INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS

INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS

Determine the unit operations needed to manufacture the tablets.
1. Mixing or Blending:
Materials that have similar physical properties will be easier to form a uniform mix or blend and will not segregate as readily as materials with large differences.
Parameters to consider
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  1. REVIEW:- INDUSTRIAL PROCESS VALIDATION OF TABLET

    http://www.pharmatutor.org/…/review-industrialprocess-validation-tablet-dosa…

    You are hereREVIEW:- INDUSTRIAL PROCESS VALIDATION OF TABLET …. Process Evaluation and Selection: – Determine the unit operations needed to 

  2. INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR

    pharmaresearchdevelopment.blogspot.com/…/industrialprocessevaluati

    Dec 17, 2010 – INDUSTRIAL PROCESS EVALUATION AND SELECTION FOR TABLETS: Determine the unit operations needed to manufacture the tablets. 1.

  3. industrial process evaluation and selection for tablets

    networkedblogs.com/NAAPU

    2 hours ago – Drug Regulatory affairs by DR ANTHONY MELVIN CRASTO, Worlddrugtracker (by DR ANTHONY MELVIN CRASTO Ph.D)

  4. Guidance for Industry: Extended Release Oral Dosage Forms

    Guidance for Industry Center for Drug Evaluation and Research (CDER) …. initial approval process or because of certain pre- or postapproval changes …. A suitable distribution of sampling points should be selected to define ….. Drug product: A finished dosage form, e.g., tablet, capsule, or solution, that contains a drug.

  5. Guidance for Industry – Food and Drug Administration

    Powder Blends and Finished Dosage Units — Stratified In-Process Dosage Unit Center for Drug Evaluation and Research (CDER) Guidance for Industry[1] …. double cones, or drum mixers), samples should be selected from at least two depths along ….. In-process dosage unit is a capsule or tablet as it is formed in the 

  6. Guidance for Industry – Food and Drug Administration

    Guidance for Industry Center for Drug Evaluation and Research (CDER) …. methods for comparing dissolution profiles; and (4) a process to help immediate release solid oral dosage forms, such as tablets and capsules, are used to …. coefficient measurement may be useful in selecting the dissolution methodology and.
  7. industrial process validation of tablet dosage form: an overview

    evaluating, documenting, and re-evaluating a series of critical steps in the …. form5,6. The strategy selected for process validation should be Simple and straightforward. Industrial process overview of tablet manufacturing5,6,11. Steps and 

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Author: DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with GLENMARK PHARMACEUTICALS LTD, Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 30 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, Dr T.V. Radhakrishnan and Dr B. K. Kulkarni, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 30 year tenure till date Dec 2017, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 9 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 50 Lakh plus views on dozen plus blogs, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 19 lakh plus views on New Drug Approvals Blog in 216 countries......http://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc

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