PDF MODULE 11: Pharmaceutical Technology (11.12 ECTS)

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MODULE 11: Pharmaceutical Technology (11.12 ECTS)

Degree Programme: Undergraduate Programme in Pharmaceutical Science and Technology Title of Module: Pharmaceutical Technology

Abbreviation: PT

Title of Class: FA3131 Pharmaceutical Technology of Liquid‐Semisolid Dosage Form

Semester: 5

Responsible for Module: Prof. Dr. Sundani Nurono S.

Lecturer:  Dr. Sasanti Tarini Darijanto

 Dr. Tri Suciati

 Dr. Diky Mudhakir Language: Indonesian and English

Assignment to Programme: Undergraduate Programme in Pharmaceutical Science and Technology, Compulsory Class, Semester 5

Class Type / Hours: Lecture / 3 h per week Workload:  Study time in class: 48 h

 Study time at home: 96 h

Credits: 4.17 ECTS

Requirements: Registered Student to Undergraduate Programme in Pharmaceutical Science and Technology

Study Goals: Knowledge:

Explain the basic principal of formulation and manufacturing process of sterile and non‐sterile of liquid‐semisolid dosage form.

Skill:

Solve problems found in the production of liquid‐semisolid dosage form.

Competence:

Design sterile and non‐sterile formulation of liquid‐semisolid dosage form in pharmaceutical industry.

Content: Preformulation of active ingredients and excipients; formulation and manufacturing technology of sterile and non‐sterile dosage form, including: solution, suspension and suspension reconstitution, emulsion, aerosol and semi‐solid; in process control, product evaluation, packaging materials, up scaling of dosage form and unit process involved.

Assessment: Written exam (mid and final exam)

Media: Handout, Slides, Board

Literature:  Lieberman.H.A, et al, (1989) Pharmaceutical Dosage Form : Disperse system vol. 1,2, Marcel Dekker, Inc., New York,

 Lieberman.H.A, et al, (1992) Pharmaceutical Dosage Form : Parenteral Medication, Marcel Dekker, Inc., New York,

 Suplemen Farmakope Indonesia edisi IV, (2006), Departemen Kesehatan RI.,

 Rowe.R.C.,2006, Handbook of Pharmaceutical Excipients, 5^th ed.,

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Pharmaceutical Press And American Pharmacist Association

 Trissel.A.L., 2001,Handbook of Injectable Drugs, American Society of Health‐System Pharmacists,

 Ansel HC et al., 2005, Pharmaceutical Dosage Forms and Drug Delivery System, 8th ed., Lippincott Williams & Wilkins.

 Gibson, M. (ed.), 2004, Pharmaceutical Preformulation and Formulation: a Practical Guide from Candidate Drug Selection to Commercial Dosage Form, CRC Press.

 Swarbrick, J. (ed), 2007, Encyclopedia of Pharmaceutical Technology , Informa Healthcare

 Niazi, S. K., 2009, Handbook of Pharmaceutical Manufacturing Technology: Liquid product & Sterile Product, 2^nd ed. vol 3 & 6, Informa Healthcare.

Abbreviation: PT

Title of Class: FA3132 Practicum of Pharmaceutical Technology of Liquid‐Semisolid Dosage Form

Semester: 5

Lecturer:  Dr. Sasanti Tarini Darijanto

 Dr. Tri Suciati Language: Indonesian and English

Class Type / Hours: Practicum / 4 h per week, tutorial / 1 h per week Workload:  Practicum in Laboratory : 48 hours

 Preparation : 48 hours

Credits: 2.78 ECTS

Study Goals / Skills: Skill:

Demonstrate formulation of liquid‐semisolid dosage form and prepare as well as examine the sterile and non‐sterile products.

Competence:

Design and analyze formulation of liquid‐semisolid dosage form in pharmaceutical industry

Content: Introduction to parenteral dosage form covering route of parenteral administration and manufacturing process to guarantee the sterility of dosage forms, formulation of sterile dosage forms, including: SVP & LVP as solution, nanosuspension, reconstituted powder, and emulsion,

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ophthalmic drops and ointment, nasal drops and otic, topical sterile cream;

manufacturing processes including final sterilization, bacterial membrane filtration, and aseptic technique with its related process validation and monitoring according to current technology and regulation, in process control and product evaluation, and also packaging materials.

Assessment: Laboratory practice and exam, and also written exam Media: Handout, Laboratory manual, laboratory equipment

Literature:  Lieberman.H.A, et al, (1992) Pharmaceutical Dosage Form : Parenteral Medication, vol. 1, 2, 3, Marcel Dekker

 Banker, G. S. (ed.), 2002, Modern Pharmaceutics, 2th ed. , Marcel Dekker.

 Trissel.A.L., 2001,Handbook of Injectable Drugs, American Society of Health‐System Pharmacists,

 Gibson, M. (ed.), 2004, Pharmaceutical Preformulation and Formulation: a Practical Guide from Candidate Drug Selection to Commercial Dosage Form, CRC Press.

 Niazi, S. K., 2009, Handbook of Pharmaceutical Manufacturing Technology: Sterile Product, 2^nd ed. vol 6, Informa Healthcare.

 WHO, 2011, WHO Technical Report Series, No. 961, Annex 6: WHO good manufacturing practices for sterile pharmaceutical products

 PIC/S, 2009, PE 009‐9 Annex 1: Manufacture of Sterile Medicinal Products

 Suplemen Farmakope Indonesia edisi IV, 2006, Departemen Kesehatan RI.,

 Swarbrick, J. (ed), 2007, Encyclopedia of Pharmaceutical Technology , Informa Healthcare

Abbreviation: PT

Title of Class: FA4131 Pharmaceutical Technology of Solid Dosage Form

Semester: 7

Lecturer:  Prof. Dr. Sundani Nurono S.

 Dr. Saleh Wikarsa

 Dr. Diky Mudhakir

 Dr. Heni Rachmawati Language: Indonesian and English

Class Type / Hours: Lecture / 2 h per week, practicum / 4 h per week, tutorial / 1 h per week Workload:  Study time in class: 32 h

 Laboratory activity : 48 h

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 Study time at home: 64 h

Credits: 4.17 ECTS

Study Goals: Knowledge:

Describe powder technology in solid dosage forms manufacturing and recognize methods to develop solid dosage form formulation

Skill:

Demonstrate suitable manufacturing methods of solid dosage form and examine/evaluate the products

Competence:

Design formulation and analyze problem solving of of solid dosage form in pharmaceutical industry

Content: Introduction, pharmaceutical powder and Polymorphism, Pre‐formulation study, Excipient, Wet and dry granulation technology, Direct compression, Compressing tablet process, Problem during tablet manufacturing, Evaluation, Dissolution, Tablet coating, Effervescent tablet, Chewable tablet, Special and sustained release tablet, Suppository and ovule, hard capsule.

Assessment: Written exam (mid and final exam), laboratory practice and exam Media: Handout, laboratory manual, laboratory equipment, Slide, Board

Literature:  Lieberman, A.H., et al., Pharmaceutical Dosage Form: Tablet Vol. 1, Vol.

2, and Vol. 3, Second Edition

 Ansel, H.C., Popovich, N.G., Pharmaceutical Dosage Forms and Drug Delivery System, Fifth edition, 1990.

 Banker, G.S., Rhodes, C.T., Modern Pharmaceutics, Second Edition, 1990.

 Goran Alderborn et.al., Pharmaceutical Powder Compaction Technology, Marcel Dekker, Inc., 1995

 Lachman, L., et.al., The Theory and Practice of Industry Pharmacy, 3rd Ed., 1986

 W.A. Ritschel und Bauer‐Brandt, A., Die Tablette, 2002

 Sucker, H., et.al., Pharmazeutische Technologie, 2 neubearbeitete Auflage, 1991

 K. Jens Carstensen, Advanced Pharmaceutical Solids, Taylor and Francis, 2001

 Sundani Nurono, S., Buku Pelajaran Teknologi Farmasi, Terjemahan Ulang, 1985

 Moji Christianah Adeyeye, Preformulation In Solid, Dosage Form Development, Informa Healthcare, 2008