TÜRKÇE
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Information
| Unit | FACULTY OF PHARMACY |
| PHARMACY PR. | |
| Code | ECS303 |
| Name | Pharmaceutical Preformulation |
| Term | 2021-2022 Academic Year |
| Semester | 5. Semester |
| Duration (T+A) | 2-0 (T-A) (17 Week) |
| ECTS | 2 ECTS |
| National Credit | 2 National Credit |
| Teaching Language | Türkçe |
| Level | Lisans Dersi |
| Type | Normal |
| Label | E Elective |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | Dr. Öğr. Üyesi ESRA DEMİRTÜRK |
| Course Instructor |
Dr. Öğr. Üyesi ESRA DEMİRTÜRK
(Güz)
(A Group)
(Ins. in Charge)
Doç. Dr. UMAY MERVE GÜVEN BÖLGEN (Güz) (A Group) (Asst. Ins.) |
Course Goal / Objective
Learn basic information about preformulation and quality assurance.
Course Content
Definition and importance of preformulation, investigation of organoleptic properties, particle size, shape and surface area, solubility, rate of dissolution, parameters affecting absorption, crystal properties and polymers, stability, incompatibility tests, quality assurance system, GMP, validation, analytical method validation
Course Precondition
Resources
Notes
Course Learning Outcomes
| Order | Course Learning Outcomes |
|---|---|
| LO01 | Evaluates basic regulations on drug characterization in preformulation. |
| LO02 | Know the parameters of the specifications of the formulation. |
| LO03 | Describe the methods of quantification of the developed formulation. |
| LO04 | Knows the properties of the active substance to be evaluated in formulation development. |
| LO05 | Defines the parameters that should be considered in choosing the appropriate pharmaceutical dosage form. |
| LO06 | To have knowledge about quality and quality assurance in medicine. |
Relation with Program Learning Outcome
| Order | Type | Program Learning Outcomes | Level |
|---|---|---|---|
| PLO01 | - | Have sufficient knowledge in pharmaceutical field and develop the knowledge gained. | 5 |
| PLO02 | - | Applies the profession in accordance with the existing laws and regulations,gains awareness of professional and ethical responsibility. | 3 |
| PLO03 | - | It serves the society as a pharmacist who is loyal to Atatürk's principles and reforms, equipped with Universal Knowledge, who uses Turkish correctly and knows at least one foreign language. | 3 |
| PLO04 | - | Communicates effectively both orally and in writing. | 5 |
| PLO05 | - | External appearance, attitude, attitude and behavior, with professional identity, role model and society becomes an example to colleagues. | 2 |
| PLO06 | - | Provides consultancy services to patients, community and health care personnel with a wide range of information on the drug,evaluates advanced knowledge and skills with a critical approach. | 5 |
| PLO07 | - | Possessing the knowledge of historical and current developments in the field of Pharmacy, monitoring, evaluation and application of scientific and evidence-based data, and adopting lifelong learning. | 2 |
| PLO08 | - | Have knowledge about health policies and health economics, pharmacy management and define the problems in pharmaceutical field. | 2 |
| PLO09 | - | Interprets information about current health and treatment problems. Plays an active role in community health. | 0 |
| PLO10 | - | Pharmacy integrates and develops professional knowledge with information from different disciplines and uses the acquired knowledge to improve the health level and quality of life of the community. | 4 |
| PLO11 | - | Students will be able to use the concepts and applications of basic sciences and basic medical sciences effectively in the field of Medicine and pharmacy and have the experience of working with these health sciences. | 0 |
| PLO12 | - | Acquires basic information about diseases, adopts and applies rational drug use on all drugs that affect systems. | 0 |
| PLO13 | - | By learning the basics of Clinical Pharmacy,will have the knowledge and skills to help provide drug/patient oriented pharmacy applications and individualized Pharmaceutical Care. | 0 |
| PLO14 | - | It plays a role in the evaluation and analysis of the events and cases related to the development of pharmacy profession and education. | 3 |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Drug characterization in preformulation | Observation-Research | |
| 2 | Identification of the physical and chemical properties of the product | Observation-Research | |
| 3 | Investigation of the pharmacokinetic properties of the drug | Observation-Research | |
| 4 | Choice of pharmaceutical shape and preparation method | Observation-Research | |
| 5 | Quantification methods | Observation-Research | |
| 6 | Validation of Quantification methods | Observation-Research | |
| 7 | Discussion | Observation-Research | |
| 8 | Mid-Term Exam | Observation-Research | |
| 9 | Licensing of Pharmaceutical Ingredients | Observation-Research | |
| 10 | Product quality control | Observation-Research | |
| 11 | Drug stability | Observation-Research | |
| 12 | Product development | Observation-Research | |
| 13 | Characterization of developped product | Observation-Research | |
| 14 | presentation | Observation-Research | |
| 15 | Discussion | Observation-Research | |
| 16 | Term Exams | Observation-Research | |
| 17 | Term Exams | Observation-Research |
Assessment (Exam) Methods and Criteria
| Assessment Type | Midterm / Year Impact | End of Term / End of Year Impact |
|---|---|---|
| 1. Midterm Exam | 100 | 40 |
| General Assessment | ||
| Midterm / Year Total | 100 | 40 |
| 1. Final Exam | - | 60 |
| Grand Total | - | 100 |
Student Workload - ECTS
| Works | Number | Time (Hour) | Workload (Hour) |
|---|---|---|---|
| Course Related Works | |||
| Class Time (Exam weeks are excluded) | 14 | 2 | 28 |
| Out of Class Study (Preliminary Work, Practice) | 14 | 1 | 14 |
| Assesment Related Works | |||
| Homeworks, Projects, Others | 0 | 0 | 0 |
| Mid-term Exams (Written, Oral, etc.) | 1 | 4 | 4 |
| Final Exam | 1 | 8 | 8 |
| Total Workload (Hour) | 54 | ||
| Total Workload / 25 (h) | 2,16 | ||
| ECTS | 2 ECTS | ||