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File: Pharmaceutical Formulations Pdf 151951 | Mpharm Syllabus
pharmaceutics 5 pharmaceutical process validation regulatory basis validation of sterile products solid dosage forms pharmaceutics i process validation and non sterile analytical method validation product development and formulations 6 quality ...

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                                        PHARMACEUTICS                                                   5.  Pharmaceutical Process Validation  
                                                                                                            Regulatory basis, Validation of sterile products; Solid dosage forms, 
                 Pharmaceutics - I 
                                                                                                            Process Validation and non-sterile Analytical method validation. 
                 (PRODUCT DEVELOPMENT AND FORMULATIONS)                                                 6.   Quality Control: Process of dosage forms Process control  
                 1.  Preformulation Studies                                                                 Control  of  quality  Validation,  Control  of  manufacturing  Process, 
                     Objective  of  preformulation  and  methodology,  solid  state  properties             Statistical  quality  control,  Control  charts,  Sampling  plans,  Automated 
                     partition  coefficient,  solubility,  dissolution,  crystal  form  and  stability,     and  process  control,  Doses  form  control,  Testing  programme  and 
                     compatibility studies,  dissolution  of  drug  substances  and  dosage  form           method,  Product  Identification  systems,  Adulteration,  Misbranding, 
                     design.                                                                                Maintenance  of  record,  Manufacturer’s  reliability,  Manufacturer/drug 
                 2.  Kinetic principles and stability testing                                               information profile. 
                     Order  of  reaction,  influence  of  pH,  temperature,  acid-base  catalysis,      7.  Bioequivalence and its determination, study design for assessment of 
                     Effect  of  ionic  strength  on  degradation,  complex  reactions,  amide              bioavailability and bioequivalence. 
                     hydrolysis,  ring  alteration,  oxidation-reduction,  chemical  and  physical          Correlation of in-vitro dissolution and in-vivo bioavailability,  
                     stability of dosage forms. Influence of packaging components on dosage                 Statistical concepts in estimation of bioavailability and bioequivalence. 
                     form stability.                                                                    8.  Pharmacokinetics 
                 3.  Optimization                                                                           Consideration  of  one,  two  and  multiple  compartment  models  of 
                     Optimization Technique in Pharmaceutics, formulation and processing.                   intravenous  administration,  intravenous  infusion  and  first  order 
                     Optimization parameters, statistical design and application.                           absorption of single dose regimens. Kinetics of multiple dosing dosage 
                 4.  Documentation                                                                          regimens, loading dose, maintenance doses, one and two compartment 
                     Relevance and importance of documentation, statuary requirements and 
                     procedure for documentation, critical examination of documents. 
                     models on intravenous administration and first order absorption of single         Pharmaceutics – II   (INDUSTRIAL PHARMACY) 
                     dosing.                                                                           1.   General Consideration, Preparation of Master Manufacturing    
                                                                                                       Procedure. 
                 Books Recommended                                                                     Material handling, Blending, Granulation, Drying, Slugging, Compression, 
                     1.  Lachman,  Leon  and  H.A.  Lieberman.  The  theory  and  industrial           Coating,   Liquid  Dosage  forms,  Contract  manufacturing  materials 
                                     rd
                         pharmacy, 3  edition. Varghese publishing Co.                                 management, Sales forecasting, cost control. 
                     2.  Gilbert S.  Banker and C. T. Rhodes, Modern Pharmaceutics. Marcel             2.  Production and Planning Management - 
                         Decker.                                                                       Space   allocation,   Environmental    factors,   Manufacturing,    materials 
                     3.  Barnard T.L. and Robert A. Narth, Pharmaceutical process validation           management, sales forecasting, Cost control. 
                         volume 23, Marcel Decker.                                                     3.  Drug Regulatory Methods 
                     4.  Norman  A.  Hodges  and  Stephen  P.  Denyer,  hand  book  of                 Definitions,  Federal  food,  drug  and  cosmetic  Act;  Kafaurver  Harre’s 
                         Microbiology Quality Control Tayler and francies, London.                     Amendments, New Drug Application, Drug efficacy study implementations, 
                     5.  Horth Tonneson, Photostability of Drugs and Drugs formulations,               Patents, Copy right, Trade Marks, Drug recalls, Product liability, Intellectual 
                         Taylor and Frances, London.                                                   Property rights (IPR), Clinical trails. 
                 Pharmaceutics –I  Practicals                                                          4.  Good Manufacturing Practices 
                 To illustrate the topics included under theory.                                       GMP in manufacturing, Processing, Packing and holding of drug ; control of 
                                                                                                       components  containers  and  closures,  Production  and  process  controls; 
                                                                                                       packaging  and  labeling  controls,  Inspection  for  compliance  with  GMP, 
                                                                                                       Potable  water  standards;  Premises;  design,  construction,  maintenance, 
                                                                                                       equipment maintenance, warehousing, ISO 9000 series. 
                   5.  Polymers and their application                                                             equipment,  Product  Uniformity  and  stability.  Raw  material  and  process, 
                   Nomenclature,       Polymer      classification,    Physicochemical       properties,          Physical Layout, Personal requirements & Reporting responsibilities. 
                   Chemistry,  Blends  of  polymer  and  properties  of  blends,  Evaluation  of                  8.  Industrial Safety  
                   polymer,  Medical  and  surgical  applications  of  polymer,  polymerization                   Industrial Results due to Fire, Accidents, Medical & electrical Equipments, 
                   mechanism,  polymerization  methods,  Properties  of  polymers  and                            Chemicals  &  Pharmaceuticals.  Monitoring  and  prevention  system  of 
                   characterization, Mechanism of drug release from polymers, Application of                      Industrial effluents, testing & treatment. 
                   Polymers in controlled release of active agents and in other formulations.                     Books Recommended 
                   6.   Packaging Materials Science                                                                    1.   Lachman, leon and  H.A. Lieberman, The theory and practices of 
                                                                                                                                                     rd
                   Packaging design and specifications, packaging validation trial, material of                             industrial pharmacy, 3  edition, Varghese publishing Co. 
                   construction, component product validation regulatory requirements, Quality                         2.   Gilberts S. Banker and C.T. Rhodes, Modern Pharmaceutics Marcel 
                   control  testing  and  standards,  GMP  requirement  and  its  deficiencies;  In                         Decker. 
                   process control during component manufacture, documentation, sterilization                          3.   Kennerth  Harburn,  Quality  control  of  packaging  material  in  the 
                   of packaging components; packaging and filling equipment; Pharmaceutical                                 Pharmaceutical Industry. 
                   packaging including sterile filling area; customer complaints.                                      4.   Sidney     H.     Willing,    Good      Manufacturing       Practice     for 
                   7.   Pilot plant Scale up Technologies                                                                   Pharmaceuticals Marcel Decker Inc. 
                   Signification of pilot plant scale up phase to affect an orderly step up from                       5.   Kinam  Park,  Shalaby.  S.W.  and  Haesun  park,  Biodegradable 
                   Laboratory procedures and formulations to routing production procedures.                                 Hydrogel of drug delivery, Technomic basel. 
                   Pilot  study  of  some  important  dosage  forms  such  as  tablets  capsules  &                    6.   Armstrong,  N.A.  and  James  K.C.,  Pharmaceutical  experimental 
                   Liquid  orals  &  Discussion  on  important  parameters  such  as  formula  &                            design and interpretation, Tayler and Francies London. 
                         7.   Brody,  A.L.  and  Marsh,  K.S.,  Encyclopedia  of  packaging                             Pharmaceutics – III 
                              Technology, John Wiley and sons, New York. 
                                                                                                                        (Advance Drug Delivery systems) 
                     
                                                                                                                        1.   Fundamentals of Controlled release Drug Delivery systems  
                    Pharmaceutics – II Practical 
                                                                                                                        Fundamentals  and  rational  of  sustained  /  controlled  delivery,  factors 
                    To illustrate the topic included under theory. 
                                                                                                                        influencing  the  design  and  performance  of  sustained  /  controlled  release 
                     
                                                                                                                        products, Drug targeting, Use of polymers in controlled release of active 
                     
                                                                                                                        agents,  Pharmacokinetics  /  Pharmacodynamic  basis  of  controlled  drug 
                     
                                                                                                                        delivery systems, Regulatory requirements. Application of Pharmacokinetics 
                     
                                                                                                                        in the design & development of drug delivery systems. 
                     
                                                                                                                        2.  Design and Fabrication of Controlled Drug Delivery systems 
                     
                                                                                                                        Novel chemical approaches for sustained drug delivery systems, Parenteral 
                     
                                                                                                                        products,  implantable  systems,  transdermal  systems,  ocular,  intra-vaginal 
                     
                                                                                                                        intra-uterine systems. 
                     
                                                                                                                        3. Biochemical and Molecular Biology : Approaches for Controlled Drug 
                     
                                                                                                                        delivery 
                     
                                                                                                                        Microparticulate drug carriers ; Liposomes, Microspheres and cells, selective 
                     
                                                                                                                        endocytosis of macromolecular drug carriers, Antibodies for drug delivery, 
                     
                                                                                                                        Research erythrocytes, Niosomes. 
                     
                                                                                                                        4.  Advances  in  the  monitoring  of  pharmacotherapeutics  and  in  drug 
                     
                                                                                                                        delivery system design. 
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...Pharmaceutics pharmaceutical process validation regulatory basis of sterile products solid dosage forms i and non analytical method product development formulations quality control preformulation studies manufacturing objective methodology state properties statistical charts sampling plans automated partition coefficient solubility dissolution crystal form stability doses testing programme compatibility drug substances identification systems adulteration misbranding design maintenance record manufacturer s reliability kinetic principles information profile order reaction influence ph temperature acid base catalysis bioequivalence its determination study for assessment effect ionic strength on degradation complex reactions amide bioavailability hydrolysis ring alteration oxidation reduction chemical physical correlation in vitro vivo packaging components concepts estimation pharmacokinetics optimization consideration one two multiple compartment models technique formulation processing i...

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