department of bioanalytical sciences - BK Birla College

B. K. BIRLA COLLEGE OF ARTS, SCIENCE AND COMMERCE

(AUTONOMOUS)

KALYAN (W.)

Affiliated to University of Mumbai

DEPARTMENT OF BIOANALYTICAL SCIENCES

Programme: Master of Science (M. Sc.)

SYLLABUS FOR:

M. Sc. Part I

M. Sc. Part II

Choice Based Credit System (CBCS) with effect from the academicyear 2018-19

1


(AUTONOMOUS)

KALYAN (W.)


Choice Based Credit System (CBCS) with effect from the academicyear 2018-19

Faculty of Science

Semester I to Semester IV

Guidelines

Syllabus Structure:

1. In M. Sc. Part I (CBCS) in Sem I and II, there will be four theory papers each with

4 credits and four practical papers each with 2 credits in each semester.

2. In M. Sc. Part II (CBCS) in Sem III and IV, there will be four theory papers each

with 4 credits and four practical papers each with 2 credits in each semester.

Evaluation:

1. Core Courses: The Core Courses I, II, III, IV will be theory and practical based

Core Courses. The College will conduct all the semester examinations of 150

marks per Core Course in the prescribed pattern of 40 marks of Internal

assessment and 60 marks for theory and 50 marks for practical during semester

end examination . The student will have to secure a minimum of 40% marks in

internal assessment as well as semester end examination per Core Course, for all

the above Core Courses.

3. In each semester, the student will have to submit Project/ Assignment/Journal/

Survey report/ Powerpoint presentations etc. for Core Courses in the College

before appearing for the Semester End Examination. The last date of internal

submission will be officially declared by the College.

2

4. The Project work will be carried out by the student with the guidance of the

concerned Faculty Member who will be allotted to the student as the Guide for the

Project.

5. In each semester, for Core Courses, the student will have to secure a minimum of

40% marks in aggregate and a minimum of 40% in each component of assessment

i.e. 16 out of 40 marks in Internal Evaluation and 24 out of 60 marks in semester

end examination and 20 out of 50 marks in Practical Examination.

Note: All other rules regarding Standard of Passing, ATKT, etc., will be as per

those decided by the Faculty of Humanities passed by the Academic Council from

time to time.

3


(AUTONOMOUS)

KALYAN (W.)


CONTENT

Programme- Master of Science (M. Sc. Bioanalytical Sciences)

Sr. No. Course Theory Code Credits Practical Code Credits

1 M. Sc. Part – I Paper I BPSBN101 04 BPSBNP101 02

2 M. Sc. Part – I Paper II BPSBN102 04 BPSBNP102 02

3 M. Sc. Part – I Paper III BPSBN103 04 BPSBNP103 02

4 M. Sc. Part – I Paper IV BPSBN104 04 BPSBNP104 02

5 M. Sc. Part – I Paper I BPSBN201 04 BPSBNP201 02

6 M. Sc. Part – I Paper II BPSBN202 04 BPSBNP202 02

7 M. Sc. Part – I Paper III BPSBN203 04 BPSBNP203 02

8 M. Sc. Part – I Paper IV BPSBN204 04 BPSBNP204 02

9 M. Sc. Part – II Paper I BPSBN301 04 BPSBNP301 02

10 M. Sc. Part – II Paper II BPSBN302 04 BPSBNP302 02

11 M. Sc. Part – II Paper III BPSBN303 04 BPSBNP303 02

12 M. Sc. Part – II Paper IV BPSBN304 04 BPSBNP304 02

13 M. Sc. Part – II Paper I BPSBN401 04 BPSBNP401 02

14 M. Sc. Part – II Paper II BPSBN402 04 BPSBNP402 02

15 M. Sc. Part – II Paper III BPSBN403 04 BPSBNP403 02

16 M. Sc. Part – II Paper IV BPSBN404 04 BPSBNP404 02


4

(AUTONOMOUS)

KALYAN (W.)


Evaluation Pattern

1. INTERNAL ASSESSMENT 40 marks

1.11.2

One class test Assignment/ Project/ Presentation/ Active participation, Overall performance/ Power point Presentation/ Survey/ Paper or Poster presentation/ Open book test/ research paper Review

15 marks25 marks

2. EXTERNAL ASSESSMENT (Semester End Examination) 60 marks

N.B. 1. All questions are compulsory 2. All questions carry equal marks.Q.1 Unit-I (with internal option)

A.

B.

C.

15 marks

Q.2 Unit-II (with internal option)

A.

B.

C.

15 marks

Q.3 Unit-III (with internal option)

A.

B.

C.

15 marks

Q.4 Unit-IV (with internal option)

A.

B.

C.

15 marks

B. K. Birla College of Arts, Science and Commerce, Kalyan (W.)

5

Syllabus w.e.f. Academic Year, 2018-19 (CBCS)

M.Sc. Bioanalytical Sciences

Preamble:Indian Pharmaceutical industry:

Indian Pharmaceutical industry has long proved its mite both at national andinternational arena. With the WTO regime just rising in the horizon our pharmacompanies are in for a great boom especially in manufacturing and marketing genericswhich would be out of patent regime during 2005 to 2007. The market for thesemolecules is expected to be around 100 billion dollars. Even if our companies make ashare of 01 % percent, substantial revenue is in the offering. Coupled with this they canstrive to have few new molecules up their scheme

Ayurveda, Siddha and Unani (ASU) Medicines - Our rich heritage:The Indian sub-continent houses one of the world's richest flora & fauna and has

one of the world's oldest medicinal systems - Ayurveda. Ayurveda (Ayur - life; Veda -knowledge) is an encyclopedia of the Indian medicinal system, which has a history ofover 3000 years. It reflects the law of nature, inherent to life of all living beings. Alongwith Ayurveda other systems of medicine like the folk medicines, Unani and Siddha arealso being practiced in the subcontinent. Ayurveda, Unani and Siddha (ASU) medicinesare quit popular among the Indians, and have been followed for over several hundredyears.

Department of Indian Systems of Medicine and Homeopathy, Government ofIndia recognizes Ayurveda, Siddha and Unani as standard systems of medicine. Havinggiven the recognition and since these medicines are gaining the trust of people the worldover, the Government is trying to implement regulatory guidelines to ensure consistentquality of efficacy & quality. Therefore, standardization of herbal medicines is the needof the hour. This will help not only lead to better acceptance of medicines of Indiansystems by the people but will also help to bring these systems on par with the modernmedicines where modern scientific principles and techniques are employed to ensurequality and efficacy of the drug formulations.

Inadequacy of Trained personnel:Major hurdle faced by the R&D centers at various Pharma laboratories is the lack

of adequately trained and GLP oriented personnel. This forms a major set back when theapplication of sophisticated technology especially in the bio analytical field is concerned.The lacunae become more evident when dealing with newer dosage forms and peptidebased drugs.

Indian ASU formulations are already in great demand. There is, however, a direneed for standardization techniques based on modern instrumental procedures andprinciples. A major hurdle in achieving this is the lack of adequate expertise among themanufacturers of ASU drugs. The same inadequacy is seen even among the nationallaboratories and other Testing and research centers.

This lacunae needs to addressed very diligently and the proposed programme is a

6

step in this direction. Bioanalytical evaluations are interdisciplinary programmes andrequire highly skilled personnel with strong background of Bio-analytical techniques.There is no programme available today for such a training to generate such expertise inanalysts. Though industry uses sophisticated instruments in QC and drug development,there is a dire need of technical personnel with an overall expertise in various bio-analytical techniques including biological techniques to be able to take up R&D in newerformulations and standardization of ASU formulations to come up with meaningfulevaluations.

Objectives of the Course

Develop trained manpower in the field of Bio-analytical Sciences with specificemphasis for exploitation of ASU system of medicine as well as its need forchanging trends of modern pharmaceutical, neutraceutical Industries

Amalgamate traditional analytical chemical techniques with modern genomic andproteomic technologies of manufacturing and analysis

Introduce the powerful tools of informatics in routine use at manufacturing, QC andresearch.

Exposure to National & International regulatory affairs with reference to drugs

B. K. Birla College of Arts, Science and Commerce, Kalyan (W.)7


M.Sc. Bioanalytical Sciences Semester- IPaper-I

Medicinal systems, Pharmacology and Laboratory SafetyCOURSE CODE: BPSBN101- (2018-19) Credits - 04

Sr. No. Modules/Units Lectures (60)1

1.11.21.31.41.5

Indian systems of Medicine (ASU) – Ayurveda, Siddha & UnaniPrinciples and practiceTypes of Drug FormulationMethods of Manufacture – Raw Material To Finished ProductTypes of DrugExcipients in various dosage form

15

22.12.22.32.42.5

Modern MedicinePrinciples and practiceAPI and concept of its formulation into a dosage formDifferent types Drug FormulationsExcipients in various dosage formsDisease Management (Comparison of ASU and Modern Drugs)

a. Diabetesb. Tuberculosisc. Hypertensiond. Hepatitise. Malariaf. Dengueg. Influenza

15

33.1

3.23.3

3.43.5

3.6

3.7

Pharmacognosy Introduction, Plants and their medicinal uses example of one plant to begivenConcepts of ethanobotany, ethno medicines and pharmacologyPhytogeographical regions to be explained with respect to endemism andhot spots (explain only concepts)Role of PTC in cultivation of medicinal plantsHerbaria evaluation to include Plant collection, Authentication, storage anddrying techniques.Raw material evaluation to include Microbial load, Raw materialcharacterization, proximate evaluation, photomicrographyConcepts of GAP and GHP for medicinal plants( only introduction)

15

4

4.14.24.3

4.44.54.64.7

Laboratory Safety Measures w.r.t handling of chemicals and biological materials General Precautions ,labels and signage’sMaterial handling and disposalMaterial Safety Data Sheets(MSDS) and SOP ( Standard OperatingProcedure)Personal safety & ClothingLevels of safetyFire safety and fire fightingWorking in Biosafety Cabinets and hoods

15



M.Sc. Bioanalytical Sciences Semester- I

Paper-I

Medicinal systems, Pharmacology and Laboratory SafetyCOURSE CODE: BPSBNP101- (2018-19) Credits - 02

1

2

345

Microscopic evaluation of sections and powders with adulteration andformulation comparision of the following medicinal plants;

1) Emblica officinalis – (Amla - dried fruit)2) Vitex nigundo - Leaves3) Asteracantha Longifolia – Whole plant4) Calotropis gigantea – Leaves5) Phyllanthus amarus – Whole plant

Calculation in terms of percent occurrence of key anatomical characteristicsin the powder to be recorded.Preparation of Herbarium of following medicinal plants;

1) Asteracanthalongifolia2) Trigonellafoenum3) Clitoriaternatea4) Coriandrumsativum5) Achyranthusaspera6) Scopariadulcis7) Amaranthusspinosa8) Phyllanthusamarus9) Calotroprisgigantea10) Vitexnigundo

Individual student must submit herbaria of ANY THREE from the above listbut in each institution herbarium of all the listed plants must be prepared.

Separation of plant pigments using paper chromatographyPreparation of Material Safety Data Sheets for Merhanol and HClPreparation of media and callus induction by PTC.




Paper-II

Indian Pharmaceutical Industry and its Quality Management –ICOURSE CODE: BPSBN102- (2018-19) Credits - 04


1.11.21.31.4

1.51.61.71.81.9

R&D and Recent trends in Indian Pharmaceutical industry Historical background with emphasis on Post 1947 periodMarket trends and activitiesGovt. initiatives and the public sector in Pharmaceutical IndustryThe role of Drug Pricing policy in India and its impact on the IndianPharmaceutical IndustryRole of Analytical chemist in Pharmaceutical Industry R&D strategies of Indian PharmaPharma R&DBulk Drug manufacturing & its R&DVaried Dosage forms and its R&D

15

22.12.2

2.3

2.4

Pharmacopeial standards and Testing Procedure Introduction to WHO guidelinesIntroduction to Pharmacopoeias IP, BP, USP( JP, EP, AP where everapplicable)Specified test in Monographs w.r.t liquid formulation (injectible) and soliddosage form (USP, EP, BP, IP)Include AP, Indian HP and AFI (wherever applicable)

15

33.13.23.33.43.53.63.73.83.9

Good Laboratory Practice (GLP)What is GLP?Practicing GLPGuidelines to GLPDocumentation of Laboratory workPreparation of SOPsCalibration recordssignificance of validation in GLPTransfer of methodsDocumentation of results

15

44.14.24.34.44.5

4.6

Quality Control (QC) and Quality Assurance (QA)IntroductionWhat is QC? What is QA?Requirements for implementing QC & QAQC & QA concepts in ASU drugsStandardizing an Analytical method

a. Preliminary requirements of a discriminatory quantitaionb. Detection of the analyte of interestc. Separation of analyte form the matrix componentsd. Sample preparation for quantitation

Factors for standardizationa. Solid-phase extractionb. Extraction sequencec. Liquid/liquid extraction

15

10

4.74.84.9

4.10

d. QuantificationSupport work & documentation ValidationAudit requirements ,audits and audit reportsPersonnel Responsibility in QA




Paper-II

Indian Pharmaceutical Industry and its Quality Management –ICOURSE CODE: BPSBNP102- (2018-19) Credits - 0 2

1

2

3

4

Students must submit a Field Note Book of their field excursion includingPresentation of the field visit

Research Paper Review

Carry out dissolution test, disintegration, hardness and friability on any onetablet preparation

Determination of percentage purity of CaCO3/MgCO3 by Titrimetry


11



Paper-III

Extraction and Identification techniques in evaluation of drugsCOURSE CODE: BPSBN103- (2018-19) Credits - 04


1.11.21.31.41.51.61.71.81.9

1.101.111.121.131.141.151.16

Principle of extraction and Isolation of analytesIntroductionPhysico-chemical properties of drugs and solventsConcept of partition & Partition CoefficientSolvent propertiesSelection of solventExtraction efficiencyIntroduction to classical methods of extractionIntroduction to modern methods of extraction- advantages & disadvantages -Include LLE (Soxhlet) and LMEApplications of extractionMicrowave assisted extraction its advantages and disadvantagesIonization and its effect on the extraction of drugsThe ‘First law of drug metabolism’Matrix components & analyte isolationConcentration of extractsIsolations of fractions and Purification of isolate

15

22.12.22.32.42.52.62.72.82.9

2.10

Solid Phase Extraction (SPE)IntroductionGeneral properties of bonded silica sorbentsSorbent/analyte interactionsSample pretreatment of different biological matricesDeveloping SPE methodsExample of an SPE method (introduction of SPME)Disc cartridges 96-Well Format (e.g. Porvair Microsep TM system)Direct injection of plasmaOther new developments

15

33.13.23.33.43.53.6

Super Critical Fluid Extraction & Chromatography (SCFE & SCFC)The concept of SCFE & SCFCInstrumentation of SCFE & SCFCFactors affecting SCFE & SCFC Benefits of SCFE & SCFC Application of SCFE for natural products and Application of SCFCConclusions and future perspectives

15

44.1

SpectroscopyPrinciples, instrumentation and applications of

a. UV ,Visible and fluorescenceb. Nephalometry and Turbidometryc. IRd. Basic concepts of NMR spectroscopye. Flame photometry

15

12

f. Atomic Emission Spectroscopyg. AASh. ICPi. X – ray diffraction




Paper-III

Extraction and Identification techniques in evaluation of drugsCOURSE CODE: BPSBNP103- (2018-19) Credits - 0 2

1

2

3

4

5

Liquid – liquid extraction of a modern drug from plasma and formulations(e.g. Diclofenac sodium, Glimiperide, Aceclofenac, Metformin etc.)

SPE of a modern drug from formulation (e.g. Atorvastatin, Diclofenacsodium etc.SPE of a modern drug from plasma (e.g. Atorvastatin, Diclofenac sodium,Sibutramine etc.)

Determination of Caffeine from a given sample by UV spectrophotometer.Preparation of calibration graphs for Li, Na, and K by flame Photometryusing their solutions of appropriate concentrations and studying interferenceof K in Na estimationIR analysis of a modern drug (e.g. Diclofenac Sodium, etc.)

13




Paper-IV

Evaluation and identification of biomoleculesCOURSE CODE: BPSBN104- (2018-19) Credits - 04


1.11.21.31.41.51.61.7

Enzymes and their role in diagnosticsWhat are Enzymes ?Enzymes as biocatalystsClassification of EnzymesKinetics of enzyme catalysed reactionsActive site determinationEnzymes in diagnosticsEnzymes in drug industry

15

22.12.22.3

2.4

ProteomicsBasic Protein ChemistrySignificance of proteome Overview of proteomics

a. Methods for cell disruption/protein extractionb. Protein purification/ Fractionation c. Protein identification and characterization

Modification of proteins (invitro/invivo)a. Post translationalb. Chemical

15

33.13.23.33.4

3.53.63.7

ElectrophoresisPrinciples of electrophoretic separationEquipment and processAgarose gel electrophoresisPAGE – Native & SDS, 2DGE, Extensions of Electrophoresis-Immunoelectrophoresis/ pulse fieldStandardization of electrophoretic techniqueDetection techniquesApplications of electrophoresis

15

44.14.24.34.44.54.64.74.84.9

4.10

Immunoassay & ELISAIntroductionDefinitionsTheory- Types of antigen antibody interactionsRequirements for immunoassayPractical aspectsData handlingAdvantages of immunoassayPrinciples and instrumentation in ELISAApplications of ELISATypes of Detection systems

15

14




Paper-IV

Evaluation and identification of biomoleculesCOURSE CODE: BPSBNP104- (2018-19) Credits - 0 2

1

2

3

4

5

6

7

8

Separation of human serum / plasma proteins / egg white usingPAGE((Protein molecular weight determination kit may be used)

Separation of proteins using 2D gel electrophoresis

Protein profiling of plant seed by SDS-PAGE

Plant DNA extraction and separation using agarose Gel.

Immunoassay of HEPALISA in serum.

Immunoassay for HCG in urine

Immunoassay for detection of Dengue

Estimation of T3 and T4

15

REFERENCES

Semester I

1.Tatsuya Sekine, Yuko ,Hasegawa, Dr.V.Mshinde ,Solvent Extraction Chemistry Fundamentalsand Applications ,Marcel Dekker Inc2. Larry T.Taylor ,Supercritical Fluid Extraction ,John Wiley and Sons3.P.D.Sethi ,Dilip Charegaokar ,Identification of Drugs in Pharmaceutical Formulations by ThinLayer Chromatography, CBS Publishers and Distributors4.John B. Taylor ,Peter D. Kennewell ,Modern Medicinal Chemistry, Ellis Horwood5. James W.Robinson ,Practical Handbook of Spectroscopy,Crc Press6. Gordon M.Barrow ,Introduction to Molecular Spectroscopy ,McGraw Hill7. Varro E.Tyler, Lynn R.Brody, James E.Robbers, Pharmacognosy 9th ed., Lea and Febiger8.W.O.George, H.A.Willis ,Computer Methods in UV Visible and IR Spectroscopy RoyalSociety of Chemistry9. Codric M.Smith, Alan M.Reynard ,Textbook of Pharmacology ,W.B.Saunders Comp10.Umesh V.Banakar ,Pharmaceutical Dissolution Testing ,Marcel Dekker11. M.H.Rubinstein ,Pharmaceutical Technology Controlled Drug Release Vol 1 ,Ellis Horwood12. David Lee, Pharmaceutical analysis, CRC Press13 Alan Harvey, Drugs From Naturall Products Pharmaceuticals and Agrochemicals, EllisHorwood14. Dr.R.O.B.Wijesekera, The Medicinal Plant Industry15. V.V.Sivarajan, Indira Balachandran, Ayurvedic Drugs and Their Plant Sources, Oxford andIBH16. L.D.Kapoor, Handbook of Ayurvedic Medicinal Plants, CRP Press17. S.K.Ramcachandra Rao, Encyclopedia of Indian Medicine Vol 1, Popular Prakashan18. H.Wagner, S.Bladt , Zgainski, Plant Drug Analysis A Thin Layer Chromatography Atlas,Springer Veriag19. Govind Kelkar, Directory of Herbal Health Care Products, Chemexcil20. Govt. Of India Ministry of Health & Family Welfare National Formlary of Unani Medicine -Part I 1ed., J.M. Jaina and Bros21. Govt.Of India Ministry of Health & Family Welfare The Ayurvedic Formulary of India Part I1 ed., J.M. Jaina and Bros22. Govt. Of India Ministry of Health & Family Welfare The Ayurvedic Pharmacopoeia of IndiaPart I Vol I, J.M. Jain and Bros23. Prof.Dr.F.C.Czygan, D.Frohne, C.Hohxel, A.Nagell, H.J., Pfainder, G.Willuhn , W.Buff,Herbal Drugs and Phytopharmaceuticals, CRC Press24. A.Vinaya Kumar, Principles of Ayurvedic Therapeutics, Sri Satguru Publisher25. Dr.C.R.Karnick, Pharmacopoeial Standards of Herbal Plants Vol I, Sri Satguru Publisher26. Regional Research Lab & IDMA, Indian Herbal Pharmacoepoeia Vol II, Regional ResearchLab27. P.C. Sharma, M.B. Yelne, T.J. Dennis, Database on Medicinal Plants use in Ayurveda Vol. 1- Vol. 5, Central Council for, Research in Ayurved and Siddha28. David Hawcroft, Diagnostic Enzymology, John Wiley & Sons29. Quentin Myrvik, Russell S.Welser, Fundamentals of Immunology 2nd ed, Lea & Febiger30.Terry M.Phillips, Analytical Techniques in Immunochemistry, Marcel Dekker Inc31. Radiommunoassay Ria in Theory and Practice, Pakard32. S.S. Bhojwani and M. K. Razadan, Plant Tissue Culture: Theory and Practice, ElsevierScience, The Netherlands, 1996.

16



M.Sc. Bioanalytical Sciences Semester- II

Paper-I

Natural Products and IPR and PatentingCOURSE CODE: BPSBN201- (2018-19) Credits - 0 4


1.11.21.31.4

1.5

1.6

IPR and Patenting- IConcept of IPR - Understanding the meaning of IPR & its significance inknowledge based economy.Types of IPR - Patents, Trade Marks & Service Marks, Design Registration,Trade Secrets, Geographical indications, Protection of New Plant Varieties,Copyright.Global Harmonization - Impact of IPR on global trade and the need forharmonization, WTO and its role in a global harmonization, TRIPS andintroduction to the articles in TRIPs document as well as the flexibilitiesprovided by TRIPS. International Agreements related to IPR & patents - Paris Convention, PCT.

15

22.1

2.2

2.3

2.4

IPR and Patenting- IIIndian Patent Act -

a. Criteria to be fulfilled for Patentability - new/novel, non-obvious/inventive step, useful/capable of industrial application.

b. Non-patentable subject matter - what is not patentable.c. Concept of Mailbox and EMR and how it has helped India in its

transition to full TRIPS compliance.d. Role of patentee and patent offices in patent management

including lab documentation, confidentiality agreements, pre- andpost-grant opposition, servicing of patents.

e. Provisional Patents, Divisional Patents & Patents of Addition.IPR as a strategic tool -

a. Concepts of piracy, reverse engineering and knowledge worker.b. Benefits of creating and/or owning patents and other IPR.c. How India has leveraged the flexibilities provided by TRIPS to

safeguard the industry and prevent ever-greening of patents.IP clearance – Precautions before launching of product anywhere in theworld -

a. Concepts of Freedom to operate (FTO) search and analysis forpatents, Exclusivity and SPC status check

b. Other IPR checks like trademarks, copyrights (for printed data onleaflets, packages etc.),

Putting IPR related disclaimers while advertising product list or sellingproducts.

15

33.13.2

PhytochemistryNatural drug substances from plants (primary and secondary metabolites)Broad classification of secondary metabolites

a. Nitrogenousb. Non nitrogenous

15

17

3.3c. Isoprenoids

Secondary drug metabolite production with special reference with integratedpathway

a. Key Factors affecting synthesis of secondary metabolitesb. Choice of solvent for extraction of phytoconstituentsc. Extraction Techniques of Crude plant material w.r.td. maceration( Types- Kwatha and Swarasa)e. percolationf. steam distillation

44.14.24.34.44.54.64.74.84.9

Neutraceuticals and functional foodsIntroduction to neutraceuticals: definitions, synonymous terms, basis of claims for a compound as a nutraceutical, regulatory issues for neutraceuticals including CODEXrole of neutraceuticals/functional foodsClinical testing of neutraceuticals and health foods;interactions of prescription drugs and neutraceuticals; adverse effects and toxicity of neutraceuticals; Neutrigenomics – an introduction and its relation to neutraceuticalsRegulatory issues w.r.t. FSSI regulations

15




Paper-I

Natural Products and IPR and Patenting

COURSE CODE: BPSBNP201- (2018-19) Credits - 0 2

1

2

3

4

Patent Claim Drafting

Comparison of classical and modern method of extraction ofphytoconstituent of medicinal plants

Effect of drying on phytoconstituents.(Terpenes, alkaloids, tannins

Phytochemical variation within a species using TLC/HPLC/HPTLC

18




Paper-II

Indian Pharmaceutical Industry and its Quality Management -IICOURSE CODE: BPSBN202- (2018-19) Credits - 0 4


1.1

1.21.31.4

Drug Act & RegulationsIndian Drugs and Cosmetics Act w.r.t Schedule Y,M,H. Include Schedule A,S (introduction)Introduction to foreign guidelines w.r.t US, EU, Australia & Japan Introduction to CFR 21 part 11Regulatory issues w.r.t OTC drugs, Cosmetics

15

22.12.22.32.42.5

Stability StudiesFactors that influence stability of drug formulationsTypes of Stability chambers and their design considerationsStability issues of ASU raw materials and finished productsGuidelines on Stability evaluationsApproaches to stability studies of ASU formulations

15

33.13.23.33.4

3.5

3.63.73.83.9

3.103.11

Packaging in Pharma industryIntroduction to PackagingFundamentals of DistributionPackaging Forms & their SignificancePackaging Materials (covering basic mfg process, applications andsignificance)Paper, Paper Board and CFB Glass, metals, Basic Polymer based materials,Polymer based composite materialsAncillary MatsPackage Material Testing Compatibility & Migration StudiesAccelerated Shelf Life Testing - Theory and Problems.Packaging ValidationPackaging Laws and regulatory compliance

15

44.14.24.34.44.54.64.7

Good Manufacturing Practice (GMP) What is GMP?Requirements of GMP implementationDocumentation of GMP practicesRegulatory certification of GMPGMP in production of ASU drugsHarmonization of SOP of manufactureAudit for GMP compliances

15

19




Paper-II

Indian Pharmaceutical Industry and its Quality Management –II


1

2

3

4

5

6

Students must submit a Report of the Industrial Visits including Presentationof the industrial visit.

Accelerated stability studies of various formulations or drugs with respect toTemperature (b) Effect of buffers / pH dependent (2 – 4 Expts.)

Test for degradation of compounds using TLC for any two drugs. Stability testing of solution and solid dosage forms for photo degradation.(2experiments).

Effect of hydrogen peroxide, hydrochloric acid and sodium hydroxidesolutions on the stability of drugs in solution at elevated temperatures androom temperature. (2 experiments).

Stability studies of drugs in dosage forms at 25oC, 60% RH and 40oC, 75%RH and at different Pressure

20




Paper-III

Analytical techniquesCOURSE CODE: BPSBN203- (2018-19) Credits - 04


1.11.21.31.41.51.61.71.81.9

1.101.111.12

Theory of Chromatographic separation, TLC and HPTLCPrinciples of chromatographic separationIntroduction to chromatographic separation techniquesPrinciples and Practice of TLCUses of TLCSome recommended solvents systemsDetection of compounds on TLC platesPrinciples and Instrumentation of HPTLCHPTLC vs TLCDensitometry & quantitaion in HPTLCHPTLC in fingerprinting & QCTroubleshootingApplications of HPTLC

15

22.12.22.32.4

HPLC – 1Principles and InstrumentationThe chromatographic process, Separation modeThe chromatogramColumn chemistry and Column switchingSystem parametersIntroduction to various HPLC techniques;

a. Ion-pair HPLCb. Reverse-phase HPLCc. Ion-exchange HPLCd. Normal-phase HPLCe. Affinity Chromatographyf. Gel permeation Chromatographyg. Chiral HPLC

15

33.1

3.23.33.43.53.6

HPLC – IIHPLC detectors

a. Introductionb. Principles of detectionc. Universal and Specific Detectorsd. Detector responsee. Sensitivity considerationsf. Selectivity

Manual and Electronic data Processingautomation in HPLC Troubleshooting Applications of HPLCRecent advances (Fast LC, online extractions, add on pumps, onlinederivatization, multi dimensional LC)

15

21

3.7 Flash Chromatography4

4.14.2

4.34.4

4.54.64.74.84.9

GC Principles and InstrumentationFactors that affect the chromatographic separation (Temperature, Type ofcolumn etc.)Types of columns and their applicationGC hardware

a. Introduction to flow and pressure controllersb. Injection techniques- on column injection, large volume injection,

split -splitless, PTV and various auto injectors- gas sampling as wellas liquid sampling

c. Column Oven- temperature programming, (High /cryogenic oventemperature)

Universal and specific Detectors in GC (FID, TCD, ECD, FPD and NPD)Derivatisation for GCGC strategy for analysis involving biological matricesTroubleshootingApplications

15




Paper-III

Analytical techniques


1

2

3

4

5

6

Prepare specific reagents and conduct qualitative test for the presence ofalkaloids, tannins, lignans, steroids and glycosides using TLC. Compare theresults using standards (if available)

.Gas Chromatograhic separation of solvent mixtures (e.g. Menthol &Ethanol, Toluene & Methanol etc.)

HPLC separation of herbal raw material from its formulation (e.g.Asteracantha longifolia from LUKOL / SPEMAN, Phyllanthus amarus fromLIV 52, Tribulus terrestris from Ghokshuradi guggul etc.)

HPLC separation of a modern drug from plasma and its formulations (e.g.Diclofenac sodium, Glimiperide, Aceclofenac, Metformin etc.)

HPLC separation of modern drugs from their combination formulation (e.g.Diclofenac Sodium &Paracetamol, Metformin &Glimiperide etc.)

HPTLC separation of a modern drug from plasma and its formulations (e.g.Diclofenac sodium, Glimiperide, Aceclofenac, Metformin etc.)

22

7

8

9

10

HPTLC fingerprinting of Herbal raw material (e.g. Asteracanthalongifolia,Ricinus cummunis, Calotropisgigantia)

HPTLC detection of herbal raw material from its formulations (e.g.Asteracantha longifolia from LUKOL / SPEMAN, Vitexnigundo fromPANCHGUN TAILA, Glycerrizhaglabra from ANU TAILA)

Gas Chromatographic separation of solutes from their matrix (e.g.Diclofenac sodium from its formulation, Methanol from plasma etc.)

Determination of Caffeine from a given sample by HPTLC & HPLC.

23




Paper-IV

Drug Development, Bioinformatics and PharmacokineticsCOURSE CODE: BPSBN204- (2018-19) Credits - 04


1.11.21.31.4

NCE and its development into a New DrugWhat is NCE?Stages in the development of NCEPreclinical studies on NCEPhases of Clinical Trials

15

22.12.22.3

2.4

2.5

BioinformaticsWhat is bioinformatics?Databases and Search ToolsApplications of bioinformatics

a. Genomicsb. Proteomicsc. Drug discovery (Docking software)

Using various libraries & tools w.r.t structure/ literature to drugdevelopment/ proteinsIntroduction to Chemi-informatics

15

33.13.2

3.33.4

BiopharmaceuticsIntroduction to BiophamaceuticalsProduction & analysis of Biopharmaceuticals.(Proteins, Hormones, Cytokines; Nucleicacids)Applications of BiopharmaceuticalsRole of Biopharmaceuticals in treatment of various health disorders

15

44.14.2

4.3

4.44.54.64.74.84.9

Basic Pharmacokinetics, pharmacodynamics and Drug propertiesBasic concepts of Pharmacokinetcs & pharmacodynamicsDifferent pharmacokinetic & pharmacodynamics parameters and theirmeaningsBasic techniques of evaluating Pharmacokinetic & pharmacodynamicsparametersBasic types of models in pharmacokinetics & pharmacodynamicsGeneral classification of Drugs and their formulationsDrug – Route of entry, Absorption and Distribution with examplesConcepts of Drug Metabolism & elimination with examplesAdverse Drug reactions( ADRs)Serious Adverse Events( SAEs)

15

24




Paper-IV

Drug Development, Bioinformatics and Pharmacokinetics


1

2

3

4

5

6

Evaluate the given data of protein and nucleic acid sequence using a globaldatabase with appropriate search engine / software (e.g. BIOEDIT). Preparea report stating the steps involved and a brief analysis of the findings.

Evaluate the given data of peptide sequence using a global database withappropriate search engine / software (e.g. BIOEDIT). Prepare a report statingthe steps involved and a brief analysis on the functional annotation of thepeptide.

Bioinformatics : Clustal W. omega, BLAST A, Blast O, Fasta, Alignment,Prosite, SCOP, Rasmol, CATH, Identification of Protein.Preparation of pharmaceutical buffers and determination of buffer capacity,physiologicalbuffersCalculation of Ka, Ke, t ½, Cmax and Tmax from the given data (2 expts.)Evaluation of specialized dosage forms (Melting tests etc)

25

REFERENCES

Semester II

1.Hobart H.Williard, Lynne Merritt, John Dean, FrankSettle, Instrumental Methods of Analysis6th Ed., CBS Publishers and Distributors2. Dale G.Deutsch, Analytical Aspects of Drug Testing, John Wiley and Sons3. Rober D.Brown ,Introduction to Instrumental Analysis ,Mcgraw-Hill InternationalEd.4. Douglas A.Skoog ,Principles of Instrumental Analysis,Saunders College Publihsing5. Garry D.Christian , Analytical Chemistry 5th ed ,John Wiley and Sons Inc6. Dr.P.D.Sethi ,Identification of Drugs in Pharmaceutical Formulations by Thin LayerChromatography ,CBS Publishers and Distributors7. Dr.P.D.Sethi ,HPTLC High Performance Thin Layer Chromatography8. B.Ravindranath ,Principles and Practice of Chromatography , Ellis Horwood Ltd9. Jack Cazes ,Chromatographic Analysis of Pharmaceuticals ,Marcel Dekker Inc10. Heman J.cortes ,Multidimensional Chromatography Techniques and Applications MarcelDkker Inc11.John A.Adam ,Chromatographic Analysis of Pharmaceuticals 2nd ed ,Marcel Dekker Inc12. Richard A.Guarino ,New Drug Approval Process ,Marcel Dekker13. M.D.B.Stephens ,Detection of New Adverse Drug Reactions, Macmillan Publisher14.Jens T. Carstensen ,Drug Stability Principles & Practices 2nd e.d.,Marcel Dekker15. Gene S.Gilbert ,Drug Safety Assessment in Clinical Trials ,Marcel DekkerMilo Gibaldi, Biopharmaceutics and Clinical Pharmacokinetics 4th ed., Lea and Febiger16. David B.Jack, Handbook of Clinical Pharmacokinetic Data, Macmillan Publisher17. Betram G.Katzung, Basic and Clinical Pharamcology 4th ed., Prentice-Hall18. Kenneth A.Connors, Gordon L.Amidon, Valentino J.Stella, Chemical Stability ofPharmaceuticals, John Wiley & Sons19. Peter G.Welling, Pharmacokinetics, Marcel Dekker20. H.Jackson Knight, Patent Strategy for Researchers and Research Managers 2nd ed, JohnWiley and Sons21. A.M.Krstulovic, Chiral Separations by HPLC,22. Ante M.Krstulovic, Reversed-Phase High Performance Liquid Chromatography - TheoryPractice and Biomedical Applications, John Wiley & Sons23. George Lunn, HPLC Methods for Pharmaceutical Analysis Vol 2 (A-D), John Wiley andSons24. George Lunn, HPLC Methods for Pharmaceutical Analysis Vol 3 (E-O), John Wiley & Sons25. George Lunn, HPLC Methods for Pharmaceutical Analysis Vol 4 (P-Z)26.Ramesh C. Gupta 1 st Edition . Nutraceuticals: Efficacy, Safety and Toxicity. 27. Arthur J. Roberts and Genelle Subak-Sharpe. Nutraceuticals: The Complete Encyclopedia of Supplements, Herbs, Vitamins and Healing Foods Jan 1, 200128. Arrigo F.G. Cicero and Alessandro Colletti . Handbook of Nutraceuticals for Clinical Use, 1st Edition

29. Robert E. C. Wildman. Handbook of Nutraceuticals and Functional Foods (Modern Nutrition), Oct 25, 2006 Second Edition30. Aluko, Rotimi E. Functional Foods and Nutraceuticals, 2nd Edition31. Monica K Gill . Biopharmaceuticals (The Biotechnology Revolution), 2nd Edition 32. Gary Walsh. Biopharmaceuticals: Biochemistry and Biotechnology, 2nd Edition

26

https://www.amazon.com/Nutraceuticals-Efficacy-Toxicity-Ramesh-Gupta/dp/0128021470/ref=sr_1_1/132-4152139-3371142?s=books&ie=UTF8&qid=1537267326&sr=1-1&keywords=nutraceutical

https://www.amazon.com/Biopharmaceuticals-Biochemistry-Biotechnology-Gary-Walsh/dp/0470843276/ref=sr_1_2?s=books&ie=UTF8&qid=1537267533&sr=1-2&keywords=biopharmaceutical

https://www.amazon.com/Biopharmaceuticals-Biotechnology-Revolution-Monica-Gill/dp/1622755820/ref=sr_1_1?s=books&ie=UTF8&qid=1537267533&sr=1-1&keywords=biopharmaceutical

https://www.amazon.com/Handbook-Nutraceuticals-Functional-Modern-Nutrition/dp/0849364094/ref=sr_1_9/132-4152139-3371142?s=books&ie=UTF8&qid=1537267326&sr=1-9&keywords=nutraceutical

https://www.amazon.com/Handbook-Nutraceuticals-Functional-Modern-Nutrition/dp/0849364094/ref=sr_1_9/132-4152139-3371142?s=books&ie=UTF8&qid=1537267326&sr=1-9&keywords=nutraceutical

https://www.amazon.com/Handbook-Nutraceuticals-Clinical-Arrigo-Cicero/dp/3319736418/ref=sr_1_6/132-4152139-3371142?s=books&ie=UTF8&qid=1537267326&sr=1-6&keywords=nutraceutical

https://www.amazon.com/Handbook-Nutraceuticals-Clinical-Arrigo-Cicero/dp/3319736418/ref=sr_1_6/132-4152139-3371142?s=books&ie=UTF8&qid=1537267326&sr=1-6&keywords=nutraceutical

https://www.amazon.com/Nutraceuticals-Complete-Encyclopedia-Supplements-Vitamins/dp/0399526323/ref=sr_1_2/132-4152139-3371142?s=books&ie=UTF8&qid=1537267326&sr=1-2&keywords=nutraceutical





M.Sc. Bioanalytical Sciences Semester- III

Paper I

Basic Microbiology, Genomics, CE and Toxicology-I

COURSE CODE: BPSBN301- (2018-19) Credits- 04

Sr. No. Modules/Units Lectures(60)1

1.11.2

1.3

1.4

Basic Microbiology and its application in pharmaceuticals Microbes & Their environment, Significance and scope of MicrobiologyBiodiversity and types of Microorganisms, Visualization of Microorganisms:stainingand Simple and compound microscopy, Electron MicroscopyGrowth of Microorganisms, methods to study growth of microorganisms,preservation of microorganisms, maintenance media, etcSources of antimicrobial agents: plants and microorganisms, therapeutic Antimicrobial Agents e.g. Erythromycin, Amphotericin B, Cephalosporins and their commercial production, Antimicrobial Drug Resistance and Drug Discovery

15

22.12.22.32.42.52.62.72.82.9

2.10

Genomics Nucleic Acid chemistryPrinciples of DNA sequencingDNA & RNA probesConcepts of Gene manipulation (introduction only)Restriction enzymes & their usesVectors & their usesProducing Transgenic organismsHybridoma technologycDNA production & applicationsGene libraries & applications

15

33.13.23.33.43.53.63.73.83.9

3.10

Basic and Regulatory ToxicologyIntroduction, scope and types of toxicological studies.Toxicants, their route of entry, distributionMetabolism & elimination of toxicantsConcept of LD50, ED50 Title: Regulatory ToxicologyTypes of toxicity studiesDesign considerations.Evaluation of resultsExtrapolation to man.OECD Guidelines on Toxicological studiesSchedule Y and its interpretation.

15

44.14.24.3

Regulatory Microbiology and its application in pharmaceutical & food industry Asepsis, Sterilization and Disinfection, concept of Death curve of microbial population, Aseptic filling in pharmaceutical industry, Classification Clean rooms / Clean areas, QA and QC in Microbiology Laboratory

15

27

4.4

4.54.64.7

Important Microbes for Food & Drug Industry, Pathogenic Organisms in Food &Pharma IndustrySources of contamination, Microbial Contamination in ASU preparationsRegulatory Microbiological testing in pharmaceuticalsMicrobiological Assays for pharmaceutical products




Paper I

Basic Microbiology, Genomics, CE and Toxicology-I


1

2

3

4

5

6

7

8

9

10

Plant DNA extraction and separation using agarose Gel.

DNA fingerprint (Genomic DNA isolation kit may be used) of two bacterialstrains e.g. Resistant and wild strains of E. coli)

Gram staining of bacteria and mounting of filamentous and non-filamentousfungi (Staphylococcus aureus, E. coli, Candida albicans, Penicilliumsps,Lactobacillus sps etc.)Sterility testing (Microbial load) of drug formulations (According to IP2013)CCl4 liver dysfunction in rats and evaluation using liver function tests (Anexperimental comparison using suitable groups of controls, natural recoveryand treatment with known hepatoprotectants to be carried out)

LD 50 evaluation using a suitable model (e.g. Daphnia / rice weevil)

Isolation & screening of industrially important microorganisms

Sterility testing of laminar airflow bench top.

Strain improvement by mutation (by UV radiation & Chemical mutagens)

Central streak with Bacillus species isolated from soil

28




Paper-II

MS applications,Metabolite studies,Thermal Analysis and Tracer Techniques-ICOURSE CODE: BPSBN302- (2018-19) Credits- 04


1.11.21.3

MS basics MSMS/MS, TQ/Ion TrapComponents: Inlets, Ion sources, Analyzers, Detectors, Vacuum System, etcIntroduction

15

22.12.22.32.4

Hyphenation- IHeadspace GC GC/MS and GC/MS/MSScan events in TQ and other tandem systems and hybrid systemsRecent advances in the field of mass spectrometry

15

33.13.23.33.43.5

Thermal analysisPrinciples of Thermal AnalysisInstrumentation RequirementsApplications of Thermal AnalysisThermal analysis of Bhasma preparations Thermal Analysis Techniques

15

44.14.24.3

Metabolite Identification and IsolationTechnique of generating drug metabolitesMetabolite IdentificationImpurity profiling

15

29



.Sc. Bioanalytical Sciences Semester- III

Paper-II

MS applications,Metabolite studies,Thermal Analysis and Tracer Techniques-I


1

2

3

GC/MS separation of plant essential oil (Demonstration)IR patterns of an Ayurvedic Bhasma preparation (e.g. calcium containingshanka bhasma – comparison with pure CaCO3 and formulations likeCalcium supplement tablets)AAS of a suitable Ayurvedic metal bhasma preparation (e.g Tamarabhasma ) / Paracetamol

30




Paper-III

Standardization of ASU drugs, Statistics & GMP-ICOURSE CODE: BPSBN303- (2018-19) Credits - 04


1.11.21.31.41.51.61.71.81.9

1.10

Standardization of ASU drugsNeed of standardization of Ayurvedic drugsWhat does standardization involve?Bioanalytical tools for standardizationClinical studies in StandardizationApproaches to standardization;Raw materialsIn-process materialsFinished productsDeveloping standardized QC methodsShelf life studies on finished products

15

22.12.22.32.42.52.62.72.82.9

2.10

General Statistical MethodsBasic concepts of sample statisticsConcept of sample size and powerConcept of ramdomisation and sampling techniquesConcept of significance and confidence limitsIntroduction to Various statistical tests - parametric and non parametricUse of Statistical Packages for Data evaluationConcept of random sampling and sampling techniquesConcept of level of significance, power of test and confidence limitsConcept of sample sizeApplication of normal distribution

15

33.13.23.33.43.53.63.73.83.9

3.103.113.12

Concepts of BiostatisticsStatistical approach to biological samplesVariations in biological samples & their statistical treatmentIntroduction to Data collection techniquesDesign of experiments with eg. Block designs, Latin squareCOV and ANOVAStudent’s t test and F testRegression analysis with application to Std GraphNon parametric tests with examplesStatistical Guidance from regulatory agenciesStudent’s T test, chi square test, Z test and F testSingle sample and two sample Non parametric tests with examplesUse of statistical packages for data analysis (SPSS software)

15

44.14.24.3

Good Manufacturing PracticeWhat is GMP?Requirements of GMP implementationDocumentation of GMP practices

15

31

4.44.54.64.7

Regulatory certification of GMPGMP in production of ASU drugsHarmonization of SOP of manufactureAudit for GMP compliances




Paper-III

Standardization of ASU drugs, Statistics & GMP-I


1

2

The project should involve industrial training of 8 to 12 weeks period. Dataevaluation must involve application of biostatistics

Problem based on Biostatistics

32




Paper-IV

BA/ BE Studies, GCP and Method Validation-I COURSE CODE: BPSBN304- (2018-19) Credits- 04


1.11.21.31.41.51.61.71.81.9

Ethical Issues in Clinical TrialsOrigin of Ethical IssuesDealing with Ethical issuesEnsuring compliance to ethical issuesEthical Committees & their set upRegulatory powers of ethical committeesEthical issues in animal studiesCompliance to ethical guidelinesDealing with Ethical issues (subject compensation and subject rights)Compliance to current ethical guidelines

15

22.12.22.32.4

Good Clinical Practice (GCP) – 1What is GCP?Origin of GCPEarlier Guidelines for GCPRequirements of GCP compliance

15

33.13.23.33.43.53.63.73.83.9

3.10

Bioavailability (BA) & Bioequivalence (BE) studies – 1What is BA?Parameters to evaluate BA of a drugFactors that influence BA of a drugEvaluating BA of a drugEstimating BA parameters of a drugWhat is BE?Parameters to evaluate BE of a drugFactors that influence BE of a drugEvaluating BE of a drugEstimating BE parameters of a drug

15

44.14.24.34.44.54.64.74.84.9

4.104.11

Analytical Method ValidationStrategies for Method developmentWhat and Why of method validationRegulatory requirements of validationIQ, OQ and PQ of analytical instrumentsUse of Reference standardsIssues of Method transferIntra and inter lab – Validation SamplingCalibration of glassware and instruments, concepts of Good weighingPracticeUse of Reference standards and working standardsformat of Certificate of Analysis

15

33




Paper-IV

BA/ BE Studies, GCP and Method Validation-I


1

2

Determination of iron from a given sample / sample solution byi) Redox titrationii)Colorimetryiii)Atomic Absorption Spectroscopy

Study of matrix effect on IR spectra using solution IR technique andquantitate the solutefrom a given sample. Identify solute from a givensolution using IR library and carry out quantitative assay.

34

REFERENCES

Semester III1. S.F.Bloomfield , R.Baird, R.E.Leak, R.Leech ,Microbial Quality Assurance inPharmaceuticals, Cosmetics and Toiletries ,Ellis Horwood2. William Hewitt ,Stephen Vincent ,Theory and Application of Microbiology Assay,AcademicPress3. Michael Pelczar ,E.C.G Chan, Noel R.Krieg ,Microbiology ,McGraw Hill4. Ronald M.Atlas ,Lawrence C.Parks ,Handbook of Microbiological Media ,CRC Press5. Raymond P.W.Scott ,Chromatographic Detectors Design Function Function and Operation,Marcel Dekker 6.W.M.A.Niessen ,Liquid Chromatography Mass Spectrometry 2nd ed ,Marcel Dekker Inc7.Hamed M.Abdon, Dissolution Bioavailbaility and Bioequivalence, MACK Publishers8. K.Robards ,Principles and Practice of Modern Chromatographic Methods ,Academic Press

9. C.M.Earnest ,Thermal Analysis of Clays Minerals and Coal, Perkin Elmer10. Randoll C.Baset ,Advances in Analytical Toxicology Vol 2 ,Year Book Medical Publishers11.Chung Chow Chan ,Y.C.Lee, Analytical Method Validation and Instrumental PerformanceVerification, Wiley Interscience12.R.S.Iyer, Schedule M and Beyond Good Manufacturing Practices, Indian Drug ManufacturersAssociation13. Fulton G.Kitson, Barbara S.Larsen, Gas Chromatography and Mass Spectrometry A PracticalGuide, Academic Press

35



M.Sc. Bioanalytical Sciences Semester- IV

Paper-I

Basic Microbiology, Genomics, CE and Toxicology-IICOURSE CODE: BPSBN401- (2018-19) Credits - 04


1.11.21.31.4

Bio assays in Pharmaceutical evaluationGeneral idea about bio assay systems used in pharmaceutical evaluationsIn vitro assays and in vivo assaysEthical issues of using animal assay systemsAlternatives to animal assays – one or two examples

15

22.12.22.32.4

Polymerase Chain Reaction (PCR) & DNA FingerprintingTypes of PCR & its applicationsDNA amplification w.r.t its applicationsDNA fingerprinting and applicationsUse of genomic techniques in diagnostics

15

33.13.23.33.43.5

Automation and analysisAutomation and its advantages in sample preparationAutomation in bioanalysisAdvanced automated liquid handling systemsRobotic WorkstationsHigh throughput Screening

15

44.14.24.34.44.5

Capillary ElectrophoresisIntroductionHow capillary electrophoresis worksWhy capillary electrophoresis worksCE hardwareUse in bioanalysis

15

36




Paper-I

Basic Microbiology, Genomics, CE and Toxicology-IICOURSE CODE: BPSBNP401- (2018-19) Credits - 0 2

1

23

4

5

6

7

8

9

CE separation of a modern drug from plasma and its formulation (e.g. DFS)

CE separation of peptides (e.g. erythropoietin as per E.P.)

PCR (PCR Kit may be used) for Plant DNA and RFLP (RFLP kit may beused) (e.g. Phyllanthussps.)

DNA sequencing using sample from a suitable organism

Identification of Genetically Modified Organism (GMO identification kitmay be used)

Blue white screening of mutated organism

Serum levels of drug attained by agar cup method

Zone of inhibition assay for penicillin (using spiked plasma and formulation)

Zone of exhibition assay for Vitamin B12

37




Paper-II

MS applications, Metabolite studies, Thermal Analysis and TracerTechniques-II

COURSE CODE: BPSBN402- (2018-19) Credits- 04


1.11.2

Applications of Quantitative AnalysisSIM quantitationMacromolecule quantitation

15

22.12.22.3

Hyphenation IIICP/MS (Principle, Instrumentation and applications)AFM (Principle, Instrumentation and applications)BET (Principle, Instrumentation and applications)

15

33.13.23.33.4

LC/MS/MSLC/MS and LC/MS/MSImpurity profile in drugs and drug productsProteomicsPesticides, pesticide residues in food

15

44.14.24.34.44.54.6

Tracer techniques in Bioanalytical assaysConcept of Radioactivity & Half life∝, β, γ emitters and their biological applicationsUsing tracers in assaysDetectors and countersConcept of autoradiographyRadio labeled probes and their uses

15

38




Paper-II

MS applications, Metabolite studies, Thermal Analysis and TracerTechniques-II


1

2

3

4

5

LC/MS/MS qunatitation of a modern drug from plasma (e.g. DiclofenacSodium)

LC/MS/MS quantitation of meatbilite of a modern drug from plasma (eg.Mycopenolic acid, metabolite of Mycophenolatemofitil)

Mass Fingerprinting of peptides using a suitable sample.LC/MS quantitation of a modern drug (e.g. Diclofenac Sodium, Ezetimibe etc.)

Demonstration of AFM and BET

39




Paper-III

Standardization of ASU drugs, Statistics & GMP-IICOURSE CODE: BPSBN403- (2018-19) Credits - 04


1.11.21.3

1.4

Regulatory Aspects of ASU drugsNational initiatives for regulation of ASU drugsSchedule T and Schedule Y of Drugs and Cosmetics ActInternational initiatives for regulation of ASU drugs with special reference toWHO guidelines on traditional medicineApproaches of US and EU to ASU drug regulationProvisions of Drugs and Cosmetics Act applied to ASU(e.g.Schedule T & Y)

15

22.12.22.32.42.52.6

2.7

Environmental Safety in Bioanalytical laboratory Strategies to reduce environmental impact of Bioanalytical laboratoryStandards of Laboratory Safety (Including Biosafety Levels)Overview of guidelines for laboratories handing Radioactive substances Introduction to ISO 14001 and OSHAS 18001.Introduction to Environment Impact Assessment & ReportingBiodiversity: Red Data Book, Endemic and endangered Medicinal PlantSpecies, Conservation and sustainable use of medicinal raw materials,Introduction to Wildlife Act of India & CITESCarbon footprints and Carbon credits.

15

33.13.23.33.43.53.6

Electronic Data ManagementElectronic Acquisition of dataManagement of data in ComputersElectronic Data Validation and regulatory requirementsElectronic signatures & its regulationGenerating reports using computersRegulatory requirements of Data evaluation

15

44.14.24.34.4

Regulatory IssuesOTC drugsCosmeticsFood supplementsNutraceuticals w.r.t. FSSI regulations

15

40




Paper-III

Standardization of ASU drugs, Statistics & GMP-IICOURSE CODE: BPSBNP403- (2018-19) Credits - 0 2

1 The project should involve preparation of herbal formulations andstandardization Student can work on one of the following formulation

Any oil based preparation or ayurvedictaila preparation Any vatti(Ayurvedic) or Guliga(Siddha) Awahela (semi-solid,jiggery/sugar syrup based formulation) Any preparation from unani e.g. Saffoof, Jawarish, Majoon.

Students should involve any modern chromatographic techniques,microscopicevaluation, chemical and physical tests for QC of formulation prepared.


41



Paper-IV

BA/ BE Studies, GCP and Method Validation-IICOURSE CODE: BPSBN404- (2018-19) Credits - 04


1.11.21.31.41.51.61.7

Therapeutic drug monitoring and PharmacovigilancePurpose of therapeutic Drug MonitoringBioanalytical techniques in TDMAnalytical and practical issues of TDMPharmacoeconomics of TDMSignificance and need for PharmacovigilanceIndian scenario and the role of regulatory in Pharmacovigilance Pharmacovigilance and safe use of medicines (with case studies)

15

22.12.22.32.42.5

Good Clinical Practice (GCP) – 2GCP guidelines of ICHGCP guidelines of ICMREnsuring GCPDocumentation of GCP practiceAudit of GCP compliance

15

33.13.23.33.43.53.63.73.83.9

3.103.113.12

Bioavailability (BA) & Bioequivalence (BE) studies – 2Design of a BA studyConduct of a BA studyData collection and evaluationReporting a BA studyRegulatory requirements of BADesign of a BE studyConduct of a BE studyRegulatory requirements of BA and BEData record and evaluationEstimating Pharmacokinetic parametersAssessment of BioequivalenceRegulatory requirements and their compliance in pharmacokinetics

15

44.14.24.34.44.54.64.74.84.9

QC and QA of ASU drugsHerbal pharmacopoeia and Ayurvedic Formulary of IndiaApproaches to Quality control of ASU formulationsGovt initiativesSome Initiatives from manufacturersQC of RM and In-process materials (some examples)QC / OA for finished products (some examples)Applications of Herbal pharmacopoeia and Ayurvedic Formulary of IndiaRecent advances in Quality control of ASU formulationsQC / OA for finished products (some examples like Taila, Vati, Churna,Sufoof, Jawarish, Majoon,etc.)

15

42




Paper-IV

BA/ BE Studies, GCP and Method Validation-IICOURSE CODE: BPSBNP404- (2018-19) Credits - 0 2

1

2

3

4

5

6

BA & BE of a modern drug (Demonstration – witnessing an actual trial)

Calculation of AUC and bioequivalence from the given data (2 expts.)

Total viable count of herbal formulations/raw material

Screening of pathogens from herbal formulation/raw material (E.coli, S. aureus,Candida albicans)

Environment audit report

Problem based on calculation of carbon credit and carbon footprint

43

REFERENCES

Semester IV1.Norberto A.Guzman ,Capillary Electrophoresis Technology ,Marcel Dekker Inc2. B.Widdop, Therapeutic Drug Monitoring, Churchill & Livingstone3. Eric Reid, Ian D.Wilson, Analysis for Drugs and Metabolites, Royal Society of Chemistry4. Edward Johnson, Robert Stevenson, Basic Liquid Chromatography, Varian Associate5. W.M.A.Niessen, J.Van der Greef, Liquid Chromatography Mass Spectrometry, MarcelDekker6. Thomas M. Vickrey, Liquid Chromatography Detectors,7. L.R.Snyder, J.J.Kirkland, Introduction to Modern Liquid Chromatography 2nd ed., JohnWiley & Sons8. Richard F.Venn, Principles and Practice of Bioanalysis, CBS Publishers1stEdition9. Charles Poole, Frank Owens Introduction to Nanotechnology 10. Murthy Raj Shankar Rath Murd . Textbook of Nanosciene and Nanotechnology 11.M.S. Ramachandra Rao, Shubra Singh . Nanoscience and Nanotechnology: Fundamentals of Frontiers12. Frank Owens Charles Poole. Introduction to Nanotechnology Paperback – 200713. P.Johnson ,J.G.Lloyd-Jones ,Drug Delivery Systems Fundamentals and Techniques ,EllisHorwood14.D.R.Karsa, R.A.Stephenson, Excipients & Delivery Systems for PharmaceuticalFormulations, The Royal Society of Chemistry

44

https://www.amazon.in/s/ref=dp_byline_sr_book_1?ie=UTF8&field-author=Frank+Owens+Charles+Poole&search-alias=stripbooks

https://www.amazon.in/Nanoscience-Nanotechnology-Shubra-Singh-Ramachandra/dp/8126542012/ref=sr_1_5?s=books&ie=UTF8&qid=1537269235&sr=1-5&keywords=nanotechnology+books

https://www.amazon.in/Nanoscience-Nanotechnology-Shubra-Singh-Ramachandra/dp/8126542012/ref=sr_1_5?s=books&ie=UTF8&qid=1537269235&sr=1-5&keywords=nanotechnology+books

https://www.amazon.in/Textbook-Nanosciene-Nanotechnology-Murthy-Shankar/dp/8173717389/ref=sr_1_2?s=books&ie=UTF8&qid=1537269235&sr=1-2&keywords=nanotechnology+books

https://www.amazon.in/Introduction-Nanotechnology-Frank-Owens-Charles/dp/8126510994/ref=sr_1_1?s=books&ie=UTF8&qid=1537269235&sr=1-1&keywords=nanotechnology+books

department of bioanalytical sciences - BK Birla College

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