SAN PEDRO UNIVERSITY

ACADEMIC VICE-RECTORATE
FACULTY OF HUMAN MEDICINE

PROFESSIONAL SCHOOL OF PHARMACY

AND BIOCHEMISTRY

SYLLABUS

PHARMACEUTICAL TECHNOLOGY
1. INFORMATION PART
1.1 Faculty : Human Medicine
1.2 Professional Career : Pharmacy and Biochemistry
1.3 Subject : Pharmaceutical Technology
1.4 Prerequisites : 102, 104, 305
1.5 Mode : In person
1.6 Code : 604
1.7 Credits :4
1.8 Study cycle : Sixth
1.9 Academic semester : 2016 - 2
1.10 Hours :6
1.10.1 Theory : 2 hours
1.10.2 Practice : 4 hours
1.10.3 Total hours : 6 hours
1.11 Duration : 17 weeks
1.12 Teachers : 02
1.12.1 Theory : Mg. QF Jaime Flores Whale
[email protected]
1.12.2 Practice : Mg. Ruben Jesus Aro Diaz
[email protected]

2. MISSION AND VISION OF THE PROFESSIONAL CAREER

2.1 Professional Career Mission.
We are a university program that trains Pharmaceutical Chemists with a high academic and
ethical level, that promotes scientific and technological research for the management of the
rational use of medicines, and exercises social projection and university extension.
2.2 Career Vision.
To be a leading professional career at a national level in the training of Pharmaceutical
Chemists with a scientific and humanistic vocation, which contributes to the social, cultural
and economic development of the region, aware of the preservation of the environment and
with ethical and moral training.

3. STUDENT PROFILE.

He/she has a solid background in basic sciences, knowledge and technological tools to promote
the proper use of medicines, interprets biochemical processes, contributes through the use of
clinical analysis to the diagnosis of diseases, interprets the relationship between the chemical
structure and biological activity of active ingredients, applies technological knowledge and health
management strategies.
4. RATIONALE
Pharmaceutical Technology is a subject that deals with the design, preparation and control of
pharmaceutical formulations, giving medicines the appropriate characteristics to facilitate their
administration, ensure correct dosage and achieve optimal therapeutic efficacy.

This subject in its program includes topics such as Industry, Good Manufacturing Practices (GMP) and
Quality Control considering Good Laboratory Practices (GLP), Stability, Design, Validation,
Preparation of solid dosage forms for oral use (capsules and tablets), liquid (injectables and syrups),
semi-solid (ointments), solid for rectal use (suppositories), their corresponding quality control and
Packaging.

These scientific and technical aspects will provide the pharmaceutical student with training that will
allow him to apply them in the different areas of his professional development, especially in the field
of the Pharmaceutical, Food and Cosmetics Industry.

5. COMPETENCES OF THE SUBJECT

5.1 GENERAL
 Ability to work autonomously.
 Ability to apply knowledge in practice.
 Understand the role played by the Pharmaceutical Industry.
 Identify pharmaceutical form formulations.
 Explain the factors that influence the quality of a drug.
 Understand the importance of quality control of the different pharmaceutical forms.
 Understand the role of the Pharmaceutical Chemist in the Pharmaceutical Industry.
 Explains the importance of Pharmaceutical Technology in understanding the quality of
medicines.
 Identify the different processes that allow the quality of the different pharmaceutical forms
to be evaluated.
 Evaluates the importance of GMP and GLP in the preparation and control of medicines
 Attend punctually and show interest.
 Actively participate in all tasks.
 Explains the basic principles for the use of materials used in the production, packaging
and quality control of a particular medicine.
 Punctually completes the reports assigned to him/her
 Work in a group with responsibility
 Demonstrate responsibility and creativity in the task at hand
 He is supportive of his colleagues

5.2 SPECIFIC
 Identify a pilot plant
 Identify the function of each of the excipients used in the manufacture of medicines.
 Recognize the different pharmaceutical forms.
 Identify the quality parameters for Tablets.
 Identify the factors that influence the stability of medications.
 It produces solid and semi-solid pharmaceutical forms.
 Describe the characteristics of the different pharmaceutical forms.

6. ACADEMIC PROGRAMMING
6.1. FIRST UNIT
 6.1.1. Name of the unit: Pharmaceutical Industry, Control and validation of analytical
processes and methods – Solid pharmaceutical forms (capsules, tablets)
6.1.2. Unit capabilities
 Explains and analyses the socioeconomic impact of the Pharmaceutical Industry on
health.
 Applies the principles of Quality Control in the different stages of the drug
manufacturing process.
 Explains the methodology to follow when trying to validate analytical methods and
processes.
 Describes the characteristics of the excipients necessary for the formulation of
capsules and tablets.
 Select appropriate technologies for the production and quality control of capsules
and tablets.

6.1.3. Contents:

Week Issue Learning Modality Date Obs.

Topic 1:
 Syllabus Socialization: Course
contents and management.
 Pharmaceutical Industry:
Evolution, harmonization of the
quality of its products. Approaches
to its socio-economic impact on the Theoretical – Expository class. 26/08/16
health of society Practical Class – Problem solving,
 FORMATIVE RESEARCH (FR) preparation of formulations,
Socialization of the content of the presentation of reports.
Development of team assignments.
topic related to IF to be developed
1°
individually or as a team during the
course.
 CULTURAL EXTENSION AND
UNIVERSITY PROJECTION
(ECYPU):
Socialization of the first unit social
projection project entitled:
“Cultivating healthy habits.
Practice: Good manufacturing
practices.
Topic 2:
 Good Manufacturing Practices
(GMP). Conceptual bases. 02/09/16
Importance. Aspects for its
Theoretical – Expository class.
2nd implementation related to: people, Practical Class – Problem solving,
infrastructure, materials, preparation of formulations,
processes, documentation. Self- presentation of reports
inspection and quality audits. Development of assignments in
Aspects of Good Laboratory teams.
Practices (GLP).
Practice: Pilot plant.
Topic 3:
 Process Quality Control. Control
Charts. Control charts by variables. Theoretical – Expository class.
Practical Class – Problem solving,
Attribute control charts. The
preparation of formulations, 09/09/16
3rd manufacturing process and presentation of reports
specifications. Process capability. Development of assignments in
Practice: Quality control – control teams
for average values
 Topic 4:
 Drug Stability.
Theoretical – Expository class.
Factors that influence the stability Practical Class – Problem solving,
of medicines. Determination of the preparation of formulations,
4th expiration period of medications. 16/09/16
presentation of reports
Standards established by official Development of assignments in
authorities in different countries for teams
drug stability studies.
Practice: Quality control – control
by attributes.
Topic 5:
 Validation in the Pharmaceutical
Industry: Theoretical – Expository class.
Practical Class – Problem solving, 23/09/16
Validation in the Pharmaceutical
preparation of formulations,
5th Industry. Validation of Analytical presentation of reports
Methods. Process Validation. Development of assignments in
Practice: Stability of Acetylsalicylic teams
Acid
Topic 6:
 Capsules. Excipients.
Manufacturing technology. Capsule Theoretical – Expository class.
Practical Class – Problem solving,
filling environments and equipment.
preparation of formulations,
6th Quality control. Microcapsules and presentation of reports 30/09/16
nanocapsules. Preparation Development of assignments in
techniques. Equipment and teams
Materials.
Practice: Validation of analytical
methods.
Topic 7:
 Tablets. Guys. Excipients.
Manufacturing. Direct compression, Theoretical – Expository class.
7th Practical Class – Problem solving,
dry granulation, wet granulation.
preparation of formulations,
Compression process. Teams. presentation of reports 07/10/16
Complications of tablet Development of assignments in
compression. teams
Practice: Feedback activity.
Seminar: Tablet coating. Materials
and equipment. Controlled release
systems. Manufacturing
Technologies. Quality control
 ECYPU: Dissemination of the social projection work of the first unit
entitled: “Cultivating healthy habits”
 IF: Presentation of the first part of the monograph of the first unit 14/10/16
8a
 PARTIAL EXAM 1st UNIT

6.2. SECOND UNIT

6.2.1. Unit name: Parenteral Products, Suspensions for oral use, Semisolids, Aerosols and
Packaging.
6.2.2. Unit capabilities
 Describes the characteristics, conditions, technologies and excipients necessary in the
preparation of parenteral preparations.
 Select appropriate technologies for the production and quality control of suspensions.
 Analyze the formulations, packaging and quality control tests of aerosols and describe the
characteristics of an ointment.
 Select appropriate technologies for the production and quality control of ointments.
  Select appropriate technologies for the production and quality control of suppositories.
 Manufacture suppositories and control their quality.

6.2.3. Contents:

Week Issue Learning Modality Date Obs.

Topic 9:
 Parenteral preparations. Nature Theoretical – Expository class.
and importance of parenteral Practical Class – Problem solving,
preparations. Vehicles. Adjuvant preparation of formulations,
9° substances: Isotonization. presentation of reports.
Packaging: Washing and Development of team assignments.
sterilization.
Practice: Capsule technology 21/10/16

Topic 10:
 Production area. Flow planning. Air
purification. Aseptic area. Theoretical – Expository class.
Practical Class – Problem solving,
Environmental control evaluation.
preparation of formulations,
10th Product preparation. Filtration. Fill. 28/10/16
presentation of reports
Closing. Sterilization. Teams. Development of assignments in
Quality control of parenteral teams.
preparation. Conditioning and/or
packaging.
Practice: Tablet Technology
Topic 11:
 Pharmaceutical Suspensions.- Nature
and importance of Suspensions. Theoretical – Expository class.
Factors that influence its stability. Practical Class – Problem solving,
Suspension Technology. Quality preparation of formulations, 04/11/16
11th
control. presentation of reports
Development of assignments in
Practice: Suspension technology teams
Topic 12:
 Semi-solid preparations: Ointments:
Excipients. Ointment manufacturing Theoretical – Expository class.
technology type: Suspension, Solution, Practical Class – Problem solving,
Emulsion. Packaging and storage. preparation of formulations,
12th 11/11/16
Ophthalmic ointments. Quality control presentation of reports
of ointments. Development of assignments in
teams
Practice: Ointment technology.
Topic 13:
 Solid preparations: suppositories.
Excipients and manufacturing Theoretical – Expository class.
Practical Class – Problem solving, 18/11/16
technology. Formulation problems
preparation of formulations,
13th Practice: Suppository Technology presentation of reports
Development of assignments in
teams
Topic 14:
 Aerosols:
Nature and importance of aerosol Theoretical – Expository class.
drugs. Technological factors and quality Practical Class – Problem solving,
control preparation of formulations,
14th
presentation of reports 25/11/16
Practice: Feedback Activity Development of assignments in
teams
 SEMINAR:
Packaging of different medicinal forms. Functions and Selection. Primary,
15th Secondary and Special Conditioning. Materials. Packaging and
conditioning operations. Conditioning quality management.
 ECYPU: Dissemination of the second unit social projection work entitled 02/12/16
“Cultivating healthy habits”.
 IF: Presentation of the second part of the monograph of the first unit.

16a  PARTIAL EXAM 2nd UNIT

09/12/16

 SUBSTITUTE EVALUATION OF DEFERRED COURSES 16/12/16

17a

7. METHODOLOGICAL STRATEGIES

MODE CLASS TYPE METHODOLOGY

Theoretical Master Class.
Development of practical
Practice experiences in the
In person Laboratory.
Progress test.
Cooperative Learning Participatory Methods
Academic Tutoring Contracts
Individual Formative Research:
Developing Assignments
Non-face-to- Collaborative forums for the
face Group development of team
assignments.

8. ASSESSMENT:
Attendance ≥ 30%

- Diagnostic: Exams and tests to understand the progress of content.

- Formative: It is permanent through the observation of responsibility, creativity, dialogic attitude,
research and participation.
- Summative: This evaluation will be done according to the established schedule.

N Note per unit weight

OR Seminar/IO/Monograph(IF) 2
PR Practice (P) 3
- Oral Evaluation
- Weekly Report
- Written examination
3 Exhibition/Social Projection 1
4 Unit Part-Time Exam 4
10

2+3+1+4
Unit Note =
10
 Course average:

A1+A2
 = -------------------
2

 Participants who have accumulated 70% attendance at the course will be eligible to
be evaluated.
 The general grading will be carried out using the vigesimal system (0 to 20).

(EU) Unit exam: consists of an objective evaluation of the contents of the unit. Maximum 20
questions of 1 point each.
(AV/P) Virtual/in-person assignments: Assignments, papers, problem solving, cases, lab
reports, individually or in teams, etc.
(EP) Practical/ongoing assessment: Weekly exams, checklist for performance assessment in
the classroom or laboratory, graded classroom practices, class participation, etc.
(IF) Formative research: Development of a monograph related to the course content, as a team
(a different topic), and which demands the student's ability to search for information, consolidate
it, organize it, evaluate it and analyze it and reach conclusions. Likewise, present the
bibliographical references in an appropriate systematic form (Vancouver). The monograph is
presented in a preview (up to the first unit) and the final document (second unit). At the end the
monograph can be evaluated through a presentation. The monograph progress reports are
delivered in PDF format and uploaded (despite having been developed as a team) individually in
the virtual classroom.
(PS/RS) Social projection / Social responsibility: Development of a questionnaire on a topic
related to the course objectives but that has a social impact. The student is asked about his or
her attitude towards a social, community, or environmental problem that can be resolved by
applying the knowledge provided in the course. Two questionnaires must be formulated, one for
each unit, with a maximum of 20 questions. Each question must have an answer supported by
bibliographical references using the Vancouver method.

9. BIBLIOGRAPHIC REFERENCES

1. Aulton MG, Pharmacy. The Science of Pharmaceutical Formulation Design. Ed. ELSEVIER.
Madrid. 2004.
2. Carstensen, J, T., Theory of Pharmaceutical Systems Vol II, Academic Press. New York 1973.
3. Cieza G., Alva P., Ramos L. Operational Qualification and Performance Suitability of a
Dissolution Equipment Apparatus 1 and 2. Research work in internship to obtain the
professional title of Pharmaceutical Chemist at the Faculty of Pharmacy and Biochemistry of the
UNT. 2008.
4. Connors, K, Amidon G. and Kennon Li., Chemical Stability of Pharmaceuticals a Handbook for
Pharmacist., Ed. John Wiley & Sons, New York. 1979.
5. Feigenbaum, AV, Total Quality Control, Third Reprint, Ed. Continental SA, Mexico, 1993.
6. Good manufacturing practices for sterile pharmaceutical products Annex 6 WHO Technical
Report Series No. 902., 2002. No. 2003.
 7. Helman, J. Theoretical and Practical Pharmacotechnics, Ed. Continental, Volume III, Mexico,
1982.
8. Howard, C., Ansel. Introduction to Pharmaceutical Dosage Forms. Ed. Lea Febige, Philadelphia
1981 9 . 32nd Report of the WHO Expert Committee on Specifications for Pharmaceutical
Preparations. WHO. 1992
9. León Lachman et al, The Theory and Practice of industrial Pharmacy. Phyladelphia 3 Ed. 1986
11 . Martin Cook et al., Remington's Practical Pharmacy. Ed. Mack Publishing 2003.
10. Martin Alfred. Physical Pharmacy. Fourth Edition. Ed. LEA & FEBIGER, Philadelphia, USA, 1993.
11. Montgomery, D. Statistical Quality Control, Ed. Iberoamerica Publishing Group, Mexico 1991.
12. Roncal S., Alva P., Gutierrez A. and Ruidias D., Influence of temperature on the stability of
Captopril in extemporaneous formulations for pediatric use. SCIENDO: SCIENCE FOR
DEVELOPMENT. 2001; 04 (1-2):63-72.
13. Rowe, Raymond, Paul J. Sheskey and Marian E. Quinn., Handbook of Pharmaceutical Excipients.-
Sixth Edition.- 2009.
14. Vila Jato, J. Pharmaceutical Technology, Ed. Synthesis SA Madrid 1997
15. Voight, R., Treatise on Pharmaceutical Technology. Ed. Acribia 1982.
16. USP (Pharmacopeia) Ed. XXXVIII Ed. Mack Publishing Co 2013.
17. Lozano, Maria del Carmen, Damian Cordoba and Manuel Cordoba; Handbook of Pharmaceutical
Technology, Ed. Elsevier Spain, 2012.
18. Piminchumo Ramón, Cesar Gamarra, Segundo Miranda and William Sagástegui, Validation of
UV-VIS Spectrophotometric Techniques of reverse optics and HPLC chromatography for
Acetaminophen dosage in Panadol tablets. SCIENDO: SCIENCE FOR DEVELOPMENT, 2004, 07(1-
2):01-10.
19. Bohuytron-Perez, Janeth Sanchez-Espinola and Ramon Piminchumo-Carranza. Validation of High
Performance Liquid Chromatography Technique for Prednisone, in Nisone Syrup. SCIENDO:
SCIENCE FOR DEVELOPMENT, 2005, 08(1-2):27-34.
20. Piminchumo-Carranza, Ramón, Controlled Release Dosing Systems for Oral Administration.
SCIENDO: SCIENCE FOR DEVELOPMENT, 2005, 08(1-2):121-130