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Chemistry

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Also known as: Foznol, 587-26-8, Lanthanum sesquicarbonate, Phosbloc, Carbonic acid, lanthanum(3+) salt (3:2), Lanthanum(3+);tricarbonate
Molecular Formula
C3La2O9
Molecular Weight
457.84  g/mol
InChI Key
NZPIUJUFIFZSPW-UHFFFAOYSA-H
FDA UNII
0M78EU4V9H

Lanthanum Carbonate
Lanthanum Carbonate is the carbonate salt of lanthanum, a silvery white metallic element of the lanthanoids family, with phosphate binding property. Lanthanum carbonate dissociates in gastric acid to release lanthanum ions, which then binds dietary phosphate. This agent inhibits the absorption of phosphate by forming highly insoluble lanthanum-phosphate complexes that reduce concentrations of serum phosphate and calcium phosphate.
1 2D Structure

Lanthanum Carbonate

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
lanthanum(3+);tricarbonate
2.1.2 InChI
InChI=1S/3CH2O3.2La/c3*2-1(3)4;;/h3*(H2,2,3,4);;/q;;;2*+3/p-6
2.1.3 InChI Key
NZPIUJUFIFZSPW-UHFFFAOYSA-H
2.1.4 Canonical SMILES
C(=O)([O-])[O-].C(=O)([O-])[O-].C(=O)([O-])[O-].[La+3].[La+3]
2.2 Other Identifiers
2.2.1 UNII
0M78EU4V9H
2.3 Synonyms
2.3.1 MeSH Synonyms

1. Fosrenol

2. Lantharenol

2.3.2 Depositor-Supplied Synonyms

1. Foznol

2. 587-26-8

3. Lanthanum Sesquicarbonate

4. Phosbloc

5. Carbonic Acid, Lanthanum(3+) Salt (3:2)

6. Lanthanum(3+);tricarbonate

7. Lanthanum(3+) Carbonate

8. Lanthanum (iii) Carbonate

9. Lanthanum Carbonate (2:3)

10. Lanthanum Carbonate Anhydrous

11. 0m78eu4v9h

12. Dilanthanum Tricarbonate

13. Carbonic Acid,lanthanum(3+) Salt (3:2), Octahydrate (8ci,9ci)

14. Lanthanum(3 ) Carbonate

15. Einecs 209-599-5

16. Lanthanum(3+) Tricarbonate

17. Unii-0m78eu4v9h

18. Hsdb 7758

19. Carbonato De Lantano

20. Carbonate De Lanthane

21. Carbonato De Lantanio

22. Carbonato Di Lantanio

23. Lanthanum(iii) Carbonate

24. Lanthanum Carbonate Powder

25. Ec 209-599-5

26. Lanthanum(3+) Salt (3:2)

27. Lanthanum Carbonate [mi]

28. Dtxsid30890512

29. Lanthanum Carbonate (la2(co3)3)

30. Lanthanum Carbonate [who-dd]

31. Db06792

32. Lanthanum(3 ) Carbonate [hsdb]

33. Q421317

34. Carbonic Acid,lanthanum(3+) Salt (3:2), Hydrate (9ci)

2.4 Create Date
2005-08-08
3 Chemical and Physical Properties
Molecular Weight 457.84 g/mol
Molecular Formula C3La2O9
Hydrogen Bond Donor Count0
Hydrogen Bond Acceptor Count9
Rotatable Bond Count0
Exact Mass457.76696 g/mol
Monoisotopic Mass457.76696 g/mol
Topological Polar Surface Area190 Ų
Heavy Atom Count14
Formal Charge0
Complexity18.8
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count5
4 Drug and Medication Information
4.1 Therapeutic Uses

Lanthanum; Kidney Failure, Chronic

National Library of Medicine's Medical Subject Headings online file (MeSH, 2009)


Lanthanum carbonate is indicated to reduce serum phosphate in patients with end stage renal disease. /Included in US product label/

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


4.2 Drug Warning

Adverse effects reported in 5% or more of patients receiving lanthanum carbonate and more frequently than with placebo include nausea, vomiting, dialysis graft occlusion, and abdominal pain.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2755


Patients with acute peptic ulcer, ulcerative colitis, Crohn's disease or bowel obstruction were not included in lanthanum carbonate clinical studies. Caution should be used in patients with these conditions.

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


While growth abnormalities were not identified in long-term animal studies, lanthanum was deposited into developing bone including growth plate. The consequences of such deposition in developing bone in pediatric patients are unknown. Therefore, the use of lanthanum carbonate in this population is not recommended.

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


/Patients taking lanthanum carbonate should be advised of the/ importance of taking lanthanum carbonate with or immediately after meals.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2755


For more Drug Warnings (Complete) data for Lanthanum Carbonate (9 total), please visit the HSDB record page.


4.3 Drug Indication

Used to reduce serum phosphate in patients with end stage renal disease (ESRD).


FDA Label


5 Pharmacology and Biochemistry
5.1 Pharmacology

In vitro studies have shown that lanthanum binds phosphate in the physiologically relevant pH range of 3 to 7. In simulated gastric fluid, lanthanum binds approximately 97% of the available phosphate at pH 3-5 and 67% at pH 7, when lanthanum is present in a two-fold molar excess to phosphate. Bile acids have not been shown to affect the phosphate binding affinity of lanthanum. In order to bind dietary phosphate, lanthanum carbonate must be administered with or immediately after meals.


5.2 FDA Pharmacological Classification
5.2.1 Pharmacological Classes
Phosphate Chelating Activity [MoA]; Phosphate Binder [EPC]
5.3 ATC Code

V - Various

V03 - All other therapeutic products

V03A - All other therapeutic products

V03AE - Drugs for treatment of hyperkalemia and hyperphosphatemia

V03AE03 - Lanthanum carbonate


5.4 Absorption, Distribution and Excretion

Absorption

Bioavailability very low (<0.002%) following single or multiple dose oral administration.


Route of Elimination

No information is available regarding the mass balance of lanthanum in humans after oral administration. In rats and dogs, the mean recovery of lanthanum after an oral dose was about 99% and 94%, respectively, and was essentially all from feces. Biliary excretion is the predominant route of elimination for circulating lanthanum in rats.


Clearance

In healthy volunteers administered intravenous lanthanum as the soluble chloride salt (120 g), renal clearance was less than 2% of total plasma clearance.


Lanthanum is minimally absorbed from the GI tract following oral administration; bioavailability is less than 0.002%. In patients receiving therapeutic dosages of lanthanum for up to 2 years, mean plasma concentrations of the drug remained low (ie, 1.1 ng/mL or less).

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2755


Following single or multiple dose oral administration of lanthanum carbonate to healthy subjects, the concentration of lanthanum in plasma was very low. Following oral administration in ESRD patients, the mean lanthanum Cmax was 1.0 ng/mL. During long-term administration (52 weeks) in ESRD patients, the mean lanthanum concentration in plasma was approximately 0.6 ng/mL. There was minimal increase in plasma lanthanum concentrations with increasing doses within the therapeutic dose range. The effect of food on the bioavailability of lanthanum carbonate has not been evaluated, but the timing of food intake relative to lanthanum administration (during and 30 minutes after food intake) has a negligible effect on the systemic level of lanthanum

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


In vitro, lanthanum is highly bound (>99%) to human plasma proteins, including human serum albumin, alpha1-acid glycoprotein, and transferrin. Binding to erythrocytes in vivo is negligible in rats.

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


In studies in mice, rats and dogs, lanthanum concentrations in many tissues increased over time and were several orders of magnitude higher than plasma concentrations (particularly in the GI tract, bone and liver). Steady state tissue concentrations in bone and liver were achieved in dogs between 4 and 26 weeks. Relatively high levels of lanthanum remained in these tissues for longer than 6 months after cessation of dosing in dogs. There is no evidence from animal studies that lanthanum crosses the blood-brain barrier.

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


For more Absorption, Distribution and Excretion (Complete) data for Lanthanum Carbonate (13 total), please visit the HSDB record page.


5.5 Metabolism/Metabolites

Lanthanum is not metabolized.


Lanthanum is not metabolized and is not a substrate of CYP450. In vitro metabolic inhibition studies showed that lanthanum at concentrations of 10 and 40 ug/mL does not have relevant inhibitory effects on any of the CYP450 isoenzymes tested (1A2, 2C9/10, 2C19, 2D6, and 3A4/5).

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


5.6 Biological Half-Life

Elimination half-life of 53 hours.


Lanthanum was cleared from plasma following discontinuation of therapy with an elimination half-life 53 hours.

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


... Estimates of elimination half-life from bone ranged from 2.0 to 3.6 years.

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


5.7 Mechanism of Action

Lanthanum carbonate is a phosphate binder that reduces absorption of phosphate by forming insoluble lanthanum phosphate complexes that pass through the gastrointestinal (GI) tract unabsorbed. Both serum phosphate and calcium phosphate product are reduced as a consequence of the reduced dietary phosphate absorption.


Lanthanum carbonate dissociates in the acid environment of the upper GI tract to release lanthanum ions that bind dietary phosphate released from food during digestion. Lanthanum carbonate inhibits absorption of phosphate by forming highly insoluble lanthanum phosphate complexes, consequently reducing both serum phosphate and calcium phosphate product.

US Natl Inst Health; DailyMed. Current Medication Information for Fosrenol (Lanthanum carbonate) (January 2006). Available from, as of June 17, 2009: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?id=3132


The carbonate salt of lanthanum is practically insoluble in water but dissociates in the acidic environment of the upper GI tract to release trivalent lanthanum ions, which bind dietary phosphates released during digestion, thereby forming highly insoluble lanthanum phosphate complexes. Consequently, phosphate absorption, serum phosphorus concentrations, and serum calcium times phosphorus product (Ca X P) are reduced. Lanthanum ions have a high affinity for phosphate; in vitro studies indicate that when lanthanum is present at pH 3-5 (pH corresponding to that of gastric fluid) in twofold molar excess to phosphates, the drug binds about 97% of available phosphates.

American Society of Health System Pharmacists; AHFS Drug Information 2009. Bethesda, MD. (2009), p. 2755


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22-Jan-2021
05-Oct-2024
KGS
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DRUG PRODUCT COMPOSITIONS

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DOSAGE - TABLET, CHEWABLE;ORAL - EQ 1GM BASE

USFDA APPLICATION NUMBER - 21468

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ABOUT THIS PAGE

Lanthanum Carbonate Manufacturers

A Lanthanum Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Lanthanum Carbonate, including repackagers and relabelers. The FDA regulates Lanthanum Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Lanthanum Carbonate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.

click here to find a list of Lanthanum Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.

Lanthanum Carbonate Suppliers

A Lanthanum Carbonate supplier is an individual or a company that provides Lanthanum Carbonate active pharmaceutical ingredient (API) or Lanthanum Carbonate finished formulations upon request. The Lanthanum Carbonate suppliers may include Lanthanum Carbonate API manufacturers, exporters, distributors and traders.

click here to find a list of Lanthanum Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.

Lanthanum Carbonate USDMF

A Lanthanum Carbonate DMF (Drug Master File) is a document detailing the whole manufacturing process of Lanthanum Carbonate active pharmaceutical ingredient (API) in detail. Different forms of Lanthanum Carbonate DMFs exist exist since differing nations have different regulations, such as Lanthanum Carbonate USDMF, ASMF (EDMF), JDMF, CDMF, etc.

A Lanthanum Carbonate DMF submitted to regulatory agencies in the US is known as a USDMF. Lanthanum Carbonate USDMF includes data on Lanthanum Carbonate's chemical properties, information on the facilities and procedures used, and details about packaging and storage. The Lanthanum Carbonate USDMF is kept confidential to protect the manufacturer’s intellectual property.

click here to find a list of Lanthanum Carbonate suppliers with USDMF on PharmaCompass.

Lanthanum Carbonate JDMF

The Pharmaceuticals and Medical Devices Agency (PMDA) established the Japan Drug Master File (JDMF), also known as the Master File (MF), to permit Japanese and foreign manufacturers of drug substances, intermediates, excipients, raw materials, and packaging materials (‘Products’) to voluntarily register confidential information about the production and management of their products in Japan.

The Lanthanum Carbonate Drug Master File in Japan (Lanthanum Carbonate JDMF) empowers Lanthanum Carbonate API manufacturers to present comprehensive information (e.g., production methods, data, etc.) to the review authority, i.e., PMDA (Pharmaceuticals & Medical Devices Agency).

PMDA reviews the Lanthanum Carbonate JDMF during the approval evaluation for pharmaceutical products. At the time of Lanthanum Carbonate JDMF registration, PMDA checks if the format is accurate, if the necessary items have been included (application), and if data has been attached.

click here to find a list of Lanthanum Carbonate suppliers with JDMF on PharmaCompass.

Lanthanum Carbonate KDMF

In Korea, the Ministry of Food and Drug Safety (MFDS) is in charge of regulating pharmaceutical products and services.

Pharmaceutical companies submit a Lanthanum Carbonate Drug Master File in Korea (Lanthanum Carbonate KDMF) to the MFDS, which includes comprehensive information about the production, processing, facilities, materials, packaging, and testing of Lanthanum Carbonate. The MFDS reviews the Lanthanum Carbonate KDMF as part of the drug registration process and uses the information provided in the Lanthanum Carbonate KDMF to evaluate the safety and efficacy of the drug.

After submitting a Lanthanum Carbonate KDMF to the MFDS, the registered manufacturer can provide importers or distributors with the registration number without revealing confidential information to Korean business partners. Applicants seeking to register their Lanthanum Carbonate API can apply through the Korea Drug Master File (KDMF).

click here to find a list of Lanthanum Carbonate suppliers with KDMF on PharmaCompass.

Lanthanum Carbonate WC

A Lanthanum Carbonate written confirmation (Lanthanum Carbonate WC) is an official document issued by a regulatory agency to a Lanthanum Carbonate manufacturer, verifying that the manufacturing facility of a Lanthanum Carbonate active pharmaceutical ingredient (API) adheres to the Good Manufacturing Practices (GMP) regulations of the importing country. When exporting Lanthanum Carbonate APIs or Lanthanum Carbonate finished pharmaceutical products to another nation, regulatory agencies frequently require a Lanthanum Carbonate WC (written confirmation) as part of the regulatory process.

click here to find a list of Lanthanum Carbonate suppliers with Written Confirmation (WC) on PharmaCompass.

Lanthanum Carbonate NDC

National Drug Code is a comprehensive database maintained by the FDA that contains information on all drugs marketed in the US. This directory includes information about finished drug products, unfinished drug products, and compounded drug products, including those containing Lanthanum Carbonate as an active pharmaceutical ingredient (API).

Finished drug products

The FDA updates the NDC directory daily. The NDC numbers for Lanthanum Carbonate API and other APIs are published in this directory by the FDA.

Unfinished drugs

The NDC unfinished drugs database includes product listing information submitted for all unfinished drugs, such as active pharmaceutical ingredients (APIs), drugs intended for further processing and bulk drug substances for compounding.

Pharmaceutical companies that manufacture Lanthanum Carbonate as an active pharmaceutical ingredient (API) must furnish the FDA with an updated record of all drugs that they produce, prepare, propagate, compound, or process for commercial distribution in the US at their facilities.

Compounded drug products

The NDC directory also contains data on finished compounded human drug products that contain Lanthanum Carbonate and are produced by outsourcing facilities. While these outsourcing facilities are not mandated to assign a Lanthanum Carbonate NDC to their finished compounded human drug products, they may choose to do so.

click here to find a list of Lanthanum Carbonate suppliers with NDC on PharmaCompass.

Lanthanum Carbonate GMP

Lanthanum Carbonate Active pharmaceutical ingredient (API) is produced in GMP-certified manufacturing facility.

GMP stands for Good Manufacturing Practices, which is a system used in the pharmaceutical industry to make sure that goods are regularly produced and monitored in accordance with quality standards. The FDA’s current Good Manufacturing Practices requirements are referred to as cGMP or current GMP which indicates that the company follows the most recent GMP specifications. The World Health Organization (WHO) has its own set of GMP guidelines, called the WHO GMP. Different countries can also set their own guidelines for GMP like China (Chinese GMP) or the EU (EU GMP).

PharmaCompass offers a list of Lanthanum Carbonate GMP manufacturers, exporters & distributors, which can be sorted by USDMF, JDMF, KDMF, CEP (COS), WC, API price, and more, enabling you to easily find the right Lanthanum Carbonate GMP manufacturer or Lanthanum Carbonate GMP API supplier for your needs.

Lanthanum Carbonate CoA

A Lanthanum Carbonate CoA (Certificate of Analysis) is a formal document that attests to Lanthanum Carbonate's compliance with Lanthanum Carbonate specifications and serves as a tool for batch-level quality control.

Lanthanum Carbonate CoA mostly includes findings from lab analyses of a specific batch. For each Lanthanum Carbonate CoA document that a company creates, the USFDA specifies specific requirements, such as supplier information, material identification, transportation data, evidence of conformity and signature data.

Lanthanum Carbonate may be tested according to a variety of international standards, such as European Pharmacopoeia (Lanthanum Carbonate EP), Lanthanum Carbonate JP (Japanese Pharmacopeia) and the US Pharmacopoeia (Lanthanum Carbonate USP).

Inform the supplier about your product requirements, specifying if you need a product with particular monograph like EP (Ph. Eur.), USP, JP, BP, or any other quality. In addition, clarify whether you need hydrochloride (HCl), anhydricum, base, micronisatum or a specific level of purity. To find reputable suppliers, utilize the filters and select those certified by GMP, FDA, or any other certification as per your requirement.
For your convenience, we have listed synonyms and CAS numbers to help you find the best supplier. The use of synonyms and CAS numbers can be helpful in identifying potential suppliers, but it is crucial to note that they might not always indicate the exact same product. It is important to confirm the product details with the supplier before making a purchase to ensure that it meets your requirements.
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