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Ferric derisomaltose

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2D chemical structure of 1345510-43-1
Ferric derisomaltose.png

Ferric derisomaltose

WeightAverage: 562.297
Monoisotopic: 562.117975Chemical FormulaC18H34FeO16

Monover, JAPAN 2022, 2022/3/28

Monoferric (TN);
Monover (TN)

Anti-anemic, Hematinic, Supplement (iron)

CAS 1345510-43-1

デルイソマルトース第二鉄

  • NS32
  • WHO 9712
  • UNII-AHU547PI9H
Originator CompanyPharmacosmos
Active CompaniesNippon Shinyaku Co Ltd;Pharmacosmos A/S;Wasserburger Arzneimittelwerk Gmbh;Zealand University Hospital

iron(3+) (2S,3R,4R,5R)-6-{[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-({[(2S,3R,4S,5S,6R)-3,4,5-trihydroxy-6-(hydroxymethyl)oxan-2-yl]oxy}methyl)oxan-2-yl]oxy}hexane-1,2,3,4,5-pentol

  • alpha-D-Glucan, (1-6)-, reduced, reaction products with iron hydroxide (Fe(OH)3)

Ferric derisomaltose is an iron injection used in the treatment of iron deficiency anemia.

Ferric derisomaltose, sold under the brand name Monoferric, is a medication for the treatment of iron deficiency anemia (IDA) in adults who have intolerance to oral iron or have had unsatisfactory response to oral iron or who have non-hemodialysis dependent chronic kidney disease (NDD-CKD).[1] It was approved for use in the United States in January 2020.[1][2][3] It is given intravenously.[1]

Iron deficiency is an extremely common condition and is the most frequent cause of anemia worldwide. Iron deficiency results when iron intake, iron stores, and loss of iron from the body do not adequately support production of erythrocytes, also known as red blood cells. Though it is generally considered non life-threatening, iron deficiency may considerably affect quality of life.3

Ferric derisomaltose is a form of iron used in the treatment of iron deficiency. This drug is a complex of iron (III) hydroxide and derisomaltose. The latter is an iron carbohydrate oligosaccharide that works to release iron. Ferric derisomaltose was developed by Pharmacosmos Therapeutics ad was granted FDA approval in January 2020.8,9 Clinical trials show that it is non-inferior to iron sucrose, another form of iron that is often administered in iron deficiency, and less likely to cause serious hypersensitivity that is associated with other forms of injectable iron.1,4

This drug is indicated for the treatment of iron deficiency anemia in adult patients who have experienced intolerance to oral iron preparations or insufficient clinical response to orally administered iron. Ferric derisomaltase is also indicated for patients with non-hemodialysis dependent chronic kidney disease.8 In Australia and United Kingdom, ferric derisomaltase is indicated for cases in which rapid delivery of iron is required.10,11

Iron deficiency is an extremely common condition and is the most frequent cause of anemia worldwide. Iron deficiency results when iron intake, iron stores, and loss of iron from the body do not adequately support production of erythrocytes, also known as red blood cells. Though it is generally considered non life-threatening, iron deficiency may considerably affect quality of life. Ferric derisomaltose is a form of iron used in the treatment of iron deficiency. This drug is a complex of iron (III) hydroxide and derisomaltose. The latter is an iron carbohydrate oligosaccharide that works to release ironFerric derisomaltose was developed by Pharmacosmos Therapeutics ad was granted FDA approval in January 2020. Clinical trials show that it is non-inferior to [iron sucrose], another form of iron that is often administered in iron deficiency, and less likely to cause serious hypersensitivity that is associated with other forms of injectable iron.

Monoferric is an iron replacement product containing ferric derisomaltose for intravenous infusion. Ferric derisomaltose is an iron carbohydrate complex with a matrix structure composed of interchanging layers of ferric hydroxide and the carbohydrate derisomaltose. Derisomaltose consists of linear, hydrogenated isomaltooligosaccharides with an average molecular weight of 1000 Da and a narrow molecular weight distribution that is almost devoid of mono-and disaccharides.

Ferric derisomaltose has an average molecular weight of 155,000 Da and has the following empirical formula:

{FeO(1-3X) (OH)(1+3X) (C6H5O73-)X}, (H20)T, –
(C6H10O6)R(-C6H10O5-)Z(C6H13O5)R, (NaCl)Y

X= 0.0311; T = 0.25; R = 0.14; Z = 0.49; Y = 0.14

Iron atoms placed in the electronegative cavities of the 3-D structure between and within the derisomaltose molecules. A schematic representation is presented below

MONOFERRIC (ferric derisomaltose) Structural Formula Illustration

Monoferric is a sterile, dark brown, non-transparent aqueous solution with pH 5.0-7.0, containing ferric derisomaltose dissolved in water for injections and filled into Type I glass vials.

Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection.

Each 1 mL of solution contains 100 mg of elemental iron as ferric derisomaltose in water for injection.

Mkt.
Status
Active IngredientProprietary NameAppl. No.Dosage FormRouteStrengthTE CodeRLDRSApplicant Holder
RXFERRIC DERISOMALTOSEMONOFERRICN208171SOLUTIONINTRAVENOUS1GM/10ML (100MG/ML) RLDRSPHARMACOSMOS AS
DISCNFERRIC DERISOMALTOSEMONOFERRICN208171SOLUTIONINTRAVENOUS100MG/ML (100MG/ML) RLD PHARMACOSMOS AS
DISCNFERRIC DERISOMALTOSEMONOFERRICN208171SOLUTIONINTRAVENOUS500MG/5ML (100MG/ML) RLD PHARMACOSMOS AS
Mkt.
Status
Active IngredientProprietary NameAppl. No.Dosage FormRouteStrengthTE Code>RLDRSApplicant Holder

MONOFERRIC (FERRIC DERISOMALTOSE)
1GM/10ML (100MG/ML)
Marketing Status: Prescription

Active Ingredient: FERRIC DERISOMALTOSE
Proprietary Name: MONOFERRIC
Dosage Form; Route of Administration: SOLUTION; INTRAVENOUS
Strength: 1GM/10ML (100MG/ML)
Reference Listed Drug: Yes
Reference Standard: Yes
TE Code:
Application Number: N208171
Product Number: 003
Approval Date: Jan 16, 2020
Applicant Holder Full Name: PHARMACOSMOS AS
Marketing Status:  Prescription
Patent and Exclusivity Information

Patent and Exclusivity for: N208171

Product 003
FERRIC DERISOMALTOSE (MONOFERRIC) SOLUTION 1GM/10ML (100MG/ML)

Patent Data

Product NoPatent NoPatent ExpirationDrug SubstanceDrug ProductPatent Use CodeDelist RequestedSubmission Date
003881530108/14/2029DSDPU-2734 02/14/2020
0031041483103/25/2029DSDP  02/14/2020

PATENT

AU2009342799B2

US10414831B2 

US2012010166A1 

 US2014303364A1 

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References

  1. Jump up to:a b c d “Monoferric- ferric derisomaltose solution”DailyMed. 24 January 2020. Retrieved 16 February 2020.
  2. ^ “Monoferric approval letter” (PDF). U.S. Food and Drug Administration (FDA). 16 January 2020. Retrieved 16 February 2020. Public Domain This article incorporates text from this source, which is in the public domain.
  3. ^ “Drug Approval Package: Monoferric Injection”U.S. Food and Drug Administration (FDA). 7 May 2020. Retrieved 13 August 2020.

External links

Clinical data
Trade namesMonoferric
AHFS/Drugs.comMonograph
License dataUS DailyMedFerric_derisomaltose
Routes of
administration
Intravenous (IV)
ATC codeNone
Legal status
Legal statusUS: ℞-only [1]
Identifiers
showIUPAC name
CAS Number1345510-43-1
PubChem CID86278348
DrugBankDB15617
UNIIAHU547PI9H
KEGGD11808
Chemical and physical data
FormulaC18H34FeO16+3
Molar mass562.299 g·mol−1
3D model (JSmol)Interactive image
showSMILES
showInChI

/////////////Ferric derisomaltose, デルイソマルトース第二鉄 , APPROVALS 2022, JAPAN 2022, NS32, WHO 9712

[Fe+3].OC[C@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO[C@H]2O[C@H](CO)[C@@H](O)[C@H](O)[C@H]2O)[C@@H](O)[C@H](O)[C@H]1O

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DR ANTHONY CRASTO

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DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO Ph.D

DR ANTHONY MELVIN CRASTO, Born in Mumbai in 1964 and graduated from Mumbai University, Completed his Ph.D from ICT, 1991,Matunga, Mumbai, India, in Organic Chemistry, The thesis topic was Synthesis of Novel Pyrethroid Analogues, Currently he is working with AFRICURE PHARMA as ADVISOR, earlier assignment was with GLENMARK LIFE SCIENCES LTD, as CONSUlTANT, Retired from GLENMARK in Jan2022 Research Centre as Principal Scientist, Process Research (bulk actives) at Mahape, Navi Mumbai, India. Total Industry exp 32 plus yrs, Prior to joining Glenmark, he has worked with major multinationals like Hoechst Marion Roussel, now Sanofi, Searle India Ltd, now RPG lifesciences, etc. He has worked with notable scientists like Dr K Nagarajan, Dr Ralph Stapel, Prof S Seshadri, etc, He did custom synthesis for major multinationals in his career like BASF, Novartis, Sanofi, etc., He has worked in Discovery, Natural products, Bulk drugs, Generics, Intermediates, Fine chemicals, Neutraceuticals, GMP, Scaleups, etc, he is now helping millions, has 9 million plus hits on Google on all Organic chemistry websites. His friends call him Open superstar worlddrugtracker. His New Drug Approvals, Green Chemistry International, All about drugs, Eurekamoments, Organic spectroscopy international, etc in organic chemistry are some most read blogs He has hands on experience in initiation and developing novel routes for drug molecules and implementation them on commercial scale over a 32 PLUS year tenure till date Feb 2023, Around 35 plus products in his career. He has good knowledge of IPM, GMP, Regulatory aspects, he has several International patents published worldwide . He has good proficiency in Technology transfer, Spectroscopy, Stereochemistry, Synthesis, Polymorphism etc., He suffered a paralytic stroke/ Acute Transverse mylitis in Dec 2007 and is 90 %Paralysed, He is bound to a wheelchair, this seems to have injected feul in him to help chemists all around the world, he is more active than before and is pushing boundaries, He has 100 million plus hits on Google, 2.5 lakh plus connections on all networking sites, 100 Lakh plus views on dozen plus blogs, 227 countries, 7 continents, He makes himself available to all, contact him on +91 9323115463, email amcrasto@gmail.com, Twitter, @amcrasto , He lives and will die for his family, 90% paralysis cannot kill his soul., Notably he has 38 lakh plus views on New Drug Approvals Blog in 227 countries......https://newdrugapprovals.wordpress.com/ , He appreciates the help he gets from one and all, Friends, Family, Glenmark, Readers, Wellwishers, Doctors, Drug authorities, His Contacts, Physiotherapist, etc He has total of 32 International and Indian awards

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