DISCIPLINE RECORD/ COURSE / SEMINAR DESCRIPTION

Transcription

1 Universitatea de Medicină şi Farmacie Grigore T. Popa Iaşi Comisia pentru asigurarea calităţii DISCIPLINE RECORD/ COURSE / SEMINAR DESCRIPTION 1. Information about the program UNIVERSITY: GRIGORE T. POPA UNIVERSITY OF MEDICINE AND PHARMACY OF 1.1. IAŞI 1.2. FACULTY: PHARMACY SCHOOL / DEPARTMENT: PHARMACEUTICAL SCIENCES II 1.3. SUBJECT: INDUSTRIAL PHARMACEUTICAL TECHNOLOGY 1.4. STUDY FIELD: PHARMACY 1.5. STUDY CYCLE: UNDERGRADUATE 1.6. STUDY PROGRAMME: IN ENGLISH 2. Subject data 2.1. SUBJECT: INDUSTRIAL PHARMACEUTICAL TECHNOLOGY 2.2. Module leader: Lecturer Carmen Gafitanu, PhD, Assoc. Prof. Gratiela Popa, PhD 2.3. Seminar leader: Lecturer Carmen Gafitanu, PhD, Assoc. Prof. Gratiela Popa, PhD, Assist. Andreea 2.4. Year of study Creteanu, PhD V 2.5. Semester in which is taught I 2.6. Evaluation type 3. Duration of the course (hours per semester) E Subject status Compulsory 3.1. Number of hours Number of Seminar / lab 3 / week hours / week 3.4.Total number of learning hours Total number of learning hours seminar / lab Distribution of activities in the course hours Study based on the manual, printed course, bibliography and notes 5 Additional research in the library, on specialized e-platforms and field study 5 Preparation for seminars, practical courses, portfolios and essays 10 Tutoring 10 Assessment - Other activities Number of hours of individual study Number of hours per semester Number of ECTS 4 4. Previous Knowledge (if applicable) 4.1. course related Pharmaceutical Propaedeutics, Physical Chemistry, Pharmaceutical Technology (3 rd and 4 th year of study, homogenous and heterogenous pharmaceutical dosage forms) skill related - notions about the homogenous and microheterogenous pharmaceutical dosage forms; - basic notions on formulation, preparation and quality control of pharmaceutical dosage forms.

2 5. Requirements (if applicable) 5.1. course conditions Video projector, work sheets, flip chart seminar / laboratory conditions Laboratory glassware, specific compounding tools, active drugs and excipients, laboratory-scale equipments for dosage forms preparation (pharmaceutical standard sieves, semi-automatic capsule filling apparatus, tablet press) ; devices for the quality control of pharmaceutical dosage forms. 6. Specific Skills Acquired Professional skills displayed by knowledge and skills Transversal skills (role skills, professional and personal skills) Design, formulation, industrial manufacture and packaging of medicines and dietary supplements. Storage, preservation and distribution of industrially manufactured medicines and dietary supplements. Quality control of medicines, dietary supplements, cosmetics and other health care products. Consultancy and expertise in the field industrial manufacture of medicines. Valorization of the acquired theoretical knowledge and adaptation to the requirements of the pharmaceutical industry. Communication skills (oral and in writing) specific to the pharmaceutical profession. Autonomy and resonsibility in taking professional decisions. 7. Course Objectives (confirmed by the grid of specific skills acquired) 7.1. General Objective Knowledge of the main important steps involved in the industrial design and manufacture of drugs: specific guidances for industry, preformulation and formulation aspects, industrial manufacture flow of dosage forms Specific Objectives Knowledge of solid oral dosage forms manufactured in the industry: medicated powders, capsules, granules, tablets, modified-release solid dosage forms. 8. Contents 8.1. Course Teaching methods Observations Manufacture steps of the industrial dosage forms Research and development: pilot scale manufacture and scale-up 2 hours steps; industrial manufacture of dosage forms. Definition, components and characteristics of the pharmaceutical industry, global concept of a pharmaceutical manufacturing plant. Essential elements in the quality of drug products: the four M concept: personnel (men), raw materials, machinery and methods. Industrial packaging, storage and shelf life of an industrial dosage form. Quality assurance and Good Manufacturing Practice in the pharmaceutical industry. Validation Solid dosage forms as heterogeneous disperse systems Dosage forms composed of individual particles -Powders: definition, advantages and limitations, types of powders, formulation goals. Pharmacopoeial standards. Factors influencing powder formulation. Powder properties. 8 hours

3 -Structural and dimensional properties: shape, particle size and diameter, size distribution of particles in a powder bed; density of powders. Electrical properties, superficial properties, mechanical properties, flow properties (rheology of powders). Technological properties influencing formulation; raw materials for powders: drugs, excipients. -Manufacture technology of powders: unit operations. Drying of solids; heat transfer methods: air circulation drying, conduction (hot surface) drying, radiation drying, microwave drying, drying of diluted solutions and suspensions, freeze-drying. Particle size reduction: methods and equipments for cutting and grinding; equipments for particle size reduction: mills. Powder sieving; pharmaceutical sieves: classification and characterization according to Pharmacopoeias; factors influencing powder sieving. Mixing of powders: mechanisms, mixing equipments. Technology of powders: clean rooms; manufacture steps. Quality assurance and control of powders. Encapsulated dosage forms -Definition, advantages, limitations, types of capsules. Starch capsules. Hard gelatin capsules: types, formulation, raw materials. Industrial manufacture: capsule wall, capsule content. Small scale filling of hard gelatin capsules (laboratory scale and pharmacy scale). -Industrial filling of hard gelatin capsules: equipments. Bioavailability, quality assurance and control of hard gelatin capsules. -Soft gelatin capsules. Formulation of content. Industrial manufacture: methods, equipments. Packaging and storage, quality assurance and control, bioavailability of soft gelatin capsules. Solid dosage forms made by aggregation and agglomeration of particles -Medicated gums. Soft lozenges. Hard candy lozenges. Medicated lollipops. Molded tablets. Medicated chocolates. -Granules: definition, advantages and limitations, formulation. Mechanisms of granulation. Raw materials. Industrial manufacture: dry granulation method. -Wet granulation methods: conventional wet granulation, high shear granulation, fluidized bed granulation, centrifugal bed granulation, spray drying granulation. Problems of granule drying: solvent migration. Packaging, storage, quality assurance and control. Bioavailability of granules. -Pellets definition, advantages, limitations. Formulation of pellets. Industrial methods: extrusion-spheronization, powder coating, centrifugal fluidization, liquid spray coating, spray congealing, meltextrusion. Quality assurance and control of pellets. Solid dosage forms made by agglomeration and compaction -Tablets definition, advantages, limitations; types of tablets, formulation. Desired characteristics for tabletting: compressibility, powder flow. Evaluation of compression behavior of powders and granules. -Physics of the compression process: factors influencing compaction and compression. Raw materials for tablet manufacture; excipients: fillers, binders, disintegrants, superdisintegrants, lubricants, glidants, 4 hours 5 hours 5 hours

4 other excipients. Manufacturing steps: compression cycle. -Tablet presses: types; tabletting steps through various methods: direct compression and indirect compression (dry granulation and wet granulation). Packaging and storage, quality assurance and control. Bioavailability of tablets. -Special formulations of fast release tablets: effervescent tablets, orally disintegrating tablets, sublingual tablets. -Tablets for other administration routes: vaginal, implantable tablets. Coated solid dosage forms -Definition, advantages, limitations, types of coating, formulation. Mechanisms of film formation, principles of coating. Coating technologies: equipments, methods. -Sugar coating, steps of industrial process. Film coating of tablets, press coarting, melt coating. Packaging and storage, quality assurance and control, bioavailability of coated dosage forms. Modified release dosage forms -Prolonged release dosage forms: formulation, manufacture. Sustained release, sequential release, controlled release dosage forms (tablets, capsules): reservoir systems, matrix systems, osmotic systems, gastroretentive systems, floating systems, bioadhesive systems. Targeted release systems. Video projections, (short Video projections, (short 2 hours 2 hours -Microcapsules, nanocapsules. Bibliography 1. Delivery Systems. 10th Edition. Allen LV, Ansel HC (editors). Lippincott, Williams & Wilkins, Popovici I, Lupuleasa D. Pharmaceutical Technology. 3 rd Edition, vol. I. Iasi: Polirom Publishing House, Popovici I, Lupuleasa D. Pharmaceutical Technology. Vol. III. Iasi: Polirom Publishing House, Leucuta S. Industrial Pharmaceutical Technology. Cluj-Napoca: Dacia Publishing House, Swarbrick J, Boylan JC. Encylopedia of Pharmaceutical Technology. New York: Ed. M. Dekker Inc., vol. I-IV, ***The Romanian Pharmacopoeia, 10 th Edition, 1993 and Supplements Bucharest: Medical Publishing House Seminar / Practical lessons Teaching Methods Observations 1. Solid dosage forms as macro-heterogeneous disperse systems Oral solid dosage forms. Pharmaceutical powders. Preparation, unit operations: drying, grinding/particle size reduction, sieving, mixing of powders 2. Powders -Pharmacopoeial standards: monographs in the Romanian Pharmacopoeia 10 th edition, European Pharmacopoeia 7 th edition; single active drug powders; packaging, storage and quality control. Compounding powders: bulk powders and divided powders; powders with different apparent densities, magistral preparations. -Multiple active drug powders (bulk powders): compounded and officinal preparations containing substances with water of hydration. Hygroscopic powders and eutectic mixture formation in powders. Industrial products: examples. -Powders with potent active drugs: controlled drugs (addictive, toxic drugs). Calculations of maximum therapeutic doses. Powders Performing the studied unit operations in laboratoryscale; Compounding the studied magistral examples; the studied topic. 3 hours 15 hours

5 containing coloured substances. -Powders containing lipophilic active drugs, volatile oils and substances. Industrial products: examples. -Topical powders- magistral and industrial examples. Quality control of powders, rheological behavior. 3. Capsules -Monographs in the Romanian Pharmacopoeia 10 th edition and Supplement Preparation of soft gelatin capsules by immersion method. Soft gelatin capsules containing lipophilic vitamins. Industrial examples. -Hard gelatin capsules laboratory scale filling of capsules using the Feton apparatus. Industrial examples of hard gelatin capsules. Quality control of capsules: in vitro disintegration test for soft and hard gelatin capsules. Laboratory-scale filling of hard gelatine capsules (using the Feton apparatus); 4. the studied topic. 5. Granules. Molded tablets. Lozenges -Granules Monographs in the Romanian Pharmacopoeia 10 th edition and Supplement Formulation, laboratory scale preparation of granules by conventional wet granulation method. Industrial and Laboratory-scale magistral examples of granules. preparation of granules; -Quality control of granules, in vitro disintegration test. Molded tablets, lozenges, medicated chocolates formulation, preparation methods, industrial examples. 6. Tablets -Monographs in the Romanian Pharmacopoeia 10 th edition, European Pharmacopoeia 7 th edition. Preparation of tablets by direct compression. Industrial examples. -Evaluation of compression and rheological properties of raw materials used in the preparation of tablets (via direct compression or with prior granulation): particle shape and size, flow speed, angle of repose, apparent volume, bulk density, tapped density of powders and granules. Hausner ratio, Carr index. -Preparation of tablets via indirect compression method: compression of granules obtained by wet granulation; drying, sieving and lubrication of granules. -Coated tablets: types, industrial examples. Quality control of tablets prepared in the laboratory and of industrial products. Disintegration test and dissolution test. 7. Interactions occurring in pharmaceutical dosage forms -Drug interactions and ways of avoiding them. Magistral formulations containing solid industrial products. the studied topic. Laboratory-scale compression of tablets on a single-punch tablet press; the studied topic the studied topic 6 hours 6 hours 9 hours 3 hours Bibliography 1. Delivery Systems. 10th Edition. Allen LV, Ansel HC (editors). Lippincott, Williams & Wilkins, Popovici I, Lupuleasa D. Pharmaceutical Technology. Vol. III. Iasi: Polirom Publishing House, Swarbrick J, Boylan JC. Encylopedia of Pharmaceutical Technology. New York: Ed. M. Dekker Inc., vol. I-IV, ***The Romanian Pharmacopoeia. 10 th Edition and Supplements Bucharest: Medical

6 Publishing House. 9. The agreement between the course contents and the expectations of the representatives of the epistemic communities, professional associations and employers in the field related to the program - Implementing the practical notions in the pharmaceutical compounding activity; - Correlating the theoretical notions with the specific requirements of industrial manufacturing of dosage forms. 10. Assessment Activity Assessment criteria Assessment methods Percentage of the final grade Course Knowledge of the notions Final exam at the end of 50% taught in course the semester; Seminar / Practical Activity of the student Written tests, oral 15% lessons during the semester assessment; Knowledge of the practical notions taught during the lab classes; Final practical exam; 35% Minimal standard of proficiency Promoting the exam with a minimum grade of 5 (on a scale of 1 to 10). Date: Signature of Coordinator for Teaching Activities Prof. Ilena Cojocaru, PhD Assoc. Prof. Gratiela Popa, PhD Lecturer Carmen Gafitanu, PhD Date of indorsement in the Council of the Department Signature of The Department Director Prof. Anca Miron, PhD