Pharmaceutics 2: Pharmaceutical Technology

Code

PHAR2056

School

Pharmacy

Level

2

Credits

20

Semesters

Full Year Malaysia

Summary

This module provides a foundation course on the principles that underlie the processing and manufacture of solid dosage forms within the pharmaceutical industry.  The course attempts to provide an understanding of the material science and physical chemistry of pharmaceutical powders, their processing, and subsequent formulation and production into a solid dosage form. The theoretical aspects of the module will be complemented via a series of practical classes that provide advanced skills in the area of pharmaceutical technology and has particular emphasis on the methods, materials and testing procedures associated with the manufacture of pharmaceutical grade tablets. Experiments or demonstrations illustrate the flow properties of powders, mixing and milling of powders, wet and dry granulation methods, powder particle size analysis, tabletting technology and dissolution of dosage forms. The module will draw on basic information and practical skills from level 1 pharmaceutics module.

INTRODUCTION TO PHARMACEUTICAL TECHNOLOGY  (0.5 lecture)

PREFORMULATION  (2.5 lectures) 
Definition. Place within industrial programme. Preformulation tests including colour, taste, purity, measurement of physicochemical properties - solubility, dissolution, particle size, stability, compatibility. Post-preformulation studies.

DRUG CRYSTAL STRUCTURE AND PROPERTIES (3 lectures)
Relevance to pharmacy. Crystal form, polymorphorism, concepts. Solvents, pseudopolymorphorism. Crystal habit, combination of crystallographic forms.  Crystallisation process. Kinetics of crystallisation process. Conditions of crystallisation modifying crystal habit. Prediction of tendency to polymorphorism. Techniques for determining crystal properties, eg, differential scanning calorimetry, thermomicroscopy. Solvent effects on crystals. Poisoning of crystals. Effect of particle size reduction on crystal type. Therapeutic examples. 

PARTICLE SIZE ANALYSIS OF PHARMACEUTICAL POWDERS  (3 lectures)
Spherical particles. Equipment diameters. Distribution of diameters. Normal and lognormal distribution. Probability plots. Sampling and errors in size analysis. Sieving. The Coulter Counter.  Sedimentation. Light scattering. Particle size analysis of aerosols.

PROPERTIES OF PHARMACEUTICAL POWDERS  (3 lectures)
Powder flow - particle size and shape, angle of repose, bulk density, flow from orifices.  Powder mixing - physics of mixing, mixing indices, perfect and random mixes, ordered mixing, demixing.  Powder particle size reduction - advantages and disadvantages, theory of milling, forces during milling, milling process, types of size reduction equipment. 
 
TABLET PROPERTIES AND FORMULATION (5 lectures) Introduction. Different types.  Granulation. Process of powder moistening. Practical aspect of granulation. Dry granulation. Drying to the solid state. Excipients and formulation. Fillers/diluent.  Binder. Lubricants. Glidants. Disintegrants. Compression. Tablet machines - schematic of operation. Physics of tablet composition. Particle - particle interactions. Fell-Newton Law. Heckel equation. Frictional/adhesion forces. Forces within tableting process. Properties of tablets influenced by compression: densities/porosity/specific surface area/pressure and density in tablet. Formulations of Speciality tablets: Direct compression tablets, Effervescent tablets, Sublingual tablets, Buccal tablets, Lozenges and Sustained release tablets. Supportive CAL packages are available. 

COATING OF TABLETS  (1 lecture)
Sugar coating. Film coating. Internal stress in films/plasticizers.  

MATERIAL PROPERTIES OF POLYMERS AND OTHER RELEVANT SOLIDS (2 lectures)
Solid behaviour and properties of important pharmaceutical materials. Theory of diffusion in solid matrices and membranes.

EVALUATION OF TABLET QUALITY AND SPECIFICATIONS  (1 lecture)
Official tests. Weight variation. Uniformity of diameter. Contents uniformity.  Disintegration tests. Unofficial tests. Crushing strength. Resistance to abrasion.

DRUG RELEASE FROM PHARMACEUTICAL DOSAGE FORMS  (2 lectures) 
Drug liberation from prompt release oral dose forms. Biopharmaceutical problems of impaired release. Disintegration mechanism. Factors affecting dissolution: types of disintegrants, disintegration test methods. Dissolution: theoretical aspects, physicochemical, formulation and physiological factors. Dissolution test methods. Practical aspects and problems. 

PELLET DOSAGE FORMS (1 lecture)
Spheronization and extrusion. Coated non pariel pellets.

CAPSULE PROPERTIES AND FORMULATIONS  (1 lecture)
Introduction. Hard gelatin capsules. Shell composition. Capsule production. Prediction of capsule size. Capsule filling. Methods of powder filling. Gravity. Lightly compacted powder. Soft gelatin capsules: Production, formulation. Supportive CAL packages are available. 

PHARMACEUTICAL AEROSOLS  (2 lectures)
Applications of inhalation, inhaled drugs, challenges, delivery systems - nebulisers, metered-dose inhalers, dry powder inhalers: description, formulation, aerosol generation, operation, advantages/disadvantages, manufacture, evaluation. 

REGULATORY LEGISLATION PERTAINING TO QUALITY ASSURANCE (2 lectures)
The essentials of GMP guidelines/regulations for active pharmaceutical ingredients for human, herbal/plant products, and veterinary products. Guidelines to good distribution practices and good storage practices in pharmaceutical industry.

OPTIMIZATION TECHNIQUE IN PHARMACEUTICAL INDUSTRIES (3 lectures)
The basic concept of quality by design and lean six sigma in pharmaceutical industries. Definition and concept of quality target product profile. Determination and measure of critical quality attributes, quality risk assessment, design of experiments, verification and control, statistical quality control and continuous improvement.

STERILITY IN PHARMACEUTICAL MANUFACTURING (4 lectures)
Factors affecting microbial antimicrobial agents, sterile pharmaceutical products, contamination and spoilages, sterile manufacturing process and quality control, sterilisation techniques and sterility assurance.

Workshop 
There is one workshop (2hr) associated with the course.  This involves two elements, (1) a staff led review of the course and common problems encountered in examinations and (2) an interactive problem solving session based upon key elements of the course and past exam questions.    

PRACTICAL 1: POWDER PROCESSING (6 hours)

PRACTICAL 2: DIRECT COMPRESSION (6 hours)

PRACTICAL 3: GRANULATION (6 hours)

PRACTICAL 4: DISSOLUTION STUDIES (2 hours demonstration)

Target Students

BSc Pharmaceutical and Health Sciences students

Classes

• One 2-hour workshop each week for 2 weeks
• One 1-hour lecture each week for 11 weeks
• Two 1-hour lectures each week for 12 weeks
• One 2-hour laboratory
• One 6-hour laboratory each week for 3 weeks

Assessment

• 20% Practical write up: In module (proforma/report)
• 20% ExamSys: In module (45 min, semester 2)
• 60% Written Exam (2-hour): 2 hours (end of semester 1)

Assessed by end of autumn semester

Educational Aims

Learning Outcomes

Provides the student with the fundamental science base of physical chemistry and its relationship to medicine design, manufacture and stability. Basic science crucial to understanding many future parts of the BSc Pharmaceutical and Health Sciences programme. Deductive reasoning, problem solving, numerical analysis, information retrieval and analysis, library and literature searching are also supported.

After successful completion of this module, you should be able to:
A. Knowledge and understanding
• A3 Principles of design, manufacture and performance of dosage forms

B. Intellectual skills
• B1 Critically appraise, analyse and summarise information
• B2 Undertake independent, reflective, self-directed learning
• B3 Understand principles of experimental and research methodology
• B4 Cite and reference work appropriately

C. Professional/practical skills
• C2 Undertake practical experimental work using appropriate materials, operating procedures and instruments

D. Transferable/key skills
• D1 Effective communication in a variety of forms, including written, verbal and visual
• D2 Critically use information resources, including library and electronic sources
• D3 Work effectively as an individual or as part of a team

Conveners

• Dr Wai Hau Tung