Anda di halaman 1dari 14

NORTH MAHARASHTRA UNIVERSITY, JALGAON STRUCTURE AND SYLLABUS FOR M. PHARM.

I. NOMENCLATURE: Ordinances regulating including scheme and syllabi relating to the degree of master of pharmacy (M. Pharm.) Post graduate course (modified) with effect from academic year (2011-12) Course title: Master of Pharmacy Abbreviation: M. Pharm. North Maharashtra University Jalgaon offers Master of Pharmacy (M. Pharm.) course of two years (Four semesters) duration in the following specialization; 1) Biopharmaceutics 2) Industrial Pharmacy II. ELIGIBILITY: The eligibility for admission to the M Pharm. course is as under: The candidate who has passed the examination for the degree of B. Pharm. of University of North Maharashtra University, Jalgaon or any other statutory University, recognized as equivalent thereto by this university, with at least 60% of aggregate marks or equivalent grade (55% marks for S.C./S.T., teacher and sponsored candidates) will be eligible for admission to one of the specializations of pharmacy mentioned above. III. FEES: The Fees and deposits shall be as prescribed by the competent Authority appointed by Govt. of Maharashtra. IV. DURATION: The duration of Master of Pharmacy (M. Pharm.) Course is of 24 months, divided into four semesters, each semester of 6 months. V. GRANT OF TERMS: The candidate will be granted a term provided he/she has satisfactorily completed the prescribed course of study & has kept 75% attendance for theory & practical (wherever applicable) separately for each subject. Similarly the student will have to keep 75% attendance for guest Lectures, Seminars, Group Discussion, Journal Club activities etc. VI. SEMINAR: The student will have to appear for one seminar in each semester. The topic of M.Pharm. I & II sem. shall be selected from paper of specialization. The topic for M.Pharm III shall be selected from dissertation. The topic for M.Pharm. IV sem. shall be on entire work of dissertation

The grades will be awarded for the performance in each seminar as follows: O - 80% or above marks. A - 60% but less than 80% marks. B - 50% but less than 60% marks. C - Less than 50% marks. D - Less than 40% marks. The student will be considered to have passed in seminar provided he/she has obtained at least C grade. If a student fails to secure minimum C Grade in the seminar even at the second attempt, he/she will be required to give the seminar again in the next semester. The grade awarded to the student in the seminar will be shown separately in his statement of marks of the concerned semester. (Note: Bound volume of seminar record should be maintained and separate seminar grade sheet should be submitted to university within time schedule for each semester) VII. SCHEME OF EXAMINATION A. Internal examination (Sessional Examination): There shall be one internal examination in each subject conducted at the college level in M.Pharm I and M.Pharm-II semesters for both theory and practical after completion of at least two third of the semester instructional weeks. The sessional examination shall include both theory and practical (Scaling down technique will be applied for sessional examination marks).
Internal Examination (Sessional Examination) Theory Practical Duration (Hours) Marks 01 20 06 20

B. University Examination: There shall be a University examination at the end of M.Pharm I and II sem. And M.Pharm- III & IV sem. (combined) thesis evaluation). University Examination Theory Practical Duration (Hours) Marks 03 80 06 80

C. Scheme for Theory Examination: Each university theory paper will consist of 80 marks. There will be total twelve questions; out of which the candidate will have to attempt eight questions. Each question will be of 10 marks.

D. Dissertation: Every student after completion of M. Pharm.-IV sem. is required to submit five typewritten copies of the Dissertation duly certified by the Guide and Principal to the College ( Concern college will retain two copies for guide and library) and three will be submitted to the University for Evaluation. The dissertation is to be submitted not before 23 months from the date of commencement of first term of M. Pharm. Course. If candidate fails to submit his/her dissertation within 24 months, he/she will have to submit dissertation in subsequent semester. The Principal of the concerned College/Institute will forward the dissertation to the University Examination Section. There shall be not more than six submissions of dissertations in one academic year under each fulltime recognized PG guide by NMU. Fulltime recognized PG Teacher/Guide from other institute in same university jurisdiction shall submit not more than two dissertations in a one academic year. If the subject of dissertation entails collaboration with other departments or specialties, the collaborative portion of the work will be supervised by Co-Guide, designated by the Principal of the College/Institute in consultation with the Guide. Where a Co-Guide is involved, the dissertation will be certified jointly by the Guide & Co-guide. The Guide or any other Recognized Postgraduate teacher in the subject (Internal Examiner) and an External Examiner appointed by the University will examine the dissertation. The Examiners will jointly assign the marks for dissertation out of 300 (including viva-voce of 100 marks). The allotment of marks of the dissertation shall be as under.

Dissertation Work a) Reference work b) Experimental work c) Scientific contents d) Presentation/ communication d) Results / Conclusion Total Marks

= 30 = 60 = 20 = 40 = 50 = 200

Viva voce a) Scientific contents b) Presentation / Communication c) Discussion d) Report Total Marks

= 20 = 20 = 20 = 40 = 100

E. Standard of Passing of Theory and Practical: There will be separate passing of theory and practical examinations for each subject. Students will have to qualify Internal (Sessional) and University Examination separately. The students will be declared to have pass M.Pharm I and II semester examinations if he has obtained at least 45 % marks in all theory and practical examinations independently. VIII. Award of Class: Class will be awarded to the student on the basis of aggregate marks obtained by him/her at M. Pharm. I Sem., II sem. III sem. and IV sem. Examination taken together. First Class with Distinction - 70 % and above marks First Class - 60% and above, but less than 70% marks Second Class 50 % and above, but less than 60 % marks
3

IX. A.T.K.T/BACKLOG: A candidate can proceed from M. Pharm. I sem. to M. Pharm.-II sem. irrespective of the number of subjects in which he/she has failed. A candidate is allowed to proceed from M.Pharm.- II Sem. to M. Pharm.-III Sem., irrespective of the number of subjects in which he/she has failed in I & II sem. A candidate is also allowed to continue his/her research work and submit the dissertation irrespective of the subjects he/she has failed in I & II sem., however overall result of the M. Pharm. examination will be considered as fail until he/she has passed the M. Pharm. I & II sem. Examinations.

M.PHARM. COURSE STRUCTURE SPECIALIZATION: BIOPHARMACEUTICS Branch Code: BP

Sem.

Code

Paper

Scheme of Teachin g Hrs/Wee ks

Scheme of Examination Theory/Practical

Total

Hr MT- 100 MT- 100P BP - 101 BP 101P Modern Analytical Techniques (T) Modern Analytical Techniques (P) Biopharmaceutics (T) Biopharmaceutics (P) Elective-I (T) Seminar Drug Regulatory Affairs and Intellectual Property Rights (T) Research Methodology and Biostatistics (T) Pharmacokinetics (T) Pharmacokinetics (P) Elective-II (T) Seminar Research Work Seminar on Research Work Research Work Dissertation Defense Viva/voce Seminar on Dissertation 03 06 UE 03 06 IE 01 06 01 06 01

Marks UE 80 80 80 80 80

IE 20 20 20 20 20

100 100 100 100 100 500 100 100 100 100 100 500 --

03 03 06 06 03 03 Grade: O/A/B/C/D 03 03 03 03

MT-200 MT-300 II BP - 201 BP-201 P

01 01 01 06 01

80 80 80 80 80

20 20 20 20 20

03 03 06 06 03 03 Grade: O/A/B/C/D -42 Grade: O/A/B/C/D -42 Grade: O/A/B/C/D Grand Total

---

---

---

III IV

300 1300

UE- University Examination; IE Internal (Sessional) Examination Note: 1. O/A/B/C/D indicates the grade secured by the student in the seminar; O- Excellent; A-very good; B- good; C- Average; D- Poor. 2. Elective I and Elective II should be chosen from the specialization

BIOPHARMACEUTICS (Theory) Semester I


Duration: 3 Hrs/week Total Hours: 45

Section-I
Sr. No. 1. 2. Topic Hours Introduction to Biopharmaceutics : Concept of Bio- 04 pharmaceutics scope and its importance Absorption: GI absorption of drug, cell membrane structure 09 and physiology, Mechanism of drug absorption, Routs of drug administration (oral & non oral), Factors influencing drug absorption & bioavailability. Distribution: Factors influencing distribution of drugs, 09 Volume of distribution, Plasma protein binding and its clinical significance, Tissue protein binding of drug. 22 Number of Lectures Section-II Elimination: Mechanism of bio-transformation, Hepatic 09 metabolism - chemical pathway & factors affecting it, Renal excretion, Non-renal excretion. Bioavailability and bioequivalence: Definition, Objectives of 14 bioavailability, parameters of bioavailability, Determination of AUC, Methods of enhancement of bioavailability (solubilization, pro-drugs and enhancement of dissolution characteristics & bioavailability enhancers) Drug dissolution rate & bioavailability Theories of dissolution. In vitro drug dissolution testing models. In-vitro in-vivo correction. Various invitro and in vivo models. Bioequivalence - Pharmaceutical equivalents, biological equivalents, therapeutic equivalents. Selection of animal. Number of Lectures 23

3.

4.

5.

BIOPHARMACEUTICS (Practical)
Duration: 6 Hrs/week

Sr. No. 1. 2. 3. 4. 5. 6. 7. 8. 9 10 11 12 13

Name of Experiment

No. of Experiment

To study the kinetics of plasma protein binding. To study the effect of pH on urinary excretion of aspirin To study the relationship of blood glucose level and chlorpromide level. To study the effect of pH of dissolution media on rate of dissolution of acidic drugs. Dissolution and bioequivalence studies of different brands of tablets. Studies on salivery excretion of drugs such as paracetamol. Effect of excipients such as binders or diluents on the dissolution and bioavailability of drugs. To study the effect of surfactant concentration of dissolution of poorly water soluble drugs. To study the effect of complexation on In-vitro dissolution of drugs like tetracycline. To study the urinary excretion of drug To study the effect of drug-drug interaction on urinary excretion of drug. Determine the rate of in-vitro absorption of the given drug using everted intestinal sack Determine the effect of different pH condition on solubility of a weekly acidic or basic drug and study PH partition hypothesis

01 01 01 01 05 01 03 01 01 01 01 01 01

Reference: 1. Biopharmaceutics and pharmacokinetics - Milo Gibaldi; Lea and Febiger book publication. 2. Biopharmaceutics and pharmacokinetics - An introduction - Robert E. Notary. 3. Biopharmaceutics - Swarbrick, Lea & Febiger book publications. 4. Remington Pharmaceutical Sciences. 5. Applied Biopharmaceutics and pharmacokinetics - Leon Shargel 6. Biopharmaceutics and pharmacokinetics - A treatise D.M.- Brahmankar & S.B. Jaiswal 7. Biopharmaceutics and relevant pharmacokinetics-T. G. Wagner 8. Biopharmaceutics and Drug interactions-Cadwallader 9. Pharmacokinetics- M. Gibaldi and D. Perrier

PHARMACOKINETICS Semester II
Duration: 3 Hrs/week Total Hours: 45

Section-I
Sr. No. 1. 2. Topic Introduction to pharmacokinetics. Basic concept Definition & introduction to absorption rate constant, bioavailability, volume of distribution, elimination half life, elimination rate constant, clearance, extraction ratio, area under curve, protein binding and tissue binding. Calculation of parameters from plasma and urine data Therapeutic regimens Therapeutic response and toxicity. Constant rate regimens. Multiple dose regimens. Compartment modeling Concept of compartment modeling, open and closed models. One compartment open model- IV bolus, IV infusion extra vascular administration Multi compartment modeling 2 compartment and 3 compartments models, determination of pharmacokinetic parameters. Integration with kinetics Inter relation between kinetic parameters and physiological variable, induction and inhibition of metabolism decreased hepatocellular activity, alteration of blood flow, tubular selection and plasma protein binding. Number of Lectures Section-II Non linear pharmacokinetics Saturable enzymatic elimination process, drug elimination by capacity limited pharmacokinetics, mixed drug elimination, time dependent pharmacokinetics, bio-availability of drug that follow non-linear pharmacokinetics, non-linear pharmacokinetics due to protein binding (eq. Phenytoin) Pharmacokinetics basis of variability in clinical response :Genetics Age and weight, Disease altering / affecting pharmacokinetic parameter. (special reference to hepatic and renal disease) Drug interactions :classification altered absorption and distribution, therapeutic implication causes of drug interaction, alteration in drug metabolism Assessment of AUC, estimation of elimination half life from urine data, estimation of absorption kinetics from plasma concentration datamean residence time, amount of drug in body on accumulation to plateau, distribution of drugs extensively bound to plasma proteins, blood plasma concentration ratio. Estimation of creatinine clearance under non-steady conditions. Problems based on all above chapters. Number of Lectures Hours 02 04

3.

04

06

5.

06

22 06

6.

7.

04

8.

04

9.

05

10.

04 23
7

PHARMACOKINETICS (Practical)
Duration: 6 Hrs/week

Sr. No. 1. 2. 3. 4. 5.

Name of Experiment

No. of Experiment

6.

7. 8.

Determine the percentage protein binding of the given drug. Determine oral bioavailability of the given drug/formulation by urinary excretion method. Perform bioequivalence study of two different brands of the marketed tablets of the given drug using animal model Establish IVIVC for the given sample of drug. Calculate elimination rate constant and elimination half life of the given drug data administered by i.v. bolus injection represented by one compartment model Calculate various pharmacokinetic parameters from the given data generated after single extra vascular administration of drug represented by one compartment model Calculate various pharmacokinetic parameters from the given data obtained by using two Compartment open model To study the pharmacokinetics of suitable drug after oral administration.

01 01 01 01 02

01

02 01

Recommended Books 1. Clinical pharmacokinetics concept & application- Malcohm Rowland C., Thomas N. Tozer Lea & Febiger Book. 2. Applied bio-pharmaceutics & pharmacokinetics Leon Shargel 3. Bio-pharmaceutics & pharmacokinetics Milo Gibaldi. 4. Bio-pharmaceutics & pharmacokinetics An introduction Rober E. Notary. 5. Pharmacokinetics Milo Gibaldi & Donald Perrier. 6. Bio-pharmaceutics & Pharmacokinetics - A treatise D.M. Brahmankar, S.B. Jaiswal. 7. Bio-pharmaceutics & pharmacokinetics P.L. Madan 8. Handbook of clinical pharmacokinetics Gibaldi & Pancot.

M.PHARM. COURSE STRUCTURE SPECIALIZATION: INDUSTRIAL PHARMACY Branch Code: IP

Sem.

Code

Paper

Scheme of Teachin g Hrs/Wee ks

Scheme of Examination Theory/Practical

Total

Hr MT- 100 MT- 100P IP - 101 IP 101P Modern Analytical Techniques (T) Modern Analytical Techniques (P) Advanced Industrial Pharmacy-I (T) Advanced Industrial Pharmacy-I (P) Elective-I (T) Seminar Drug Regulatory Affairs and Intellectual Property Rights (T) Research Methodology and Biostatistics (T) Advanced Industrial Pharmacy-II (T) Advanced Industrial Pharmacy-II (P) Elective-II (T) Seminar Research Work Seminar on Research Work Research Work Dissertation Defense Viva/voce Seminar on Dissertation 03 06 UE 03 06 IE 01 06 01 06 01

Marks UE 80 80 80 80 80

IE 20 20 20 20 20

100 100 100 100 100 500 100 100 100 100 100 500 --

03 03 06 06 03 03 Grade: O/A/B/C/D 03 03 03 03

MT-200 MT-300 II IP - 201 IP 201P

01 01 01 06 01

80 80 80 80 80

20 20 20 20 20

03 03 06 06 03 03 Grade: O/A/B/C/D -42 Grade: O/A/B/C/D -42

---

---

---

III IV

300 Grade: O/A/B/C/D Grand Total 1300

UE- University Examination; IE Internal ( Sessional ) Examination Note: 1. O/A/B/C/D indicates the grade secured by the student in the seminar; O- Excellent; A-very good; B- good; C- Average; D- Poor. 2. Elective I and Elective II should be chosen from the specialization

ADVANCED INDUSTRIAL PHARMACY-I (Theory)

Semester I
Duration: 3 Hrs/week Total Hours: 45

Section-I
Sr. No. 1. Topic Hours Pilot plant scale up techniques: significance, pilot study of some 07 important dosage forms such as tablets, capsules and liquid orals, discussion on important parameters such as formula, equipments, product uniformity and stability, raw material process and physical layouts, personnel requirements and reporting responsibilities. Production, Planning, Control and Documentation: production scheduling, forecasting, vendor development, capacity assessment (plant, machines, human resources), production management, production organization, objectives and policies. Productivity, management and cost controls. Inventory management, Material Management and Maintenance 09 Management: Costs in inventory, inventory categories - special considerations, selective inventory control, reorder quantity methods and EOQ, inventory models, safety stock - stock out, lead time - reorder time methods, modern inventory management systems, inventory evaluation. Materials - quality and quantity, value analysis, purchasing centralized and decentralized, vendor development, buying techniques, purchasing cycle and procedures, stores management, salvaging and disposal of scrap and surplus. Selection of material handling systems, maintenance of material handling equipment, unit-load, palletization and containerization, types of material handling systems. Classification of maintenance, corrective (breakdown) maintenance, scheduled maintenance, preventive maintenance, predictive maintenance. Human Resource Development: Human resource planning, Interviews 07 & principles required for impressive personality, Recruitment, Selection Orientation and placement, Personal training, Job analysis, Job design & job specification & Motivation. Job enlargement and enrichment, Performance appraisal and Labor welfare. 23 Number of Lectures Section-II Industrial hazards, safety, pollution control and effluent treatment: 12 Introduction, Factory act and rules, fundamentals of accident prevention, elements of safety programme and safety management, electrical hazards, chemicals hazards and management of over exposure to chemicals, Gas hazards and handling of gases, dust explosion and its control, Fire prevention and control, Physicochemical measurements of
10

2.

3.

4.

5.

effluents, BOD, COD, Determination of some contaminants, Effluent treatment procedure, treatment of some characteristic effluent. Drinking water standards as per EPA, USA, WHO and BIS. Entrepreneurship and project management: Creativity, innovation 04 entrepreneurship & project management. Optimization Techniques: Optimization parameters, classical optimization, statistical design and applied optimization methods. Number of Lectures 06 22

6.

ADVANCED INDUSTRIAL PHARMACY-I (Practical)


Duration: 6 Hrs/week

Sr. No. 1. 2. 3.

Name of Experiment

No. of Experiment

To study the effect of particle size, moisture content and 01 lubricants on flowability and compressibility of powders 01 To study various micromeritic properties of granules. Development and formulation of the following dosage forms: 01 Cough syrup, multivitamin syrup, antibiotic dry syrup and suspension, antibiotic dispersible tablet, chewable tablet, antibiotic ointment, external application, lozenges and sterile dosage of antibiotics and anti- inflammatory drugs To perform sugar coating and non-enteric and film coating on 01 tablets. To prepare and evaluate sustained release drug polymer 01 matrix.

4. 5.

6. 7. 8. 9. 10.

To prepare and evaluate microcapsules of different drugs by 01 various technique. To prepare pellets by extrusion method. 01 To study the influence of air-entrapment on rheology of 01 cream To study in-vitro release of medicaments from ointments. 01 To evaluate antibiotic ointment by microbiological assay. 01

11

ADVANCED INDUSTRIAL PHARMACY-II (Theory) Semester II


Duration: 3 Hrs/week Total Hours: 45

Section-I
Sr. No. 1. Topic Hours Size reduction: Definition, objectives of size reduction, factors 05 affecting size reduction, laws governing energy and power requirements of a mill, various types of mills including equipments for nanosizing, colloid mill, high pressure homogenization, microfluidizers, and ultrasonicators. Mixing: Theory of mixing and types of mixers including high speed 04 mixers, ultrasonic mixers, industrial mixer-Nauta mixer and RMG, Diosna. Filtration and centrifugation: Theory of filtration, filter media, 06 industrial filters including filter press, rotary filer, edge filter, cartridge filters, and membrane filters, ultrafiltration, reverse osmosis; factors affecting filtration, optimum-cleaning cycle in batch filters, Principles of centrifugation, industrial centrifugal filters and centrifugal sedimeters, ultracentrifugation. Drying: Introduction, mode of heat transfer, internal mechanism of 07 moisture flow, psychrometry, drying mechanism, drying mechanism, drying methods for pharmaceutical granulation and equipments. Moisture content and mechanism of drying, rate of drying and time of drying, calculations, classification and types of dryers, dryers used in pharmaceutical industries and special drying methods, e.g., tray, fluidized bed, spray, freeze, tunnel, microwave, granulators-cum-driers IR dryers. 22 Number of Lectures Section-II Principles of improved tablets production system design: 05 Introduction, benefits of improved tablet production system, material, processing step combination or elimination, unit operation improvements, Role of computer process control and tablet tooling. Pelletization technology: Introduction, pelletization process and formulation, equipments for pelletization spheronizers. 04

2.

3.

4.

5.

6.

7.

Capsulation technology: Advances in capsulation technology: Hard

04
12

and gelatin capsules.. 8. Parenteral technology: Environmental control and design considerations for parenteral production facility, processing and manufacturing of small and large volume parenterals, isolator technology. Packaging Material Science: Packing design and specification, packaging validation trials, materials of construction, component product validation, regulatory requirements, quality control testing and standards, GMP requirements and its deficiencies. In process control during component manufacture, documentation, Sterlisation of packing component, packging and filling equipment, pharmaceutical packaging including sterile area. Stability Testing: Physicochemical and biological factors affecting stability of drugs, Methods to find out degradation pathways, Determination of shelf life by accelerated stability testing, Overages. 04

9.

03

10.

03

Number of Lectures

23

13

ADVANCED INDUSTRIAL PHARMACY-II (Practical)


Duration: 6 Hrs/week

Sr. No. 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. 12.

Name of Experiment

No. of Experiment

To evaluate acid neutralizing capacity of marketed antacid preparation To study stability of dosage form at various temperature and humidity conditions. Evaluation of potency of antibiotics by different methods To perform sugar coating and non-enteric and film coating on tablets. Development of dissolution media. Formulation and stability of multiple emulsion.. To prepare pellets by suitable method and study micromeritic properties. . Studies on drug excipients interactions. Evaluation of dermatological and transdermal formulation. Preparation and evaluation of microspheres/microcapsules. Dissolution and diffusion study by dialysis membrane & animal skin Formulation & evaluation of ascorbic acid injection I.P

01 03 01 01 01 01 01 01 01 01 02 01

REFERENCES 1. Evans, Anderson, Sweeney and Williams Applied production and operations management 3rd edition, West publishing company Ltd. St.paul. 2. Peter F. Drucker. Management (task, responsibility and practices) Allied publication. Bangalore 3. HWTomski A Text of Pharmacy management Kogan Page ltd. London 4. Harold Koonz, Cyril a Donnell, Heinz, Weihrich Essentials of Management McGraw Hill Book Company. New Delhi. 5. Lachman L Liberman Theory and practice of industrial pharmacy by 3 rd edition 6. Sidney H Willing, Murray M, Tuckerman. Williams Hitchings IV, Good manufacturing of pharmaceuticals (A Plan for total quality control) 3rd Edition. Bhalani publishing house Mumbai. 7. ISO 9000 and 14000 Series 8. The Pharmaceutical Sciences; the Pharma Path way Pure and applied Pharmacy by D. A Sawant, Pragathi Books Pvt Ltd. 9. Pharmaceutical Production and management by C.V.S. Subrahmanyam, Vallabh Prakashan. 10. Alderban, ed., Pharmaceutical powder compaction technology, Marcel Dekker Inc, New York. 11. Carlton and Agallaco, Aseptic process. Avis, Lachman, and Libermann, Pharmaceutical dosage forms: Tablets, vol. II, Marcel Dekker Inc, New York.
14

Anda mungkin juga menyukai