0% found this document useful (0 votes)
60 views26 pages

Pharmaceutical Manufacturing Module Guide

The document is a module guide for the Bachelor of Pharmacy program at the University of Limpopo, focusing on Pharmaceutical Manufacturing for second-year students. It includes a detailed time schedule of learning activities, assessment criteria, module coordinators, and a background philosophy on module construction. The curriculum emphasizes an integrated learning model and aims to promote self-directed learning and interdisciplinary understanding among students.
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd
0% found this document useful (0 votes)
60 views26 pages

Pharmaceutical Manufacturing Module Guide

The document is a module guide for the Bachelor of Pharmacy program at the University of Limpopo, focusing on Pharmaceutical Manufacturing for second-year students. It includes a detailed time schedule of learning activities, assessment criteria, module coordinators, and a background philosophy on module construction. The curriculum emphasizes an integrated learning model and aims to promote self-directed learning and interdisciplinary understanding among students.
Copyright
© All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PDF, TXT or read online on Scribd

DEPARTMENT OF PHARMACY

SCHOOL OF HEALTH SCIENCES

UNIVERSITY OF LIMPOPO (TURFLOOP Campus)

BACHELOR OF PHARMACY

Second Year

Pharmaceutical Manufacturing

MPCC 022

Module Guide
2025

© University of Limpopo (Turfloop Campus) 2025

1
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

CONTENTS

PAGE

1. LEARNING ACTIVITIES 3

2. TIME SCHEDULE 5

3. ASSESSMENT CRITERIA 10

4. MODULE CO-ORDINATORS 10

5. CONSULTATION PROCEDURE 10

6. BACKGROUND PHILOSOPHY TO MODULE 11


CONSTRUCTION

7. AIM OF THE MODULE 17

8. TOPICS, SUB-TOPICS AND LEARNING OBJECTIVES 18

9. RESOURCES 24

2
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

1. TIME SCHEDULE

1st Week (10 June – 14 June)

Date Time Activity Staff

Tuesday 09:00 to 09:30 Introduction to the module Ms Seabi ME

10 June

Wednesday 09:00 to 12:00 Tutorial 1: Introduction to Pharmaceutics Ms Seabi ME

11 June

14:00 to 15:00 Tutorial 2: Physico-Chemical Principles in Class discussion


Formulation

09:00 to 10:00
Thursday Tutorial 3: Powder Flow & Particle Size Ms Seabi ME

12 June
14:00 to 15:00
Tutorial 4: Material Science & Excipients Class discussion

Friday
07:30 to 16:00 Practical Skill 1: Measuring & Calibration Mr Maseko S
13 June

2nd Week (16 June – 21 June)

Date Time Activity Staff

Monday

16 June PUBLIC HOLIDAY

Tuesday 09:00 to 11:30 Workshop 1: Pharmaceutical Mr Chanyandura


Calculations JT
17 June 13:00 to 16:00

Wednesday 08:00 to 16:00 Workshop 2: Pharmaceutical Mr Chanyandura


Calculations JT
18 June

3
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Thursday 09:00 to 16:00 Tutorial 5: Mixing, Blending, Sieving Ms Seabi ME

19 June

Tutorial 6: Powders and granules Class discussion

Friday 07:30 to 16:00 Practical skill 2: Particle size distribution Mr S Maseko

20 June

3rd Week (23 June – 27 June)

Date Time Activity Staff

Monday 09:00 – 10:30 Test 1 Staff

23 June 11:30 to 13:30

Tuesday 09:00 to 12:00 Tutorial 7: Granulation Processes Mr Manyama TL

24 June Tutorial 8: Tablets

Wednesday MID-YEAR RE-ASSESSMENT


BEGINS
25 June

Thursday

26 June

Friday

27 June

4th Week (30 June – 04 July)

Date Time Activity Staff

Monday

30 June

Tuesday 09:00 to 12:00 MID-YEAR RE-ASSESSMENT ENDS

01 July

4
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Wednesday 09:00 to 12:00 Tutorial 9: Capsules (Hard and soft Mr Manyama TL


gelatin)
02 July

Thursday 09:00 to 12:00 Tutorial 10: Coating Mechanisms Mr Manyama TL

03 July

Friday 07:30 to 16:00 Practical skill 3: Flow properties Mr Maseko S

04 July

5th Week (07 July– 11 July)

Date Time Activity Staff

Monday 09:00 to 12:00 Tutorial 11: Creams Ms Seabi ME

07 July 14:00 to 15:00 Tutorial 12: Ointments Class Discussion

Tuesday 09:00 to 12:00 Tutorial 13: Suppositories Ms Seabi ME

08 July 14:00 to 15:00 Tutorial 14: Gels and pastes Class Discussion

Wednesday 09:00 to 12:00 Tutorial 15: Suspensions Ms Seabi ME

09 July 14:00 to 15:00 Tutorial 16: Emulsions & syrups Class Discussion

Thursday 09:00 to 16:00 Tutorial 17: Aerosols Ms Seabi

10 July 14:00 to 15:00 Tutorial 18: Pharmaceutical Packaging Class Discussion

Friday 07:30 to 16:00 Practical skill 4: Preparation of Mr Maseko S


acetaminophen granules and
11 July
compression

6th Week (14 July – 18 July)

Date Time Activity Staff

Monday 09:00 to 10:30 Test 2 Staff

14 July

5
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Tuesday 07:30 to 16:00 Self-study Students

15 July

Wednesday 07:30 to 16:00 Self-Study Students

16 July

Thursday 07:30 to 16:00 Practical skill 5: QC of tablets Mr Maseko S

17 July

Friday 07:30 to 16:00 Practical skill 6: Capsule filling and QC Mr Maseko S


tests
18 July

7th Week (21 July – 25 July)

Date Time Activity Staff

Monday 9h00 to 11:30 Reflection Test 2 Staff

21 July

Tuesday 07:30 to 16:00 Practical skill 7:Manufacturing of Mr Maseko S


acetaminophen syrup and Aqueous
22 July
cream

Wednesday 07:30 to 16:00 Presentations Day 1 Staff

23 July

Thursday 07:30 to 16:00 Presentations Day2 Staff

24 July

Friday 07:30 to 16:00 Practical skill 8: Manufacturing of Students


suppositories
25 July

8th Week (28 July- 01 August)

6
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Monday PREPARATION FOR END OF MODULE EXAM

28 July (Both written and practical exams)

Tuesday All day Self-study Students

29 July

Wednesday
8:00 to 11:00 END OF MODULE EXAM P1 Staff
30 July

Thursday
All day Self-study Students
31 July

Friday
07:30 to 16:30 END OF MODULE EXAM P2 Staff
01 August
(OSPE EXAM)

3. ASESSMENT CRITERIA

TYPE OF ASSESSMENT Percentage of Module mark

1. CONTINUOUS ASSESSMENT

Tutorial quizzes 15%

Short written tests 60%

Practical skills 15%

Assignments (individual and/or group) 10%

TOTAL 60

2. END OF MODULE ASSESSMENT

Objective Structured Practical Examination (OSPE) 40%


(P2)
60%
Written paper (P1)
40
TOTAL

7
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

NOTES ON ASSESSMENT
1. Tutorial quizzes: The quizzes will contain true/false questions, multiple choice questions, short written
questions and calculations.
2. Short written tests: Each test will contain true/false questions, multiple choice questions abbreviations, short
written questions and relevant calculations.
3. Practical skills: Practical reports will be assessed (group and individual).
4. Assignments: Assessment will depend upon the nature and content of the assignment. A group mark or
individual mark will be assigned.
5. End-of-module written paper: The EOM paper will be set in a similar format to that of a short written test.
6. Objective Structured Practical Examination (OSPE): Practical skills and knowledge will be tested, where
the exam contains questions related to the practicals performed and calculations involved in the laboratory
classes.

4. MODULE COORDINATORS
Ms ME Seabi will be the module coordinator; Mr TL Manyama will act as the module co-
coordinator and Mr S Maseko will act as practical’s coordinator.

5. CONSULTATION PROCEDURE
Appointments should be made with staff members on an individual basis. General queries
regarding this module should be directed to Ms Mmakgomo Seabi (O-Block office 1013,
[Link]@[Link] , 0152682181). In her absence consult Mr Manyama at (O-
Block office 1007, [Link]@[Link] 0152684212, Department of pharmacy,
University of Limpopo (TurfLoop). Queries related to practical should be directed to Mr Sfiso
Maseko, in his absence consult Ms Mmakgomo Seabi

6. BACKGROUND PHILOSOPHY TO MODULE CONSTRUCTION

If we observe the process which we call instruction, we see two parties con-jointly engaged
– the leaner and the teacher. The object of both is the same, but their relations to work to
be done are different……..[The] essential part, the appropriation and assimilation of
knowledge by the mind, can be performed by no one but the learner……[from which]… it
follows that he is in fact his own teacher, and….that learning is self-teaching……The
Teacher’s part then in the process of instruction is that of a guide, director, or superintendent
of the operations by which the pupil teaches himself or herself. (Joseph Payne, 1883)

Preamble
The curriculum is modular and attempts shall be made to have it integrated, both
horizontally and vertically as much as possible, given that not everything can be integrated.
There are several views of integrating a curriculum as shown in the following table, that
have been taken into consideration when developing the curriculum for the BPharm Degree
at the University of Limpopo, Turfloop Campus.

8
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Ten views for integrating curriculum

Fragmented Connected

This is the traditional model of separate and In this case each subject area, course content
distinct discipline, which fragments the subject is connected topic to topic, concept to concept,
area. one year’s work to the next, and relates ideas
explicitly
Pharmaceutical chemistry: pharmacognosy,
medicinal chemistry, synthetic chemistry, Physical pharmacy: From atoms to medicine
analytical chemistry

Nested Sequenced

The student within a subject acquires multiple Topics or units of study are rearranged and
skills: a social skill, a thinking skill, and content- sequenced to coincide within one another.
specific skill Similar ideas are taught in concert while
remaining separate subjects
Pharmacy practice/social pharmacy:
Bio-pharmaceutics and Pharmacology or
Pathological science and Pharmacology

Shared Webbed

Shared planning and teaching take place in two A rich theme is webbed to curriculum contents
disciplines in which overlapping concepts or and disciplines; subjects use the theme to sift
ideas emerge as organizing elements out appropriate concepts, topics and ideas.

Physiology of the eye and ocular pharmacology; Rational drug use or Drug utilization (WHO
staff teaching physiology of special senses and definition)
ocular pharmacology can team teach.

Threaded Integrated

In this approach, thinking and social skills, This interdisciplinary approach matches
multiple intelligences, technology, and study subjects for overlaps in topics and concepts
skills are threaded through the various with some team teaching in an authentic
disciplines. A study area related to another integrated model (not quite the same as
subject, but goes beyond it in some way. Shared). In this case more disciplines are
involved after identifying a patterning models
Drug delivery system
and approach content through these patterns

Immersed Networked

The disciplines become part of the student’s The student filters all learning the expert’s eye
lens of expertise: the students filters all content and makes internal connections that lead to
external networks of experts in related fields

9
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

through this lens and becomes immersed in his Industrial pharmacy: while making an effort to
or her own experience understand and to adapt pharmaceutical
technology for product design, the student
Research projects: the student is allowed or
networks with experts in the field and expands
guided to choose an area of expert interest and
her knowledge base
to see all learning through that lens

The intention of the Department of Pharmacy is to adopt international best practice derived
standards set by the Global Federation of Pharmacists and Pharmaceutical Science and
adopted by the South African Pharmacy Council.

Each module content is system based and divided into a number of interdisciplinary blocks
and organized according to basic science. For example, for clinical/pharmacology based
modules, the module content is system based according to the major organ in the body,
and divided into a number of interdisciplinary blocks and organized according to basic
science such as anatomy, biochemistry chemistry and physiology; major disease process
(pathology and pathophysiology), diagnosis and pharmacotherapy and health promotions
planned and taught in a coordinated fashion. The integrity of each subject area, however,
remains intact. This will allow continual growth of knowledge which is problem oriented and
relevant new subject areas without unnecessary addition to the programme.
For the non-clinical based modules e.g. industrial pharmacy, similar concept is also used
where each module content is system based (e.g. good manufacturing practice (GMP) and
divided into a number of interdisciplinary blocks and organized according to basic science
such as mathematics (pharmaceutical calculations), organic chemistry, etc.

In each module a student will be introduced to pharmacy practice experience. This will
involve interactions with other health care professionals, case studies and /or actual clinical
cases within the institutional settings, under appropriate supervision. Clinical skills, where
resources permit, will be interfaced with didactic course work that provides an introduction
to the profession, and continue in a progressive manner leading to entry into the advanced
pharmacy practice experiences in fourth year.

Integrated Learning Model


Modules are developed in accordance with principles of an Integrated Learning Model which
is student centred pedagogy i.e. the activation of self-directed learning that helps the student
make connections across curricula. It attempts to bring together traditionally separate
subjects in Pharmacy so that the student can grasp a more authentic understanding and

10
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

helps the student to slowly transit from studying example to solving problems without
academic overload. The student, in order to demonstrate interdisciplinary understanding,
will bring together concepts, methods, or languages from for example, Pharmacy Practice
and Pharmaceutical Sciences or established areas of expertise in order to explain a
pharmaceutical phenomenon, solve a problem, create a product, or raise a question. This
is crucial to promote scientific thinking and integrative reasoning skills.

Problem based learning becomes very useful later in the learning process. Problems that
student will face later, often demand contribution from different subject areas and he/she
will learn by experience how information he/she will take from the subjects is interrelated
and how it will assist in solving the problem..

The following diagram summarizes the processes to be followed in order to achieve the
purpose and rationale of the qualification as stipulated in the SAQA document ID 65130

SAQA QUAL ID 65130

Pharmacist Exit Level


Outcomes

Curriculum Review Committee

Non-compartmentalized Subjects

Relevant Level Exit OutcomesUnit


Standards

Integrated Topics

Important
1. Sub -Topics
General Learning Objectives
Integrated
Linkages

*Detailed Learning Objectives


(DLOs)
11
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Learning Activities (LAs) including

Lectures

Case Studies

Assignments

Tutorials Embedded
Knowledge
Practicals/Demonstrations
Critical
Individual Posters Preparation Outcomes

Student Directed Learning

The diagram below shows a concept map describing activities that encourage integrative
learning in many universities in the US which helps a student to understand that the world
outside of the classroom at the university is not a stand-alone.

12
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Self-directed Learning

This form of learning will make considerable demands on the student’s ability to ‘direct their
own work. The student has to learn to manage and organize their own learning process,
making use of the opportunities for learning, such as case studies, group work,
assignments, tutorial and lectures with guided notes. Guided notes are lecturer prepared
hand-outs that outline or map lectures but leave ‘blank’ spaces for key concepts, facts,
definitions etc. This is to help the student to fill in the spaces with content as part of their
activated self-directed learning. The guided notes should also help the student follow a
lecture, identify its important points and develop a foundation of content to study and to
apply to problem solving and case studies.

Integrated Assessment

All over the world educators are increasingly convinced of the following:

The intent of instruction is to promote student’s abilities as thinkers, problem-solvers, and


inquirers…….Assessments, if they are to be aligned with current views on instruction and
human learning must more closely resemble meaningful learning tasks and assess the
acquisition of high-level thinking and reasoning abilities as integral to subject matter
knowledge (International Encyclopedia of Education, 1994:370

Assessment is going to be part of the curriculum and the learning programme development.
We cannot assess in an integrated way if we do not teach and learn in an integrated way,
because integrated learning comes before integrated assessment.

Our teaching, learning and assessment activities must be developed as a valid, reliable and
coherent process taking into account;

• Purpose/Rationale/Exit Level Outcomes

• Learning and Teaching strategy

• Fields of Learning and assessment criteria

• Assessment strategy.

The validity of our assessment method will be best achieved by setting authentic or applied
tasks in the learning programme that closely simulate real world contexts. According to the

13
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Council on Higher Education, CHE the questions, “Are we assessing the right things?” and
“Are we assessing things right that are important and provide guidance in terms of the
fitness of and fitness for the purpose of the assessment (CHE, 2001: 114)

Reliability in assessment is about consistency and the extent to which in similar contexts
same judgments can be made in order to analyze statistically (SAQA, 2001:18). Errors may
arise from assessor practice, the environment for the assessment or from the sample of
learning that is to be assessed.

7. AIM OF THE MODULE


The aims of this module are to provide students with the necessary knowledge in the area
of pharmaceutical technology, to help them to understand the fundamentals and importance
of the unit operations in the manufacture of dosage forms through to the large scale
production and packaging of medicines and submission to the relevant health authorities
for production licence and marketing. In order to facilitate the learning the module is
structured in four topics as given below.

Topics:
1. Physico-chemical and pharmaceutical principles of production (Unit operations)
2. Overview of the manufacture of pharmaceutical dosage forms
3. Packaging and labeling
4. Pharmaceutical calculations

Physico-chemical and pharmaceutical principles of production (Unit operations):

The subject Unit Operations is based on fundamental laws, physicochemical principles. Unit
Operations gives idea about science related to specific physical operation; different
equipments, its design, material of construction and operation.

Overview of the manufacture of pharmaceutical dosage forms:

This topic deals with the basic science of solid, semisolid and liquid dosage forms, provide
the fundamental principles used to formulate, manufacture and control of different types of
dosage forms such as tablets, granules, capsules, suspensions, ointments, suppositories
etc.

14
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Packaging and labeling:

Deals with specification requirements for pharmaceutical packaging and labelling, quality
control procedures on packaging materials.

Pharmaceutical calculations:

For this module, the main objectives are to understand and be able to do a variety of basic
pharmaceutical calculations which are frequently encountered by the pharmacists within the
practice of manufacturing pharmacy.

15
8. TOPICS, SUB-TOPICS AND DETAILED LEARNING OBJECTIVES

The following section pays attention to the study process and demonstrates clearly what is expected from the student.

TOPIC SUB-TOPICS DETAILED LEARNING OBJECTIVES (DLO’S) LEARNING ACTIVITIES

CT-1, CT-2 & ASSIG-1


Topic 1: Physico-chemical and 1. Dosage form design a) Classification of dosage forms and their
pharmaceutical principles of production (Unit applications
operations)
b) The factors which influence the design of
pharmaceutical dose forms

CT-3, CT-4, CT-6, CT-9,


2. Unit Operations: In the case of each unit Operation:
PS-3
i. Mixing a) Define the unit process
ii. Milling
b) Describe the unit process
iii. Granulation
iv. Drying c) Describe the equipment used in the process
d) Basic mechanisms by which equipment
works
e) Discuss the advantages and disadvantages
of the equipment
f) Identify common problems that may occur
with the operation of each piece of equipment
and Suggest solutions

CT-4, CT-5, PS-2,


Micrometrics a) Methods used for determination of powder
density, with practical examples

16
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

b) Flow properties

c) Compaction

d) Particle size and size distribution.

e) Methods for determining particle size

CT-7
3. Pre-formulation a) Concept of pre-formulation.

b) Study of physical properties of drug like


physical form, particle size, shape, density,
wetting, dielectric constant, solubility, dissolution
and organoleptic properties and their effect on
formulation, stability and bioavailability.

c) Study of chemical character of drug molecule


like hydrolysis, oxidation, reduction,
recemization, polymerization, etc. and their
influence on stability of products.

d) Factors affecting dissolution rate, theory of


dissolution, Noyes-Whitney equation.

CT-8, Asign-2
Topic 2: Overview of the manufacture of Powders a) Bulk and divided powder
b) Powder mixing
pharmaceutical dosage forms
c) Dividing of powder
d) Powder with special problems; e.g.
deliquescent, efflorescent
e) Effervescent powder
f) Dusting powder

17
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

CT-9, CT-10, PS-4,PS-5,


Tablets a) Introduction to unit solid dosage forms
b) Tablet excepients Asign-2
c) Formulation of tablets; tablet machines
(single punch and rotary press machine).
d) Granulation techniques; wet and dry
granulation.
e) Tablets prepared by direct compression
f) Problems associated with tablet
manufacture (e.g Lamination, Capping,
sticking, picking)
g) Quality control tests for tablets (weight
variation, disintegration, dissolution,
thickness and diameter, friability).
CT-11, PS-6, Asign-2
Capsules a) Advantage and disadvantages of capsule
dosage form, material for production of hard
geletin capsules, size of capsules.
b) Methods of capsule production, soft gelatin
capsule shell and capsule content.
c) Understand and discuss the various types of
excipients and the role of the excipients in
capsule formulations
d) Quality control, stability testing and storage
of capsule dosage forms
e) Identify capsule manufacturing problems
and will be able to apply this knowledge to
perform trouble shooting and problem
solving
f) Types of microcapsules; importance of
microencapsulation in pharmacy.
g) Microcapsulation by phase seperation co-
acervation multiorifice, spray drying,
h) spray congealing, polymerization, complex
emulsion, air suspension technique,
i) coating pan and other techniques

18
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

CT-16
Tablet Coating a) Sugar coating
b) Film coating
c) Compression coating
d) Methods of coating
e) Insoluble monolayers (polymeric materials)
f) Applications: film coatings
g) Reasons for coating, enteric coating
h) Coating faults / problems
CT-12, Asign-2
Suspensions a) The design and evaluation of suspension.
b) Electrical and steric stabilization of solid-
liquid dispersions.
c) Flocculated and deflocculated systems.
d) Suspending agents, their classification and
stability.
e) Physical Stability of suspensions
f) Rheology
CT-13, Asign-2
Emulsions a) Theories of emulsification; emulsion type.
b) Emulsifying agents and their classification;
Hydrophilic-Lipophilic Balance (HLB).
c) Adsorption; monomolecular,
multimolecular and solid-particle
adsorption.
d) Physical stability of emulsion and their
evaluation.
e) Multiple emulsion and Microemulsions
f) Rheology
CT-15, PS-7, Asign-2
Suppositories a) Factors affecting drug release from
suppositories; physiological and
physicochemical considerations.
b) Ideal requirements, bases
c) Manufacturing procedure
d) Quality control tests
e) Packaging and storage

19
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

CT-14, Asign-2
Semisolid dosage forms a) Introduction and anatomy of the skin.
b) Definitions, types, mechanism of drug
(Creams, Ointments and penetration through skin.
gels) c) Factors influencing penetration, semisolid
bases and their selection.
d) General formulation of semisolids (ointment
and gel), manufacturing
e) procedure, evaluation and packaging
CT-17
Pharmaceutical aerosols a) Physicochemical principles of aerosol
science and technology.
b) Aerosol propellants, containers, valve and
actuator systems.
c) Product development, manufacturing,
stability testing and performance
evaluations of all types of aerosol products.
d) Non-pressure pack aerosols, atomizers,
packaging, containers

CT-18
Topic 3: Packaging and labeling a) Identify common packaging materials e.g.
glass, plastic, metal, rubber, paper
b) Discuss the advantages and disadvantages
of relevant packaging materials
c) Identify the activities that that are carried out
in the packaging cycle
d) Discuss packaging and labelling methods
e) Highlight the legal requirements pertaining
to the packaging cycle, with particular
attention to labelling requirements
f) Discuss specialised packs for specific
dosage forms e.g. aerosols, parenterals,
unit dose, combi-packs etc.
g) Discuss control procedures applied to:
the packaging materials (particularly printed
matter),

20
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

h) In-process controls for finished product


packaging
a) Concentration (Amount / strengths, Ratio WS1, WS2, WS3
Topic 4: Pharmaceutical calculations
strengths, Parts per million, Percentage
concentration, Conversion of different types
of concentrations)
b) Dilutions (Simple dilutions, Serial dilutions,
Mixing concentrations)
c) Formulations (Reducing or enlarging
pharmaceutical formulas, Ratio and
proportion in pharmaceutical formulas,
Percentage and ratio strengths).
d) Calculation of doses (Dose and Dosage
regime, Pediatric doses, Doses based on
body surface area, Doses based on weight
of the drug, Doses based on body weight,
Doses based on units)
e) Calculations involving molecular weight
(Molecular weight, Moles and millimoles,
Milliequivalents
f) Parenteral solutions and Isotonicity
(Rates of flow of IV solutions, Isotonicity)

*CT= Class Tutorial, WS= Workshop, PS= Practical Skill, Assig= Assignment

21
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

10. Group Presentation Schedule

Day 1 Group Topic

09h00 – Blue Formulation and Stability of Liquid Dosage Forms


9h30 Focus: Ingredient selection, formulation steps, potential
instabilities, and preservation methods.

09h30 - Green Pharmaceutical Manufacturing in South Africa: Opportunities


10h00 and Challenges
Focus: Local industry landscape, regulatory
environment, barriers to production, and strategic
improvements.

10h00 – Yellow Formulation and Stability of Semisolid Dosage Forms


10h30 Focus: Ingredient selection, formulation steps, potential
instabilities, and preservation methods.

10h30- Red Procurement and Selection of Raw Materials in


11h00 Pharmaceuticals
Focus: Procurement cycles, quality requirements,
regulatory considerations, and examples of excipient
and API sourcing.

Day 2 Purple Pre-formulation Studies: Laying the Foundation for


Successful Drug Development
9h00-
09h30 Focus: Solubility, stability, compatibility, and importance
in formulation planning.

09h30 – White Comparative Analysis of Tablet Coating Techniques


10h00 Focus: Film coating vs. sugar coating vs. compression
coating – process, materials, and applications.

10h00 – Black Designing an Ideal Packaging System for a Pediatric Oral


10h30 Medicine
Focus: Child safety, palatability, accurate dosing, and
regulatory compliance in packaging design.

10h30 – Pink Solubility Enhancement Techniques in Liquid Drug


11h00 Formulations
Focus: Use of cosolvents, complexation, surfactants,
and micronization for poorly soluble APIs.

22
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

11. Group Presentation Marking Rubric

Criteria Excellent (5) Good (4) Satisfactory Needs


(3) Improvement
(1-2)

Content Demonstrates Shows good Basic Limited or


Knowledge deep understanding understanding, inaccurate
understanding with minor some understanding
and integrates gaps inaccuracies
material
comprehensively

Organization Presentation Generally Some Disorganized


flows logically organized organization or confusing
and clearly with minor but may be
issues unclear at
times

Visual Aids Effective, Appropriate Basic visuals, Poorly


creative and and mostly somewhat designed or
well-integrated clear visuals relevant missing visuals
visuals

Engagement Highly engaging, Keeps Some Monotone or


encourages audience’s engagement disengaged
questions attention

Teamwork All members Most Uneven One or two


contribute members participation dominate; little
equally and participate collaboration
effectively actively

Time Within time limit; Slightly Rushed or Significantly


Management well-paced over/under slow in parts over/under
time time

23
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

Blue Green Yellow Red

Mahanuke SP Mahlase NK Mohuba C Kekana LL

Mohlala PD Ndove TG Maeko AM Pilusa KK

Rapetsoa M Shongwe LB Matjia T Lekhwa AP

Magagula SM Gabara TM Nukeri N Malau EK

Ramavhona M Mokubedi SY Mncwanga MN Morwapama MM

Dlali Q Makopo TD Musa FE Ratsidi TE

Madzusa MM Napjane T Malesa LO Khokho AL

Mathye V Ramoshaba TH Makgaretsa MD Makgato PM

Mnisi S Sekwakwa KLS Hlokwe T Nageli KP

Purple White Black Pink

Mohale NM Mandlazi H Mohlala MC Mulaudzi TB

Mabunda NB Phaswana O Gabela N Mathebula T

Ramakonya M Mashele T Msana LY Mokgathi LW

Lesufi KS Mphahlele PM Munyai NS Sepuru LR

Xego A Matlatse TM Makhua T Manyuha T

Dayimani Y Mohatli ETM Tefu KB Maripane K

Mabotha KP Tjale P Zitha CV Rapetsoa NB

Mannya MK Mdletshe A Mthombeni MKC Mabogwana AM

Kgatla TS

24
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

12. RESOURCES
1. Anderson JT et al., (Editors). Remington’s Pharmaceutical Sciences. Mack
Publishing Company. Pennsylvania. 14, 15 or 16 th editions.
2. Ansel's Pharmaceutical Dosage Forms and Drug Delivery System. Ed., Allen,
Popovich and Ansel (2005). Publisher: Lippincott Williams and Wilkins.
3. Applied biopharmaceutics and pharmacokinetics (3rd edn.). Shargel, L. and Yu,
A.B.C.

4. Aulton ME (Editor). Pharmaceutics: The Science of Dosage Form Design. Second


Edition. London: Churchill Livingstone, 2002.

5. British Pharmacopoeia. London. Her Majesties' Stationery Office. 1988 editions.


6. Carter S. J., Cooper and Gunn’s Dispensing for Pharmaceutical Students, 12 th
edition, 1987.
7. Handbook of Pharmaceutical Excipients. Second Edition. A joint publication of the
American Pharmaceutical Association and the Royal Pharmaceutical Society of
Great Britain.
8. [Link]
9. Lachman L, Lieberman HA, Kanig JL (Editors). The Theory and Practice of
Industrial Pharmacy.
10. Pharmaceutical Calculations (2005), Ed., Howard C. Ansel and Mitchell J.
Stoklosa, Publisher: Lippincott, Williams and Wilkins.
11. Martin's Physical Pharmacy and Pharmaceutical Sciences. Ed. Patrick J. Sinko
(2006). Publisher: Lippincott Williams and Wilkins
12. MEDICINES AND RELATED SUBSTANCES CONTROL ACT 101 OF 1965 and
regulations.
13. Reynolds JEF (Editor). Martindale, The Extra Pharmacopoeia. 29, 30 or 31 st
edition. London, Royal Pharmaceutical Society.
14. SA guide to GMP from [Link]
15. The United States Pharmacopoeia (USP) and National Formulary (NF)

25
B. Pharm Module: Pharmaceutical Manufacturing MPCC 022 Module Guide

26

Common questions

Powered by AI

Practical skills training in the pharmaceutical manufacturing module serves to provide students with hands-on experience in key manufacturing processes such as measuring and calibration, particle size distribution, and tablet quality control . These skills are evaluated through practical reports assessed on group and individual bases, ensuring students can apply theoretical knowledge to practical scenarios .

The teaching approach of the Pharmaceutical Manufacturing module is effective due to its focus on integrated learning and self-directed education, enabling students to become adept at handling complex, real-world pharmacy challenges . The curriculum includes a mix of theoretical lectures, practical skills sessions, and comprehensive assessments that collectively equip students with both knowledge and experience necessary for professional practice . This prepares them for addressing and solving practical challenges encountered in pharmaceutical settings. .

The integrated learning model enhances students' comprehension by connecting traditionally separate subjects, allowing for interdisciplinary understanding and application of concepts across different areas such as Pharmacy Practice and Pharmaceutical Sciences . This model encourages active student engagement, self-directed learning, and the ability to relate theoretical knowledge to practical applications in pharmaceutical phenomena .

The key components of the pharmaceutical manufacturing curriculum include physico-chemical principles, manufacturing processes, packaging and labeling, and pharmaceutical calculations . These components are significant for students' learning outcomes because they provide comprehensive knowledge and skills crucial for understanding drug formulation, manufacturing, quality control, and regulatory processes, preparing them for professional practice .

A modular curriculum structure is important because it allows for integration both horizontally and vertically, facilitates comprehensive learning by connecting various subjects, and enables flexibility in teaching and assessment methods . In the B. Pharm program at the University of Limpopo, it is implemented through the integration of seemingly disparate topics such as pharmaceutical chemistry and practice, ensuring that students gain a holistic understanding of the pharmacy field .

The curriculum addresses the connection between different dosage forms and pharmaceutical calculations by including objectives that focus on understanding the principles behind formulating various forms like tablets, capsules, and syrups . This involves applying mathematical skills to ensure accurate dosage and formulation, which is vital for ensuring therapeutic efficacy and safety . Students learn to integrate knowledge of physical properties and dosage computations essential for manufacturing and clinical applications .

The Pharmaceutical Manufacturing module at the University of Limpopo integrates self-directed learning by requiring students to manage and organize their own learning process through various activities such as case studies, group work, assignments, tutorials, and lectures with guided notes . This form of learning is important for pharmacy students as it develops their ability to manage their education independently, helps them to develop problem-solving skills, and prepares them for real-world applications beyond the academic setting .

Advantages of using equipment in pharmaceutical unit operations include improved precision and control in processes like mixing, milling, and granulation, leading to consistent product quality . However, disadvantages may involve equipment complexity, which requires specific expertise to handle and troubleshoot, increasing operational costs and maintenance requirements . Students are taught to evaluate the equipment based on operational efficiency and potential issues to make informed decisions during manufacturing .

The University of Limpopo ensures that assessments align with educational goals by designing them to reflect the curriculum's integrated learning model, which emphasizes problem-solving and critical thinking . Assessments include continuous tutorials, quizzes, practical skill tests, and an objective structured practical examination, all aimed at evaluating both subject matter knowledge and applied skills in real-world contexts .

Challenges in tablet manufacturing include lamination, capping, sticking, and picking, which affect product quality. Solutions taught include adjusting formulation techniques like wet and dry granulation, selecting appropriate excipients, and using quality control tests to ensure consistency and integrity of the tablets . This comprehensive approach equips students with the skills needed to troubleshoot and optimize tablet production .

You might also like