46-PHARMACEUTICAL TECHNOLOGY UNIT OPERATIONS
Aims of the course: Basic knowledge of the design and operation of pharmaceutical
units and of the steps of development of dosage forms through to the final product
and submission to the Health authorities for Production licence and marketing.
The concept and the importance of particle size and particle shape in drug formulation.
Understanding of the mechanism of basic pharmaceutical operations including size
reduction, mixing, separation processes, filtration, drying and freeze-drying, its
importance in drug formulation and practical application on a laboratory scale. The
teaching with lecture presentation is enhanced with practical classes using drugs and
excipients of pharmaceutical specifications.
Skills: Familiarisation with basic pharmaceutical processes and application of the
knowledge to solve formulation problems on a laboratory scale.
Teaching methods:
Power point lecture presentations, demonstrations and practical classes
Contents of the course: The design and operation of pharmaceutical industry.
Development of pharmaceutical dosage forms. Production licence. Basic
pharmaceutical operations. Size reduction – Mechanism, material properties, energy
considerations, specific cases. Methods and milling equipment. Size distribution of the
productand changes during milling. Mechanical separation of particles. Methods,
assessment of efficiency. Separation from air with sieving, aerodynamic classification,
sedimentation, elutriation. Filtration and factors that affect the filtration rate,
mechanisms and filtration means. Mixing of powdered materials – Mechanism of
random mixing and interactive mixing. Sampling techniques, size and mixing indices.
Factors affecting the mixing process. Types, characteristics and operation of mixers.
Drying- Definitions. Measurement of relative humidity. Theory of drying, movement of
liquid during drying, mechanism of heat transfer, drying periods, equilibrium moisture
and influence of material. Dryers. Freeze drying – Principles of freeze-drying and
applications in Pharmacy.
The practical classes involve the processes of Particle size analysis by sieving and
air permeability, size reduction, mixing and drying. Computers and appropriate
software are used for data processing.
Proposed literature:
- I. Nikolakakis Lecture notes on Pharmaceutical Unit Operations (2010). They are
aupdated every year and are made available in the internet through the Blackboard.
- T. Allen. Particle Size Measurement, 3rd edition Chapman and Hall, 1981
Aulton M.E. (editor) Pharmaceutics The Science of Dosage Form Design Churchill
Livingstone 2nd edition, 2002.
Educational activities:
Lectures and practical classes. The main goals of the subject are to understand the
concept of particle size and its measurement. The understanding of basic processes
applied in the production of medicines. The purpose of laboratory classed is to
familiarise the students with the above processes.
Evaluation process and methods:
Sitting 3h examination at the end of Semester. Evaluation is based on the student
response in writing on 5-6 topics plus 1-2 questions/problems from laboratory work.
Results are disclosed and shown on notice board of The Department within 1-2
weeks from the examination. Before sitting the exam the student completes a
written detailed report on the work conducted in the practical classes
Use of ICTs (Information and Communication Technologies) / Electronic
distribution of the lectures
The lectures and tuition presentations are delivered using Powerpoint, video
presentations etc.)
Teaching:
A) Lectures.
They are 3h presentations once a week in Room D12 of Physics Dept and delivered
via electronic means. Teaching material including overhead projections and
PowerPoint slides, lecture notes (150 pages) and Laboratory Class manual are
available to the students via the Blackboard program operated by the University
Library.
Lecture
1
2
Title
Pharmaceutical industry
Particle size analysis, particle diameters and
shape
Tutor
I. Nikolakakis
I. Nikolakakis
3
I. Nikolakakis
10
Size distributions and particle size analysis
methods
. Size reduction – possible influence of
crystallinity and fracture mechanism
Size reduction – description and operation of
mills
Mechanical
separation
of
particles
and
evaluation of the efficiency of the process –
Aerodynamic classifiers, separation in gas and
liquid medium. Filtration and factors that affect,
mecahanisms and equipment
Powder mixing – Mechanism of random and
interactive mixing. Sampling, sample size and
mixing indices
Factors affecting the result of mixing process
Drying –Definitions. Measurement of relative
humidity.
Drying
theory,
heat
transfer,
movement of water through the powder during
drying, drying periods, moisture content
Dryers – Characteristics and operation
11
Freeze drying – Characteristics and operation
12
Supercritical fluids I
D. Fatouros
13
Supercritical fluids II
D. Fatouros
4
5
6
7
8
9
I. Nikolakakis
I. Nikolakakis
I. Nikolakakis
I. Nikolak
Nikolakakis
akis
I.
I. Nikolakakis
I. Nikolakakis
Β) Laboratory work
Laborato
ry
1
2
3
4
Title
Tutor
Size reduction and size analysis by analytical sieves I.I.Nikolaka
kis
and air-permeametry
Powder mixing
D.
Fatouros
Drying of lactose granules
I.Nikolakaki
s
Size analysis by Sedimentation - Andreassen I.Nikolaka
Pipette
kis
c) Tutorials
Tutorial
1
Title
Calculations involved in the laboratory classes.
Discussion of the results
Tutor