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M.PHARM. PHARMACY PRACTICE Courses of Study:
First Semester
MPPC 101: Instrumental methods of Analysis - Theory (Common to all Branches)
MPPC 102: Modern Analytical Techniques - Theory (Common to all Branches)
MPPC 103: Pharmacotherapeutics including Pathophysiology I
MPPC 104: Hospital Pharmacy Theory
MPPC 105: Community Pharmacy Theory
MPPP 106: Pharmaceutical Analysis Practical (Common to all Branches)
MPPP 107: Pharmacotherapeutics including Pathophysiology I (Practical)
II Semester
MPPC 201: Biopharmaceutics - Theory (Common with M. Pharm. Industrial Pharmacy and M.Pharm Pharmacology)
MPPC 202: Clinical Pharmacokinetics - Theory (Common with M. Pharm. Industrial Pharmacy and M.Pharm Pharmacology)
MPPC 203: Pharmacotherapeutics including Pathophysiology II Theory
MPPC 204: Clinical Pharmacy - Theory
MPPC 205: Pharmacy Practice Theory
MPPP 206: Biopharmaceutics Practical (Common with M. Pharm. Industrial Pharmacy)
MPPP 207: Pharmacy Practice Practical
III - Semester
MPPC 301: Research methodology and Pharmaceutical Statistics Theory (Common to All Branches)
MPPE 302: Electives:
1. MPPE 302(1) Advances in Industrial Pharmacy Theory 2. MPPE 302(2) Pharmaceutical Healthcare Theory 3. MPPE 302(3) Analytical Method Development Theory 4. MPPE 302(4) Clinical Pharmacology - Theory 5. MPPE 302(5) Strategy In Drug Synthesis 6. MPPE 302(6) Pharmacobiotechnology - Theory
MPPT 303: Thesis Phase I
IV Semester
MPPT 401 Thesis Phase II
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Scheme of Examinations M.Pharm.-Pharmacy Practice
Subject Hrs/Week Credits Evalutation (Marks) L T P Sessional Univ. Exam Total
I.Semester MPPC 101 Instrumental methods
of Analysis 2 1 -- 3 25 75 100
MPPC 102 Modern Analytical Techniques 2 1 -- 3 25 75 100
MPPC 103 Pharmacotherapeutics including Pathophysiology I 2 1 -- 3 25 75 100
MPPC 104 Hospital Pharmacy 2 1 -- 3 25 75 100 MPPC 105 Community Pharmacy 2 1 -- 3 25 75 100 MPPP 106 Pharmaceutical Analysis (Practical) -- -- 4 2 40 60 100
MPPP 107 Pharmacotherapeutics including Pathophysiology I
(Practical) -- -- 6 3 40 60 100
II-Semester MPPC 201 Biopharmaceutics 2 1 -- 3 25 75 100
MPPC 202 Clinical Pharmacokinetics 2 1 -- 3 25 75 100
MPPC 203 Pharmacotherapeutics including Pathophysiology II 2 1 -- 3 25 75 100
MPPC 204 Clinical Pharmacy 2 1 -- 3 25 75 100 MPPC 205 Pharmacy Practice 2 1 -- 3 25 75 100
MPPP 206 Biopharmaceutics (Practical) -- -- 4 2 40 60 100
MPPP 207 Pharmacy Practice (Practical ) -- -- 6 3 40 60 100
III Semester MPPC 301 Research
Methodology and Pharmaceutical Statistics (Theory)
2 1 -- 3 25 75 100
MPPE 302 Elective 2 1 -- 3 25 75 100 MPPT 303 Thesis Phase I 15 6 40 60 100
IV Semester MPPT 401 Thesis Phase II 13 40 60 100
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Syllabus
I SEMESTER
MPPC 101: INSTRUMENTAL METHODS OF ANALYSIS (Theory) 35 Hrs.
1. UV-Visible Spectrophotometry: Theory Beer and Lambert - Limitations of the law, Design and working of single beam and double beam spectrophotometers. Applications of UV absorptions spectrophotometry in qualitative analysis and quantitative analysis.
2. Fluorimetry: Theory - Photoluminescence Fluorescence and Phosphorescence. Chemical structure and fluorescence - factors affecting fluorescence intensity. Instrumentation and Pharmaceutical applications of fluorimetry.
3. Flame Photometry and Atomic Absorption Spectrophotometry: Theory, Instrumentation Types of interference and elimination of interference - Pharmaceutical applications
4. Chromatography: Principle, technique and applications of HPTLC, Gel filtration, Ion exchange chromatography and super critical fluid chromatography.
5. Chromatography: HPLC, GC, Plate theory, Van Deempter equation - Principle, Instruments and application. Chromatographic attributes: Capacity factor, resolution, theoretical plates and symmetry factor
6. Preliminary studies on X-Ray Diffraction and Inductively coupled plasma mass spectrometry
7. Introduction to Radio Immuno Assay
Books for Reference:
1. GN. Jeffery, Jbassett, J. Mendham and R.C. Denney, (ed), Vogels textbooks of quantitative inorganic analysis, ELBS, London.
2. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone Press London.
3. D.A. Skoog, D.M., West and F.J. Holler Fundamentals of Analytical Chemistry, Saunders College publishing, New York.
4. D.A. Skoog and J.J Leary Principles of Instrumental Analysis, Saunders college publishing, New York.
5. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis, Wadsworth, New York.
6. V.K. Srivastava and K.K. Srivastav, Introduction to Chromatography, S. Chand & Company, New Delhi.
7. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.
8. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall London.
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9. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric Identification of organic Compounds, John Wiley & Sons, New York.
10. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.
11. Undenfriend S., Florescence in biology and Medicine, Academic Press , New York.
12. Mofat, A.C (EdLondon.
13. Pharmacopoeia of India, Govt. of India, Ministry of Health.
14. British Pharmacopoeia, ministry of Health and Social Welfare, UK.
15. United States Pharmacopoeia, US Pharmacopoeia Convention Inc. Rockville, USA.
16. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
17. Robet V. Smith, James T. Stewart, text books of Biopharmaceutical Analysis, Lea & Febiger, Philadelphia.
MPPC 102: MODERN ANALYTICAL TECHNIQUES (Theory) 35 Hrs.
1. IR-Spectrophotometry: Theory, molecular vibration, instrumentation sample preparation - application of IR spectrophotometry in pharmacy. Introduction to FTIR
2. NMR-Spectrometry: Theory and instrumentation spin-spin coupling, chemical shift, magnetic equivalence spin-spin decoupling shift reagents, applications of NMR spectrometry in pharmacy and interpretation of NMR spectra (using spectra of simple organic compound as example)
3. Mass Spectrometry: Theory, fragmentation pattern, ionization techniques: electron bombardment, chemical ionization, field desorption, fast atom bombardment. Different analysers. Interpretation of mass spectra, determination of molecular weight and molecular formula and applications of mass spectrometry
4. Theory, instrumentation and applications of Differential Thermal Analysis and Differential Scanning Calorimetry.
5. A preliminary study of principle, Instrument and applications of 13C NMR
6. Introduction to Bio Assay- bio assay of Insulin Microbiological assay of Vitamins & antibiotics
Books for reference:
1. A.H. Beckett and J.B. Stenlake, Practical pharmaceutical chemistry, part I and II, the Athlone Press London.
2. D.A. Skoog and Leary J.J., Principles of Instrumental Analysis, Saunders college publishing, New York.
3. H.H Willard, L.L. Meritt, J.A. Dean and F.A. Settle, Instrumental methods of Analysis, Wadsworth, New York.
4. H. Strobel and W.R. Heinemann Chemical Instrumentation, Addition-Wisely, Boston.
5. John R. Dyer, Applications of absorption Spectroscopy of Organic Compounds, Prentice Hall London.
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6. Robert M. Silverstein, Clayton Bassler and Terence C. Morril, Spectrophotometric Identification of organic Compounds, John Wiley & Sons, New York.
7. Y.H. Sharma, Elementary Organic Absorption Spectroscopy, S. Chand & Co., New Delhi.
8. Barrow, G.M., Introduction to molecular spectroscopy, McGraw-Hill. London.
9. Haris, R.K. Nuclear Magnetic Resonance Spectroscopy, Pitman, London.
10. A.K. Srivastava, P.C. Jain Chemical Analysis, S. Chand & Company Ltd., New Delhi.
MPPC 103 PHARMACOTHERAPEUTICS INCLUDING PATHOPHYSIOLOGY 35 Hrs
Theory :
1. Pathophysiology and applied therapeutics of diseases associated with the following systems/ diseases with special reference to the drugs of choice.
2. Cardiovascular System: Hypertension, Congestive cardiac failure, Ischaemic heart diseases, Arrhythmias, Hyperlipidemias.
3. Respiratory System: Pulmonary function tests, Asthma, Chronic obstructive airways disease, Drug induced pulmonary diseases.
4. Renal System: Acute renal failure, Chronic renal failure, Renal dialysis and transplantation, Drug dosage in renal impairment, Drug induced renal diseases.
5. Haematological diseases: Anaemia, Thrombo-embolic disorders, Drug induced haematological disorders.
6. Endocrine System: Diabetes, Thyroid diseases, Oral Contraceptives, Hormone replacement therapy, Osteoporosis.
TEXT BOOKS:
1. Clinical Pharmacy and therapeutics-Roger and Walker, Churchill Livingstone publication,2nd ed, 1999
2. Pharmacotherapy : A Patho-Physiological approach Joseph T.Dipiro et.al, Appleton and Lange. 2nd ed, 1988
REFERENCE BOOKS :
1. Pathologic basis of diseases Robins SL.W.B.Saunders Pulication. 2. Pathology and therapeutics for pharmacist : a basis for Clinical Pharmacy Practice, Green and
Harris, Chapman and Hall Publication. 3. Clinical Pharmacy and Therapeutics Eric Herfindal, Willams and Wilkins Publication. 4. Applied Therapeutics : The clinical use of drugs, Llyod young and Koda-Kimble MA {ISBN 0
333 65881 7} 5. th Edn, 1997, Aids international Limited. 6. Relevant review articles from recent medical and pharmaceutical literature.
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MPPC 104 HOSPITAL PHARMACY 35 Hrs
a) The role of hospital pharmacy department and its relationship to other hospital departments and
staff. b) Hospital drug policy Drug Committee, formulary and guidelines , other hospital committees such
as infection control committee and research & ethics committee. c) Hospital Pharmacy management Staff (Professional and non-professional), Materials (drugs,
non-drugs consumables), Financial (drug budget, cost centers, Planning Infrastructure requirements (building, furniture and fitting, specialized equipments, maintenance and repairs), Work load statistics, Hospital formulary.
d) Organisation of Hospital Pharmacy Services.
DRUG DISTRIBUTION Purchasing, warehousing (Storage conditions, expiry date control, recycling of drugs, stock
taking, drug recalls), Drug distribution methods ( ward stock, individual patient dispensing, unit doses ), specific requirements for inpatients, outpatients, casuality /
emergency theatre, ICU/ICCU, Drugs of dependence.
MANUFACTURING Sterile and non sterile production, including total parentral nutrition, cytotoxics.
Radio-Pharmaceuticals, IV additive service, Pre-Packing and labeling, Quality control.
RESEARCH Practice-based research, Research support including clinical trials, Laboratory-based
research.
REFERENCES : 1.Hospital Pharmacy-Hassan WE, Lec and Febiger Publication., 1999
2.Text book of Hospital Pharmacy-Allowood MC and Blackwell., 1980, 1st ed
reatment, 4th edition, Adis international limited.
4.Managing Drug Supply-2nd Edition, Management Sciences for Health, Kumarian press, 1997.
MPPC 105 COMMUNITY PHARMACY 35 Hrs
1. COMMUNITY PHARMACY
a) Introduction to the concept of Community Pharmacy its activities and professional responsibilities. b) The role of the community pharmacy and its relationship to other health care providers. c) Prescribed medication order-Interpretation and legal requirements. d) Patient counselling in Community Pharmacy.
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e) Over the counter (OTC) sales. f) Health education and Community Pharmacy, Family Planning, First Aid, Immunization programme,
prevention,smoking cessation, screening programs. g) Services to Nursing homes / Clinics. h) Community Pharmacy Management, Financial, Material and staff management, Infrastructure
requirements, Drug information resources, Computers in Community Pharmacy. i) Code of ethics for Community Pharmacists. j) Polypharmacy and its implications.
2. COMMUNICATION SKILLS
Principle and elements of communication skills, non-verbal communication in pharmacy, barriers in communication, listening skills, questioning skills, explaining skills and ethics in communication.
3. RESPONDING SYMPTOMS
Symptoms and causes of the following disorders.
Respiratory tract disorders, Gastro intestinal symptoms, Skin disorders, Headache, Eye disorders.
4. Administration and mode of use of various drug delivery systems.
REFERENCES :
1.Hospital Pharmacy-Hassan WE, Lec and Febiger Publication. 1999, 4th Ed.
2.Text book of Hospital Pharmacy-Allowood MC and Blackwell. 1988, 1st Ed th edition, Adis international limited.
4.Managing Drug Supply-2nd Edition, Management Sciences for Health, Kumarian press, 1997.
MPPP 106 PHARMACEUTICAL ANALYSIS PRACTICAL 45Hrs
1. Experiments based on theory subjects Instrumental methods of analysis and Modern Analytical techniques
2. Experiments would be selected illustrating the principles involved in estimation of raw materials and finished products representing major categories of drug formulations from pharmacopoeias.
MPPC 107 PHARMACOTHERAPEUTICS INCLUDING PATHOPHYSIOLOGY I PRACTICAL 70 Hrs.
The students are required to be posted in various clinical wards for their exposure with therapeutic management and other clinical aspects. They are expected to have experience and do a tutorial as well as case presentation in the following clinical conditions.
1. Cardiology
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a) Arrhythmias b) Ischaemic heart diseases, c) Congestive heart failure, d) Myocardial infarction e) Hypertension f) Thrombo-embolic diseases, g) Endocarditis
2. Gastroenterology
a) Diarrhoea, Contipation, b) Acid peptic disease, c) Hepatic diseases-Hepatitis, Cirrhosis & Drug induced hepatic disorders d) Oseophageal reflux e) Helicobactor pylori induced gastric disorders.
3. Rheumatology
a) Rheumatoid arthritis b) Gout c) Degenerative joint disease Temporal arthritis, Polymyalgia rheumatica etc., d) Systemic lupus erythematosus (SLE)
4. Respiratory Medicine
a) Asthma b) Congestive obstructive airways disease (COAD), c) Acute respiratory failure, d) Respiratory tract infections, e) Interstitial Lung disease, f) Respiratory aids
5. Surgery
a) Prophylactic Antibiotics, b) Anticoagulants Heparin, Warfarin, c) Thrombolytics d) Adjunctive therapy e) Pre-operative medications f) Analgesia
6. Geriatric Medicine
a) Postural hypotension b) Dementia and Delirium c) Compliance assessment
7. Paediatrics
a) Acute otitis media, b) Tonsillitis c) Paediatric asthma d) Paediatric gastreoenteritis e) Colic
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f) Immunisation g) Attention deficit disorder h) Febrile neutropenia
8. Oncology
a) Breast Cancer b) Lung cancer small cell, Non-small cell. c) Gastric cancer, d) Colon cancer, e) Genitourinary tract cancer Bladder, Prostate, Testicular f) Skin cancer g) Radiation therapy h) Adjunctive therapy Anti-emetics, Mouth care , Nutrition, Extravasations, Pain control and
Blood products i) Colony stimulating factors j) Infections disease in immuno compromised patients k) Hypercalcemia l) Cerebral edema m) Maligant effusions.
9. Renal
a) Acute renal failure b) Chronic renal failure c) Drug induced renal diseases.
10. Haematology
a) Leukaemias, b) Lymphomas Non- c) Multiple myeloma d) Anaemia e) Bleeding disorders.
11. Infections Disease
a) Respiratory tract infections b) Tuberculosis c) Urinary tract infections d) Joint and bone infections e) Skin and soft tissue infections
12. Critical Care
a) Haemodynamic monitoring b) Parenteral and enteral nutrition, c) Pharmacotherapy of ventilated patients d) Shock Septic, Cardiogenic
13. Endocrinology
a) Diabetes b) Osteoporosis
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c) Thyroid disorders d) Syndrome of inappropriate anti diuretic hormone secretion e) Adrenal disorders
14. Dermatology
b) Psoriasis c) Dermatitis d) Drug induced skin disorders
15. Convulsive disorder
a) b) Neuro degenerative disorders c) Stroke d) TIAs
16. Psychiatry
a) Uni-polar and bipolar disorders b) Anxiety c) Psychosis d) Alcohol abuse e) Drug abuse
17. Opthalmology
a) Occular infections b) Conjunctivitis c) Glaucoma d) Post-operative management
Books for References
1. Clinical Pharmacy and Therapeutics Roger and Walker, Churchill Livigstone, 5th Ed. 2. Pharmacotherapy: A pathophysiologic approach- Joseph, T. Dipiro et al. Appleton & Lange, 8th Ed. 3. Pathologic basis for disease Robins S.L. 8th Ed. 4. Pathology and Therapeutics for pharmacists: A basis for clinical pharmacy practice, 3rd Ed. 5. Clinical pharmacy and therapeutics, Eric T. Herfindal 5th Ed. 6. Applied therapeutics: The clinical use of drugs, Lloyd Young and Koda- Kimble MA. 7. Averis drug treatment, 4th Ed., Adis International Ltd. 8. Relevent review articles from recent medical and pharmaceutical literature.
Second Semester
MPPC 201: BIOPHARMACEUTICS (Theory) 35 Hrs.
1. Drug absorption and disposition: Mechanism of drug transport, factors affecting absorption, distribution, bio- transformation and elimination.
2. First order process, rate constants, half-life; Zero order process
3. Open one compartment model: Description, volume of distribution, drug concentration in plasma, kinetics of I.V. administration, short term constant rate I .V. infusion, absorption rate and drug
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effects , continuous constant rate infusion, repetitive dosing- average concentration of drug at steady state , loading dose , dosing interval.
4. Open two-compartment model; Kinetics of absorption, distribution and elimination. Multiple dose administration. Limitation of multi- compartmental analysis.
5. Non-compartmental model; Area under first moment curve (AUMC), Apparent volume of distribution, mean residence time (MRT), Drug absorption predicting steady state concentration.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger, Philadelphia, 1991.
3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker, Inc., New York, 1987.
4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics A Treatise, 2nd Edn., Vallabh Prakashan, New Delhi, 1998.
5. Swarbrick J, Current Concept in Phramaceutical Science: Bio Pharmaceutics, Lea & Febiger, Philadelphia, 1970.
MPPC 202: CLINICAL PHARMACOKINETICS (Theory) 35 Hrs.
1. Clearance concepts- organ clearance, total clearance, renal clearance and excretion.
2. Hepatic clearance and elimination, other non renal clearance. Extraction ratio
3. Bio-availability and bio equivalency testing; Estimation methods, dissolution testing, in vitro & in vivo correlation study , bio equivalency testing of dosage forms.
4. Pharmacokinetic variability; Body weight & size, obesity, age. Drug metabolism, Plasma protein binding and renal excretion in newborn & children. Sex, pregnancy and genetic factors. Poly morphic acetylation and oxidation.
5. Pharmcokinetic variability: Drug interactions
6. Effect of disease states on drug disposition, therapeutic drug monitoring and dosage prediction of digoxin, gentamycin and anticonvulsants. Hypothesis of individualisation & optimisation of drug therapy.
Books for Reference:
1. Gennaro A R, Remington: The Science and Practice of Pharmacy, 20th Edn.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Gibaldi M, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th edn., Lea and Febiger, Philadelphia, 1991.
3. Notari R E, Bio-Pharmaceutics and Clinical Pharmacokinetics, 4th Edn., Marcel Dekker, Inc., New York, 1987.
4. Brahmankar and Jaiswal, Bio- Pharmaceutics and Pharmacokinetics, 2nd Edn., Vallabh Prakashan, New Delhi, 1998.
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5. Wagner J G, Bio- Pharmaceutics and relevant Pharmacokinetics, Drug Intelligence Publications, Washington DC, 1971.
6. Rowland M and Tozer TN, Clinical Pharmacokinetics concepts and applications, 3rd Edn., Lea & Febiger, Philadelphia, 1995.
7. Shargel L and Yu AB, Applied Bio-Pharmaceutics and Pharmacokinetics, Appleton & Lange, Norwalk, CT, 1993.
MPPC 203 PHARMACOTHERAPEUTICS INCLUDING PATHOPHYSIOLOGY II
35 Hrs. Pathophysiology and applied therapeutics of diseases associated with following system/diseases with special reference to the drugs of choice.
Psychiatric disorders: Schizophrenia, Depression, Anxiety disorders, Sleep disorders.
Gastro intestinal System: Ulcer diseases, inflammatory bowel diseases, Hepatitis, Jaundice, Drug dosing in liver dysfunction, Diarrhoea and Constipation.
Rheumatic diseases: Rheumatoid arthritis, Osteoarthritis, Gout, Juvenile rheumatoid arthritis.
Infectious Diseases-Meningitis, Respiratory tract infections, Gastroenteritis, Pneumonia, Bacterial endocarditis, Septicaemia, Otitis media, Urinary tract infections, Tuberculosis, Leprosy, Protozoal infections and Helminthiasis, HIV and Opportunistic infections, Fungal infections.
Skin and sexually transmitted disease-Psoriasis, Acne, Eczema and Scabies, Syphillis and Gonorrhoea.
Oncology-General principles of cancer,chemotherapy, commonly used cytotoxic drugs and their indications.
Ophthalmology: Glaucoma, Eye infections.
Pain management: Pain pathways, Analgesics and NSAIDs, opiates, Local anaesthetics, neuralgia including post herpetic, trigeminal and glosso-pharyngeal neuralgias.
TEXTBOOKS 1. Clinical Pharmacy and therapeutics-Roger and Walker, Churchill Livingstone publication.2nd ed,
1999 2. Pharmacotherapy. A Patho-physiological approach-Joseph T.Dipiro et.al. Appleton and Lange. 2nd,
1997 REFERENCE BOOKS:
1. Pathologic basis of diseases-Robins SL. W.B. Saunders Publication. 2. Pathology and therapeutics for pharmacist; a basis for Clinical Pharmacy Practice Green and
Harris, Chapman and Hall publication. 3. Clinical Pharmacy and Therapeutics Eric Herfindal, Williams and Wilkins Publication. 4th ed., 1988 4. Applied Therapeutics: The clinical use of drugs, Lyod Young and Koda-Kimble MA{ISBN-0-68881-7}
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5. th edn.1997,Aids international Limited. 6. Relevent review articles from recent medical and pharmaceutical literature.
MPPC 204 CLINICAL PHARMACY 35 Hrs.
Introduction to Clinical Pharmacy (Definition, Development and Scope)
Clinical laboratory tests used in the evaluation of disease states and interpretation of test results
Haematological tests, Liver function tests, Renal function tests, ests associated with cardiac disorders, Fluid and electrolyte balance, common tests in Urine, Sputum, Faeces and CSF.
Sensitivity screening for common pathogenic microorganisms, its significance, resistance in disease states and selection of appropriate anti-microbial regimens.
PATIENT DATA ANALYSIS :
medication history review, Presentation of cases, teaching skills. Understanding common medical abbreviations and terminology used in Clinical Practices.
DRUG & POISONS INFORMATION :
Introduction to information resource available,Design of literature searchers. Preparation of written and verbal reports. Development of a drug and poison information database.
DRUG THERAPY MONITORING :
Medication chart review, clinical review, TDM, Pharmacist interventions, Ward round participation, Adverse drug reaction management, Medication history and patient
counselling. Drug utilization evaluation (DUE) and review (DUR), Quality Assurance of Clinical Pharmacy services.
EDUCATION AND TRAINING :
Training of technical staff, Training and continuing education for pharmacists, pharmacy students, Medical staff and students, Nursing staff and students. Formal and informal
meetings and lectures, Drug and therapeutics newsletter. CLINICAL TRIALS :
Various phases of clinical trails, design and execution of trails in different clinical settings.
REFERENCES :
1. Basic skills in interpreting laboratory data-Scott LT, American-society of health system pharmacists Inc.
2. Practice, Standards and definitions-The Society of hospital Pharmacist of Australia. ClinicalPpharmacokinetics-Rowland Tozer, Williams and Wilkins publication.
3. Biopharmaceutics and Applied Pharmacokinetics-Leon Shargel, prentice Hall publication. 4. Elevent review articles from recent medical and pharmaceutical journals.
MPPC 205 PHARMACY PRACTICE 35 Hrs.
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1. Rational use of drugs 2. Essential drugs concept Pharmaceutical policy 3. Pharmacoeconomics 4. Therapeutics in practice decision making in drug therapy 5. Pharmacoepidemiology 6. Public health policy and Health care system.
REFERENCES :
1. Role of Pharmacist in the Health care system, WHO / PHARM / 94. 569 2. th edition Lippin cott Williams and Welkens. 3. Medicare scenario in India : Perception and perspectives Delhi society for promotion of rational
use of drugs.
MPPP 206 BIOPHARMACEUTICS - PRACTICAL 45 Hrs.
1. Experiments based on Biopharmaceutics theory would be selected for the practical.
MPPP 207: PHARMACY PRACTICE - PRACTICAL 70 Hrs.
i) Patient medication history, interview, answering drug information questions, patient medication counselling, participation in ward rounds. Case studies related to laboratory investigations covering the topics dealt in theory classes.
ii) The students are required to be posted in various clinical wards for their exposure with therapeutic management and other clinical aspects. There will be tutorial and case presentation in various clinical conditions.
THIRD SEMESTER MPPC 301: RESEACH METHODOLOGY AND PHARMACEUTICAL STATISTICS (Theory) 35 Hrs.
[Student should be familiar with pharmaceutical/chemical applications and use statistical tools, by way of calculations, but not expected to derive and find proof.]
1. Writing of articles, thesis scientific writing, preparing title, abstracts; organization of thesis and conventions adopted in writing; citing references; preparation of oral, poster presentation. Accessing required information in a systematic manner from abstracts, books journals, conference proceedings, thesis and dissertations, internet, CDROM etc. Ethics, rights, permissions
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2. The Population - The sample; measures describing the center of data distributions; measurement of spread of data. Introduction to Probability - The Binomial and Normal distributions - their significance.
3. Statistical inference: -Statistical estimation (confidence intervals) - Hypothesis testing - t tests, F tests, ANOVA [one way], Chi square test.
4. Linear regression and correlation. 5. Control charts Constructing control charts, between batch variation as a measure of variability,
quality control charts in research and development, quality control charts for proportions. 6. Non parametric methods 7. Data characteristics suitable to non parametric procedures; Sign test, Wilcoxon signed rank test;
Wilcoxon rank sum test; kruskal Wallis test[one way ANOVA]; Runs test for randomness; Contingency tables.
References:
1. Pharmaceutical Statistics, 2nd Ed., Sanford Bolton, Dekker series. 2. How to write and publish a scientific paper, 4th Ed., Robert A Day Cambridge University presses. 3. Fundamentals of Analytical Chemistry 7th Ed., Skoog, West, Holler Saunders College
Publishing.
MPPE 302(1) ADVANCES IN INDUSTRIAL PHARMACY (Theory) 35 Hrs
1. Pre formulation studies and new formulation development.
2. New drug development and approval process: Investigational New Drugs (IND), New Drug Application ( NDA ), Supplemental New Drug Application ( SNDA ) , ICH requirements for registration of pharmaceuticals.
3. Validation techniques.
4. Methods of enhancing bioavailability, solubilisation, pro drugs, enhancement of dissolution characteristics, bioavailability enhancers.
5. Pharmaceutical product stability testing- ICH guidelines.
6. Polymers: Pharmaceutical applications, molecular weight, conformation, polymer solution, gel formation, coacervation, phase separation, microencapsulation, mechanical properties, biomedical uses of polymers.
Books for Reference:
1. Gennaro A R, Remington, The Science and Practice of Pharmacy, 20th Ed.,Vol I & II, Lippincott Williams & Willkins, Philadelphia, PA, 2000.
2. Lachman L & Liberman H A, The theory and Practice of Industrial Pharmacy, 3rd Ed., Vergese Publishing House, Mumbai, 1991.
3. Banker G S and Rhodes C T, Modern Pharmaceutics, 3rd Ed., Marcel Dekker, Inc., New York, 1995.
4. Aulton M E., Pharmaceutics The Science of Dosage Form Design, 1st (International Student) Ed., Churchill Livingstone, New York, 1996.
5. Ansel H C, Allen, Jr., L V et al, Pharmaceutical Dosage Forms and Drug Delivery Systems, 7th Ed., Lippincott Williams & Wilkins, Philadelphia, PA, 2000.
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6. FDA Code of Federal Regulations, Title 21, Part 300 314.
7. Guarino, R A, New Drug Approval Process, Marcel Dekker, Inc., New York, 1987.
8. Martin A et al, Physical Pharmacy, Indian Ed., New Delhi, 1998.
MPPE 302(2) PHARMACEUTICAL HEALTH CARE - THEORY 35 Hrs.
1. Concept and necessity of Pharmaceutical Health care. 2. A rational approach in paediatrics and geriatric care. 3. Therapeutic consideration with rational approach during pregnancy and lactation. 4. Evaluation of Immune system and its fuctions. 5. Rational use of antimicrobials. 6. Assessment and clinical significance of malnutrition, enteral and parentral nutrition, Nutritional
consideration in major organ failure. 7. Standard treatment protocols of the following diseases Hypertention, Diabetes mellitus, Peptic
Ulcer, Diarrhoea, Urinary tract infection, Bronchitis, Asthma. 8. Self care: Constipation, Common cold, cough, pain, and sun light protection.
REFERENCES :
1. Drug Treatment Protocols, Edited by Damil H.Albert, 2nd Ed., American Pharmaceutical Association, Washington.
2. Role of Pharmacist in the health care system , WHO / PHARM / 94. 569
3. Handbook of Nonprescription Drugs, American Pharmaceutical Association, 12th Ed., 1996.
4. Standard Treatment Guidelines
d) by WHO e) by Government of India f) by Various state governments
MPPE 302(3) ANALYTICAL METHOD DEVELOPMENT THEORY 35 HRS.
1. Errors in Analysis: Accuracy (absolute method, comparative method); Precision; classification of errors, estimation of errors, sources of errors, minimization of errors, normal distribution of errors. Significant figures in analytical chemistry rules and computations.
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2. Calibrations, Standardisations: Calibrating signals, apparatuses; calibration curves external standard methods, internal standard method, standard addition method [applications in HPLC and GLC with calculations], linear regression of straight line calibration curves using the regression equation [applications and calculations].
3. Obtaining and Preparing Samples For Analysis: Importance of sampling techniques sampling techniques random, stratified, systematic, cluster, for quality control. Sample preparation reducing particle size, making solutions, separating analyte from interferants extraction, automated extraction, solid phase extraction, solid phase micro extraction, super critical fluid extraction and micro wave assisted extraction.
4. Validating the analytical method including bio-analytical method: Need for validation; historical background; validation of analytical procedures-- methodology guidelines of ICH; FDA; USP. Understanding of the following concepts in validation accuracy, precision, specificity, limit of detection, limit of quantification, blind analysis of standard sample, ruggedness testing, robustness testing, equivalency testing. Validating the method as standard method collaborative test two sample collaborative testing, control charts.
5. Development of HPLC method: Selection of tools: Choice of HPLC mode, Column, Mobile phase, Special additives. Method Development guiding tools: Separation factor, Selectivity factor, Resolution, Tailing factor. Controlling selectivity: Solvent: Organic phase, Aqueous phase, Additional Variables: pH, Stationary Phase, Temperature. Column Conditions: Flow, Column dimension, Particle diameter. Derivatisation.
6. System suitability tests as per Pharmacoepoeial specification.
7. Development of stability indicating analytical method
Books for References:
1. HPLC method development, Lunn. G(1996),John wiley & Interscience.
2. Pharmacopoeia of India, 4th Ed. (1996), Govt.of India, Ministry of Health and Family Welfare.
3. British Pharmacopeia (1993) London, 4. ICH guide lines: validation of analytical procedures, methodology, November 1996.
5. quantitative inorganic analysis 5th Ed.
6. Pharmaceutical process validation II Ed., Ira R berry, Robert a Nash; Marcel Decker series, 1993.
7. Pharmaceutical statistics II Ed., Sanford Bolton, Decker series, Newyork and Basel.
8. Fundamentals of analytical chemistry 7th Ed.; Skoog, West, Holler, Saunders college publishing.
MPPE 302(4): CLINICAL PHARMACOLOGY -THEORY (35 Hrs)
1. (a) Definition and scope of clinical pharmacology, measurement of drug response in man.
(b) Clinical trails- Phase I, Phase II , Phase III and post marketing surveillance data analysis & presentation skills
(c) Pharmaco- epidemiology.
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2 (a) Drug Drug interaction, Drug food interaction, and Drug disease interaction in clinical pharmacology.
(b) Adverse drug reactions and ADR monitoring.
3 (a) Essential drug list, national drug policy
(b) Orphans drugs
vension in Therapeutic drug monitoring in special situations such as pediatrics, geriatric and pregnant cases.
Books for reference:
1. Goodman and Gil Pharmacological Basis of Therapeutic 9th Ed.
2. Pharmacology, by H.P.Rang and M.M. Dale 3rd Ed.
3. iences 19th Ed.
4. Evaluation of drug activities pharmacometrics by D.R.Laurence and A.L.Bachanarach Vol 1. and 2
5. Modern Drug Research Paths to better and safe drugs by Y.C.Martin, E.Kutter and V.Austel
6. Practical approach in toxicity studies by pooley and leslie
7. Screeining methods in Pharmacology by R.A.Tuner
8. Clinical Pharmacology by D.R.Laurence and P.N.Bennett
9. Methods of clinical drug trials by Aln Sperit and Smion
10. Alternatives to animal experiments: Developing in-vitro methods and changing legislation. TIPS., 11:1990 104-107
11. Alternatives to animals in toxicity testing. Scientific American., 261(1989): 16-22
12. Clinical drug trial and tribulations by Allan E.Cato (1980).
13. The Oxford text book of Clinical Pharmacology and drug therapy by D.G.Grehame-Smith and J.K.Aronson.
14. International aspects of drug evaluation and usage by Jouhar and Grayson.
MPPE 302(5): STRATEGY IN DRUG SYNTHESIS Theory 35 Hrs. 1. Organic Name Reaction :
Aldol Condensation, Arndt-Eistert Synthesis, Bayer-Villiger rearrangement, Beckmann rearrangement, Cannizaro reaction, Claisen condensation, Claisen rearrangement, Curtius rearrangement, Diels-Alder reaction, Favoriskii rearrangement, Fries rearrangement, Hoffman rearrangement, Pinacol rearrangement, Mannich reaction, Perkin reaction, Reformatsky reaction, Scmidt rearrangement.
2. Introduction: Basic rules in disconnection. 3. Application of Synthon approach to drug synthesis: Case Studies. a. Antihistaminic agents: Promethazine, Cyclizine, Diphenhydramine.
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b. Adrenergic agents: Stimulants, Epinephrine, Ephedrine. c. Adrenergic blocking agents: Propranolol, Guanethidine. d. Psychotropic agents: Chlorpromazine, Chloprothixene. e. Antidepresants: Imipiramine. f. CNS Stimulants: Amphetamine. g. Narcotic analgesics: Meperidine, Methadone, Propoxyphene.
Books for Reference:
1. Organic Chemistry, Morrison and Boyd, Prentice Hall Pvt. Ltd., New Delhi.
2. Advanced Organic Chemistry, Jerry March, Mc-Graw-Hill.
3. Solomons Organic chemistry 5th Ed.
4. Organic Chemistry, I.L. Finar Vol. I, ELBS.
5. Modern Synthetic reaction, H.O.House.
6. Some Modern Method of Organic Synthesis, W. Carruthers.
7. Designing organic synthesis with work book a programmed introduction to the synthon approach, Stuart Warren.
MPPE-302(6): PHARMACOBIOTECHNOLOGY (Theory) 35 Hrs.
1. Fermentation (Microbial biotechnology): Introduction and scope, Fermentation process. Types of Fermentation processes: Batch culture, Continous culture, Fed-batch culture, Cascade fermentation. Upstream processes, Fermentation process, Monitoring microbial growth, Down stream processing, Microbial products, Improvements in microbial strains. Production of Riboflavine, Ascorbic acid, Fungal amylases, Citric acid, L-Glutamic acid and Penicillin.
2. Enzyme Biotechnology: Introduction, Properties and charateristics of enzymes. Basic nomenclature of enzymes. Factors influencing enzyme action. Sources of enzymes. Methods of enzyme production. Profile of some important enzymes: Hyaluronidase, Penicillinase, Streptokinase, Amylases, Protease. Enzyme Immobilization: Carrier matrices, Materials and Methods of immobilization (Adsorption method, Covalent bonding, Entrapment, Encapsulation). Advantages and disadvantages of immobilization. Application of Enzymes and Immobilized enzymes.
3. Plant Tissue Culture Technology: Introduction and scope. Princple underlying plant culture (totipotency). Nutrient media composition and preparation. Role of plant growth regulators in Cell culture. Laboratory requirements for plant tissue culture. Aseptic techniques and Maintenance of Aseptic environment. Basic steps in plant tissue/cell/organ culture. Selection and preparation of explants. Surface sterilization of explants.
4. Types of Plant culture: Callus culture, Suspension cell culture, Meristem culture, Organ culture, Protoplast culture. Subculture techniques. Precautions in Plant Tissue/Cell culture. Applications of plant tissue/cell culture: Micropropagation & Cloning, Genetically modified plants, Medicinal plant
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improvement, Production of secondary metabolites. Survey of phytochemicals produced through plant cell cultures.
5. Bio-Transformation: Introduction, Types of biotransformation reactions. Design and Methodologies for biotransformation. Cell immobilization, Advantages of cell immobilization. Illustrations of biotransformations with special reference to steroids. Examples of biotransformations using plant cells (Steviol, Codeine, Scopalamine, Hydroxylation of beta methyl digitoxin, Arbutin).
6. Genetic Engineering: Introduction, Properties of DNA. Replication of DNA, and enzymes involved. Steps in engineering the Genes and the enzymes involved. Cloning vectors. Introduction of rDNA into a host cell. Screening and selection of recombinants. Typical examples of Recombinant DNA technology products (human insulin, human growth hormone, Alteplase, Interferons, Vaccines, Coagulation factors etc).
Books for Reference:
1. Duby R. C., Textbook of Biotechnology, 2006, S. Chand & Company, New Delhi. 2. Nagori B.P. and Roshan Issarani, Foundations in Pharmaceutical Biotechnology, 2007, Pharma
Book Syndicate, Hyderabad. 3. Sambamurthy K. And Ashutosh Kar, Pharmaceutical Biotechnology, 2006, New Age International
Publishers, New Delhi. 4. Ashutosh Kar, Pharmacognosy and Pharmacobiotechnology, 2nd Ed., 2006, New Age
International Publishers Ltd., New Delhi. 5. NIIR Board of Consultants and Engineers, Enzymes Biotechnology Handbook, 2004, NIIR, New
Delhi. 6. NIIR Board, Plant Biotechnology Handbook, 2004, NIIR, New Delhi. 7. NIIR Board, Biotechnology Handbook, 2003, NIIR, New Delhi.
MPPT 303: Thesis Phase I
Field training for a period of one month in the institute, CRO or R&D of Pharma industries is to be completed at the beginning of Third Semester. The candidate has to prepare an Orientation Report.
FOURTH SEMESTER
MPPT 401: Thesis Phase II
THESIS III and IV SEMESTERS
Phase-I In the third semester, students will be placed to Pharmaceutical Industries / Hospitals / other allied organizations to provide orientation & exposure. Simultaneously the student will carry out a small project leading to a report at the end of that period. The faculty member of the department and an expert from the respective organization jointly evaluate the report for 10 marks. The students are expected to identify a project towards their thesis and start working on it and submit Phase I thesis during this stay. The students will come back to the Department to appear for third semester examination. On completion of third semester examination the students will return back to the industry/ Hospitals / other allied organizations where he was placed and would continue the thesis work under the collective guidance of a faculty member and a guide drawn from the collaborating organization.
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Phase-II The students would continue the thesis work in the fourth semester, in collaborating organizations, under the supervision of two guides one from the Department and another from collaborating organization allotted by the Head of the Department of Pharmacy.
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