Umm Al-Qura University

Faulty of Pharmacy
Department of Pharmaceutics

Study Guide and

Syllabus
For Pharmacy Students

Pharmaceutics I
Course code:
Course title: Pharmaceutics I
Credit Units: 2 +1 = 3 units
Academic year: Second, First semester.
Workload Requirements:
The subject will be covered over 14 weeks of 1 lecture 2 hours, and 1 practical
session 2 hours per week (1st term).
Instructor: Dr.
Telephone:

Office Hours:
Ext.

email:

Lecture Time:
Lecture Place:
Prerequisites:

1- Evaluation Methods: (100 %)

1st periodic Exam: 5 %
Med-term Exam: 20 %
2nd periodic Exam: 5 %
Final Written exam: 50 %
Final Laboratory Exam: 20 %
2- The final grade will be assigned according to the following distribution:
A+: 95%, A 90 %, B+: 85%, B: 80 % - C+: 75%, C: 70 % - D+: 65%, D: 60
% - F 60 %
3- The format of the examinations will typically include multiple-choice questions with
one best answer, short essay questions, and problems.

Course Description

This course includes an introduction to the history of pharmacy, prescription

terminology, systems of measurement and pharmacy calculations. Students will
apply appropriate mathematical concepts found within the practice of pharmacy,
including prescription compounding and patient specific determinations. Preparation
of some dosage forms, such as solution, mixtures and powder, will be involved.
Emphasis will be placed on improving and applying problem-solving skills for the
needs of an individual prescription.

Course Objectives:
At the end of this course the student should be able to:
1. understand of the weights, measures and calculations used in pharmacy practice;
the principles of drug administration.
2. Perform pharmaceutical calculations; the preparation of certain pharmaceutical
dose forms.
3. Appreciate the need for accuracy and thoroughness in manufacture of
pharmaceutical products; the factors which influence the design of pharmaceutical
dose forms.
4. Use pharmacopeias and other sources of information.
5. Define a solution and describe all types of solution.
6. Define solubility and know its various expression
7. Formulate liquid, mixture and powder pharmaceutical products.
8. Calculate isotonicity and osmolarity of pharmaceutical preparations.
9. Apply problem-solving skills for the needs of an individual patient within the
practice of pharmacy.

Course content:

1. Types dosage forms (2CU):

The oral, rectal, parenteral and topical routes of drug administration. Bulk
powders, individual powders, capsules, pills, tablets, ointments, creams,
emulsions, solutions, suspensions, drops (eye, ear and nose), suppositories and
pessaries.
2. Introduction to Pharmaceutical calculations (2 CU):
-

Sources of pharmaceutical information, pharmacopeias and formularies.

The prescription, main parts of prescription.
Different types of prescriptions.

Posology and dosage regimen.

3. Introduction to Pharmaceutical calculations (continue) (2 CU):

-

Some fundamentals of measurements and calculations.

the metric system of weights and measures, other common systems,
conversions.
calculation of doses for children.
reducing and enlarging formulae.

4. Introduction to Pharmaceutical calculations (continue) (2 CU):

-

density, specific gravity and specific volume.

percentage solutions and allegation.
Water and spirit.

5. Solution formulation (2CU).

- Principles of formulation.
- pharmaceutical solvents; solutes, mechanisms of solution, concentration.
- Factors effecting solubility, including temperature, pH, complexation,
solubilization and co-solvency.
- Vehicles for solutions.
6. Solutions (continue) (2CU).
- Solutions as oral dosage forms; e.g. elixirs, linctuses, mixtures
- Solutions installed into body cavities.
- Solutions for external use.
7. Mixtures (2CU).
- Simple mixture.
- Mixtures containing insoluble diffusible solids.
- Mixtures containing insoluble indiffusible solids.
- Mixture containing slightly miscible liquids.
- Mixture containing prescipitable forming liquids.
- Miscellaneous mixture.
8. Incompatibilities (2CU).

- Types of pharmaceutical incompatibilities.

- Physical and Chemical incompatibilities.
- Manifestations, correction and prevention with reference to typical
examples.
9. Isotonic solutions and electrolyte solution(2CU).
10. Powders (2CU).

- Bulk and divided powder

- Powder mixing
- Dividing of powder
- Powder with special problems; e.g. deliquescent, efflorescent..
11. Powders (continue) (2CU).
- Effervescent powder
- Dusting powder
12. Galinical preparations
Infusion, decoction, fluid extracts, tinctures.
13. Galinical preparations (continue)
Extraction processes. Maceration; purpose and process, Percolation; purpose
and process, liquid-liquid extraction.

Practical:

1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
11.
12.
13.

Introduction to laboratory equipment ands procedures.

Weighing techniques.
Measuring techniques.
Problems based on how to manipulate the prescription
Preparation of Waters; e.g. aromatic water.
Compounding of selected examples of solutions.
Compounding of selected examples of simple mixture.
Compounding of selected examples of mixtures containing insoluble diffusible
solid.
Compounding of selected examples of mixtures containing insoluble indiffusible solid.
Compounding of elixirs, gargles, aromatic waters, spirits, ear drops.
Preparation of buffer solutions and isotonic solution.
compounding of divided and bulk powder, effervescent powder and
effervescent granules.
Galinical preparation.

Reading list:

1. Pharmaceutical Calculations (2005), Ed., Howard C. Ansel and Mitchell J.

Stoklosa, Publisher: Lippincott, Williams and Wilkins
2. Martindale: The complete drug reference, Sweetman, S. C., Ed., Kathleen
Parfitt; The Pharmaceutical Press, London, UK.
3. Ansel's Pharmaceutical Dosage Forms and Drug Delivery System. Ed., Allen,
Popovich and Ansel (2005). Publisher: Lippincott Williams and Wilkins.
4. British Pharmacopoeia.
5. US Pharmacopoeia.

Pharmaceutics II
Course code:
Course title: Pharmaceutics II
Credit Units: 3 +1 = 4 units
Academic year: Second, second semester.
Workload Requirements:
The subject will be covered over 14 weeks of 1 lecture 3 hours, and 1 practical
session 2 hours per week (2nd term).
Instructor: Dr.
Telephone:

Office Hours:
Ext.

email:

Lecture Time:
Lecture Place:
Prerequisites:

1- Evaluation Methods: (100 %)

1st periodic Exam: 5 %
Med-term Exam: 20 %
2nd periodic Exam: 5 %
Final Written exam: 50 %
Final Laboratory Exam: 20 %
2- The final grade will be assigned according to the following distribution:
A+: 95%, A 90 %, B+: 85%, B: 80 % - C+: 75%, C: 70 % - D+: 65%, D: 60
% - F 60 %
3- The format of the examinations will typically include multiple-choice questions with
one best answer, short essay questions, and problems.
Course description:

This course involves the study of the physical and physicochemical behavior of drug
molecules, dosage forms, and drug delivery systems and their composition. This includes
the study of interfacial phenomenon and viscosity The course also includes the study of
the pharmaceutical principles for disperse systems; suspension, emulsion, aerosols. Also

studied are the mechanisms of drug release. The preparation and characterization of
liposomes will also involved.
Course Objectives:
At the end of this course the student should be able to:
1. Differentiate surface and interfacial tension; describe methods of
determination of surface/interfacial laws; describe the solibilization
phenomenon.

2. understand the physical and physicochemical behavior of drug molecules,

dosage forms, and drug delivery systems and formulation and preparation
of certain dosage forms.
3. Understand the principles of drug administration; the principles of dosage
form design.
4. Differentiate various routes of drug administration and peculiarities of drug
delivery systems designed for each specific route.
5. Understand the production, formulation and use of suspensions and
emulsions; the formulation, properties and uses of aerosols.
6. Describe the different types of radioisotopes used to make
pharmaceuticals; explain the use of radiopharmaceuticals in nuclear
pharmacy/medicine.
7. Perform pharmaceutical calculations; the preparation of pharmaceutical
dose forms.

Course content:
Part I; Physical Pharmacy:
1. Rheology (3CU)
-

Difinition and fundamental concepts

properties contributing to rheological behavior, Shear stress, strain and

strain rate.
Newtonian system.
Non-Newtonian systems; plastic, pseudoplastic and dilatant flow.
Thixotropy,
Rheograms.

2. Rheology (continue) (3CU).

-

Determination of rheologic properties; capillary viscometer, falling-sphere

viscometer, Cup-and-Bob viscometer and Cone-and-Plate viscometer.
Factors affecting rheological properties.
Applications.

3. Surface properties (3CU).

- Surface and interfacial tensions.

- Surface free energy.

- Measurement of surface and interfacial tensions, adhesion, cohesion,
friction.
- Spreading coefficient and wetting.
- Adsorption at liquid and at solid interfaces.
4. Surface properties (continue) (3CU).

- Types of isotherms, factors influencing, non-adsorption techniques.

- Applications in pharmacy and medicine.
- Surface active agents; classifications.
- Micellization and solubilization.
- Systems of hydrophile-lipophile classification.
Part II: Disperse systems:
5. Colloids (3CU).
-Types of colloidal systems.
- kinetic, optical, electrical properties, stability of colloids.
- Applications in pharmacy.
6. Coarse dispersion; Suspensions (3CU).
- The design and evaluation of suspension.
- Electrical and steric stabilization of solid-liquid dispersions.

- Flocculated and deflocculated systems.

- Suspending agents, their classification and stability.
- Physical Stability of suspensions.
7. Coarse dispersion; Emulsions (3CU).
- Theories of emulsification; emulsion type.
- Emulsifying agents and their classification; Hydrophilic-Lipophilic Balance
(HLB).
- Adsorption; monomolecular, multimolecular and solid-particle adsorption.
- Physical stability of emulsion and their evaluation.
- Multiple emulsion and Microemulsions.
8. Pharmaceutical Aerosols (3CU).
- Physicochemical principles of aerosol science and technology.
- Aerosol propellants, containers, valve and actuator systems.
- Product development, manufacturing, stability testing and performance
evaluations of all types of aerosol products.
- Non-pressure pack aerosols, atomizers, packaging, containers.
9. Liposomes (3CU).
- Introduction.
- Classifications and structure.
- Physical and chemical properties of lipids.
- Applications in drug delivery.
10. Complexation (3CU)
- Complexation and Protein Binding.
- Metal complexes, Organic molecular complexes, inclusion compounds.
- Methods of analysis, complexation and drug action, crystalline structure of
complexes, thermodynamic treatment of stability constants.

10

11. Polymer Science (3CU)

- Pharmaceutical applications of polymers.
- Polymers as thickening agents, Preparing polymer solutions, Phase
separation.
- Gel formation, Mechanical properties of polymeric films.
- Future trends in pharmaceutical and other biomedical uses of polymers.
12. Preformulation studies (3CU).
- Concept of preformulation.
- Study of physical properties of drug like physical form, particle size, shape,
density, wetting, dielectric constant, solubility, dissolution and organoleptic
properties and their effect on formulation, stability and bioavailability.
- Study of chemical character of drug molecule like hydrolysis, oxidation,
reduction, recemization, polymerization, etc. and their influence on stability
of products.
- Factors affecting dissolution rate, theory of dissolution, Noyes-Whitney
equation.
13. Drug Delivery Systems (3CU).
- Introduction.
- Pro-drug approaches.
- Routes of drug administration;
- gastrointestinal route (oral route)
- Parenteral administration
- Mucosal drug delivery; oral mucosal route, pulmonary mucosa, nasal
mucosa.
- Pulmonary administration
- Intrauterine, rectal and vaginal administration.
- Ocular Administration.
- Dermal and trans-dermal delivery systems.

11

14. Rate and order of reactions (2CU).

Practical:
1. Determination of the effect of glycerol concentrations on the viscosity.
2. Determination of the Critical Micelle Concentration (CMC) of Surfactant(s).
3. Determination of the Hydrophilic/Lipophilic Balance (HLB) of surfactant(s).
4. Study of Flocculation and deflocculation of Kaolin Suspensions.
5. Determination of the sedimentation volume of suspensions; effect of
electrolytes on the sedimentation volume, effect of viscosity on the
sedimentation volume.
6. Construction of caking diagram.
7. Determination of the stability of a hydrophobic colloidal sol. By
determination of the Critical Coagulation Concentration (CCC).
8. Preparation of different types of emulsions (o/w and w/o types) using
different methods.
9. The effect of change in volume and nature of the disperse phase on the
stability of emulsion.
10. Determination of emulsion systems.
11. Preparation and characterization of liposomes.
12. Drug dissolution; study of the effect of dissolution medium on the
drug dissolution.
13. Determination of the apparent partition coefficient of some drugs.

Reading list:
1. Martin's Physical Pharmacy and Pharmaceutical Sciences. Ed. Patrick J. Sinko
(2006). Publisher: Lippincott Williams and Wilkins
2. Physical Pharmacy, Ed., Alfred martin 4Th edition, Publisher: Lippincott,
Williams and wilkinsons
3. Pharmaceutics; the Science of Dosage Form Design. Ed., Michael E. Aulton
(2006). Publisher: Thomson Learning.
4. Remington; the Science and Practice of Pharmacy (21st edition). Publisher:
Lippincott Williams and Wilkins.

12

Pharmaceutics III
Course code:
Course title: Pharmaceutics III
Credit Units: 2+1 = 3 units
Academic year: Third, first semester.
Workload Requirements:
The subject will be covered over 14 weeks of 1 lecture 2 hours, and 1 practical
session 2 hours per week (1st term).
Instructor: Dr.
Telephone:

Office Hours:
Ext.

email:

Lecture Time:
Lecture Place:
Prerequisites:

1- Evaluation Methods: (100 %)

1st periodic Exam: 5 %
Med-term Exam: 20 %
2nd periodic Exam: 5 %
Final Written exam: 50 %
Final Laboratory Exam: 20 %
2- The final grade will be assigned according to the following distribution:
A+: 95%, A 90 %, B+: 85%, B: 80 % - C+: 75%, C: 70 % - D+: 65%, D: 60
% - F 60 %
3- The format of the examinations will typically include multiple-choice questions with
one best answer, short essay questions, and problems.
Course Description:

This course introduces the student to the basic science of solid and semisolid dosage
forms. The course will cover the formulation of different types of tablets, granules,
capsules, microcapsules, ointments and suppositories. Drug release and quality control

13

studies of each dose form will be discuss. Sustained release formulation will also be
addressed.

Course Objectives:
At the end of this course the student should be able to:
1. understand of the formulation of specified dose forms.
2. Understand the concept of particle size, shape and density of a powder and its
impact on pharmaceutical processing/formulation.
3. Explain the science of solid and semisolid dosage forms.
4. Point out the factors affecting formulation design.
5. Discuss the role of formulation design and additives in modifying the drug
bioavailability.
6. Define and describe specified types of solid dosage forms.
7. Explain the methods and factors, which affect the formulation and production
of solid dosage forms.
8. Discuss the role of formulation design and additives in modifying the drug
bioavailability.
9. Explain the science of modified release dosage forms.
10. Identify dermal and transdermal delivery system.
11. Define the methods and factors affecting the formulation of suppositories.
12. Support the in-vitro and in-vivo characteristics of various dosage forms and
their impact on the therapeutic effectiveness of the drug product.
13. Perform pharmaceutical calculations; the preparation of pharmaceutical dose
forms (tablets, ointments, creams and suppositories).
14. Appreciate the need for accuracy and throughness in the preparation of
pharmaceutical products; the factors which influence the design of
pharmaceutical dosage form.

Course content:
1. Micromeritics (2CU).
-

Particle size and size distribution.

Methods for determining particle size.
Particle shape and surface area.

2. Micromeritics (continue); drived properties of powder (2CU).

-

Porosity.
Densities of particles.
Methods used for determination of powder density, with practical
examples
Flow properties.
Compaction.

3. Tablets (2CU).

14

- -Introduction to unit solid dosage forms

- Tablet excepients
- Formulation of tablets; tablet machines (single punch and rotary press
machine).
- Granulation techniques; wet and dry granulation.
- Tablets prepared by direct compression.
4. Tablets (continue) (2CU).
- Tablet coating.
- Type of tablet coat (sugar, film and compression coat).
- Methods of coating.
- Functional coat.
5. Tablets (Continue) (2CU).
- Tablet standers.
- Problems associated with tablet manufacture (e.g Lamination, Capping,
sticking, picking,)
- Quality control tests for tablets (weight variation, disintegration, dissolution,
thickness and diameter, friability).
6. Capsules (2CU).
- Advantage and disadvantages of capsule dosage form, material for production
of hard geletin capsules, size of capsules.
- Methods of capsule production, soft gelatin capsule shell and capsule content,
importance of base absorption and minim/gm factors in soft capsules.
- Quality control, stability testing and storage of capsule dosage forms.
7. Microcapsulation (2CU).
- Types of microcapsules; importance of microencapsulation in pharmacy.
- Microcapsulation by phase seperation co-acervation multiorifice, spray drying,
spray congealing, polymerization, complex emulsion, air suspension technique,
coating pan and other techniques.
8. Sustained and Controlled Drug Delivery (2CU).

15

Design and development, Physico chemical, biological and pharmacokinetic

properties.
Influencing design and performance of controlled release products.
Materials and methods used in their formulation, dose designing.
In vitro and In vivo evaluation.
Novel Drug Delivery Systems :Introduction to novel drug delivery
systems, their merits and demerits, drug targeting.

9. Semisolid Dosage Forms (2CU).

-

Introduction and anatomy of the skin.

Definitions, types, mechanism of drug penetration through skin.
factors influencing penetration, semisolid bases and their selection.
General formulation of semisolids (ointment and gel), manufacturing
procedure, evaluation and packaging.

10. Transdermal delivery system (2CU).

- Transdermal therapeutic systems (TTS); types and preparation.
- Novel mechanisms and devices to enhance skin delivery; Penetration
enhancers, types and mechanism of action; Liposomes and other vesicles;
Electrically assisted transdermal delivery system (iontophoresis and
electroporation).Sonophoresis, high velocity particles and stratum corneum
bypass.
11. Suppositories.
- Anatomy of the rectum and vagina.
- Factors affecting drug release from suppositories; physiological and
physicochemical considerations.
- Ideal requirements, bases, manufacturing procedure, packaging and
evaluation.
12. Suppositories (cont.)
-Formulation
- Quality control tests
- Packaging and storage

Practical:
1. Grinding and communition of powders.
2. Powder flowability studies using angle of repose method.
3. Particle size analysis of powders.

16

4.
5.
6.
7.

Methods of tablet manufacture; wet granulation.

Methods of tablet manufacture; dry granulation.
Methods of tablet manufacture; direct compression.
Quality control tests for tablets; Disintegration testing, Dissolution testing,
Uniformity of weight and content testing and Friability testing.
8. Quality control tests for tablets (continue).
9. Formulation and characterization of ointments.
10. Formulation of emulsion type (o/w and w/o) ointment bases.
11. Drug release from ointment.
12. Formulation and characterization of suppositories using the displacement
value method.

Reading list:
1. Pharmaceutics; the Science of Dosage Form Design. Ed., Michael E. Aulton
(2006). Publisher: Thomson Learning.
2. Remington; the Science and Practice of Pharmacy (21st edition). Publisher:
Lippincott Williams and Wilkins.
3. Ansel's Pharmaceutical Dosage Forms and Drug Delivery System. Ed., Allen,
Popovich and Ansel (2005). Publisher: Lippincott Williams and Wilkins.

17

Biopharmaceutics
Course code:
Course title: Biopharmaceutics
Credit Units: 2+0 = 2 units
Academic year: Third, second semester.
Workload Requirements:
The subject will be covered over 14 weeks of 1 lecture 2 hours per week (2nd term).
Instructor: Dr.
Telephone:

Office Hours:
Ext.

email:

Lecture Time:
Lecture Place:
Prerequisites: pharmacology I

1- Evaluation Methods: (100 %)

1st periodic Exam: 10 %
Med-term Exam: 30 %
2nd periodic Exam: 10 %
Final Written exam: 50 %
2- The final grade will be assigned according to the following distribution:
A+: 95%, A 90 %, B+: 85%, B: 80 % - C+: 75%, C: 70 % - D+: 65%, D: 60
% - F 60 %
3- The format of the examinations will typically include multiple-choice questions with
one best answer, short essay questions, and problems.
Course Description:

This course includes the factors influencing the absorption of drugs; the factors
influencing the distribution and disposition of drugs in the body; the principles of drug
metabolism and elimination; drug absorption processes, bioavailability and
bioequivalence determination and interpretation will be included The principals of this
course underlie the preparation, stability, liberation, absorption, distribution and action of
drug from modified release and targeted dosage forms.

18

Course Objectives:
At the end of the course students should be able to:
1. Define biopharmaceutics, bioequivalence, bioavailability and the parameters
involved.
2. Describe the mechanisms and factors involved in drug absorption.
3. Explain how drugs are distributed, metabolised excreted and factors affecting
them.
4. Review the role of formulation design in modifying the drug absorption,
distribution and elimination.
5. Explain how drug absorption can be optimized.
6. Support the characteristics of various drug delivery systems and their impact
on the drug pharmacokinetics.
7. Understand the influence of different physicochemical, physiological and
dosage form design on the drug bioavailability.
8. Design bioavailability and bioequivalent studies.

Course content:
1. Introduction to biopharmaceutics (2CU).
-

Concepts and definitions; biopharmaceutics, bioavailability,

pharmacokinetics.
LADME (liberation, absorption, distribution, metabolism and excretion)
system.
Nature of cell membrane.

2. Drug absorption (2CU).

-

Absorption mechanisms
Factors affecting passive diffusion; concentration gradient, partition
coefficient, degree of ionization.
Ficks law and pressure diffusion.
pH-partition theory.
Active transport.
Facilitated diffusion.
Vesicular transport.
Ion-pair formation.
Combined absorption model.

3. Gastrointestinal absorption of drugs (2CU).

-

Rate-limiting steps in drug absorption.

Physicochemical factors affecting drug absorption from GIT.
Factors affecting drug dissolution rate in the GIT; Physiological factors;
viscosity of GI fluids, degree of agitation, volume of GIT fluids, rate of
absorption.

19

4. Physicochemical factors affecting drug dissolution in the GIT (2CU).

-

Effect of particle size.

Solid dispersions.
Crystal form.
Salt form.
Complexation.

5. In-vitro dissolution testing (2CU).

-

Noyes Whitney equation.

Compendial methods of dissolution.
Compendial methods for testing entric-coated products.
Unofficial methods of dissolution testing.

6. Physiological factors influencing drug absorption from

gastrointestinal tract (2CU).
-

Surface area of the gastrointestinal absorption sites.

pH of the gastro intestinal fluid.
Gastric emptying rate.
Intestinal motality.
Drug stability in the gastrointestinal tract.
Hepatic metabolism.
Influence of food and diet.
Miscellaneous factors.

7. Dosage form factors influencing drug absorption from the

gastrointestinal tract (2CU).
-

Influence of excipients; diluents, surfactants, viscosity enhancing agents

Influence of the type of dose form.

8. Multiple IV bolus dose administration (2CU).

-

Single dose review

Multiple dose.
Drug accumulation.
Development of general equation.

9. Drug distribution and protein binding (2CU).

-

Physiological factors affecting drug distribution; body fluids, diffusion and

hydrostatic pressure, tissue perfusion and initial drug distribution, drug
accumulation, permeability of cell and capillary membranes, Apparent
volume of distribution and plasma drug-protein binding.

10.Drug elimination (2CU).

-Drug excretion and biotransformation.

20

- Renal excretion of drugs; anatomic consideration of the kidney, glomerular

filtration, active renal secretion, tubular re-absorption.
- Hepatic elimination of drugs; enzyme kinetics, kinetics of enzyme
inhibition.
- Factors affecting biotransformation.
11. Other routes of drug excretion (2CU).
- Hemodialysis, biliary excretion, pulmonary excretion, salivary excretion,
renal disease considerations.
12. Metabolism (2CU).
- Metabolic reaction, induction and inhibition, hepatic clearance, systemic
availability.
13. Bioavailability consideration of modified release drug products and
targeted drug delivery (2CU).
- Oral dosage forms; modified release and delayed release
- Intramuscular dosage forms; depot injection, water-immscible
injection (e.g. oil).
- Subcutaneous dosage forms; implants.
- Transdermal delivery systems; e.g. patches
- Targeted delivery systems.

Reading list:
1. Comprehensive pharmacy review, 3rd edn., Lippincott Williams and Wilkins.
2. Applied biopharmaceutics and pharmacokinetics (3rd edn.). Shargel, L. and
Yu, A.B.C.
3. Pharmaceutics; the Science of Dosage Form Design. Ed., Michael E. Aulton
(2006). Publisher: Thomson Learning.

21

Pharmaceutics IV
Course code:
Course title: Pharmaceutics IV
Credit Units: 2+1 = 3 units
Academic year: Fourth, first semester.
Workload Requirements:
The subject will be covered over 14 weeks of 1 lecture 2 hours, and 1 practical
session 2 hours per week (1st term).

Instructor: Dr.
Telephone:

Office Hours:
Ext.

email:

Lecture Time:
Lecture Place:
Prerequisites:

1- Evaluation Methods: (100 %)

1st periodic Exam: 5 %
Med-term Exam: 20 %
2nd periodic Exam: 5 %
Final Written exam: 50 %
Final Laboratory Exam: 20 %

2- The final grade will be assigned according to the following distribution:

A+: 95%, A 90 %, B+: 85%, B: 80 % - C+: 75%, C: 70 % - D+: 65%, D: 60
% - F 60 %
3- The format of the examinations will typically include multiple-choice questions with
one best answer, short essay questions, and problems.

22

Course Description:
This course will provide the fundamental principles used to formulate, manufacture
and control sterile products, primarily injectables. Topics to be covered will include
formulation criteria, steam, dry heat and ethylene oxide sterilization, sterile filtration,
aseptic filling, process validation and packaging selection and evaluation.
Demonstrations and experiments will provide first-hand experience in the use of
equipment and procedures employed to manufacture sterile products.
The course will provide the students with knowledge of the applications of
Radiopharmaceuticals, measurement of radioactivity and formulation of
radiopharmaceuticals. The course also presents the novel techniques adopted to
enhance drug delivery through different delivery systems. This course also provides
an overview of FDA guidelines and cGMPs. The course imparts to the student the
principles of drug development and production and equip the student with basic skills
in the good manufacture of pharmaceuticals.

Course objectives:
At the end of this course students should be able to:
1. Formulate the various types of sterile products.
2. Describe and apply different methods of packaging and labelling of sterile
products.
3. Explain the importance of closures.
4. Describe the different types of radioisotopes used to make pharmaceuticals.
Explain the use of radiopharmaceuticals in nuclear pharmacy/medicine.
5. Use and explain the terminology in Radiopharmacy i.e. radioimaging,
radioimmunoassay.
6. Apply the various methods of designing drug delivery systems.
7. Define GMP, quality assurance and quality control
8. Apply the guidelines of GMP to improve the quality of pharmaceutical
products.
9. Design a prototype pharmaceutical industry and standard operating
procedures for pharmaceutical industrial processes.

Course Content:
1. Sterile Products (2CU).
- Introduction
- Types of sterile products
- Sterilization techniques; moist heat and dry heat sterilization, radiation,
gaseous, filtration, etc.
2. Sterile Products (continue) (2CU).
- Parentrals.
-

Advantages and disadvantages.

23

- Total parenteral nutrition - (TPN)

- Powders for injection.

- Containers and closures
- Pyrogens
- Vehicles.
- Added substances (preservatives, antioxidants, solubilizer. suspending agents,
buffers, stabilizers etc.)
3. Sterile preparation (continue) (2CU).
- Requirements and manufacturing of:
-implants

- ophthalmic products; ophthalmic ointments

- Quality assurance
4. Sterile preparation (continue) (2CU).
-

Design of Sterile Area.

Sterile area and its classification; building and equipment
Complete sterility (aseptic area)
Air control, (Laminar flow etc).
Air locks, environmental monitoring methods. Added substances
(preservatives, antioxidants, solubilizer. suspending agents, buffers,
stabilizers etc.)

5. Sterile preparation (continue) (2CU).

-

Filling/ packaging (plastic and glass containers).

Validation of equipment; e.g autoclave filters, etc.

Validation of filling and packing machines.

6. Radiopharmaceutics (2CU).
-

Introduction.
Measurement of radioactivity.
Interaction of radiation with biological system.
Formulation, quality control.
Radiopharmacology/therapy

24

7. Advanced drug Delivery System (2CU).

- Transdermal drug delivery system.
- Mucosal drug delivery system.
- Nasal drug delivery system.
- Ocular drug delivery system, intrauterine drug delivery system.
8. 7. Advanced drug Delivery System (2CU).
- Liposomes and nanoparticles drug delivery system.
- Biodegradable drug delivery system.
- Hydrogel based drug delivery system.
- Drug delivery to the lungs, metered dose inhalers and dry powder inhalers.
9. Good Manufacture Practice (GMP) (2CU).
- Introduction.
- Role of drug product and drug product quality.
- Drug development and production.
- Provisions for GMP; building and facilities.
10. Current Good Manufacture Practice (cGMP) (2CU).
- Introduction to FDAs provisions for cGMP.

- Personnel and training: principles, training and hygiene.

- Premises and equipment.
- Principles; storage areas and equipment.
11. Good Manufacture Practice (cGMP) (2CU).

- Documentation: principles, specification, records and batch.

- Master-formula.
12. Good Manufacture Practice (cGMP) (2CU).

- Quality, principles, quality assurance, GMP and quality control.

- In process control.

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13. Good Manufacture Practice (cGMP) (2CU).

- Manufacture: principles, validation, contamination, starting and intermediate
materials, packaging material and packing.
- Recovered materials, complaints procedures and product recall.
- Good laboratory practices.
14. Study toure
- A visit tour to a pharmaceutical manufacture is an integrated part of this
course.

Practical:
1.
2.
3.
4.

Preparation of calcium gluconate injections.

Ampoule filling, sealing and sterilization.
Quality control for ampoule sealing.
Quality control tests for glass containers; glass apparatus, crush glass and
ampoules.
5. Quality control tests for plastic containers for injection.
6. Quality control tests for rubber closures.
7. Flow chart for the production of all dosage forms (tablets, capsules,
ointments, suppositories, sterile products, syrup, emulsion, suspension),
including in process control and quality control.

Reading list:

1.
2.
3.
4.

Pharmaceutical dosage forms: Parenteral medications vol. 1, 2nd edn,

Dekker, 1992
Sterile Dosage Forms: Their preparation and clinical application. Ed.,
Salvatore Turco, Publisher:Lippincott Williams and Wilkins.
Good pharmaceutical manufacture practice, rational and compliance, by Jhon
Sharp.
Pharmaceutics; the Science of Dosage Form Design. Ed., Michael E. Aulton
(2006). Publisher: Thomson Learning.

Further reading:
1. Remington; the Science and Practice of Pharmacy (21st edition). Publisher:
Lippincott Williams and Wilkins.
2. Ansel's Pharmaceutical Dosage Forms and Drug Delivery System. Ed., Allen,
Popovich and Ansel (2005). Publisher: Lippincott Williams and Wilkins.
3. Martindale: The complete drug reference, Sweetman, S. C., Ed., Kathleen
Parfitt; The Pharmaceutical Press, London,UK
4.

26

DISPENSING OF MEDICATIONS

Course code:
Course title: Dispensing of medications
Credit Units: 3+1 = 4 units
Academic year: Third, second semester.
Workload Requirements:
The subject will be covered over 14 weeks of 1 lecture 3 hours, and 1 practical
session 2 hours per week (2nd term).

Instructor: Dr.
Telephone:

Office Hours:
Ext.

email:

Lecture Time:
Lecture Place:
Prerequisites: Pharmaceutical calculations.

1- Evaluation Methods: (100 %)

1st periodic Exam: 5 %
Med-term Exam: 20 %
2nd periodic Exam: 5 %
Final Written exam: 50 %
Final Laboratory Exam: 20 %

2- The final grade will be assigned according to the following distribution:

A+: 95%, A 90 %, B+: 85%, B: 80 % - C+: 75%, C: 70 % - D+: 65%, D: 60
% - F 60 %
3- The format of the examinations will typically include multiple-choice questions with
one best answer, short essay questions, and problems.

27

Course description:
This course involves processing

prescription

or medication

order,

the

preparation and dispensing of pharmaceutical solution, emulsion, suspension,

semi-solid and solid dosage forms and development and practice of the patient
counseling skills necessary for proper use of the compounded product. During
the laboratory session, emphasis will be placed on the selection of proper
excipients, based on physico-chemical principles, for use in the extemporaneous
compounding preparation. The course also provides the students with knowledge
on the communication process and skills to enable them to communicate
effectively.

Course Objectives:
At the end of this course the student should be able to:
1.
2.
3.
4.
5.
6.
7.
8.

Determine the identity, purity and strength of medications.

Weigh, measure and mix drugs and other medicinal compounds.
Provide information to the prescribers, clients and others.
development and practice of the patient counseling skills necessary for
proper use of the compounded product.
Keep comprehensive records of all medications dispensed in order to satisfy
the provision of law.
Order and maintain a supply of drugs, chemicals and pharmaceutical stock.
Become proficient in the expression of quantitative relationships and can
perform the needed mathematical operations to infer their consequences.
Define communication and explain the goals.
Understand and describe the basics of communication

9.
10. Define the fidelity of communication and factors affecting it.

11. Communicate with various audiences by written, verbal and electronic

media for a variety of purposes
12. Know and describe the types of communication.
11. Know and explain the pharmacist-patient communication process.
Course contents:
1. Introduction to institutional practice, including order processing, medication
administration records (3 CU).
2. Extemporaneous dispensing of some formulations; solid, semi-solid and liquid
preparations (3CU).
3. Problems associated with extemporaneously prepared formulae (3CU).

28

4. Introduction to institutional practice, including order processing, medication

administration records (3CU).
5. Dispensing of radio pharmaceuticals (3CU).
6. Dispensing of I. V. admixtures (3CU).
7. Aseptic Dispensing (continue) (3CU).
TPN, cytotoxic dispensing, semi-sterile dispensing (eye drops, ear drops),
hypcralimentation.
8. Dispensing to ambulatory patients, distribution of control substances,
dispensing during off-hours, manufacturing bulk and sterile, the Pharmacy
central sterile supply room (3CU).
9. Definitions and background of community pharmacy (3CU).
7. Patient assessment (3CU).
8. Basics of patient-pharmacist communication: process models; types; fidelity;
skills; listening and meaning and communications (3CU).
9. Non-verbal communication (3CU).
10. Patient education and counseling (3CU).
11. Role of pharmacist as Public Health Educator in the community for drug
monitoring and drug information (3CU).

Practical:
-The practical course will focus on Compounding of selected examples of:
solutions, mixtures, elixirs, linctuses, Gargles, aromatic waters, spirits and ear
drops as well as practical simulation of how to dispense drug product to the
patient.
- During the laboratory session, emphasis will be placed on the selection of
proper excipients, based on physico-chemical principles, for use in the
extemporaneous compounding preparation.

Reading list:
1.Pharmaceutical Practice, ed., Diane M. Collett and M.E.Aulton, Publisher:
Churchel Livingstone.
2. The United States Pharmacopoeia (USP) and National Formulary (NF)
3.The British Pharmacopoeia
4. Pharmaceutical Codex.
5. Martindale: The complete drug reference, Sweetman, S. C., Ed., Kathleen
Parfitt; The Pharmaceutical Press, London, UK.
6. Communication skills for pharmacist

29

Industrial Pharmacy
Course code:
Course title: Industrial Pharmacy
Credit Units: 3+0 = 3 units
Academic year: Fifth, first semester.
Workload Requirements:
The subject will be covered over 14 weeks of 1 lecture 3 hours per week (1st term).
Instructor: Dr.
Telephone:

Office Hours:
Ext.

email:

Lecture Time:
Lecture Place:
Prerequisites:

1- Evaluation Methods: (100 %)

1st periodic Exam: 10 %
Med-term Exam: 30 %
2nd periodic Exam: 10 %
Final Written exam: 50 %
2- The final grade will be assigned according to the following distribution:
A+: 95%, A 90 %, B+: 85%, B: 80 % - C+: 75%, C: 70 % - D+: 65%, D: 60
% - F 60 %
3- The format of the examinations will typically include multiple-choice questions with
one best answer, short essay questions, and problems.
Course Description:

An introduction to basic engineering principles that are involved in the commercial

manufacture of pharmaceutical dosage forms. Discussions will focus on the design
and operation of equipment used for each unite operation in the factory; and how such
principles as blending, mixing, heat and mass transfer are utilized to design and
specify equipment used in producing powders, tablets, capsules and other dosage
forms.
Course Objectives:

30

At the end of this course the student should be able to:

1. Outline the design and mechanism of action of the instruments included in
the unite operation in pharmaceutical practice.
2. Point out the principles of each unite operation in pharmaceutical processes.
3. Support the equipment used for each unite operation in relation to its
advantages, disadvantages and mechanism of action.
4. Define the physical principle of each unite operation in industrial pharmacy.
5. Understand the concepts of pharmaceutical operations.
6. Review the use and application of each operation in relation to its advantages,
disadvantages and mechanism of action.
7. Rationalize the use of the equipment for a specific application in
pharmaceutical industry.
8. Predict the relationship between the equipment design and product
characteristics.
9. Explain and discuss the use of different equipment to achieve certain
operation in pharmaceutical industry.
10. Diagrammatically design the studied equipments for each operation.

Course contents:
1. Pharmaceutical Lay Out and Plant Designing (3CU).
- General layout and plant designing of the Pharmaceutical Industry
Pharmaceutical plant construction, nature and properties of important materials
employed in construction and erection of plant, convenience and storage of raw
materials, semi finished and finished product.
2. Heat transfer (3CU).
- Classification of heat flow process.
- Overall coefficient of heat transfer.
- Mechanisms of heat transfer, conduction, convection and radiation.
3. Flow of heat (3CU).
-

Design of heating equipment.

Steam as a heating medium.
Tubular heaters; heat transfer by radiation and convection.
Tubular heaters; heat interchangers, inductive heating.

4. Drying (3CU).
-

Classification of dryers
dryers for dilute solutions and suspensions.
Dryers for solid materials.
Convectional and conduction dryers.
Theory of drying loss on drying and moisture content, equilibrium moisture
content.
- Principles of freeze drying, freeze dryers.
5. Evaporation (3CU).
- General principals of evaporation.
- Types of evaporators, jacketed kettles, tube evaporators, forced circulation
evaporators and evaporator accessories.

31

- Evaporation under reduced pressure.

- Multiple effect evaporation.
6. Filtration (3CU).
- Theory of filtration and filtration media.
- Darcys equation.
- Filter aids.
- Classification of filtration filters (e.g. plate and frame filter, leaf filter, filter
press, rotary filter..).
7. Centrifugal filtration (3CU).
- Theoretical consideration.
- Laboratory equipment.
- Large scale equipment; continuous conical centrifuge, semi-continuous
centrifuge.
8. Size reduction (communition) (3CU).
- Theory and reasons of size reduction
- Factors influencing size reduction.
- Pharmaceutical applications.
- Energy requirments
- Mechanisms and equipments used for size reduction; e.g. roller mill, ball
mill, hammer mill, fluid energy mill, colloid mill.
9. Size separation (3CU).
- Standard screens.
- Oscillating tray sitter grating sifters, cyclone separators.
- Sedimentation and elutriation.
- Handling of powders.
10. Size enlargement (2CU).
- Methods and mechanisms of granule formation.
- Reasons for size enlargement.
- Pharmaceutical granulation equipments; high speed mixer granulator,
oscillating granulator, extruder.
11. Mixing (1CU).
- Fundamentals and mechanism.
- Mixing equipments used in liquid/liquid, liquid/solid and solid/solid mixing.
12. Distillation (3CU).
- Theory of distillation of mixtures
(a) binary mixtures of miscible liquids,
(b) binary mixtures of immiscible liquids,
(c) Rectification rectifying columns fractionating column and simple
calculations.
- Industrial equipment for vacuum, steam, reflux and molecular distillation.
13. Crystallization (3CU).
- Classification, batch crystallizers, simple vacuum crystallizers.
- Nucleation and crystal growth
- critical humidity prevention of caking, material and energy balances.

32

14. Packaging Technology (2CU).

Influence of packaging materials, stability, packaging lines, packaging area,
packaging equipment.
15. Study tour.
A visit to pharmaceutical industries will be an integrated part of the syllabi.

Reading list:
1.
2.
3.
4.

Theory and Practice of Industrial Pharmacy-Lachman,Lieberman and Kanig.

Tutorial Pharmacy - Cooper and Gunn.
Bentley's TextBook of Pharmaceutics - Rowlin.
An introduction to Chemical Engineering - Badger and Banchero.

33