الرئيسية » الأقسام العلمية » قسم الصيدلانيات والصيدلة الصناعية » توصيف المقررات
Physical Pharmacy (صيدلة فيزيائية)
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- (PH102)
- 3 Units
- 2 hrs Theory
- 2 hrs Laboratory
- General
- Physics
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- Physical Pharmacy by Alfred Martin, Sixth edition
- Experimental pharmaceutics by Eugene, Parott.
- Tutorial pharmacy by Cooper and Gunn.
- Stocklosam J. Pharmaceutical calculations, Lea &Febiger, Philadelphia.
- Liberman H.A, Lachman C., Pharmaceutical Dosage forms, Tablets, Volume-1 to 3, Marcel Dekkar Inc.
- Remington: the science and practice of pharmacy, 20th edition, A. Gennaro, Lippincott, last edition.Course Description: (وصف المقرر)
Brief Description:
This course involves the study of the mathematical preparation, states of matter. This includes study of phase rule, interfacial phenomena, solutions and solubility, determination of partition coefficient, and study of solutions properties. Also covers the study of buffered and isotonic solution, rheology and colloids. Theory and practical components of the subject help the student to get a better insight into various areas of formulation research and development, and stability studies of pharmaceutical dosage forms.
Course Objectives:
Upon the completion of the course student shall be able to: Understand various physicochemical properties of States of matter. Know the principles of phase equilibrium and phase rule, solutions of non- electrolytes, adsorption, solubility, buffers and isotonic solutions and rheology. Differentiate surface and interfacial tension; describe methods of determination of surface/interfacial laws; describe the solubilization phenomenon. Understanding the characteristic, types of solutions, colloids and Incompatibility.
Generic Skills:
The faculty is committed to ensuring that students have the full range of knowledge and skills required for full participation in all aspects of their lives, including skills enabling them to be life-long learners. To ensure graduates have this preparation, such generic skills as literacy and numeric, computer, interpersonal communications, and critical thinking skills will be embedded in all courses.
Attendance Expectations:
Students are expected to attend every session of class, arriving on time, returning from breaks promptly and remaining until class is dismissed. Absences are permitted only for medical reasons and must be supported with a doctor’s note.
Content Breakdown:
SessionWeek
Topical Coverage
Session 1(Week 1)
Unit I: Mathematical preparation:
• Units
• Dimensions and statistical analysis of errors
Unit II: States of matter:
• Liquid state, vapor pressure, boiling point, surface tension
Session 2 (Week 2)
• Solid state.
• Crystalline and amorphous state, crystal systems habits and imperfections.
• Polymorphism, hydrates, other solvates, clathrates and hygroscopicity.
• Melting point and x-ray diffraction.
Session 3 (Week 3)
Unit III: Micrometrics:
• Definition & significance of particle size, particle size distribution
• Particle size analysis and separation
• Determining particle size shape and surface area
Session 4 (Week 4)
• Calculation of particle porosity and density
• Flow property of powder (Hausner ratio, Carr’s index, Angle of repose).
Session 5 (Week 5)
Unit IV: The phase rule:
• One, two and three component systems.
• One, two and three component systems.
• Eutectic mixtures, solid solutions and glass solutions.
Session 6 (Week 6)
Unit V: Interfacial phenomena:
• Classification of interfaces.
• Intermolecular forces.
• Surface tension and surface free energy.
• Interfacial tension.
• Measurement of surface and interfacial tension.
a. Capillary rise method.
b. Du nouytensiometer.
Session 7 (Week 7)
• Adsorption as liquid interfaces.
a. Surface active agents.
b. HLB system.
Session 8 (Week 8)
• Types of monolayers at liquid surfaces.
• Liquid/vapor system, Liquid/liquid system.
• Adsorption at solid interfaces: Solid / liquid interfaces.
• Factor affection the extent of adsorption.
• Longmuir adsorption isotherm, Freundlich adsorption isotherm, Brunaure, Emmett, and taller.
Session 9 (Week 9)
• Electric properties of interfaces.
• The electric double layer.
• Nernst zeta potentials.
Session 10 (Week 10)
Unit VI: Solution and solubility:
• Definition.
• Solubility expressions.
• Solubility of liquids.
• Complete miscibility.
• Partial miscibility.
Session 11 (Week 11)
Midterm Assessment
Session 12 (Week 12)
Session 13 (Week 13)
Session 14 (Week 14)
Session 15 (Week 15)
• Extended Hildebrand solubility approach.
• Solubility parameters.
• Solubility of salts in water.
• Solubility of slightly water-soluble electrolytes.
• Solubility of weak electrolytes.
Session 16 (Week 16)
• Calculating of the solubility of weak electrolytes influenced by pH.
• Influence of solvents on solubility of drug.
• Combined effect of pH and solvents.
• Influence of complexation and particle size
Session 17 (Week 17)
Unit VII: Distribution of solutes between immiscible solvent:
• Determination of partition coefficient.
• Effect of ionic dissociation and molecular association on partition coefficient
Session 18 (Week 18)
• Solubility and partition coefficient.
• Extraction.
• Preservative action of weak acids in oil-water system. Drug action and partition coefficient.
Session 19 (Week 19)
Unit VIII: Colligative properties of solutions:
• Vapor pressure.
• Boiling point.
• Freezing point.
• Osmotic pressure.
• Diffusion.
• Osmosis.
• M. Wt. Determination.
• Choice of colligative properties.
Session 20 (Week 20)
Unit IX: Buffered and isotonic solution:
• Definition, buffer equation (for weak acid and base).
• Drugs as buffers, buffer capacity, pharmaceutical buffers, tissue irritation.
Session 21 (Week 21)
• Buffered isotonic solutions, measurement of tonicity, methods of adjusting tonicity and pH.
Session 22 (Week 22)
Unit X: Rheology:
• Newtonain systems.
• Non-Newtonian systems.
• Thixotropy
• Determination of rheological properties.
• Applications to pharmacy.
Session 23 (Week 23)
Unit XI: Polymers:
· Definition and classification of polymers.
· Properties of polymers.
· Pharmaceutical applications of polymers.
· Behavior of polymers in solution (effect on viscosity, gel formation, heterogels, syneresis, estimation of molecular weight).
Session 24 (Week 24)
· Plasticization of polymers, glass transition temperature, the behavior of polymers during dissolution testing, aging of polymers.
Session 25 (Week 25)
Unit XII: Colloids:
· Definition of colloid.
· Types of colloidal system.
· Preparation of colloids,
· Pharmaceutical applications of colloids.
Session 26 (Week 26)
· Kinetic properties of colloids.
a) Brownian motion.
b) Diffusion.
c) Sedimentation.
d) Viscosity.
e) Properties of colloids, (electrical, optical, osmotic properties, and particle size).
Session 27 (Week 27)
• Electrokinetic phenomena.
• Donnan membrane equilibrium.
• Stability of colloidal systems.
Unit XIII: Incompatibility:
• Definition.
• Types of physical incompatibilities.
Session 28 (Week 28)
• Types of chemical incompatibilities.
• Factors affecting incompatibility.
• Prevention of incompatibility.
Practical work
The purpose of the laboratory in this course is to provide students with:
· Identification of laboratory apparatus and specific techniques which are essential in understanding this course and how to Improve report writing skills.
· Analysis of Errors.
· Ternary phase diagram.
· Intermolecular binding forces.
· Determination of surface tension of given liquids.
· Determination the solubility of drug at room temperature.
· Solubility of benzoic acid in water.
· The effect of Tween 80 on the solubility of benzoic acid in water.
· Determination of viscosity using Stoke’s equation.
· Determination of partition coefficient of benzoic acid in benzene and water.
· Evaluation of the particle size of solids and measure their flowability.
· Methods of improving the flowability of solids.
· Estimation of the molecular weight of polymers.
· Prediction of the shelf life of dosage forms.
· Determination of % composition of NaCl in a solution using phenol-water system by CST method
· Determination of pKa value by Half Neutralization/ Henderson Hasselbalch equation.
Delivery:
- Lectures (Tools: board, data show). The lectures were added on the internet site of the faculty to be available to the students all the time as an e-learning.
- Practical Session (Tools: labs., boards, instruments, chemicals, glassware, equipment).
- Assignments, seminars, research and posters.
Course Assessments:
- 20% Midyear exam
- 10% Quizzes, reports, presentation
- 10% Practical continuous assessment, exam
- 20% Final Practical exam
- 40% Final theoretical exam
- 100% Total
Textbooks:
Pharmaceutics I (صيدلانيات 1)
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- (PH103)
- 4 Units
- 3 hrs Theory
- 2 hrs Laboratory
- Specialty
- –
-
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- C. Ansel et al., Pharmaceutical Dosage Form and Drug Delivery System, Lippincott Williams and Walkins, New Delhi.
- Carter S.J., Cooper and Gunn’s-Dispensing for Pharmaceutical Students, C publishers, New Delhi.
- E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone, Edinburgh.
- British pharmacopoeia.
Course Description: (وصف المقرر)
Brief Description:
This course is designed to impart fundamental knowledge on the preparatory pharmacy with the arts and science of preparing the different conventional dosage forms. The students will study in this subject the history of pharmacy and Orientation to Pharmacy, technique of weighing, concept of pre-formulations, and formulation, pharmaceutical systems, and techniques of measurements. Also, the course covers other topics as pharmaceutical calculations, introduction to dosage forms, pharmaceutical solutions and suspension, and Clinical preparations.
Course Objectives:
Upon completion of this course the student should be able to: Know the history of profession of pharmacy. Understand the basics of different dosage forms, pharmaceutical calculations and technique of weighing. To understanding the concept of pre-formulations and formulation. Understand the pharmaceutical solutions and suspensions. Preparation of various conventional dosage forms.
Generic Skills:
The faculty is committed to ensuring that students have the full range of knowledge and skills required for full participation in all aspects of them lives, including skills enabling them to be life-long learners. To ensure graduates have this preparation, such generic skills as literacy and numeric, computer, interpersonal communications, and critical thinking skills will be embedded in all courses.
Attendance Expectations:
Students are expected to attend every session of class, arriving on time, returning from breaks promptly and remaining until class is dismissed. Absences are permitted only for medical reasons and must be supported with a doctor’s note.
Content Breakdown:
Content BreakdownWeek
Topical Coverage
Session 1 (Week 1)
Unit I: History of pharmacy:
• Introduction to drug and pharmacy
• The influence of Arabic civilization in the development of Pharmacy
• The role of Arabic scientists in the development of pharmacy
Session 2 (Week 2)
Unit II: Orientation to Pharmacy:
• Introduction to the subject of pharmaceutics
• Pharmacy as profession (Hospital, Retail, Industry)
• The role of the pharmacist in the health care system
• The relationship between pharmacist and other health care professionals
• Reviewing and dispensing prescriptions and medication order
• Labeling of dispensed medications
• Computer labeling
• Scope of pharmaceutics
Session 3 (Week 3)
Unit III: Technique of weighing:
• Description of prescription balance
• Care and use of prescription balance
• Weighing of small doses (Aliquot method of weighing)
Session 4 (Week 4)
Unit IV: Concept of pre-formulations and formulation:
• Biopharmaceutical and therapeutic considerations in dosage form design.
• Drug incompatibility: (Physical, Chemical, Pharmacokinetics, and Pharmacodynamic).
Session 5 (Week 5)
• Introductory aspects of physicochemical properties with their applications.
Session 6 (Week 6)
• Pharmaceutical recipients: solvents, colorants, flavors, diluents, binders, disintegrants, lubricants, thickening agents, emulsifying agents, etc.
Session 7 (Week 7)
Unit V: Pharmaceutical systems and techniques of measurements:
• Common systems, Weights, and measures – Imperial & Metric system, ( units and terminology, CGS, FFs, units of mass, units of
• amount of substance, units of length, units of radiation, dose equivalent)
• The relationship and unit conversions of systems
Session 8 (Week 8)
Unit VI: Pharmaceutical calculations:
• General dilutions: using stock solutions, allegation method, least weighable amounts/percentage error
Session 9 (Week 9)
• The calculation of dose: Miscellaneous dosage problem,
• calculation of doses of children.
• Calculation of body surface area.
Session 10 (Week 10)
• Reducing and enlarging formulas
Session 11 (Week 11)
Midterm Assessment
Session 12 (Week 12)
Session 13 (Week 13)
Session 14 (Week 14)
Session 15 (Week 15)
· Density and specific gravity: sp. Gravity of liquids and solids, calculation of volume and weight from sp. Gravity
Session 16 (Week 16)
· Ratio strength and stock solutions
Session 17 (Week 17)
Unit VII: Introduction to dosage forms:
· Short description and properties of different dosage forms
Session 18 (Week 18)
· The need for dosage forms
· Therapeutic consideration in dosage form design
Session 19 (Week 19)
· Routes of drug administration: Oral, parentral, rectal, nasal, etc.
Session 20 (Week 20)
Unit VIII: Pharmaceutical solutions:
· Introduction
· Advantages and disadvantages
Session 21 (Week 21)
· Aqueous solutions: Standards for water, aromatic waters, aqueous acids, solutions douche, enemas, gargles, mouth washes, juices,
· sprays, syrups, honey, optic solutions, irrigations, toothache drops
Session 22(Week 22)
· Aromatic waters: Types and method of preparation
· Non-aqueous solutions: Elixirs, spirits, collodious, liniments, tinctures, mucilages
· proof spirit and isotonic solutions
· Pharmaceutical solvents: glycol, alcohol, etc.
Session 23 (Week 23)
Unit IX: Pharmaceutical Suspension:
· Definition.
· Advantages of oral suspensions.
· Classification based on type of preparation and route of administration
Session 24 (Week 24)
· Types of suspensions.
· Manufacturing
Session 25 (Week 25)
· Sedimentation rate and factors affecting it.
· Evaluation of stability of suspension
Session 26 (Week 26)
Unit X: Clinical preparations:
· Principle and methods of preparation: infusion, decoction, maceration, percolation.
Session 27 (Week 27)
· Principle and methods of preparation: infusion, decoction, maceration, percolation.
Session 28 (Week 28)
· Principle and methods of preparation: infusion, decoction, maceration, percolation.
Practical work
Practical Part:
· identification of laboratory apparatus
· pharmaceutical calculations
· chloroform water
· peppermint water
· aqueous iodine solution
· weak iodine solution
· orange tincture
· simple syrup
· orange syrup
· camphor liniment
· Ferrous sulphate mixture
Delivery:
- Lecture-based, Group interaction and discussion.
- Use of video technique, practical classes.
Course Assessments:
- 20% Assessment Exam
- 10% in lab activities
- 10% in class activities e.g.: quizzes
- 40% Final theoretical exam
- 20 % Final Practical Exam
- Total 100%
Textbooks:
- C. Ansel et al., Pharmaceutical Dosage Form and Drug Delivery System, Lippincott Williams and Walkins, New Delhi.
- Carter S.J., Cooper and Gunn’s-Dispensing for Pharmaceutical Students, C publishers, New Delhi.
- E. Aulton, Pharmaceutics, The Science& Dosage Form Design, Churchill Livingstone, Edinburgh.
- British pharmacopoeia.
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Pharmaceutics II (صيدلانيات 2)
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- (PH204)
- 3 Units
- 2 hrs Theory
- 2 hrs Laboratory
- Specialty
- Pharmaceutics I
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-
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Course Description: (وصف المقرر)
Brief Description:
This course is designed to impart a fundamental knowledge on the preparatory pharmacy with arts and science of preparing the different conventional dosage forms.
Course Objectives:
Upon completion of this course the student should be able to: Know the history of profession of pharmacy. Understand the basics of different dosage forms, pharmaceutical incompatibilities and pharmaceutical calculations Understand the professional way of handling the prescription Preparation of various conventional dosage forms
Generic Skills:
The faculty is committed to ensuring that students have the full range of knowledge and skills required for full participation in all aspects of their lives, including skills enabling them to be life-long learners. To ensure graduates have this preparation, such generic skills as literacy and numeric, computer, interpersonal communications, and critical thinking skills will be embedded in all courses.
Attendance Expectations:
Students are expected to attend every session of class, arriving on time, returning from breaks promptly and remaining until class is dismissed. Absences are permitted only for medical reasons and must be supported with a doctor’s note.
Content Breakdown:
Content BreakdownWeek
Topical Coverage
Session 1 (Week 1)
Unit I. Emulsions:
• Definition.
• Purposes of emulsification.
• Theories of emulsification.
Session 2 (Week 2)
• Types of emulsifying agents.
• Tests for determination of emulsion type.
Session 3 (Week 3)
• Preservation of emulsions.
• Manufacturing.
Session 4 (Week 4)
Unit II: Semi – solid dosage forms:
a) Ointments:
• Definition.
• Function of ointments and ointments bases Excipients used in semi solid dosage forms. Evaluation of semi solid dosage forms.
• Release rate of semi-solid dosage form.
Session 5 (Week 5)
• Classification of ointments bases.
Session 6 (Week 6)
• Considerations in compounding and dispensing, e.g., quality, suitability
Session 7 (Week 7)
b) Creams and gels:
• Types of creams and gels.
• Formulation.
• Filling and Packaging.
• Type of base & Functions.
Session 8 (Week 8)
• Packaging.
Session 9 (Week 9)
• Type of base & Functions.
Session 10 (Week 10)
c) Suppositories:
• History
• Types and therapeutic uses, advantages and disadvantages, types of bases, methods of preparations. Displacement value & its calculations, evaluation of suppositories.
Session 11 (Week 11)
Midterm Assessment
Session 12 (Week 12)
Session 13 (Week 13)
Session 14 (Week 14)
Session 15 (Week 15)
• Anatomy of rectum & factors affecting drug absorption
Session 16 (Week 16)
• Classification of suppository bases
• General consideration of compounding & dispensing
• Manufacturing, packaging, evaluation and stability of semidolid dosage forms.
Session 17 (Week 17)
Unit III: Modified-release Pharmaceutical Dosage forms (MRPD):
• Pharmaceutical Concepts.
• Formulation of (MRPD).
Session 18 (Week 18)
• Mechanisms of drug release from MRPD.
Session 19 (Week 19)
Unit IV: Complexation and protein binding:
• Definitions and Introduction.
• Types of complexes.
Session 20 (Week 20)
• Types of complex reactions.
• Methods of complex analysis.
Session 21 (Week 21)
• Protein binding.
• Equilibrium dialysis.
Session 22 (Week 22)
• Dynamic dialysis.
Session 23 (Week 23)
• Complexation and drug action.
Session 24 (Week 24)
Unit V: Kinetics:
• Rate and order of reactions.
• Determination of order of reactions.
• Factors influencing the reaction rate.
Session 25 (Week 25)
Unit VI: Product stability:
• Factors affecting drug stability.
• Reactions causing drug decompositions.
Session 26 (Week 26)
• Types of stability tests.
• Prediction of shelf life and expiry dates.
Session 27 (Week 27)
• Stability tests of pharmaceutical dosage forms.
Session 28 (Week 28)
• Stabilization of pharmaceutical products
Practical Part:
Practical Part:
• Preparation of arachis oil emulsion
• Preparation of liquid paraffin emulsion
• Preparation of calamine lotion
• Preparation of salicylic acid lotion
• Preparation of aminobenzoic acid lotion
• Preparation of lubricating jelly
• Preparation of zinc oxide paste
• Preparation of vanishing cream
• Preparation of cold cream
• Preparation of suppositories using theobroma oil and displacement value (calculation (theoretical)
• Preparation of suppositories using glycerol-gelatin base and displacement value (calculation (theoretical)
• Determination of rate, rate constant and half-life of zero order reaction (theoretical)
• Determination of rate, rate constant and half-life of first order reaction
• (theoretical)
Delivery:
Lecture-based, Group interaction and discussion, Use of video technique, practical classes.
Course Assessments:
- 20% Assessment Exam
- 10% in lab activities
- 10% in class activities e.g.: quizzes, reports, discussion…
- 40% Final theoretical exam
- 20 % Final Practical Exam
- Total 100%
Textbooks:
- Alfonso R. Gennaro Remington. The Science and Practice of Pharmacy, Lippincott Williams, New Delhi.
- Carter S.J., Cooper and Gunn’s. Tutorial Pharmacy, CBS Publications, New Delhi.
- A. Rawlins, Bentley’s Textbook of Pharmaceutics, English Language Book Society, Elsevier Health Sciences, USA.
- Isaac Ghebre Sellassie: Pharmaceutical Pelletization Technology, Marcel Dekker, INC, New York.
- Dilip M. Parikh: Handbook of Pharmaceutical Granulation Technology, Marcel Dekker, INC, New York.
Francoise Nieloud and Gilberte Marti-Mestres: Pharmaceutical Emulsions and Suspensions, Marcel Dekker, INC, New York.
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Pharmaceutical Technology (تقنية صيدلانية)
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- (PH208)
- 4 Units
- 3 hrs Theory
- 2 hrs Laboratory
- Specialty
- Pharmaceutics I
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-
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Course Description: (وصف المقرر)
Brief Description:
This course focuses on the study of the interrelationships between formulation and physiological factors and pharmacokinetic aspects of drug absorption, distribution, metabolism, and excretion.
Course Objectives:
Upon completion of the course, the student shall be able to: To have the expertise and knowledge needed to be involved in different pharmaceutical care settings in community pharmacies, industrial sector, pharmaceutical sales and marketing. Supplying information about pharmaceutical packaging, GMP, validation, contamination, sterilization and pharmaceutical plant. Supplying information about aerosol.
Generic Skills:
The faculty is committed to ensuring that students have the full range of knowledge and skills required for full participation in all aspects of their lives, including skills enabling them to be life-long learners. To ensure graduates have this preparation, such generic skills as literacy and numeric, computer, interpersonal communications, and critical thinking skills will be embedded in all courses.
Attendance Expectations:
Students are expected to attend every session of class, arriving on time, returning from breaks promptly and remaining until class is dismissed. Absences are permitted only for medical reasons and must be supported with a doctor’s note.
Content Breakdown:
Content BreakdownWeek
Topical Coverage
Session 1 (Week 1)
Size reduction and size separation: (powder, granulation technology)
• Definitions, factors affecting size reduction
• Principles, laws and factors affecting energy requirements
Session 2 (Week 2)
• Methods of size reduction
• Hammer mill, fluid energy mill and disintegrator.
Session 3 (Week 3)
• Size separation: various methods and equipments employed for size separation: e.g., sieving, sedimentation, centrifugal elutriation microscopic methods… etc.
• Pelletization.
Session 4 (Week 4)
• Dust control
Session 5 (Week 5)
Safety measuring and industrial hazards
Session 6 (Week 6)
Introduction to production management
Session 7 (Week 7)
Heat transfer
Session 8 (Week 8)
Evaporation
Session 9 (Week 9)
Drying
Session 10 (W- 10)
• Drying continue.
Session 11 (Week 11)
Midterm Assessment
Session 12 (Week 12)
Session 13 (Week 13)
Session 14 (Week 14)
Session 15 (Week 15)
Mass transfer and fluid mechanics
Session 16 (Week 16)
Filtration
Centrifugation
Session 17 (Week 17)
Crystallization
Mixing
Session 18 (Week 18)
Pharmaceutical Packaging Technology
Session 19 (Week 19)
Topical and transdermal drug delivery techniques
Session 20 (Week 20)
Pulmonary drug delivery techniques (Aerosols)
Session 21 (Week 21)
Pharmaceutical nanotechnology and nanomedicines
Session 22 (Week 22)
Sterile products
Session 23 (Week 23)
Pilot plane and scale up
Session 24 (Week 24)
Structure of pharmaceutical plan
Session 25 (Week 25)
Surgical ligature
Session 26 (Week 26)
Current good manufacturing practice
Session 27 (Week 27)
• Current good manufacturing practice
Session 28 (Week 28)
Manufacturing authorization and product registration
Practical Work:
• preparation of simple ointment and Sulphur ointment.
• preparation of emulsifying ointment and Whitfield ointment.
• preparation of non-staining iodine ointment
• preparation of vanishing cream
• preparation of cold cream
• preparation of salicylic acid and sulphuric cream
• preparation of cetrimide cream
• preparation of tragacanth jelly
• preparation of boric acid suppositories
• preparation of zinc oxide suppositories
• preparation of toothpaste
• solubility curves
• calculation of filter media resistance and cake resistance
• rate of sedimentation
• particle size analysis.
Delivery:
- Lecture-based, Group interaction and discussion,
- Self-directed activities
- Active participation,
- Computer lab
- Lab experiments
Course Assessments:
- 20% Assessment Exam
- 10% Quizzes, reports, ….
- 10% Lab classes and activities
- 20% Final Lab exam
- 40% Final theoretical exam
- 100% Total
Textbooks:
- Remington’s pharmaceutical sciences
- Aulton’s pharmaceutics
- Sciences direct web
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Biopharmaceutics and Pharmacokinetics (الصيدلة الحيوية وحركية الدواء)
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- (PH301)
- 4 Units
- 3 hrs Theory
- 2 hrs Laboratory
- Specialty
- Pharmaceutics I & II
- Physical Pharmacy
Course Description: (وصف المقرر)
Brief Description:
This course focuses on the study of the interrelationships between formulation and physiological factors and pharmacokinetic aspects of drug absorption, distribution, metabolism, and excretion.
Course Objectives:
Upon completion of the course student should be able to: Understand the basic concepts in biopharmaceutics and pharmacokinetics and their significance. Use of plasma drug concentration-time data to calculate the pharmacokinetic parameters to describe the kinetics of drug absorption, distribution, metabolism, excretion, elimination. To understand the concepts of bioavailability and bioequivalence of drug products and their significance. Understand various pharmacokinetic parameters, their significance & applications.
Generic Skills:
The faculty is committed to ensuring that students have the full range of knowledge and skills required for full participation in all aspects of their lives, including skills enabling them to be life-long learners. To ensure graduates have this preparation, such generic skills as literacy and numeric, computer, interpersonal communications, and critical thinking skills will be embedded in all courses.
Attendance Expectations:
Students are expected to attend every session of class, arriving on time, returning from breaks promptly and remaining until class is dismissed. Absences are permitted only for medical reasons and must be supported with a doctor’s note.
Content Breakdown:
|
Content BreakdownWeek |
Topical Coverage |
|
Session 1 (Week 1) |
I) BIOPHARMACEUTICS: 1. Introduction: • Definition and concepts. • Fundamental principles of biopharmaceutics. • Biopharmaceutical Classification System • Concept of bioavailability. |
|
Session 2 (Week 2) |
2. Drug adsorption from gastrointestinal tract (G.I.T): • Anatomic and physiologic considerations. • Physicochemical factors influencing drug absorption from the G.I.T. – Drug dissolution constant (pka) and lipid solubility. – Dissolution rate of drugs (Particle size and Surface area, Crystal form, Polymorphism, Solvation, Salt forms, Complexation, Solid solutions, Adsorption, Eutectics, Surfactants). – Chemical stability of drugs in the G.I.T. |
|
Session 3 (Week 3) |
• Physiological factors influencing drug absorption from the G.I.T – Surface area of the G.I. absorption sites. – pH of the G.I. fluids. – Gastric emptying. – Intestinal motility. 3. Dosage form factors influencing drug absorption from the G.I.T. • General consideration (design of the appropriate dosage from, bioavailability, rate-limiting steps). • Influence of the type of dosage form (solution, suspension, capsules compressed tablets, modified-release dosage forms). • Influence of excipients (diluents, surfactants, viscosity-enhancing agents). |
|
Session 4 (Week 4) |
4. Mechanisms of drug transport the G.I / blood barrier: • Passive diffusion. • Carrier-mediated transport (Active & Facilitated diffusion). • Other mechanisms (Ion-pair transport, Pore transport, Pinocytosis). |
|
Session 5 (Week 5) |
5. Drug absorption via different routes of administration: • Drug absorption via buccal, sublingual, pharyngeal and nasogastric mucosa. • Rectal drug absorption. • Ophthalmic drug absorption. • Parenteral drug absorption. • Inhalation drug delivery systems. • Percutaneous drug absorption. • Absorption through other routes. |
|
Session 6 (Week 6) |
6. Disposition factors influencing drug activity: • Drug distribution. – Binding to blood components. – Tissue distribution. – Membrane transport (PH partition, uptake into CSF). • Drug metabolism – Principles and pathways of biotransformation. – Factors affecting drug biotransformation. |
|
Session 7 (Week 7) |
• Drug excretion – Renal excretion (Glomerular filtration, Active tubular secretion, Passive tubular reabsorption). – Non-renal excretion (Biliary, Salivary, Mummary, Pulmonary. Skin, Genital). – Relative contribution of renal excretion in bioavailability |
|
Session 8 (Week 8) |
II. PHARMACOKINETICS: 1. Introduction: • Definition and aims (Pharmacokinetic, Pharmacodynamics, Therapeutic window etc.). • Kinetic concepts of drug absorption, distribution & elimination. – Compartments and models. – Rates and order of kinetics. – Volume of distribution. |
|
Session 9 (Week 9) |
2. Basic Pharmacokinetics: • Pharmacokinetics of IV bolus single dose. – Compartmental Approach – non- compartmental approach |
|
Session 10 (W- 10) |
• Drug clearance. – Renal clearance. – Hepatic clearance. – Biliary and salivary clearance |
|
Session 11 (Week 11) |
Midterm Assessment |
|
Session 12 (Week 12) |
|
|
Session 13 (Week 13) |
|
|
Session 14 (Week 14) |
|
|
Session 15 (Week 15) |
• Pharmacokinetics of IV bolus doseusing urine data |
|
Session 16 (Week 16) |
• Pharmacokinetics of oral-single dose. |
|
Session 17 (Week 17) |
• Pharmacokinetics of Intravenous Infusion |
|
Session 18 (Week 18) |
• Pharmacokinetics of Multiple dosing |
|
Session 19 (Week 19) |
• Non-linear pharmacokinetics. – Causes and characteristics. – Determination (Michaelis–Menten kinetics) |
|
Session 20 (Week 20) |
3. Bioavailability and Bioequivalence Studies: • Definition and concept. • Relative and Absolute bioavailability • Bioequivalence requirements and design. |
|
Session 21 (Week 21) |
• Bioequivalence studies. • Methods of documenting bioequivalency and therapeutic equivalence. |
|
Session 22 (Week 22) |
4. In Vitro- In Vivo correlation: • Introduction • Correlation levels |
|
Session 23 (Week 23) |
• Development and assessment of IVIVC • Application of IVIVC |
|
Session 24 (Week 24) |
5. Therapeutic Drug Monitoring monitoring: • Clinical Pharmacokinetic conceptsand equations |
|
Session 25 (Week 25) |
• Dosage Regimen adjustment and equations in renal impairment. |
|
Session 26 (Week 26) |
• Dosage Regimen adjustment and equations in hepatic impairment. |
|
Session 27 (Week 27) |
• Selected Problems in Clinical Pharmacokinetics – Antibiotics. – Cardiovascular drugs. – Anticonvulsants. – Immunosuppressants. – Anticoagulants. – Other drugs. |
|
Session 28 (Week 28) |
6. Plasma Drug Concentration and Therapeutic Response: • An Introduction to Pharmacodynamics |
|
Practical Work One lab per week:
|
1. Using Winnonlin, Phoenix or Excel-Pk-solver Software to: 1.1. Determination of AUC using Trapezoidal rule 1.2. Determination of absolute and relative bioavailability 1.3. Determine Pharmacokinetics parameters from plasma concentration profile after IV bolus drug administration 1.4. Determine Pharmacokinetics parameters from plasma concentration profile oral drug administration 1.5. Determine Pharmacokinetics parameters from plasma concentration profile after IV infusion drug administration. 1.6. Determine Pharmacokinetics parameters from plasma concentration profile after Multiple dosing 1.7. Determine Pharmacokinetics parameters using non-compartmental approach. 1.8. Determine Pharmacokinetics parameters of Aspirin and Riboflavin using urine excretion data 1.9. Applications of IVIVC
2. Lab experiments: 2.1. Study the effect of pH of site on in Vitro absorption of weakly acidic drugs. 2.2. Effect of permeation enhancers on the Percutaneous absorption of drugs. 2.3. Study the dissolution profile of marketed paracetamol tablets 2.4. Study the effect of urine pH on urinary excretion of Aspirin 2.5 Effect of surface area and particle size of drug on the dissolution and absorption of drug. 2.6. Bioavailability of acetaminophen in saliva. 2.7. Effect of drug concentration, pH and polysorbate 80 on drug absorption in Goldfish. |
Delivery:
- Lecture-based, Group interaction and discussion,
- Self-directed activities
- Active participation
- Computer lab
- Lab experiments …..etc
Course Assessments:
- 20% Assessment Exam
- 10% Quizzes, reports, ….
- 10% Lab classes and activities
- 20% Final Lab exam
- 40% Final theoretical exam
- 100% Total
Textbooks:
- Leon Shargel, Andrew B.C. Yu, eds. Applied Biopharmaceutics and Pharmacokinetics, 7th edition. New York: McGraw Hill, 2016. ISBN: 978-0-07- 183093-5.
- Derendorf, Hartmut; Schmidt, Stephan. Rowland and Tozer’s Clinical Pharmacokinetics and Pharmacodynamics – Concepts and Applications, 5th Ed, Walters-Kluwer: 2020, ISBN: 978-1-49-638504-8.
- Principles and Applications of Biopharmaceutics and Pharmacokinetics: for Pharmacy. Late Dr. H.P Tipnis and Dr. Amrita Bajaj ISBN: 8188739146, 9788188739141
Additional Resources:
- Lecture slides
- Microsoft Office Excel software with PK Solver tool Winnonlin or Phoenix Software
- Small ruler and scientific calculator or laptop calculator/calculation tool (in class)
- Rectilinear and semi logarithmic graph papers
Industrial Pharmacy (صيدلة صناعية)
ــــــــــــــــــــــــــــــــــــــــــ
- (PH302)
- 4 Units
- 3 hrs Theory
- 2 hrs Laboratory
- Specialty
- Pharmaceutics I & II
Course Description: (وصف المقرر)
Brief Description:
The course deals with the basic pharmaceutical operations that take place in the pharmaceutical industry, as well as how to establish a pharmaceutical factory. The course also focuses in the devices industry. Course enables the student to understand and appreciate the influence of pharmaceutical additives and various pharmaceutical dosage forms on the performance of the drug product.
Course Objectives:
Upon completion of the course student should be able to: Know the various pharmaceutical dosage forms and their manufacturing techniques. Understand the process of technology transfer from lab scale to commercial batch. Know various considerations in development of pharmaceutical dosage forms. Formulate solid, liquid and semisolid dosage forms and evaluate them for their quality.
Generic Skills:
The faculty is committed to ensuring that students have the full range of knowledge and skills required for full participation in all aspects of their lives, including skills enabling them to be life-long learners. To ensure graduates have this preparation, such generic skills as literacy and numeric, computer, interpersonal communications, and critical thinking skills will be embedded in all courses.
Attendance Expectations:
Students are expected to attend every session of class, arriving on time, returning from breaks promptly and remaining until class is dismissed. Absences are permitted only for medical reasons and must be supported with a doctor’s note.
Content Breakdown:
|
Content BreakdownWeek |
Topical Coverage |
|
Session 1 (Week 1) |
Solid dosage forms: a) Free powder dosage forms b) Granules |
|
Session 2 (Week 2) |
c) Tablets • History, advantages and classification |
|
Session 3 (Week 3) |
• Single compressed tablets • Recipients (diluents, binders, disintegrants, lubricants, colorants and flavoring agents) |
|
Session 4 (Week 4) |
Manufacture i) Dry methods • Direct compression • Granulation by compression – slugging ii) Wet methods • Wet granulation • Special procedures: Spray drying granulation, fluidized-bed granulation- Tablet machines (single punch, intermediate type and • rotary tablet machines) |
|
Session 5 (Week 5) |
• Processing problems – capping, picking, weight variation, non- disintegrating tablet, etc. • Classification: Chewable, buccal, sublingual and effervescent tablets. • Evaluation -Hardness, friability, disintegration, dissolution rate, weight and content uniformity, etc. |
|
Session 6 (Week 6) |
d) Capsules and microencapsulation • Hard gelatin capsules : • Extemporaneous filling methods – Machine filling methods |
|
Session 7 (Week 7) |
– Quality control: Weight variation, content uniformity, capsule – disintegration, dissolution test. |
|
Session 8 (Week 8) |
• Soft gelatin capsules (3 hrs) – Plate process, rotary die process, Norton capsule machine, – Accogel capsule machine |
|
Session 9 (Week 9) |
• Microencapsulation (5 hrs) – Definition, materials used, equipment, methods of applications |
|
Session 10 (W- 10) |
• Microencapsulation (continue) – Definition, materials used, equipment, methods of applications |
|
Session 11 (Week 11) |
Midterm Assessment |
|
Session 12 (Week 12) |
|
|
Session 13 (Week 13) |
|
|
Session 14 (Week 14) |
|
|
Session 15 (Week 15) |
• Coating of solids: • Reasons, equipment, core tablet characteristics, types • Sugar coating, film coating (nonenteric and enteric) |
|
Session 16 (Week 16) |
• Equipment: Pan coating, air suspension coating, compression coating, multiple compressed tablets, long-acting tablets. |
|
Session 17 (Week 17) |
II. Prolonged acting pharmaceuticals: • Terminology, sustained release, prolonged action, repeat action, coated slow-release beads, Tablets and slow-release granules, Tablet mixed release granules, Porous inert carrier, Ion exchange resins, |
|
Session 18 (Week 18) |
• Multiple layer tablets/Repeat action tablets, slightly soluble salts or complex, Evaluation of prolonged released dosage forms, In vitro and In vivo evaluation |
|
Session 19 (Week 19) |
III. Cosmetology: • Classification of cosmetic and cosmeceutical products • Definition of cosmetics as per Indian and EU regulations, Evolution of cosmeceuticals from cosmetics, cosmetics as quasi and OTC drugs • Cosmetic excipients: Surfactants, rheology modifiers, humectants, emollients, preservatives. Classification and application • Skin: Basic structure and function of skin. • Hair: Basic structure of hair. Hair growth cycle. • Oral Cavity: Common problem associated with teeth and gums. |
|
Session 20 (Week 20) |
• Lather shaving creams and brushless shaving cream, |
|
Session 21 (Week 21) |
• Shampoos, • Lipsticks, Face powders (loose and compact), • Different types of creams, |
|
Session 22 (Week 22) |
• Toothpaste (Formulation, manufacture and evaluation) • Principles of Cosmetic Evaluation: Principles of sebumeter, corneometer. Measurement of TEWL, Skin Color, Hair tensile strength, Hair combing properties • Soaps, and syndet bars. Evolution and skin benefits. |
|
Session 23 (Week 23) |
IV. Fermentation technology: • Production of penicillin and streptomycin |
|
Session 24 (Week 24) |
• Production of penicillin and streptomycin (continue) |
|
Session 25 (Week 25) |
V. Blood products and preparations: |
|
Session 26 (Week 26) |
• Blood products and preparations (continue) |
|
Session 27 (Week 27) |
VI. Structure of pharmaceutical factory: • Structure of pharmaceutical factory, structure of each division, duties and responsibilities of each department. |
|
Session 28 (Week 28) |
VII. Pilot-plant scale-up: • Lay out of pharmaceutical factory. • Materials used in construction. |
|
Practical Work: |
· Preparation of effervescent granules by dry method and wet method. · Preparation of tablet containing different types of drug substances by wet granulation, dry granulation and direct compression methods. · Evaluation of prepared tablets/ commercial tablets, capsules. · Weight evaluation test, disintegration test, hardness, friability. · Formulation and filling of capsules. · Preparation of cosmetics such as cold cream, vanishing cream, shaving cream, toothpaste, shampoo, face-powders etc. Evaluation of the quality of these products. · Preparation of non-staining iodine ointment. · Preparation of prolonged release formulations such as microspheres. · Determination of bulk properties of granules such as bulk, density, true · Density, compressibility, flow properties (angle or repose) etc. |
Delivery:
- Lectures (Tools: board, data show). The lectures were added on the internet site of the faculty to be available to the students all the time as an e-learning.
- Practical Session (Tools: labs., boards, instruments, chemicals, glassware, equipment).
- Assignments, seminars, research and posters.
Course Assessments:
- 20% Midyear Examination
- 10% Practical continuous Assessment, Exam
- 10% Quiz, reports, presentation
- 20% Final practical Examination
- 40% Final written Examination
- 100% Total
Textbooks:
- Modern Pharmaceutics by Gilbert S. Banker & C.T. Rhodes, 3rd Edition
- Remington: The Science and Practice of Pharmacy, 20th edition Pharmaceutical Science (RPS)
- Theory and Practice of Industrial Pharmacy by Liberman & Lachman
- Pharmaceutics- The science of dosage form design by M.E. Aulton, Churchill Livingstone, Latest edition
- Additional Resources: Lectures Notes
Account & Pharmaceutical Management (محاسبة وإدارة الأعمال الصيدلية)
ــــــــــــــــــــــــــــــــــــــــــ
- (PH408)
- 2 Units
- 2 hrs Theory
- Specialty
- –
Course Description: (وصف المقرر)
Brief Description:
يحتوي منهج المحاسبة التعريفات والأهداف والمصطلحات المحاسبية، ومعادلة الميزانية، كذلك الدورة المحاسبية بخطواتها بشكل مختصر وقد تم التطرق إلى بعض الأمثلة الافتراضية عن عمليات البيع والشراء لشكات الأدوية والصيدليات حتى يسهل استيعاب الدورة لدى طالب الصيدلة. والجزء الثاني إدارة الأعمال الصيدلية حيث يسلط الضوء على عمليات التسويق والدعاية والتسعير، وأيضا دراسة اتفاقية الجات سنة 1994 وأثارها الإيجابية والسلبية، والتي ركزت على تجارة الأدوية وأثر هذه الاتفاقية على الدول النامية. كما تم دراسة الرقابة على شركات الأدوية، وتقييم الأداء المالي، ومشاكل التسويق والإنتاج والجودة ومستقبل شركات الأدوية في القرن الواحد والعشرين، والفرق بين شركات الأدوية العربية والأجنبية.
Course Objectives:
بدراسة المقرر سيكون الطالب قد أثبت بشكل موثوق القدرة على: فهم الدورة المحاسبية ومشاكل شركات الأدوية ووضع الحلول المقترحة. كيفية تحديد الأرباح لدى شركات الأدوية وتقييمها. التعرف على مجالات الرقابة الدوائية ومستقبل شركات الأدوية العربية. تحديد المشكلة والأحكام والشروط عند استيراد الأدوية وتخزينها. تطوير مهارات الطالب في عمليات البيع والشراء في شركات الأدوية والصيدليات ومعرفة العمليات المدينة والدائنة.
Generic Skills:
تلتزم الكلية بضمان حصول الطلاب على كامل المعرفة والمهارات اللازمة للمشاركة الكاملة في جميع جوانب حياتهم، بما في ذلك المهارات التي تمكنهم من أن يكونوا متعلمين مدى الحياة، لضمان حصول الخريجين على هذا الإعداد، سيتم تضمين مهارات عامة مثل الكمبيوتر والاتصالات الشخصية ومهارات التفكير.
Attendance Expectations:
يجب على الطلاب حضور كل المقرر الدراسي في الوقت المحدد، ولا يسمح بالتغيب إلا لأسباب طبية ويجب دعمه بتقرير طبي.
Content Breakdown:
|
Content BreakdownWeek |
Topical Coverage |
|
Session 1 (Week 1) |
المحاسبة: • الإطار النظري لعلم المحاسبة |
|
Session 2 (Week 2) |
• معادلة الميزانية |
|
Session 3 (Week 3) |
• معادلة الميزانية |
|
Session 4 (Week 4) |
• الدورة المحاسبية |
|
Session 5 (Week 5) |
• إجراء القيود اليومية |
|
Session 6 (Week 6) |
• الترحيل إلى حساب الأستاذ |
|
Session 7 (Week 7) |
• ترصيد الحسابات |
|
Session 8 (Week 8) |
• مثال شامل وحلول وتمارين |
|
Session 9 (Week 9) |
• إعداد ميزانية المراجعة |
|
Session 10 (W- 10) |
• إعداد قائمة الدخل |
|
Session 11 (Week 11) |
• الامتحان الجزئي |
|
Session 12 (Week 12) |
|
|
Session 13 (Week 13) |
|
|
Session 14 (Week 14) |
|
|
Session 15 (Week 15) |
• إعداد الميزانية العمومية |
|
Session 16 (Week 16) |
• مثال شامل وحلول وتمارين |
|
Session 17 (Week 17) |
إدارة الأعمال الصيدلية: • التسويق |
|
Session 18 (Week 18) |
• التسويق |
|
Session 19 (Week 19) |
• الدعاية |
|
Session 20 (Week 20) |
• التسعير |
|
Session 21 (Week 21) |
• اتفاقية الجات |
|
Session 22 (Week 22) |
• مشاكل الإنتاج والجودة لدى شركات الأدوية العربية |
|
Session 23 (Week 23) |
• الرقابة على شركات الأدوية |
|
Session 24 (Week 24) |
• تقييم أداء شركات الأدوية |
|
Session 25 (Week 25) |
• مستقبل شركات الأدوية في القرن 21 |
|
Session 26 (Week 26) |
• مقارنة شركات الأدوية العربية والأجنبية |
|
Session 27 (Week 27) |
• الحلول المقترحة وسبل التطور |
|
Session 28 (Week 28) |
مراجعة عامة |
Delivery:
- المحاضرات
- التفاعل والنقاش الجماعي
- الأنشطة الموجهة ذاتيا.
- المشاركة النشطة
Course Assessments:
- 40% الامتحان النصفي
- 60% الامتحان النهائي
- 100% المجموع
Textbooks:
- مبادئ المحاسبة، إدريس اشتيوي.
- إدارة الأعمال الصيدلية، محمد أحمد بغدادي
- إدارة المستشفيات وشركات الأدوية، فريد النجار
البريد الإلكتروني
رقم الهاتف
00218-93-4959445
العنوان
بجانب مركز زليتن الطبي
زليتن - ليبيا
أوقات العمل
الأيام: السبت – الخميس
التوقيت : 8:00 صباحاً – 2.00 مساءً
