & post natal factors.
CASE PRESENTATION ON ACUTE GASTROENTERITIS.Bhavana
This is a case presentation of a 72 year old female patient who was admitted in the hospital with the chief complaints of loose stools since 6 Days and generalised weakness and history of one episode of vomiting (one day back).
Interventional radiology is a medical specialty that uses imaging techniques, such as X-rays, CT scans, and ultrasound, to guide minimally invasive procedures to diagnose and treat a variety of conditions. These procedures can be an alternative to open surgery, often resulting in shorter recovery times for patients.
These lecture slides, by Dr Sidra Arshad, offer a simplified description of the physiology of insulin and glucagon.
Learning objectives:
1. Describe the synthesis and release of insulin
2. Explain the mechanism of action of insulin
3. Discuss the metabolic functions of insulin
4. Elucidate the effects of insulin on adipose tissue, skeletal muscle, and liver
5. Enlist the factors which stimulate and inhibit the release of insulin
6. Explain the mechanism of action of glucagon
7. Discuss the metabolic functions of glucagon
8. Elucidate the role of insulin and glucagon in glucose homeostasis during the fasting and fed states
9. Discuss the role of other hormones in the glucose homeostasis
10. Differentiate between the types of diabetes mellitus
11. Explain the pathophysiology of the features of diabetes mellitus
12. Discuss the complications of diabetes mellitus
13. Explain the rationale of oral hypoglycemic drugs
14. Describe the features of hyperinsulinemia
Study Resources:
1. Chapter 79, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 24, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 39, Berne and Levy Physiology, 7th edition
4. Chapter 19, Human Physiology, From Cells to Systems by Lauralee Sherwood, 9th edition
5. Chapter 3, Endocrine and Reproductive Physiology, Bruce A. White and Susan P. Porterfield, 4th edition
6. Insulin and Insulin Resistance, https://www.ncbi.nlm.nih.gov/pmc/articles/PMC1204764/
7. Complications of diabetes mellitus,
https://pdb101.rcsb.org/global-health/diabetes-mellitus/monitoring/complications
an huge problem we are facing about the anaemia , we slight our contribution to aware with one of its class , with detailed description. it is usefull for health , medicine , pharmacy , nursing.
These are the class of Drugs that are used to treat and prevent cardiac arrhythmias by blocking ion channels involved in cardiac impulse generation and conduction. Class I drugs like quinidine and procainamide block sodium channels to prolong the action potential duration, while Class IB drugs like lignocaine shorten repolarization. Class III drugs like amiodarone block potassium channels to prolong the action potential. Calcium channel blockers like verapamil inhibit calcium influx. Other drugs include adenosine for paroxysmal supraventricular tachycardia, beta blockers for supraventricular arrhythmias, and atropine for bradycardias. Adverse effects vary between drugs but include arrhythmias, heart block and QT prolong
These simplified lecture slides by Dr Sidra Arshad offer a concise look at the cardiovascular effects of heart failure:
1. Define cardiac failure, its pathophysiology and clinical manifestations
2. Differentiate between the factors causing hyper-effective and hypo-effective heart functions
3. Differentiate between right and left heart failure based on their presentation
4. Outline the physiology of treatment of cardiac failure
- Video recording of this lecture in English language: https://youtu.be/AWaobASkZM4
- Video recording of this lecture in Arabic language: https://youtu.be/1cQRmJ3SKWc
- 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
Definition of mental health nursing, terminology, classification of mental disorder, ICD-10, Indian Classification, Personality development, defense mechanism, etiology of bio psychosocial factors,
2. Preformation Concepts
THE CONCEPT OF PREFORMULATION:-
Almost all drugs are marketed as tablets, capsules or both. Prior to the development of
these major dosage forms, it is essential that certain fundamental, physical and
chemical properties of the drug molecule and other properties of the drug powder are
determined. This information decides many of the subsequent events and approaches
in formulation development.
This first learning phase is known as preformulation
Definition:-
It can be defined as an investigation of physical and chemical properties of a drug
substance - alone and or when combined with excipients.
The overall objective of preformulation testing is to generate information useful to the
formulator in developing stable and safe dosage forms with good bioavailability.
3. During the early development of a new drug substance, the synthetic
chemist, alone or in cooperation with specialists in other disciplines
(including preformulation), may record some data which can be
appropriately considered as preformulation data.
This early data collection may include such information as
- Gross particle size,
- Melting point,
- Infrared analysis,
- Thin-layer chromatographic purity,
- And other characteristics .
These data are useful in guiding, and becoming part of, the main body
of preformulation work.
4. Drug Excipient interactions -
different methods
drugs excipients interaction is also called incompatibility and hence
An incompatibility may be defined as…..
“An undesirable drug interaction with one or more components of a formulation, resulting in changes in physical,
chemical, microbiological or therapeutic properties of the dosage form.”
An incompatibility in dosage form can result in any of the following changes:
change in colour/appearance;
loss in mechanical properties (e.g., tablet hardness)
changes to dissolution performance;
physical form conversion;
loss through sublimation;
a decrease in potency; and
increase in degradation products.
Excipient compatibility studies are conducted mainly to predict the potential incompatibility of the drug in the
final dosage form.
These studies also provide justification for selection of excipients, and their concentrations in the formulation as
required in regulatory filings.
There fillings has also been an increased regulatory focus on the Critical Quality Attributes (CQA) of excipients
and their control strategy, because of their impact on the drug product formulation and manufacturing process
which enhanced due to increasing QbD trend.
5. Compatibility tests are categorised as:
1. Compatibility test for solid state reactions
much slower and difficult to interpret
2. Compatibility test for liquid state reactions
easier to detect
According to Stability Guidelines by FDA,
following conditions should be evaluated for solutions
or suspensions:
1. Acidic or alkaline pH
2. Presence of added substances
3. High oxygen and nitrogen atmospheres
4. Effect of stress testing conditions
Typical Modalities of Compatibility Testing
a) Study Execution
b) General Steps and decisions
7. General Steps in Compatibility Studies:
1. Experimental Design
2. Sample preparation
3. Storage
4. Sample Analysis & Data Interpretation
I. Experimental Design
The design of experiments is governed by the potential formulation choices, and excipient preferences.
These decisions are made in conjunction with all the other available preformulation data, API
characteristics, and marketing preferences.
These also determine the types of pharmaceutical excipients that are evaluated.
Ex: compatibility studies for a liquid formulation of an insoluble compound would differ widely, and
include excipients such as surfactants and suspending agents, from the studies designed for a highly
soluble compound.
Compatibility studies are commonly carried out by accelerated stress testing, and evaluation of its effect on
the binary or multicomponent drug–excipient mixtures.
Designs:
Two- or Multi-component Systems
8. Binary mixtures of drug and common pharmaceutical excipients
such as diluents or ternary mixtures of drug, a diluent, and excipients
used in lower proportions such as disintegrants and lubricants.
And are incubated at accelerated conditions of temperature and
humidity for extended periods of time, using drug alone and excipient
alone as controls.
Incompatibilities are physically identified by
> Visual observation for color or physical form changes,
>Spectroscopic and calorimetric methods, and
>Chemically quantified by analytical assays for drug content and
impurities.
9. n-1 Design & Mini formulations
Compatibility studies are often aimed at solving
formulation stability issues.
In such cases studies are carried out with the exclusion
of only one component in each sub-lot to identify the
source of incompatibility.
Often, mini-formulations are prepared with the
exclusion of non-critical, quantitatively minor, and/or
easily interchangeable ingredients, e.g., colors and
flavors, from solutions and suspensions.
10. II. Sample Preparation
a. For solid state reactions:
Sample A: -mixture of drug and excipient
Sample B: -Sample + 5% moisture
Sample C: -Drug itself without excipients
All the samples of drug-excipient blends are kept for 1-3 weeks at specified storage conditions.
Then sample is physically observed.
It is then assayed by TLC or HPLC or DSC
Whenever feasible, the degradation product are identified by MASS SPECTROSCOPY, NMR or other
relevant analytical techniques.
b. For liquid state reactions:
Place the drug in the solution of additives.
In case of oral liquids, compatibility with ethanol, glycerin, sucrose, preservatives and buffers are
usually carried out.
Both flint and amber vials are used.
This will provide information about
Susceptibility to oxidation,Susceptibility to light exposure,Susceptibility to heavy metals.
11. . Storage Conditions
The storage conditions used to examine compatibility can vary widely in term of temp. & humidity,
but a temp. of 50°C for storage of compatibility sample is considered appropriate.
Some compounds may require high temp. to make reaction proceed at a rate that can be measured
over a convenient time period.
Sample Analysis & Data Interpretation
Monitoring Drug Degradation
Thermal Methods (DSC, DTA, etc.)
Monitoring to form changes
PXRD, ssNMR, NIR spectroscopy, etc.
Data analysis
15. Stability testing
Establish a re-test period for the drug substance or a shelf life for the drug product and recommended
storage conditions.
Stability Studies are preformed on ...
Drug Substances (DS) The unformulated drug substance that may
subsequently be formulated with excipients to produce the dosage form.
Drug Products (DP) The dosage form in the final immediate packaging
intended for marketing…….
controlled and documented determination of acceptable changes of the drug substance
or drug product
16. Arrhenius Equation
K = Se-Ha /RT
where..k = specific rate of degradation.
R = gas constant ( 1.987 calories degree -1mole)
T = absolute temperature.
S = frequency factor.
Logarithmically ,
ln k = -Ha/ RT + ln S
converting to log 10
Log k = -ΔHa/2.303 R .1/T + log S
log k = specific rate of degradation
S = constant
Plot of log K v/s 1/T….yields a slope equal to -ΔHa/2.303 R ….. From which heat of activation (ΔHa) can be
calculated.
Log k2/k1 = ΔHa/2.303 R . ( T2 – T1 )/ T2.T1
17. Scope
• Solubility Profile
• Hygroscopicity
• Thermal stability
(Melting point,
Polymorphism)
• Chemical stability
1 Batch
Up to 3 month
Scope
• Determination of expire date
• Determination of preliminary
specifications
• Release of clinical batches
• Monitoring of samples during the clinical
phases
• Definition of storage conditions
• Definition of Tests for registration
stability
Up to 36 month
Selection of samples
• API, excipient, batches
Scope
• Appearance
• Appropriate physical-chemical
parameter
• Assay / Degradation products
Up to 3 month
Stability studies at different stages
18. Theories of dispersion
Solid – Dispersion System
Definition
1. Solid dispersion is defined as dispersion of one or more active ingredients in an inert carrier or matrix at solid state prepared
by the melting, solvent or melting solvent method.
1. Molecular diffusion: obeys ficks first law and 2nd law of diffusion
2. Fick's first law relates the diffusive flux to the concentration under the assumption
of steady state.
3. J= -D(dS / dx)
4. j= flux, D = diffusivity , S= is concentration
5.
Fick's second law predicts how diffusion causes the concentration to change with
time. It is a partial differential equation which in one dimension reads:
where
•φ is the concentration in dimensions of [(amount of substance) length−3], example
mol/m3; φ = φ(x,t) is a function that depends on location x and time t
•t is time [s]
•D is the diffusion coefficient in dimensions of [length2 time−1], example m2/s
•x is the position [length], example m
19. Fick's second law predicts how diffusion causes the
concentration to change with time. It is a partial differential
equation which in one dimension reads:
dY/dT= D (d2Y/d2x)
where
•φ is the concentration in dimensions of [(amount of
substance) length−3], example mol/m3; φ = φ(x,t) is a function
that depends on location x and time t
•t is time [s]
•D is the diffusion coefficient in dimensions of [length2 time−1],
example m2/s
•x is the position [length], example m
20. Mechanical dispersion:
because of the variations in the microscopic velocity within each flow channel
and from one channel to another. spreading is present
Eddy diffusion : the mixing process that is due to the random fluctuation of
fluid mass or the occurrence of eddies in the condition described as turbulent
flow ,exist in porous media in slight extent more in large particles
Mixing due to structural control: the apparent mixing mechanism due to large-scale
structural variations in the granular material These variation scontrol the direction of
movement of a given fluid particle; hence, if an average concentration is taken along a given
plane parallel or transverse to the direction of flow, a large-scale mixing is observed
21. 1.Adsorption:
a process which differs from the others in that the amount of
mass transported depends on the physicochemical interaction of
the transported substance and the solid of the medium.
The existence of an unbalanced force field causes migration of a
liquid-borne contaminant from the liquid to the solid surface
In some instances the contaminant is permanently fixed on the
surface,whereas in others it moves continuously from
liquid to solid, or vice versa
22. Emulsion
An emulsion is a mixture of two or more liquids that are normally immiscible (unmixable or
unblendable). Emulsions are part of a more general class of two-phase systems of matter called colloids
In an emulsion, one liquid (the dispersed phase) is dispersed in the other (the continuous phase).
for example vinaigrettes,
homogenized milk,
mayonnaise, and
some cutting fluids for metal working.
Multiple emulsions are also possible, including a "water-in-oil-in-water" emulsion and an "oil-in-water-
in-oil" emulsion
The droplets dispersed in the liquid matrix (called the “dispersion medium”) are usually assumed to
be statistically distributed.
23. Instability[edit]
Emulsion stability refers to the ability of an emulsion to resist change in its
properties over time. There are four types of instability in
emulsions: flocculation, creaming, coalescence, and Ostwald ripening. An
everyday example of Ostwald ripening is the re-crystallization of water
ice cream which gives old ice cream a gritty, crunchy texture. Larger ice
crystals grow at the expense of smaller ones within the ice cream, creating
coarser texture
Flocculation occurs when there is an attractive force between the droplets,
they form flocs, like bunches of grapes. Coalescence occurs when droplets
bump into each other and combine to form a larger droplet, so the
droplet size increases over time. Emulsions can also undergo creaming,
where the droplets rise to the top of the emulsion under the influence
of buoyancy, or under the influence of the centripetal force induced when
a centrifuge is used.
An appropriate "surface active agent" (or "surfactant") can increase the
kinetic stability of an emulsion so that the size of the droplets does not
change significantly with time. It is then said to be stable.
24. Mechanisms of emulsification:
A number of different chemical and physical processes and mechanisms
can be involved in the process of emulsification:
Surface tension theory – according to this theory, emulsification takes
place by reduction of interfacial tension between two phases
Repulsion theory – the emulsifying agent creates a film over one phase
that forms globules, which repel each other. This repulsive force causes
them to remain suspended in the dispersion medium
Viscosity modification – emulgents like acacia and tragacanth, which are
hydrocolloids, as well as PEG (or polyethylene glycol), glycerine, and other
polymers like CMC (carboxymethyl cellulose), all increase the viscosity of
the medium, which helps create and maintain the suspension of globules
of dispersed phase
25. suspensionis a heterogeneous mixture containing solid particles that are sufficiently large
for sedimentation
suspension is a heterogeneous mixture in which the solute particles do not dissolve but get suspended
throughout the bulk of the medium
A suspension of liquid droplets or fine solid particles in a gas is called an aerosol or particulate. In
the atmosphere these consist of fine dust and soot particles, sea
salt, biogenicand volcanogenic sulfates, nitrates, and cloud droplets.
a significant thermodynamic problem in suspension formulation comes from Ostawald ripening , crystals
growth not because of phase change ,but as a result of the difference in the solubility as a function of crystal
size
RT/M ln(S2/S1)= 2a/p{1/r1 -1/r2}
R gas contant
T absolute temperature
M mol.wt of solute mol.
a specific surface
r1 and r2 is radious of particle
26. preparation and stability Large and small
volume parental
definition of parenterals
Parenterals are those preparations intended for
injection through the skin or other external boundary tissue,
rather than through the alimentary canal, so that the active
substances they contain are administered using gravity or
force directly into a blood vessel, organ, or tissue.
27. Parenterals are those preparations intended for
injection through the skin or other external boundary
tissue, rather than through the alimentary canal, so
that the active substances they contain are
administered using gravity or force directly into a
blood vessel, organ, or tissue.
Necessities of parenteral preparations:
Sterility (must)
Free from pyrogen (must)
Free from particulate matter
Clarity (must)
Stability (must)
28. Isotonicity (should)
Solvents and vehicles used must meet special purity
and other standard
Do not use coloring agents
Must be prepared under aseptic conditions
Specific and high quality packaging
29. MANUFACTURING PROCESS:
• A suitable test method for the preservative properties of the formulation are
provided under Efficacy of antimicrobial preservation.
• Methods designed to ensure sterility and to avoid the introduction of
contaminants and the growth of micro-organisms follow the method of
sterilization.
• Water used in the manufacture of parenteral preparations complies with the
requirements of water for injections
• The design and maintenance of the equipment and the method of
manufacture must be such as to ensure the stability of the active substance
and of the final product and sterility of the injection.
30. PARENTERAL PREPARATIONS
DEFINITION:
Parenteral preparations are sterile preparations which may consist of one or more active
ingredients intended for administration by injection, infusion or implantation into the body.
REQUIRED EXCIPIENTS:
• Solvents
• substances to enhance solubility
• suspending agents
• buffering agents
• substances to make the preparation isotonic with blood
and
• stabilizers or antimicrobial preservatives
31. TESTS
• Parenterals are tested for particulate contamination: sub-visible
particles.
• For preparations for human use, solutions for infusion or solutions for
injection supplied in containers with a nominal content of more than
100 ml comply with the test.
• Sterility. Parenteral preparations comply with the test for sterility.
32. Formulation of parenteral products
In the preparation of parenteral products, the following substances are added to make a stable
preparation:
The active drug
Vehicles
Aqueous vehicle (e.g. water for injection, water for injection free from CO2 )
Non-aqueous vehicle (e.g. Ethyl alcohol, propylene glycol, almond oil)
Adjuvants
Solubilizing agents (e.g. Tweens & polysorbates)
Stabilizers & antioxidants (e.g. thiourea, ascorbic acid, tocopherol)
Buffering agents (e.g. citric acid, sodium citrate)
Antibacterial agents (e.g. benzyl alcohol, metacresol, phenol)
Chelating agents (e.g. EDTA)
Suspending, emulsifying & wetting agents (e.g. MC, CMC)
Tonicity factor (e.g. sodium chloride, dextrose)
33. Formulation of SVP :
Aqueous vehicle :
Types :- purified water, WFI, sterile WFI, bacteriostatic WFI, sterile WF
Irrigation.
Preparation :- Distillation, ion exchange or reverse osmosis.
Except purified water all are pyrogen free
Non aqueous vehicle :
Because of safety
purity
biocompatibility
Several SVPs are marketed as oily solutions
34. The oil must be vegetable in origin (sesame, olive, or cottonseed oil).
Product USP Oil
Ampicillin(suspension) Vegetable
Diethyl stilbestrol Sesame, cotton
Epinephrine(suspension) Sesame
Penicillin G procaine Vegetable
(suspension)
Co solvents :-
Are used to increase the stability of poorly soluble drug in water and
and prevent drug chemical degradation by hydrolysis.
Eg. propylene glycol or in combination with ethanol and polyethylene
glycol.
35. Ingredients or added substances
Antimicrobial preservatives :
Maintain the stability of the product during storage.
Phenylmercuric nitrate and Thimerosal 0.001% , Benzethonium
chloride 0.01%, Benzyl alcohol 0.5- 10.0%, Phenol or cresol 0.5%,
chlorobutanol 0.5%.
Buffers :
Added to maintain pH Results in stability of drug against hydrolytic
degradation or enhance the solubility of drug in solution.
36. Common buffers used in SVPs
pH Buffer system Conc. %
3.5-5.7 Acetic acid-acetate 0.22
2.5-6.0 Citric acid-citrate 0.5
6.0-8.2 Phosphoric acid- 0.8-2
phosphate
8.2-10.2 Glutamic acid- 1-2
glutamate
Antioxidants :
Antioxidants function by preferentially with molecular oxygen and minimizing or
terminating the free radical auto-oxidation reaction.
eg. Reducing agents: Ascorbic acid 0.02-0.1%, Sodium Bisulfite 0.1-0.15%,
Thiourea 0.005%
Blocking agents: Ascorbic acid esters 0.01-0.015%, Tocopherols 0.05-0.075%
37. Tonicity adjusters :
Electrolytes: Nacl
Non electrolytes: Glucose, Mannitol, Glycerine
Eg. Of isotonic: Dextrose injection 5% & Nacl injection 0.9%
Some solutions are iso-osmotic but not isotonic this is because
the physiology of the cell membranes must be considered.
For eg. the cell membrane of the RBC is not semi- permeable to
all drugs it allows ammonium chloride, alcohol, boric acid,
glycerin, propylene glycol, and urea to diffuse freely.
In the eye the cell membrane is semi permeable to boric acid
a 2% solution is an isotonic ophthalmic solution.
38. But even though a 2% solution of boric acid is an isotonic with
the eye and is iso-osmotic, it is not isotonic with blood since
boric acid can freely diffuse through the RBC– and it may cause
HEMOLYSIS.
Tonicity can be measurement by: osmometer
Other ingredients :
Bulking agents – for freeze dried preparations(solids) eg
mannitol, lactose sucrose, dextrose.
Suspending agents – Carboxy methyl cellulose, sorbitol.
Emulsifying agents – lecithin, polysorbate 80
Ophthalmic ointments bases – petrolatum.
39. Manufacturing of parenterals
The production area where the parenteral preparation are manufactured
can be divided into five sections:
Clean-up area
Preparation area
Aseptic area
Quarantine area
Finishing,lebelling & packaging area
40. Clean-up area:
It is not aseptic area.
All the parenteral products must be free from foreign particles & microorganism.
Clean-up area should be withstand moisture, dust & detergent.
This area should be kept clean so that contaminants may not be carried out into aseptic area.
Preparation area:
In this area the ingredients of the parenteral preparation are mixed & preparation is made for filling operation.
It is not essentially aseptic area but strict precautions are required to prevent any contamination from outside.
41. Aseptic area:
The parenteral preparations are filtered, filled into final container & sealed
should be in aseptic area.
The entry of personnel into aseptic area should be limited & through an
lock.
Ceiling, wall & floor of that area should be sealed & painted.
The air in the aseptic area should be free from fibers, dust and
microorganism.
The High efficiency particulate air filters (HEPA) is used for air.
UV lamps are fitted in order to maintain sterility.
42. Quarantine area:
>After filling, sealing & sterilization the parenteral product are
held up in quarantine area.
>Randomly samples were kept foe evaluation.
>The batch or product pass the evaluation tests are transfer in to
finishing or packaging area.
Finishing & packaging area:
Parenteral products are properly labelled and packed.
Properly packing is essential to provide protection against
physical damage.
The labelled container should be packed in cardboard or plastic
container.
Ampoules should be packed in partitioned boxes
43. EVALUATION OF PARENTERAL PREPARATIONS
The finished parenteral products are subjected
to the following tests, in order to maintain
quality control:
A) sterility test
B)clarity test
C)leakage test
D)pyrogen test
E)assay
44. A) sterility test
It is a procedure carried out to detect and conform
absence of any viable form of microbes in or on
pharmacopeia preparation or product.
1) Method of sterility testing
i ) METHOD 1 Membrane filtration method
ii) METHOD 2 Direct inoculation method
45. Membrane filtration method (METHOD 1):
Membrane filtration Appropriate for : (advantage)
Filterable aqueous preparations
Alcoholic preparations
Oily preparations
Preparations miscible with or soluble in aqueous or oily (solvents with no
antimicrobial effect)
All steps of this procedure are performed aseptically in a Class 100 Laminar Flow Hood
46. Composition of culture medium for sterility testing
Fluid Thioglycollate Soybean- casein
L- cystine 0.5gm -
Sodium chloride 2.5gm 5.0gm
Dextrose 5.0/5.5gm 2.3/2.5gm
Pancreatic digest of casein 15.0gm 17.0gm
Papaic digest of soya bean - 3.0gm
Dibasic potassium phosphate - 2.5gm
Granular agar (moisture<15%) 0.75gm -
Yeast extract (water soluble) 5.0gm -
Sodium thioglycollate or thioglycolic acid 0.5gm or
0.3ml
-
Resazurin (0.10%w/v fresh solution) 1.0ml -
Purified water 1000ml 1000ml
Components Culture medium
47. Membrane filter 0.45μ porosity
Filter the test solution
After filtration remove the filter
Cut the filter in to two halves
First halves (For Bacteria) Second halves (For Fungi)
Transfer in 100 ml culture media
(Fluid Thioglycollate medium)
Incubate at 30-350 C for not less then 7 days
Transfer in 100 ml culture media
(Soyabeans-Casein Digest medium)
Incubate at 20-250 C for not less then 14 days
Observe the growth in the media Observe the growth in the media
48. Direct inoculation method (METHOD 2):
Suitable for samples with small volumes
volume of the product is not more than 10% of the volume of the
medium
suitable method for aqueous solutions, oily liquids, ointments and
creams
Direct inoculation of the culture medium suitable quantity of the
preparation to be examined is transferred directly into the
appropriate culture medium & incubate for not less than 14 days.
49. B)clarity test
Particulate matter is defined as unwanted mobile insoluble matter
other than gas bubble present in the product.
If the particle size of foreign matter is larger than the size of
R.B.C.. It can block the blood vessel.
The permit limits of particulate matter as per I.P. are follows:
51. C)leakage test
The sealed ampoules are subjected to small cracks which occur due
to rapid temperature changes or due to mechanical shocks.
Filled & sealed ampoules
Dipped in 1% Methylene blue solution
Under negative pressure in vacuum chamber
Vacuum released colored solution enter into the ampoule
Defective sealing
Vials & bottles are not suitable for this test because the sealing
material used is not rigid
52. D)pyrogen test
Pyrogen = “Pyro” (Greek = Fire) + “gen” (Greek = beginning).
Fever producing, metabolic by-products of microbial growth and
death.
Bacterial pyrogens are called “Endotoxins”. Gram negative bacteria
produce more potent endotoxins than gram + bacteria and fungi.
Endotoxins are heat stable lipopolysaccharides (LPS) present in
bacterial cell walls, not present in cell-free bacterial filtrates
53. Method
Dissolve the subs being examined in, or dilute it with a pyrogen free
saline solution
Warm the liquid being examined to approx. 38.5o C temp before
injection
The volume of injection is NLT 0.5ml/kg & NMT 10ml/kg of body
weight
Withhold water during test
Clinical thermometer is inserted into the rectum of rabbit to record
body temp
2 normal reading of rectal temp are should be taken prior to the test
injection at an interval of half an hr & its mean is calculated- initial
temp
The solution under test is injected through an ear vein
Record the temp of each rabbit in an interval of 30 min for 3 hrs
The difference between initial temp & maximum temp is recorded-
taken as response
54. Limulus amebocyte lysate [LAL] test
Limulus amebocyte lysate [LAL] test another method for the
determination of pyrogenic endotoxins
In this method the test solution is combined with a cell lysate from
the ameabocyte [blood cells] of horse shoe crab
Any endo toxin that might be present will be coagulated with
protien fraction of the ameabocytes and results in the formation
of a gel
This consider to be simple,rapid and of greater sensitivity that the
rabbit test
55. E)assay
Assay is performed according to method given In the
monograph of that parental preperation in the
pharmacopoeia
Assay is done to check the quantity of medicament
present in the parenteral preperation
56. References
Lachman/Lieberman’s “The Theory and Practice Of Industrial
Pharmacy” Fourth Edition 2013, Edited by: Roop K Khar, SP Vyas,
Farhan J Ahmad, Gaurav K Jain, CBS Publishers and Distributors Pvt
Ltd, New Delhi.
Doornbos C and Hann P. Optimization Techniques in Formulation and
Processing. In Encyclopedia of Pharmaceutical Technology. Swarbrick J
and Boylan JC, Eds., Vol. II, Marcel Dekker, New York. 199
Modern Pharmaceutics Fourth Edition, Revised and Expanded, Edited
By G.S.Banker & C.T.Rhodes, Marcel Dekker pg387-389.
The Science & practice of Pharmacy, By Remington, Vol-01, 21st
Edition, Lippincott Publication, pg-838-840.