MSc/PGDiploma in Clinical Research and Regulatory Affairs MCR104 - BASICS OF PHARMACY, DRUG DISCOVERY AND DEVELOPMENT

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1 PROGRAM SEMESTER SUBJECT BOOK ID MSc/PGDiploma in Clinical Research and Regulatory Affairs MCR - BASICS OF PHARMACY, DRUG DISCOVERY AND DEVELOPMENT B709 SESSION FALL 0 No Question/Answer key Marks Total Marks Q A Define packaging with respect to pharmaceuticals. List out the functions of packaging. Describe the different types of packaging in drug industry. ( Unit ; Section.,.. ) Defining packaging It is defined as the collection of different components which surround the pharmaceutical product from the time of production until its use. Packaging also refers to the process of design, evaluation, and production of packages. Packaging can be described as a coordinated system of preparing goods for transport, warehousing, logistics, sale, and end use. Listing the functions of packaging A] Containment: The containment of the product is the most fundamental function of packaging for medicinal products. This requires the packaging: not to leak, nor allow diffusion and permeation of the product to be strong enough to hold the contents when subjected to normal handling Not to be altered by the ingredients of the formulation in its final dosage form. B] Protection: The packaging must protect the product against all adverse external influences that may affect its quality or potency, such as: Light Moisture Oxygen Biological contamination Mechanical damage C] Stability Parameters: Protect the Product from Moisture and Gas. Light and Temperature Protection. Microbiological Integrity ph Stability Q A "primary", "secondary", tertiary, Unit-dose packaging and Device packaging Discuss briefly about "primary", "secondary", tertiary, Unit-dose packaging and Device packaging. Define DMF. List out the types of Drug Master Files. Explain the submissions to Drug Master Files. ( Unit 6 ; Section 6.6 )

2 Defining DMF A Drug Master File (DMF) is a submission to the Food and Drug Administration (FDA) that may be used to provide confidential detailed information about facilities, processes, or articles used in the manufacturing, processing, packaging, and storing of one or more human drugs. A DMF is submitted solely at the discretion of the holder. The information contained in the DMF may be used to support an Investigational New Drug Application (IND), a New Drug Application (NDA), an Abbreviated New Drug Application (ANDA), another DMF, an Export Application, or amendments and supplements to any of these. Q A Types of DMFs There are five types of DMFs: ) Type I: Manufacturing site, facilities, operating procedures, and personnel. ) Type II: Drug substance, drug substance intermediate, and material used in their preparation, or drug product. ) Type III: packaging material. ) Type IV: Excipient, colorant, flavor, essence, or material used in their preparation. ) Type V: FDA accepted reference information. Submissions to Drug Master Files Each DMF submission should contain a transmittal letter, administrative information about the submission, and the specific information to be included in the DMF. The DMF must be in the English language. Whenever a submission contains information in another language, an accurate certified English translation must also be included. Each page of each copy of the DMF should be dated and consecutively numbered. An updated table of contents should be included with each submission. Define pharmacokinetics and pharmacodynamics. Briefly describe the different pharmacokinetic processes that determine the drug concentration in the body when medicines are prescribed. ( Unit ; Section.7 ) Defining pharmacokinetics and pharmacodynamics Defining Pharmacokinetics: Pharmacokinetics sometimes abbreviated as PK and it is the area related to pharmacology and biopharmaceutics, dedicated to the determination of the fate of substances administered externally to a living organism. In short, it deals with ADME (Absorption, Distribution, Metabolism and Elimination or Excretion) of the drug. Defining pharmacodynamics: Pharmacodynamics is sometimes abbreviated as "PD". It is the study of the biochemical and physiological effects of drugs and the mechanisms of drug action and the relationship between drug concentration and effect. It is often summarily stated that pharmacodynamics is the study of what a drug does to the body. Pharmacokinetic processes-adme Describing different pharmacokinetic processes-adme Pharmacokinetic processes that determine the drug concentration in the body Brief description of different pharmacokinetic processes that determine the drug concentration in the body when medicines are prescribed.

3 Q A Define personalized medicine. Explain the advantages and disadvantages of personalized medicine in respect to health care industry in future. ( Unit ; Section.,..,.. ) Definition of personalized medicine Personalized medicine is moving us closer to more precise, predictable and powerful medicine which is customized for the individual patient. Therefore matching patients to treatments by screening their genetic makeup is the goal of some drugs companies. Advantages of personalized medicine a) More powerful medicine b) Safer drugs c) More accurate drug dosages d) Screening for disease e) Better vaccines f) Economically viable personalized medicine Disadvantages of personalized medicine ) Not everybody welcomes personalized medicine with the same enthusiasm as doctors and those with an increased risk of inherited diseases. The idea of having their health records and, even worse, their genetic data stored in a central database scares many people in the First World, who already feel insufficiently protected against intrusions into their private lives and many ethicists and doctors agree, as the possibilities for abuse are numerous. ) Health insurers might increase premiums for people with a high number of risk factors. ) Employers might decide against applicants or even lay off workers if their genetic make-up indicates that they have a higher risk of developing job-related ailments. ) Life insurance companies might refuse to insure people who have a higher chance of stroke, heart failure or cancer. ) Physicians fear that storing health and genetic data might impede medical practice and biomedical research when patients refuse to disclose this information if they do not trust their physicians to use it in their best interest. Q A Define chromatography. Classify different chromatographic methods and explain. ( Unit ; Section.,.. ) Defining Chromatography Chromatography is a dynamic process in which a molecular mixture is separated depending upon the differential affinity of solutes between two immiscible phases (mobile and stationary phase). Mobile phase - mobile phase can be liquid, mixture of solutions or solvents or a pure gas or mixture of gases. Stationary phase - it is a fine bed of large surface area. It may be highly porous or finely divided solid or granular solid or it can also be a thin film of liquid supported on a suitable inert solid (support). Classification of chromatography By the physical state of the mobile phase and stationary phase By the method of contact between the mobile phase and stationary phase or By the chemical or physical mechanism responsible for separating the sample s constituents.

4 Different chromatographic techniques based on the classification Describe different chromatographic techniques based on the classification in details. A) Based on principle of separation i) Adsorption chromatography ii) Partition chromatography iii) Ion-exchange chromatography iv) Size-exclusion chromatography v) Electrophoretic separation B) Based on mode of separation ) Normal Phase Chromatography ) Reverse Phase Chromatography C) Based on mode of bringing together the stationary and mobile phase ) Column chromatography ) Paper chromatography ) Gel permeation chromatography ) Liquid chromatography (LC) ) Gas chromatography 6) High Performance Liquid Chromatography (HPLC) 7) Thin-Layer Chromatography (TLC) 8) High Performance Thin-Layer Chromatography (HPTLC) 8 Q 6 A 6 Discuss different criteria used in selecting the analytical methods. ( Unit ; Section.. ) Listing design criteria Listing different criteria which are used in selecting the analytical methods are: accuracy, precision, sensitivity, specificity, selectivity, robustness, ruggedness, scale of operation, analysis time, availability of equipment and unit cost of the analysis. Discussing each criteria i) Accuracy: It is a measure of how closely the result of an experiment agrees with the expected result. ii) Precision: When a sample is analyzed several times, the individual results are rarely the same. Instead, the results are randomly scattered. Precision is a measure of this variability. iii) Sensitivity: It is the change in signal per unit change in the amount of analyte. Sensitivity is often confused with a method s detection limit. iv) Selectivity: The extent to which the method can determine a particular analyte in a complex mixture without interference from other components in the mixture. v) Robustness: For a method to be useful, it must provide reliable results. vi) Ruggedness: Random variations in experimental conditions also introduce uncertainty. If a method s sensitivity is highly dependent on experimental conditions, such as temperature, acidity, or reaction time, then slight changes in those conditions may lead to significantly different results. A rugged method is relatively insensitive to changes in experimental conditions. vii) Instrumentation, time and cost: Analytical methods can be compared in terms of their need for equipment, the time required to complete an analysis, and the cost per sample.methods relying on instrumentation are equipment-intensive and may require significant operator training. The time needed to complete an analysis for a single sample is often fairly similar from method to method. The cost of an analysis is determined by many factors, 8

5 including the cost of necessary equipment and reagents, the cost of hiring analysts, and the number of samples that can be processed per hour. In general, methods relying on instruments cost more per sample than other methods. viii) Making the final choice: The best method is often dictated by the sample s properties.