Formulation Development of Pharmaceuticals

Formulation Development of Pharmaceuticals

  • Ramkumar Ponnuraj 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?
    Ramkumar Ponnuraj · Apex Laboratories

    This article may help you even it does not answers your query 

  • Debasish Pradhan added an answer:
    Would you like to collaborate with me for indo austria DST-FWF programme?

    RELATED AREA- Cancer,Immunity,Plant Drug/Phytoanalysis,Pharmaceutical Sc.

    Debasish Pradhan · Utkal University

    The other person should be from Austria 

  • Krishnan Umachandran added an answer:
    What general attributes should a best in class subcutaneous formulation for a biologics have?

    Subcutaneous formulations are developed based on the science of pharmaceutical drug formulations and empirically detected biological behavior. What are "golden rules" to develop a general "best in class approach for subcutaneous formulations to inject a new biologic (antibody, antibody-drug conjugates or vaccines) into the "biological compartment"?

    Krishnan Umachandran · Professor

    Broad variety of attributes:
    • Molecular Weight (MW):

    1. small molecules
    2. medium molecules
    3. large molecules

    • Chemistries and the level of structural complexity:

    1. biopolymers built from amino acids, nucleotides, saccharides
    2. Conjugates of large molecules with medium size (CovX) or small molecules (PEG)

    • Manufacturing or source of the material:

    1. Small molecules are made by well understood and controlled chemical synthesis
    2. Proteins (including antibodies) are made by less controlled fermentation
    3. Cell components
    4. Cells or tissues

    • Regulatory cutoff in the US (may be different in other countries):

    1. Peptides and oligonucleotides fall under NDA
    2. Proteins and antibodies

    • Functional class

    1. Enzyme
    2.  Antibodies
    3. Hormones

    • Others

  • Nicolas W. G. Chen added an answer:
    How much time must be given for plant leaves to get dried completely at 105 degrees Celsius?

    As per the regulations for making herbal medicines in dry powder form (leaves), it has been written that leaves must be dried at 105 degree Celsius. But duration is not mentioned (duration of drying,i.e., 1 hour or 2 hour or 24 hours likewise...). I would like to know what would be the ideal duration. 

    Nicolas W. G. Chen · University of Angers

    Dear Dr Rahul,

    It can take quite a lot of times to dry leaves, and it depends on the thickness/amount of leaves you want to dry, as well as the conditions of humidity and temperature. I would say that it can take several day  to completely dry the leaves.

    To be sure, you can weigh one or few samples of leaves with a precision weighing balance, then let them dry again for half a day or more. Afterwards, weigh the same samples again. If the samples lost weight, that means that they were still loosing weight due to water loss. If not, that means that they were completely dry. You can check this again and again, until your leaves are completely dry.

    Hope this will help you !

    Nicolas Chen

  • Patrick Druggan added an answer:
    Does cosmetic product development require clinical trial?

    My question does not just refer to their commercial use but also the R&D one… Let’s say I want to submit a Horizon 2020 project for a nano-functionalized cosmetic crème (not a medical grade one), would I still have to foresee clinical trials?
    Does anyone have any experience on the EU’s ethics guidelines on this point?

    Alexander,

    My apologies for not getting back to you at an earlier date.

    EC 1223/2009 article 11(2) d states that there must be proof of the effect claimed. This could only really be done with objectivity with a clinical trial, though you may not have to go through the whole consenting and ethics process. It wouldn't hurt to follow the principles as they are good science.

    I'd recommend the following book by Allan Hackshaw

    A concise guide to clinical trials ISBN1405167742. I have this book and it is the easiest to read clinical trial book I have, and it is very informative.

  • Monika Dvoráková added an answer:
    Do any one know how to perform the antioxidant capacity test with trolox material?

    Hi there is a material called trolox using which we can perform the antioxidant capacity of a material. Any one aware about the analytical procedure along with calculation part kindly share. 

    Thanks in advance 

    Monika Dvoráková · Comenius University in Bratislava

    Follow this article:

    If you have any question, do not hesitate to ask.

  • Ramkumar Ponnuraj added an answer:
    What type of phospholipids are best used for topical delivery of drugs?

    What are the best phospholipids that can be used for topical drug delivery and manufacturers?

    Ramkumar Ponnuraj · Apex Laboratories

    Soyalecithin available in various grades can be used. You can get it from Lipoid who manufactures pure and quality grades. 

  • Ossama Y Abdallah added an answer:
    Can we apply Dialysis tubing in suppositories?

    Could the dialysis tubing concept in nanoparticle purification be used as in vitro dissolution tests for suppositories?

    Ossama Y Abdallah · Alexandria University

    yes you can use it .According to my exper. non membrane dissolution test for supp. was better correlated to the in vivo data.

  • Dharmaraj More added an answer:
    What are the best methodologies to deliver an oligonucleotide in cells of the digestive track?

    I would like to deliver in a cell specific manner an antisense in the colon

    Dharmaraj More · UDCT, NMU, Jalgaon

    Best and feasible way to target colon with colon specific micro or nano particles using different polymer or combination of polymeric material which are biodegradable or pH sensitive toward colonic area. Like chitosan 

  • Tamer H. Hassan added an answer:
    Is the non-ionic surfactant triton x-100 safe and FDA approved for oral formulations?

    Triton X-100 is nonionic surfactant which may be used for dispersing and encapsulation of poorly water soluble drugs. Is it justified and safe for enhancing the bioavailability of poorly water soluble drugs?

  • Luis F. Gouveia added an answer:
    What if the accelerated stability study fail but the long term stability study is ok?

    Stability study of pharmaceutical products

    Luis F. Gouveia · University of Lisbon

    From a RA standpoint the requested (to authorities) shelf-life must be based on real-time stability data and no extrapolation is allowed. According to WHO guidelines if accelerated stability was OK you could ask for extrapolation up to twice the real-time stability data (minimum of 12 mo real-time stability) but no more than 12 months extrapolation. Refer to Ali's attachments for details.

  • Gopa Roy Biswas added an answer:
    How can we find A & B in the Kopcha dissolution Model?

    Dear All,

    Can any one share me how to find A and B in Kopcha model of dissolution. Is there any software to do it? If so how to incorporate in it and get the results? Can we get it using excel sheet? Pls share your views as I want this details urgently. 

    Thanks in advance 

    Gopa Roy Biswas · NSHM Knowledge Campus

    You know A = diffusional constant and B = erosion constants,

     To be diffusion dominated drug release  A must be much higher than B.

     Theoretically  A/B should be more than 1 for that purpose.

  • Taksim Ahmed added an answer:
    what are the considerations in keeping volume of dissolution medium and amount of formulation with dissolution studies of niosomal formulations?

    When we perform dissolution studies of niosomal formulations how much volume of dissolution medium and how much quantity of niosomal formulation be added into dialysis bag, what consideration should be taken into account for this??

    Taksim Ahmed · University of Waterloo

    I completely agree with Mr. Vikram Shenoy. Additionally, if the model drug is already in the market (commercial product), you might want to consider the strength of that dosage as well. This will make your product (formulations) more relevant to the commercial products. Then, consider the solubility of the drug in a particular dissolution medium. In my personal experience, one does not need to use a 900mL dissolution vessel for doing such dissolution study. You can simply conduct it in a glass vial, less than 50 mL size. I hope this will work for you. 

  • What are the major platforms in computation and in vitro techniques for measuring oral bioavailability?

    We are interested to screen molecules particularly peptides that can be delivered orally. Please write name of software or web server which we can use for predicting oral-delivery potential of a molecule. I will appreciate if you write free (open source software) for predicting bio availability of molecules particularly peptides and proteins. Please also write in vitro techniques (assays ) that correlate with in vivo bio availability of molecules.

    Gajendra Pal Singh Raghava · Institute of Microbial Technology

    Thanks

  • Martin Sullivan added an answer:
    Is it legitimate to call hollow core shell materials "molecular sieves"?

    We  know that now a days,  the hollow core shell  materials are popular due to their applications in drug delivery system.  As they can separate molecules based on their pore size, can we call it as meso to macro molecular sieves?  However, I have not seen this material called a molecular sieve anywhere in literature? Why is this so?

    Martin Sullivan · Huazhong University of Science and Technology

    A sieve in the typical sense means a sheet of a porous material. A hollow core shell particle, in particular for the application of drug delivery, are independent particles, and thus I do not believe they can be used for the filtration of materials based on size.

  • How to dissolve copper(II) sulphate in polycaprolactone?

    How to dissolve Copper(II) sulphate anhydrous (powder) in polycaprolactone (MW 80,000) - pellets?

    Solvents and solvent mixtures tried so far:
    THF, DCM, toluene, EtOH, EtAc, water. These were tested while experimenting with different temperatures, stirring times, mixture ratios and order of adding the solvent with no success.

  • R. Jagathesh Chandra Bose 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.
  • Ashish Kumar added an answer:
    Can thiomers be used in topical preparations?

    For example, gels.

    Ashish Kumar · Amity University

    thiomers are chitosan , having thiol group attached to it. in case of topical application it is very possible to use it as a polymer for topical application. but its compatibility should be checked with Active pharmaceutical ingredient.

  • Carlos Araújo Queiroz added an answer:
    How can I desiccate microcapillary tubes filled with a gelatin solution to coat them?

    Help! We don't have a speed vac and when I tried the freeze drier the solution was just spat out the ends of the tube. Solutions contain antibiotics so I need to watch the temperature. Any suggestions appreciated!

    Carlos Araújo Queiroz · New University of Lisbon

    For answers to a somewhat related question earlier posed at this forum, also dealing with gelatin coating: «Can anyone suggest a method to coat surgical grade titanium with a gelatin based film?» ─ you may check: https://www.researchgate.net/post/Can_anyone_suggest_a_method_to_coat_surgical_grade_titanium_with_a_gelatin_based_film

  • Can someone advise me about the purification of carbamazepine?

    The color of synthetic carbamazepine is cream, but in references it is white. how can i purify it to white crystalline.

    Hi Fazel 

    I hope that following paper be useful.
    Best regards 

  • Why do functionalized monomers can help solubility and drug release?

    For the synthesis of the pressure sensitive adhesive solution polymerization

    Hi Reza

    Well I can't say if the attached paper and link are good/bad because the subject does not fit with my interest field, please check them.
    With my best regards

  • Can anybody suggest me the proper pathway for Generic/NCE/Complex Parenteral formulation development?

    Also I want to know an application of log P and pKa (single and multiple pKa compound) application in parenteral formulation development.

    Thanks

    Hi Sagar

    You might be interested in the sites, please check out

    Have a nice day

  • Maruthinath Karicheti added an answer:
    How do you handle CDI (1,1′-Carbonyldiimidazole) or other highly moisture sensitive solids?

    I purchased CDI from Sigma (115533-10G) only 3 months back and used it for only 7-10 times. Now the NMR shows that CDI has been hydrolyzed to imidazole. I was quick to weigh out and transfer CDI when I used it but don't think quick enough. How do you actually handle solids under inert gas? If it was a liquid, I could use syringe to transfer it, but solid?

    Thank you in advance for your reply.

    Yes that CDI is moisture sensitive and we preserved it at 2-80c  that container filled with nitrogen. even though that lost its activity some extent ,I mean we used 1.2 molar equivalent instead of 1.0 molar equivalent. and in that reaction we got some unknown impurities. 

  • Fars Alanazi added an answer:
    Is there a simple method to wash and separate liposomal formulation from the free drug?

    I have tried to separate it using centrifugation at 12000 rpm for 10 min. 

    Fars Alanazi · King Saud University

    It is good question

    you have to know your drug soulbility 

    if your drug is lipophilic will precipitate due to centrifugation so it is better to use density gradient to float liposome, you can have look under microscope for any traces of drug crystal

    Whil if you drug is water soluble you can run the regular method you mentioned

    using gel or column are suffer from drug loss and cost,

    I do really recommend you know the soulbility and use the ease method 

  • Rana M Obaidat added an answer:
    In Ionic gelation method of Chitosan, will the drug only be entrapped in the core or will it be entrapped along with some chitosan also?

    In Ionic Gelation Method Chitosan and TPP will be used to cross link and produce nanocapsules. Drug will be entrapped in the nanocapsules. 

    My question is whether only the drug will be present within the entrapment of Chitosan Nanocapsules or it will be entrapped with some Chitosan with in the entrapment? 

    Also let me know whether Poloxamer will help to reduce the aggregation of Nanocapsules in physiological fluids. 

    Hope my question is clear. 

    Thanks in advance

    Rana M Obaidat · Jordan University of Science and Technology

    I think it depends on the type of the drug (physico-chemical characteristics) and on the method of preparation. Release profile and scanning electron microscopy will give evidence about drug location.

  • Chakravarthi Simhadri added an answer:
    How do you dissolve the BIBN 4096 (most favorably, without using DMSO)?

    I need your help regarding a problem I faced during dissolving of a CGRP antagonist BIBN 4096 (10mg, Tocris).

    I dissolved it in 1:1 ratio of 100% DMSO (500 micro liter) and water for inj. (500micro liter). but couldn't get success in doing so even after using ultra-sonicator. It would be a great help if you could suggest how to dissolve this drug at this stage (to make stock solution). We are planning to purchase the fresh drug and to use it again with new dilutions.

    Chakravarthi Simhadri · University of Victoria

    Hello Mayank,

    I didn't use BIBN 4096 but I came across this kind of solubility issues and I solved them.

    Solution I #

    1. You have to lyophilize  your sample (for recovery)

    2.  Try to dissolve your sample in pure DMSO sonicate if you need

    3. Dilute with water now.

    Solution-II #

    Your compound looks hydrophobic and it contains primary and secondary amines so make either HCl or Oxalic acid salt by treating with respected acids. Hopefully salts will dissolve in water (not always so) and make sure when you calculate  M.Wt of the compound include counter ion M.Wt as well.

    Good luck

  • Santosh Kumar Behera added an answer:
    How can I study interaction of BSA (Bovine Serum albumin) with a fluorescence active molecule ? ?

    I need to study interaction with a drug with BSA,but here my drug is also florescence active.I am used to study quenching of BSA with Drug,where i kept BSA as a fluorescence active,but i have faced some problems,when i seen DE-quenching due to interaction of drug with BSA .It means, the fluorescence absorption is increasing with the increase of drug concentration.,i have used 20uM (BSA fixed) and drug concentration increase from 20uM to 320uM concentration.

    Santosh Kumar Behera · Indian Institute of Technology Guwahati

    Please Check following link, may help you

    http://pubs.rsc.org/en/content/articlelanding/2014/pp/c4pp00099d#!divAbstract

  • Rajan Bhattarai added an answer:
    Can degradation of PEG 3350 or polysorbate 80 cause yellow colour formation?

    An API is formulated with PEG 3350, Polysorbate 80, NaCl, Methyl paraben. While heating small batch in water bath at 120 C , no color change was observed, but while heating in an autoclave of large scale, a small amount of yellow colored substance was observed at the top of the API. What causes this color formation?

    Rajan Bhattarai · University of Toledo

    Thanks Mr. Dhurv Bhutani. It was very helpful. In addition, I wondering about the micelle forming abilities of polysorbate 80. What could impact the stability of micelles of Polysorbate 80? 

  • Simin Khanda added an answer:
    Nanoparticles of a drug shall be crystalline or amorphous?

    I planned to develop nanoparticles of a drug. The drug is available both in Crystalline and Amorphous forms. The method of preparing the nanoparticles is by dissolving the drug and gelation of nanoparticles by ionic gellation method. 

    1. Whether I can use amorphous or crystalline form of drug for this?

    2. If I want to use amorphous form whether Powder XRD is required to be performed on drug and nanoparticles or not? since amorphous form of drug will not show any sharp diffraction. 

    Thanks in advance 

    Simin Khanda · Meril Life Sciences Pvt. Ltd.

    use amorphous form of drug. and yes XRD is required

About Formulation Development of Pharmaceuticals

Formulation development of various dosage forms

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