Department of Pharmaceutics

Syllbus

Republic of Iraq / Ministry of Higher Education and Scientific Research
College Of Pharmacy / Al-Nahrain University
Pharmacognosy Department
1st Semester, 3rd Stage, 2021-2022
Assistant Lecturer Ayah Fadhil Al-Qrimli


Course Delivery Plan

Coarse title: Pharmacognosy Theory II.
Reference books:
Robbers JE, Speedie MK, Tyler VE(Eds); pharmacognosy and pharmaco- biotechnology.
Objectives: this course should enable students to:

NO. OBJECTIVE No. of attribute covered
1 Study the chemistry of natural products, namely glycosides, flavonoids, volatile oils, fixed oils, and tannins. 1-10
2 Study the phytochemistry and pharmacology of secondary medicinal plant constituents. 1-9
3 Study the uses of these constituents and the plants containing these constituents. 1-10
4 Understand nature and role of hormones and vitamins 10
5 Study the chemistry and pharmacology of toxic non- medicinal plants 11

Al-Nahrain University/College of Pharmacy
Title of the course:: Pharmaceutical Calculation
Credit hours: Theory 2 hours Laboratory 1 hour
Reference book: Pharmaceutical Calculation by Stoklosa

Depart. Of pharmaceutics
Level: 1st Year, 2nd Semester






Objectives:

It involves the computation of pharmaceutical ingredients, dosage forms, pharmaceutical formulations of extemporaneous compounding, and biological parameters of drug substances. The course teaches calculations for dilution and concentration of different types of liquids and those involved in preparing isotonic solutions, electrolyte solutions and intravenous admixtures.

NO. SUBJECTS HOURES
1 Dilution and concentration of pharmaceutical preparations. 10
2 Isotonic solutions. 6
3 Electrolyte solutions (milliequivalents, millimoles and milliosmoles). 6
4 Constituted solutions, I.V admixtures and flow rate calculations. 8

Al-Nahrain University/College of Pharmacy
Title of the course:Experimental of Pharmaceutical Calculations
Credit hours: Exp. Lab.1 credit 2 hours/week
Reference book: Lab Manual for Practical Pharmacology Adopted by the Department

Depart. Of pharmaceutics
Level: 1st Year, 2nd Semester

NO. SUBJECTS HOURES
1 Demonstration of different glass wares and equipments used in the field of pharmacy. 2
2 Pharmaceutical measurements. 4
3 Volume measurements. 4
4 Preparation of aromatic waters. 2
5 Preparation of simple solutions. 4
6 Reducing and enlarging prescription contents. 4
7 Percentages in calculating prescription contents. 4
8 Stock solutions and dilution technique during dispensing technique. 6

Al-Nahrain University/College of Pharmacy
Title of the course: Physical Pharmacy I
Credit hours: Theory 2 hours Laboratory 1 hour
Reference book:: Physical Pharmacy by Alfred Martin et al.

Depart. Of pharmaceutics
Level: 2nd Year, 1st Semester






Objectives:

To understand the application of quantitative and theoretical principles of the physical characters of matter to the practice of pharmacy. It helps the pharmacist predict the solubility, compatibility and biological activity of drug products. As a result of this knowledge, it is helpful in the development of new drugs and dosage forms as well as in the improvement of various modes of administration.

NO. SUBJECTS HOURES
1 States of matter, binding forces between molecules, gases,liquids, solid and crystalline matters; phase equilibria and phase rule; thermal analysis. 10
2 Thermodynamics, first law, thermochemistry, second law,third law, free energy function and applications. 8
3 Solutions of non-electrolytes, properties, ideal and real colligative properties, molecular weight determination. 7
4 Solution of electrolytes, properties, Arrhenius theory of dissociation, theory of strong electrolytes, ionic strength, Debye-Huchle theory, coefficients for expressing colligative properties. 5
5 Ionic equilibria, modern theories of acids, bases and salts, acid-baseequilibria, calculation of pH, acidity constants, the effect of ionic strength and free energy. 8
6 Buffered and isotonic solutions: Buffer equation; buffer capacity; methods of adjusting tonicity and pH; buffer and biological system. 7

Al-Nahrain University/College of Pharmacy
Title of the course: : Practical Physical Pharmacy I
Credit hours: Exp. Lab. 1 credit 2 hours/week
Reference book: Lab Manual for Practical Pharmacology Adopted by the Department

Depart. Of pharmaceutics
Level: 2nd Year, 1st Semester

NO. SUBJECTS HOURES
1 Expression of concentrations in pharmaceutical preparations 4
2 Two component systems containing liquid phases. 4
3 Three component systems. 4
4 Tie linear for three component systems. 4
5 Partition coefficient: Measurements and evaluation. 2
6 Solubility methods. 4
7 Buffer solutions. 4
8 Determination of solubility product constant of slightly soluble salts. 4

Al-Nahrain University/College of Pharmacy
Title of the course:Physical Pharmacy II
Credit hours: Theory 3 hours Laboratory 1 hour
Reference book:: Physical Pharmacy by Alfred Martin et al.

Depart. Of pharmaceutics
Level: 2nd Year, 2nd Semester






Objectives:

To understand the application of quantitative and theoretical principles of the physical characters of matter to the practice of pharmacy. It helps the pharmacist predict the solubility, compatibility and biological activity of drug products. As a result of this knowledge, it is helpful in the development of new drugs and dosage forms as well as in the improvement of various modes of administration.

NO. SUBJECTS HOURES
1 Solubility and distribution phenomena, solvent-solute interactions, solubility of gases in liquids, solubility of liquids in liquids, solubility of non-ionic solids in liquids, distribution of solutes between immiscible solvents. 10
2 Complexation, classification of complexes, methods of analysis, thermodynamic treatment of stability constants. 5
3 Kinetics, rate and orders of reactions, influence of temperature and other factors on reactions rate, decomposition of medicinal agents and accelerated stability analysis. 9
4 Interfacial phenomena, liquid interfaces, surface free energy, measurement of interfacial tension, spreading coefficient, surface active agents and wetting phenomena. 5
5 Colloids, dispersed system and its pharmaceutical application, types of colloidal systems, kinetic properties, diffusion, zeta potential, solubilization. 5
6 Micrometrics, particle size, methods of determining particle size, particle shape and surface area, porosity, density. 3
7 Rheology, Newtonian systems, thixotropy measurement, negative thixotropy, determination of thixotropy. 5
8 Polymer science, definitions pharmaceutical applications, molecular weight averages 3

Al-Nahrain University/College of Pharmacy
Title of the course:Practical Physical Pharmacy II Credit
Credit hours: Exp. Lab. 1 credit 2 hours/weeks
Reference book:: Physical Pharmacy by Alfred Martin et al.

Depart. Of pharmaceutics
Level: 2nd Year, 2nd Semester

NO. SUBJECTS HOURES
1 Solubilization of components of pharmaceutical preparations. 4
2 Solubilization of Aspirin. 4
3 Review and tutorial 2
4 Surface tension: measurements and calculations. 4
5 Rate kinetic: Application in stability of pharmaceutical stability. 4
6 Review and tutorial 2
7 Viscosity: Measurements and calculation. 6
8 Adsorption isotherm. 4

Al-Nahrain University/College of Pharmacy
Title of the course: Pharmaceutical Technology I
Credit hours: Theory 3 hoursLaboratory 1 hour
Reference book:Pharmaceutical Dosage forms and
Drug Delivery Systems By Haward A. Ansel; latest edition. andSprowel's American Pharmacy.

Depart. Of pharmaceutics
Level: 3rd Year, 1st Semester







Objectives:

To teach theoretical bases for the technology of preparing different dosage forms with respect to their raw materials, composition, methods of preparation, stability, storage and uses.

NO. SUBJECTS HOURES
1 Dispersed systems: their classification; comparisons between different systems. 2
2 Solutions and types of solutions. 2
3 Solubility: Factors affecting solubility; expression of dissolution; dissolution rate versus solubility; preparation of solutions containing non-volatile materials. 4
4 Official solutions; classification of official solutions; preparation and uses. 4
5 Aqueous solutions containing aromatic principles; aromatic waters; methods of preparations; stability. 4
6 Syrups: sugar based syrups; artificial and sorbitol based syrups; stability of syrups. 4
7 Definition and methods of clarification; filter aids in clarification. 3
8 Preparation of solutions using mixed solvent systems; spirits, and elixirs. 3
9 Extraction; maceration and percolation. 3
10 Tinctures; fluid extracts; extracts of resins and oleoresins. 4
11 Colloidal dispersions; lyophilic; lyophobic. 6
12 Coarse dispersion; suspensions. 6

Al-Nahrain University/College of Pharmacy
Title of the course: : Practical Pharmaceutical Technology I
Credit hours:Exp. Lab.1 credit2 hours/week
Reference book: : Lab Manual for Practical Pharmacology Adopted by the Department

Depart. Of pharmaceutics
Level: 3rd Year, 1st Semester

NO. SUBJECTS HOURES
1 Solutions (Into body cavity, oral and external use). 4
2 Syrups: Preparation techniques and quality evaluation. 4
3 Review and tutorial 2
4 Elixirs: Preparation techniques and quality evaluation. 4
5 Spirits: Preparation techniques and quality evaluation. 4
6 Review and tutorial 2
7 Suspensions: Preparation techniques and quality evaluation. 6
8 Dispersion of oils in inhalations. 4

Al-Nahrain University/College of Pharmacy
Title of the course: Pharmaceutical Technology II
Credit hours:Exp. Lab.1 credit2 hours/week
Reference book: : Lab Manual for Practical Pharmacology Adopted by the Department

Depart. Of pharmaceutics
Level: 3rd Year, 2nd Semester






Objectives:

To teach theoretical bases for the technology of preparing different dosage forms with respect to their raw materials, composition, methods of preparation, stability, storage and uses; in addition to define and characterize the possible incompatibilities that may occur in dosage forms.

NO. SUBJECTS HOURES
1 Emulsions; purpose of emulsification; methods of emulsification; emulsifying agents; HLB system; stability of emulsions. 10
2 Lotions; liniments and collodions. 5
3 Suppositories. 6
4 Powdered dosage forms. 10
5 Semisolid dosage forms. 10
6 Incompatibilities in pharmaceutical dosage forms. 4

Al-Nahrain University/College of Pharmacy
Title of the course: : Practical Pharmaceutical Technology II
Credit hours:Exp. Lab.1 credit2 hours/week
Reference book: : Lab Manual for Practical Pharmacology Adopted by the Department

Depart. Of pharmaceutics
Level: 3rd Year, 2nd Semester

NO. SUBJECTS HOURES
1 Emulsions: Preparation techniques and quality evaluation. 4
2 Suppositories: Preparation techniques and quality evaluation. 4
3 Review and tutorial 2
4 Powders: Preparation techniques and quality evaluation. 4
5 Capsules: Preparation techniques and quality evaluation. 4
6 Review and tutorial 2
7 Semisolid dosage forms: Preparation techniques and quality evaluation. 8
8 Review and tutorial 2

Al-Nahrain University/College of Pharmacy
Title of the course: Biopharmaceutics
Credit hours:: Theory 2 hours Laboratory 1 hour
Reference book: Shargel L, Yu AB, (Eds.), Applied Biopharmaceutics and Pharmacokinetics.

Depart. Of pharmaceutics
Level: 3rd Year, 2nd Semester






Objectives:

: The course deals with the physical and chemical properties of drug substance, dosage form and the biological effectiveness of drugs or drug products administration, including drug availability in human or animal body from a given dosage form. The pharmacokinetic part of the coarse deals with the time-course of drugs in the biological system, and quantification of drug concentration pattern in normal subjects and in certain disease states.

NO. SUBJECTS HOURES
1 Introduction to biopharmaceutics. 2
2 Biopharmaceutic aspects of products; drug absorption; mechanisms of absorption; physicochemical factors; dissolution rate; effects of excipients; type of dosage forms. 6
3 One compartment open model. 2
4 Multicompartment models. 2
5 Pharmacokinetics of drug absorption. 2
6 Bioavailability and bioequivalence. 2
7 Clearance of drugs from the biological systems. 2
8 Hepatic elimination of drugs. 2
9 Protein binding of drugs. 2
10 Intravenous infusion 2
11 Multiple dosage regimens. 2
12 Non-linear pharmacokinetics. 2
13 Dosage adjustment in renal diseases. 2

Al-Nahrain University/College of Pharmacy
Title of the course: Practical Biopharmaceutics
Credit hours:Exp. Lab.1 credit 2 hours/week
Reference book: Shargel L, Yu AB, (Eds.), Applied Biopharmaceutics and Pharmacokinetics.

Depart. Of pharmaceutics
Level: 4th Year, 1st Semester

NO. SUBJECTS HOURES
1 Preparation of calibration curve of salicylic acid. 2
2 In vitro evaluation of bulk laxative. 2
3 In vitro evaluation of antacids. 2
4 Dissolution of tablets. 4
5 Review and tutorial 2
6 Determination of pharmacokinetic parameters from CP-time by residual method. 4
7 Determination of pharmacokinetic parameters from CP-time by trapezoidal method. 4
8 Determination of pharmacokinetic parameters from urine excretion samples. 4
9 Hydrolysis of aspirin in buffer pH 6.8. 4
10 Review and tutorial 2

Al-Nahrain University/College of Pharmacy
Title of the course: Industrial Pharmacy I
Credit hours: Theory 3 hours Laboratory 1 hour
Reference book:The Theory and Practice of Industrial Pharmacy by Leon Lachman

Depart. Of pharmaceutics
Level: 4th Year, 2nd Semester






Objectives:

:: To teach students the steps and lines upon which the preformulation processing of pharmaceutical dosage forms are based. It provides the required principles to integrate knowledge of Pharmaceutical Technology in preformulation of perfect dosage form. It includes milling, mixing, drying, filtration and sterilization to achieve a proper processing of dosage forms.

NO. SUBJECTS HOURES
1 The principles of pharmaceutical processing; mixing; fluid mixing; flow characteristics; mechanisms of mixing; mixing equipments; batch and continuous mixing; mixer selection; solid mixing theory and particulate solid variables; forces and mechanisms. 7
2 Milling; pharmaceutical application; size measurement methods; theory and energy of commenution; types of mills; factors influencing milling; selection of mill techniques; specialized drying methods. 7
3 Drying: definition; purpose; humidity measurement; theory of drying; drying of solids, and classification of dryer; specialized drying methods. 7
4 Clarification and filtration: Theory; filter media; filter aids; selection of drying method; non-sterile and sterile operations; integrity testing; equipments and systems (commercial and laboratory). 7
5 Sterilization; validation of methods; microbial death kinetics; methods of sterilization (thermal and non-thermal); mechanisms; evaluation. 7
6 Pharmaceutical dosage form design; pre-formulation; preliminary evaluation; bulk characterization; solubility and stability analysis. 3
7 Pharmaceutical dosage forms; sterile products; development; formulation; production; processing; quality control. 7

Al-Nahrain University/College of Pharmacy
Title of the course:Practical Industrial Pharmacy I
Credit hours:Exp. Lab. 1 credit2 hours/week
Reference book: Lab Manual for Practical Pharmacology Adopted by the Department

Depart. Of pharmaceutics
Level: 4th Year, 2nd Semester

NO. SUBJECTS HOURES
1 Introduction in industrial pharmacy and pre-formulation. 2
2 Effervescent granules: Preparation and characterization. 2
3 Flow properties and rheology of granules. 4
4 Tablet dosage form: Preparation and characterization. 4
5 Review and tutorial 2
6 Evaluation of tablets. 4
7 Preparation of children aspirin by wet granulation method. 2
8 Sustained release dosage forms: Preparation and characterization. 4
9 Coating techniques of tablets. 4
10 Review and tutorial 2

Al-Nahrain University/College of Pharmacy
Title of the course:: Industrial Pharmacy II
Credit hours: Theory 3 hours Laboratory 1 hour
Reference book:The Theory and Practice of Industrial Pharmacy by Leon Lachman

Depart. Of pharmaceutics
Level: 5th Year, 1st Semester






Objectives:

::To provide technical setup that coordinates the standards of formulating typical dosage forms, and to emphasize the principles needed to learn mass production of different pharmaceutical dosage forms. The syllabus includes different dosage forms, such as tablets, capsules, aerosols, emulsion, etc, besides the advanced techniques, including enteric coating and micro-encapsulation.

NO. SUBJECTS HOURES
1 Pharmaceutical dosage forms: Tablets; role in therapy; advantages and disadvantages; formulation; properties; evaluation; machines used in tableting; quality control; problems; granulation, and methods of production; excipients, and types of tablets. 10
2 Tablet coating; principles; properties; equipments; processing; types of coating (sugar and film); quality control, and problems. 4
3 Capsules: Hard gelatin capsules; materials; production; filling equipments; formulation; special techniques. 3
4 Soft gelatin capsules: Manufacturing methods; nature of capsule shell and content; processing and control; stability. 2
5 Micro-encapsulation; core and coating materials; stability; equipments and methodology. 2
6 Modified (sustained release) dosage forms; theory and concepts; evaluation and testing; formulation. 3
7 Liquids: Formulation; stability and equipments. 3
8 Suspensions: Theory; formulation and evaluation. 3
9 Emulsions: Theory and application; types; formulation; equipments and quality control. 3
10 Semisolids: Percutaneouse absorption; formulation; types of bases (vehicles) 3
11 Suppositories: Rectal absorption; uses of suppositories; types of bases; manufacturing processes; problems and evaluation. 3
12 Pharmaceutical aerosols: Propellants; containers; formulation; types and selection of components; stability; manufacturing; quality control and testing. 6

Al-Nahrain University/College of Pharmacy
Title of the course:: Practical Industrial Pharmacy II
Credit hours:Exp. Lab.1 credit2 hours/week
Reference book: Lab Manual for Practical Pharmacology Adopted by the Department

Depart. Of pharmaceutics
Level: 5th Year, 1st Semester

NO. SUBJECTS HOURES
1 Direct compression method for preparation of tablets. 4
2 Wet granulation method for preparation of tablets. 4
3 Dry granulation method for preparation of tablets. 4
4 Review and tutorial 2
5 Evaluation of tablets. 4
6 Capsules dosage form: Preparation and evaluation. 6
7 Parenteral dosage forms 4
8 Review and tutorial 2

Al-Nahrain University/College of Pharmacy
Title of the course:: Dosage form Design
Credit hours: Theory 2 hours
Reference book: Pharmaceutical Dosage Forms and Drug Delivery Systems by Haward A. Ansel. Latest Edition.

Depart. Of pharmaceutics
Level: 5th Year, 2nd Semester






Objectives:

:: To help students understand the principles and factors that influence the designing of dosage forms; and the applications of these principles to the practice of pharmaceutical industry.

NO. SUBJECTS HOURES
1 Pharmaceutical consideration: The need for the dosage form. 1
2 General consideration of the dosage form. 3
3 Pre-formulation; physical description, microscopic examination. 2
4 Melting point; phase rule; particle size; polymorphism; solubility. 2
5 Permeability; pH; partition coefficient; pka; stability; kinetics; shelf life. 2
6 Rate reaction; enhancing stability. 2
7 Formulation consideration: Excipients; definition and types; appearance; palatability; flavoring. 2
8 Sweetening; coloring pharmaceuticals; preservatives; sterilization; preservatives selection. 2
9 Biopharmaceutical considerations: Principle of drug absorption; dissolution of the drugs. 4
10 Bioavailability and bioequivalancy; FDA requirements. 3
11 Assessment of bioavailability; bioequivalence among drug products. 3
12 Pharmacokinetic principles: Half life; clearance; dosage regimen considerations. 4

Al-Nahrain University/College of Pharmacy
Title of the course::Pharmaceutical Biotechnology
Credit hours: Theory 1 hours ,course code
Reference book:Pharmaceutical biotechnology J . A . Crommelin , Robert D. Syinder

Depart. Of pharmaceutics
Level: 5th Year, 2nd Semester

NO. SUBJECTS HOURES
1 Biotechnology - introduction 1
2 Formulation of biotechnology product (biopharmaceutical consideration) Microbial consideration- sterility-pyrogen viral decontamination . Excipients of parental products - solubility enhancer-anti adsorption agents buffer components preservatives – osmotic agents. 4
3 Route of administration : Parentral route , Oral route Alternative 5
4 Pharmacokinetic of peptides and proteins: Introduction, Elimination of proteins (proteolysis-excretion-metabolism). 5

Staff Member

 
Dr. Fryal Hashim

Head Of The Department

 
Rwaa mohammed

Lecturer

 
Basar

Lecturer

 
Ali Qasim

Lecturer

vission

The vision of Pharmaceutics department is to be focusing on innovative work in research and education that related to pharmaceutics and drug delivery to achieve the superiority in this respect.

Mission

The mission of Pharmaceutics department involved two targets, one related to education and training mission and other related to research and innovation mission. The first target attained by offering undergraduate and postgraduate students with essential knowledge for understanding the physicochemical and biopharmaceutical aspects of dosage form design, evaluation and manufacturing. Whereas the second target accomplished by performing and directing new knowledge to external partners to amend drug delivery and patients care.

SIENTFIC ACTIVITY DEPARTMENT