Learning objectives
The aim of the course is to provide students with theoretical knowledge of the fundamental properties of the active ingredients that influence the choice of pharmaceutical form and formulation, as well as the methods for their experimental determination. The emphasis of the course is also placed on the derived properties and methods for their determination both in reference to the active ingredient and in combination with the excipients. These properties in fact represent the foundation at the base of the correct formulation development.
The expected learning outcomes are:
1. Knowledge and understanding: Knowledge of the fundamental elements for formulation development.
2. Applying knowledge and understanding: Ability to independently apply the acquired knowledge to identify the preparation methods and excipients suitable for the development of a given dosage form.
3. Communication skills: Ability to use the specific language of this specialized discipline.
4. Making judgments: Critical ability to face formulation choices based on objective and measurable data. Ability to evaluate the implications and results of preformulation studies on the characteristics of the pharmaceutical form.
5. Learning skills: Ability to use the knowledge and basic elements for exercising the profession of pharmaceutical formulator. Ability to update, with the consultation of scientific publications in the field of pharmaceutical-technological-application disciplines.
Prerequisites
It is suggested to attend the course after having already passed the general chemistry, organic chemistry and drug analysis exams
Course unit content
The transformation of an active ingredient into to a medicinal product involves a preformulation step, a formulation step and a control step. The course deals with the first step, i.e. the study of the chemical-physical characteristics of the active ingredients as well as of the excipients associated with them in order to obtain a finished formulation (medicinal) suitable for the therapeutic purpose, stable, and that can be produced in a reliable, repeatable and industrially acceptable way.
Full programme
Fundamental properties of the active ingredient
Solubility
Coefficient of dissociation
Partition coefficient
Experimental determination
Salts
Derived properties
Properties of the solid-state thermodynamic aspects and measurement methods and techniques
Compressibility Compactability and compressibility
Solid fraction / compression force equations
Drug / excipient compatibility
Stability
Bibliography
PHARMACEUTICAL PREFORMULATION the physicochemical properties of drug substances James Wells - Ellis Horwood Limited 1988.
AULTON PHARMACEUTICAL TECHNOLOGIES The design and manufacture of Medicines. Elsevier 2013
Teaching methods
The course will be carried out through frontal lessons
Assessment methods and criteria
To achieve a positive assessment, the student must demonstrate to have understood, and to be able to use, the fundamental concepts of each topic by taking an oral exam, in the appeals of the official exam calendar of the Department of Food and Drug Sciences
The evaluation, expressed as eligibility, will be carried out based on the following criteria:
1. knowledge and capacity for theoretical and applicative understanding of the topics studied;
2. autonomy of judgment and ability to connect between the topics studied;
3. communication skills and appropriateness in the use of technical language;
4. learning ability.
Other information
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