Pharmaceutical Technology II is a mandatory subject of the 2nd semester of the 4th year of the Pharmacy Degree.

In this subject the knowledge needed to prepare the different pharmaceutical dosage forms will be achieved. The design of the manufacturing process, the equipment required and the quality controls to be performed for the preparation of medicines, both at extemporaneous and industrial levels, will be addressed.

The program is divided into six modules that include the oral, parenteral, ophthalmic, nasal, ear, rectal, vaginal and topical dosage forms, as well as other drug delivery systems. There are also two modules corresponding to the seminars and laboratory experiments, where solid, semi-solid and liquid dosage forms are prepared and controlled.

This subject is of noteworthy importance in the Pharmacy Degree, as it prepares the students, pharmaceutics in the close future, for several professional careers, such as, working in a Community Pharmacy or a Hospital Pharmacy Service (extemporaneous preparation and control of medicines), pharmaceutical industry (industrial manufacturing and control of medicines), or research (development and optimization of new pharmaceutical dosage forms).

SPECIFIC SKILLS

1. To know and select the more appropriate excipients for the development of different pharmaceutical dosage forms.

2. To design the manufacturing process, the equipment required and the quality controls to be performed for the preparation of medicines, both at extemporaneous and industrial levels.

3. To develop different pharmaceutical dosage forms and to apply the corresponding quality controls.

4. To know the quality control systems and the most commonly used standards (European Pharmac poeia, FDA, ICH)



TRANSVERSAL SKILLS

1. Learn to communicate correctly in written form



LEARNING OUTCOMES

At the end of the course, the student has to:



1. Identify and select the most suitable excipients for preparing the different dosage forms.

2. Design the manufacturing process, select the equipment needed, and know the control tests needed for the different pharmaceutical dosage forms either at extemporaneous or industrial level.

3. Know elaborating the different pharmaceutical dosage forms and doing the quality controls.

4. Know the quality controls and most used regulations (European Pharmacopoeia, FDA, ICH)

5. Improve the written communication.

THEORETICAL PROGRAM

INTRODUCTION

1.- Introduction. Drug, dosage form and medicine. Administration routes. Classification of pharmaceutical dosage forms, excipients, concept, characteristics and relevance. Recommended reading.

MODULE I: ORAL PHARMACEUTICAL DOSAGE FORMS

2.- Capsules. Definition and classification. Advantages and disadvantages. Hard capsules. Production of the two components of capsules. Types of capsules. Formulation of hard gelatin capsules. Excipients. Capsule filling methods. Assays.

3.- Soft capsules. Type of capsules. Advantages. Production methods. Enteric capsules. Assays.

4.- Tablets. Concept. Advantages and disadvantages. Classification. Processing phases. Excipients.

5.- Procedures for tablet manufacture. Direct compression. Granulation. Tablet presses:

eccentric and rotary press. Advantages and disadvantages. Compression steps. Optimization.

6.- Coated tablets. Objectives. Classification. Advantages and disadvantages. Sugar coating. Film coating. Technological process of production. Functional coatings. Enteric coating. Substances used for enteric coating. Production methods. Enteric coating disaggregation. Assays.

7.- Other solid forms of drug administration. Special tablets. Sublingual tablets. Effervescent tablets. Chewable tablets. Multilayer tablets. Sustained or controlled release pharmaceutical dosage forms.

8.- Tablet testing. Content of active ingredient. External appearance. Colour. Size. Average weight. Hardness. Friability. Disintegration and dissolution test methods. Packing.

9.- Oral liquid pharmaceutical dosage forms. Definition and classification. Advantages and disadvantages. Production methods. Alterations of syrups. Assays. Special syrups. Elixirs. Conditioning.



MODULE II: PHARMACEUTICAL DOSAGE FORMS INTENDED FOR PARENTERAL ADMINISTRATION

10.- Injectables. Definition. Characteristics of injectables: isotonicity, pH, pyrogenicity and sterility. Advantages and disadvantages. Selection of excipients and auxiliary substances.

11.- Isotonization. Isotonic and isoosmotic properties. Physical-chemical and biological methods of isotonization.

12.- Pyrogens. Cause and types. Methods for evaluation of activity.

13.-Formulation of injectables. Vehicles. Classification. Water for injectables. Characteristics. Essays. Non-aqueous solvents: water-insoluble and non-hydromiscible. Oily vehicles Excipients (antioxidants, preservatives, buffer). Preservative effectiveness test. Other auxiliary substances.

14.- Parenteral products technology. 14. Processing area requirements. Preparation of parenteral formulations of small and large volume: preparation, filling and sterilization. Conditioning. Injectable controls. Other parenteral administration systems: infusion pumps, osmotic pumps.



MODULE III: PHARMACEUTICAL DOSAGE FORMS INTENDED FOR OPHTHALMIC, NASAL AND OTIC ADMINISTRATION

15.- Preparations for ophthalmic use. Eye-drops. Concept and demands. Auxiliary substances. Preservatives and buffers. Elaboration process. Oily eye-drops. Testing of eye-drops. Controlled release eye systems.



MODULE IV: RECTAL AND VAGINAL PHARMACEUTICAL DOSAGE FORMS

17.- Suppositories. Advantages and disadvantages. Excipients and auxiliary substances. Preparation methods. Assays. Conditioning. Enemas Pharmaceutical forms of vaginal administration: ovules and tablets. Assays. Intrauterine systems



MODULE V: PHARMACEUTICAL DOSAGE FORMS FOR CUTANEOUS APPLICATION

18.- Ointments and dermatological preparations. Classification. Excipients. Preparation, testing and conditioning of ointments. Ophthalmic ointments. Transdermal drug delivery systems

MODULE VI: OTHER DRUG DELIVERY SYSTEMS

19.- Microencapsulation. Theoretical fundament. Nature of the cover. Preparation methods. Coacervation. Applications. Nanocapsules Liposomes: Classification. Preparation methods. Properties



SEMINARS

I.- Isotonization of pharmaceutical preparations.

II.- Analysis and interpretation of data obtained in quality controls of solid pharmaceutical dosage forms for oral administration (1st Part: capsules and 2nd Part: tablets).

III.-Galenic development and process design of pharmaceutical dosage forms



LABORATORY PRACTICES

1. Preparation of copper sulphate suppositories.

2. Preparation of hard gelatin capsules of methylene blue.

3. Elaboration of a syrups containing paracetamol.

4. Tablet testing.

5. Identification of excipients of different dosage forms.

6. Preparation of a parenteral solution of C vitamin.

7. Semisolid and liquid pharmaceutical dosage forms for topical application I.

8. Semisolid and liquid pharmaceutical dosage forms for topical application II.

9. Preparation of microemulsions.

Lectures

Laboratory practices

Seminars (Classroom practices)

Tutorials

e-Gela virtual platform. https://egela.ehu.es/

• Continuous Assessment System
• Final Assessment System
• Tools and qualification percentages:
  • Written test to be taken (%): 60
  • Multiple-Choice Test (%): 5
  • Realization of Practical Work (exercises, cases or problems) (%): 25
  • For classroom practices (%): 10

Assessment tools and criteria

Theoretical-practical exam (70%)*

objective test, including multiple choice questions, short-answer questions and case studies about the contents seen in the lectures and in the lab experiments.



Evaluation criteria

Relevance of the responses given

Good knowledge of the concepts, clear, organised and coherent.

Connection level between theoretical and practical contents.

Mastering of procedures, methods and equipment used in the preparation of the different pharmaceutical dosage forms.

Lack of conceptual mistakes.

Degree of solution of new case studies and problems.



For the seminars (15%)

Assignment written by the students (control test guides and case studies solved)

Oral presentation during the seminar



Evaluation criteria

Suitable use of the information sources

Adequate organization of the information (order and clarity)

Involvement in the class, communicative attitude



For the lab experiments

Check-list of the lab experiments (Applicable/Not Applicable)**



Evaluation criteria

Capability for teamwork and showing an implicated attitude

Skills for the lab work

Organized and clean work, suitable residue removal

Correct execution of the lab experiment

Thoughtful attitude against the results obtained



Summarised report (10%)



Evaluation criteria

Structured information (order and clarity)



Multiple choice questions via moodle (5%)



Evaluation criteria

Relevance of the responses given



* 50% of the written test is required to in order to pass the subject

** Students who get Not Applicable must pass a practical exam in the Laboratory, in order to be able to take the final written exam.





CHOICE OF THE EVALUATION SYSTEM: CONTINUOUS OR FINAL

Students will be entitled to a single final test (10-point test), regardless of whether the student has participated or not in the continuous assessment system. For that purpose, students have to communicate it in writing to the lecture responsible for the subject within a period of 9 weeks since the beginning of the semester, according to the center´s calendar.



RESIGNATION OF THE CAL

1.- The resignation of the call will mean the qualification of not presented

2.- In the case of continuous assessment, students may waive the call in a period that, at least, will be up to one month before the end date of the teaching-period of the corresponding subject. This resignation must be submitted in writing to the faculty responsible for the subject.

3.- When it comes to the final evaluation, the no presentation to the test stablished on the official date of the exams supposes the automatic resignation to the corresponding call.

ABOUT THE EXTRAORDINARY CALL

1. Those students who do not pass the subject in the ordinary call, regardless of the evaluation system chosen in it, will have the right to take exams and assessment activities that make up the final evaluation test of the extraordinary call.

2. The evaluation of the subjects in the extraordinary calls will be made exclusively through the final evaluation system.

3. The final evaluation test of the extraordinary call will consist of how many exams and evaluation activities are necessary to be able to evaluate and measure the defined learning results, in a manner comparable to how they were evaluated in the ordinary call. The positive results obtained by the students during the course can be preserved. In the case of having obtained negative results through the continuous assessment carried out during the course, these results can not be maintained for the extraordinary call, in which the students will be able to obtain 100% of the grade.

Basic bibliography

1.- Martínez Pacheco, R. Tratado de Tecnología Farmacéutica. Volúmenes I, II y III Ed. Síntesis. Madrid. 2016.

2.- Vila Jato. Tecnología Farmacéutica. Vol. II. Formas farmacéuticas. Ed. Síntesis. Madrid (1997).

3.- Lozano, C., Córdoba, D., Córdoba, M. Manual de Tecnología Farmacéutica. Ed. Elsevier. Barcelona. 2012.

4.- Aulton, M.E. La ciencia del diseño de las formas farmacéúticas. 3ª Edición. Ed. Elsevier. España. (2007).

5.- Farmacopeas: Española, Europea y US Pharmacopoeia (USP)

6.- Formulario Nacional. 1ª Edición. Ed. Ministerio de Sanidad y Consumo, Madrid (2003)

In-depth bibliography

1. Ansel, H.C. Pharmaceutical Dosage Forms and drug delivery systems. Ed. Lea & Febiger. Philadelphia. 2005.
2. Banker, G.S., Rhodes, C.T. Modern Pharmaceutics. Ed. Marcel Dekker. New York, 4ª Edición 2002.
3. Benéitez Palomeque, E. Good Manufacturing Practices. La gestión técnica en la fabricación de medicamentos. Ed. Centro de Estudios Superiores de la Industria Farmacéutica. Madrid, 1995.
4. Kibbe, A.H. Handbook of Pharmaceutical excipients. Pharmaceutical Press. Londres, 2000.
5. Martindale. The Extra Pharmacopeia. 38ª Edición. Ed. Pharmaceutical Press. Londres, 2014.
6. Remington. The science and practice of pharmacy. Ed. Lippincott. 21ª Edición 2005.
7. Salazar, R. Tecnología farmacéutica industrial. Editorial Romargraf. Barcelona, 2003.
8. Salazar, R. Gestión de la calidad en la fabricación industrial de medicamentos. Editorial Romargraf. Barcelona, 2001.
9. C.O.F. de Vizcaya. Formulación Magistral de Medicamentos. Bilbao, 2004.
10.- Swarbrick, J. Boylan, J.C. Encyclopedia of Pharmaceutical Technology. 2º Ed. Marcel Dekker Inc. New York, 14 Vols.

Journals

Journals
International Journal of Pharmaceutics
http://www.sciencedirect.com/science/journal/03785173

European Journal of Pharmaceutical Sciences
http://www.sciencedirect.com/science/journal/09280987

European Journal of Pharmaceutics and Biopharmaceutics
http://www.sciencedirect.com/science/journal/09396411

Pharmaceutical Research
http://www.springerlink.com/content/105282/

Advanced Drug Delivery Reviews
http://www.sciencedirect.com/science/journal/0169409X

Journal of Controlled Release
http://www.sciencedirect.com/science/journal/01683659

Pharmaceutical Science & Technology Today
http://www.sciencedirect.com/science/journal/14615347

Web addresses

http://www.portalfarma.com
http://www.msc.es
http:// www.ema.europa.eu
http://www.ncbi.nlm.nih.gov/pubmed
http://www.accesowok.fecyt.es
https://scifinder.cas.org/
http://scientific.thomson.com/products/ipa/