GUJARAT TECHNOLOGICAL UNIVERSITY
M.Pharm
PHARMACEUTICS
SEMESTER: I
Subject Name: MODERN PHARMACEUTICS
Subject Code: MPH103T
SCOPE: Course designed to impart advanced knowledge and skills required to learn various aspects and
concepts at pharmaceutical industries
OBJECTIVES: Upon completion of the course, student shall be able to understand
1. The elements of preformulation studies.
2. The Active Pharmaceutical Ingredients and Generic drug Product development
3. Industrial Management and GMP Considerations
4. Optimization Techniques & Pilot Plant Scale Up Techniques
5. Stability Testing, sterilization process & packaging of dosage forms.
Sr.No Course content Total Hrs
1. a. Preformation Concepts – Drug Excipient interactions – different methods, 10
kinetics of stability, Stability testing. Theories of dispersion and
pharmaceutical Dispersion (Emulsion and Suspension, SMEDDS)
preparation and stability Large and small volume parental – physiological
and formulation consideration, Manufacturing and evaluation.
b. Optimization techniques in Pharmaceutical Formulation: Concept and 10
parameters of optimization, Optimization techniques in pharmaceutical
formulation and processing. Statistical design, Response surface method,
Contour designs, Factorial designs and application in formulation
2. Validation : Introduction to Pharmaceutical Validation, Scope & merits of 10
Validation, Validation and calibration of Master plan, ICH & WHO
guidelines for calibration and validation of equipments, Validation of
specific dosage form, Types of validation. Government regulation,
Manufacturing Process Model, URS, DQ, IQ, OQ & P.Q. of facilities.
3. cGMP & Industrial Management: Objectives and policies of current good 10
manufacturing practices, layout of buildings, services, equipments and their
maintenance Production management: Production organization, , materials
management, handling and transportation, inventory management and
control, production and planning control, Sales forecasting, budget and
cost control, industrial and personal relationship. Concept of Total Quality
Management.
4. Compression and compaction: Physics of tablet compression, compression, 10
consolidation, effect of friction, distribution of forces, compaction profiles.
Solubility
5. Study of consolidation parameters; Diffusion parameters, Dissolution 10
parameters and Pharmacokinetic parameters, Heckel plots, Similarity factors
– f2 and f1, Higuchi and Peppas plot, Linearity Concept of significance,
Standard deviation , Chi square test, students T-test , ANOVA test
REFERENCES:
1. Theory and Practice of Industrial Pharmacy By Lachmann and Libermann
2. Pharmaceutical dosage forms: Tablets Vol. 1-3 by Leon Lachmann.
3. Pharmaceutical Dosage forms: Disperse systems, Vol, 1-2; By Leon Lachmann.
4. Pharmaceutical Dosage forms: Parenteral medications Vol. 1-2; By Leon Lachmann.
5. Modern Pharmaceutics; By Gillbert and S. Banker.
6. Remington’s Pharmaceutical Sciences.
7. Advances in Pharmaceutical Sciences Vol. 1-5; By H.S. Bean & A.H.Beckett.
8. Physical Pharmacy; By Alfred martin
9. Bentley’s Textbook of Pharmaceutics – by Rawlins.
10. Good manufacturing practices for Pharmaceuticals: A plan for total quality control, Second edition;
By Sidney H. Willig.
11. Quality Assurance Guide; By Organization of Pharmaceutical producers of India.
12. Drug formulation manual; By D.P.S. Kohli and D.H.Shah. Eastern publishers, New Delhi.
13. How to practice GMPs; By P.P.Sharma. Vandhana Publications, Agra.
14. Pharmaceutical Process Validation; By Fra. R. Berry and Robert A. Nash.
15. Pharmaceutical Preformulations; By J.J. Wells.
16. Applied production and operations management; By Evans, Anderson, Sweeney and Williams.
17. Encyclopaedia of Pharmaceutical technology, Vol I – III.
Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
M.Ph- SEMESTER–I • EXAMINATION – WINTER-2022
Subject Code: MPH103T Date: 05/04/2023
Subject Name: Modern Pharmaceutics
Time: 02:30PM TO 05:30PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) What do you mean by model-dependent method for comparing dissolution 06
profile. Enlist these methods and discuss any one.
(b) Enlist the excipients used in large volume parenterals and discuss the 05
formulation of large volume parenteral with respect to industrial perspective.
(c) Explain the theory of dispersion for suspensions and highlight the effect of 05
flocculation on stability of the suspension.
Q.2 (a) Describe factorial designs and its application in the formulation. 06
(b) Write a note on contour plots. 05
(c) Describe accelerated stability studies. 05
Q.3 (a) Write a note on “Student’s T Test”. 06
(b) Explain plotting, interpretation and application of Heckel plot. 05
(c) Explain similarity and dissimilarity factors to compare two dissolution profile. 05
Q.4 (a) Describe various methods to study drug excipient interactions. 06
(b) Explain the factors affecting dissolution. 05
(c) Explain what do you mean by compression, compaction and consolidation. 05
Q.5 (a) Discuss layout of buildings for manufacturing of pharmaceutical products as per 06
cGMP.
(b) Describe Total Quality Management (TQM) in detail. 05
(c) Write a note on production planning. 05
Q. 6 (a) Describe the material handling and transport in the pharmaceutical industry. 06
(b) Explain the factors affecting the compression of the tablet. 05
(c) Discuss the objectives of cGMP. 05
Q.7 (a) What do you mean by Validation. Describe scope and merits of validation. 06
(b) What is Qualification. Describe IQ, OQ and PQ. 05
(c) Describe the validation of direct compression process in tablet manufacturing. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph.- SEMESTER– I EXAMINATION – SUMMER-2022
Subject Code: MPH103T Date: 07/09/2022
Subject Name: Modern Pharmaceutics
Time: 10:30am to 01:30pm Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Write importance of drug-excipient interaction in solid oral dosage form. 06
(b) Give an account of WHO guidelines for validation of equipments. 05
(c) Describe the evaluation aspects of large volume parenterals. 05
Q.2 (a) Write a short note on SMEDDS. 06
(b) Describe Concept and parameters of optimization in pharmaceutical 05
formulations.
(c) What is Preformulation. Explain its significance. 05
Q.3 (a) Discuss equipment and their maintenance for manufacturing of pharmaceutical 06
product as per cGMP.
(b) Discuss layout of buildings for manufacturing of pharmaceutical product. 05
(c) Write a note on tablet physics. 05
Q.4 (a) Explain force volume relationship and application of Heckel plot in 06
compression.
(b) Explain “Helium pycnometer” to measure volume of powder. 05
(c) Write a note on real time and accelerated stability studies. 05
Q.5 (a) Explain: Independent variables, Dependent variables, P value. 06
(b) Enlist the different types of validation. Discuss any one in detail. 05
(c) Write a note on Chi square test. 05
Q. 6 (a) Discuss the scope and merits of validation. 06
(b) Discuss the Evaluation parameters for small volume parenterals. 05
(c) Enlist various applications of experimental design in pharmaceutical 05
formulation.
Q.7 (a) Write objective of cGMP. 06
(b) Write a note on ICH Q10 guideline. 05
(c) Describe significance of drug excipients interaction studies in pharmacy. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM SEMESTER-1 EXAMINATION – SUMMER-2024
Subject Code: MPH103T Date: 13/06/2024
Subject Name:Modern Pharmaceutics
Time: 02:30 PM TO 05:30 PM Total Marks:80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Discuss Plackett-Burman design for preliminary screening of variables. 06
(b) Explain the following terms: compression, compaction, consolidation. 05
(c) Write a note on tablet physics. 05
Q.2 (a) Describe importance of self-inspection and quality audit as per GMP. 06
(b) Write a note on “Student’s T-test”. 05
(c) Describe validation of wet granulation process for tablet manufacturing. 05
Q.3 (a) Discuss budget and cost control in production organization. 06
(b) What is a drug release mechanism? Discuss Higuchi and Peppas plot with 05
respect of release kinetics.
(c) Write a note on computer system validation. 05
Q.4 (a) Write significance of similarity factors f2 and f1. 06
(b) Explain composition of SMEDDS and discuss each in detail. 05
(c) Write factors affecting dissolution. 05
Q.5 (a) Explain cGMP. Describe objectives and policies of cGMP. 06
(b) Enlist various applications of factorial design in pharmaceutical formulation. 05
(c) Write a short note on Heckel Plot. 05
Q. 6 (a) Give the organization of ICH and discuss it’s objective. 06
(b) Write a note on contour plots. 05
(c) Write a note on ICH Q10 guideline. 05
Q.7 (a) What is Validation? Describe types, scopes, merits of validation. 06
(b) Discuss stability testing of large volume parental. 05
(c) Describe physiological and formulation consideration of large volume 05
parenterals.
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph.- SEMESTER– I EXAMINATION – WINTER 2023
Subject Code: MPH103T Date: 16/01/2024
Subject Name: Modern Pharmaceutics
Time: 2:30 PM to 5:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.
Q.1 (a) Discuss stability studies of large volume parenterals. 06
(b) Describe significance of drug excipients interaction studies in pharmacy. 05
(c) Discuss theory of emulsion. 05
Q.2 (a) Discuss types of validation. 06
(b) Write a note on ICH Q10 guideline. 05
(c) Discuss the formulation of small volume parenterals. 05
Q.3 (a) Describe matrixing and bracketing methods as per ICH. 06
(b) Describe physiological and formulation consideration of large volume 05
parenterals.
(c) Write a note on contour plots. 05
Q.4 (a) Write a note on total quality management. 06
(b) Describe Concept and parameters of optimization in pharmaceutical 05
formulations.
(c) Describe objectives and policies of cGMP. 05
Q.5 (a) Discuss equipment and their maintenance for manufacturing of pharmaceutical 06
product as per cGMP.
(b) Describe effect of friction and distribution of forces in tablet compression. 05
(c) Discuss inventory management and control in production organization. 05
Q. 6 (a) Discuss budget and cost control in production organization. 06
(b) What is pharmaceutical validation? Describe its scope and merits. 05
(c) What do you understood by drug release mechanisms? Discuss zero order, first 05
order and Higuchi plot with respect of release kinetics.
Q.7 (a) Write significance of similarity factors f2 and f1. 06
(b) Discuss preformulation aspects of SMEDDS. 05
(c) Write a note on tablet physics. 05
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Seat No.: _____ Enrolment No. _____________
GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM - SEMESTER–1 EXAMINATION – SUMMER -2023
Subject Code: MPH103T Date: 09-08-2023
Subject Name: Modern Pharmaceutics
Time: 02:30 PM TO 05:30 PM Total Marks: 80
Instructions:
1. Attempt any five questions.
2. Make suitable assumptions wherever necessary.`
3. Figures to the right indicate full marks.
Q.1 (a) Design a drug excipient interaction study protocol for a film coated tablet, making 06
suitable assumptions.
(b) Explain different theories of dispersion 05
(c) Enlist various additives used in formulating a pareneteral formulation citing suotbale 05
examples of each
Q.2 (a) Enlist different types of experimental designs. 06
(b) Using a schematic explain the different steps involved in response surface 05
methodology
(c) Describe the importance of optimization techniques in pharmaceutical formulations 05
Q.3 (a) Explain the contents of validation master plan 06
(b) Explain the details to be included in designing of URS, DQ, IQ for a tablet 05
disintegration apparatus
(c) Discuss the key features enlisted in WHO guideline for calibration and validation of 05
equipment
Q.4 (a) Explain the concept of shell like facility in pharmaceutical industry layout. 06
(b) Explain the concept of material management handling and transportation with respect 05
to CGMP
(c) Discuss the concept of total quality management 05
Q.5 (a) Explain the ABC concept of inventory management and control 06
(b) Explain the likely impact of having more than 50 % fines on physics of tablet 05
compression
(c) Discuss the impact of excessive friction during compression process on the product 05
obtained
Q. 6 (a) Explain factors affecting dissolution 06
(b) Justify the importance of using a student T test 05
(c) Describe the importance of Heckel plot. 05
Q.7 (a) Explain Higuchi and Peppas model of drug release 06
(b) Explain any two parameter which will increase the value of dissimilarity factor in 05
dissolution studies
(c) Explain the concept of design space using contour plots 05
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