TÜRKÇE
ENGLISH
Information
| Code | ECS303 |
| Name | Pharmaceutical Preformulation |
| Term | 2023-2024 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 |
| Mode of study | Yüz Yüze Öğretim |
| Catalog Information Coordinator | Dr. Öğr. Üyesi ESRA DEMİRTÜRK |
| Course Instructor |
Dr. Öğr. Üyesi ESRA DEMİRTÜRK
(A Group)
(Ins. in Charge)
Doç. Dr. UMAY MERVE GÜVEN (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
None
Resources
The United States Pharmacopeia, Güncel Baskı, The United States Pharmacopeial Convention, Inc., Rockville, ABD
Notes
The United States Pharmacopeia, Güncel Baskı, The United States Pharmacopeial Convention, Inc., Rockville, ABD
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 | Bilgi - Kuramsal, Olgusal | Have sufficient knowledge in pharmaceutical field and develop the knowledge. | 4 |
| PLO02 | Bilgi - Kuramsal, Olgusal | Comprehends professional knowledge with ethical responsibility through current laws and legislation. | |
| PLO03 | Beceriler - Bilişsel, Uygulamalı | Provides consultancy service to patients, community and health care personnel and evaluates advanced knowledge and skills with a critical approach. | 4 |
| PLO04 | Beceriler - Bilişsel, Uygulamalı | 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. | 3 |
| PLO05 | Beceriler - Bilişsel, Uygulamalı | Have the knowledge and skills to help provide patient-oriented pharmacy applications and individualized pharmaceutical care by learning the basics of Clinical Pharmacy, | |
| PLO06 | Yetkinlikler - Bağımsız Çalışabilme ve Sorumluluk Alabilme Yetkinliği | Takes a role in the evaluation and analysis of the events and cases related to the development of pharmacy profession and education. | |
| PLO07 | Yetkinlikler - Öğrenme Yetkinliği | Integrates and develops professional knowledge via different disciplines and uses the acquired knowledge to improve the health level and quality of life of the community. | 4 |
| PLO08 | Yetkinlikler - Öğrenme Yetkinliği | Use effectively the concepts and applications of basic sciences and basic medical sciences in the field of medicine and pharmacy and update the information. | |
| PLO09 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Communicates effectively in writing and speaking. | |
| PLO10 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Practices the profession in accordance with Atatürk's principles and reforms, equipped with universal knowledge, uses Turkish correctly and knows at least one foreign language. | |
| PLO11 | Yetkinlikler - İletişim ve Sosyal Yetkinlik | Be an example to society withexternal appearance, demeanor, attitude and behavior for the other professionals and society and with professional identity | 2 |
| PLO12 | Yetkinlikler - Alana Özgü Yetkinlik | Have knowledge about health policies and health economics, pharmacy management and define the problems in pharmaceutical field. | |
| PLO13 | Yetkinlikler - Alana Özgü Yetkinlik | Interprets information about current health and treatment problems and attends meeting on related matters . Plays an active role in community health. | |
| PLO14 | Yetkinlikler - Alana Özgü Yetkinlik | Acquires basic information about diseases, makes decisions about the drugs used in treatment in accordance with rational drug use. |
Week Plan
| Week | Topic | Preparation | Methods |
|---|---|---|---|
| 1 | Drug characterization in preformulation | Observation-Research | Öğretim Yöntemleri: Anlatım |
| 2 | Identification of the physical and chemical properties of the product | Observation-Research | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 3 | Investigation of the pharmacokinetic properties of the drug | Observation-Research | Öğretim Yöntemleri: Anlatım |
| 4 | Choice of pharmaceutical shape and preparation method | Observation-Research | Öğretim Yöntemleri: Anlatım, Soru-Cevap |
| 5 | Quantification methods | Observation-Research | Öğretim Yöntemleri: Anlatım, Bireysel Çalışma |
| 6 | Validation of Quantification methods | Observation-Research | Öğretim Yöntemleri: Anlatım, Bireysel Çalışma |
| 7 | Discussion | Observation-Research | Öğretim Yöntemleri: Anlatım, Bireysel Çalışma |
| 8 | Mid-Term Exam | Observation-Research | Ölçme Yöntemleri: Yazılı Sınav |
| 9 | Licensing of Pharmaceutical Ingredients | Observation-Research | Öğretim Yöntemleri: Anlatım, Bireysel Çalışma |
| 10 | Product quality control | Observation-Research | Öğretim Yöntemleri: Anlatım, Tartışma |
| 11 | Drug stability | Observation-Research | Öğretim Yöntemleri: Anlatım, Tartışma |
| 12 | Product development | Observation-Research | Öğretim Yöntemleri: Anlatım, Tartışma, Bireysel Çalışma |
| 13 | Characterization of developped product | Observation-Research | Öğretim Yöntemleri: Soru-Cevap, Tartışma |
| 14 | presentation | Observation-Research | Öğretim Yöntemleri: Tartışma, Bireysel Çalışma |
| 15 | Discussion 2 | Observation-Research | Öğretim Yöntemleri: Tartışma, Bireysel Çalışma |
| 16 | Term Exams | Subject repetition | Ölçme Yöntemleri: Yazılı Sınav |
| 17 | Term Exams | Subject repetition | Ölçme Yöntemleri: Yazılı Sınav |
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 | ||