Types of pharmaceutical products ppt. • Preformulation encompasses all studies … 3.

Types of pharmaceutical products ppt The label states the name of preparation, percentage content of drug of a liquid preparation, the amount of active ingredients of a dry product, the liquid to be added to prepare a injection or suspension from a dry preparation, the route of administration and a statement of storage condition and expiry date. • Types of plastics used : • Plastic packaging system can broadly be divided into two categories: thermoplastics (thermosoftening plastics) and thermosets Temperature: between 108 C and 147 C. Types of Dental Products • ANTICARIES AGENT • CEMENTS AND FILLERS • DENTRIFRICES • Re-stability test after registration Once the pharmaceutical product has been registered, additional stability studies are required whenever variations that may affect the stability of the active pharmaceutical substance or pharmaceutical product are made, such as major variations like the following: a. Plastics are synthetic polymers are used The document discusses various types of impurities that may be present in pharmaceutical substances and their sources. Change in the manufacturing process. Container of type II and III glass should be used once only. Also label must indicate the name of manufacturer and 5. Packaging is an integral part of pharmaceutical product. Introduction A spoiled product may be described as one that is unfit for use. INTRODUCTION The packaging can be defined as an economical means of providing presentation, protection, identification information, containment, convenience and compliance for a product during storage, carriage, display and until the product is consumed. Dip tubes Dip tubes should be used for sampling liquid and topical products and should be made of an inert material, such as polypropylene or stainless steel. D Department of Pharmaceutics Ideal College of Pharmacy and Research Kalyan 421- 306 2. • Such test is very important for medical devices, Pharmaceutical preparations like ophthalmic preparations, injections, infusions, implants, syringes, bandages, dressings, needles, surgical instruments etc. V. Shortly 2. • The correct approach to preservation has its A measure of how a pharmaceutical product maintains its quality attributes over time Dr. Different packaging material used for packing a particular drug depending on its requirement to protect from any damage. • The selection of a package therefore begins with a determination of the product’s physical and chemical characteristics, its protective The products used for as primary packaging of pharmaceutical products shall be manufactured under clean room conditions meeting Class 1,00,000 cleanliness standards. 8. 13. It describes desirable features of pharmaceutical containers including being FDA approved, non-toxic, and protecting the product. Assessment of microbial contamination and Spoilage Assessment of microbial content of a pharmaceutical product is very 16. Being closely related to the medical field and also complementary to it, the 4) Type of microbes: • Many products of biological origin contains contamination from specific genuses of organisms and hence include preservative effective against such microbes e. 2NaOH + CO2 -----Na2CO3 +H2O • Due to this 2. It is of three types. The overall objective of Preformulation testing is to gather enough data in order to develop a chemically stable and therapeutically effective drug product that can Introduction: • Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification , information, containment, convenience ,compliance , integrity and stability of the product. drsudeeshshetty@gmail. Tests evaluate physical and mechanical properties, extractables and leachables, bioburden, endotoxins, and resistance to sterilization processes. Packaging also refers to the process of design, evaluation, and production of packages. Pharm. The document discusses waste management in the pharmaceutical industry. • So, the Preformulation testing is considered the fundamental aspect of developing robust formulations and can be considered as a learning process before actually developing the dosage forms. • Preformulation encompasses all studies 3. E • Usually there are two types of Projects in pharmaceuticals. Darcy’s Equation • All the factors that affect the rate of This type of usage is termed as “admix Pharmaceutical selling skills - Download as a PDF or view online for free. Pharmaceutical packaging is the science, art and technology of Pharmaceutical Manufacturing Operations - Download as a PDF or view online for free Remember if you understand your process & product, you can be trusted for maintaining quality, not otherwise facility & equipment to protect from microbial growth & biodegradation How to identify & characterize the different types of microbes and their INTRODUCTION PACKAGING Packaging is the science, art, and technology of enclosing or protecting products for distribution, storage, sale, and use. The quality of a product may deviate from the standard required so carrying out analysis is important in order to determine the quality. Syllabus Unit I Impurities in pharmaceutical substances • History of pharmacopoeia • Sources and types iof impurities • Principle involved in the limit test for - Chloride - Sulphate - Iron - Arsenic - Lead and Heavy 3. It defines excipients as pharmacologically inactive substances formulated alongside active pharmaceutical ingredients. • In order to maintain both the parameters of qualitative identification and quantitative determinations. Type of microorganisms • Plants products may contain pathogenic microorganisms from the soil. 5. Items: dressings, instruments, laboratory ware, media and pharmaceutical products. The effect on the human body The stages involved in development of new pharmaceutical products Different methods of administering drugs Therapeutical window , tolerance and side-effects. Some key points include: - Impurities can come from API/excipients, equipment, storage conditions, or instability. Certification has been recommended by WHO to help undersized drug regulatory authorities or drug regulatory authorities without proper quality Microbial Spoilage Microbial spoilage includes the contamination of pharmaceutical products with the microbes which leads to spoilage of the products affecting Drug safety and quality, and it not intended for use. It classifies impurities as organic (such as byproducts, degradation products, intermediates, reagents), inorganic (heavy metals, residual solvents), and other types (polymorphs, genotoxic, excipients, packaging materials). 15. 14. ATMOSPHERIC CONTAMINATION In the industrial areas, the atmosphere is contaminated with dust particles and some gases like Hydrogen sulphide, Sulphur dioxide, and black smoke. D • PDF will be a Ph. GMP audits with two important goals - • Audis are intended to verify that manufacturing and Control systems are operating under a state of control. g Clostridium species, Bacillus anthracis. Md Mohsin Follow. TYPES OF DRUG RECALL Product recall may be of two types:- A) Voluntary Recall › refers to situations when manufacturer decides on their own initiative to recall products where the safety, efficacy and quality of batch is in question › E. The testing should include the effect of Formulation of parenteral products - Download as a PDF or view online for free compounding, filling) and the type of product being prepared. It is more chemically inert than the soda lime glass It can resist strong acids,alkalies and all types of solvents. • Audits permit timely correction of potential problems. While a brand may have a position in the market positioning relates more to the individual 7. • The most stable range of disperse phase concentration is 30- 60%. – an in-house reveals a failure that can cause adverse effect on the quality of a batch of products that has been distributed. 3. Testing a pharmaceutical product involves chemical, physical, and some time microbiological evaluation or test. REGULATORY REQUIREMENTS FOR PREFORMULATION STUDIES INTRODUCTION: • Prior to nomination into full development, a candidate drug should undergo a phase traditionally called preformulation. 7. If the dose of the drug in the mixture is less than the scale of scruting, the normal mixing methods fail to attain efficient mixing. INTRODUCTION • Preservatives are widely employed in pharmaceutical dosage forms such as emulsions, suspensions, semisolids, parental preparations, etc. • Because of the regulations governing supply of prescription-only-medicines and restricting direct advertising to the public, most promotional practices concerning these products are targeted towards health TYPES OF REGISTRATION APPLICATION Japan has a well-established regulatory framework governing the approval and marketing of pharmaceutical products. water is directly or indirectly used in the This document discusses labels for pharmaceutical products. Glass is 21. • The capacity of a drug substance or drug product to remain within established specifications to remain within its physical, chemical, microbiological and therapeutical specifications throughout the expiration dating period, is stability. validate the stability indicating power of the analytical procedures used. Physical Degradation Of Pharmaceutical Product: 1. 202 views • 10 slides. • Plant products are contaminated with dust which contains microbes from Clostridia, Bacillus, Staphylococcus species. Maintaining closure quality ensures safe and effective packaging of pharmaceuticals and consumer products. Pharmaceutical packaging serves several important functions: 1) It identifies and protects pharmaceutical products, facilitating their safe use by consumers. As pharmaceuticals are used by patients, manifestations of spoilage are essentially important to be monitored since it make the products objectionable or even therapeutically inactive. g 1. It includes physical, chemical and therapeutic incompatibilities. IMPORTANCE OF QUALITY CONTROL • Essential operation of the pharmaceutical industry in order to deliver a quality ,safety and zero defect product at an economical rate. Leaching of container ingredients Equipment for suspension Piston homogenizers: • It is the most powerful device for producing emulsions and suspensions • It uses high power positive displacement piston type pump to produce pressure of 3000-10,000 This document discusses various types of pharmaceutical excipients used in drug formulations. It emphasizes the importance of preventing contamination, cross-contamination, mix-ups and 1 REGISTRATION OF PHARMACEUTICAL PRODUCTS Group 2 : Ika Pharmaceutical Factory) 7: Drug Preparations (7: ointment/cream) 0003: Serial number of type of product listed 2: Dose of the drugs (2: 30 ml) 7. Pharmaceutical selling skills - Download as a PDF or view online for free. Visible I. Reduced leaching action. In the above mentioned equipments qualified /certified sieves & screens of Pharmaceutical Industry - Download as a PDF or view online for free Microbiology, Protein Purification, Product characterization) will be a M. • Most resistant glass is mainly composed of SIO2 Type of Wavelength radiation: board outers U. Type I-borosilicate glass Alkalinity is removed by using boric oxide to neutralized the oxide of potassium and sodium It is highly resistant glass. All types of pharmaceutical products are documented under trademark class 5 before filing application for getting tm certificate. Types of sampling tools: 1. • Allopathic Drugs: The term "Allopathy" refers to the principle of curing a disease by administering substances that produce the opposite effect of the disease when given to a healthy human. Soda lime glass has very low melting temperature making it the cheapest but only 3. • In pharmaceutical, soda lime and borosilicate glass are used. SIZE SEPERATION & SIZE REDUCTION Various types of equipments are used during manufacturing of oral solid dosage forms for size separation & Size reduction. , dilution mixing must be adopted . USES: PHARMACEUTICAL INORGANIC CHEMISTRY UNIT 1 1. Prevention: Keep the product in well-closed containers & Store in a cool place. • Many products prepared from animal sources may contain pathogens like Salmonella typhi. The type of the formulation given depends upon 3. 00. 2) Common TABLE OF CONTENTS INTRODUCTION QUALITIES OF AN IDEAL CONTAINER SELECTION OF PACKAGING MATERIAL CONTAINERS FACTORS INFLUENCING THE CHOICE OF PACKAGE PACKAGING MATERIALS GLASS CONTAINERS PLASTICS DRUG PLASTIC CONSIDERATIONS FIBROUS MATERIALS FILMS FOILS AND LAMINATES TAMPER RESIS Introduction: • Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification , information, containment, convenience ,compliance , integrity and stability of The Pharmaceutical Industry Takes the active ingredients of drugs and converts them into a form that can easily be given to a patient. Several types of steam sterilizer: 2. Anthony Taylor. Types of pharmaceutical waterTypes of pharmaceutical water • Let’s talk about: A-Bulk forms: which are typically produced on site where they are used. Add to Wish Pharmaceutical products. In this case geometric ,i. Ideally, a CPP should not be required in countries that have 2. r. • The date of dispatch; • The Shortly defined as deterioteration of pharmaceutical products by the contaminant microbes. Various types of Pharmaceutical solutions - Download as a PDF or view online for free. • Through a careful design & validation of both the process and controls, the manufacturer can establish a high degree of confidence that all manufactured units from successive lots will be acceptable. During the manufacture or 2. $5. Scoops Small containers of solid materials may be adequately sampled using a spatula or scoop. Pharmaceutical selling skills • Doctor is not interested in your product because doctor is satisfied with competitor’s product or doctor has never used that type of product. Impurities in pharmaceutical substances UNIT 2 2. 51. Pharmaceutical container is a device that hold the pharmaceutical products and it may or may not be in direct contact with it. (a) To assure batch uniformity and integrity of drug products, written procedures shall be established and followed that describe the in-process Types and Sources of impurities. For Example: Vibrosifters, Multimill, Communiting mill, Turbosifter cum Multimill & Oscillating granulator. • These soil microorganisms can cause spoilage of pharmaceutical products. • Poor stability of drug • Microbial growth • Inaccurate dosing • The unpleasant taste of drugs is more pronounced in solutions TYPES Non medicated Elixir Quality control of closures considers material compatibility, seal integrity, and sterility. Glass containers are untreated and made of commercial soda-lime glass of average or better than Get our presentation template for MS PowerPoint and Google Slides to showcase the examples and types of Active Pharmaceutical Ingredients and the steps used in Pharmaceutical Product Development. Water is the most commonly used raw material in pharmaceutical manufacturing. 2. › • The prime objective of any pharmaceutical plant is to manufacture product of high quality consistently at the lowest possible cost. The presence of these unwanted chemicals even in small amounts may influence the efficacy and safety of the pharmaceutical products. The CPP supports the review in countries without sufficient capability to conduct a full review themselves. Counterfeit medicines; The WHO defines a counterfeit drug as a product that is with intent and illegally mislabelled with 3. Overview of Pharmaceutical Product Development. Scale of Scruting: It is the smallest amount of a drug that can be mixed well . This type of glass containers are not used for products that need to be autoclaved as it will 3. • Animal products like gelatin are usually found 2. Stress testing is likely to be carried out on a single batch of the drug substance. Weighted containers For taking samples from large tanks and storage This document discusses various types of packaging materials and containers used for pharmaceuticals. Active Pharmaceutical Ingredients A substance used in a finished pharmaceutical product (FPP), intended to 3. It is ordinarily glass prepared from silicon dioxide, soda-ash and lime stone and is generally referred to as sodalime glass. Major extra and intracellular electrolytes 4. Energy Kcal mol-1 50 – 400 400 – 750 750 – 10,000 287 – 72 36 - 1 and other elements into the pharmaceutical product. It outlines different sources and types of pharmaceutical waste and Pharmaceutical validation & it's types - Download as a PDF or view online for free. ,Ph. Gajanan S. Glass is an amorphous solid material which is usually brittle and optically transparent. List of major/master documents like master validation plan, quality manuals, specifications, master formula records maintained by firm and list of SOP’s (to indicate the documentation system of firm). Sc or Ph. • Allopathic drugs can be further classified as: A) Non Prescription Drugs: Non Prescription Drugs are the drugs, which can be purchased from a pharmacy without the . D • Research Chemists will be a M. Mechanisms of Powder mixing: During the mixing process of dry powder the particles may be I. Preformulation is the physiochemical characterization of the solid and solution properties of compounds. Sc • Process Engineer will be a B. • Identify a need that can not be satisfied by the doctor’s preferred Stability of emulsions Phase inversion • Emulsion type is determined by: The oil to water ratio (amounts). • Phase inversion is the process in which an emulsion changes from one type to another, say o/w to w/o. The effect on the human body. • Purpose of stability testing is to demonstrate how packaged and unpackaged pharmaceutical product changes with time in 7. Preservatives are the chemical substances used to improve or amplify shelf life of drugs by decreasing or lowering the oxidation of active ingredients or excipients • Pharmaceutical promotion attempts to move the consumer or health worker from the state of unawareness of a drug product to one of product usage or repeat usage. • The procedures and standards are prescribed in the 11. Special labeling is required for different types of drug formulations and delivery methods, such as inhalers, capsules, creams and injections. g NaOH absorbs atmospheric CO2. • Traffic control • Air control • surface disinfection • personnel 8. Drug products have 2 main types of ingredients Active ingredients — The ingredients that biologically affect your body known as API. Cleaning validation to prevent cross-contamination and ensure cleaning procedures adequately remove residues between product 3. • It should maintain the quality, safety and stability of the medicine. 440 views • 12 slides It then discusses sources and types of impurities that can arise during the manufacturing, purification, and storage of drugs. DENTAL PRODUCTS UNIT 3 Gastrointestinal agents- 5. The goal of labeling is to ensure safe use of approved pharmaceutical products and distinguish brands. Your brand is what you stand for, what you are known for. It defines a label and describes two main types - manufacturer labels and dispensing labels. Inactive ingredients — These generally have no biological effect known as EXCIPIENTS. STERILITY TESTING • Sterility testing is defined as a testing which confirms that products are free from the presence of viable microorganisms. Sanap M. g. The main types of packaging materials discussed are glass, plastic, metal, and rubber. INTRODUCTION • The pharmaceutical packaging can be defined as an economical means of providing presentation, protection, identification, information, containment, convenience and compliance for a Type IV Glass Type NP glass/General-purpose soda lime glass This type of glass container has low hydrolytic resistance. The qualities and attributes that people think of when they hear the name of the brand, or see the visual marks of the brand. List of personnel (with designation, qualification & experience), List of equipments, instruments, utilities along with make and The type of chemical reactions like halogenations, oxidation, reduction, nitration, hydrolysis etc. - Types of impurities include identified, potential, unidentified, and in-process impurities. com 21 22. Radiation sterilization is generally applied to articles in the dry state; including surgical instruments, sutures, prostheses, unit dose ointments, plastic syringes and dry pharmaceutical products. • Protect the product against: physical damage, chemical and microbial contamination, light, moisture and oxygen as appropriate • Be user friendly, easy to open and 1. Moreover, immediate loss of the whole product occurs in case of breakage of the container. It defines impurity and describes how even small amounts can affect the efficacy, safety, and properties of pharmaceutical products. Acidifiers 6. pptx Pharmaceutical Inorganic chemistry UNIT-I (Part-II) - Download as a PDF or view online for free • There are many pharmaceutical products which when manufactured are contaminated with atmospheric CO2 and water vapour . a-Purified water(PW) b-Water for injection B- Packaged forms: 6. Sterile Products , H R Patel Institute of Pharmaceutical Education and Research, Shirpur 2. Distribution Channels • A channel level is each layer of marketing intermediaries that performs some distribution work. The presentation provides brief concept on the materials used for the primary packaging of pharmaceutical Other types of pharmaceutical glass include treated soda lime glass used for blood, plasma and infusions due to its alkali resistance. Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification, information, convenience, integrity and stability of the product. Pharmaceutical industry has a lot of constraints and specialties which make it stand on a completely different scale than any other industries. 3 Is needed by the importing country when the product in question is intended for registration (licencing, authorisation) or renewal (prolongation) of registration, with the scope of commercialisation or distribution in that country. 29. Manufacturing layout. Manufacturer labels contain drug information for medical professionals and must include the name, strength, dosage form, quantity, instructions, precautions, registration number, batch number, dates and 3. Pharmaceutical Formulation Pharmaceutical formulation is the process of combining various chemical substances with the active drug to form a final medicinal product, which is called a drug mixture or drug formulation. Pharmaceutical products. The Pharmaceuticals and Medical Devices Agency (PMDA), along with the Ministry of Health, Labor, and Welfare (MHLW), oversees the registration process for pharmaceuticals. (see next slide) • Based on the number of levels, a channel can be Direct or Indirect: • Direct marketing channel has no intermediary levels; the company sells directly to 4. UV light, with its much lower energy, and poor penetrability finds uses in the sterilization of air, for surface sterilization of aseptic work areas, for treatment of This document discusses best practices for dispensing operations to ensure they are safe, compliant, and sustainable. Dispatch and transport • Materials and pharmaceutical products should be transported in such a way that their integrity is not impaired and that storage conditions are maintained. Acids, Bases and Buffers 3. toxic substance such as dust, paints, fuel or chemicals present in the work place are capable of causing harm to the pharmaceutical products. Objective of the Quality Audits- Pharmaceutical manufacturers commonly use audits as an effective mechanism to verify compliance with GMP regulation (GMP). General Principles The purpose of stability testing is to provide evidence on how the quality of an active substance or pharmaceutical product varies with time under the influence of a variety of environmental factors such • Download as PPT, PDF • 21 likes • 13,064 views. The effect on the human body The stages involved in development of new pharmaceutical products Different methods of administering drugs CONCLUSION: Incompatibility is defined as a change resulting and an undesirable product is formed, which may affect the safety, efficacy, appearance and stability of the pharmaceutical product. High-quality water is essential for the manufacturing of pharmaceuticals. Pharmaceutical packaging can be defined as the economical means of providing presentation, protection, identification , information, 3. The container shall meet all requirements under 21 CFR Direct Food Contact and physical tests in accordance to latest USP <661>: The container shall protect the contents from In the pharma industry, this could enable suppliers and retailers to verify a product quickly and accurately — in most cases using standard technology. It has high melting point so can with stand high temperatures. Definition The packaging can be defined as the economical means of providing presentation, protection, identification, information, containment, convenience compliance, integrity and stability for a product during storage, transportation display and until it is consumed or throughout its shelf life. e. The solubility of the emulsifying agent. Pharmaceutical selling skills - Download as a PDF or view online for free Handling objectionsDoctor is not interested in your product because doctor is satisfied with competitor’s product or doctor has never used that type of product. E. , employed may also contribute to the presence of impurities in the final preparation. Pharmaceutical Filtration - Download as a PDF or view online for free Area (A, m2) The chosen filtration process must remove the contaminants from the product • At an acceptably fast rate • Economically Aulton’s Pharmaceutics 4. Containers for human blood and blood components must not be reused. The 10. • The number of intermediary levels indicates the length of a marketing channel. Observe the quantity of the black ppt of lead sulphide formed and compare 34. E. The certificate of pharmaceutical product is a certificate issued in the format recommended by the World Health Organization (WHO), which establishes the status of the pharmaceutical product. Pharmaceutical dosage forms refers to pharmaceutical preparations or formulations in which one or more Drugs (active pharmaceutical ingredients - API) and Excipients (inactive components) are presented in a preservatives preservation of pharmaceutical products use of antimicrobial agents as preservative Preservatives Prevent the growth of unwanted and harmful microorganisms in pharmaceutical products. • RFID tags can be read without the need for close contact or a direct line of sight, and offer read/write functionality, which makes them ideal for tracking products and monitoring processes. 4. STRESS TESTING Stress testing of the drug substance can help identify the likely degradation products, which can in turn help establish the degradation pathways. 110 : Sampling and testing of in-process materials and drug products. Submit Search. The below described article gives the detailed information about the types, causes and how to Sterile Products - Download as a PDF or view online for free. Green field 3. Microbial spoilage can be caused by bacteria, yeasts or fungi which are all extremely versatile in their 3. Loss of volatile ingredients: Medicinal agents like Camphor, Iodine, Menthol, Ethanol or Chloroform have a tendency to evaporate from the product during storage. INTRODUCTION Packaging is the science, art and technology of enclosing or protecting products for distribution, storage, sale, and use. Download ppt "REGISTRATION OF PHARMACEUTICAL PRODUCTS" Similar presentations 211. It is these attributes that people speak of when they talk about "brand personality". Objective; To achieve a predictable therapeutic response to a drug included in a formulation which is capable of Labels also provide storage instructions, dosage information, potential drug interactions and warnings. A drug formulation can be given to the patient in various forms like solid, semisolid or liquid. ziwzk tedzhv zka kohix hrjwn dqqtbs ahzen ycen xdbdpw vtivg