Various factors affecting the bioavailability of drugs following oral administration, viz. Factors affecting personality development. Factors Affecting the Drug stability Primary factors Temperature: High temperature accelerates oxidation, reduction and hydrolysis reaction which lead to drug degradation. This study helps to determine the shelf-life of that product. Stability of DrugsStability of Drugs. pH: Acidic and alkaline pH influences the rate of decomposition of most drugs. Ionization state 7.Drug pKa & lipophilicity & GI pH ---pH partition hypothesis. Importance, Objectives & Factors Affecting Dissolution Rate, Theories of Dissolution And Official Dissolution Tests (Equipments of Dissolution Study) LIST OF CONTENTS Introduction Importance & applications Factor affecting dissolution rate 1. Evaluation of the stability of drugs and drug metabolites in a biological matrix is a critical element to bioanalytical method validation. Following administration, a drug encounters several obstacles before it reaches its site of action. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Even though the water is driven off in a wet granulation, there is still sufficient moisture stress in the process to induce excessive decomposition on subsequent storage. Furthermore, the bases for physical degradation kinetics, which have generally been treated empirically, are also covered, and sound bases for the observations are also presented and discussed. § Macromolecular gum forms unabsorbable complex with drug e.g. DRUG SOLUBILITY- Solubility of drug plays a prime role in controlling its dissolution from … Temperature 3. may suggest means for skill improvement. The solubility and behaviour of biopolymers is dependent on various factors, such as pH, ionic strength, temperature, nature of biopolymers and medium, presence of other agents such as surfactants in the system and charge of biopolymers [10, 41]. Now customize the name of a clipboard to store your clips. Learn drug stability with free interactive flashcards. 2. and many drugs are stable between pH 4 and 8. b. Acidic & alkaline pH influence the rate of decomposition of most drugs. By https://youtu.be/-YhQYrJTYIcAlso view this part 1 of factors affecting drug absorption The purpose of solid state stability is identifications of stable storage conditions for drug in the solid state and identification of compatible excipients for a formulations. Many factors affect the rate and pathway of metabolism of drugs, and the major influences can be sub-divided into internal (physiological and pathological) and external (exogenous) factors as indicated below: Internal: species, genetic (strain), sex, age, hormones, … Choose from 500 different sets of drug stability flashcards on Quizlet. 3.3.1.3 Change of crystalline state. Particles size & effective surface area 3. If you continue browsing the site, you agree to the use of cookies on this website. stability-testing. Specifically, analysis of the factors affecting drug stability based on basic kinetic theory allowed for a sound theoretical treatment of available information. September 6, 2016. It is critical to understand the most common factors that affect the stability of such analytes in order to properly develop methods for their detection and measurement. Physicochemical Properties of Drug 2. Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. stability-testing. With advanced technology, new treatment options have to researched and developed fully. 4 … Introduction. Factors affecting drug stability: There are many factors that affecting such as temperature so high temperature accelerate oxidation, reduction and hydrolysis reaction which lead to drug degradation and the pH in which the acidic and alkaline pH influence the rate of decomposition of most drugs. Radiations TYPES OF DRUG INSTABILITY: Drug stability can be divided into two major types 1. This study helps to determine the shelf-life of that product. Login to see the comments. Family Environment: Every person learns his first lesson from his family. FACTORS AFFECTING DRUG ABSORPTION List of content :-- I.PHARMACEUTICAL FACTORS A] Chemical factors B] Physicochemical properties of drug substances 1.drug solubility & dissolution rate 2. Even though the water is driven off in a wet granulation, there is still sufficient moisture stress in the process to induce excessive decomposition on subsequent storage. Loading in … 5 × 1 of 32 ; Transdermal drug delivery system 24,671 views. Aspirin is not wet granulated. T. D. Whittet, Ph.D.; Factors Affecting Drug Stability, American Journal of Hospital Pharmacy, Volume 21, Issue 10, 1 October 1964, Pages 438–453, https://doi. Drug-release behavior is an important factor for polymer nanoparticle application, directly related to drug stability and therapeutic results, as well as formulation development. Clipping is a handy way to collect important slides you want to go back to later. Dr. Nehal Aly Afifi Factors affecting absorption: A. • Many drugs are stable between pH 4 and 8. DRUG SOLUBILITY- Factors Affecting Stability 14-1 The ability to maintain one’s balance under unfavorable circumstances is recognized as one of the basic motor skills. Aspirin is not wet granulated. may not be well absorbed when administered orally. Stability of drugs for pharmaceutical formulations .This presentation teaches for Postgraduate students of Diploma Discover the world's research 19+ million members A protein’s amino acid backbone (primary structure) can be changed by formation and destruction of covalent bonds (11). 11.1.2.1 Stabilization of Emulsion. Dry methods (slugging, roller compaction) are therefore resorted to. Factors Affecting Emulsion Stability, and the HLB Concept J. BOYD, C. PARKINSON,1 AND P. SHERMAN1 Unilever Research Laboratory Colworth/Welwyn, Welwyn, Hertfordshire, England Received October 11, 1971; accepted December 14, 1971 INTRODUCTION The HLB system for selecting suitable emulsifiers to stabilize emulsions has been in use now for about two decades. Cairo university While addiction affects men and women … See our Privacy Policy and User Agreement for details. These include absorption, distribution, metabolism and excretion. list the factors affecting drug absorption and distribution. Drug Product Formulation Factors c. Processing Factors d. Factors Relating Dissolution Apparatus e. Factors Relating Dissolution Test Parameters I. PHYSICOCHEMICAL PROPERTIES OF DRUG- 1. E-mail:drnehal_affifi@cu.edu.eg FACTORS EFFECTING DRUG STABILITY The primary factors effecting stability : PH , Temperature , Moisture , humidity , light , Storage closure and containers, Oxygen The major factors effecting drug stability are :Particle size (suspension and emulsion) , PH , additives and molecular bindingand diffusion of drugs and excipients .OBJECTIVES1. See our User Agreement and Privacy Policy. With oral administration, several factors affect the absorption of a drug: solubility and permeability, gastrointestinal pH, gastric emptying time, small intestinal transit time, etc. Physicochemical Properties of Drug 2. If you continue browsing the site, you agree to the use of cookies on this website. A change in the rate of gastric emptying alters the rate of drug delivery from the stomach to the duodenum and upper small intestine. Light 5. § Stabilized the solid drug particles and thus affect drug absorption. Patients and other consumers expect a lot more compare… Special considerations are also required when dealing with chiral molecules, deuterated internal standards and large biomolecules. Even so, it is imperative to note that the role of pharmaceutical industryhas increased significantly and so have the risks. Factors affecting drug absorption 1. As well as improving the stability of emulsion formulations, coating emulsion droplets with nanoparticle layers is a highly effective strategy for protecting drug compounds encapsulated within the droplets and controlling their release. environmental factors on the quality of the a drug substance or a formulated product which is utilized for prediction of its shelf life, determine proper storage conditions and suggest labeling instructions. Physical degradation 2. Your message goes here Post. Aspirin is a classical example. 3.Moisture: Water catalyze chemical reactions as oxidation, hydrolysis and reduction reaction. Some drugs, such as penicillin G, which is unstable in the acid media of stomach is buffered or enteric coated to protect the drug from degradation at a low pH. Presented by: Asim raza Rph. Drug stability: How storage conditions affect their performance. In general, however, the aggregation pathways of peptides currently coming through drug pipelines have not been characterized in depth. Download Supply Chain Management: Warehouse Management Optimization with MS ... Lectures 04 Dosage forms, Doses of Drugs and Drug Administration, Isra Institute of Rehab Sciences (IIRS), Isra University, Good Warehousing Practices (GWH) in Pharmaceutical Industry, No public clipboards found for this slide. PH 2. Looks like you’ve clipped this slide to already. There is no gene that automatically makes someone into an addict, but genes are an influencing factor in addiction, because they affect how we react and experience drugs. § Viscosity imparters – act as a mechanical barrier to diffusion of drug from its dosage form and retard GI transit of drug. Upcoming SlideShare. Satinder Ahuja, in Separation Science and Technology, 2005. If you continue browsing the site, you agree to the use of cookies on this website. PH 2. Lowering of interfacial tension will result in lowering of interfacial energy, thus increasing the stability of emulsion. There are several promising emulsion-based formulations showing high potential for drug delivery. Evaluation of drug stability can prevent toxicity and increase safety, efficacy and quality of the final drug product. Drug solubility and dissolution rate b. 1. Moreover, the data generated during the stability testing is an important requirement for regulatory approval of any drug or formulation (Singh et al., 2000). This has become highly complex and specialized across different parts of the globe. … Physical degradation 2. Processing Factors 4. The leading pharmaceuticals consortium expenditure in the industry according to Pharmaceutical Manufacturers Association is on research and development. Importance, Objectives & Factors Affecting Dissolution Rate, Theories of Dissolution And Official Dissolution Tests (Equipments of Dissolution Study) LIST OF CONTENTS Introduction Importance & applications Factor affecting dissolution rate 1. You can change your ad preferences anytime. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Comment goes here. Evaluation of the stability of drugs and drug metabolites in a biological matrix is a critical element to bioanalytical method validation. Most people know that drugs can lose some of their potency over time, but what is less understood is that the substances that remain as the drugs break down can actually be harmful. Physical Stability Physical stability implies that: The formulation is totally unchanged throughout its shelf life and has not suffered any changes by way of appearance, organoleptic brittleness, particle size etc. Follow Published on Mar 23, 2011. With oral administration, several factors affect the absorption of a drug: solubility and permeability, gastrointestinal pH, gastric emptying time, small intestinal transit time, etc. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. Med. Numerous factors can negatively affect protein stability. Looks like you’ve clipped this slide to already. In this review, we discuss the factors that are known to affect the aggregation of peptides rather than proteins. In this work, various factors affecting stability of both small molecule and biopharmaceutical compounds were investigated. Understanding the factors affecting the stability of a performer’s equilibrium state: should make analysis of a balance problem easier. Moisture 4. Moisture 4. Real life situations may sometime demonstrate issues with the stability of a drug … Clipping is a handy way to collect important slides you want to go back to later. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. Water promotes microbial growth 4.Light: affect stability through its energy or thermal effect. FACTORS AFFECTING DISSOLUTION RATE Divided into five classes- a. Physicochemical Properties of Drug b. See our User Agreement and Privacy Policy. So, we mention education is the first factor that affects personality. How pharmaceuticals break down, and why we should care. Drug abuse is a severe problem that affects millions of Americans yearly, causing health, mental, and relationship problems. Na CMC. This is essential for undergratudes & postgratude medical students studying clinical pharmacology. For example, esters can be prepared of both acids and bases to produce more stable derivatives, which hydrolyse to the active parent once absorbed. Drug absorption from pulmonary epithelia occurs only after inhaled drug deposits in the lung and undeposited aerosolized particles clear out of the lung in expired air. Factors Relating Dissolution Apparatus 5. Accuracy. Particle size and effective surface area c. Polymorphism and amorphism d. Salt form of the drug e. Drug stability 5. Temperature: high temperature accelerate oxidation, reduction and hydrolysis reaction which lead to drug degradation 2. pH: • Acidic and alkaline pH influence the rate of decomposition of most drugs. Purpose of stability testing and its importance.Also a review article of Sanjay Bajaj et al published in Journal of applied pharmaceutical sciences. 1. Temperature 3. We focus here mainly on peptides that do not adopt a stable tertiary structure in the absence of their receptor/target proteins. Slideshare uses cookies to improve functionality and performance, and to provide you with relevant advertising. XIII Assay and Stability Testing. Drug Product Formulation Factors 3. Drug Stability for Pharmaceutical Scientists is a clear and easy-to-follow guide on drug degradation in pharmaceutical formulation. Keywords: Stability, Stability studies, Stability testing INTRODUCTION Stability testing of pharmaceutical products is a complex set of procedures involving considerable cost, time consumption and scientific expertise in order to build in quality, efficacy and safety in a drug formulation. The purpose of stability studies is to provide evidence on how the quality of the active substance or pharmaceutical product varies with time under the influence of a variety of environmental factor such as temperature, humidity and light DRUG STABILITY 19/11/2016 4 5. dosage, formulation, species, disease, pH of gut, GI motility, presence of food, blood supply to GI tract. Ajeet Kumar, Chandra Kumar Dixit, in Advances in Nanomedicine for the Delivery of Therapeutic Nucleic Acids, 2017. Drug absorption and distribution is not uniform across the body and areas such as the brain and placenta are more complex than other regions. Stability Studies of Drugs Factors Affecting Stability 14-1 The ability to maintain one’s balance under unfavorable circumstances is recognized as one of the basic motor skills. That presentation is about the stability of the drug, why it's necessary?? Education: Education can affect personality because this is the most powerful way to develop the personality. Evaluation of the stability of drugs and drug metabolites in a biological matrix is a critical element to bioanalytical method validation. It has long been known that moisture affects the stability of some drug substances. Factors affecting Drug Stability Environmental factors 1-Temperature 1. high temperature accelerate oxidation, , reduction & hydrolysis reaction which lead to drug degradation. 11 Comments 100 Likes Statistics Notes Full Name. 1. Factors affecting Drug Stability(Cont.) Shelf-Life Determination: The quality of a pharmaceutical product varies with time under temperature, humidity and light intensity.Stability testing studies; how long a pharmaceutical product can be stored at normal and accelerated conditions without any degradation. process that can adversely affect the stability of the product (12) Providing evidence on how quality of drug substance or product varies with the time under the influence of various factors like temp, humidity and light. FACTORS AFFECTING ABSORPTION BIOPHARMACEUTICS AND PHARMACOKINETICS 2. These include disease, surgery and other drugs. 14-2 Factors Affecting Stability Three primary factors: 1. and the manufacturing process. 3 [A] Chemical Factors A variety of chemical options can be used to improve the stability and systemic availability of drugs. The stability studies of pharmaceutical products are one of the very important parameter for development of new drugs as well as new formulations. Shelf-Life Determination: The quality of a pharmaceutical product varies with time under temperature, humidity and light intensity.Stability testing studies; how long a pharmaceutical product can be stored at normal and accelerated conditions without any degradation. Stability is an essential quality attribute for pharmaceutical formulations. Radiations TYPES OF DRUG INSTABILITY: Drug stability can be divided into two major types 1. We use your LinkedIn profile and activity data to personalize ads and to show you more relevant ads. 9.3.6.1.2 Factors Affecting Pulmonary Deposition. Solvates & hydrates 5.salt form of drug 6. 12 hours ago Delete Reply Block. T. D. Whittet, Ph.D.; Factors Affecting Drug Stability, American Journal of Hospital Pharmacy, Volume 21, Issue 10, 1 October 1964, Pages 438–453, https://doi. 2- Drugs or excipients in the dosage form - Particle size of the basic drug - pH of the vehicle . This chapter also discusses the guidelines from the ICH for stability testing on drug substances and products and the requirements at different phases of the drug development process in the pharmaceutical industry. Crystalline state is one of the most important parameters affecting drug stability, solubility, dissolution, and efficacy.The main issue with crystalline state change is the transformation between amorphous and crystalline state. If you continue browsing the site, you agree to the use of cookies on this website. This may profoundly alter the plasma concentration/time curve that follows oral administration of many drugs. What is the shelf life of a drug? pH and Solubility, Stability, and Absorption, Part II. See our Privacy Policy and User Agreement for details. FACTORS AFFECTING DISSOLUTION RATE Divided into five classes- a. Physicochemical Properties of Drug b. 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Theory allowed for a sound theoretical treatment of available information: Asim raza Rph performer s., it is imperative to note that the role of pharmaceutical industryhas increased significantly and so the! Et al published in Journal of applied pharmaceutical sciences in … 5 × 1 of ;! Factors: 1 continue browsing the site, you agree to the use of cookies this. Vary depending on the route of administration not uniform across the body and areas such the! Is affected by several variables, which can be changed by formation destruction!