Available courses

SYLLABUS:

Unit I 10 Hours:

 Introduction, history of microbiology, its branches, scope and its importance. Introduction to Prokaryotes and Eukaryotes Study of ultra-structure and morphological classification of bacteria, nutritional requirements, raw materials used for culture media and physical parameters for growth, growth curve, isolation and preservation methods for pure cultures, cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable count). Study of different types of phase constrast microscopy, dark field microscopy and electron microscopy. Definition and examples of Probiotics and Prebiotics 

Unit II 10 Hours:

 Identification of bacteria using staining techniques (simple, Gram’s &Acid fast staining) and biochemical tests (IMViC). Definition of D value & Z value and its significance. Study of principle, procedure, merits, demerits and applications of physical, chemical gaseous,radiation and mechanical method of sterilization. Evaluation of the efficiency of sterilization methods. 38 Equipments employed in large scale sterilization. Sterility indicators. 

Unit III 10 :

Hours Study of morphology, classification, reproduction/replication and cultivation of Fungi and Viruses. Classification and mode of action of disinfectants Factors influencing disinfection, antiseptics and their evaluation. For bacteriostatic and bactericidal actions Evaluation of bactericidal & Bacteriostatic. Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP. 

Unit IV 08 Hours :

Designing of aseptic area, laminar flow equipments; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification. Principles and methods of different microbiological assay. Methods for standardization of antibiotics, vitamins and amino acids. Assessment of a new antibiotic. 

Unit V 07Hours:

 Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources and types of microbial contaminants, assessment of microbial contamination and spoilage. Preservation of pharmaceutical products using antimicrobial agents, evaluation of microbial stability of formulations. Growth of animal cells in culture, general procedure for cell culture, Primary, established and transformed cell cultures. Application of cell cultures in pharmaceutical industry and research. 

BP 307P.PHARMACEUTICAL MICROBIOLOGY (Practical) 4 Hours/week 

1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator, laminar flow or aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator, microscopes used in experimental microbiology. 

2. Sterilization of glassware, preparation and sterilization of media. 

3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations. 

4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with practical). 

5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other techniques. 

6. Microbiological assay of antibiotics by cup plate method and other methods 

7. Motility determination by Hanging drop method. 

8. Sterility testing of pharmaceuticals (Any two samples). 

9. Bacteriological analysis of water 

10. Biochemical test of any one microorganism.

SYLLABUS:

Unit I 10 Hours:

 Introduction, history of microbiology, its branches, scope and its importance. Introduction to Prokaryotes and Eukaryotes Study of ultra-structure and morphological classification of bacteria, nutritional requirements, raw materials used for culture media and physical parameters for growth, growth curve, isolation and preservation methods for pure cultures, cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable count). Study of different types of phase constrast microscopy, dark field microscopy and electron microscopy. Definition and examples of Probiotics and Prebiotics 

Unit II 10 Hours:

 Identification of bacteria using staining techniques (simple, Gram’s &Acid fast staining) and biochemical tests (IMViC). Definition of D value & Z value and its significance. Study of principle, procedure, merits, demerits and applications of physical, chemical gaseous,radiation and mechanical method of sterilization. Evaluation of the efficiency of sterilization methods. 38 Equipments employed in large scale sterilization. Sterility indicators. 

Unit III 10 :

Hours Study of morphology, classification, reproduction/replication and cultivation of Fungi and Viruses. Classification and mode of action of disinfectants Factors influencing disinfection, antiseptics and their evaluation. For bacteriostatic and bactericidal actions Evaluation of bactericidal & Bacteriostatic. Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP. 

Unit IV 08 Hours :

Designing of aseptic area, laminar flow equipments; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification. Principles and methods of different microbiological assay. Methods for standardization of antibiotics, vitamins and amino acids. Assessment of a new antibiotic. 

Unit V 07Hours:

 Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources and types of microbial contaminants, assessment of microbial contamination and spoilage. Preservation of pharmaceutical products using antimicrobial agents, evaluation of microbial stability of formulations. Growth of animal cells in culture, general procedure for cell culture, Primary, established and transformed cell cultures. Application of cell cultures in pharmaceutical industry and research. 

BP 307P.PHARMACEUTICAL MICROBIOLOGY (Practical) 4 Hours/week 

1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator, laminar flow or aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator, microscopes used in experimental microbiology. 

2. Sterilization of glassware, preparation and sterilization of media. 

3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations. 

4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with practical). 

5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other techniques. 

6. Microbiological assay of antibiotics by cup plate method and other methods 

7. Motility determination by Hanging drop method. 

8. Sterility testing of pharmaceuticals (Any two samples). 

9. Bacteriological analysis of water 

10. Biochemical test of any one microorganism.

3.6.7 T Pharmaceutical Biotechnology

(3 hrs / week)

Learning objectives: On successful completion of following theory topics, learner should be

able to

A. Knowledge:

1. Define Biotechnology & its state its scope in pharmacy

2. Know the basics of biotechnology techniques and the various systems used.

3. Know the method of genetic engineering for production of rDNA products including

monoclonal antibodies.

4. Know the information about the application of genetic engineering in animals.

5. Have a knowhow of enzymes and their uses by immobilization.

6. Illustrate use of Fermenter for production of fermentation products and information

about their purification by downstream process.

7. State the application of Fermenter process in production of vitamins and antibiotics

SR.NO

TOPIC

HR

1.       

Introduction to Biotechnology, Scope, Potential & Achievements

1

2.       

Gene transfer: Transformation, Transduction and Conjugation

3

3.       

Genetic Engineering techniques: Isolation of DNA, Genomic & cDNA

libraries, Gel electrophoresis,, Blotting techniques, DNA Hybridization, Site

directed mutagenesis, Restriction Fragment Length Polymorphism

(RFLP),DNA fingerprinting. Gene synthesis & gene machine, Gene

sequencing methods.

10

4.       

Recombinant DNA technology: Introduction and principle of rDNA

technology, Gene cloning- Introduction, enzymes acting on DNA

(restriction endonucleases, S1 nuclease, alkaline phosphatase, polymerase,

ligase,), types of cloning vectors(PUC 19, PBR 322,YAC,COSMID,Ti and

Shuttle vector), expression vectors(pGEX-3X, pPIC, CHO)

10

5.       

Examples of Biotechnology derived Products: Human insulin,

Somatotropin, Interferons, (Production of their rDNA constructs and uses)

Introduction to Human Gene Therapy

4

6.       

Introduction to transgenic animals and their applications. Germplasm

storage & cryopreservation

3

7.       

Steps involved in Monoclonal antibody production and its applications.

2

8.       

Enzyme Technology; Immobilization of enzyme & its applications

3

9.       

            Fermentation Technology; Fermenter its accessory components and

working, Down streaming Process in brief.

5

10.   

General application of fermentation in Manufacturing of Antibiotics and

Vitamins with one example each.

4

 

Recommended Books:

1. Olive Kaiser ,Rainer Muller, Pharmaceutical Biotechnology: Drug Discovery and Clinical Application, Wiley VCH publisher, 2004

2. Peter J. Russel, Genetics 5 th Edition ,The Benjamin Cummins Publishing California;1998

3. Watson WH Freeman and company N.Y. Recombinant DNA 2 nd edition Holtzbrinck Publishers 1992

4. Glick, Molecular biotechnology 3 rd edition ASM press Washington, USA 2003 61

5. Vyas and Dixit Pharmaceutical Biotechnology, 1 st CBS Publisher New Delhi, 1991

6. Dr. S. Iganacimuthu, Basic Biotechnology – Tata McGraw HillPublishers

7. P. K. Gupta, Elements Of Biotechnology, Rastogi Publication, 10 th edition, 2004

8. S.S. Purohit, Biotechnology Fundamentals and Applications Student edition Agrobios Publisher;2002

9. H. S. Chawala, Introduction of Plant Biotechnology, 2 nd edition, IBHPublishing Co. Pvt.Ltd. New Delhi, 2002

10. M.H. Razdan, Introduction to Plant Biotechnology , 2 nd edition Oxford and IBH Publishing Co. Pvt. Ltd, New Delhi. 2003

11. K. Sambamurthy, Ashutosh Kar, Pharmaceutical Biotechnology, 2ndedition New AGE International (LP) Limited, 2007.

12. U. Satyanarayana, Biotechnology,Books and Allied Ltd


SYLLABUS:

Unit I 10 Hours:

 Introduction, history of microbiology, its branches, scope and its importance. Introduction to Prokaryotes and Eukaryotes Study of ultra-structure and morphological classification of bacteria, nutritional requirements, raw materials used for culture media and physical parameters for growth, growth curve, isolation and preservation methods for pure cultures, cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable count). Study of different types of phase constrast microscopy, dark field microscopy and electron microscopy. Definition and examples of Probiotics and Prebiotics 

Unit II 10 Hours:

 Identification of bacteria using staining techniques (simple, Gram’s &Acid fast staining) and biochemical tests (IMViC). Definition of D value & Z value and its significance. Study of principle, procedure, merits, demerits and applications of physical, chemical gaseous,radiation and mechanical method of sterilization. Evaluation of the efficiency of sterilization methods. 38 Equipments employed in large scale sterilization. Sterility indicators. 

Unit III 10 :

Hours Study of morphology, classification, reproduction/replication and cultivation of Fungi and Viruses. Classification and mode of action of disinfectants Factors influencing disinfection, antiseptics and their evaluation. For bacteriostatic and bactericidal actions Evaluation of bactericidal & Bacteriostatic. Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP. 

Unit IV 08 Hours :

Designing of aseptic area, laminar flow equipments; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification. Principles and methods of different microbiological assay. Methods for standardization of antibiotics, vitamins and amino acids. Assessment of a new antibiotic. 

Unit V 07Hours:

 Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources and types of microbial contaminants, assessment of microbial contamination and spoilage. Preservation of pharmaceutical products using antimicrobial agents, evaluation of microbial stability of formulations. Growth of animal cells in culture, general procedure for cell culture, Primary, established and transformed cell cultures. Application of cell cultures in pharmaceutical industry and research. 

BP 307P.PHARMACEUTICAL MICROBIOLOGY (Practical) 4 Hours/week 

1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator, laminar flow or aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator, microscopes used in experimental microbiology. 

2. Sterilization of glassware, preparation and sterilization of media. 

3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations. 

4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with practical). 

5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other techniques. 

6. Microbiological assay of antibiotics by cup plate method and other methods 

7. Motility determination by Hanging drop method. 

8. Sterility testing of pharmaceuticals (Any two samples). 

9. Bacteriological analysis of water 

10. Biochemical test of any one microorganism.

BP 304 T. PHARMACEUTICAL ENGINEERING (Theory) 45 Hours

Scope: This course is designed to impart a fundamental knowledge on the art and science of

various unit operations used in pharmaceutical industry.

Objectives: Upon completion of the course student shall be able:

1. To know various unit operations used in Pharmaceutical industries.

2. To understand the material handling techniques.

3. To perform various processes involved in pharmaceutical manufacturing process.

4. To carry out various test to prevent environmental pollution.

5. To appreciate and comprehend significance of plant lay out design for optimum use of

resources.

6. To appreciate the various preventive methods used for corrosion control in

Pharmaceutical industries.

Course content:

UNIT-I 10 Hours

•Flow of fluids: Types of manometers, Reynolds number and its significance, Bernoulli’s

theorem and its applications, Energy losses, Orifice meter, Venturimeter, Pitot tube and

Rotometer.

•Size Reduction: Objectives, Mechanisms & Laws governing size reduction, factors affecting

size reduction, principles, construction, working, uses, merits and demerits of Hammer mill, ball

mill, fluid energy mill, Edge runner mill & end runner mill.

•Size Separation: Objectives, applications & mechanism of size separation, official

standards of powders, sieves, size separation Principles, construction, working, uses, merits

and demerits of Sieve shaker, cyclone separator, Air separator, Bag filter & elutriation tank.

UNIT-II 10 Hours

•Heat Transfer: Objectives, applications & Heat transfer mechanisms. Fourier’s law, Heat

transfer by conduction, convection & radiation. Heat interchangers & heat exchangers.

42

•Evaporation: Objectives, applications and factors influencing evaporation, differences

between evaporation and other heat process. principles, construction, working, uses, merits and

demerits of Steam jacketed kettle, horizontal tube evaporator, climbing film evaporator, forced

circulation evaporator, multiple effect evaporator& Economy of multiple effect evaporator.

•Distillation: Basic Principles and methodology of simple distillation,flash distillation, fractional

distillation, distillation under reduced pressure, steam distillation & molecular distillation

UNIT- III 08 Hours

•Drying: Objectives, applications & mechanism of drying process, measurements & applications

of Equilibrium Moisture content, rate of drying curve. principles, construction, working, uses,

merits and demerits of Tray dryer, drum dryer spray dryer, fluidized bed dryer, vacuum dryer,

freeze dryer.

•Mixing: Objectives, applications & factors affecting mixing, Difference between solid and

liquid mixing, mechanism of solid mixing, liquids mixing and semisolids mixing. Principles,

Construction, Working, uses, Merits and Demerits of Double cone blender, twin shell blender,

ribbon blender, Sigma blade mixer, planetary mixers, Propellers, Turbines, Paddles & Silverson

Emulsifier,

UNIT-IV 08 Hours

•Filtration: Objectives, applications, Theories & Factors influencing filtration, filter aids, filter

medias. Principle, Construction, Working, Uses, Merits and demerits of plate & frame filter,

filter leaf, rotary drum filter, Meta filter & Cartridge filter, membrane filters and Seidtz filter.

•Centrifugation: Objectives, principle & applications of Centrifugation, principles,

construction, working, uses, merits and demerits of Perforated basket centrifuge, Non-perforated

basket centrifuge, semi continuous centrifuge & super centrifuge.

UNIT- V 07 Hours

•Materials of pharmaceutical plant construction, Corrosion and its prevention: Factors

affecting during materials selected for Pharmaceutical plant construction, Theories of corrosion,

types of corrosion and there prevention. Ferrous and nonferrous metals, inorganic and organic

non metals, basic of material handling systems.

SYLLABUS:

Unit I 10 Hours:

 Introduction, history of microbiology, its branches, scope and its importance. Introduction to Prokaryotes and Eukaryotes Study of ultra-structure and morphological classification of bacteria, nutritional requirements, raw materials used for culture media and physical parameters for growth, growth curve, isolation and preservation methods for pure cultures, cultivation of anaerobes, quantitative measurement of bacterial growth (total & viable count). Study of different types of phase constrast microscopy, dark field microscopy and electron microscopy. Definition and examples of Probiotics and Prebiotics 

Unit II 10 Hours:

 Identification of bacteria using staining techniques (simple, Gram’s &Acid fast staining) and biochemical tests (IMViC). Definition of D value & Z value and its significance. Study of principle, procedure, merits, demerits and applications of physical, chemical gaseous,radiation and mechanical method of sterilization. Evaluation of the efficiency of sterilization methods. 38 Equipments employed in large scale sterilization. Sterility indicators. 

Unit III 10 :

Hours Study of morphology, classification, reproduction/replication and cultivation of Fungi and Viruses. Classification and mode of action of disinfectants Factors influencing disinfection, antiseptics and their evaluation. For bacteriostatic and bactericidal actions Evaluation of bactericidal & Bacteriostatic. Sterility testing of products (solids, liquids, ophthalmic and other sterile products) according to IP, BP and USP. 

Unit IV 08 Hours :

Designing of aseptic area, laminar flow equipments; study of different sources of contamination in an aseptic area and methods of prevention, clean area classification. Principles and methods of different microbiological assay. Methods for standardization of antibiotics, vitamins and amino acids. Assessment of a new antibiotic. 

Unit V 07Hours:

 Types of spoilage, factors affecting the microbial spoilage of pharmaceutical products, sources and types of microbial contaminants, assessment of microbial contamination and spoilage. Preservation of pharmaceutical products using antimicrobial agents, evaluation of microbial stability of formulations. Growth of animal cells in culture, general procedure for cell culture, Primary, established and transformed cell cultures. Application of cell cultures in pharmaceutical industry and research. 

BP 307P.PHARMACEUTICAL MICROBIOLOGY (Practical) 4 Hours/week 

1. Introduction and study of different equipments and processing, e.g., B.O.D. incubator, laminar flow or aseptic hood, autoclave, hot air sterilizer, deep freezer, refrigerator, microscopes used in experimental microbiology. 

2. Sterilization of glassware, preparation and sterilization of media. 

3. Sub culturing of bacteria and fungus. Nutrient stabs and slants preparations. 

4. Staining methods- Simple, Grams staining and acid fast staining (Demonstration with practical). 

5. Isolation of pure culture of micro-organisms by multiple streak plate technique and other techniques. 

6. Microbiological assay of antibiotics by cup plate method and other methods 

7. Motility determination by Hanging drop method. 

8. Sterility testing of pharmaceuticals (Any two samples). 

9. Bacteriological analysis of water 

10. Biochemical test of any one microorganism.

Dr. D. Y. Patil College of Pharmacy, Akurdi, Pune-411044
VISION
To Impart Quality Education to the Students and Mould them into Proactive Multifaceted Pharmacists
MISSION
To Establish a Center of Academic Excellence and Research in Pharmacy Education and thereby Produce Professionally Competent and Ethically Sound Pharmacists to Cater the Needs of the Global Society.
Program Educational Objectives (PEOs) 
After graduation students will
1. Reflect critical thinking and problem solving skills through their Pharmaceutical knowledge, expertise  
     and competency in industry,higher studies and research.
2. Practice ethics and values in their profession         
3. Contribute effectively in various fields of social healthcare system. 
4. Inculcate leadership and entrepreneurship capabilities through effective communications, appropriate time management and self up gradation.

3.6.7 T Pharmaceutical Biotechnology

(3 hrs / week)

Learning objectives: On successful completion of following theory topics, learner should be

able to

A. Knowledge:

1. Define Biotechnology & its state its scope in pharmacy

2. Know the basics of biotechnology techniques and the various systems used.

3. Know the method of genetic engineering for production of rDNA products including

monoclonal antibodies.

4. Know the information about the application of genetic engineering in animals.

5. Have a knowhow of enzymes and their uses by immobilization.

6. Illustrate use of Fermenter for production of fermentation products and information

about their purification by downstream process.

7. State the application of Fermenter process in production of vitamins and antibiotics

SR.NO

TOPIC

HR

1.       

Introduction to Biotechnology, Scope, Potential & Achievements

1

2.       

Gene transfer: Transformation, Transduction and Conjugation

3

3.       

Genetic Engineering techniques: Isolation of DNA, Genomic & cDNA

libraries, Gel electrophoresis,, Blotting techniques, DNA Hybridization, Site

directed mutagenesis, Restriction Fragment Length Polymorphism

(RFLP),DNA fingerprinting. Gene synthesis & gene machine, Gene

sequencing methods.

10

4.       

Recombinant DNA technology: Introduction and principle of rDNA

technology, Gene cloning- Introduction, enzymes acting on DNA

(restriction endonucleases, S1 nuclease, alkaline phosphatase, polymerase,

ligase,), types of cloning vectors(PUC 19, PBR 322,YAC,COSMID,Ti and

Shuttle vector), expression vectors(pGEX-3X, pPIC, CHO)

10

5.       

Examples of Biotechnology derived Products: Human insulin,

Somatotropin, Interferons, (Production of their rDNA constructs and uses)

Introduction to Human Gene Therapy

4

6.       

Introduction to transgenic animals and their applications. Germplasm

storage & cryopreservation

3

7.       

Steps involved in Monoclonal antibody production and its applications.

2

8.       

Enzyme Technology; Immobilization of enzyme & its applications

3

9.       

            Fermentation Technology; Fermenter its accessory components and

working, Down streaming Process in brief.

5

10.   

General application of fermentation in Manufacturing of Antibiotics and

Vitamins with one example each.

4

 

Recommended Books:

1. Olive Kaiser ,Rainer Muller, Pharmaceutical Biotechnology: Drug Discovery and Clinical Application, Wiley VCH publisher, 2004

2. Peter J. Russel, Genetics 5 th Edition ,The Benjamin Cummins Publishing California;1998

3. Watson WH Freeman and company N.Y. Recombinant DNA 2 nd edition Holtzbrinck Publishers 1992

4. Glick, Molecular biotechnology 3 rd edition ASM press Washington, USA 2003 61

5. Vyas and Dixit Pharmaceutical Biotechnology, 1 st CBS Publisher New Delhi, 1991

6. Dr. S. Iganacimuthu, Basic Biotechnology – Tata McGraw HillPublishers

7. P. K. Gupta, Elements Of Biotechnology, Rastogi Publication, 10 th edition, 2004

8. S.S. Purohit, Biotechnology Fundamentals and Applications Student edition Agrobios Publisher;2002

9. H. S. Chawala, Introduction of Plant Biotechnology, 2 nd edition, IBHPublishing Co. Pvt.Ltd. New Delhi, 2002

10. M.H. Razdan, Introduction to Plant Biotechnology , 2 nd edition Oxford and IBH Publishing Co. Pvt. Ltd, New Delhi. 2003

11. K. Sambamurthy, Ashutosh Kar, Pharmaceutical Biotechnology, 2ndedition New AGE International (LP) Limited, 2007.

12. U. Satyanarayana, Biotechnology,Books and Allied Ltd



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