KING KHALID UNIVERSITY

Transcription

1 KING KHALID UNIVERSITY COLLEGE OF PHARMACY DEPARTMENT OF PHARMACEUTICS COURSE SCHEDULE MALE SECTION SOLID DOSAGE FORMS FOR PHARMACEUTICAL SCIENCES/CLINICAL PHARMACY BY PROF DR MOHAMED FATHY Academic Session st Semester September January

2 Course Specification Course title Solid Dosage Forms Course code (PHT 304) Credit hours Program(s) in which the course is offered Name of faculty member responsible for the course Lecture Timings Theory Lecture Timings Practical 3 HOURS BACHELOR OF PHARMACEUTICAL SCIENCES/ CLINICAL PHARMACY PROF. DR. MOHAMED FATHY 1-1:50 (SUNDAY) & 8-8:50 TUESDAY 1-2:50 WEDNESDAY & 3-4:50 (THURSDAY) Level/year at which this course is offered LEVEL 5 ( THIRD YEAR) Pre-requisites for this course (if any) PHT- 202 Co-requisites for this course (if any) NO CO-REQUISITES Location if not on main campus ABHA, KKU ALSAMER CAMPUS, ALSAMER (GIRLS) Total number of teaching weeks 15 WEEKS Total number of lectures Theory 30 HOURS Total number of Practical Hours 15 HOURS Course Description This course will introduce students to the theory and formulation of different types of solid dosage forms. Topics covered will include theory and formulation of individual and bulk powders, granulation, granules, tablets and tableting, hard and soft capsules, rectal and vaginal dosage forms. 2

3 THE MAIN LEARNING OUTCOMES FOR STUDENTS ENROLLED IN THE COURSE The main purpose for this course: The students must Be conversant with the types of solid dosage forms. Be able to prepare individual and bulk powders and granules. drying. reconstitution and packaging. Understand theoretical aspects of granulation, granulating agents and methods of preparations. Identify the types and application of tablets. Recognize the function of pharmaceutical additives in the formulations, tablet characteristics and quality control. Differentiate between hard and soft gelatin capsules. Realize the advantages and applications of capsules. hard and soft capsules. Enable students to understand the common knowledge of rectal, urethral and vaginal dosage form, their benefits and limitations, methods of manufacturing and quality assurance. TEXT BOOK FOR REFERENCE Pharmaceutical Dosage Forms and Drug Delivery Systems, by Loyd V. Allen, Nicholas G. Popovich and Howard C. Ansel; 9th edition, Williams & Wilkins, 2011 REFERENCE BOOKS Pharmaceutics: The Science of Dosage Form Design, 2nd edition, Aulton, Michael E., Chrchill Livingstone, London, Remington: The Science and Practice of Pharmacy, Vol-I & II, 20th edition, Gennaro, Alfonso R.,Lippincott Williams & Wilkins, New York, Pharmaceutical dosage forms Herbert Lieberman, Joseph B. Schwartz, Leon Lachman 3

4 SCHEDULE OF ASSESSMENT TASKS Quiz- I Practical I Mid Term Exam Practical II Scientific activities (assignment, presentation...etc) Final Exam Total 5 Marks 10 Marks 30 Marks 10 Marks 5 Marks 40 Marks 100 Marks Examination protocol Quiz-I The type of questions for Quiz I : MCQ Topics for Quiz- I Will be discussed in its due course MID-TERM EXAM The type of questions for Midterm : MCQ + 20% written Topics for Mid-term exam Will be discussed in its due course MID-TERM EXAM WILL TAKE PLACE IN 6 Th to 10 Th TEACHING WEEK. END SEMSTER EXAM Final exam will consist of 60 multiple choice questions for 40 marks. 4

5 TEACHING SCHEDULE FOR SOLID DOSAGE FORMS THEORY Week No Course Content 1-Powders and granules Introduction 1.2. Forms of powders Oral Powders Dentifrices Douche Powders Insufflations 1.3. Advantages of non-enclosed oral powders 1.4. Disadvantages of non-enclosed oral powders: 1.5. Granules 1.6. Particle size 1.7. United States Pharmacopeia (USP) descriptive terms Micromeritics Determination of equivalent diameter The projected area diameter The projected perimeter diameter Feret's diameter Martin's diameter Particle size analysis methods Sieve methods Microscope methods: Electrical stream sensing zone method (Coulter Counter): Laser light scattering methods Particle size distribution Frequency and Cumulative frequency distribution data Size Separation 2- Particle Properties True density Bulk density Porosity Flowability OF powders 2.1. Definition 2.2. Reasons for producing free flowing powders 5 Name of the Faculty Prof Dr. Mohamed Fathy

6 2.3. Factors affecting powder flowability 2.4. Particle properties 2.5. Indirect quantitative measurements of flowability: Angle of repose Bulk density Flow rate Improvement of flowability 2.7. Types of forces that can be applied to the particles Compressive force; Tensile forces Shearing forces; 2.8.Blending of Powders Spatulation, Trituration, Sifting, Tumbling 2.9. Factors affecting mixing of solids Particle size Density difference Electrostatic charges 3- Granulation 3.1. Methods of preparing granules for tablet preparation: Dry Granulation Wet Granulation 3.2. Effervescent Granulated Salts Methods of Preparation of effervescent granules The fusion method The wet method 4- Tablet and Tabletting 4.1. Definition 4,2, Characteristics of well made compressed tablet 4.3. Advantages of tablets as dosage form 4.4.Tablet compression machines 1-Singe punch tablet machine, or Rotary tablet machine 4.5. Tablet ingredients Diluents (or filler) Binders (or adhesives) 6

7 Disintegrants Mechanism of action of disintegrants Lubricants Glidants Optional excepinets Colorants Flavoring agents Sweetening agent 4.6. Methods of tablet manufacture Direct Compression Slugging: (by tablet presses Compression rollers: ( by Chilsonator) Wet Granulation 4.7. Problems of tablet manufacturing Capping and Lamination ulation Sticking Picking Mottling 4.8. Types of Tablets Lozenges Chewable Tablets Effervescent Tablets Sublingual and Buccal Tablets Implants: Multilayer Tablets: Film-Coated Tablets Enteric coated tablets(e/ct) Sugar coated tablets Sustained release tables Solution Tablets: Hypodermic Tablets Ophthalmic Tablets Rapidly disintegrating Tablets 5- Capsules 5.1. Raw materials for gelatin capsules Gelatin Plasticizers Colorants Preservatives 5.2. Hard Gelatin Capsules Determination of capsule fills weight Filing of hard gelatin capsules Dry Solids 7

8 Semisolids: Factors affecting the release from hard gelatin capsules Active ingredient Diluent Glidants and lubricants 5.3. Soft Gelatin Capsules Description: Advantages of soft gelatin capsules as a dosage form: Formulation problems that may be solved by preparing in soft gelatin capsule. Compression problems Stability problems Bioavailability problems Formulation of Soft gelatin capsules Gelatin Plasticizer Water Preservatives: Colours: Opacifiers Enteric treatment Bioavailability aspects of soft gelatin capsules: Acid soluble drugs Acid insoluble drugs Drugs dissolved in an oil 6- Suppositories 6.1. Definition 6.2. Advantages of rectal route 6.3. Disadvantages of rectal route 6.4. Anatomy of the rectum 6.5.The factors that affect rectal absorption of a drug Physiologic Factors The colonic contents, Circulation route, The ph 8

9 Physicochemical Factors of the Drug and Suppository Base Lack of buffering capacity of the rectal fluids Lipid-Water Solubility Particle Size 6.6. Formulation of suppositories 6.7. Suppository Bases 6.8. Classification of Suppository Bases Fatty or oleaginous bases, Water-soluble or water-miscible bases, Miscellaneous bases, generally combinations of lipophilic and hydrophilic substances Calculating the quantity of base that the active medication will occupy and the quantities of ingredients required are: Dosage replacement factor, Density factor, Occupied volume methods Manufacture of Suppositories Quality control Revision 9

10 TEACHING SCHEDULE FOR SOLID DOSAGE FORMS (PRACTICAL) WEEK Day / Date Topic Faculty Name 1 Particle size analysis methods 17/12/1437 Sieve methods 2 24/12/ /1/ /1/1438 Flowability OF powders Angle of repose Flowability OF powders Bulk density Flowability OF powders Flow rate /1/1438 Bulk powders for external use 6 22/1/1438 Bulk powders for Internal use Prof Dr. Mohamed Fathy & Dr.Amged Awad El- Gied 7 29/1/ /2/ /2/ /2/ /3/ /3/ /3/ /3/ /4/1438 Mid Term Examination Divided powders for external use Divided powders for Internal use Methods of preparing granules for tablet preparation: Wet Granulation Methods of preparing granules for tablet preparation: Dry Granulation Hard Gelatine Capsules. Determination of capsule fills weight Hard Gelatine Capsules. Filing of hard gelatine capsules Suppositories : Water-soluble Fatty Bases Practical Examination 10