Formulation Development of Pharmaceuticals

Formulation Development of Pharmaceuticals

  • Edward Russak added an answer:
    What is the best source for information about light sensitive medications?
    What is the best source for information about light sensitive medications?
    Edward Russak · University at Buffalo, The State University of New York

    This link may be useful

  • Syed Umer added an answer:
    What is the Polymer of choice now a days for SR Tablets?

    We want to synthsize and evaluate new polymers for SR Tablet formulations and need your expertize in this regard.

    Syed Umer · University of Balochistan

    Thank you Harita for your valuable information. Actually we are interested in newly synthsized polymers. We already have synthsized PGA, PGA-Co-Caprolactone and Pentadecalactnes etc and want to use them in drug formulations.. 

  • Dr. Mayur Mohanrao Aitawade asked a question:
    Does anyone have information about Emulsifiable Concentrate (EC or E).

    Please give any information regarding the same in view of Agrochemicals.

  • Geeta Yadav added an answer:
    What are the main drawbacks of conventional anti-malarial therapy ?
    Conventional antimalarial therapy has numerous disadvantages as far as the patient is concerned. I am looking for the major disadvantages which are preventing the therapy to be utmost useful as far as its action is concerned
    Geeta Yadav · Institute of Chemical Technology, Mumbai

    thanks Paula for your reply.

  • Fakhrul Khan added an answer:
    Can IDR be performed for innovator study or not?
    IDR is mainly performed for pure API. As per USP, we should take time points up to 10 % of labelled amount taken or the point up to which linearity is maintained without disturbing the surface area. My question is whether IDR can be performed for innovator characterization of dissolution. If yes, how many time points should we consider and what is the advantage of doing this? If the dose of the product is 0.1 mg, then it is very difficult to prepare a pellet by compaction. In that case how to proceed?
    Fakhrul Khan · Galgotias University

    http://www.gelfand.umd.edu/Imai&Gelfand2009.pdf

    http://pubmedcentralcanada.ca/pmcc/solr/mlt;jsessionid=4433A5F76B20427EA7A431E304B7D1EB.thrasher?mltid=2085684&idtype=acc&term=author%3A(%22Amidon%2C+Gordon+L.%22)&pageSize=25

  • Fakhrul Khan added an answer:
    How can we optimize the Pullulan for Oral Dispersible fims?
    Because pullulan is available in different viscosity , which one is better and what temperature is better for its drying? Moreover, I have seen the addition of thickening agents to pullulan. Is it necessary for all variety of grades of pullulan?
    What is the best RPM and temperature to be maintained in the layering machine.
    Fakhrul Khan · Galgotias University

    i hope these links will help you

    https://www.google.co.in/url?sa=t&rct=j&q=&esrc=s&source=web&cd=1&cad=rja&uact=8&ved=0CBsQFjAA&url=http%3A%2F%2Fwww.ijppsjournal.com%2FVol4Suppl3%2F2869.pdf&ei=_9jZU7S9CpKD8gXckoGwCA&usg=AFQjCNHtPApes9jf3swZ_RS94DLhCLxnRg&bvm=bv.72185853,d.dGc

    https://www.google.co.in/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&cad=rja&uact=8&ved=0CCwQFjAC&url=http%3A%2F%2Fglobalresearchonline.net%2Fjournalcontents%2Fvolume9issue1%2FArticle-024.pdf&ei=_9jZU7S9CpKD8gXckoGwCA&usg=AFQjCNH-Qx1QHsIxJc-N_Bm4iyIF_l33eA&bvm=bv.72185853,d.dGc

    https://www.google.co.in/url?sa=t&rct=j&q=&esrc=s&source=web&cd=3&cad=rja&uact=8&ved=0CCwQFjAC&url=http%3A%2F%2Fglobalresearchonline.net%2Fjournalcontents%2Fvolume9issue1%2FArticle-024.pdf&ei=_9jZU7S9CpKD8gXckoGwCA&usg=AFQjCNH-Qx1QHsIxJc-N_Bm4iyIF_l33eA&bvm=bv.72185853,d.dGc

    http://www.ijpras.com/pdfs/june_issue/Formulation_and_Evaluation_of_Mouth_Dissolving_Film_of_Ropinirole_r.pdf

    http://ijperonline.com/jan_mar_2011/74-80.pdf

  • Fakhrul Khan added an answer:
    I am looking for process of converting Phentermine HCL into a Phentermine Resin. Any ideas on process or source?
    Phentermine Resin
    Fakhrul Khan · Galgotias University

    i hope these links will help you

    https://www.google.co.in/url?sa=t&rct=j&q=&esrc=s&source=web&cd=7&cad=rja&uact=8&ved=0CDwQFjAG&url=http%3A%2F%2Fwww.inchem.org%2Fdocuments%2Fpims%2Fpharm%2Fpim415.htm&ei=xDfXU9mCFIbJuAT_74DABg&usg=AFQjCNEusA5Xfr5bzVwz96f8CCQSdJWK0A&bvm=bv.71954034,d.c2E

    https://www.google.co.in/url?sa=t&rct=j&q=&esrc=s&source=web&cd=10&cad=rja&uact=8&ved=0CFIQFjAJ&url=http%3A%2F%2Fwww.google.co.in%2Fpatents%2FUS8580298&ei=xDfXU9mCFIbJuAT_74DABg&usg=AFQjCNE_ooQLRL3mmaloJCGboFblzGhndw&bvm=bv.71954034,d.c2E

  • How many grams of sample are suitable for a formulation development experiment?
    I am starting an experiment to evaluate the effect of excipients on the behaviour of a cream. However, I don't know the suitable quantity of the cream for the formulation of the development study in general. My test for validation only needs about 50 mg of cream. I am the newcomer of this field.

    Hi for All

    Although I highly agree with Abhay Asthana, but I think the papers attached have much information pleas check out them

  • Kamal Jonnalagadda added an answer:
    What is the significance of using the reduced factorial model instead of full factorial model?

    When we use the full factorial model for any design for formulating any dosages form, we get responses that are significant and some response aren't. Since they have some values I would like to know aren't they affecting final result and why do we only consider the significant models in design study.

    Kamal Jonnalagadda · University of the Sciences in Philadelphia

    The only rationale is to cut down on the toal number of experiments, and elimiate factors that may have no contribution to your desired outcome.

  • What are the different types of coating available for tablet formulations? Is gastric resistance the only condition for coating?
    What are the different types of coating available for tablet formulations? Is gastric resistance the only condition for coating?
    Chandrasekaran Arcot Ravindran · Allianze University College of Medical Sciences
    coating depends on the API.
    Sugar coating now a days reducing.
    coating is to protective coat - from degradation by moisture.
    coating - aqueous coating, non aqueous coating
  • Arafat Idrees added an answer:
    What is the best criteria to choose a polymer which is competible with a lipophilic drug to incorporate in transdermal patches.
    Please give the detail.thanks
    Arafat Idrees · Hajvery University
    Eudragit
  • Pieter Annaert added an answer:
    Why does Invirase (saquinavir mesylate) have less bio-availability than Fortovase (saquinavir) from a formulation point of view?
    In some cases, we add rotinavir to invirase to enhance the bioavailability of invirase.
    Pieter Annaert · KU Leuven
    As far as I know, the standard approach is to add ritonavir (or cobicistat) whenever a protease inhibitor (like saquinavir) is administered. In other words, boosted HIV PI therapy is the standard and unboosted HIV PI-based regimens have become an exception.
    Whereas a formulation that promotes the dissolution of saquinavir may enhance the bioavailability (also) by saturating intestinal CYP enzymes, ritonavir will certainly also affect hepatic CYP3A activity, thus influence the half-life of saquinavir. The latter may not be achieved through the formulation.
    I am not sure what is meant by "patient aesthetics", but it is clear that a formulation that can be stored at room temperature is preferred over a formulation that expires within 3 months, except when kept in the fridge.
  • Shailender Mohan added an answer:
    Does the moisture content of API not need to be changed even after wet granulation and further drying process?
    see above
    Shailender Mohan · Rajasthan University of Health Sciences
    polymorphs do effect the physicochemical and biopharmaceutical property of the API as they owe different solubility and stability in different solvent and at different pHs/temp. Moisture presence may change the polymorphic state of API that will ultimately effects it bio-availability.
  • Daniel M Kamiński added an answer:
    Which solvent can be used for eudragit RS100 for nanoparticle formulation?
    I am trying to prepare nanoparticles with alcoholic herbal extract. Suggest to me polymers that can be used?
    Daniel M Kamiński · University of Life Sciences in Lublin
    SLES (detergent) can be an option it is used in many cases also for drugs. Another option is kolifor or ricin oil. In all cases the taste will be terrible :)
  • Ramy N Elsergany added an answer:
    Why does charcoal from different manufacturers have different adsorption capacities?
    Adsorption Isotherm.
    Ramy N Elsergany · Delta University for Science and Technology
    Yes, but what is the cause? Let us suppose that different manufacturing process can lead to difference in the adsorption capacity. OK

    There are many factors affect the adsorption:
    1-Concentration
    2-Temperature and pH
    3-Particle size of adsorbate (solute)
    4-Contact time between adsorbent and adsorbate
    5-Particle size of adsorbent (surface area)

    Where factors from 1 to 4 are related to adsorbate where factor 5 is linked to adsorbent. The smaller the particle size, the higher surface area exposed to the solute that leads to more adsorption.
    So, we can see that adsorption capacity of M. Indica activated charcoal is 0.076 while the capacity of A. Indica activated charcoal is 0.026.

    This difference can be attributed to the internal surface area available for adsorption which is characteristic to each source. The question in this case; if porosity can be a significant factor in adsorption capacity of each source where an equilibrium may be established between the molecules adsorbed in the small cavities and the molecules adsorbed on the surface and this may be a source difference in the manufacturing conditions.
  • Ramy N Elsergany added an answer:
    What is the role of P-chart as SQC in ensuring good quality of a pharmaceutical product?
    Statistical quality control.
    Ramy N Elsergany · Delta University for Science and Technology
    Yes, thank you for valuable information.
  • Nguyen Nhung added an answer:
    Is T max considered as important in sustained release formulation (IM Route)?
    Our formulation is acheving t max in 48 hrs where as the reference formulation is attaining in 4 days, although our formulation attain T max quickly but our C max is almost same as the reference.
    Nguyen Nhung · Hanoi University of Pharmacy
    I think, it really depends on therapeutic requirement of the formulation.
    For example, if the active ingredient is time dependent antibiotic, time above MIC is nearly the most important one (not Tmax)
    For sustained release formulation, personally the time above MEC should be much considered than T max
  • Ramy N Elsergany added an answer:
    What is the most important US pharmacopeial test for PVP?
    Particularly from formulation point of view?
    Ramy N Elsergany · Delta University for Science and Technology
    The most important test is peroxides level which is NMT 400 ppm. The peroxides level comes from related impurities produced during its synthesis. The peroxides are known as potent oxidizer agents for drugs liable for oxidation.
    An accident reported by FDA for crospovidone batch produced by Chinese Pharmaceutical Company where the peroxides level are more than 400 ppm. FDA reported that any pharmaceutical manufacturers of any products contain this crospovidone batch should be rejected. Also, FDA reported that the limit of peroxides in PVP or crospovidone should not be more than 400 ppm.
  • Syed Umer added an answer:
    How can the solubility of a lipophilic drug be enhanced?
    I want to enhance the solubilty of clofazimine, which is a lipophilic drug. Any suggestions?
    Syed Umer · University of Balochistan
    Thank you Dhakshna for the information.
  • Dhakshna Moorthy added an answer:
    compression of coated pellets
    can any one help me with live example, how to protect pellets from cracking while compression in an ER product.
    Please do not suggest what is in the litrature. I went through them and tried them but of no use.
    please suggest me from industrial prospective.
  • Hassan Reza added an answer:
    What is the possible formulation approaches for reduction of the Hepato-toxic side effect of nimesulide?
    The metabolite of nimesulide is of known hepatotoxicity.
    Hassan Reza · Aavishkar (PVT) Ltd.
    Why not if we go for Oro dispersible tablets(odt)???
  • Ramy N Elsergany added an answer:
    Why does paracetamol need a certain moisture level and binder concentration for good compression into a tablet?
    With acceptable hardness and friability.
    Ramy N Elsergany · Delta University for Science and Technology
    Yes, Paracetamol has an elastic property which means recovery its initial state after compression or tapping. So, type of binder is very important for such materials like PVP which is plastic deformed under compression force. The concentration of PVP in this case is very important (dilution potential). But Aviclel, for example, is a binder but its capillary structure can absorb water in this case.
  • Hassan Reza added an answer:
    Implementation of DESIGN OF EXPERIMENT to Pharmacy curriculum is necessary ?
    As per current ICH guidelines, Q8R2 is the current demand of the pharmaceutical formulation development to implement Quality By Design in the pharma industry. Therefore, the chemists and scientists should have the knowledge of QbD. However, academics show the least amount of interest.
    Hassan Reza · Aavishkar (PVT) Ltd.
    actually the concept of the study should be bit more practical and not just solving problems rather than sitting and solving complicated numerical .... lot of software are available now a days .... only thing required is the proper interface of the students with the concept of the topic of designs and QbD.
  • Peter Rue added an answer:
    What is concentrated water?
    I was making a dilution and there was a mention of using 'concentrated water'.
    Peter Rue · Aston University
    Actually, its made from dehydrated water but by adding less than the recommended volume of solvent
  • Harald Enzmann added an answer:
    What factors should be considered to show significant therapeutic efficacy of a compound over another?
    Big issue on patentability of new forms of known compounds like esters, morphs, derivatives etc. In India.
    Harald Enzmann · Bundesinstitut für Arzneimittel und Medizinprodukte
    And file three of three
  • Imran Khan asked a question:
    Can anyone suggest which solvent to use to obtain chromatogram from Contramid?
    Contramid is a high amylose starch use for controlled release of drugs.
  • Ingo Schreiber added an answer:
    Which polymer produces thickening effect in oily material or organic solvent?
    In formulation of dosage form with oily material, I need to add thickening agent. Which is the best thickening agent?
    Ingo Schreiber · Aromatarius et Unguentarius
    For which application of your formulation you want to use a thickener?
  • Tejas Ganatra added an answer:
    What is the influence of ulcerative colitis on colon pH?
    And can develop pH sensitive system in case of ulcerative colitis?
    Tejas Ganatra · School of Pharmacy, RK University
    As I know, in severe/active Ulcerative colitis, the pH of colon will become low (towards acidic side).
    Here are some reference which support this:
    http://www.ncbi.nlm.nih.gov/pubmed/8223071
    http://www.salix.com/healthcare-professionals-resources/gi-digest-newsletter/gi-digest-archive/index/intraluminal-ph-in-ulcerative-colitis.aspx
  • Sarita Shah added an answer:
    How to determine the % cumulative drug release from PLGA microparticles?
    I am determining the in vitro drug release profile from micro-particles, where I have 10 mg microparticles suspended in 5 ml release medium and at each time points I withdraw 1 ml of supernatant (replacing with 1 ml of fresh release medium) and analyze it with HPLC. However, I am getting a bit confused regarding % cumulative release calculations. Do I simply add up the percentage release values at each time points? My confusion is that since I withdraw just 1 ml (out of 5 ml) for analysis, do I need to account for total volume and how do I account for dilution when I replace with 1 ml fresh media? Any help will be appreciated. Thank you.
    Sarita Shah · Rice University
    You could also remove all of the medium and replace it with fresh. You would also create a better sink for release that way. Centrifuge the PLGA microparticles down and carefully aspirate with a pipetter.

About Formulation Development of Pharmaceuticals

Formulation development of various dosage forms

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