Buy highly pure saxagliptin hydrochloride api, cas no. Metformin hydrochloride is freely soluble in water and. Metformin hydrochloride is a white to offwhite crystalline compound with a molecular formula of c4h11n5 hcl and a molecular weight of 165. Commonly reported adverse reactions include respiratory tract infection, urinary tract infection, and headache. A new simple economical reverse phase high performance liquid chromatographic method was developed for the determination of metformin hcl mfh and saxagliptin sgp in bulk and dosage form. Saxagliptin bms477118 is a selective and reversible dpp4 inhibitor with ic50 of 26 nm and ki of 1. Take saxagliptin exactly as your doctor tells you to. Saxagliptin rinn is an orally active hypoglycemic antidiabetic drug of the new dipeptidyl peptidase4 dpp. Onglyza saxagliptin tablets as saxagliptin hydrochloride part i. Sds of saxagliptin hydrochloride, safety data sheets, cas 709031.
We can also offer its intermediates with supportive technical package required for evaluation. Prasugrel hydrochloride, dronedarone, and saxagliptin. Saxagliptin hydrochloride cas no 709031787 manus aktteva biopharma llp, a global supplier of saxagliptin hydrochloride, 709031787 offers for your requirements of rnd development quantities or commercials, based on status of the product. Bristolmyers squibb australia pty ltd date of pbac consideration. Download pdf info publication number wo2014102832a2. Information about saxagliptin in the present dossier is the same as for the approved product onglyza, updated with stability data. Saxagliptin 5 is a substratemimicking pyrrolidinebased dpp4 inhibitor. No unexpected safety findings were observed with saxagliptin metformin ir admini. Wo2014102832a2 saxagliptin hydrochloride solid dispersion. Saxagliptin hydrochloride dihydrate c18h30cln3o4 pubchem. Saxagliptin has been approved as add on to metformin for the treatment of t2dm via the eu centralised procedure.
Saxagliptin is primarily metabolized by cytochrome p450 3a4 and 3a5 to 5hydroxy saxagliptin, which is half as potent as saxagliptin in inhibiting dpp4 su et al. Following a single 50 mg dose of 14c saxagliptin, 24%, 36%, and 75% of the dose was excreted in the urine as saxagliptin, its active metabolite, and total radioactivity, respectively. Auspar onglyza saxagliptin as hydrochloride bristolmyers squibb australia pty ltd pm20110117435 final march 20 page 5 of 32. Uses advised against not for food, drug, pesticide or biocidal product use. The specifications of the tablets include tests and limits that adequately control the appearance and assays at release and at expiry for saxagliptin and metformin hydrochloride. Healthy males and nonpregnant females, general population.
Before you start the treatment, read the manufacturers printed information leaflet from inside the pack. You can use an alternative approach if the approach satisfies. Manus aktteva biopharma llp, a global supplier of saxagliptin hydrochloride, 709031787 offers for your requirements of rnd development quantities or commercials, based on status of the product. However, in this case the core is not inert but contains metformin hydrochloride. The present invention provides a novel amorphous solid dispersion of saxagliptin hydrochloride in combination with a pharmaceutically acceptable carrier, process for its preparation and pharmaceutical compositions comprising it. Saxagliptin rinn is an orally active hypoglycemic antidiabetic drug of the new dipeptidyl peptidase4 dpp4 inhibitor class of drugs. Consider the risks and benefits of onglyza in patients. Make up to the volume with diluent and mixed to obtain 700.
Onglyza should not be used to treat people with type 1 diabetes or diabetic ketoacidosis increased ketones in the blood or urine. It does not create or confer any rights for or on any person and does not operate to bind fda or the public. Australian public assessment for saxagliptin as hydrochloride. It will give you more information about saxagliptin tablets and will provide you with a full list of the sideeffects which you may experience from taking them. Simultaneous estimation of saxagliptin hydrochloride and. It contains a cyanomethanoproline moiety at the p1 site and a large hydrophobic adamantyl moiety at the p2 site to fit the s2 pocket. Please see full prescribing information and medication guide for onglyza. Safety data sheet creation date 16nov2010 revision date 18jan2018 revision number 4 1. Bioequivalence of saxagliptinmetformin immediate release ir. Early development was solely by bristolmyers squibb. Active application number us252,682 other versions. The product is a respiratory sensitiser, subcategory 1a.
Saxagliptin hydrochloride is 1r,3r22r2amino23hydroxy1adamantylacetyl2 azabicyclo hexane3carbonitrile hydrochloride 17,19,21 as show in figure no. The retention time of metformin and saxagliptin was found to be 5. Maximum plasma concentration cmax for saxagliptin during treatment with fixed dose combination tablet of metformin plus saxagliptin compared with individual metformin xr and saxaglitpin tablets time frame. An efficient and telescopic process for the preparation of saxagliptin hydrochloride 1 is described using t3p as a reagent for condensation and dehydration steps. Slightly hazardous in case of skin contact sensitizer. The wavelength for metformin and saxagliptin at 225 nm was found to be appropriate. Prasugrel hydrochloride, dronedarone, and saxagliptin hydrochloride daniel a. Pdf printable version of this page pdf 91 kb public summary document. Pdf an efficient and telescopic process for synthesis of. Draft guidance on saxagliptin hydrochloride this draft guidance, once finalized, will represen t the food and drug administration s fdas current thinking on this topic. Us8410288b2 polymorphs of saxagliptin hydrochloride and. Saxagliptin cd2 hydrochloride safety data sheet according to regulation ec no. Us8410288b2 us252,682 us2011252682a us8410288b2 us 8410288 b2 us8410288 b2 us 8410288b2 us 2011252682 a us2011252682 a us 2011252682a us 8410288 b2 us8410288 b2 us 8410288b2 authority us united states prior art keywords saxagliptin saxagliptin hydrochloride crystalline theta degrees prior art date 20101004 legal status the legal status is an assumption and.
Hazardous identification material safety data sheet material metformin hydrochloride extendedrelease tablets 500 mg and mg manufacturer lupin limited goa 403 722 india. H330500 casno 5470111 synonyms hydroxylammonium chloride, oxammonium hydrochloride recommended use laboratory chemicals. Australian public assessment for saxagliptin metformin. Prescribing information including boxed warning consumer site health care. Onglyza saxagliptin adult type 2 diabetes medication. Many of these individuals are candidates for percutaneous coronary inter. Removal of both the alcohol and amine protecting groups with hcl afforded. Astrazeneca pharmaceuticals lp extended release kombiglyze xr. Identification of the substancemixture and of the companyundertaking product name. View and buy high purity saxagliptin hydrochloride. Onglyza is currently approved for the treatment of patients with type 2 diabetes mellitus t2dm, as follows. Saxagliptin, tablet, 5 mg as hydrochloride, onglyza sponsor.
Simultaneous estimation of saxagliptin hydrochloride and metformin hydrochloride in active pharmaceutical ingrident by rphplc a new simple, accurate, precise and reproducible rp hplc method has been developed for the simultaneous estimation of saxagliptin and metformin in bulk drug form using c 18 column phenomenex, 250 x 4. A new simple, accurate, precise and reproducible rp hplc method has been developed for the simultaneous estimation of saxagliptin and metformin in bulk drug form using c 18 column phenomenex, 250 x 4. Saxagliptin is eliminated by both renal and hepatic pathways. Saxagliptin hydrochloride and metformin hydrochloride. Chromatographic separation was done on kinetex columnc 18 4. Saxagliptin hydrochloride safety data sheet section 2. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.
Saxagliptin hydrochloride and metformin hydrochloride is a hypoglycemic agent that is fda approved for the treatment of type 2 diabetes mellitus. For 5hydroxy saxagliptin, following ingestion of saxagliptin 5 mg, the c max of 47 ngml was achieved at 4 h and the auc was 214 ng9hml onglyza, 2014. Common adverse reactions include diarrhea, nauseavomiting, upper respiratory tract infection, urinary tract infection, headache and nasopharyngitis. Accidental release measures contain spill and collect, as appropriate.
Health professional information summary product information route of administration dosage form strength clinically relevant nonmedicinal ingredients oral tablet, 2. Kombiglyzetm xr abbreviated prescribing information indications and usage. Discovery and preclinical profile of saxagliptin bms477118. Jul 29, 2019 each filmcoated tablet of onglyza for oral use contains either 2. Saxagliptin hydrochloride is the hydrochloride salt form of saxagliptin, an orally bioavailable, potent, selective and competitive, cyanopyrrolidinebased inhibitor of dipeptidyl peptidase 4 dpp4, with hypoglycemic activity. There is a black box warning for this drug as shown here. A bioequivalence study of the fixed dose combinations of. The developed method is found to be rapid and sensitive which can be used for estimation of combination of metformin and saxagliptin in. Two chromatographic methods were suggested for the simultaneous determination of a binary mixture containing saxagliptin hcl sag and metformin hcl met. Tocris bioscience is the leading supplier of novel and exclusive tools for life science research with over 30 years experience in the industry.
Material safety data sheet hydrochloric acid lsu health new. Saxagliptin hydrochloride and metformin hydrochloride wikidoc. The separation was eluted on a zodiac c18 column 150 mm x 4. Saxagliptin significantly impaired left ventricular developed pressure compared to controls. Get emergency medical help if you have signs of an allergic reaction. Saxagliptin, its metabolite, m2, and metformin in plasma. Identification product name hydroxylamine hydrochloride cat no.
Kombiglyzetm xr is indicated as an adjunct to diet and exercise to improve glycaemic control in adults with type 2 diabetes mellitus when treatment with both saxagliptin and metformin is appropriate. Saxagliptin hydrochloride safety data sheet as in any fire, wear selfcontained breathing apparatus pressuredemand niosh approved or equivalent, and full protective gear to prevent contact with skin and eyes. Saxagliptin metformin hydrochloride extended release tablets. Download product insert pdfdownload safety data sheet sds pdf. Bioequivalence of saxagliptinmetformin immediate release. Chemicalbook provide chemical industry users with saxagliptin boiling point melting point, saxagliptin density msds formula use,if you also need to saxagliptin. Saxagliptin, tablet, 5 mg as hydrochloride, onglyza. Identification of the substancemixture and of the companyundertaking. Peripheral edema was more commonly reported in patients treated with the combination saxagliptin and thiazolidinedione. Saxagliptin monohydrate is described chemically as 1 s,3 s,5 s22 s2amino23. Saxagliptin, sold under the brand name onglyza, is an oral hypoglycemic antidiabetic drug of the dipeptidyl peptidase4 dpp4 inhibitor class. Kombiglyze xr saxagliptin and metformin hcl extendedrelease tablets. Saxagliptin hydrochloride, 709031787, manufacturer. Saxagliptinmetformin hydrochloride extended release tablets.
1155 1230 1428 292 983 501 1664 449 446 1351 1331 1730 1609 212 209 948 400 697 445 1522 1539 1080 1223 760 1044 1429 856 1704 1450