Pharmaceutical Development

Pharmaceutical Development

  • Sanket Niranjanbhai Patel added an answer:
    Any suggested protocol for Nadph oxidase activity assay with luminol?
    I want to quantify the activity of NADPH oxidase in protein solution from cell lysis using luminol and NADPH. Any suggested protocols?
    Sanket Niranjanbhai Patel · University of Houston

    Griendling et al 1994 - Angiotensin II stimulates NADH and NADPH oxidase activity in cultured vascular smooth muscle cells.

    Rajagopalan et al 1996 - Angiotensin II-mediated hypertension in the rat increases vascular superoxide production via membrane NADH-NADPH oxidase activation. Contribution to alterations of vasomotor tone.

  • Shiv Shankar Bingi added an answer:
    What will happen (the mechanism) if tetanus and diphtheria vaccine storage is done at -20 ° C?
    Regarding vaccine storage.
    Shiv Shankar Bingi · Panacea Biotec Ltd.
    Hi Issanto,

    The recommended storage temperature for adsorbed Diphtheria and Tetanus vaccines is 2-8⁰C. Freezing of these vaccines will induce changes in the structure and morphology of adsorbent thereby altering the physical appearance of adsorbed vaccines, whether they are monovalent or combined vaccines. Exposure to freezing temperature will result in development of agglomerates, floccules or other granular matter which produces an increase in sedimentation rates, and the granules do not form a uniform suspension even after vigorous shaking. The size of the granules can increase on repeated freezing and thawing. The amount of antigen present in this non-homogeneous vaccine will vary greatly as most of the antigens will be adsorbed onto the adjuvant, and the administration of such a vaccine may be associated with a reduced immune response or an increased incidence of local reactions such as sterile abscesses. When a vaccine is damaged by freezing, the lost potency can never be restored and the damage is permanent.
  • Jose Martinez Calderon added an answer:
    What is the best statistical test for drug release studies?
    I'd like to hear some people's opinions on what is the most appropriate statistical test to perform on data from drug release studies. Specifically, I've been developing nanoparticles that release their drug contents in response to light, and therefore am looking more at the statistical significance at a specific time point(s) (between nanoparticles exposed to light and those kept in the dark) that an overall difference between release profiles. I've been using T-tests (correcting for multiple comparisons) rather than the usual ANOVA, but wanted to hear some additional feedback.
  • How do you calculate a sample size in an in vitro model of new drugs, and what is the best statistical test to analyze it?
    I have 6 molecules to evaluate the anti-inflammatory properties and the possibility to inhibits cancer cells. My model is macrofagos (RAW) stimulated with LPS, and I will evaluate ILs, NFkB & iNOS. But I don't have complete security to use a proposed n of 50000 cell by triplicate in each molecule; second I propose to evaluate with ANOVA two-tails, but in a test I find Schef's test but don't have enough weight to pharmacology. Can anybody help me?
    Victor Hugo Siordia Sanchez · University of Guadalajara
    Thaks Jerome
  • Md Musfizur Hassan added an answer:
    Can someone suggest to me the best thickening agent in a liquid dosage form meeting the following specification?
    I need some characteristic in thickening agent like clarity of thickening agent must be like water and not turbid, medium grade viscosity like oil, good stability, no foaming or bubble formation, giving pH range between 7-9, no odor or bad smell on long term storage, no sedimentation of thickening agent, disperse throughout vehicle. Please suggest a thickening agent that is suited to do this.
    Md Musfizur Hassan · University of New South Wales
    Both HPMC and CMC hear like thickening agent but my experience, they are not good thickening agent, mostly they have suspending property which are mostly used suspension and emulsion but sometimes hinder the homogeneity and clarity of liquid as well as increase the rheological property that may interrupt the pouring of liquid. Sometimes we have some formulations they are very light liquid(Syrup) which is confused with elixir by appearance. In that cases we need to convert it bit a thick.

    My suggestion is optimum concentration of Colloidal silicondioxide with Sodium chloride is best thickening agent of this liquid. Moreover ,sodium chloride will enhance the palatability of the preparation. This is actually the formulation art where we don't focus straightly but they make difference.
  • Harald Enzmann added an answer:
    How I can find those studies with negative results?
    We know that we must avoid the bias produced by publishing/reading only clinical trials with positive results. However, the journals do not accept them (as easily as one with positive results) and the pharmaceutical industry reserves the right to disclose when a product did not yield the expected results. If we must avoid repeating the same mistakes or if we want to know how many negative studies were "necessary" before one tested positive, we need that information. So, where are these data published?
    Harald Enzmann · Bundesinstitut für Arzneimittel und Medizinprodukte
    The public record on medicines that never made it may guide you to negative studies – including negative studies that originally were interpreted positive but were not accepted as positive by the regulators.
    At the EMA website, try:

    Withdrawn applications:

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/wapp_search.jsp&mid=WC0b01ac0580


    Refused applications

    http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d12501d128

    here tick the box refused (and possibly the box withdrawn post approval)

    Go from there, pick any product you are interested in, and for example look at the Q&A for:
    What did the company present to support its application?
    What were the CHMP’s main concerns that led to the refusal?

    kind regards
    Harald
  • Michael J Mitchell added an answer:
    Which nano-formulation is best suitable to target liver cells?
    I would like to prepare nano-formulation to target liver cells, but I am not sure which would be most appropriate to deliver the drug to desired site.
    Nanoparticles clear to the liver when they are deliver systemically. To target liver cells specifically, it is important to focus on the particular targeting agent, such as an antibody or protein, in addition to the nanoparticle.
  • Stephanie A Maddox added an answer:
    Is Clozapine-n-oxide (CNO) in drinking water or chow a good method of delivery for sustained activation of the DREADD receptor?
    I am trying to determine if the use of CNO in drinking water or chow is a reasonable method of delivery for sustained activation of the DREADD receptor.
    Stephanie A Maddox · Emory University
    Not a reference from my lab, but Gary Aston-Jones' lab gave 3 different systemic doses of CNO 0.1, 1.0 and 10mg/kg 20min before a behavioral task and found behavioral effects at all three doses.
    http://www.pnas.org/content/early/2014/02/19/1310025111.full.pdf

    Mark Mayford's lab has a Science paper from a few years back giving systemic CNO in mice at 0.5mg/kg 28mins before behavior and shows behavioral effects. http://www.sciencemag.org/content/335/6075/1513.full
  • Md Musfizur Hassan added an answer:
    How to improve the disintegration for Microcrystalline cellulose pellets prepared by extrusion and spheronization?
    Particularly for BCS class II drugs such as NSAIDs
    Md Musfizur Hassan · University of New South Wales
    Sodium starch glycolate with avicel pH 102 is the best combination to improve disintegration time of pellets.If you use providone as a binder for pelleting than it will be tough to disintegrate. HPMC 5 or 15 cps is the best binder in this case.
  • Harita Desai added an answer:
    What is the effect of some dicarboxylic acids like adipic acid on the amorphous content of certain drug exposed to energetic mechanical processes?
    Mechanical processes used in the pharmaceutical industry like mixing and milling. Such processes have an effect on the bioavailability of these drugs. What is the effect of dicarboxylic acid if mxed or co-milled with the drug during its manufacture?
    Harita Desai · PhD(Tech)-Institute of Chemical Technology, Mumbai
    The mixing or comilling of a drug with dicarboxylic acid leads to interaction between the two by means of various forces like hydrogen bonding, vander waals etc. One of such interaction results in formation of cocrystal which shows changes in the inherent features of drug i.e. crystallinity, stability, solubility etc. The extent of change depends on the pharmaceutical profile of the acid in concern.
    The interaction is governed by the energy changes involved in the respective processes.
  • Muhammad Razi Ullah Khan added an answer:
    How we can decrease the oral intake of medicine?
    As I have seen that many time doctors recommended 25 mg or 50 mg or 100 mg or 500 mg of pills to patient and that medicine metabolites and distributed in complete body. But medicine is required only for specific area of the body yet we used medicine for whole body. I want decrease oral intake of medicine as 1 mg or 2 mg or less and that medicine should utilized only in specific area of the body.
  • Sagar Thoke added an answer:
    What are the possible causes of failure of content uniformity of low dose or potent drugs?
    Particularly for wet granulation process.
    Sagar Thoke · SciTech Specialities Pvt Ltd, India.
    Hello,
    cocentrate on particle size for proper distribution of API
  • 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.
  • Nicolas Nikitin added an answer:
    Who can present me with the 1H-NMR spectra of HP-β-CD & Me-β-CD with numbered hydrogen atoms?
    Here are two spectra of HP-β-CD & Me-β-CD in the file "2CDs.pdf".
    Nicolas Nikitin · Academy of Sciences of the Republic of Bashkortostan
    Thx a lot for your link.
    But unfortunally, my attempts to realize this actions led to nothing
  • Félix Almendra-Arao added an answer:
    Where can I find a guideline for superiority margin to be used in a clinical trial?
    I need a guideline or a reference that contains an explanation of the superiority margin I can use in a clinical trial, or how to decide it. I have found one from FDA for non-inferiority, but none about superiority.
    Félix Almendra-Arao · National Polytechnic Institute
    Dear Thais, you will find a very complete explanation of this and related topics in the book:
    Design and Analysis of Non-Inferiority Trials
    Rothmann, Wiens and Chan.
    Chapman &Hall. 2012.
  • 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
  • Frédéric Balssa added an answer:
    How can I remove the Hg from the floor?
    As we know, mercury is poisonous and it can damage the human nervous system and brain. I want to clean the surface of the floor where mercury has spilled, without using sulphur and wet towel.
    Frédéric Balssa · LHC France

    I used a water vacuum pump with a flask trap to aspirate the large drops and then I spilled sulfur on the floor to destroy the remaining Hg.

  • 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.
  • Dhakshna Moorthy added an answer:
    What is the threshold amount of sorbitol in an oral formulation affecting the bioavailability of the active principle?
    Sorbitol is an excipient used for oral formulations and it is generally know to affect drug bioavailability. However it is not known if there is a threshold.
  • 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)???
  • Hassan Reza added an answer:
    How can I prepare film using pullulan, and what plasticizer suits it?
    Please add the viscosity grade of the pullulan, the plasticizer to be used, the ratio, and if any modification is to be made.
    Hassan Reza · Aavishkar (PVT) Ltd.
    Its used to be in the formulation of film
  • Atanu kumar Behera added an answer:
    What's the effect of solid dispersions on first pass metabolism and protein binding ?
    Do solid dispersions prevent first pass metabolism and protein binding or it enhances?
    Atanu kumar Behera · PPDC, Vadodara
    SD is to improve solubility, so it is going to prevent accumulation and by taking consideration of formulation type u may avoid the FPM to a some extent.......
  • Nashwan Yousif added an answer:
    How does urea come into the stomach so that helicobacter pylori act on urea and cause peptic ulcers?
    Source of urea in the stomach.
    Nashwan Yousif · Ministry of Health, Iraq
    Hi,
    Urea is produced in the liver through metabolism of some amino acid of proteins. Urea then dissolves in blood and excreted in urine. Some urea is also excreted into stomach which becomes a substrate for H. Pylori to be metabolized to ammonia and carbon dioxide.
  • J. Keith Guillory added an answer:
    Can anyone suggest GC method for White Petrolatum?
    I am trying with GC-FID.
    J. Keith Guillory · University of Iowa
    Although intended for petroleum, this might be a good place to start: http://www.restek.com/pdfs/59551A.pdf
  • 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.
  • Swapan Ghosh added an answer:
    Which thickening agent is best for mineral oil?
    In preparation of emulsion with mineral oil like liquid paraffin, I need a thickening agent. Which thickening agent is best for this purpose?
    Swapan Ghosh · Pest Control (India) Pvt. Ltd
    Try with bentonite powder
  • Hassan Reza added an answer:
    Do you agree that all the QC tests for pharmaceuticals we perform are destructive?
    Dissolution, Disintegration, Friability, Assay, etc.
    Hassan Reza · Aavishkar (PVT) Ltd.
    Ya , we can do it in another way . Why there is QC , to check the quality of desired nature is present or not. WHY NOT IF THE DESIRED QUALITY IS INBUILT IN THE PRODUCT WITH REPEATABILITY. This will be helping to bring down the the losses which may incrases sometimes if there is some error. Specially as per ICH guidlines Q8R(2) SUGGEST THE USE OF QUALITY BY DESIGN. YOU CAN CHECK THE GUIDELINES FOR FURTHER DETAILS.
  • Hassan Reza added an answer:
    How to find the best method for taste masking of any drug?
    How can this be checked that for a particular drug the method which is being used is suitable or not if the drug is very costly or is available is very less amount for testing
    Hassan Reza · Aavishkar (PVT) Ltd.
    Well the techniques sound good but only some are effective in large scale , Complexation often results problems while mixing in tanks, beta cylodextrine is a very costly alternative for taste masking in large scale. Even artficial sweetners face regulatory blocking by regulatory bodies like FDA. So whats the practical approach?
    What I suggest is natural sweetners like : licorice , stevia ,etc.
    Secondly using Competitive inhibitors of bitterness like ,sodium chloride, pottasium chloride and citric acid.
    As per my practical concept combination of the two methods can be effective in a effective and economical, what we use up in industry.
  • Ahmed R.Gardouh asked a question:
    I prepared this MIP for the same drug but with BIsacrylamide as a crosslinker and the result was gelatinous material - what are your thoughts?
    Your detailed precipitation polymerization procedure.

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