Veidlapa Nr. M-3 (8)

Course Description Status: Approved

Course Description Version: 25/26.P.3.00

Description Period: 2025./26 academic year pavasara semestris

Study Course Accepted: -

Study Course Description

Industrial Dosage Form Technologies and Placement

Main Study Course Information

Course Code
LFK_028
Branch of Science
Basic medicine; Technology of Drug Forms
ECTS
12.00
Target Audience
Pharmacy
LQF
Level 7
Study Type And Form
Full-Time

Study Course Implementer

Course Supervisor
Beāta Denisa
Structure Unit Manager
Baiba Mauriņa
Structural Unit
Department of Applied Pharmacy
Contacts

Riga, 21 Consula Street, lfk@rsu.lv, +371 67061547

About Study Course

Objective

1. Encourage acquisition of knowledge and formation of understanding about theoretical bases and practical methods of development, manufacturing, quality evaluation of dosage forms. 2. Encourage acquisition of practical skills in preparation and quality evaluation of dosage forms. 3. To gain insight into the requirements of good manufacturing practice, environmental and occupational safety requirements, and the production of finished dosage forms in a pharmaceutical company or RSU Final dosage form laboratory

Preliminary Knowledge

Inorganic, Organic, Pharmaceutical Chemistry, Quantitative Analysis, Plant and Animal Biology, Mathematics, Informatics, Physics, Physical Pharmacy, Medical Biochemistry, Environmental health, Microbiology, Medical chemistry, Pharmaceutical chemistry Pharmacognosy, Pharmaceutical Pharmacology, Pharmacotherapy. Desirable knowledge in Human Anatomy, Normal Physiology, English.

Learning Outcomes

Knowledge

1.Understand the process of dosage form development

Individual work and tests

Documentation of Laboratory Work (protocol writing) • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Colloquium: Spirtometry, phytopharmaceuticals • Practice in 2 or more pharmaceutical companies • Colloquium: solid dosage forms (powders, granules, tablets) • Colloquium: solid dosage forms (capsules, sticks) • Colloquium: rectal drug form; semi-solid drug form • Exam

2.Understand the theoretical principles of the manufacture of pharmaceutical dosage forms.

Individual work and tests

Exam • Colloquium: rectal drug form; semi-solid drug form • Colloquium: solid dosage forms (capsules, sticks) • Colloquium: solid dosage forms (powders, granules, tablets) • Tasks on different concentrations of solutions, preparation of statements, mass balance, load and settings of production equipment. • Colloquium: Spirtometry, phytopharmaceuticals • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Documentation of Laboratory Work (protocol writing)

3.To characterize the quality of pharmaceutical dosage forms in accordance with the regulatory requirements

Individual work and tests

Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Documentation of Laboratory Work (protocol writing) • Colloquium: Spirtometry, phytopharmaceuticals • Colloquium: solid dosage forms (powders, granules, tablets) • Colloquium: solid dosage forms (capsules, sticks) • Colloquium: rectal drug form; semi-solid drug form • Exam

4.Knowledge of the requirements of good manufacturing practice in a pharmaceutical company.

Individual work and tests

Exam • Practice in 2 or more pharmaceutical companies • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Documentation of Laboratory Work (protocol writing)

5.Knowledge of environmental and labour protection requirements in a pharmaceutical company.

Individual work and tests

Practice in 2 or more pharmaceutical companies • Exam

Skills

1.As a result of the completion of the study course, students will be able to apply knowledge of the functional properties of excipients in the development of pharmaceutical dosage forms.

Individual work and tests

Colloquium: solid dosage forms (powders, granules, tablets) • Colloquium: solid dosage forms (capsules, sticks) • Exam • Colloquium: rectal drug form; semi-solid drug form • Documentation of Laboratory Work (protocol writing) • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Colloquium: Spirtometry, phytopharmaceuticals

2.As a result of the completion of the study course, students will be able to use technological techniques in the preparation of pharmaceutical dosage forms.

Individual work and tests

Colloquium: Spirtometry, phytopharmaceuticals • Tasks on different concentrations of solutions, preparation of statements, mass balance, load and settings of production equipment. • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Documentation of Laboratory Work (protocol writing) • Colloquium: rectal drug form; semi-solid drug form • Exam • Colloquium: solid dosage forms (capsules, sticks) • Colloquium: solid dosage forms (powders, granules, tablets)

3.As a result of the completion of the study course, students will be able to calculate the quantities of raw materials for the preparation of pharmaceutical dosage form.

Individual work and tests

Colloquium: solid dosage forms (powders, granules, tablets) • Colloquium: rectal drug form; semi-solid drug form • Colloquium: solid dosage forms (capsules, sticks) • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Documentation of Laboratory Work (protocol writing) • Tasks on different concentrations of solutions, preparation of statements, mass balance, load and settings of production equipment. • Colloquium: Spirtometry, phytopharmaceuticals • Exam

4.As a result of the completion of the study course, students will be able to establish a manufacturing process flow diagram and describe the manufacturing process steps.

Individual work and tests

Exam • Colloquium: Spirtometry, phytopharmaceuticals • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Documentation of Laboratory Work (protocol writing) • Colloquium: solid dosage forms (capsules, sticks) • Colloquium: rectal drug form; semi-solid drug form • Colloquium: solid dosage forms (powders, granules, tablets)

5.As a result of the completion of the study course, students will be able to perform quality evaluation of pharmaceutical dosage forms in accordance with the requirements of the European Pharmacopoeia.

Individual work and tests

Colloquium: solid dosage forms (powders, granules, tablets) • Colloquium: rectal drug form; semi-solid drug form • Colloquium: solid dosage forms (capsules, sticks) • Documentation of Laboratory Work (protocol writing) • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Colloquium: Spirtometry, phytopharmaceuticals • Exam

6.As a result of the completion of the study course, students will be able to correctly record and present the results of their practical work in accordance with the requirements of Good Manufacturing Practice.

Individual work and tests

Exam • Documentation of Laboratory Work (protocol writing) • Practice in 2 or more pharmaceutical companies

7.As a result of the completion of the study course, students will be able to comply with labour protection requirements in the pharmaceutical company.

Individual work and tests

Practice in 2 or more pharmaceutical companies • Exam

Competences

1.As a result of the completion of the study course, students will be able to assess the importance and usage of theoretical basic principles of final dosage form production.

Individual work and tests

Documentation of Laboratory Work (protocol writing) • Colloquium: solid dosage forms (powders, granules, tablets) • Colloquium: solid dosage forms (capsules, sticks) • Colloquium: rectal drug form; semi-solid drug form • Exam • Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms • Tasks on different concentrations of solutions, preparation of statements, mass balance, load and settings of production equipment. • Colloquium: Spirtometry, phytopharmaceuticals

2.As a result of the internship, students will be able to supplement the theoretical knowledge gained in the study course about equipment and technological processes with their practical application in manufacturing.

Individual work and tests

Practice in 2 or more pharmaceutical companies

Assessment

Individual work

Title
% from total grade
Grade
1.

Documentation of Laboratory Work (protocol writing)
0.00% from total grade
Test

Documentation of laboratory work (protocol), recording of the obtained results and providing answers to the questions about the theory of pharmaceutical technology.
2.

Tasks on different concentrations of solutions, preparation of statements, mass balance, load and settings of production equipment.
-
Test

Independent Calculations
3.

Practice in 2 or more pharmaceutical companies
-
Test

Introduction to Latvian pharmaceutical, dietary supplement, or cosmetics manufacturing companies

  • Production documentation, its types, and significance. Batch release (Regulatory. Recording. Reporting. Work of the Qualified Person in manufacturing.)
  • Raw materials and packaging materials, their flow and storage. (Warehouse, its zoning, climate maintenance and monitoring. Receipt, issuance, return of materials. Control. Statuses.)
  • Bulk preparation (Weighing. Dry mixing. Wet granulation. Dusting. In‑process control.)
  • Tablet manufacturing process (Tableting. Equipment and tooling. Tablet coating process. In‑process control.)
  • Packaging of oral dosage forms – primary (blistering, bottle filling) and secondary (cartoning).
  • Types of packaging materials. Manufacturing premises (Requirements. Classification. Air handling. Monitoring.)
  • Organization of flows in manufacturing and their importance (Personnel flow. Raw material and material flow. Production waste flow. Airlocks.)
  • Manufacture of cytotoxic products. Capsule filling process. (Requirements for cytotoxic product manufacturing. Hard gelatin capsules. Types of capsule filling, equipment. In‑process control.)
  • Ointment manufacturing process. (Including product filling and packaging. In‑process control.)
  • Manufacture of ethanol‑containing gels (Requirements and solutions for premises and equipment. Purified water, its production, distribution, and quality control.)

Examination

Title
% from total grade
Grade
1.

Colloquium: introduction and good manufacturing practice; solutions and liquids; sterile dosage forms
10.00% from total grade
10 points

Test with 20 questions, 1 correct answer possible.
2.

Colloquium: Spirtometry, phytopharmaceuticals
10.00% from total grade
10 points

Test with 20 questions, 1 correct answer possible.
3.

Semester counting
-
Test

Automatically credited if all tasks, protocols and successful colloquial grades (for the relevant semester) have been credited to the offset date.
4.

Colloquium: solid dosage forms (powders, granules, tablets)
10.00% from total grade
10 points

Test with 20 questions, 1 correct answer possible.
5.

Colloquium: solid dosage forms (capsules, sticks)
10.00% from total grade
10 points

Test with 20 questions, 1 correct answer possible.
6.

Colloquium: rectal drug form; semi-solid drug form
10.00% from total grade
10 points

Test with 20 questions, 1 correct answer possible.
7.

Semester report (II)
-
Test

Automatically credited if all tasks, protocols and successful colloquial grades (for the relevant semester) have been credited to the offset date.
8.

Exam
50.00% from total grade
10 points

If the average score in colloquiums before rounding is 8 or higher (taking colloquiums with the first time), the test score is equal to the average colloquial score (100% cumulative score).

If the average score in colloquiums before rounding is below 8 points, the exam shall be taken in the form of a test giving 50% of the final score and 50% shall be compiled by the average colloquial score.

Study Course Theme Plan

FULL-TIME
Part 1

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Dosage forms' classification and characterisation. Guidelines on dosage forms' development. Classification and characterisation of the main processes of pharmaceutical technology.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Basic rules for industrial production of medicinal products. Good Manufacturing Practice (GMP).
European Pharmacopoeia.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Extraction preparations. Herbals as porous materials for extraction. Factors affecting the extraction process. Assortment and characterisation of solvents. Methods of extraction. Apparatus and devices to be used for extraction. Herbal teas. Preparations of fresh plant material.
Classification of tinctures. The technological process of tincture and methods of extraction. Classification of extracts. Technological process of liquid extracts, thick and dry extracts. Hardware. Maximum purified phytopreparations. Characterisation of the extractive and purification process. Removal of individual active substances from plant material.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Solutions. Liquid pharmaceutical forms.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Parenteral dosage forms. Quality indicators of parenterals.
Technological process of manufacturing parenteral medicinal products. Preparation of containers for parenteral medicinal products. Preparation, stabilising, purification of injection solutions. Preparation of suspensions, emulsions, liophile dried powders. Process of filling the solution.
Description of the sterilization methods. Machines for sterilizing air, fluids and dry substances. Sterility test. Pyrogenic substances and bacterial endotoxins. Ophthalmic dosage forms.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Pharmaceutical excipients characterisation. Characterisation of packing materials for dosage forms.
Stabilising pharmaceutical forms. Study stability and timing of active substances and dosage forms. Packaging of medicinal products. Labelling of dosage forms.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Pharmaceutical excipients characterisation. Characterisation of packing materials for dosage forms.
Stabilising pharmaceutical forms. Study stability and timing of active substances and dosage forms. Packaging of medicinal products. Labelling of dosage forms.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Pharmaceutical excipients characterisation. Characterisation of packing materials for dosage forms.
Stabilising pharmaceutical forms. Study stability and timing of active substances and dosage forms. Packaging of medicinal products. Labelling of dosage forms.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Solid pharmaceutical forms. Powders, granules and their preparation technology. Quality control. Tablets. Classification of tablets, measurement of tablet quality. Theoretical justification of tablets preparation. Excipients for the preparation of tablets.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

The technological process of tablets manufacturing. Tablet presses, their description. Packing of tablets. Characteristics and preparation technology of moulded tablets.
Coated tablets. Description of excipients to be used for couting. Tablets coating technology. The technology for making dragee and pellets.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Medical capsules

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Medical sticks
Rectal and vaginal dosage forms.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Dispersible systems. Preparation and quality testing of emulsions and suspensions. Aerosols. Propellents characterisation. Aerosol technology and quality testing.

  1. Video Lecture

Modality
Location
Contact hours
Off site
Video
2

Topics

Semi-solid dosage forms.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Solutions. Liquid pharmaceutical forms.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Solutions. Liquid pharmaceutical forms.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Alcoholimetry.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Extraction preparations. Herbals as porous materials for extraction. Factors affecting the extraction process. Assortment and characterisation of solvents. Methods of extraction. Apparatus and devices to be used for extraction. Herbal teas. Preparations of fresh plant material.
Classification of tinctures. The technological process of tincture and methods of extraction. Classification of extracts. Technological process of liquid extracts, thick and dry extracts. Hardware. Maximum purified phytopreparations. Characterisation of the extractive and purification process. Removal of individual active substances from plant material.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Extraction preparations. Herbals as porous materials for extraction. Factors affecting the extraction process. Assortment and characterisation of solvents. Methods of extraction. Apparatus and devices to be used for extraction. Herbal teas. Preparations of fresh plant material.
Classification of tinctures. The technological process of tincture and methods of extraction. Classification of extracts. Technological process of liquid extracts, thick and dry extracts. Hardware. Maximum purified phytopreparations. Characterisation of the extractive and purification process. Removal of individual active substances from plant material.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Extraction preparations. Herbals as porous materials for extraction. Factors affecting the extraction process. Assortment and characterisation of solvents. Methods of extraction. Apparatus and devices to be used for extraction. Herbal teas. Preparations of fresh plant material.
Classification of tinctures. The technological process of tincture and methods of extraction. Classification of extracts. Technological process of liquid extracts, thick and dry extracts. Hardware. Maximum purified phytopreparations. Characterisation of the extractive and purification process. Removal of individual active substances from plant material.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Extraction preparations. Herbals as porous materials for extraction. Factors affecting the extraction process. Assortment and characterisation of solvents. Methods of extraction. Apparatus and devices to be used for extraction. Herbal teas. Preparations of fresh plant material.
Classification of tinctures. The technological process of tincture and methods of extraction. Classification of extracts. Technological process of liquid extracts, thick and dry extracts. Hardware. Maximum purified phytopreparations. Characterisation of the extractive and purification process. Removal of individual active substances from plant material.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Medical sticks

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Medical sticks
Total ECTS (Creditpoints):
6.00
Contact hours:
64 Academic Hours
Final Examination:
Test (Semester)
Part 2

  1. Class/Seminar

Modality
Location
Contact hours
On site
Study room
4

Topics

Solid pharmaceutical forms. Powders, granules and their preparation technology. Quality control. Tablets. Classification of tablets, measurement of tablet quality. Theoretical justification of tablets preparation. Excipients for the preparation of tablets.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Study room
4

Topics

Solid pharmaceutical forms. Powders, granules and their preparation technology. Quality control. Tablets. Classification of tablets, measurement of tablet quality. Theoretical justification of tablets preparation. Excipients for the preparation of tablets.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Study room
4

Topics

The technological process of tablets manufacturing. Tablet presses, their description. Packing of tablets. Characteristics and preparation technology of moulded tablets.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Study room
4

Topics

The technological process of tablets manufacturing. Tablet presses, their description. Packing of tablets. Characteristics and preparation technology of moulded tablets.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Medical capsules

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Medical capsules

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

The nature and importance of biopharmacy in dosage form technology. Description of methods for evaluating the biological usefulness of dosage forms.
Food and drug interaction. Exposure of food products to excretion of active substances from the formulation, absorption, biotransport and elimination.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

The nature and importance of biopharmacy in dosage form technology. Description of methods for evaluating the biological usefulness of dosage forms.
Food and drug interaction. Exposure of food products to excretion of active substances from the formulation, absorption, biotransport and elimination.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Rectal and vaginal dosage forms.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Semi-solid dosage forms.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Semi-solid dosage forms.

  1. Class/Seminar

Modality
Location
Contact hours
On site
Laboratory
4

Topics

Excursion to RSU Final Dosage Form Laboratory

  1. Placement

Modality
Location
Contact hours
On site
Placement location
8

Topics

Placement - excursion to pharmaceutical company

  1. Placement

Modality
Location
Contact hours
On site
Placement location
8

Topics

Placement - excursion to pharmaceutical company

  1. Placement

Modality
Location
Contact hours
On site
Study room
8

Topics

Solutions. Liquid pharmaceutical forms.
Placement - excursion to pharmaceutical company
Total ECTS (Creditpoints):
6.00
Contact hours:
48 Academic Hours
Final Examination:
Exam (Written)

Bibliography

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.Suitable for English stream

2.

European Directorate for the Quality of Medicines and Healthcare. 2019-2021. European pharmacopoeia. 10th ed. Strasbourg: Council of Europe.Suitable for English stream

3.

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).Suitable for English stream

4.

Fox, S. C. 2014. Pharmaceutics / Shelley Chambers Fox. 1st ed. London: Pharmaceutical Press. Available from: via Ebook Central (ProQuest).Suitable for English stream

5.

Jones, D. 2016. Pharmaceutics - dosage form and design / David Jones. Second ed. London: Pharmaceutical Press.Suitable for English stream

6.

Rowe, R. C. 2020. Handbook of pharmaceutical excipients / edited by Raymond C. Rowe [et al.] London; Philadelphia: Pharmaceutical Press; Washington, DC: American Pharmaceutical Association.Suitable for English stream

7.

Prakses programma

Additional Reading

1.

Allen, L. V. 2020. Suppositories / Loyd V. Allen, Jr, with contributions by Dennis B. Worthen, and Bill Mink. London; Chicago: Pharmaceutical Press.Suitable for English stream

2.

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.Suitable for English stream

3.

Labarre, D. J. P. 2011. Biomedical and pharmaceutical polymers / Denis J.-P. Labarre, Gilles Ponchel, Christine Vauthier. 1st ed. London; Chicago: Pharmaceutical Press.Suitable for English stream

4.

Sandle, T. 2013. Sterility, sterilisation and sterility assurance for pharmaceuticals: Technology, validation and current regulations / Tim Sandle. 1st ed. Philadelphia, PA: Woodhead Publishing.Suitable for English stream