Perspective Dosage Forms

Study Course Description

Course Description Statuss:Approved

Course Description Version:5.00

Study Course Accepted:01.09.2022 09:05:14

Study Course Information
Course Code:		ZFTK_011		LQF level:		Level 7
Credit Points:		2.00		ECTS:		3.00
Branch of Science:		Basic Sciences of Medicine, including Pharmacy; Pharmacology		Target Audience:		Pharmacy
Study Course Supervisor
Course Supervisor:		Ilze Bārene
Study Course Implementer
Structural Unit:		Department of Applied Pharmacy
The Head of Structural Unit:
Contacts:		Riga, 16 Dzirciema Street, zftkrsu[pnkts]lv, +371 67061547
Study Course Planning
Full-Time - Semester No.1
Lectures (count)		13	Lecture Length (academic hours)		2	Total Contact Hours of Lectures		26
Classes (count)		3	Class Length (academic hours)		2	Total Contact Hours of Classes		6
Total Contact Hours								32
Part-Time - Semester No.1
Lectures (count)		13	Lecture Length (academic hours)		2	Total Contact Hours of Lectures		26
Classes (count)		3	Class Length (academic hours)		2	Total Contact Hours of Classes		6
Total Contact Hours								32
Study course description
Preliminary Knowledge:
In inorganic and organic chemistry, quantitative analysis, plant and animal biology, mathematics and computer science, physics, physical pharmacy, medical biochemistry, environmental health, microbiology, medicinal chemistry, pharmaceutical chemistry, pharmacognosy with phytopharmacy course, pharmacology. Knowledge of human anatomy, normal physiology and English is desirable.
Objective:
1. To promote knowledge acquisition and forming of understanding of the characteristics and importance of perspective dosage forms. 2. To develop understanding of the role of polymers in prolonging the life of active substances. 3. To develop understanding of the theoretical basis of substance prolongation and its practical relevance for the development of sustained-release medicinal products. 4. To develop understanding of the specifics of the dosage forms used in paediatric practice. 5. To develop understanding of veterinary dosage forms.
Topic Layout (Full-Time)
No.	Topic			Type of Implementation		Number	Venue
1	Characterisation of perspective dosage forms.			Lectures		4.00	auditorium
2	Oral insulin release systems. Excipients – polymers as excipients in dosage form technology.			Lectures		4.00	auditorium
				Classes		1.00	laboratory
3	Prolonging the action of medicinal substances. Characterisation of sustained-release dosage forms.			Lectures		3.00	auditorium
				Classes		1.00	laboratory
4	Paediatric dosage forms.			Lectures		1.00	auditorium
				Classes		1.00	laboratory
5	Characterisation of veterinary dosage forms.			Lectures		1.00	auditorium
Topic Layout (Part-Time)
No.	Topic			Type of Implementation		Number	Venue
1	Characterisation of perspective dosage forms.			Lectures		4.00	auditorium
2	Oral insulin release systems. Excipients – polymers as excipients in dosage form technology.			Lectures		4.00	auditorium
				Classes		1.00	laboratory
3	Prolonging the action of medicinal substances. Characterisation of sustained-release dosage forms.			Lectures		3.00	auditorium
				Classes		1.00	laboratory
4	Paediatric dosage forms.			Lectures		1.00	auditorium
				Classes		1.00	laboratory
5	Characterisation of veterinary dosage forms.			Lectures		1.00	auditorium
Assessment
Unaided Work:
Individual work – solving situations, according to the topics of the study course.
Assessment Criteria:
Examination: • final examination – solving situations at the end of the semester.
Final Examination (Full-Time):		Exam (Written)
Final Examination (Part-Time):		Exam (Written)
Learning Outcomes
Knowledge:		After successful fulfilment of the requirements of the study course students will have mastered knowledge, which will allow: 1. To understand the basic principles of sustained-release dosage formulation. 2. To describe the polymers used in the preparation of sustained-release dosage forms. 3. To describe the quality of sustained-release dosage forms in accordance with the requirements of laws and regulations. 4. To understand the specific approach to the development of paediatric dosage forms. 5. To describe the specific nature of veterinary medicinal products.
Skills:		As a result of completing the study course, students will be able: 1. To evaluate the physical, chemical and functional properties of excipient-polymers and their use in the preparation of paediatric dosage forms and sustained-release medicinal products. 2. To evaluate technological methods in the preparation of paediatric dosage forms. 3. To evaluate the quality of dosage forms according to the requirements of the European Pharmacopoeia. 4. To present the results of one’s practical work correctly.
Competencies:		As a result of completing the study course, students will be able to appreciate the role of polymers and technological achievements in the development and formulation of sustained-release dosage forms and paediatric dosage forms.
Bibliography
No.	Reference
Required Reading
1	Aulton, M. E. and Taylor, K. 2022. Aulton's pharmaceutics: The design and manufacture of medicines / edited by Michael E. Aulton and Kevin M.G. Taylor. 4th ed. Edinburgh, [etc.]: Churchill Livingstone/Elsevier.
2	Rowe, R. C. 2020. Handbook of pharmaceutical excipients / edited by Raymond C. Rowe [et al.]. 7th ed. London; Philadelphia: Pharmaceutical Press; Washington, DC: American Pharmaceutical Association.
3	European Directorate for the Quality of Medicines and Healthcare. 2016. European pharmacopoeia. 9th ed. Strasbourg: Council of Europe.
4	Florence, A. T. 2016. Physicochemical principles of pharmacy: In manufacture, formulation and clinical use / Alexander T. Florence and David Attwood. 6th ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).
5	Fox Shelley Chambers. 2014. Pharmaceutics. London
6	Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. 2nd ed. London: Pharmaceutical Press.
Additional Reading
1	Pharmaceutical Capsules. 2nd ed. 2004. Edited by Fridrun Podczeck. 288 pp.
2	Loyd Allen Jr. 2008. Suppositories. 256 pp.
3	Labarre, D. J. P. 2011. Biomedical and pharmaceutical polymers / Denis J.-P. Labarre, Gilles Ponchel, Christine Vauthier. 1st ed. London; Chicago: Pharmaceutical Press.
4	David Jones. 2008. Pharmaceutics-Dosage Form and Design. 286 pp.
5	Adrian C. Williams. 2003. Transdermal and Topical Drug Delivery. 256 pp.
6	Gibson, M. 2009. Pharmaceutical preformulation and formulation: A practical guide from candidate drug selection to commercial dosage form / edited by Mark Gibson. 2nd ed. Boca Ration: CRC Press, Taylor and Francis Group.
7	Sandle, T. 2013. Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations / Tim Sandle. 1st ed. Philadelphia, PA: Woodhead Publishing.
Other Information Sources
1	Eiropas Zāļu Aģentūras (EMA) izdotas vadlīnijas
2	LR Ministru kabineta noteikumi Nr. 600 "Veterināro zāļu reģistrēšanas kārtība".
3	ICH Topic E 11 Clinical Investigation of Medicinal Products in the Paediatric Population
4	Guideline on pharmaceutical development of medicines for paediatric use EMA/CHMP/QWP/805880/2012 Rev.2
5	Ārvalstu studentiem/For international students
6	ICH Topic E 11 Clinical Investigation of Medicinal Products in the Paediatric Population
7	Guideline on pharmaceutical development of medicines for paediatric use EMA/CHMP/QWP/805880/2012 Rev.2