Pharmaceutical Development

Pharmaceutical Development

  • M. Eugenio Vazquez added an answer:
    Does anyone know a simple technique for studying small molecule-DNA interactions, especially binding type kinetics?
    M. Eugenio Vazquez

    By the way, we have also used single-molecule fluorescence to study the dynamics of the binding process. Take a look at:

    J. Bordello, M.I. Sánchez, M.E. Vázquez, J.L. Mascareñas, W. Al-Soufi, M. Novo, Chem. Eur. J., 2014, (DOI: 10.1002/chem.201404926).

    J. Bordello, M.I. Sánchez, M.E. Vázquez, J L. Mascareñas, W. Al-Soufi, M. Novo. 
Angew. Chem. Int. Ed., 2012, 51, 7541–7544. (DOI: 10.1002/anie.201201099).

  • Patrick M Dansette added an answer:
    Does anyone know an in-vitro protocol for inhibition of Monoamine Oxidase-A and B? can you send Protocol or share some useful articles?

    Hi, all researcher I want to check activity of plant extracts against Monoamine Oxidase-A and B. If someone have its few or detailed protocol kindly send it to me. Every single effort will be highly appreciate.  

    Patrick M Dansette

    In principle seleginine (deprenyl) will inhibit MAO B (suicide inhibitor)

    and clorgynine will inactivate MAO-A (you could also use  isoproniazide.

    We used these inhibitors in the joined paper

  • Arpana Mishra added an answer:
    Is aluminum a good material for electrodes regarding an In vivo Electroporation project?

    I will be conducting an in vivo test to define transdermal delivery via topical/skin electroporation. I will be applying a drug to the patients skin and using an in vivo electrode to carry the drug into the dermis. I need help however when it comes to the electrode. I want to make 'meander' electrodes, and I would like to know if aluminum is a good material to make electrodes from. Here is a schematic drawing of meander electrodes:  (picture A.)

    I will be using the btx ecm 830 electroporator. If not aluminum, then what other metal besides gold or platinum could I use? I intend on buying a sheet of said metal and cutting it into the meander electrode shape, then mounting this onto a handle(in a nutshell!). So please, do list a metal that can be readily purchased in sheets. Thank you!

    Arpana Mishra

    In my opinion Aluminium is best metal for use as electrode . Reasons are low cost,easily available ,less oxidation at anod and cathode which is removable ,less toxic than iron ions ions.

              Due to these properties of Aluminium it used in HT lines of electricity.

  • Ali Abdil Razzaq Muhammed Noori Aldallal added an answer:
    Does the volume of injection affect the bioavailability by intraperitoneal route?

    Does the volume of injection affect the bioavailability by intraperitoneal route? Will it improve the F value significantly? For example, if I need to give 10 mg/kg of drug to a rat. In one set I dissolved the same dose in 0.4 ml and in other set I dissolved it in 2 ml and gave all of these volumes.  The drug is a zwitterion, polar molecule. Any thoughts on F value variations, since the dose is kept constant? I am thinking it might improve the onset of action but the over all F should remain constant since it is the AUC which matters during F value calculations.

  • Sudip Mukherjee added an answer:
    What is the serum concentration we should use for drug release study?

    Fbs can be used for drug release study. But shall we use 100% FBS or 50%?

    Sudip Mukherjee

    Thanks  Mr. George Dakwar for your answer.

  • James Kilgore added an answer:
    Why was development of T1249 halted as a second generation fusion inhibitor besides having promising results in Phase I and Phase II clinical trials?

    This question is related to HIV drug class called fusion inhibitors. There is only one Fusion inhibitor called T20 (Enfuvirtide) approved by the FDA. I couldn't find the exact reason why the Roch and its partner company halted the development of T1249 in the middle of Phase II clinical trials despite of having good results!

    James Kilgore

    If people are looking for lessons learned with T20, you might look at the peptide design issues.  T20 was a 36-mer made of all proteinogenic amino acids. There are two immediate issues with this: Firstly, nearly all successful peptide drugs incorporate either D-AAS or otherwise non-proteinogenic units to slow proteolysis.  Secondly, the length put it in a range where fermentative preparation wasn't really a good option, but the all-synthetic method used was extremely expensive, hence a 5-figure per-patient annual price-tag.  I have no information about how quickly the drug loses effectiveness as it's metabolized but it's hard to imagine that this isn't a drawback of the design.    

    A lot of optimizaiton has gone into producing T20, T1249, Enfuride and related drugs.  The 30 amino acids separating the pocket binding domain and the lipophilic anchoring region in the HIV sequence the fusion-blocking peptides are based on have been reduced to 23 in T1249, but that still leaves a 40-mer peptide overall.  A group in Portugal showed that cholesterol can serve as the peptide lipid binding region (an 8-mer segment in T1249).  It really seems that the drugs should be chimeras with non-peptide linkers such as PEG bridging the necessary recognition sequences, resulting in minimum peptide lengths and modifications to extend half-lives (and possibly reduce reactions at the injection site?) 

    Lets all check back in 5-10 years to see if that;s right. 

  • Chiranjeevi Srinivasa Rao Vusa added an answer:
    Can someone help me in understanding the comparative catalytic properties of d-metals?

    Are there any books/research papers/reviews to understand the comparative catalytic properties of transition metals, something like periodic trends(acidity,basicity,etc) or properties of elements?

    Chiranjeevi Srinivasa Rao Vusa

    Hi Sumant,

    I did refer JD LEE, but i did not get any info regarding my question. Can you please tell me that in which chapter you have come a cross this info? 

  • 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.

  • Ali A R Aldallal 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?
    Ali A R Aldallal

    Several of the early studies on metformin in PCOS were compiled in a meta-analysis by Lord and colleagues [Lord et al. 2003]. They concluded accordingly that metformin was an effective treatment to induce ovulation in PCOS patients and that it was justifiable to use it as a first-line treatment. However, they emphasized that it should be used in conjunction with a change in lifestyle. They included 7 studies comprising a total of 156 PCOS patients who received metformin of whom 72 (46%) ovulated versus 1154 who received either placebo or no treatment of whom 37 (24%) ovulated. They also reported that the combination of metformin and clomiphene citrate (CC) resulted in more ovulation than CC alone. However, this was based on relatively smaller number of patients included in two and three studies.

    In a later meta-analysis by Palomba and colleagues, the authors concluded that the combination of metformin with CC is not superior to CC alone [Palomba et al. 2009] with regards to ovulation, pregnancy, or live birth rates. They also found no difference in the miscarriage rates between the two treatment modalities. With regards to metformin in combination with CC, that was more effective than metformin alone in ovulation and pregnancy rates. They based their conclusion on combinations between four randomised controlled trials (RCTs) that were published after the meta-analysis by Lord and colleagues [Zain et al. 2009; Legro et al.2007; Moll et al. 2006; Palomba et al. 2005]. They also commented on the heterogeneity of body mass index (BMI) among the populations of the four studies and that the patients in the study by Palomba and colleagues were not representative of the PCOS population [Palomba et al. 2005], i.e. they were relatively slimmer. Others used menstrual regularity as evidence of resumption of ovulation and reported in a RCT that included obese PCOS women that weight loss alone through lifestyle modification was more effective in restoring regular menses [Tang et al. 2006].

    It is important in analysing the outcome of all such studies and meta-analyses to realize that the duration of treatment also plays a role in the outcome. Metformin is likely to take longer to exert an effect in comparison to CC, therefore CC should be considered the first line of treatment in ovulation induction among PCOS patients and that life-style change leading to a sustainable weight loss is an important adjuvant to all types of medications in such patients.

    The use of gonadotrophins for ovulation induction in conjunction with metformin also received attention and was the subject of a meta-analysis [Costello et al. 2006]. However, due to the small number of studies included and small sample size in each study along with the difficulty disentangling potential confounding variables a conclusion could not be reached on the efficacy of metformin as a coadjuvant to gonadotrophins for ovulation induction in PCOS women. It seems, however, that the length of ovarian stimulation was shorter among those receiving a combination of gonadotrophins and metformin [Costello et al. 2006].

    For more plz read at following link

    Kind regards

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