- Valentina Reiner 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?
I'm fully agree with Marijke, as to refer to AUC (extend of absorption) and not to Cmax (rate of absorption), provided to know the lineartity among the range 25 -100 mg doses.Following
- 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?
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.Following
- 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.
cover the container with nitrogen. we can use it for long time.Following
- 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!
Thank you :)Following
- 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?
Thanks a lot!!!Following
- 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
thank you very much for your answersFollowing
- Dipen Sureja added an answer:Lovastatin, prava and atorvaIs anybody hahing the uv detection method for the lova, prava and atorvastatin?
- 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.
Let all of use try to find a method to stabilize Aspartame at PH range above 5, It is a worthy challenge.Following
- 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.
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?Following
- Ossama Y Abdallah added an answer:Does compression force affect the dissolution behavior of a drug?
Do you know any example?
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.Following
- 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,
- 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?
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.Following
- 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.
Check the link below;
- Amjad Khan added an answer:Is there a technology to prepare Intravenous Sustained Release formulation?
An intravenous (IV) formulation is desired for a high dose drug that needs to be delivered over a period of 8 to 10 hours. This sustained release approach would allow a bolus of drug (approximately 40 to 60%, burst release ) to be delivered quickly upon IV administration followed by the remaining dose to be delivered in a near zero order fashion.
It is possible. Intravenous drug release can be tailored by Temperature Controlled Hydro gels using various PolymersFollowing
- Riyaz Ali Osmani added an answer:Can anyone suggest any review or paper related to biphenyl containing commercially available drugs?
Commercial available biphenyl moiety containing drugs?Following
- Mohammed D Alrekabi added an answer:Hyosine-N-butylbromide syrup dosage form has a bitter taste which would make it unacceptable by children. Why can't it be prepared sweetly ?
I mean , is there a methods that make it sweet ?
- Ahmad Mohamad Zaiter added an answer:Will I need dose calculation sustained release buccal drug delivery?
I am doing sustained release buccal drug delivery of statin having shorter half life (about 3 hrs), I am sustaining it for 12 hrs, will it require dose calculation?
Sorry ur question isn't clear at all ! ......
U want to calculate in vitro release of sustain release formulation ?
Or u r asking about is the half life of drug will be different for sustain release ?
Please clarify ur question, paraphrase it !Following
- Varsha Dilip- Jadhav (Rathod) 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.
if u r analyzed moisture content first on dry weight basis it will easy because drying conditions for leaves are totally depends on it's physical properties. It is variable species to species .
First u should try to shade dry the lvs. it will be best for further analysisFollowing
- 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.
Eulalia vidal mam please write your e mail.
Thanks and regards.Following
- 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?
This article may help you even it does not answers your queryFollowing
- 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"?
Broad variety of attributes:
• Molecular Weight (MW):
- small molecules
- medium molecules
- large molecules
• Chemistries and the level of structural complexity:
- biopolymers built from amino acids, nucleotides, saccharides
- Conjugates of large molecules with medium size (CovX) or small molecules (PEG)
• Manufacturing or source of the material:
- Small molecules are made by well understood and controlled chemical synthesis
- Proteins (including antibodies) are made by less controlled fermentation
- Cell components
- Cells or tissues
• Regulatory cutoff in the US (may be different in other countries):
- Peptides and oligonucleotides fall under NDA
- Proteins and antibodies
• Functional class
- 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?
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.Following
- 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
Follow this article:
If you have any question, do not hesitate to ask.Following
- 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?
Soyalecithin available in various grades can be used. You can get it from Lipoid who manufactures pure and quality grades.Following
- 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?
yes you can use it .According to my exper. non membrane dissolution test for supp. was better correlated to the in vivo data.Following
- 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
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 chitosanFollowing
- 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?Following
- 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
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.Following
About Formulation Development of Pharmaceuticals
Formulation development of various dosage forms