MSc Pharmaceutical Industry Advanced Training (PIAT) / Course details

Year of entry: 2021

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Course unit details:
Solid Oral Dosage Forms 2 (PIAT 7)

Unit code PHAR71070
Credit rating 15
Unit level FHEQ level 7 – master's degree or fourth year of an integrated master's degree
Teaching period(s) Variable teaching patterns
Offered by Pharmacy
Available as a free choice unit? No

Overview

This unit builds on the teaching from Oral Solid Dosage Forms – 1. It begins by covering the basic pharmacokinetic concepts associated with oral controlled release and continues with an introduction to polymer science. This is followed by sections on matrix release systems and reservoir systems.

Further topics include the manufacture of soft gelatin capsule, the formulation of poorly soluble compounds, formulation and process design, evaluation of oral solid dosage forms, experimental design and design of experiments, continuous manufacturing of oral solid dosage forms and expert systems. 

Aims

The unit aims to build on what was learned in the PHAR17040: Solid Oral Dosage forms - 1 by introducing students to:

  • pharmacokinetics of multiple dosing and modified release;
  • formulation of modified release oral solid dosage forms;
  • polymer chemistry;
  • formulation and manufacture of soft gelatin capsules;
  • formulation of poorly soluble drugs;
  • evaluation of oral solid dosage forms;
  • formulation and process design and development;
  • experimental design;
  • continuous manufacturing for oral solid dosage forms;
  • expert systems.

Teaching and learning methods

Students are provided with the learning material in soft copy form. The learning material comprises 13 chapters and builds on the foundational knowledge acquired in PHAR71040 to cover more in-depth themes relating to oral solid dosage forms. Each chapter contains a number of exercises together with suggested answers for students to check their learning as they progress through the unit. A reference list of further reading is provided for each chapter allowing the student to investigate the subject area more deeply, and the unit tutor is available to answer queries and provide guidance as required. The face-to-face workshop at the annual workshop event explores key areas of the unit through a range of hands-on exercises and practical demonstrations.


 

 

Knowledge and understanding

Students should be able to: 

  • Understand the reasons for and the formulation of modified release oral solid dosage forms. 
  • Understand sufficient polymer chemistry to work efficiently with polymer chemists.
  • Understand the formulation and manufacture of soft gelatin capsules.
  • Understand the requirements for the formulation design and development process and experimental designs.
  • Understand the differences between traditional manufacture and continuous manufacturing for oral solid dosage forms.
  • Understand the evaluation of oral solid dosage forms. 

Intellectual skills

Students should be able to: 

  • Assess the applicability of different delivery technologies for the formulation of poorly soluble drugs.
  • Demonstrate awareness of expert systems and how they can be applied in pharmaceutical formulation.

Practical skills

Students should be able to:

•    Advise on the formulation design and development of modified release oral solid dosage forms, and the formulation of poorly soluble compounds (including soft gelatin capsule).
•    Provide input on the evaluation and control of oral solid dosage forms.
•    Advise on current trends in the design, development and manufacture of oral solid dosage

Assessment methods

Method Weight
Written assignment (inc essay) 100%

Feedback methods

Feedback returned by email within 15 working days.

Recommended reading

References cited, and suggested further reading, are given at the end of the individual chapters of the unit.  Eg:

•    Gibaldi M, Biopharmaceutics and Clinical Pharmacokinetics; Lee & Febinger, Philadelphia, PA, (1984), Figure 1.4, p5.
•    Jantzen GM and Robinson JR, Chapter 15: Sustained- and Controlled-Release Drug-Delivery Systems, in Modern Pharmaceutics, 4th Ed., Banker GS, Siepman J and Rhodes CT (eds.), (2002), Marcel Dekker, New York, p. 748.
•    Karim A, (1988), Importance of assessing “food effects” in evaluating controlled release formulations, in Oral sustained release formulations: Design and evaluation, Yacobi A and Halperin-Walega E (eds.), Pergamon Press, Oxford, 157 – 181.
•    Collett JH and Dhillon S, Chapter 22: Dosage regimens. in: Aulton’s Pharmaceutics: The Design and Manufacture of Medicines, 4rd Ed. Aulton ME and Taylor KMG (eds.), Churchill Livingston, (2013), pp. 355 - 366.
•    Guidance for Industry; SUPAC-MR: Modified Release Solid Oral Dosage Forms; Scale-Up and Post-Approval Changes: Chemistry, Manufacturing, and Controls; In Vitro Dissolution Testing and In Vivo Bioequivalence Documentation, FDA, September 1997.

Study hours

Independent study hours
Independent study 150

Teaching staff

Staff member Role
Richard Moreton Unit coordinator

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