Chhattisgarh Swami Vivekanand Technical University, Bhilai (C.G.)

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1 Scheme of Teaching and Examination Master of Pharmacy (M. Pharm) (Pharmaceutical Technology) IInd Semester S. No. Board of Study Subject Code Subject Periods per Week Scheme of Examination Theory / Practical L T P ESE CT TA Total Marks Credi t L+(T +P)/2 1 Pharmacy (41) Pharmaceutical Technology -I (Advanced Drug Delivery Systems) Pharmacy (41) Pharmaceutical Technology -II (Biopharmaceutics and Pharmacokinetics) Pharmacy (41) Pharmaceutical Technology -III (Product Development) Pharmacy (41) Pharmaceutical Technology -IV (Packaging Technology) Pharmacy (41) Pharmaceutical Technology I Lab (Advanced Drug Delivery Systems) Pharmacy (41) Pharmaceutical Technology II Lab (Biopharmaceutics and Pharmacokinetics) Pharmacy (41) Pharmaceutical Technology - III Lab (Product Development) Total L Lecture, T Tutorial, P - Practical, Duration of Theory Paper 3 Hours ESE End Semester Examination, CT Class Test, TA Teacher Assessment

2 Semester: M-Pharm. II Semester Branch: Pharmacy Subject: Pharmaceutical Technology-I Code: (41) (Advanced Drug Delivery Systems) Total Theory period: 50 Total Tutorial period: 12 Unit - 1: Controlled Drug Delivery Fundamentals of controlled release (CR) drug delivery: Rationale of sustained/controlled drug delivery, physicochemical and biological factors influencing design and performance of CR products Theory of mass transfer: Fick's first and second laws and their applications in drug release and permeation. Unit 2: Vesicular Carrier Drug Delivery: Preparation, evaluation and applications of liposomes, niosomes, ethosomes, transfersomes, pharmacosomes, phytosomes, polymeric micelles, multiple emulsions, micro- emulsions. Unit 3: Particulate Carrier Drug Delivery: Preparation, evaluation and applications of nanoparticles, microspheres, magnetic microspheres, microparticles, microcapsules and resealed erythrocytes. Unit -4: Protein and Peptide Drug Delivery: Concepts, delivery techniques, formulation, stability testing, causes of protein destabilization, stability and destabilization. Polymers/co-polymers- introduction, classification, characterization, polymerization techniques, application in CDDS/NDDS. Biodegradable and natural polymers. Unit - 5: Targeted Drug Delivery Systems: Importance, concept, biological process and events involved in drug targeting, design, formulation & evaluation, methods in drug targeting. Pulsatile & Colon specific drug delivery, brain specific drug targeting, drug targeting to tumor cells, ophthalmic targeting and nasal targeting. Unit-6: Transdermal Drug Delivery Systems: Theory, design, formulation and evaluation of transdermal patch. Iontophoresis, Implantable products and other latest developments in skin delivery systems. 1. Robinson JR and Lee VHL. Controlled Drug Delivery - Fundamentals and Applications. Vol. 29 and Vol. 31, Marcel Dekker, New York. Latest 2. Bruck SD. Controlled Drug Delivery. Vol. I (Basic Concepts), CRC Press, Florida. Latest 3. Bruck SD. Controlled Drug Delivery. Vol. II (Clinical Applications), CRC Press, Florida. Latest 4. Tyle P and Ram B. Targeted Therapeutic Systems, Marcel Dekker, New York. Latest 5. Chein YW. Novel Drug Delivery System by, Marcel Dekker, Inc. 6. Vyas SP and Khar RK. Targeted and Controlled Drug Delivery. CBS, New Delhi. Latest 7. Jain NK. Advances in Controlled and Novel Drug Delivery. CBS, New Delhi. Latest

3 Semester: M-Pharm. II Semester Branch: Pharmacy Subject: Pharmaceutical Technology-II Code: (41) (Biopharmaceutics and Pharmacokinetics) Total Theory period: 50 Total Tutorial period: 12 Unit 1: Clinical Pharmacokinetics Introduction, pharmacokinetic relationships, duration of response, kinetics of pharmacological response, explanation of clinical response via pharmacokinetics, monitoring of plasma concentrations of drugs during clinical use including problems encountered in clinical investigations, individualization of dosage and dosage regimen, variability, genetics, age, weight, disease, interacting drugs. Unit -2: Biopharmaceutics Review of physicochemical, pharmaceutical and physiological variables affecting absorption. Bioavailability and bioequivalence concepts, assessment of bioavailability from serum and urine level data, crossover design and analysis of bioequivalence trials. Unit-3: Pharmacokinetics Models Basic consideration, Pharmacokinetic models, Compartment modeling: One compartment model IV bolus, IV infusion, Extra-vascular; Multi Compartment models; Two compartment model Iv bolus, IV infusion, Extra-vascular, Three Compartment model in brie, Application of Pharmacokinetics in new drug development and designing of dosage forms and Novel drug delivery systems. Unit -4: In vitro and In vivo Correlations (IVIVC) Concepts, biopharmaceutical classification scheme, various IVIVC approaches with applications and limitations, dissolution as a surrogate to bioavailability for immediate release and extended release formulations, IVIVR, IVIVM. Unit -5: 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. 1. Wagner JG. Fundamentals of Clinical Pharmacokinetics, Drug Intelligence Publication, Hamilton. Latest 2. Wagner JG. Pharmacokinetics for the Pharmaceutical Scientist, Technomic, Pennsylvania. Latest 3. Shargel L, Yu ABC and Wu-pong S. Applied Biopharmaceutics and Pharmacokinetics McGraw- Hill Medical Publishers, New Delhi. Latest 4. Gibaldi M and Perrier D. Pharmacokinetics. Informa Healthcare, New York. Latest 5. Gibaldi M. Biopharmaceutics and Clinical Pharmacokinetics, Lea & Febiger, Philadelphia. Latest 6. Dressman B and Lennernas H. Oral Drug Absorption: Perdiction & Assessment, Marcel Dekker, New York. Latest 7. Bourne DEA. Mathematical Modelling of Pharmacokinetic Data. Technomic, Technomic, Pennsylvania. Latest 8. Welling PG and Tse FLS. Pharmacokinetics: Regulatory, Industrial and Academic Perspectives, Marcel Dekker, New York. Latest 9. Gibaldi M and Prescott L. Handbooks of Clinical Pharmacokinetics, ADIS, New York. Latest 10. Rowland M and Tozer TN. Clinical Pharmacokinetics: Concepts and Applications, Lippincott Williams & Wilkins. New York. Latest

4 Semester: M-Pharm. II Semester Branch: Pharmacy Subject: Pharmaceutical Technology-III Code: (41) (Product Development) Total Theory period: 50 Total Tutorial period: 12 Unit -1: Tablet Technology: Layout of facilities, materials flow, quality assurance procedures, and design of facilities, construction considerations, equipment consideration, environmental consideration, materials management and inventory control of tablet production. Unit -2: Parenteral Technology: Processing of small volume parenterals (SVP s) and related sterile products: Planning and scheduling, material and personnel management, documentation control. Facilities - AHU's, humidity and temperature controls, air filtration systems, dust collectors, etc. Manufacturing including various aspects of preparing SVP solutions, suspensions, powders/freeze dried powders for reconstitution, filling, sealing, inspection and labeling. Manufacture of LVP s: Raw materials including water, stability, storage and inventory control, batch mixing, clarification by membrane filters and support systems. Parenteral controlled drug delivery systems. Unit -3: Cosmetic Technology: Formulation considerations of various cosmetic products, skin preparations, hair preparations and their evaluation techniques, Cosmetic regulations, GRAS agents, preservatives, natural raw materials used in cosmetics. Novel approaches of cosmetics. Clear shampoo, hair cream, Face wash, Sunscreen Lotion, Antiwrinkle cream, herbal cosmetics etc. Unit-4: Herbal drug Technology: Extraction Techniques for Herbals, Role of Process Simulation to Extraction Technologies, Maceration, Percolation and Infusion Techniques for the Extraction of Herbals, Decoction and Hot Continuous Extraction Techniques, Microdistillation, Thermomicrodistillation and Molecular Distillation Techniques, Solid Phase Micro-extraction and Headspace Trapping Extraction, Supercritical Fluid Extraction, Flash Chromatography and Low Pressure Chromatographic Techniques for Separation of Phytoconstituents, Quality Control of Plants or herbals and their Extracted Products. Phytochemical screening and Antioxidant Assays. Unit-5: Pharmaceutical Engineering Technology: Crystallization, drying, mixing, filtration, cryopreservation, pelletization techniques, granulation techniques, hot melt extrusion technology. Fluidized bed granulator, specialized mixers, equipments for humidification and dehumidification operations. Design and environment control of manufacturing area, colloids, lyophilization. 1. Lieberman HA and Lachman L. Pharmaceutical Dosage Forms: Tablets. Vol. I, II and III, Marcel Dekker, New York. Latest 2. Avis KE, Lachman L and Lieberman HA, Pharmaceutical Dosage Forms: Parentera1s. Volume I and II, Marcel Dekker, New York. Latest 3. Badger W L and Banchero JT. Introduction to Chemical Engineering, McGraw Hill, NY. 4. Remington JP, Science and Practice of Pharmacy. Lippincot Williams and Wilkins, New York. Latest

5 Semester: M-Pharm. II Semester Branch: Pharmacy Subject: : Pharmaceutical Technology-IV Code: (41) (Packaging Technology) Total Theory period: 50 Total Tutorial period: 12 Total marks in the end Semester: 100 Minimum of class test to be conducted:2 Unit-1: Packaging of Injectable, Ophthalmic and Aerosols Unit-2: Plastics containers for pharmaceuticals Classification of plastics, plastic polymers and their physio-chemical, mechanical and biological properties: Additives and fabrication processes, plastic container for parenteral and transfusion sterile drip kits. Quality control testing and biological toxicity. Unit-3: Paper and paperboard, Types of paper, folding cartons, quality control testing to paper and paperboard. Glass containers for pharmaceuticals, glass types, their manufacture chemical performances testing and quality control. Metal containers, Aluminum and tinplate drums collapsible tubes and aerosol containers, lacquering, coating and lining. Caps and Closures; Types caps closure liners, child resistant caps, and Elastomeric closures for parenterals, classification of elastomers, physical chemical and biological properties and their quality control. Unit-4: Packaging and labeling technology Labels and labeling; Types of labels, adhesives, inject and barcoding. Flexible packaging - Types of films, Co-extruded films, foils, coating and laminates, shrink and stretch films. Corrugated and solid fibreboards and boxes Types of corrugation methods and types of box design and Quality control. Tamper evident packaging systems - Various types and their mechanism. Unit -5: Packaging Machinery Including strip packaging, form, fill and seal machines, liquid and solid filling machines, capping machines. Product Package compatibility: Stability of product, package selection and development criteria. Reference Books: 1. Martin Alfred, Physical Pharmacy, Lippincott. 2. Handbook of Package Engineering by Joseph. F. Handlon. 3. Packaging Materials & Containers by F.A. Paine 4. Industrial Packaging by Fried man & Kipness. 5. Packaging of Pharmaceuticals, C.F. Ross 6. Packaging laws & Regulation, Chowdhary & Subramanian 7. Wiley s Encyclopedia of Packaging Technology 8. Pharmaceutical Packaging by Dean & Evans

6 Semester : M-Pharm. 2nd Semester Branch : Pharmacy Subject : Pharmaceutical Technology I-Lab Code : (41) (Advanced Drug Delivery Systems) Total Practical period: 72 Total Tutorial period: Preparation and evaluation of different polymeric membranes. 2. Formulation and evaluation of sustained release oral matrix tablet. 3. Formulation and evaluation of sustained release oral reservoir system. 4. Formulation and evaluation of microspheres / microcapsules. 5. Study of in-vitro dissolution of various SR products in market. 6. Formulation and evaluation of transdermal films. 7. Formulation and evaluation of mucoadhesive system. 8. Formulation and evaluation of liposomes. 9. Formulation and evaluation of modified liposomes (ethosomes/ niosomes/ transfersomes). 10. Preparation and evaluation of dermatological formulations. 1. Robinson J R and Lee VHL. Controlled Drug Delivery- Fundamentals and Applications. Vol.29 and Vol.31, Marcel Dekker, New York. Latest Edition. 2. Bruck SD. Controlled Drug Delivery, Vol.1 (Basic Concepts), CRC Press, Florida. Latest 3. Bruck SD. Controlled Drug Delivery, Vol.II (Clinical Applications), CRC Press, Florida, Latest Editions. 4. Tyle P and Ram B Targeted Therapeutic Systems, Marcel Dekker, New York Latest 5. Chein YW. Novel Drug Delivery System by, Marcel Dekker, Inc. 6. Vyas Sp and Khar RK. Targeted and Controlled Drug Delivery, CBS, New Delhi, Latest 7. Jain NK. Avances in Controlled and Novel Drug Delivery, CBS, New Delhi. Latest

7 Semester : M-Pharm. 2nd Semester Branch : Pharmacy Subject : Pharmaceutical Technology II--Lab Code : (41) (Biopharmaceutics and Pharmacokinetics) Total Practical period: 72 Total Tutorial period: Comparative dissolution studies on different dosage forms for drugs. 2. Effect of ph / particle size on dissolution studies. 3. Plasma protein binding studies on different drugs. 4. Estimation of pharmacokinetic parameters in urine / serum samples. 5. Estimation of creatinine clearance. 6. Estimation of pharmacokinetic parameters for the given urinary excretion data. 7. Estimation of pharmacokinetic parameters for the given oral absorption data. 8. Comparison of dissolution studies of two different marketed products. 9.Calculation ka, ke, t1/2, Cmax/ 10. Calculation of AUC and bioequivalence from the given data for two drugs. 1. Wagner JG. Fundamental of Clinical Pharmacokinetics, Durg Intelligence Publications, Hamilton. Latest 2. Wagner JG. Pharmacokinetics for the Pharmaceutical Scientist, Technomic, Pennsylvania, Latest 3. Shargel L, Yu ABC and Wu-pong S. Applied Bio pharmaceutics and Pharmacokinetics McGraw- Hill Medical Publishers, New Delhi. Latest Edition 4. Gibaldi M and Perrier D Hparmacokinetics. Informa Healthcare, New York Latest 5. Gibaldi M. Biopharmaceutics and Clinical Pharmacokinetics, Lea & Febiger, Philadelphia. Latest 6. Dressman B and lennernas H Oral Drug Absorption : Perdiction & Assessment, Marcel Dekker, New York. Latest 7. Bourne DEA. Mathematical Modelling of Pharmacokinetic Data. Technomic, Technomic, Pennesylvania. Latest 8. Welling PG and Tse FLS. Pharmacokinetics : Regulatory, Industrial and Academic Perspectives, Marcel Dekker, New York. Letest Editions. 9. Gibaldi M and Prescott L. Handbooks of Clinical Pharmacokinetics, ADIS, New York. Latest Editions. 10. Rowland M and Tozer TN. Clinical Pharmacokinetics: Concepts and Applications. Lippincott Williams & Wilkins. New York. Latest

8 Semester : M-Pharm. 2nd Semester Branch : Pharmacy Subject : Pharmaceutical Technology III-Lab Code : (41) (Product Development) Total Practical period: 72 Total Tutorial period : Isolation & screening of industrially important microorganisms 2. Sterility testing of laminar airflow bench top. 3. Shake flask experiment on fermentative production. 4. Product development and protocol preparation using preformulation data for tablets and capsules. 5. Dissolution of drugs in different ph media for comparison of performance with innovator. 6. Stability studies of drugs in dosage forms at 25 o C, 60% RH and 40 o C, 75% RH. 7. Preparation & evaluation of sterile products. 8. Preparation & evaluation of cosmetic products. 9. Preparation & evaluation of herbal cosmetic formulations. 10. Determination of aldehydes in volatile oil. 11. Determination of marker compound in herbal extract by UV/HPLC. 1. Lieberman HA and Lachman L. Pharmaceutical Dosage Forms : Tablets. Vol.I, II and III Marcel Dekker, New York, Latest 2. Avis KE, Lachman L and Lieberman HA, Pharmaceutical Dosage Forms : Parenterals. Volume I and II, Marcel Dekker, New York. Latest 3. Badger W L and Banchero JT, Introduction to Chemical Engineering, McGraw Hill, NY. 4. Remington JP, Science and Practice of Pharmacy. Lippincot Williams and Wilkins, New York. Latest

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