Formulation Development of Pharmaceuticals

Formulation Development of Pharmaceuticals

  • Ramy N Elsergany added an answer:
    What is the most important US pharmacopeial test for PVP?
    Particularly from formulation point of view?
    Ramy 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.
  • Abhay Asthana added an answer:
    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.
    Abhay Asthana · Maharishi Markandeshwar University, Mullana
    The objective is to evaluate the effect of excipients on cream formulation. In this case you would be using various excipients with your ointment base and medicament in appropriate pre-decided ratio. One thing as you stated the minimum quantity that is required by you must always be kept in mind including limit of detections and number of trials sufficient enough to calculate statistical figure. Second is your cream texture analysis, description, content, viscosity and stability study etc., which are all very essential parameters to be considered while developing any cream formulation. For example if you had emulsified your preparation than optimization of surface active agents with respect to not only their quantity but HLB value in your formulation will be your prime objective. Thus adding all these at end point for evaluation purpose, you can get to the quantity required. I recommend you to first make a list of "critical parameters" to be accessed and thereafter, other important parameters and studies, in formulation development to decide the batch size. Neve forget to include packaging evaluation in your formulation development, with respect to stability and shelf-life estimation. Good Luck.
  • 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 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.
  • Mahmoud Samy Abdallah 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.
    Mahmoud Abdallah · Tanta University
    For studies to determine bioequivalence of sustained release preparation in single dose studies , AUC(0-τ) and Cmax,should be analysed. A statistical evaluation of tmax is not required. However, if rapid release is claimed to be clinically relevant and of importance for onset of action or is related to adverse events, there should be no apparent difference in median tmax and its variability between test and reference product.
  • 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?
  • 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.
  • Humera Ahmad asked a question:
    I am looking for process of converting Phentermine HCL into a Phentermine Resin. Any ideas on process or source?
    Phentermine Resin
  • Ramy N Elsergany added an answer:
    Does the moisture content of API not need to be changed even after wet granulation and further drying process?
    see above
    Ramy Elsergany · Delta University for Science and Technology
    Solvates are known as pseudopolymorphs in which solvent like ethanol or isopropyl alcohol is a part of crystalline structure of the drug. when the solvent is water, it can be called as hydrates. Polymorphs are known to have different physical, chemical and may biopharmaceutical properties like dissolution rate and bioavailability. For example, Theophylline anhydrous form has higher bioavailability than theophylline monohydrated form. This is due to water acts as bridge that links two molecules of theophylline that requires energy during dissolution process. So, if we have hydrated form of drug like pefloxacin mesylate dihydrate (moisture content by Karl Fischer 7.5-8.5%), and is processed by wet granulation and subjected to drying in FBD. The change in moisture content (by KF) can lead to change in the biopharmaceutical properties if the two forms having different properties. So, in line monitoring by NIR must be designed in FBD to determine the moisture content during drying stage to avoid the bad impact on biopharmaceutical properties of drug. Crystalline solids Vippagunta SR1, Brittain HG, Grant DJ
  • 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
  • Hassan Reza asked a question:
    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.
  • 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.
  • 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 Everyone for your Answers !!!
  • Adam J Smith 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?
    Adam Smith · University of South Florida
    You may find this paper useful. "Nanolipidic particles improve the bioavailability and alpha-secretase inducing ability of epigallocatechin-3-gallate (EGCG) for the treatment of Alzheimer's disease."
  • 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.
  • Ram Vikas added an answer:
    measuring zeta potential .
    is there any alternative way to measure zeta potential other than zeta meter????
    Ram Vikas · Sanofi, India
    Do in Malvern's Nano Zeta sizer.
  • Titus Sobisch added an answer:
    Can pure DMSO be used as a vehicle in mice?
    I need to do anticancer activity and some biochemical parameters of plant extract in mice, my extracts dissolves well in pure DMSO. Is it safe to use pure DMSO as a vehicle if not, what percentage of dilution is normally recommended?
    Titus Sobisch · LUM GmbH
    what do you think of ethyl lactate, which maybe a similar or better solvent than DMSO.
  • Dr. M. P. Venkatesh asked a question:
    How can in situ gel using PDLL and Pluronic F-127 be made? Suggest any common solvent?
    Drug to be incorporated is water insoluble.
  • siva Mallika Donepudi added an answer:
    Find free full text scientific articles in PDF Format
    Find free full text scientific articles in PDF Format. This search engine indexes more than 10 millions of free references (mostly to journal articles, conference papers and technical reports). http://goo.gl/248em Regards jeevan
    siva Mallika Donepudi · Acharya Nagarjuna University
    Thank for the link
  • Kishore Rapolu added an answer:
    How can I produce thyroxine coated microspheres of poly(DL-lactide-co-glycolide) ?
    We are attempting to formulate a one monthly injectable for thyroxine. I am aware this has previously been done by through the use of an extrusion method.
    Kishore Rapolu · HLL Lifecare Limited
    Good question... But if u want to deliver the thyroxine release for one month, coating is not sufficient on Poly DL..... Possibility is you have to make thyroxine loaded microspheres...
  • Gaetano Ragno added an answer:
    What should be the temperature and humidity settings of the stability chamber, while assessing the photostability of an orally used dosage form?
    Pharmaceutics.
    Gaetano Ragno · Università della Calabria
    The temperature must be maintained by a cool device
  • Sarasija Suresh added an answer:
    How can I mask the odour of amino acids by simple methods?
    I don't have many resources, so what are the simplest methods that can be used to prepare tablets of amino acids?
    Sarasija Suresh · National Institute of Pharmaceutical Education and Research
    Cyclodextrins are used to enhance the water solubility of lipophilic drugs. Cyclodextrins have a hydrophobic core where the lipophilic drug forms an inclusion complex or the so-called host-guest complex. The drug is held within the cyclodextrin cavity because of Van-der-Waals forces and further stabilised by intermolecular interactions. The charge and polarity of the guest compound influence the complex formation. In general, highly water-soluble molecules are unsuitable for cyclodextrin complexation.
  • Fakhrul Khan added an answer:
    Which transdermal polymer gives more drug release and drug penetration across skin barriers?
    In formulation of transdermal patch, which is the most suitable polymer for fast drug release and drug penetration.
    Fakhrul Khan · Galgotias University
    i hope this link could be helpful for you, http://www.ncbi.nlm.nih.gov/pmc/articles/PMC2700785/
  • Titus Sobisch added an answer:
    How to produce emulsion with unkonwon oil?
    As a part of research work, I have to prepare emulsion of unknown oil. I have tried several emulsifying agents, but can't get it to work. How to formulate stable emulsion?
    Titus Sobisch · LUM GmbH
    In case of fast creaming is a problem you may add e.g. Glycerol.

About Formulation Development of Pharmaceuticals

Formulation development of various dosage forms

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