MPH103T GTU SEM 1 2018-23 Qustion paper M.pharm Modern Pharmaceutics

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Seat No.: ________ Enrolment No.______________

GUJARAT TECHNOLOGICAL UNIVERSITY

M.PHARM – SEMESTER -1- EXAMINATION –WINTER – 2018

Subject Code: MPH103T Date: 05/01/2019
Subject Name: Modern Pharmaceutics
Time: 10:30 AM TO 01:30 PM Total Marks: 80
Instructions:

1. Attempt any five questions.
2. Make Suitable assumptions wherever necessary.
3. Figures to the right indicate full marks.

 

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY
M. Ph. – SEMESTER– I • EXAMINATION – SUMMER 2018

Subject Code: MPH103T Date: 07/05/2018
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) Describe strategy for analytical method development for a new solid dosage formul0a6ti on
and discuss any two validation parameters as per ICH guidelines.

(b) Write a note on computer system validation. 05
(c) What are main functions of WHO? What is significance of WHO guidelines? 05

Q.2 (a) Discuss matrixing and bracketing methods of sampling as per ICH. 06
(b) What is process validation? Discuss the advantages and disadvantages of 05

organizational structures for process validation.
(c) Describe evaluation of the stability data as per ICH guidelines. 05

Q.3 (a) Give the organization of ICH, & it’s objective. 06
(b) Enlist various methods for Drug – Excipient Interaction study, discuss any one 05

in details.
(c) Describe formulation details to prepare small volume parenterals. 05

Q.4 (a) Enlist various evaluation parameters for Large Volume Parenterals and discuss 06
any two in details.

(b) Enlist various techniques of optimization for pharmaceutical formulation, 05
discuss any one detail.

(c) Enlist various applications of factorial design in pharmaceutical formulation. 05

Q.5 (a) Discuss criteria for selection of pharmaceutical manufacturing plant location. 06
(b) Enlist various objectives of cGMP. 05
(c) Write a note on batch packaging records. 05

Q. 6 (a) Describe importance of self inspection and quality audit as per GMP. 06
(b) Enlist various factors affecting compression of tablet and discuss any one in 05

detail.
(c) Write a note on distribution of forces in preparing tablet formulation. 05

Q.7 (a) Enlist various parameters affecting Dissolution and describe any one in detail. 06
(b) What is Heckel Plot? Describe its role in tablet physics. 05
(c) Enlist various applications of similarity factor f2 and f1 and ANOVA test in 05

pharmaceutical formulation.

***************

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – WINTER-2019

Subject Code:MPH103T Date: 01/01/2020
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) What is Validation? Describe types, scopes, merits of validation 06
(b) What is caliberation. Describe caliberation of dissolution apparatus 05
(c) What is Qualification? Describe IQ, OQ, PQ 05

Q.2 (a) Explain cGMP. Describe objectives and policies of cGMP 06
(b) What is inventory. Write different techniques of Inventory control 05
(c) Describe Total Quality Management (TQM) in detail 05

Q.3 (a) Describe different methods to study drug excipient interactions. 06
(b) Describe the evaluation aspects of large volume parenterals 05
(c) What is Accelerated stability Testing. Explain in detail. 05

Q.4 (a) Write a note on Student T Test and ANOVA test 06
(b) Explain Higuchi, Korsemeyer plots with their release kinetics. 05
(c) Write a note on Chi square test 05

Q.5 (a) What is Photostability? Explain Arrhenius equation wrt stability. 06
(b) Explain Similarity and dissimilarity factors with rates of dissolution 05
(c) Describe validation of wetr granulation process of tablet manufacturing 05

Q. 6 (a) Give the general requirements of stability testing 06
(b) Write a short note on SMEDDS. 05
(c) Give an account of WHO guidelines for validation of equipments 05

Q.7 (a) What is optimization? Describe different approaches of the same. 06
(b) Explain in detail response Surface Methodology 05
(c) What is Preformulation. Explain its significance. 05

***************

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – SUMMER-2019

Subject Code: MPH103T Date: 01/06/2019
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) Comment on the following: 06
1. Change in the initial oral drug dose changes the tmax.
2. Zeta potential is an important evaluation parameter for osmotically

controlled tablets.
(b) Explain: Total Clearance, Volume of distribution 05
(c) Enlist the model dependant methods for explaining kinetics of drug release from 05

extended release tablets. Discuss any one.

Q.2 (a) Explain the following terms: compression, compaction, consolidation 06
(b) Elucidate different properties of tablet influenced by compression. 05
(c) Write a note on “Inventory management and control”. 05

Q.3 (a) Discuss the scope and merits of validation. 06
(b) Write a short note on Heckel Plot. 05
(c) Write a note on “Students T-test”. 05

Q.4 (a) Explain: Independent variables, Dependent variables, P value. 06
(b) Write a note on contour plots. 05
(c) Enlist the different types of validation. Discuss any one in detail. 05

Q.5 (a) Discuss DSC as a method to study Drug-Excipient compatibility. 06
(b) Write a note on formulation of SMEDDS. 05
(c) Discuss the Evaluation parameters for small volume parenterals. 05

Q. 6 (a) Discuss the layout of building as per cGMP guidelines. 06

(b) Write a note on “Total Quality Management” 05
(c) Write a note on real time and accelerated stability studies. 05

Q.7 (a) Give the merits, demerits and application of statistical designs in formulation 08
development.

(b) Enlist various parameters affecting Dissolution and describe any one in detail 08

***************

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – SUMMER-2019

Subject Code: MPH103T Date: 01/06/2019
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) Comment on the following: 06
1. Change in the initial oral drug dose changes the tmax.
2. Zeta potential is an important evaluation parameter for osmotically

controlled tablets.
(b) Explain: Total Clearance, Volume of distribution 05
(c) Enlist the model dependant methods for explaining kinetics of drug release from 05

extended release tablets. Discuss any one.

Q.2 (a) Explain the following terms: compression, compaction, consolidation 06
(b) Elucidate different properties of tablet influenced by compression. 05
(c) Write a note on “Inventory management and control”. 05

Q.3 (a) Discuss the scope and merits of validation. 06
(b) Write a short note on Heckel Plot. 05
(c) Write a note on “Students T-test”. 05

Q.4 (a) Explain: Independent variables, Dependent variables, P value. 06
(b) Write a note on contour plots. 05
(c) Enlist the different types of validation. Discuss any one in detail. 05

Q.5 (a) Discuss DSC as a method to study Drug-Excipient compatibility. 06
(b) Write a note on formulation of SMEDDS. 05
(c) Discuss the Evaluation parameters for small volume parenterals. 05

Q. 6 (a) Discuss the layout of building as per cGMP guidelines. 06

(b) Write a note on “Total Quality Management” 05
(c) Write a note on real time and accelerated stability studies. 05

Q.7 (a) Give the merits, demerits and application of statistical designs in formulation 08
development.

(b) Enlist various parameters affecting Dissolution and describe any one in detail 08

***************

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY
M.PHARM – SEMESTER–1 EXAMINATION – SUMMER-2020

Subject Code:MPH103T Date: 06/11/2020
Subject Name: Modern Pharmaceutics
Time: 10:30 AM TO 1:30 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) Write importance of drug – excipient interaction in solid oral dosage form. 06
(b) What is dose dependent kinetics? Explain michaelis menten kinetics. 05
(c) Explain composition of SMEDDS and discuss each in detail. 05

Q.2 (a) Enlist various techniques of optimization for pharmaceutical formulation, 06
discuss any one in detail.

(b) Enlist types of experimental design and explain Box-Behnken design. 05
(c) Write application of response surface method of optimization in formulation. 05

Q.3 (a) How validation master plan prepared? 06
(b) Write scope & merits of validation. 05
(c) Explain process validation in detail. 05

Q.4 (a) Write objective of Cgmp. 06
(b) Write classification of production system and explain Batch production. 05
(c) Write short note on Production planning. 05

Q.5 (a) Explain quality control tools of TQM. 06
(b) Explain “Helium pycnometer” to measure volume of powder. 05
(c) Explain force volume relationship and application of Heckel plot in 05

compression.

Q. 6 (a) Enlist different reasons for capping and lamination in compression with 06
remedies.

(b) Write note on Distribution of forces in compression. 05
(c) Write factors affecting dissolution. 05

Q.7 (a) Write note on difference factor (f1) and similarity factor (f2) 06
(b) Draw flow chart of equipment validation. 05
(c) Explain evaluation of Parenteral preparation. 05

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Seat No.: _____ Enrolment No. _____________

GUJARAT TECHNOLOGICAL UNIVERSITY
M. PHARM. – SEMESTER– I • EXAMINATION – WINTER -2021

Subject Code:MPH103T Date: 15/03/2022
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) Explain Bio pharmaceutical Drug – excipient interaction and Excipient – 06
excipient interaction with examples.

(b) Discuss stability testing of large volume parental. 05
(c) Explain: Interfacial tension theory of dispersion with modern approach. 05

Q.2 (a) Enlist methods used for optimization. Discuss lagrangian method of 06
optimization in pharmaceutical formulation.

(b) Write the application of factorial design in formulation. 05
(c) Brief on contour design for optimization in pharmaceutical formulation. 05

Q.3 (a) Explain URS in brief. Draw the general format of URS. 06
(b) What is validation master plan? Explain contents of VMP in brief. 05
(c) Define validation. Write scope and merit of validation. 05

Q.4 (a) What is plant layout? Write imortance and principles of plant layout. 06
(b) Write common problems in GMP execution. 05
(c) Write objective of Industrial Relationship. Explain causes of poor industrial 05

relationship.

Q.5 (a) Describe effect of friction and distribution of forces in tablet compression. 06
(b) What is a drug release mechanism? Discuss higuchi and peppas plot with 05

respect of release kinetics.
(c) Write a note on tablet physics. 05

Q. 6 (a) Give the organization and objective of ICH. 06
(b) Discuss WHO guidelines for calibration of pharmaceutical weighing balance. 05
(c) Discuss material handling and transportation in production organization. 05

Q.7 (a) Write a note on student T-test & ANOVA test 06
(b) Describe validation of wet granulation process for tablet manufacturing. 05
(c) Write general regulatory requirements of stability testing. 05

***************

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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

***************

 

www.DuloMix.com

 

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 -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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