Master of industrial Pharmacy Program

• Mission

To prepare competitive pharmaceutical professionals through an enriching academic environment, pioneering research, and robust community partnerships. The Master of Industrial Pharmacy program supports the development of a knowledge-based economy and society, equipping graduates to excel in the pharmaceutical industry and healthcare sectors. Through a dynamic learning environment, creative thinking, and the application of advanced technologies, graduates are empowered to contribute meaningfully to societal well-being.

• Objectives

1. Enhance Knowledge and Skills: To provide students with a comprehensive understanding of pharmaceutical sciences, including formulation development, drug delivery systems, and quality assurance practices.
2. Research and Innovation: To foster a culture of research and innovation in pharmaceutical sciences, encouraging students to engage in research projects that contribute to the advancement of the field.
3. Professional Development:  To prepare graduates for successful careers in the pharmaceutical industry, academia, and regulatory agencies by developing critical thinking, problem-solving, and leadership skills.
4. Regulatory Compliance: To instill a strong understanding of regulatory requirements and Good Manufacturing Practices (GMP) to ensure that graduates can navigate the complexities of pharmaceutical regulations.
5. Interdisciplinary Collaboration: To promote interdisciplinary collaboration among students, faculty, and allied professionals to address current challenges in pharmaceutical sciences.

Graduates of the Master of Industrial Pharmacy program at Prince Sattam bin Abdulaziz University are equipped with advanced scientific knowledge and practical skills that open diverse career paths across the pharmaceutical industry, regulatory agencies, and academic institutions. Graduates of the program are qualified to work in a variety of sectors, including:

• Pharmaceutical and Biotechnology Industries: Including companies involved in the development and production of biopharmaceuticals, gene therapies, and biosimilars.
• Regulatory and Governmental Agencies: Such as the SFDA and MoH, where graduates contribute to drug safety, policy, and regulation enforcement.
• Academic and Research Institutions: Opportunities include teaching, research, and academic consulting roles in higher education and research centres.
• Pharmaceutical Start-ups and Technology Ventures: Involvement in innovative companies focusing on advanced drug development, formulation technologies, and pharmaceutical entrepreneurship.

The relevant occupational/professional sectors for students graduating with a Master of Industrial Pharmacy

1. Biotechnology Industry: Focuses on developing biopharmaceutical products, such as biologics, gene therapies, and biosimilar. Graduates contribute to research, development, and production processes.
2. Academic and Educational Institutions: Includes universities, research institutes, and training centers. Graduates may take on roles as educators, researchers, or academic consultants in pharmaceutical sciences.
3. Clinical Research Specialist: Manages clinical trials, ensures compliance with protocols, and contributes to drug development by overseeing patient safety, data collection, and regulatory adherence in clinical research settings

1. Comprehensive Knowledge of Industrial Pharmacy: Graduates master formulation science, drug delivery, manufacturing processes, and regulatory frameworks (SFDA, GMP, FDA, EMA, and ICH guidelines) to meet industrial pharmacy standards.
2. Critical Thinking and Innovation in Pharmaceutical Development: Graduates apply problem-solving, data analysis, and innovation to design and optimize safe, effective, and compliant drug products.
3. Effective Communication and Interdisciplinary Collaboration: Graduates demonstrate clear scientific communication and teamwork with professionals across pharmaceutical sciences, engineering, and healthcare.
4. Ethics, Quality, and Regulatory Compliance: Graduates uphold professional integrity, ethical practice, and strict adherence to SFDA and international pharmaceutical regulations.
5. Leadership, Autonomy, and Industrial Responsibility: Graduates take responsibility and leadership in projects, ensuring that their work advances societal health and the pharmaceutical industry.
6. Research and Innovation in Industrial Pharmacy: Graduates design and execute independent research projects, applying appropriate methodologies, analyzing data, and interpreting findings to advance industrial pharmacy and the development of new products or formulations.

• Research Methods and Applied Biostatistics: This course deals with ethics in scientific research and applied statistics in pharmaceutics. This course will address research ethics as well as such topics as authorship and research misconduct. Also, it will emphasize principles of experimental design, methods of data collection, exploratory data analysis, and the use of graphical and statistical tools commonly used by scientists to analyze data. The course will include discussion about classical test theory (p values, scales of measurement, assumptions of analyses, etc.) and application of this theory for various statistical analyses, such as t tests, ANOVA, correlation, regression, and nonparametric analyses.

• Physical Pharmacy and Pre-formulation Considerations: This course describes fundamentals of physical pharmacy, physical properties of drug molecules and excipients that can influence formulation performance. Topics include the states of matter, physicochemical properties of drug molecules (Ionic balance, surface chemistry and overall properties). An overview of pharmaceutical excipients used in formulations, polymorphism in drugs, methods used for determining a polymorphic state, morphology, hygroscopicity, complexation and protein binding, drug-excipient interaction, and the compatibility tests. In addition to applications of polymers as pharmaceutical excipients. The practical part of the course is designed to familiarize students with some relevant subjects belonging to certain topics covered within the context of the theoretical part.

   

• Drug Delivery Systems: This course aims to demonstrate the most recent drug delivery systems. In addition, to study and understand all biological factors affecting drug delivery, the physiochemical factors associated with it, advanced preparation techniques, drug formulations and the development of various drug delivery systems. This course also aims to study advanced preparation techniques, drug formulations, and the development of non-parenteral drug delivery systems that include various methods of use, including oral drug delivery, the oral cavity, the nose, the eye, transdermal, rectal, and vaginal delivery.

   

• Applied Pharmaceutical Analysis: This course gives in-depth knowledge concerning methodology for the analysis of pharmaceuticals in biological samples as well as in pharmaceutical preparations. It also deals with basic analytical techniques such as spectroscopic, chromatographic techniques, mass spectroscopy, and thermal analytical techniques.

   

• Drug Stability: This course is designed to deal with the stability studies ensuring the maintenance of drug quality, safety, and efficacy throughout the shelf life, which are considered a pre-requisite for the acceptance and approval of any pharmaceutical product. These studies are required to be conducted in a planned way, following the guidelines issued by ICH and WHO and or other agencies.

• Advanced Biopharmaceutics: This course explores advanced concepts in biopharmaceutics and pharmacokinetics. It covers the absorption, distribution, metabolism, and excretion (ADME) of drugs, including the application of one-compartment and multi-compartment pharmacokinetic models. Students will learn to calculate and interpret pharmacokinetic parameters and understand their relevance in drug development. Topics also include bioavailability and bioequivalence, biopharmaceutical considerations in drug product design, in vitro drug performance evaluation, and the correlation between in vitro and in vivo data (IVIVC).

   

• Good Manufacturing Practice (GMP) of Pharmaceutical Dosage Forms: This course deals with basic requirements for pharmaceutical and manufacturing quality management. Topics will cover GMP, total quality management, quality costs, and manufacturing quality management, in addition, regulatory aspects, design and performance qualification and documentation. Also, quality control, quality assurance and assessment of various dosage forms. Moreover, validation of pharmaceutical formulation processes and evaluation of dosage forms according to USP, BP, FDA regulations will be covered.

   

• Seminar I: Seminar - I offer an enriching platform for students to transcend conventional coursework boundaries. This coursework propels students into the realm of advanced topics, fostering exploration of cutting-edge developments and specialized fields within pharmaceutical science and technology. Additionally, students will undertake concise reviews on selected topics or specialized articles pertinent to industrial pharmacy and engage in critical evaluation of scientific papers specific to this domain. Through this comprehensive approach, students refine their analytical skills, deepen their understanding of industrial pharmacy, and significantly contribute to the advancement of pharmaceutical science and technology.

   

• Advanced Pharmaceutical Technology: This course provides an overview of the processes that occur in the pharmaceutical industry, with specific reference to the tablets manufacturing and the instruments used for that, including the processes of reducing and enlarging the size of particles, mixing, freeze-drying, spray-drying, tablet manufacturing, coating, and the modern technologies used.

   

• Scale-up Techniques and Pilot Plant: This course deals with the development of scale-up manufacturing processes of pharmaceuticals. Plant design/plant layout of large-scale manufacturing unit for sterile and nonsterile products will be covered. Pilot plant/scale-up techniques, technology transferring procedures from R&D results to a pilot plant, and then to production scale will be determined. The dimensional analysis and scale up in theory and industrial application of pharmaceutical products will be discussed. Finally, the engineering aspects of scale up processes and pilot plant design of various pharmaceutical dosage forms such as tablets, capsules and liquid dosage forms will be described.

   

• Regulatory Affairs of Pharmaceutical Dosage Forms: This course aims to provide students with a comprehensive understanding of global regulatory compliance and quality assurance in pharmaceutical manufacturing with a focus on FDA, EMA, and SFDA guidelines. The course covers post approval regulation obligations including pharmacovigilance, drug advertising compliance, and manufacturing inspections. Students will have a comprehensive understanding of the regulatory considerations and submissions involved drug approvals such as Investigational New Drug application (IND), New Drug Application (NDA), and Abbreviated New Drug Application (ANDA). Biosimilars regulation will also be explored.

   

• Drug Development and Approval Process: This course aims to provide students with a comprehensive understanding of the drug development process. Students will gain knowledge in designing new drug entities to effectively combat diseases and reverse their effects. They will acquire skills in identifying and evaluating promising compounds through relevant experiments. Additionally, students will learn about the evaluation of preclinical research, including in-vitro and in-vivo studies, to assess the safety and effectiveness of drugs before proceeding to human trials. The course will also cover the application of clinical research principles in drug development, focusing on the design and implementation of clinical trials and the interpretation of drug interactions with the human body. Furthermore, students will be equipped with the necessary knowledge with strategic milestones to obtain regulatory approval for marketing a new drug.

   

• Seminar II: Seminar II in the Master of Science in Industrial Pharmacy program offers students a vital platform to enhance their presentation skills and explore contemporary issues in the field. Through oral presentations focused on chosen topics or specialized articles related to the scope of the students’ fields, students deepen their understanding of relevant subject matter aligned with their research proposals. This seminar facilitates effective communication of complex ideas and encourages critical thinking through engaging with current trends and regulatory considerations. The interactive format promotes constructive dialogue among peers, culminating in a final evaluation through open discussion. Overall, Seminar II empowers students to excel as communicators, critical thinkers, and contributors to the field.

   

• Registration of Pharmaceutical Dosage Forms: This course focuses on the rules regulating registration of pharmaceutical dosage forms in Saudi Arabia. Official decisions concerning registration and all manufacturing treaties. Registration of imported medications. Registration of control locally manufactured drugs. All requirements and documents for registration. Relationship between the responsible administrations in the FDA of Saudi Arabia.

   

• Research Project: The Research Project course (PHT 646) offers students a practical, hands-on opportunity to apply the knowledge gained from previous coursework in industrial pharmacy. Under the supervision of a major advisor and a Research Project Committee, consisting of at least two additional faculty members, students will engage in independent research to solve real-world pharmaceutical challenges. The course emphasizes key research skills, including problem identification, literature review, experimental design, data collection, and analysis. Project proposals require pre-approval and guidance from the committee. Students will present their findings through a written report and an oral presentation, which will determine their final grade. This course equips students for advanced roles in research and development within the pharmaceutical industry.

The Research Project course offers students a practical, hands-on opportunity to apply the knowledge gained from previous coursework in industrial pharmacy. Under the supervision of a major advisor and a Research Project Committee, consisting of at least two additional faculty members, students will engage in independent research to solve real world pharmaceutical challenges. The course emphasizes key research skills, including problem identification, literature review, experimental design, data collection, and analysis. Project proposals require pre approval and guidance from the committee. Students will present their findings through a written report and an oral presentation, which will determine their final grade. This course equips students for advanced roles in research and development within the pharmaceutical industry.

• Students must complete an original research project under faculty supervision.
• The research topic must align with industrial pharmacy and the university’s research directions.