BIO09065 2016 Formulation and Delivery of Biopharmaceuticals

General Details

Full Title
Formulation and Delivery of Biopharmaceuticals
Transcript Title
Formulation and Delivery
Code
BIO09065
Attendance
N/A %
Subject Area
BIO - Bio Tech/Eng/Chem
Department
LIFE - Life Sciences
Level
09 - NFQ Level 9
Credit
05 - 05 Credits
Duration
Semester
Fee
Start Term
2016 - Full Academic Year 2016-17
End Term
9999 - The End of Time
Author(s)
Ailish Breen
Programme Membership
SG_SBPRO_M09 201600 Master of Science in Bioprocessing SG_SBPRO_O09 201700 Postgraduate Diploma in Science in Bioprocessing SG_SBPRO_M09 201600 Master of Science in Bioprocessing
Description

This module deals with advanced methods of biopharmaceutical formulation and finish for stable drug delivery other than oral dosage forms which are not typically used for biopharmaceuticals.

Learning Outcomes

On completion of this module the learner will/should be able to;

1.

Describe the key principles of preformulation.

2.

Discuss the delivery methods for modern therapeutic proteins such as antibodies, growth factors etc.

3.

Outline various non-invasive methods for drug delivery such as nasal, pulmonary, transdermal etc.

4.

Describe polymer-based and lipid-based systems of drug delivery.

5.

Explain the principal methods of characterisation of modern drug delivery systems

6.

Describe the operating principles of various formulation technologies such as freeze drying (lyophilisation), spray drying, mixing, microencapsulation and homogenisation.

7.

Describe the causes and effect of protein instability and post-translational modification including glycosylation

Teaching and Learning Strategies

Teaching and learning will be performed using online learning to supplement classroom based teaching, enquiry based learning and evidence based learning. The learning outcomes will be matches to the QQI Award Standards for Science in knowledge, know how and competence.

 

Module Assessment Strategies

The assessment approach for this module will be 100% Continuous Assessment with a range of assessment methods employed including some of the following: short-form assessment exams incl. MCQ’s, project assignments, practical work, group reports and essays and oral presentations.

Repeat Assessments

Repeat assignments will be given

Indicative Syllabus

Topics covered will include some of the following: pre-formulation in advance of actual formulation; the design and characterisation of biopharmaceutical drug delivery systems; non-invasive methods of drug delivery - nasal, pulmonary, transdermal etc.; polymer-based, lipid-based methods of drug delivery; formulation technologies such as freeze drying, spray drying, microencapsulation, mixing and homogenisation.

Coursework & Assessment Breakdown

Coursework & Continuous Assessment
100 %

Coursework Assessment

Title Type Form Percent Week Learning Outcomes Assessed
1 Continuous Assessment Continuous Assessment Assessment 100 % OnGoing 1,2,3,4,5,6,7
             
             

Full Time Mode Workload


Type Location Description Hours Frequency Avg Workload
Online Lecture Online Online Lecture 1 Weekly 1.00
Directed Learning Flat Classroom Workshop / tutorial 2 Weekly 2.00
Total Full Time Average Weekly Learner Contact Time 3.00 Hours

Required & Recommended Book List

Recommended Reading
2001-12-25 Pharmaceutics: The Science of Dosage Form Design, 2e Churchill Livingstone
ISBN 0443055173 ISBN-13 9780443055171

A comprehensive textbook covering the design of dosage forms and all aspects of drug delivery systems. 'Pharmaceutics' in its broadest sense is the 'art of the apothecary' or, in simple terms, pharmaceutical preparations. It remains a diverse subject in the pharmacy curriculum, encompassing design of drugs, their manufacture, and the elimination of micro-organisms from the products. This books encompasses all those areas and pays particular attention to the design of dosage forms and their manufacture.

Recommended Reading
2013-12-16 Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs Wiley-Blackwell
ISBN 111817979X ISBN-13 9781118179796

"Biotechnology and Biopharmaceuticals: Transforming Proteins and Genes into Drugs, Second Edition" addresses the pivotal issues relating to translational science, including preclinical and clinical drug development, regulatory science, pharmaco-economics and cost-effectiveness considerations. The new edition also provides an update on new proteins and genetic medicines, the translational and integrated sciences that continue to fuel the innovations in medicine, as well as the new areas of therapeutic development including cancer vaccines, stem cell therapeutics, and cell-based therapies.

Recommended Reading
2005-09-14 Therapeutic Peptides and Proteins: Formulation, Processing, and Delivery Systems, Second Edition CRC Press
ISBN 0849316308 ISBN-13 9780849316302

Upon publication of the first edition of Therapeutic Peptides and Proteins ten years ago there were only 19 biotechology medicines on the market. Currently there are more than 100, with at least 400 more in various stages of development. That alone would be grounds for a new edition. Add to that the fact that it is still difficult to find up-to-date, relevant information on protein formulation and/or delivery systems and the need for a new edition is self-evident. This second edition continues the tradition of providing a ready-to-use reference of accurate information, tables, and illustrations.

The book begins with the basics of the origin of recombinant proteins, explores structural and analytical aspects, and moves on to discuss the stability of proteins and peptides. Against this background, the author addresses preformulation and formulation considerations and provides detailed information on important topics such as lyophilization. He goes on to discuss various delivery systems, including controlled release delivery systems and products currently on the market. The book also contains newly added regulatory information and thoroughly investigates therapeutic drugs made from proteins as well as protein-based vaccines. A new chapter on recombinant protein subunit vaccines and their delivery systems has been added.

The work of a single author, the book provides complex information in a simple, elegant, and cohesive style. The author minimizes overlap between coverage and includes extensive cross-referencing that links related topics. Completely revised and updated, packed with cutting-edge information, the second edition once again fills the need for a reference that pulls all the relevant information together into one resource.

Module Resources

URL Resources

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Other Resources

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Additional Information

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