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ORGANIC SPECTROSCOPY

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DR ANTHONY MELVIN CRASTO Ph.D

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......https://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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The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients


The new APIC Guidance on Handling of Insoluble Matter and Foreign Particles in the Manufacture of Active Pharmaceutical Ingredients

The occurrence of foreign particles in the manufacture of active pharmaceutical ingredients is always undesirable. For the responsible QA departments it involves an increased effort as concerns the search for the root causes and for CAPA measures. A new APIC Guidance offers concrete recommendations for the GMP compliant handling of foreign particles in APIs, intermediates and raw materials.

Foreign particles in APIs or medicinal preparations are undesirable and sometimes lead to a recall of the batches concerned. Depending on the type of particles their presence in active pharmaceutical ingredients may be harmless; in many cases they are inevitable. In any case the manufacturer must find an adequate way how to handle those impurities visible to the human eye. The search for a guideline or another official document in the relevant regulations is in vain. Visible particles or fibres are only mentioned in the USP chapter <790>, in chapter 2.9.20 of the European Pharmacopoeia as well as in the United States Food, Drug and Cosmetic Act (FD&C Act).

In order to remedy this lack of guidance or recommendations a group of experts within APIC has drawn up a guidance on the handling of foreign particles. This “Guidance on Handling of insoluble Matter and Foreign Particles in APIs” describes in detail

  • the types of particles which can often occur during the manufacture of APIs, API intermediates and raw materials (including packaging materials),
  • suitable measures to minimize the presence of particles or to remove them,
  • how to determine them analytically
  • how to identify the source and to carry out subsequent CAPA measures and an adequate risk management.

This APIC guidance offers valuable assistance for all API manufacturers that are confronted with the problem of the occurrence of foreign particles in their products, intermediates or raw materials. The implementation of the very concrete and practicable recommendations in this guidance offers also valuable supporting arguments for GMP inspections or audits and can help to avoid unpleasant surprises.

http://www.gmp-compliance.org/enews_05022_The-new-APIC-Guidance-on-Handling-of-Insoluble-Matter-and-Foreign-Particles-in-the-Manufacture-of-Active-Pharmaceutical-Ingredients_9300,S-WKS_n.html

 

 

 

///////APIC Guidance,   Handling of Insoluble Matter and Foreign Particles, Manufacture, Active Pharmaceutical Ingredients

Application of Process Modelling Tools in the Scale-Up of Pharmaceutical Crystallisation Processes


Abstract Image

Crystallisations are frequent process steps in the manufacture of active pharmaceutical ingredients (APIs). They are the primary means of intermediate or product formation and separation to achieve the desired purity and form. These unit operations are complex processes which are difficult to control due to the interlinked chemical and physical effects. For example, chemical aspects such as salt and polymorph concerns are in the forefront of process research, but physical effects manifesting themselves on scale-up, due to equipment influences, can be equally important for the successful outcome of a campaign. Several operational parameters, such as temperature or impeller speed, need to be understood and controlled to achieve constant desupersaturation, consistent narrow particle size distribution around the desired mean, minimal attrition, and homogeneous growth conditions. This paper focuses on the equipment influence on crystallisations, relating it to first principles with respect to heat and momentum transfer, analysing it with computational fluid dynamics (CFD), and demonstrating its process impact using examples from recent development work. Dynamic process modelling and CFD are state-of-the-art engineering tools to identify process requirements and match them with equipment capabilities. The work reported here demonstrates how a semiquantitative application of these tools can lead to a controllable, robust process in an existing plant despite the time and resource limitations usually encountered in the industry.

http://pubs.acs.org/doi/full/10.1021/op040013n

Application of Process Modelling Tools in the Scale-Up of Pharmaceutical Crystallisation Processes

GlaxoSmithKline Pharmaceuticals, Old Powder Mills, Tonbridge, Kent, United Kingdom
Org. Proc. Res. Dev.20048 (6), pp 998–1008
DOI: 10.1021/op040013n

Characterization of the “hygroscopic” properties of active pharmaceutical ingredients


J Pharm Sci. 2008 Mar;97(3):1047-59.

Characterization of the “hygroscopic” properties of active pharmaceutical ingredients.

Source

SSCI, Inc., West Lafayette, IN, USA. ann.newman@aptuit.com

http://www.ncbi.nlm.nih.gov/pubmed/17630643

Abstract

The amount of water vapor taken up by an active pharmaceutical ingredient (API) as a function of relative humidity is routinely evaluated to characterize and monitor its “hygroscopicity” throughout the drug development process. In this minireview we address the necessity of going beyond the measurement of water vapor sorption isotherms to establish the various mechanisms by which solids interact with water and the important role played by the crystalline or amorphous form of the solid. Practical approaches for choosing experimental conditions under which water vapor sorption should be measured, including the pre-treatment of samples and the time allowed to reach an equilibrium state are presented. With the assistance of a flowchart, we provide a basis for the systematic examination of samples to establish the likely mechanisms of sorption and the indicators pointing toward future problems with physical and chemical instabilities. Finally, we present strategies for managing materials that might be susceptible to the detrimental effects of water vapor sorption.

(Copyright) 2008 Wiley-Liss, Inc.

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