Pharmaceutical Development

Pharmaceutical Development

  • Pichan Prabhasankar added an answer:
    Is anybody interested in forming an international collaboration for research into formulation development and in vivo evaluation?

    Our major area of research is formulation development and in vivo evaluation. We are doing consultancy for industries too for the same. We would also like to do some collaboration under various schemes of Indian governments between two country researchers. We believe that such collaboration will always strengthen the research activities due to involvement of experts. Any one interested for the same, please contact me.

    Pichan Prabhasankar

    Yes, I am interested for collaboration. Please let me know terms and conditions

  • Nashwan Yousif added an answer:
    Could anyone suggest the best method for storage and shelf life of Gemcitabine after reconstitution?

    I am using a Pharmaceutical preparation of Gemcitabine which is reconstituted in saline for use, in animal models and cell function assays. As I do not have storage information beyond one week after reconstitution, I am trying to use it before that by storing at 4 degrees for that week. Please help if you have any experience with storage beyond one week after reconstitution.


    Nashwan Yousif

    Dear Mr. Srinivasa

    I think that you should depend on the storage conditions stated on the label of the product available to you as these conditions were determined depending on stability study after reconstitution where the product may degrade into ineffective or lower potency products after that. Extending the period of storage should depend on a study to justify that , otherwise, use it as stated on the label or you may not get the expected and reliable results from your experiment


  • Madhukar Baburao Deshmukh added an answer:
    How to separate flavonoids from methanolic extract?
    I have macerated the crude powder with petroleum ether 60-80 and have further extracted with methanol using soxhlet apparatus. After that, I have used rotary vacuum evaporator to concentrate the extract and used freeze drier to dry. Now, how can I separate flavonoids from the extract?
    Madhukar Baburao Deshmukh

    You can separate flavonoids from methanolic extract by column chromatography using solvent Methanol:Chloroform in the proportion ( 0.5 :9.5) by volume.

  • Nirmala S.V.S.G added an answer:
    Does anyone have experience on the pH of crevicular fluid in the periodontal pocket)?
    The available literature is not conclusive, since we find changes that leave the pocket with basic pH (> 8-9) until researchers those postulate the pH is acidic closer to that of the establishment of dental caries process (<4.5). Can anyone help me? I'm in a line of research with polymeric bioadhesive systems for sustained release of drugs into periodontal pocket.
    Nirmala S.V.S.G

    I think you get sufficient information given by Noori Aldallal 

  • Ramkumar Ponnuraj added an answer:
    Do antioxidants in topical formulation act on the surface of skin or do they need to penetrate the Stratum Corneum Layer?

    We know that there are lot of antioxidant topical creams in the market. These antioxidant help to reduce the radicals and prevents for oxidative stress and aging. But I am confused whether these antioxidants act on surface of skin or it need to penetrate into the skin (stratum corneum) to act. Anyone aware about this can help me out. Thanks in advance.

    Ramkumar Ponnuraj

    Thanks Nashwan & Hosam for your reply 

    My drug is natural and it will not create any problem if it gets absorbed into systemic circulation. I thought to improve the therapeutic response of the topical cream on its application.

    As rightly pointed out I need find the physico-chemical properties of Resveratrol and its penetration and will try to find that.

    I will try to get it done using penetration cell enhancer. 

    If any of one could find any other additional details I will be great to hear.

  • Swapnil Borse added an answer:
    What are novel techniques for the estimation of drug interactions pre-clinically?
    Pre-clinical drug-drug interaction (DDI) assessment using in-vivo animal models along with in-vitro human systems based assays, aids in early prediction of clinical interactions possibilities and may help to prevent late phase failure of drug in clinic.
    But DMEs and transporters of animals vary remarkably from humans, thus limiting their use for clinical predictions. Owing to these limitations "humanized" animal models are developed, which serves as a better model for prediction of metabolism and potential DDI in humans.
    Apart from these humanized animal models what are other pre-clinical novel methodologies which are used for investigating/ predicting clinical DDI?
    Swapnil Borse

    @AKM Mahmudul Haque, Dear Its freely available :

  • Andriy V. Proskochilo added an answer:
    Can anyone suggest which solvent to use to obtain chromatogram from Contramid?
    Contramid is a high amylose starch use for controlled release of drugs.
    Andriy V. Proskochilo

    Dear Mr. Imran Khan. Unfortunately I have not found any mentions about the chromatographic study of Contramid. Other methods are discussed in the attached document.

  • Wayne Briner added an answer:
    Does anyone have a manual or a link for the old Szent-Gyorgi & Blum Continuous flow system? Anyone have a manual for this?
    It seems like it might be useful, but not sure what else I would need.
    Wayne Briner


    Thank you so much for your efforts.  Not really the info I am looking for however.

  • Valentino Dhiyu 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.
    Valentino Dhiyu

    I had experience in making paracetamol tablets and met problems exactly as same as yours. 1) yes, paracetamol granules has elastic property make it vulnerable for tablet capping 2) beside optimize the binder and moisture, please also optimize the tablet shape. it will be better to choose caplet shape.

  • Syed Umer added an answer:
    Which one is the best and why in CR tablet formulations as co-excipeint: starch, CMC, or HPMC?
    Tablete Formulations
    Syed Umer

    Thank you indeed Ali A. Razzaq

  • Larry Carey added an answer:
    Does anyone have experience working with any commercially available antibodies for TRPV1 that have worked well for you?

    Or on the other hand, have you used a TRPV1 antibody that has been a failure?

    Larry Carey

    Thanks everyone for your input so far. I know a major concern with these antibodies is their propensity to produce non-specific labeling, and certain ones can label different regions of the TRPV1 receptor giving the appearance of non-specific labeling. Has this issue came up at all with any of these antibodies you all have suggested?

  • Gerry Fitzgerald added an answer:
    Can the amount of amino acid be expressed in % of total amino acid present?
    Analysis was carried out by uplc amino acid analyzer. The result obtained is in the above mentioned question, but in the research paper it is expressed as residue per 1000.
    Gerry Fitzgerald

    Total Dissolved Solids (TDS) are the total amount of mobile charged ions, including minerals, salts or metals dissolved in a given volume of water, expressed in units of mg per unit volume of water (mg/L), also referred to as parts per million (ppm).

    Parts per Million (ppm) is the weight-to-weight ratio of any ion to water.

  • Habibur Rahman added an answer:
    Is there a reduction in temperature for curcumin SLN?
    What is the change of melting point of plain curcumin? What impact is having on the curcumin solubility?
    Significance of curcumin DSC studies in evaluating the in vivo changes in PK of curcumin - Is there is any basis to correlate DSC results and PK Changes.
    • Source
      [Show abstract] [Hide abstract]
      ABSTRACT: Curcumin (CU) loaded solid lipid nanoparticles (SLNs) of fatty acids (FA) were prepared with a coacervation technique based on FA precipitation from their sodium salt micelles in the presence of polymeric non-ionic surfactants. Myristic, palmitic, stearic, and behenic acids, and different polymers with various molecular weights and hydrolysis grades were employed as lipid matrixes and stabilisers, respectively. Generally, spherical-shaped nanoparticles with mean diameters below 500 nm were obtained, and using only middle-high hydrolysis, grade-polymer SLNs with diameters lower than 300 nm were produced. CU encapsulation efficiency was in the range 28-81% and highly influenced by both FA and polymer type. Chitosan hydrochloride was added to FA SLN formulations to produce bioadhesive, positively charged nanoparticles. A CU-chitosan complex formation could be hypothesised by DSC analysis, UV-vis spectra and chitosan surface tension determination. A preliminary study on HCT-116 colon cancer cells was developed to evaluate the influence of CU-loaded FA SLNs on cell viability.
      Journal of Microencapsulation 06/2011; 28(6):537-48. DOI:10.3109/02652048.2011.590615
    Habibur Rahman

    Yes there is wast reduction in enthaply of curcumin SLN

  • Ali Abdil Razzaq Muhammed Noori Aldallal added an answer:
    Any pharmacopeial requirements on quality control tests/criteria for Oral strips?

    Looking for guidance on technical Specification for Oral strips. Is there any guidance on qualitative and quantitative quality control testing? 

  • P.F. Zabrodskii added an answer:
    What is the impact of immunostimulatory and immunosuppressive drugs on the following parameters?
    1. Body weight of animals (in vivo study)
    2. Thymus and spleen weight
    3. Blood cells (WBC's)
    4. Delayed Type hypersensitivity
    5. Haemagglutination titre
    6. NO production in macrophages
    7. Oxidative burst
    8. Plaque forming cells

    A comparative account is expected.

    P.F. Zabrodskii

    Dear Bhavesh Tiwari,

    answers to many of your questions are obvious. There are a lot of literature data.

    Something I do not know. Explore!

    The correct answers will give you a pilot study.

    You want me you predicted the results of experiments?

    I can make suggestions...

    I wish you success in your experimental studies!

  • Alaa J Mahrath added an answer:
    How I can separate, purify, isolate BSA from DEX BSA?

    I need protocol, if there is one, to separate BSA from compound DEX-BSA. I attached a chemical structure of DEX-BSA?? Any idea, protocol will be very helpfull.

    Alaa J Mahrath

    could you please, explain the BSA abbreviation? this will help to known the nature of the bond between carbonyl group and the other side . 

  • Closed account added an answer:
    Do you think a patient with terminal renal failure may benefit from treatment with statins?
    Some studies have questioned the effectiveness of lipid-lowering agents in patients with renal replacement therapy, but it is not clear whether this "inefficiency" is the same for patients treated with hemodialysis or peritoneal dialysis.

    Dear Juan and followers of this question,

    - The 1st URL shows registered statin studies in matching the search term "dialysis" (n=22). 

    - Probably a few or very few records (probably zero too) in other registries (EudraCT, ChiCTR, UMIN, among others). 

    - Database available in the 2nd URL

    - Expert search terms included -----> copy & paste (PubMed, Embase, EBSCO Discovery Service, Google Scholar, or any other database)

    - Have fun :)

  • Nisarg Modi added an answer:
    Can anyone provide me a normal TDDS preparation method of chitosan?
    I need a detailed research paper related to anticancer drugs.
    Nisarg Modi

    First of all you have to find out solubility of drug in water. To make chitosan TDDS, you need to have water in the formulation with acid media.

  • Reinaldo Briones added an answer:
    I am preparing vaccine by using oil emulsion as adjuvant but problem is it settle down and on shaking its become i can stop the settling down?
    This is a pasteruella vaccine foe chickens.
    Reinaldo Briones

    You could try an emulsifier as saponins. Some saponins have an adjuvant activity for themselves

    I work in the isolation of saponins from Quillaja saponaria for immunological uses

  • Closed account 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?

  • Bhavesh Tiwari added an answer:
    industrial training
    can any one suggest me which pharmaceutical company is best for vocational industrial training
    Bhavesh Tiwari

    I agree with suggestion given by Nilesh Deore. Anchrom laboratories, Mumbai will be helpful for HPTLC analysis and method validation. You may also visit PS Ramnathan Laboratory (F10) at Ramnarain Ruia College for advanced training on various sophisticated instruments like GC MS, FTIR, UPLC, AAS, etc.

  • Sultan Salah added an answer:
    What is the role of metformin in polycystic ovary syndrome?
    What is the relation between insulin intolerance and the polycystic ovary syndrome?
    Sultan Salah

    Polycystic ovary syndrome is the most common endocrinological disorder affecting 4–12% of women and also the most controversial. Metformin was logically introduced to establish the extent to which hyperinsulinaemia influences the pathogenesis of the condition.

    Metformin was the first insulin sensitising drug (ISD) to be used in PCOS to investigate the role of insulin resistance in the pathogenesis of the syndrome.

    Reference: The Adv Endocrinol Metab. Jun 2010; 1(3): 117–128.
    doi: 10.1177/2042018810380215

  • Closed account 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.

    i hope these links will help you,d.dGc,d.dGc,d.dGc

  • Jose Martinez Calderon added an answer:
    Are there any recommendations regarding the limits of related substances in stability testing of pharmaceutical products?

    There are pharmacopeial requirements regarding related substances of API in the raw material and finished products. I would like to know are these limits also considered for determination of pharmaceutical product expiry date with accelerated or long-term stability and if possible what guidelines are stating this.

  • Sanket N. 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 N. Patel

    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
    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.
  • Victor Hugo Siordia Sanchez added an answer:
    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
    Thaks Jerome

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