course specification industrial pharmacy -1 · course specification industrial pharmacy -1 ......

Course Specification

Industrial Pharmacy -1

Programme(s) on which the course is given: B. Sc. in pharmaceutical science

Major or Minor element of programmes: Major

Department offering the programme: Faculty of Pharmacy

Department offering the course: Industrial Pharmacy

Academic year / Level: 2009/2010, fourth year ( 1st semester)

Date of specification last approval: 16/2/2011

1-Basic Information

Title: Industrial Pharmacy -1 Code:PHI-522

Level: fourth year ( 1st semester)

Department: Industrial Pharmacy

Unit:3 Units

Lecture: 2 hours/week Tutorial/Practical: 3 hours/week

Total: 5 hours/week

2- Aims of Course

The aims of this course are to provide students with the necessary

knowledge in the area of pharmaceutical technology, and to help

them to understand the fundamentals and importance of the unit

operations in the manufacture of dosage forms.

3- Intended Learning Outcomes of Course(ILOs)

a- Knowledge and Understanding:

Upon completion of the course, students will:

al- acquire the principles of pharmaceutical unit operations

performed in pharmaceutical industry like filtration, drying,

evaporation, crystallization and sedimentation.

a3- describe the equipment used in industrial pharmacy, their

operation and applications.

Assiut University

Faculty of Pharmacy

Quality Assurance Unit

Department of Industrial Pharmacy

2

b- Intellectual Skills:

The student should be able to,

b11 - select the most appropriate equipment used for certain unit

operation.

c-Professional and practical Skills:

The student should have the ability to:

c1- preserve and store the pharmaceutical products safely.

c2- collect data about different equipment used in pharmaceutical

industry and their operation.

c11- conduct research studies and analyze results.

d- General and Transferable Skills:

The student should be able to:

d1- apply information technology skills including word proceeding ,

spreadsheet use and database use.

d9- work effectively as a part of team in order to fulfill certain project.

d12- manage her/ his time effectively.

d13- demonstrate critical thinking and problem solving in different

theoretical and practical situations.

4-Course Contents:

Topic No. of

hours

Lecture

(2 hr)

Tutorial/

Practical

Overview on the course of industrial pharmacy-1 during the whole semester. *Units and dimensions

3 1 1

Heat flow * Heat flow problems -1

3 1 1

Heat flow * Heat flow problems -2

3 1 1

Sedimentation * Comparison between different types of suspending agents.

3 1 1

Filtration *Comparison between different concentrations of suspending agents and electrolytes.

6 2 2

Extraction *Determination of suspension stability.

3 1 1

Introduction of evaporation. * Evaporation problems -1

3 1 1

3

Topic No. of

hours

Lecture

(2 hr)

Tutorial/

Practical

Evaporation * Evaporation problems -2

3 1 1

Crystallization * Collaborative projects assignment.

3 1 1

Mid- Term examination - - - Drying * Effect of drying time on the weight loss of crystalline solids

3 1 1

Drying * Effect of drying time on the weight loss of amorphous solids

3 1 1

Centrifugation *Revision of some practical lessons

3 1 1

Refrigeration *Practical exam

3 1 1

Material of construction 2 1 ––––––– Total hours 44 15 14

*Practical lesson

5- Teaching and Learning Methods

5.1- Lectures.

5.3- Group tutorial and discussion in practical chapters.

5.4-Project tasks for groups of students (10 each) to prepare a

report related to the topics lectured and make presentation for

that report.

5.5- executing practical procedures and demonstrations in the lab.

6- Teaching and learning methods for disables

Not applicable

7- student Assessment

a- Student Assessment methods

7.1- Written exams including the mid- and final-term exams to

assess the understanding of the scientific background in the

course.

7.2- Practical exam to assess the professional and practical skills.

7.3- Oral exam to assess the understanding of the theoretical part of

the course.

7.4-Collaborative projects assignment to assess the ability to work

in group , solve problems, present data and discussion.

7.5- Practical notebook to assess student performance and

understanding of equipment construction and operation.

4

b- Student Assessment Schedule

No. Assessment week

1. Mid-term exam 10th week

2. Practical exam 14th week

3. Collaborative projects

assignment

9th

week

4. Practical notebook Evaluated periodically

every week

5. Final exam At the end of semester

6. Oral exam At the end of semester

c- Weighting of Assessments

No. Exam. Mark %

1. Mid-Term Examination 15 10.00

2. Final-Term Examination 70 46.67

3. Oral Examination 20 13.33

4. Practical Examination 30 20.00

5. Semester Work 10 6.67

6- Practical notebook 5 3.33

Total 150 100%

8- List of References

a-Course Notes

Lecture and practical notes prepared by the stuff members

of the department.

b- Essential Books (Text Books)

- Remington: The Science and Practice of Pharmacy, Alfonso, R.G.

(Ed.), 20th

ed. The University of the Sciences in Philadelphia,

U.S.A., 2000.

- Allen, L. V., Popovich, N. G., and Ansel, H. C., Ansel’s

Pharmaceutical Dosage Forms and Drug Delivery

Systems, Lippincott Williams & Wilkins Publishers, 8th

Edition, 2005.

c-Recommended Books

- United States Pharmacopoeia, The United States Pharmacopeial

Convention, Inc., Rockville, MD, U.S.A. , 31st ed., 2008.

- Reynold, J.E.F., Martindale, The Extra Pharmacopoeia, The

Pharmaceutical Press, London, 32nd ed., 2000.

- McCabe, W. L., Smith, J. C. and Harriott, P., Unit Operations of

Chemical Engineering, McGraw-Hill,. 7th Edition, 2005.

5

d- Periodicals, Web Sites, …. etc Periodicals as Drug Development and Industrial Pharmacy,

International Journal of Pharmaceutics.

http:/www.polymerfactory.com, http:/www.capsugel.com

,and companies home pages.

9- Facilities Required for Teaching and Learning

More laboratory facilities are required to cover the important

parts of the course in order to develop the practical skills of

students.

Course Coordinator:

Jelan Abd El-razik Abd El-aleem,Ph.D.

Head of Department:

Sayed Ibrahim Abdel-Rahman, Ph. D., Professor

5

University Assiut Course Title Industrial Pharmacy-1

Faculty Pharmacy Course Cod. PHI-522

Department Industrial Pharmacy

Matrix of the Intended Learning Outcomes (ILOs) of the Course

General and

Transferable Skills

Professional and

Practical Skills Intellectual Skills Knowledge and

Understanding Week Topic

d12,d13

c1,c2,c11

- a1 1 Overview on the course of

industrial pharmacy-1 during

the whole semester.

*Units and dimensions

d12,d13

c1,c2,c11

b11 a1, a3 2 Heat flow

* Heat flow problems -1

d12,d13

c1,c2,c11

b11 a1, a3 3 Heat flow

* Heat flow problems -2

d12,d13

c1,c2,c11

b11 a1, a3 4 Sedimentation

* Comparison between

different types of

suspending agents.

d12,d13

c1,c2,c11

b11 a1, a3 5 Filtration

*Comparison between

different concentrations of

suspending agents and

electrolytes.

d12,d13

c1,c2,c11

b11 a1, a3 6 Extraction

*Determination of

suspension stability.

6

General and

Transferable Skills

Professional and



d12,d13

c1,c2,c11

b11 a1, a3 7 introduction of evaporation.

* Evaporation problems -1

d12,d13

c1,c2,c11

b11 a1, a3 8 Evaporation

* Evaporation problems -2

d1,d9,d12,d13

c1,c2,c11

b11 a1, a3 9 Crystallization

* Collaborative projects assignment.

a1, a3 10 Mid- Term examination

d12,d13

c1,c2,c11

b11 a1, a3 11 Drying

* Effect of drying time on

the weight loss of crystalline

solids

d12,d13

c1,c2,c11

b11 a1, a3 12 Drying

* Effect of drying time on

the weight loss of

amorphous solids

d12,d13

c1,c2,c11

b11 a1, a3 13 Centrifugation

*Revision of some practical

lessons

- - b11 a1, a3 14 Refrigeration

*Practical exam

- - b11 a1, a3 15 Material of construction

Course Coordinator: Jelan Abd El-razik Abd El-aleem,Ph.D.

Head of Department: Sayed Ibrahim Abdel-Rahman, Ph. D., Professor

7


Industrial Pharmacy -2

Programme(s) on which the course is given: B. Sc. in pharmaceutical science

Major or Minor element of programmes: Major

Department offering the programme: Faculty of Pharmacy

Department offering the course: Industrial Pharmacy

Academic year / Level: 2009/2010, Fourth year (2nd

semester)

Date of specification last approval: 16/2/2011

1-Basic Information

Title: Industrial Pharmacy -2 Code: PHI-543

Level: Fourth year (2nd

semester)


Unit: 3 Units

Lecture: 2 hours /week Tutorial/Practical: 3 hours /week

Total: 5 hours /week

2- Aims of Course

The aims of this course are to provide students with the basic understanding in

the area of tablet technology, and to help them to know the fundamentals and

importance of some unit operations as size reduction, mixing, and air

purification.



Upon completion of the course, students will:

al- acquire the principles of pharmaceutical unit operations

performed in pharmaceutical industry like filtration, drying,

evaporation, crystallization and sedimentation.

a3- describe the equipment used in industrial pharmacy, their

operation and applications.

Assiut University

Faculty of Pharmacy

Quality Assurance Unit


8

a13-acquire the necessary knowledge concerning good manufacturing practice

(GMP) and quality assurance protocols in pharmaceutical industry.


The student should be able to,

b6- choose rationally the adjuvants used in tablet formulation.

b11- select the most appropriate equipment used for certain unit operation.

c- Professional and practical Skills:


c1- preserve and store the pharmaceutical products safely.

c2- collect data about different equipment used in pharmaceutical


c7- handle properly chemicals in the lab and be aware of guide lines in

pharmacy practice.




d1- apply information technology skills including word proceeding ,

spreadsheet use and database use.

d9- work effectively as a part of team in order to fulfill certain project.




9

4-Course Contents: Topic No. of

hours

Lecture

(2 hr)

Tutorial/

Practical

Overview on the course of industrial pharmacy-2 during the whole semester, and introduction of powder flow. * The flow properties of powders and granules

3 1 1

Powder flow * Improvement of powder flowability

3 1 1

Particle size analysis * Sieve analysis-1

3 1 1

Size reduction * Sieve analysis-2

3 1 1

Mixing *Comparison between different methods of mixing.

3 1 1

Mixing *Determination of optimum time of mixing.

3 1 1

Introduction of Tablets. * Tablet Manufacture-1

3 1 1

Tablets * Tablet Manufacture-2

3 1 1

Tablets * Collaborative projects assignment.

3 1 1

Mid- Term examination 3 1 1 Tablets * Tablet compression

3 1 1

Air purification * Tablet Evaluation-1

3 1 1

Good manufacturing practice * Tablet Evaluation-2

3 1 1

Good manufacturing practice *Practical exam

3 1 1

Good manufacturing practice 2 1 Total hours 44 15 14

*Practical lesson

5- Teaching and Learning Methods

5.1- Lectures.


5.3-Project tasks for groups of students (10 each) to prepare a

report related to the topics lectured and make presentation for

that report.

5.5- executing practical procedures and demonstrations in the lab.

10

6- Teaching and learning methods for disables

Not applicable

7- student Assessment a- Student Assessment methods

7.1- Written exams including the mid- and final-term exams

to assess the understanding of the scientific background in the

course.



the course.


in group and the ability to solve problems, present data and

discussion.

7.5- Lab and sketch notebook to assess student performance and

understanding of equipment construction and operation.


No. Assessment week

1. Mid-term exam 10th week

2. Practical exam 13 th

week

3. Collaborative projects

assignment

9 th

week

4. Practical notebook Evaluated periodically every week

5. Final exam At the end of semester

6. Oral exam At the end of semester


No. Exam. Mark %

1. Mid-Term Examination 15 10.00

2. Final-Term Examination 70 46.67

3. Oral Examination 20 13.33

4. Practical Examination 30 20.00

5. Semester Work 10 6.67

6- Practical notebook 5 3.33

Total 150 100%


a-Course Notes Lecture and practical notes prepared by the stuff members

of the department.

11



(Ed.), 20th ed. The University of the Sciences in Philadelphia,

U.S.A., 2000.




Edition, 2005.

-Lieberman, H.A., Lachman, L. and Schwartz, J.B.,Pharmaceutical

Dosage Forms: Tablets, Vol. 3, Marcel Dekker, Inc.

New York and Basel,1990. .

c-Recommended Books





- McCabe, W. L., Smith, J. C. and Harriott, P., Unit Operations of

Chemical Engineering, McGraw-Hill,. 7th Edition, 2005.



http:/www.polymerfactory.com, http:/www.capsugel.com,

http:/www.tablet press.net ,and companies home pages.

9- Facilities Required for Teaching and Learning

More laboratory facilities are required to cover the important parts of the

course in order to develop the practical skills of students.

Course Coordinator:

Jelan Abd El-razik Abd El-aleem,Ph.D.

Head of Department:

Sayed Ibrahim Abdel-Rahman, Ph. D., Professor

Program Director

12

University Assiut Course Title Industrial Pharmacy-2

Faculty Pharmacy Course Cod. PHI-543



General and

Transferable Skills

Professional and



d12,d13

c1,c2,c7,c11

- a1 1 Overview on the course of

industrial pharmacy-2 during

the whole semester, and

introduction of powder flow.

* The flow properties of

powders and granules

d12,d13

c1,c2,c7,c11

b11 a1, a3 2 Powder flow

* Improvement of powder

flowability

d12,d13

c1,c2,c7,c11

b11 a1, a3 3 Particle size analysis

* Sieve analysis-1

d12,d13

c1,c2,c7,c11

b11 a1, a3 4 Size reduction

* Sieve analysis-2

d12,d13

c1,c2,c7,c11

b11 a1, a3 5 Mixing

*Comparison between

different methods of mixing.

d12,d13

c1,c2,c7,c11

b11 a1, a3 6 Mixing

*Determination of optimum

time of mixing.

13

General and

Transferable Skills

Professional and



d12,d13

c1,c2,c7,c11

b6,b11 a1, a3 7 Introduction of Tablets.

* Tablet Manufacture-1

d12,d13

c1,c2,c7,c11

b6,b11 a1, a3 8 Tablets

* Tablet Manufacture-2

d1,d9,d12,d13

c1,c2,c7,c11


* Collaborative projects assignment.

d12,d13

c1,c2,c7,c11


* Tablet compression

d12,d13

c1,c2,c7,c11

b6,b11 a1, a3 11 Air purification

* Tablet Evaluation-1

d12,d13

c1,c2,c7,c11

b6,b11 a1, a3,a13 12 Good manufacturing practice

* Tablet Evaluation-2

- - b11 a1, a3,a13 13 Good manufacturing practice

*Practical exam

- - b11 a1, a3,a13 14 Good manufacturing practice

Course Coordinator

Head of Department

14


Pharmaceutical Manufacturing

1-Basic Information

Title: Pharmaceutical Manufacturing Code: PHIE005

Element: Elective Course

Level: undergraduate,4th

year students


Unit: 3 Units

Lecture: 2h/w Tutorial/Practical: 2h/w

Total: 4 h/w

2- Aims of Course

The aims of this course are to provide students with the basic

understanding in the area of preformulation study, manufacturing of

capsules. In addition to the fundamentals and importance of

liposomes, nanoparticles, sterile area, target drug delivery systems,

stability, and good laboratory practice.



Upon completion of the course, students will be:

al- acquire the principles of pharmacy practice.

a3- acquire the principles of drug manufacturing in different dosage

forms e.g. manufacturing of capsules, liposomes and target drug delivery

systems in addition to the design of sterile area and different methods of

sterilization.

a13- acquire the necessary knowledge concerning pharmacy technology

applications and preparation of different pharmaceutical dosage forms

including capsules, liposomes, nanoparticles and target delivery systems.

Assiut University

Faculty of Pharmacy Quality Assurance Unit


15


By the end of studying this course, the student should be able to,

b6- choose rationally the adjuvants used in concerned formulations.

b11- select the most appropriate equipment used for filling of tablets and

semisolids into hard gelatin capsules.

b13- recogonize and select guidelines in pharmacy practice as good

laboratory practice

c- Professional and practical Skills:


c1- preserve and store the concerned pharmaceutical products safely.

c2- collect data about different equipments used in pharmaceutical


c7- handle properly chemicals in the lab and be aware of the rules of good

laboratory practice.




d1- apply information technology skills including word

proceeding , spreadsheet use and database use.

d9- work effectively as a part of team in order to fulfill certain

project.




Course Contents

Topic No. of

hours

Lecture Tutorial/

Practical

Introduction+ Nanoparticles 4 2 2

Target organs for drug targeting 3 1.5 1

Preformulation 3 1.5 2

Good laboratory practice 3 1.5 1

Manufacturing of capsules 3 1.5 2

Sterilization 3 1.5 1

Construction and validation of sterile area

in pharmaceutical industry

3 1.5 1

Stability testing of solid dosage forms 4 2 2

Liposomes 4 2 2

4- Teaching and Learning Methods 4.1-Powerpoint using computers and data show in the lectures.

4.2- Transparences using over-head projectors.


16

5- Teaching and learning methods for disables Office hours of stuff members to meet the students and answer questions

concerning the course.

6- student Assessment a- Student Assessment methods

6.1- Written exams including the final-term exam

to assess the understanding of the scientific background in the

course.



the course.


in group and the ability to solve problems, present data and

discussion.


No. Assessment week

1. tutorial and practical

exam

14th week

2. Final exam 15 th

week

3. Oral exam 15 th

week


No. Exam. Mark %

1. Final-Term Examination 60 60

3. Oral Examination 20 20

4. Practical Examination 20 20

Total 100 100%


a-Course Notes

Lecture notes prepared by the stuff members

of the department.



(Ed.), 20th

ed. The University of the Sciences in Philadelphia,

U.S.A., 2000.

17




Edition, 2005.

Pharmaceutics, The science of dosage forms, M. Aulton.

c-Recommended Books







http:/www.polymerfactory.com, http:/www.capsugel.com,

.

8- Facilities Required for Teaching and Learning More laboratory facilities are required to cover the important

parts of the course in order to develop the practical skills of

students.

Course Coordinator:

Dr. Jelan Abd Elrazik Abd Elaleem

Head of Department:

Prof. Dr. Sayed Ibrahim Abdel-Rahman

Program Director

18

University Assiut University Course Title

Pharmaceutical

Manifacturing

Faculty Pharmacy Course Code.

......................................



General and

Transferable Skills

Professional and

Piratical Skills Intellectual Skills Knowledge and


d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 1,2 Introduction+

Nanoparticles

d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 3 Target organs for drug

targeting

d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 4 Target organs for drug

targeting +

Preformulation

d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 5 Preformulation

d1,d9,d12,d13 c1, c2, c7, c11 b6, b13 a1, a3, a13 6 Good laboratory practice

d1,d9,d12,d13 c1, c2, c7,c11 b6, b11, b13 a1, a3, a13 7 Good laboratory practice

+Manufacturing of

capsules

d1,d9,d12,d13 c1, c2, c11 b6, b11 a1, a3, a13 8 Manufacturing of

capsules

d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 9 Sterilization

d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 10 Sterilization +Construction

and validation of sterile area

in pharmaceutical industry

19

General and

Transferable Skills

Professional and

Piratical Skills Intellectual Skills Knowledge and


d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 11 Construction and validation

of sterile area in

pharmaceutical industry

d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 12 Stability testing of solid

dosage forms

d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 13 Stability testing of solid

dosage forms

d1,d9,d12,d13 c1, c2, c11 b6 a1, a3, a13 14 Liposomes+ tutorial and

practical exam

c1, c2, c11 b6 a1, a3, a13 15 Liposomes

Course Coordinator: Dr. Jelan Abd Elrazik Abd Elaleem

Head of Department: Prof. Dr. Sayed Ibrahim Abdel-Rahman

course specification industrial pharmacy -1 · course specification industrial pharmacy -1 ......

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