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Chemistry

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Also known as: Benclay, Bentolite l, Bentone 34, Aquagel, Askangel, Magbond
Molecular Formula
Al2H2O6Si
Molecular Weight
180.06  g/mol
InChI Key
SVPXDRXYRYOSEX-UHFFFAOYSA-N

Bentonite
Bentoquatam is a topical medication intended to act as a shield against exposure to the irritating substance urushiol, found in plants such as poison ivy or poison oak. Bentoquatam contains bentonite, a clay, and is only effective as long as the film is visible on the skin.
1 2D Structure

Bentonite

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
dioxosilane;oxo(oxoalumanyloxy)alumane;hydrate
2.1.2 InChI
InChI=1S/2Al.O2Si.H2O.3O/c;;1-3-2;;;;/h;;;1H2;;;
2.1.3 InChI Key
SVPXDRXYRYOSEX-UHFFFAOYSA-N
2.1.4 Canonical SMILES
O.O=[Al]O[Al]=O.O=[Si]=O
2.2 Synonyms
2.2.1 MeSH Synonyms

1. Bentone 34

2. Dimethyldioctadecylammonium Montmorillonite

3. Ivy Block

4. Quaternium 18-bentonite

2.2.2 Depositor-Supplied Synonyms

1. Benclay

2. Bentolite L

3. Bentone 34

4. Aquagel

5. Askangel

6. Magbond

7. Otaylite

8. Tixoton

9. Volclay

10. Wilkinite

11. Bengel

12. Culvin

13. Filgel

14. Akajo

15. Asama

16. Bentogrout

17. Soap Clay

18. Bentonit T

19. Bentolite Hs

20. Bulgarben Ba

21. Accugel F

22. Altonit Sf

23. Bengel A

24. Bengel Fw

25. Southern Bentonite

26. Bengel Hvp

27. Bentosolon 82

28. Aquagel Gold Seal

29. Detercal G 1fc

30. Detercal G 2fc

31. Detercol P 2

32. Bentone 27

33. Accofloc 352

34. Cosintam 403

35. Hi-jel

36. Bengel 11

37. Bengel 15

38. Bengel 23

39. Bentonite 2073

40. Bentone 660

41. Cvis

42. Fulbent 570

43. Volcaly Bentonite Bc

44. Aluminosilicate Hydrate

45. Imvite I.g.b.a

46. Bentonite [jan:nf]

47. Bentonite, Sodium Form

48. Panther Creek Bentonite

49. Clarit Bw 100

50. Clarit Bw 125

51. Black Hills Bh 200

52. Bentonite, Calcian-sodian

53. Unii-a3n5zcn45c

54. G 100 (clay)

55. Ex 0030 (clay)

56. Albagel Premium Usp 4444

57. Ccris 3663

58. Hsdb 392

59. Gk 129sa3

60. Gk 129sa5

61. Aeg 325

62. Ex-m 703

63. Einecs 215-108-5

64. Mfcd00130611

65. Ex 0276

66. 250m

67. Dioxosilane;oxo(oxoalumanyloxy)alumane;hydrate

68. Q20817027

2.3 Create Date
2005-03-27
3 Chemical and Physical Properties
Molecular Weight 180.06 g/mol
Molecular Formula Al2H2O6Si
Hydrogen Bond Donor Count1
Hydrogen Bond Acceptor Count6
Rotatable Bond Count0
Exact Mass179.925141 g/mol
Monoisotopic Mass179.925141 g/mol
Topological Polar Surface Area78.5 Ų
Heavy Atom Count9
Formal Charge0
Complexity52.4
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count0
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count3
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameIvy block
Active IngredientBentoquatam
Dosage FormLotion
RouteTopical
Strength5%
Market StatusOver the Counter
CompanyStand Homeopath

2 of 2  
Drug NameIvy block
Active IngredientBentoquatam
Dosage FormLotion
RouteTopical
Strength5%
Market StatusOver the Counter
CompanyStand Homeopath

4.2 Drug Indication

Used to prevent or reduce the severity of allergic contact dermatitis due to urushiol, the allergenic resin of poison ivy, poison oak, and poison sumac.


5 Pharmacology and Biochemistry
5.1 Pharmacology

Bentoquatam protects the skin like a shield against poison ivy, poison oak, and poison sumac by physically blocking skin contact with their resin. The best protection against getting these conditions is to avoid contact with these plants. This medicine does not dry oozing and weeping caused by the rash of poison ivy, poison oak, or poison sumac.


5.2 MeSH Pharmacological Classification

Dermatologic Agents

Drugs used to treat or prevent skin disorders or for the routine care of skin. (See all compounds classified as Dermatologic Agents.)


5.3 Mechanism of Action

The mechanism of action is unknown. It is thought topically applied bentoquatam acts as a physical barrier that interferes with the adsorption of antigens onto the skin and reduces absorption of antigens into the skin. It probably does not work by modifying the systemic allergic response.


API Reference Price

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12-May-2021
10-Apr-2024
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Drugs in Development

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Details:

Altamira will extend the territory covered by their exclusive license and distribution agreement by Nuance for Bentrio (bentonite) nasal spray by several countries across South East and East Asia.


Lead Product(s): Bentonite

Therapeutic Area: Immunology Brand Name: Bentrio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Nuance Pharma

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Licensing Agreement September 16, 2024

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01

SupplySide West 2024
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SupplySide West 2024
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Details : Altamira will extend the territory covered by their exclusive license and distribution agreement by Nuance for Bentrio (bentonite) nasal spray by several countries across South East and East Asia.

Brand Name : Bentrio

Molecule Type : Small molecule

Upfront Cash : Undisclosed

September 16, 2024

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Details:

Under the agreement, Pharma Nordic will market and commercialize Bentrio (bentonite), a nasal spray for protection against airborne allergens, in Sweden and Denmark.


Lead Product(s): Bentonite

Therapeutic Area: Immunology Brand Name: Bentrio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Altamira Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Agreement August 23, 2024

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Pharma Nordic

Norway
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SupplySide West 2024
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Pharma Nordic

Norway
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Details : Under the agreement, Pharma Nordic will market and commercialize Bentrio (bentonite), a nasal spray for protection against airborne allergens, in Sweden and Denmark.

Brand Name : Bentrio

Molecule Type : Small molecule

Upfront Cash : Undisclosed

August 23, 2024

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Details:

Under the agreement, Pharma Nordic will market and commercialize Bentrio (bentonite), a nasal spray for protection against airborne allergens, in Norway and potentially further Scandinavian countries.


Lead Product(s): Bentonite

Therapeutic Area: Immunology Brand Name: Bentrio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: Altamira Therapeutics

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Collaboration July 20, 2023

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Pharma Nordic

Norway
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SupplySide West 2024
Not Confirmed

Pharma Nordic

Norway
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SupplySide West 2024
Not Confirmed

Details : Under the agreement, Pharma Nordic will market and commercialize Bentrio (bentonite), a nasal spray for protection against airborne allergens, in Norway and potentially further Scandinavian countries.

Brand Name : Bentrio

Molecule Type : Small molecule

Upfront Cash : Undisclosed

July 20, 2023

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Details:

Under the cooperation agreement, DKSH HK will provide full-agency services including key account management, marketing promotion, supply chain, and distribution for Bentrio (bentonite) Nasal Spray sales operation in Hong Kong and Macau.


Lead Product(s): Bentonite,Mono Propylene Glycol,Citric Acid

Therapeutic Area: Immunology Brand Name: Bentrio

Study Phase: ApprovedProduct Type: Small molecule

Sponsor: DKSH

Deal Size: Undisclosed Upfront Cash: Undisclosed

Deal Type: Partnership November 28, 2022

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SupplySide West 2024
Not Confirmed
SupplySide West 2024
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Details : Under the cooperation agreement, DKSH HK will provide full-agency services including key account management, marketing promotion, supply chain, and distribution for Bentrio (bentonite) Nasal Spray sales operation in Hong Kong and Macau.

Brand Name : Bentrio

Molecule Type : Small molecule

Upfront Cash : Undisclosed

November 28, 2022

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FDA Orange Book

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STAND HOMEOPATH

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BENTOQUATAM

Brand Name : IVY BLOCK

Dosage Form : LOTION;TOPICAL

Dosage Strength : 5%

Approval Date : 1996-08-26

Application Number : 20532

RX/OTC/DISCN : OTC

RLD : Yes

TE Code :

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DATA COMPILATION #PharmaFlow

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Excipient Market Overview: Roquette, Seqens, Evonik make strategic moves; new guidelines deal with contamination
The pharmaceutical industry has long recognized the critical role excipients or inactive ingredients play in drug formulation and delivery. Excipients can comprise up to 90 percent of a medicine's total ingredients and serve crucial functions as binders, disintegrants, coatings, preservatives, colors, and flavorings. According to recent market research, the pharmaceutical excipients market was valued at US$ 9.27 billion in 2023. It is growing at a compound annual growth rate (CAGR) of 7.03 percent and is projected to reach US$ 18.48 billion by 2032. The main factors driving market growth is an increased demand for multifunctional excipients, coupled with the expanding use of generic medications. The development in the biologics sector and advancements in nanotechnology are also contributing significantly to market growth. Major excipient providers include BASF, Evonik, Merck KGaA owned MilliporeSigma, Gangwal Healthcare, Roquette Frères, DuPont, Croda International, Seqens, Boai NKY Pharmaceuticals, PMC Isochem, Minakem, Kewpie Corporation, Ashland Global, SPI Pharma, Pfanstiehl, Nanjing Well Pharmaceutical, ICE Pharma, Anhui Ribobay Pharmaceutical and Nippon Fine Chemical.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available) WHO, India’s CDSCO tighten regulations; new GMP guidelines implemented to curb contamination Last year, the World Health Organization (WHO) issued a health alert linking at least 300 child deaths in the Gambia, Uzbekistan, and Indonesia to the ingestion of contaminated cough syrups containing unacceptable levels of diethylene glycol (DEG) and ethylene glycol (EG). In response to the tragic events, the WHO released two draft appendices to its guideline on good manufacturing practices (GMPs) for excipients this year. Manufacturers are now required to use suitable risk assessment tools to identify and mitigate potential hazards.  Since India-made cough syrups had been linked to the deaths, India’s drug regulator — Central Drugs Standard Control Organization (CDSCO) — took steps to prevent contamination, and advised drugmakers to only use pharmaceutical-grade excipients from approved sources. Furthermore, the Indian Health Ministry proposed amendments to the Drugs and Cosmetics Rules, 1945 to include details of excipients on drug labels. While listing all excipients on every strip of medicine may be challenging, the ministry suggested mentioning those causing hypersensitivity on the label. Applicants now mandatorily need to submit evidence of stability and safety of excipients. These regulatory developments have significant implications for excipient manufacturers and pharmaceutical companies worldwide. Leading pharmaceutical excipient firms like Gangwal Healthcare, Sigachi Industries, and Nitika Pharmaceuticals are well-positioned to meet these heightened quality and safety standards, given their long-standing commitment to producing high-quality, compliant excipients.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Roquette buys IFF’s pharma unit for US$ 2.85 bn; Evonik opens new spray-drying facility in Darmstadt In a significant industry move, France-based Roquette entered into an agreement to acquire IFF's pharma solutions business in a deal valued at US$ 2.85 billion. This acquisition is set to rebalance family-owned Roquette’s portfolio around health and nutrition. The deal is expected to accelerate Roquette’s growth and significantly strengthen its presence in the excipients market. Evonik has opened a new facility for drying aqueous dispersions of its Eudragit polymers at its site in Darmstadt, Germany. The facility will help Evonik meet increasing demand from drugmakers for its oral drug delivery solutions. The plant uses green energy solutions. The company has also partnered University of Mainz to commercialize a new class of polyethylene glycols (PEG) lipids for nucleic acid delivery. Evonik’s Health Care business has been growing its nucleic acid drug and vaccine delivery portfolio.  Germany’s Johannes Gutenberg University of Mainz was the first to develop randomized polyethylene glycols (rPEGs). This collaboration aims to expand Evonik’s toolbox of technologies for nucleic acid-based medicines, offering an improved immunogenicity profile for lipid nanoparticle carriers used in mRNA vaccines and therapeutics. Asahi Kasei made significant strides in addressing a pressing industry concern that emerged in 2018 when potentially carcinogenic nitrosamine impurities were detected in several pharmaceuticals. Guided by regional authorities, such as the European Medicines Agency and the US Food and Drug Administration, the pharmaceutical industry has been carrying out extensive assessments and research to identify the cause of these impurities. In response to this challenge, Asahi Kasei developed its Ceolus microcrystalline cellulose with extremely low nitrite levels. The Japanese company achieved nitrite concentrations of 0.1 micrograms per gram or less, which is equivalent to 0.1 parts per million (ppm). The company also started full commercial operation of its second manufacturing facility for Ceolus in Japan, enhancing supply capacity and stability. JRS Pharma and Gujarat Microwax opened a state-of-the-art cotton-based croscarmellose sodium plant in Mehsana, Gujarat (India). This facility aims to produce high-quality excipients that meet global standards, potentially reducing India's dependency on imports and boosting its presence in the global excipient market. The Indian excipient industry accounts for less than 1 percent of the global market share.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Seqens to advance innovative polymer; biologics, personalized medicine create demand for specialized excipients Recent industry collaborations highlight the ongoing innovation in novel excipients. France’s Seqens, with over 20 years of polymer development experience, was chosen by Pleryon Therapeutics to advance its leading osteoarthritis candidate – an innovative GMP polymer. This collaboration leverages Seqens’ newly expanded and modernized cGMP plant in Aramon, France, demonstrating the industry’s commitment to investing in advanced manufacturing capabilities for novel excipients.  The rise of biologics and personalized medicine has created a demand for specialized excipients capable of stabilizing complex molecules and enabling targeted drug delivery. Roquette’s launch of Lycagel Flex, a hydroxypropyl pemix for nutraceutical and pharmaceutical softgel capsules, exemplifies this trend. Built on Roquette’s market-first Lycagel pea starch technology, this plant-based alternative to gelatin offers manufacturers the flexibility to customize formulations for a range of production and end-user needs. The innovative pea starch foundation also underscores the industry’s move towards sustainable bio-based excipients. The trend towards patient-centric drug development has also influenced excipient innovation. Excipients that can improve palatability, ease of swallowing, or enable novel dosage forms (such as orally disintegrating tablets) are in high demand. For example, IFF brought a super disintegrant Ac-Di-Sol, that supports faster disintegration and drug dissolution in oral disintegrating tablets, improving patient experience.  View Our Dashboard on Major Excipient Companies in 2024 (Free Excel Available)   Our view The heightened regulatory scrutiny on excipients due to product contamination incidents has created a high risk perception and uncertainty around the regulatory acceptance of novel excipients. That said, novel excipients are central to the development of new drug modalities and therapies. Going forward, sustainability will also become an increasingly important factor in excipient selection and development. As the industry innovates towards biologics, personalized therapies, and patient-centric formulations, the role of high-quality, multifunctional excipients will only grow more vital in ensuring drug stability, bioavailability, and patient compliance. Companies that can navigate the complex regulatory landscape, invest in R&D, and offer high-quality, multifunctional excipients will be well-positioned to succeed in this evolving market.   

Impressions: 1485

https://www.pharmacompass.com/radio-compass-blog/excipient-market-overview-roquette-seqens-evonik-make-strategic-moves-new-guidelines-deal-with-contamination

#PharmaFlow by PHARMACOMPASS
12 Sep 2024

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