PHARMACEUTICAL PRODUCTION TECHNOLOGY

Improved  Tablet  Production:   Tablet production process, unit operation improvements, granulation and pelletization equipments, continuous and batch mixing, rapid mixing granulators, rota granulators, speronizers and marumerisers, and other specialized granulation and drying equipments.  Problems encountered. 

Coating Technology:    Process, equipments, particle coating, fluidized bed coating, application techniques.   Problems encountered. 

  

Parenteral  Production:      Area planning & environmental control, wall and floor treatment, fixtures and machineries, change rooms, personnel flow, utilities & utilities equipment location, engineering and maintenance. 

Lyophilization Technology:  Principles, process, freeze-drying equipments.   

  

Capsule Production:   Production process, improved capsule manufacturing and filling machines for hard and soft gelatin capsules.  Layout and problems encountered. 

Disperse Systems Production:  Production processes, applications of mixers, mills, disperse equipments including fine solids dispersion,   problems encountered.  

  

Packaging  Technology:    Types of packaging materials, machinery, labeling, package printing for different dosage forms.   

Air Handling Systems:  Study of AHUs, humidity & temperature control, air filtration systems, dust collectors. 

PHARMACEUTICAL PRODUCT DEVELOPMENT

Preformulation Studies: Molecular optimization of APIs (drug substances), crystal morphology and variations, powder flow, structure modification, drug-excipient compatibility studies, methods of determination.

Formulation Additives: Study of different formulation additivies, factors influencing their incorporation, role of formulation development and processing, new developments in excipient science, determination methods, drug excipient interactions.  Design of experiments – factorial design for product and process development. 

Solubility: Importance, experimental determination, phase-solubility analysis, pH-solubility profile, solubility techniques to improve solubility and utilization of analytical methods – cosolvency, salt formation, complexation, solid dispersion, micellar solubilization and hydrotropy. 

Dissolution: Theories, mechanisms of dissolution, in-vitro dissolution testing models – sink and non-sink. Factors influencing dissolution and intrinsic dissolution studies. Dissolution test apparatus – designs, dissolution testing for conventional and controlled release products.  Data handling and correction factor. Biorelevent media, in-vitro and in-vivo correlations, levels of correlations.

Product Stability: Degradation kinetics, mechanisms, stability testing of drugs and pharmaceuticals, factors influencing-media effects and pH effects, accelerated stability studies, interpretation of kinetic data (API & tablets). Solid state stability and shelf life assignment. Stability protocols, reports and ICH guidelines. 

BIOPHARMACEUTICS AND PHARMACOKINETICS

Bioavailability and Bioquiovalence:   Objectives, bioavailability & variations, measurements of bioavailability, enhancing bioavailability, concepts of equivalents, official bioequivalence protocols & therapeutic equivalence. 

 

Drug Absorption:  General consideration, absorption / drug transport mechanisms, role factors affecting absorption, absorption of drug non-peroral routes, methods of determining absorption-in-vitro, in-situ, and in-vivo methods. 

Drug Distribution:  Factors affecting, protein & tissue binding, kinetics, determination of rate constants & different plots (direct, Scatchard, & reciprocal). 

Pharmacokinetcs:    Parameters & determination, pharmacokinetic models – one compartment, multi compartment in IV bolus, IV infusion & extra vascular, drug & metabolites levels in blood, urine and other 

biological fluids.  Integration of kinetics. 

Application of pharmacokinetics in new drug development, design of dosage forms and novel drug delivery systems.   

Drug Disposition and Excretion:   Biotransformation,  factors  affecting biotrasformation, Phase I &  Phase-II reactions. 

Clearance:  Concept, renal, non-renal clearance, mechanism, determination, % drug metabolized, different volume of distribution.   

Pharmacokinetics of Multiple Dosing:   Various terminology, determination, adjustment of dosage in renal & hepatic impairment, individualization of therapy, therapeutic drug monitoring. 

Non-linear kinetics:   Cause of non-linearity, estimation of various parameters, bioavailability of drugs that follow non-linear kinetics. Chronopharmacokinetics & pharmacokinetics of elderly and infants. 

QUALITY ASSURANCE

Quality Assurance Systems:  Basic concept of quality control & quality assurance, functions, sources of variation, quality assurance for raw materials,  APIs, packing materials & finished products (specifications, receipt, testing, sampling and certificate of analysis), production (change control, aseptic process control, temperature, pressure & humidity control tests, tests for air flow pattern, microbiological monitoring) buildings & facilities (design and construction features, construction materials, lighting, air handling systems, sanitation & maintenance) equipments (construction, cleaning and maintenance, calibration & handling).

In-process quality control:  Importance, inspection, IPQC tests for tablets (weight variation, hardness, thickness, friability, disintegration tests and content uniformity), suspensions and emulsions  (appearance and feel, volume check, viscosity, particle size distribution, electrical conductivity and content uniformity) and parenterals (pH, volume check, clarity, content uniformity, integrity of seals and particulate matter). Problems encountered and trouble shooting.

Thermal Methods of Analysis: Principles, instrumentation and applications of thermogravimetric analysis (TGA), differential thermal analysis (DTA), differential scanning calorimetry (DSC), and thermo mechanical analysis (TMA).

X-Ray Diffraction Methods: Origin of X-rays, basic aspects of crystals, X-ray    crystallography, miller indices, rotating crystal technique, single crystal diffraction, powder diffraction, structural elucidation and applications.

Good Laboratory Practices:  Scope, organization, personnel – desirable qualities of analyst, responsibilities of key personnel in the QC lab.  Validation of analysis methods. Facilities, equipments, testing facilities operation – systems and procedures in QC lab, analytical worksheet, test methods, evaluation of test results.  Test and control articles – incoming samples, retention samples, reference materials, reagents, specification reportory.  Safety guidelines in QC lab.

 
  Statistical Quality Control:   Scope, sampling – importance, sampling plans, sample size, statistical consideration - probability, frequency distribution. Sampling procedures, handling, labeling & preservation.  Analysis of data, Control charts – X charts, R charts, applications.

ADVANCES IN DRUG DELIVERY SYSTEMS

Concept & Models for NDDS:   Classification of rate controlled drug delivery systems (DDS), rate programmed release, activation modulated & feedback regulated DDS,  effect of system parameters in controlled drug delivery, computation of desired release rate and dose for controlled release DDS, pharmacokinetic design for DDS – intermittent, zero order & first order release. 

Carriers for Drug Delivery:   Polymers / co-polymers-introduction, classification, characterization, polymerization techniques, application in CDDS / NDDS, biodegradable & natural polymers. 

 

Study of Various DDS:  Concepts, design, formulation & evaluation of controlled release oral DDS, Mucoadhesive DDS (buccal, nasal, pulmonary). 

 

Transdermal Drug Delivery Systems:  Theory, design, formulation & evaluation including iontophoresis and other latest developments in skin delivery systems. 

Advances in Drug Delivery:  Pulsatile, colon specific, liquid sustained release systems. 

    

Targeted Drug Delivery Systems:  Importance, concept, biological process and events involved in drug targeting, design, formulation & evaluation, methods in drug targeting – nanoparticles, liposomes, niosomes, pharmacosomes, resealed erythorocytes, microspheres, magnetic microspheres.  Specialized pharmaceutical emulsions – multiple emulsions, micro-emulsions. 

 

Protein / Peptide Drug Delivery Systems:  Concepts, delivery techniques, formulation, stability testing, causes of protein destabilization, stability and destabilization.   

Biotechnology in Drug Delivery Systems:  Brief review of major areas-recombinant DNA technology, monoclonal antibodies, gene therapy.