Formulation Development of Pharmaceuticals

Formulation Development of Pharmaceuticals

  • Zahra Kazemi added an answer:
    What is the difference between Emulsifier and the Partial Glyceride?

    In the Sasol Excipients for pharmaceuticals, the Emulsifiers are separated from Partial Glycerides. What is the reason for it? Why should Imwitor 372 and Imwitor 948 be separated, whereas both of them can be used as emulsifier? 

    Zahra Kazemi

    Dear Rafik,

    Thank you very much for your clear and helpful explanation.



  • Aiman Eid Al-Rawajfeh added an answer:
    What is the role of lactose in solid form pharmaceuticals?

    What is the role of lactose in solid form pharmaceuticals?

    Aiman Eid Al-Rawajfeh

    Thank you very much for you answer.

    Can we use sucrose in very small amount and the rest is kept Lactose ?

  • Abhijeet P. Pandey added an answer:
    How to apply Quality by Design to NDDS?

    As per ICH, Quality by Design is nowadays mandatory requirement for regulatory procedures.

    Abhijeet P. Pandey

    QbD can be applied via step by step analysis of each step involved in your formulation design. If you are woking on nanoparticles or liposomes and you want to explore QbD for their optimization then you need to use step as following:

    1.Selection of critical quality attribute of your final product.

    2.Failure mode effect analysis. (it includes selection of factors using knowledge space and ishikawa diagram followed by risk priority numbering of the factors, selection of high risk factor)

    3. Preliminary study of high risk factors.

    4. Selection of upper and lower limit of factors at which you re getting desired response.

    5. Use of PB screening design for screening factors having significant effect on response.

    6. Use of RSM for optimization of screened factors.

    7. Design space establishment.

    8. Assessment of design space robustness.

  • Kiran Avadhani added an answer:
    Is there a way to Convert a drug dose in mg/kg for treating animals to mg/ml for treating cell lines ?

    The dose is standardised in animals in mg/kg.
    i just wanna extend the same treatment to cell lines and was trying to find a way to convert Drug dose from mg/kg to mg/ml ?

    Kiran Avadhani

    Thank you Tushar for this discussion. Thanks to Rafik too for sharing valuable article. It is helpful for all. Thank you Alain and Sagar.

  • Hamdy Abdelkader added an answer:
    How can i increase the stability of the cationic niosomes?

    I have prepared cationic niosomes composed of surfactants and DC-Cholesterol but i found these niosomes were not stable and tend to agregates in a couple of days although the ZP was around 75mV, so does any one has an explaination of that and how can i increase their stability?


    Hamdy Abdelkader

    The stability of niosomes could be altered by surfactant to cholesterol ratio. selection of surfactant type, span 60  has been to be the best of its congers.

    • prepare them in a freeze dryed formf or longer term stability.
  • Carlos Pineda added an answer:
    What fluid has the potential or ability to replace human SYNOVIAL FLUID?

    Synovial fluid is normally a thick, straw-colored liquid found in small amounts in joints, bursae (fluid-filled sacs in the joints), and tendon sheaths.

    Carlos Pineda

    Synovial fluid (SF)  is a plasma dialysate modified by constituents secreted by the joint tissues. The major difference between synovial fluid and other body fluids derived from plasma is the high content of hyaluronic acid (Hyaluronate) in SF. The proteins of coagulation are not found in normal synovial fluid, while proteins of the plasmin system may be found in variable quantities. To date I am not aware of a practical SF replacement. For osteoarthritis treatment viscosupplementation based on doses of hyaluronic acid that are injected into the knee but their long-term efficacy remains uncertain.

  • Rakesh Singh Chaudhary added an answer:
    How can I make white Eucerin using Lanolin?

    As you know Lanolin is yellow substance and produce yellow eucerin . How can I bleach lanolin or eucerin?

    + 1 more attachment

    Rakesh Singh Chaudhary

    There is a bleached Lanolin available from "Parachem" 415 Huguenot Street, new Rochelle, New York 10801, 1-800-282-3982..

  • Ram Nath Mishra added an answer:
    Looking to make a carboxamide prodrug?

    I am trying to couple my compound with terminal carboxamide amine to lysine amine. Is there any prodrug for carboxamide so that the Lysine-compound conjugate breaks down to give carboxamide?

    Ram Nath Mishra

    Might help!

    Recent Trends in Targeted Anticancer Prodrug and ... › NCBI › Literature › PubMed Central (PMC)
    by Y Singh - ‎2008 - 
    Prodrug and conjugate design involves the synthesis of inactive drug .... Tegafur is a slow-releasing prodrug of 5-FU, which avoids the rapid breakdown of drug in ...... FUDR to aliphatic carboxylic acid chains to improve drug permeability [134]. ... greatest in the prodrugs with lysine and arginine residues giving IC50 values ..

  • Kundan Ingale added an answer:
    Are there any formulation development labs in india?

    I am looking for development of topical formulation, including preformulation and stability studies. Is there any GLP certified lab which can perform the development and clinical manufacturing. 

    Kundan Ingale

    Hello mushtaq thanks for the site got useful information. 

  • Mohamed Aly Abd El Aziz Aly El Degwy added an answer:
    Any advise on the disintegration Issue in ODT compressed tablets of highly hygroscopic extracts?

    Hello Everyone,

    We are facing disintegration issue in one of our product development. Its an ODT (orally disintegrating tablets) dosage form with a target DT of less than 30 sec. We are not able to achieve a DT of 30 sec with a hardness of 30 N with wet granulation. If we lessen the hardness DT would be around 25 sec but that's not preferable as the hardness is very low and chances of friability will increase. 

    Though the solution seems easy by using disintegrant like Croscarmellose and Crospovidone but we already tried with many of them .As the extracts are very hygroscopic tablets are not able to disintegrate within 30 sec. 

    With MCC its giving good results but the mouth feel is unpleasant.

    Any suggestions?

    Mohamed Aly Abd El Aziz Aly El Degwy

    Preferably use silicifed microcrystalline cellulose or Avicel pH 112 with syloid or Aerosil 200 according to the target active density. Regarding the disintegrants, AcDisol with Crospovidone Xl 10 upto 20% of tablet weight as previously mentioned  Pearlitol Flash Mannitol

  • Mitali Patel added an answer:
    Does anybody know how to solve the problem of withania somnifera and curcumin solubility?

    I have a water extract of Withania somnifera and Curcumin (soluble in alcohol and acetic acid). I want to use them for disc diffusion assay for which I need a complete solution.I am unable to dissolve them in their respective solvents. I cannot use acetic acid as I am doing antibacterial study. I tried DMSO for both but they are not soluble. 


    Mitali Patel

    Hi Adam, I tried with Acetic acid and even used as a control but in negative control as well I am getting inhibition zone. They should be completely soluble but I am seeing some visible particles of the extract in the solvents like Ethanol, DMSO,Water (for Withania somnifera).

  • Swayamprakash Patel added an answer:
    How can I calculate Dose of drug after its bioavailability improvement?

    I am working on Curcumin Bioavailabilty improement.

    My product (Test) have dose 25 mg and Reference product have dose 100 mg.

    Test product have Cmax 1.46 mcg/ml and reference product have 1.16 mcg/ml Cmax.

    How can i calculate Dose of test product to have same Cmax of reference?

    Swayamprakash Patel

    Thank you all friends

  • Vladimir A. Kulchitsky added an answer:
    What are the best methods to make a single crystal of pharmaceutical API along with addition of a coformer??

    I am trying to prepare cocrystals of one of the pharmaceutical API, from XRD results it shows formation of cocrystals.

    1- I want to evaluate the same for it's all information about new single co-crystal for that i need to make a single crystal.

    Please suggest me the best methods for single crystal preparation.
    2- How can i confirm that, this is a single crystal?

    Vladimir A. Kulchitsky

    All the best. I hope, somebody will help you more.

  • Fabio Sonvico added an answer:
    is it possible that supersaturated solutions are formed with the shake flask method leading to errors in the quantification of the solubility?

    if so how it is prevented? 

    thanks in advance 

    Fabio Sonvico

    For sure you have to proceed for an efficient phase separation method with a good control of temperature (centrifuge).

  • Ali A R Aldallal added an answer:
    Is there any literature on carboxamide prodrug?

    I am trying to make a prodrug where it breaks down metabolically to give carboxamide. Is there any literature on carboxamide prodrug?

    Ali A R Aldallal


    Plz see the attached link, may be helpful.


    + 1 more attachment

  • Mubashar Rehman added an answer:
    Can you please suggest me a type of mixer or mixer shaft to mix a viscous oil with powder at high temperature to produce a tacky and viscous mixture?

    I have a small volume (<10ml) of viscous oil that I want to mix with a powder at high temperature. The mixture will be a tacky blend and viscous. So far I have been preparing the mixture using a mortar and pestle but this is not convenient and very messy. Does anyone have a suggestion for mixer or a mixer shaft (or any other type of blending device) that can be used to accomplish my objective?

    Mubashar Rehman

    You can also use geometric mixing to mix powder in viscous liquid using glass slab and spatula.

  • Khalid Ferji added an answer:
    What method should I utilise for encapsulation of a hydrophobic and hydrophilic active agents in one/multilayer capsule?

    I need small particles between 5 and 10 um.What material would be suitable? What encapsulation specific procedures would fit for such small particles? I manage to obtain encapsulation in alginate of both hydrophobic and hydrophilic agents but the particles are to big (240 um).

  • Tobias Speerschneider added an answer:
    What is the physiologically acceptable amount of cyclodextrin in a phosphate buffer (pH 4.5) meant for IP injection in mice?

    I need to dissolve Dronedarone-hydrochloride for intraperitoneal injections in mice. However, due to its hydrochloride form Dronedarone is quite differcult to dissolve in aqueous solutions. Phosphate buffers ranging from pH 3 to 5 with added cyclodextrin should increase the solubility of Dronedarone and be well tolerated at the injection site. I'm perparing a phosphate buffer (NaH2PO4, pH 4.5), but I'm not sure about what the cyclodextrin concentration should be? 

    Tobias Speerschneider

    Thanks a lot for your advices. 

    @Samit, I will preform the IP injection during isoflurane anaesthesia as I'm doing echocardiography of the mouse meanwhile. So, the abdominal pain will not be an acute issue. However, I will keep it in mind if I need to make several injections in the same mouse (over days).

    As far as I have been informed, Dronedarone-hydrochloride will precipitate at a pH above 5. But I will try with a slightly higher pH and CD at a 5% concentration, and go from there. 

    @Ferenc, thanks for sharing your knowledge, I will take it into account and use HPBCD as the preferred CD-form.

  • Karthik San 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.

    Karthik San

    cover the container with nitrogen. we can use it for long time.

  • Yaminisri Anbalagan added an answer:
    Can anyone explain to me why is it so we take in count of AC=Y for steady state of transdermal drug diffusion?

    I really need to know ASAP. Thank You!

    • Source
      [Show abstract] [Hide abstract]
      ABSTRACT: The delivery of drugs through dermal layers known as transdermal drug delivery is one of the important contributions in medical practice. It represents an alternative to oral drug delivery and is poised to provide a substitute to hypodermic injections too. The diffusion of drug from the source to the target site is therefore an important issue to address.AimThis paper is an attempt to establish a mathematical model for the diffusion of drugs through the transdermal drug delivery system. The model identifies the pattern of drug diffusion in human body and its effective absorption rates at various compartments of skin and sub-cutaneous tissues.Methods The finite element method has been used to obtain the solution of the mass diffusion equation with appropriate boundary conditions. The tissue absorption rate of drug has been taken as the decreasing function of drug concentration from the skin surface towards the target site. The concentration at nodal points has been calculated which in turn determines the drug absorption at various layers.Conclusion The drug concentration at the nodal points of different dermal layers has been computed and the graphs were plotted between drug concentration and thickness of dermal layers using MATLAB software. It has been observed that due to dense network of connective tissues in dermal and sub-dermal parts, the drug absorption is maximum as compared to cutaneous tissues.
      Full-text · Article · Nov 2014
    Yaminisri Anbalagan

    Thank you :)

  • Enrique Martinez added an answer:
    How can I calculate regulation impact on pharmaceutical impact?

    I would like to know how regulation on pharmceutical industry has affected its productitivy. Has anyone done something similar?

    Enrique Martinez

    Thanks a lot!!!

  • Sara Lima added an answer:
    Is the lysozyme able to cleave glycosidic bond between two D.-glucosamine or its only between two N-acetyl glucosamine?

     I am trying to read about this but I could not get a final answer and clear one 

    Sara Lima

    thank you very much for your answers

  • Dipen Sureja added an answer:
    Lovastatin, prava and atorva
    Is anybody hahing the uv detection method for the lova, prava and atorvastatin?
    Dipen Sureja

    Contact me.....

  • Anwar A Hussain added an answer:
    What is the safe limit of aspartame in orally disintegrating tablets?

    I would like to use aspartame in an orally disintegrating tablet. In literature there is lot of variation for the %age of aspartame so I would like to know the safe limit which I can use.

    Anwar A Hussain

    Let all of use try to find a method to stabilize Aspartame at PH range above 5, It is a worthy challenge.

  • Stanton de Riel added an answer:
    Is it possible to encapsulate oils in soft gelatin without oil spillage?

    When we encapsulate oils in soft gelatin capsules, the capsules are getting coated with oil.

    Stanton de Riel

    Soft gel encapsulation is inherently messy, since your gelatin sheets are gloppy, the oil is filled under pressure, and the encapsulator isn't pressure-tight! (No way it could be, in continuous-movement mode.) So, don't fret. You could rinse the exterior of the capsules with a non-toxic volatile hydrocarbon (a couple dips in COLD butane should do it), before air-drying; don't know what solvent is commercially used for this, perhaps IPA?

  • Ossama Y Abdallah added an answer:
    Does compression force affect the dissolution behavior of a drug?

    Do you know any example?

    Ossama Y Abdallah

    if compression affects disintegration it will decrease the dissolution. if you have a formula that shows good disintegration no effect of compression is expected. for matrix or non disintegrated sr tablet  the compression will be of low value.

  • Dr Scott Burtis added an answer:
    Does anyone have advice on procuring injectable oxaloacetate?

    Oxaloacetate has been shown to be an effective glutamate scavenger.   Oral supplements have low bioavailability.   IV should be more effective, especially in crossing into the blood brain barrier.

    Thank you in advance for your help,

    Dr. Burtis

    Dr Scott Burtis

    Thank you!!


  • Xuannam Truong 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?

    Xuannam Truong

    In addition, when polysorbate 80 is hydrolyzed in acidic solution, the fatty acid (hydrophobic part of polysorbate 80) is produced. When the content of fatty acid is over its solubility, visible aggregates appears in the solution.

  • Muhammad Imran added an answer:
    Is the non-ionic surfactant triton X 100 toxic for the skin?

    I wonder if I can use it in topical drug delivery formulations as a permeation enhancer.

    Muhammad Imran

    Dear Imren

    Check the link below;

About Formulation Development of Pharmaceuticals

Formulation development of various dosage forms

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