TRANSDERMAL DRUG DELIVERY SYSTEMS (TDDS)
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TRANSDERMAL DRUG DELIVERY SYSTEMS (TDDS) FOR SKIN TREATMENT
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1) It defines drug dissolution rate and the processes involved, such as wetting, disintegration, and diffusion of dissolved particles.
2) It describes several theories of drug dissolution, including the diffusion layer model, Danckwert's penetration model, and the interfacial barrier model.
3) It lists many factors that can affect a drug's dissolution rate, such as its physical and chemical properties, the dosage form characteristics, and the dissolution test conditions.
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This document presents an overview of ICH Q8 guidelines for pharmaceutical product development using Quality by Design (QbD) principles. It discusses key QbD concepts like Quality Target Product Profile, critical quality attributes, critical process parameters, and design space. The document also summarizes the contents that should be included in the CTD quality module regarding drug substances, formulation development, manufacturing process, container closure system, microbiological attributes, and compatibility studies. Finally, it emphasizes that QbD ensures quality is built into the product design rather than relying solely on end-product testing.
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The document discusses gastrointestinal absorption of drugs. It describes the major absorption sites in the gastrointestinal tract including the stomach, small intestine and large intestine. It then discusses the various mechanisms of drug absorption including passive diffusion, carrier-mediated transport such as facilitated diffusion and active transport, ionic diffusion, ion pair transport, and endocytosis. Carrier-mediated transport uses carriers or enzymes to transport drugs against or along a concentration gradient, while passive diffusion occurs down a concentration gradient without carriers.
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The document discusses drug dissolution, including:
1) It defines drug dissolution rate and the processes involved, such as wetting, disintegration, and diffusion of dissolved particles.
2) It describes several theories of drug dissolution, including the diffusion layer model, Danckwert's penetration model, and the interfacial barrier model.
3) It lists many factors that can affect a drug's dissolution rate, such as its physical and chemical properties, the dosage form characteristics, and the dissolution test conditions.
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The document discusses various concepts related to validation of pharmaceutical processes including user requirement specification (URS), design qualification (DQ), installation qualification (IQ), operational qualification (OQ), performance qualification (PQ), and maintenance qualification (MQ). It explains that URS is a critical document that defines the requirements for the system. Validation involves qualification of the design, installation, operation, and performance of the system to ensure it meets predetermined specifications.
Cytochorme p450 enzyme
Cytochrome P450 enzymes are monooxygenase enzymes involved in metabolizing various substances like medications, toxins, and other chemicals. They are found in humans, plants, animals and prokaryotes, primarily in the liver and on endoplasmic reticulum membranes. CYP enzymes participate in synthesis and metabolism through various reactions like oxygenation and hydroxylation. Certain CYP enzymes metabolize most drugs, and genetic variations in these enzymes can impact drug metabolism and response. CYP enzymes are also involved in drug interactions as their activity can be inhibited or induced by other drugs. Bacterial CYP enzymes show potential for applications in biotechnology due to their regioselective oxidation abilities.
CTD AND ECTD
The document discusses the Common Technical Document (CTD) format and electronic CTD (eCTD) format for registration dossier submissions. It provides background on the International Conference on Harmonization (ICH) and its role in harmonizing technical requirements for drug registration. The key points covered are:
1) The CTD format was created by ICH to provide a standardized common format for drug registration submissions across regions/countries.
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Computer aided drug design
This document provides an overview of computer aided drug design (CADD). It discusses how CADD uses computational methods like molecular docking, virtual screening, and quantitative structure-activity relationships (QSAR) to aid in the drug design process. Molecular docking uses software to predict how drug molecules bind to biological targets. QSAR analyzes relationships between chemical structure and biological activity. CADD aims to identify and optimize lead drug compounds in silico to reduce costs and save on experimental trials in drug development.
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Bioavailability and bioequivalance studies
This document discusses guidelines for bioavailability and bioequivalence studies. It defines key terms like bioavailability, bioequivalence, pharmaceutical equivalents and alternatives. It outlines when bioequivalence studies are necessary, such as for modified release drugs, and when they are not required, such as for parenteral solutions. It also describes the different types of studies including pharmacokinetic, pharmacodynamic and clinical endpoint studies. Finally, it provides details on study design, population, conditions and statistical evaluation for pharmacokinetic bioequivalence studies.
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Surveying: Object Principles & Types of Surveying; Site Plans, Plans & Maps; Scales & Unit of different Measurements.
Linear Measurements: Instruments used. Linear Measurement by Tape, Ranging out Survey Lines and overcoming Obstructions; Measurements on sloping ground; Tape corrections, conventional symbols. Angular Measurements: Instruments used; Introduction to Compass Surveying, Bearings and Longitude & Latitude of a Line, Introduction to total station.
Levelling: Instrument used Object of levelling, Methods of levelling in brief, and Contour maps.
Chapter 4
Buildings: Selection of site for Buildings, Layout of Building Plan, Types of buildings, Plinth area, carpet area, floor space index, Introduction to building byelaws, concept of sun light & ventilation. Components of Buildings & their functions, Basic concept of R.C.C., Introduction to types of foundation
Chapter 5
Transportation: Introduction to Transportation Engineering; Traffic and Road Safety: Types and Characteristics of Various Modes of Transportation; Various Road Traffic Signs, Causes of Accidents and Road Safety Measures.
Chapter 6
Environmental Engineering: Environmental Pollution, Environmental Acts and Regulations, Functional Concepts of Ecology, Basics of Species, Biodiversity, Ecosystem, Hydrological Cycle; Chemical Cycles: Carbon, Nitrogen & Phosphorus; Energy Flow in Ecosystems.
Water Pollution: Water Quality standards, Introduction to Treatment & Disposal of Waste Water. Reuse and Saving of Water, Rain Water Harvesting. Solid Waste Management: Classification of Solid Waste, Collection, Transportation and Disposal of Solid. Recycling of Solid Waste: Energy Recovery, Sanitary Landfill, On-Site Sanitation. Air & Noise Pollution: Primary and Secondary air pollutants, Harmful effects of Air Pollution, Control of Air Pollution. . Noise Pollution Harmful Effects of noise pollution, control of noise pollution, Global warming & Climate Change, Ozone depletion, Greenhouse effect
Text Books:
1. Palancharmy, Basic Civil Engineering, McGraw Hill publishers.
2. Satheesh Gopi, Basic Civil Engineering, Pearson Publishers.
3. Ketki Rangwala Dalal, Essentials of Civil Engineering, Charotar Publishing House.
4. BCP, Surveying volume 1
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