ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS (MIP 201T)
Scope
This course is designed to impart knowledge and skills necessary for dose calculations, dose adjustments and to apply Biopharmaceutics theories in practical problem solving.
Objectives
On completion of this course it is expected that students will be able to understand,
The basic concepts in Biopharmaceutics and pharmacokinetics.
The use of raw data and derive the pharmacokinetic models and parameters the best describe the process of drug absorption, distribution, metabolism and elimination.
To critically evaluate Biopharmaceutics studies involving drug product equivalency.
To design and evaluate dosage regimens of the drugs using pharmacokinetic and biopharmaceutic parameters.
THEORY 60 Hrs
1. Drug Absorption From The Gastrointestinal Tract: Gastrointestinal tract, Mechanism of drug absorption, Factors affecting, pH–partition theory, Formulation and physicochemical factors: Dissolution rate, Dissolution process, Noyes–Whitney equation and drug dissolution, Factors affecting the dissolution rate. Gastrointestinal absorption: role of the dosage form: Solution (elixir, syrup and solution) as a dosage form ,Suspension as a dosage form, Capsule as a dosage form, Tablet as a dosage form
,Dissolution methods ,Formulation and processing factors,
Correlation of in vivo data with in vitro dissolution data. Transport model: Permeability-Solubility-Charge State and the pH Partition Hypothesis, Properties of the Gastrointestinal Tract (GIT), pH Microclimate Intracellular pH Environment, Tight-Junction Complex. Solubility: Experimental methods. Permeability: In-vitro, in-situ and In-vivo methods.
Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance: Introduction, Biopharmaceutic Factors Affecting Drug Bioavailability, Rate- Limiting Steps in Drug Absorption, Physicochemical Nature of the
12
Hrs
12
Hrs
Drug Formulation Factors Affecting Drug Product Performance, In Vitro: Dissolution and Drug Release Testing, Compendial Methods of Dissolution, Alternative Methods of Dissolution Testing, Meeting Dissolution Requirements, Problems of Variable Control in Dissolution Testing Performance of Drug Products: In Vitro–In Vivo Correlation, Dissolution Profile Comparisons, Drug Product Stability, Considerations in the Design of a Drug Product.
Pharmacokinetics: Basic considerations, Pharmacokinetic models, Compartment modeling: One compartment model- IV bolus, IV infusion, Extra-vascular; Multi Compartment model: Two compartment - model in brief, Non-Linear Pharmacokinetics: Cause of non-linearity, Michaelis – Menten equation, Estimation Kmax and Vmax. Drug interactions: Introduction, The effect of protein-binding interactions, The effect of tissue-binding interactions, Cytochrome P450-based drug interactions, Drug interactions linked to transporters.
Drug Product Performance, In Vivo: Bioavailability and Bioequivalence: Drug Product Performance, Purpose of Bioavailability Studies, Relative and Absolute Availability, , Methods for Assessing Bioavailability, Bioequivalence Studies, Design and Evaluation of Bioequivalence Studies, Study Designs, Crossover Study Designs, Evaluation of the Data, Bioequivalence Example, Study Submission and Drug Review Process, The Biopharmaceutics Classification System, Generic Biologics (Biosimilar Drug Products),Clinical Significance of Bioequivalence Studies, Special Concerns in Bioavailability and Bioequivalence Studies, Generic Substitution.
Application of Pharmacokinetics: Modified-Release Drug Products, Targeted Drug Delivery Systems and Biotechnological Products. Relationship between Pharmacokinetics including Pharmacodynamics: Generation of a pharmacokinetic– pharmacodynamic (PKPD) equation, Pharmacokinetic and pharmacodynamic, interactions. Pharmacokinetics and pharmacodynamics of biotechnology drugs: Introduction, Proteins and peptides, Monoclonal antibodies, Oligonucleotides, Vaccines (immunotherapy),Gene therapies.
12
Hrs
12
Hrs
12
Hrs
REFERENCES
Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th edition,Philadelphia, Lea and Febiger, 1991
Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar and Sunil B.J aiswal., Vallab Prakashan, Pitampura, Delhi
Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC, 2nd edition, Connecticut Appleton Century Crofts, 1985
Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R. Hiremath,Prism Book
Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker Inc.,New York, 1982
Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J, Lea and Febiger, Philadelphia, 1970
Clinical Pharmacokinetics, Concepts and Applications 3rd edition by Malcolm Rowland and Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995
Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack Publishing Company, Pennsylvania 1989
Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th edition, revised and expande by Robert. E. Notari, Marcel Dekker Inc, New York and Basel,1987.
Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and M.Pemarowski, 1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971.
Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.Boylan, Marcel Dekker Inc, New York, 1996.
Basic Pharmacokinetics,1 st edition, Sunil S Jambhekar and Philip J Breen,pharmaceutical press, RPS Publishing,2009.
Absorption and Drug Development- Solubility, Permeability, and Charge State, Alex Avdeef, John Wiley & Sons, Inc,2003.
SCALE UP AND TECHNOLOGY TRANSFER (MIP 202T)
Scope
This course is designed to impart knowledge and skills necessary to train the students to be on scale up, technology transfer process and industrial safety issues.
Objectives:
On completion of this course it is expected that students will be able to understand,
Manage the scale up process in pharmaceutical industry.
Assist in technology transfer.
To establish safety guidelines, which prevent industrial hazards.
THEORY 60 Hrs
1. Pilot plant design: Basic requirements for design, facility, equipment selection, for tablets, capsules, liquid orals, parentral and semisolid preparations.
Scale up: Importance, Technology transfer from R & D to pilot plant to plant scale, process scale up for tablets, capsules, liquid orals, semisolids, parentral, NDDS products – stress on formula, equipments, product uniformity, stability, raw materials, physical layout, input, in-process and finished product specifications, problems encountered during transfer of technology
Validation: General concepts, types, procedures & protocols, documentation, VMF. Analytical method validation, cleaning validation and vender qualification.
Equipment Qualification: Importance, IQ, OQ, PQ for equipments – autoclave, DHS, membrane filter, rapid mixer granulator, cone blender, FBD, tablet compression machine, liquid filling and sealing machine. Aseptic room validation.
Process validation: Importance, validation of mixing, granulation, drying, compression, tablet coating, liquid filling and sealing, sterilization, water process systems, environmental control.
12
Hrs
12
Hrs
12
Hrs
12
Hrs
Industrial safety: Hazards – fire, mechanical, electrical, chemical and pharmaceutical, Monitoring & prevention systems, industrial effluent testing & treatment. Control of environmental pollution.
12
Hrs
REFERENCES
Pharmaceutical process validation, JR Berry, Nash, Vol 57, Marcel Dekker, NY.
Pharmaceutical Production facilities, design and applications, by GC Cole, Taylor and Francis.
Pharmaceutical project management, T.Kennedy, Vol 86, Marcel Dekker, NY.
The theory & Practice of Industrial Pharmacy, L.Lachman, H.A.Lieberman,
Varghese Publ. Bombay.
Tablet machine instruments in pharmaceuticals, PR Watt, John Wiloy.
Pharmaceutical dosage forms, Tablets, Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
Pharmaceutical dosage forms, Parentral medications, Vol 1, 2 by K.E. Avis, Marcel Dekker, NY.
Dispersed system Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
Subrahmanyam, CVS, Pharmaceutical production and Management, 2007, Vallabh Prakashan,Dehli.
PHARMACEUTICAL PRODUCTION TECHNOLOGY (MIP 203T)
Scope
This course is designed to impart knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in Production
Objectives
On completion of this course it is expected that students will be able to understand,
Handle the scheduled activities in a Pharmaceutical firm.
Manage the production of large batches of pharmaceutical formulations.
THEORY 60 Hrs
Improved Tablet Production: Tablet production process, unit
1. operation improvements, granulation and pelletization equipments, continuous and batch mixing, rapid mixing granulators, rota granulators, spheronizers and marumerisers, and other specialized granulation and drying equipments. Problems encountered.
Coating Technology: Process, equipments, particle coating, fluidized bed coating, application techniques. Problems encountered.
Parenteral Production: Area planning & environmental control, wall and floor treatment, fixtures and machineries, change rooms, personnel flow, utilities & utilities equipment location, engineering and maintenance.
Lyophilization & Spray drying Technology: Principles, process, freeze-drying and spray drying equipments.
Capsule Production: Production process, improved capsule manufacturing and filling machines for hard and soft gelatin capsules. Layout and problems encountered.
Disperse Systems Production: Production processes, applications of mixers, mills, disperse equipments including fine solids dispersion, problems encountered.
12
Hrs
12
Hrs
12
Hrs
12
Hrs
Packaging Technology: Types of packaging materials, machinery, labeling, package printing for different dosage forms.
Air Handling Systems: Study of AHUs, humidity & temperature control, air filtration systems, dust collectors. Water Treatment Process: Techniques and maintenance – RO, DM, ultra – filtration, WFI.
12
Hrs
REFERENCES
The Theory & Practice of Industrial Pharmacy, L. Lachman, Varghese Publ, Bombay.
Modern Pharmaceutics by Banker, Vol 72, Marcel Dekker, NY.
Pharmaceutical Dosage Forms, Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
Pharmaceutical Dosage Forms, Parentral medications, Vol 1, 2 by K.E. Avis, Marcel Dekker, NY.
Pharmaceutical Production Facilities, design and applications, by G.C. Cole, Taylor and Francis.
Dispersed System Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
Product design and testing of polymeric materials by N.P. Chezerisionoff.
Pharmaceutical Project Management, T.Kennedy, Vol 86, Marcel Dekker, NY.
Packaging Pharmaceutical and Health Care, H.Lockhard.
Quality Control of Packaging Materials in Pharmaceutical Industy,
.Kharburn, Marcel Dekker, NY.
Freeze drying / Lyophilization of Pharmaceuticals & Biological Products, L. Ray, Vol 96, Marcel Dekker, NY.
Tablet Machine Instrumentation In Pharmaceuticals, PR Watt, Ellis Horwoods, UK.
ENTREPRENEURSHIP MANAGEMENT (MIP 204T)
Scope
This course is designed to impart knowledge and skills necessary to train the students on entrepreneurship management.
Objectives:
On completion of this course it is expected that students will be able to understand,
The Role of enterprise in national and global economy
Dynamics of motivation and concepts of entrepreneurship
Demands and challenges of Growth Strategies And Networking
THEORY 60 Hrs
1. Conceptual Frame Work: Concept need and process in entrepreneurship development. Role of enterprise in national and global economy. Types of enterprise – Merits and Demerits. Government policies and schemes for enterprise development. Institutional support in enterprise development and management.
Entrepreneur: Entrepreneurial motivation – dynamics of motivation. Entrepreneurial competency –Concepts. Developing Entrepreneurial competencies - requirements and understanding the process of entrepreneurship development, self-awareness, interpersonal skills, creativity, assertiveness, achievement, factors affecting entrepreneur role.
Launching And Organising An Enterprise: Environment scanning – Information, sources, schemes of assistance, problems. Enterprise selection, market assessment, enterprise feasibility study, SWOT Analysis. Resource mobilisation - finance, technology, raw material, site and manpower. Costing and marketing management and quality control. Feedback, monitoring and evaluation.
Growth Strategies And Networking: Performance appraisal and assessment. Profitability and control measures, demands and challenges. Need for diversification. Future Growth – Techniques of expansion and diversification, vision strategies. Concept and dynamics. Methods, Joint venture, co-ordination and feasibility study.
12
Hrs
12
Hrs
12
Hrs
12
Hrs
Preparing Project Proposal To Start On New Enterprise Project work – Feasibility report; Planning, resource mobilisation and implementation.
12
Hrs
REFERENCES
Akhauri, M.M.P.(1990): Entrepreneurship for Women in India, NIESBUD, New Delhi.
Hisrich, R.D & Brush, C.G.(1996) The Women Entrepreneurs, D.C. Health
& Co., Toranto.
Hisrich, R.D. and Peters, M.P. (1995): Entrepreneurship – Starting, Developing and Managing a New Enterprise, Richard D., Inwin, INC, USA.
Meredith, G.G. etal (1982): Practice of Entrepreneurship, ILO, Geneva.
Patel, V.C. (1987): Women Entrepreneurship – Developing New Entrepreneurs, Ahmedabad EDII.
INDUSTRIAL PHARMACY PRACTICAL - II (MIP 205P)
Improvement of dissolution characteristics of slightly soluble drug by Solid dispersion technique.
Comparison of dissolution of two different marketed products /brands
Protein binding studies of a highly protein bound drug & poorly protein bound drug
Bioavailability studies of Paracetamol (Animal).
Pharmacokinetic and IVIVC data analysis by WinnolineR software
In vitro cell studies for permeability and metabolism
Formulation and evaluation of tablets
Formulation and evaluation of capsules
Formulation and evaluation of injections 10.Formulation and evaluation of emulsion 11.Formulation and evaluation of suspension. 12.Formulation and evaluation of enteric coating tablets.
Preparation and evaluation of a freeze dried formulation. 14.Preparation and evaluation of a spray dried formulation.
ADVANCED BIOPHARMACEUTICS & PHARMACOKINETICS (MIP 201T)
Scope
This course is designed to impart knowledge and skills necessary for dose calculations, dose adjustments and to apply Biopharmaceutics theories in practical problem solving.
Objectives
On completion of this course it is expected that students will be able to understand,
The basic concepts in Biopharmaceutics and pharmacokinetics.
The use of raw data and derive the pharmacokinetic models and parameters the best describe the process of drug absorption, distribution, metabolism and elimination.
To critically evaluate Biopharmaceutics studies involving drug product equivalency.
To design and evaluate dosage regimens of the drugs using pharmacokinetic and biopharmaceutic parameters.
THEORY 60 Hrs
1. Drug Absorption From The Gastrointestinal Tract: Gastrointestinal tract, Mechanism of drug absorption, Factors affecting, pH–partition theory, Formulation and physicochemical factors: Dissolution rate, Dissolution process, Noyes–Whitney equation and drug dissolution, Factors affecting the dissolution rate. Gastrointestinal absorption: role of the dosage form: Solution (elixir, syrup and solution) as a dosage form ,Suspension as a dosage form, Capsule as a dosage form, Tablet as a dosage form
,Dissolution methods ,Formulation and processing factors,
Correlation of in vivo data with in vitro dissolution data. Transport model: Permeability-Solubility-Charge State and the pH Partition Hypothesis, Properties of the Gastrointestinal Tract (GIT), pH Microclimate Intracellular pH Environment, Tight-Junction Complex. Solubility: Experimental methods. Permeability: In-vitro, in-situ and In-vivo methods.
Biopharmaceutic Considerations in Drug Product Design and In Vitro Drug Product Performance: Introduction, Biopharmaceutic Factors Affecting Drug Bioavailability, Rate- Limiting Steps in Drug Absorption, Physicochemical Nature of the
12
Hrs
12
Hrs
Drug Formulation Factors Affecting Drug Product Performance, In Vitro: Dissolution and Drug Release Testing, Compendial Methods of Dissolution, Alternative Methods of Dissolution Testing, Meeting Dissolution Requirements, Problems of Variable Control in Dissolution Testing Performance of Drug Products: In Vitro–In Vivo Correlation, Dissolution Profile Comparisons, Drug Product Stability, Considerations in the Design of a Drug Product.
Pharmacokinetics: Basic considerations, Pharmacokinetic models, Compartment modeling: One compartment model- IV bolus, IV infusion, Extra-vascular; Multi Compartment model: Two compartment - model in brief, Non-Linear Pharmacokinetics: Cause of non-linearity, Michaelis – Menten equation, Estimation Kmax and Vmax. Drug interactions: Introduction, The effect of protein-binding interactions, The effect of tissue-binding interactions, Cytochrome P450-based drug interactions, Drug interactions linked to transporters.
Drug Product Performance, In Vivo: Bioavailability and Bioequivalence: Drug Product Performance, Purpose of Bioavailability Studies, Relative and Absolute Availability, , Methods for Assessing Bioavailability, Bioequivalence Studies, Design and Evaluation of Bioequivalence Studies, Study Designs, Crossover Study Designs, Evaluation of the Data, Bioequivalence Example, Study Submission and Drug Review Process, The Biopharmaceutics Classification System, Generic Biologics (Biosimilar Drug Products),Clinical Significance of Bioequivalence Studies, Special Concerns in Bioavailability and Bioequivalence Studies, Generic Substitution.
Application of Pharmacokinetics: Modified-Release Drug Products, Targeted Drug Delivery Systems and Biotechnological Products. Relationship between Pharmacokinetics including Pharmacodynamics: Generation of a pharmacokinetic– pharmacodynamic (PKPD) equation, Pharmacokinetic and pharmacodynamic, interactions. Pharmacokinetics and pharmacodynamics of biotechnology drugs: Introduction, Proteins and peptides, Monoclonal antibodies, Oligonucleotides, Vaccines (immunotherapy),Gene therapies.
12
Hrs
12
Hrs
12
Hrs
REFERENCES
Biopharmaceutics and Clinical Pharmacokinetics by Milo Gibaldi, 4th edition,Philadelphia, Lea and Febiger, 1991
Biopharmaceutics and Pharmacokinetics, A. Treatise, D .M. Brahmankar and Sunil B.J aiswal., Vallab Prakashan, Pitampura, Delhi
Applied Biopharmaceutics and Pharmacokinetics by Shargel. Land YuABC, 2nd edition, Connecticut Appleton Century Crofts, 1985
Textbook of Biopharmaceutics and Pharmacokinetics, Dr. Shobha Rani R. Hiremath,Prism Book
Pharmacokinetics by Milo Gibaldi and D. Perrier, 2nd edition, Marcel Dekker Inc.,New York, 1982
Current Concepts in Pharmaceutical Sciences: Biopharmaceutics, Swarbrick. J, Lea and Febiger, Philadelphia, 1970
Clinical Pharmacokinetics, Concepts and Applications 3rd edition by Malcolm Rowland and Thom~ N. Tozer, Lea and Febiger, Philadelphia, 1995
Dissolution, Bioavailability and Bioequivalence, Abdou. H.M, Mack Publishing Company, Pennsylvania 1989
Biopharmaceutics and Clinical Pharmacokinetics, An Introduction, 4th edition, revised and expande by Robert. E. Notari, Marcel Dekker Inc, New York and Basel,1987.
Biopharmaceutics and Relevant Pharmacokinetics by John. G Wagner and M.Pemarowski, 1st edition, Drug Intelligence Publications, Hamilton, Illinois, 1971.
Encyclopedia of Pharmaceutical Technology, Vol 13, James Swarbrick, James. G.Boylan, Marcel Dekker Inc, New York, 1996.
Basic Pharmacokinetics,1 st edition, Sunil S Jambhekar and Philip J Breen,pharmaceutical press, RPS Publishing,2009.
Absorption and Drug Development- Solubility, Permeability, and Charge State, Alex Avdeef, John Wiley & Sons, Inc,2003.
SCALE UP AND TECHNOLOGY TRANSFER (MIP 202T)
Scope
This course is designed to impart knowledge and skills necessary to train the students to be on scale up, technology transfer process and industrial safety issues.
Objectives:
On completion of this course it is expected that students will be able to understand,
Manage the scale up process in pharmaceutical industry.
Assist in technology transfer.
To establish safety guidelines, which prevent industrial hazards.
THEORY 60 Hrs
1. Pilot plant design: Basic requirements for design, facility, equipment selection, for tablets, capsules, liquid orals, parentral and semisolid preparations.
Scale up: Importance, Technology transfer from R & D to pilot plant to plant scale, process scale up for tablets, capsules, liquid orals, semisolids, parentral, NDDS products – stress on formula, equipments, product uniformity, stability, raw materials, physical layout, input, in-process and finished product specifications, problems encountered during transfer of technology
Validation: General concepts, types, procedures & protocols, documentation, VMF. Analytical method validation, cleaning validation and vender qualification.
Equipment Qualification: Importance, IQ, OQ, PQ for equipments – autoclave, DHS, membrane filter, rapid mixer granulator, cone blender, FBD, tablet compression machine, liquid filling and sealing machine. Aseptic room validation.
Process validation: Importance, validation of mixing, granulation, drying, compression, tablet coating, liquid filling and sealing, sterilization, water process systems, environmental control.
12
Hrs
12
Hrs
12
Hrs
12
Hrs
Industrial safety: Hazards – fire, mechanical, electrical, chemical and pharmaceutical, Monitoring & prevention systems, industrial effluent testing & treatment. Control of environmental pollution.
12
Hrs
REFERENCES
Pharmaceutical process validation, JR Berry, Nash, Vol 57, Marcel Dekker, NY.
Pharmaceutical Production facilities, design and applications, by GC Cole, Taylor and Francis.
Pharmaceutical project management, T.Kennedy, Vol 86, Marcel Dekker, NY.
The theory & Practice of Industrial Pharmacy, L.Lachman, H.A.Lieberman,
Varghese Publ. Bombay.
Tablet machine instruments in pharmaceuticals, PR Watt, John Wiloy.
Pharmaceutical dosage forms, Tablets, Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
Pharmaceutical dosage forms, Parentral medications, Vol 1, 2 by K.E. Avis, Marcel Dekker, NY.
Dispersed system Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
Subrahmanyam, CVS, Pharmaceutical production and Management, 2007, Vallabh Prakashan,Dehli.
PHARMACEUTICAL PRODUCTION TECHNOLOGY (MIP 203T)
Scope
This course is designed to impart knowledge and skills necessary to train the students to be on par with the routine of Industrial activities in Production
Objectives
On completion of this course it is expected that students will be able to understand,
Handle the scheduled activities in a Pharmaceutical firm.
Manage the production of large batches of pharmaceutical formulations.
THEORY 60 Hrs
Improved Tablet Production: Tablet production process, unit
1. operation improvements, granulation and pelletization equipments, continuous and batch mixing, rapid mixing granulators, rota granulators, spheronizers and marumerisers, and other specialized granulation and drying equipments. Problems encountered.
Coating Technology: Process, equipments, particle coating, fluidized bed coating, application techniques. Problems encountered.
Parenteral Production: Area planning & environmental control, wall and floor treatment, fixtures and machineries, change rooms, personnel flow, utilities & utilities equipment location, engineering and maintenance.
Lyophilization & Spray drying Technology: Principles, process, freeze-drying and spray drying equipments.
Capsule Production: Production process, improved capsule manufacturing and filling machines for hard and soft gelatin capsules. Layout and problems encountered.
Disperse Systems Production: Production processes, applications of mixers, mills, disperse equipments including fine solids dispersion, problems encountered.
12
Hrs
12
Hrs
12
Hrs
12
Hrs
Packaging Technology: Types of packaging materials, machinery, labeling, package printing for different dosage forms.
Air Handling Systems: Study of AHUs, humidity & temperature control, air filtration systems, dust collectors. Water Treatment Process: Techniques and maintenance – RO, DM, ultra – filtration, WFI.
12
Hrs
REFERENCES
The Theory & Practice of Industrial Pharmacy, L. Lachman, Varghese Publ, Bombay.
Modern Pharmaceutics by Banker, Vol 72, Marcel Dekker, NY.
Pharmaceutical Dosage Forms, Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
Pharmaceutical Dosage Forms, Parentral medications, Vol 1, 2 by K.E. Avis, Marcel Dekker, NY.
Pharmaceutical Production Facilities, design and applications, by G.C. Cole, Taylor and Francis.
Dispersed System Vol 1, 2, 3 by Lachman, Lieberman, Marcel Dekker, NY.
Product design and testing of polymeric materials by N.P. Chezerisionoff.
Pharmaceutical Project Management, T.Kennedy, Vol 86, Marcel Dekker, NY.
Packaging Pharmaceutical and Health Care, H.Lockhard.
Quality Control of Packaging Materials in Pharmaceutical Industy,
.Kharburn, Marcel Dekker, NY.
Freeze drying / Lyophilization of Pharmaceuticals & Biological Products, L. Ray, Vol 96, Marcel Dekker, NY.
Tablet Machine Instrumentation In Pharmaceuticals, PR Watt, Ellis Horwoods, UK.
ENTREPRENEURSHIP MANAGEMENT (MIP 204T)
Scope
This course is designed to impart knowledge and skills necessary to train the students on entrepreneurship management.
Objectives:
On completion of this course it is expected that students will be able to understand,
The Role of enterprise in national and global economy
Dynamics of motivation and concepts of entrepreneurship
Demands and challenges of Growth Strategies And Networking
THEORY 60 Hrs
1. Conceptual Frame Work: Concept need and process in entrepreneurship development. Role of enterprise in national and global economy. Types of enterprise – Merits and Demerits. Government policies and schemes for enterprise development. Institutional support in enterprise development and management.
Entrepreneur: Entrepreneurial motivation – dynamics of motivation. Entrepreneurial competency –Concepts. Developing Entrepreneurial competencies - requirements and understanding the process of entrepreneurship development, self-awareness, interpersonal skills, creativity, assertiveness, achievement, factors affecting entrepreneur role.
Launching And Organising An Enterprise: Environment scanning – Information, sources, schemes of assistance, problems. Enterprise selection, market assessment, enterprise feasibility study, SWOT Analysis. Resource mobilisation - finance, technology, raw material, site and manpower. Costing and marketing management and quality control. Feedback, monitoring and evaluation.
Growth Strategies And Networking: Performance appraisal and assessment. Profitability and control measures, demands and challenges. Need for diversification. Future Growth – Techniques of expansion and diversification, vision strategies. Concept and dynamics. Methods, Joint venture, co-ordination and feasibility study.
12
Hrs
12
Hrs
12
Hrs
12
Hrs
Preparing Project Proposal To Start On New Enterprise Project work – Feasibility report; Planning, resource mobilisation and implementation.
12
Hrs
REFERENCES
Akhauri, M.M.P.(1990): Entrepreneurship for Women in India, NIESBUD, New Delhi.
Hisrich, R.D & Brush, C.G.(1996) The Women Entrepreneurs, D.C. Health
& Co., Toranto.
Hisrich, R.D. and Peters, M.P. (1995): Entrepreneurship – Starting, Developing and Managing a New Enterprise, Richard D., Inwin, INC, USA.
Meredith, G.G. etal (1982): Practice of Entrepreneurship, ILO, Geneva.
Patel, V.C. (1987): Women Entrepreneurship – Developing New Entrepreneurs, Ahmedabad EDII.
INDUSTRIAL PHARMACY PRACTICAL - II (MIP 205P)
Improvement of dissolution characteristics of slightly soluble drug by Solid dispersion technique.
Comparison of dissolution of two different marketed products /brands
Protein binding studies of a highly protein bound drug & poorly protein bound drug
Bioavailability studies of Paracetamol (Animal).
Pharmacokinetic and IVIVC data analysis by WinnolineR software
In vitro cell studies for permeability and metabolism
Formulation and evaluation of tablets
Formulation and evaluation of capsules
Formulation and evaluation of injections 10.Formulation and evaluation of emulsion 11.Formulation and evaluation of suspension. 12.Formulation and evaluation of enteric coating tablets.
Preparation and evaluation of a freeze dried formulation. 14.Preparation and evaluation of a spray dried formulation.