Super Refined™ Pharmaceutical Excipients for Parenteral Applications

Super Refined™ Pharmaceutical Excipients for Parenteral Applications
Product Description

The formulation of active pharmaceutical ingredients (APIs) for parenteral applications demands the highest quality standards and attention to detail. Excipient selection is critical to drug stability, formulation integrity and patient safety.
Croda’s Super Refined™ excipients offer multiple benefits, including:

  • Minimised API degradation
  • Reduced impurities for improved drug compatibility
  • Increased oxidative stability
  • Reduced cellular irritation
  • Optimised drug efficacy
  • Increased product shelf life
  • Decreased formulation development time
  • Decreased time to market
For more information please contact us.

Croda Europe Limited

  • GB
  • 2015
    On CPhI since
  • 2
    Certificates
Manufacturer/Innovator

Croda Europe Limited

  • GB
  • 2015
    On CPhI since
  • 2
    Certificates
Manufacturer/Innovator

More Products from Croda Europe Limited

  • Excipient: Super Refined™ PEG 400

    Product Excipient: Super Refined™ PEG 400

    Super Refined PEGs are solvents for use with the most sensitive active ingredients across dosage forms including injectable and oral. Super Refining removes polar impurities (including primary and secondary oxidation products) from an excipient without altering its chemical composition, reducing excipient-API interaction and subsequent API degradation. The benefits of Super Refined PEGs over standard pharmaceutical PEGs include: • Better API stability and finished formulation integrity • Reduced potential for cellular irritation • Improved taste profile when used in oral liquid dosage forms • Reduced crosslinking in gelatin capsules Please download the datasheet for more detailed information.

    Chemical Description
    • Polyethylene Glycol 400
    Pharmacopoeia Compliance
    • FDA-IID Listed
    • JP
    • PhEur
    • USP/NF
    Chemical Group
    • Ethoxylate
    • Polyethylene glycol
    Administration Route
    • Auricular
    • Nasal
    • Ophthalmic
    • Oral
    • Parenteral
    • Rectal and Vaginal
    • Topical
    Functions
    • Solvent
    Market Application
    • Human Pharmaceutical
    • Veterinary Health
    Physical Form
    • Colourless viscous liquid
  • Vaccine Adjuvant: Adju-Phos®

    Product Vaccine Adjuvant: Adju-Phos®

    • Adju-Phos® is a range of aluminium phosphate gel products which have been specifically developed for use as an adjuvant in vaccines
    • The gel is a suspension of hydrated amorphous aluminium hydroxyphosphate nano/micron size crystal in loose aggregates. Adju-Phos products have a net negative charge at neutral pH and effectively adsorb positively charged antigens
    • The primary purpose of the adjuvant in vaccines is to boost the antibody-mediated (Th2) immune response to the antigens
    • Adju-Phos products can be combined with other adjuvant types (such as monophosphoryl lipids) to achieve a balanced Th1/Th2 immune response
    • Adju-Phos is supplied in two variants with pH-values at ca. 6.5 and at ca. 5.0. Both variants contain 0.9% NaCl (saline) to reduce injection site discomfort
    • Adju-Phos is produced in classified clean rooms to prevent contamination, sterilised and aseptically filled in a grade A clean room.
    Chemical Group
    • Aluminium oxyhydroxide
    Administration Route
    • Vaccine Adjuvant
    Market Application
    • Human vaccines
    • Veterinary vaccines
    Functions
    • Vaccine Adjuvant
    Physical Form
    • A gel-like aqueous suspension. A supernatant forms when the product is left idle.
  • Excipient: Super Refined™ Polysorbate 80

    Product Excipient: Super Refined™ Polysorbate 80

    Super Refined Polysorbates solubilise and stabilise the most sensitive active ingredients across dosage forms including injectable and oral. Super Refining removes impurities (including primary and secondary oxidation products) from an excipient without altering its chemical composition, helping to reduce API interaction and degradation. The benefits of Super Refined Polysorbates over standard pharmaceutical polysorbates include: Better API stability and finished formulation integrity Reduced potential for cellular irritation Improved taste profile when used in oral liquid dosage forms.

    Chemical Description
    • Polysorbate 80
    Pharmacopoeia Compliance
    • FDA-IID Listed
    • JP
    • PhEur
    • USP/NF
    Chemical Group
    • Ester
    • Polysorbate
    • Sorbitan ester
    Administration Route
    • Auricular
    • Nasal
    • Ophthalmic
    • Oral
    • Parenteral
    • Rectal and Vaginal
    • Topical
    Functions
    • Emulsifier
    • Plasticiser
    • Solubiliser
    • Wetting agent
    Market Application
    • Human Pharmaceutical
    • Veterinary Health
    Physical Form
    • Clear, essentially colourless liquid
  • Excipient: Super Refined™ CCMG 400

    Product Excipient: Super Refined™ CCMG 400

    Super Refined CCMG 400 is a multi-compendial, high purity mixture of caprylocaproyl polyoxylglycerides. This product has undergone intense purification, by which impurities and other reactive species that could negatively impact API and formulation stability have been removed.

    Pharmacopoeia Compliance
    • FDA-IID Listed
    • PhEur
    • USP/NF
    Chemical Group
    • Glyceryl ester
    Administration Route
    • Oral
    • Topical
    Functions
    • Excipient
    • Nonionic surfactant
    • Self-emulsifying drug delivery
    • Solubiliser
    • Solvent
    Market Application
    • Human Pharmaceutical
    Physical Form
    • Liquid
  • Vaccine Adjuvant: QS-21

    Product Vaccine Adjuvant: QS-21

    • Quillaja saponaria Molina is a South American tree native to Chile whose bark is rich in a complex mixture of triterpenic saponins
    • Quillaja-derived saponins such as Quil-A® are currently used as veterinary vaccine adjuvants
    • One specific fraction of the Quil-A saponin mixture, QS-21, is an extremely potent adjuvant with potential use in a broad variety of vaccines
    • It has been shown to enhance antibody- and cell-mediated immune response and has been investigated for human vaccine applications
    • It was originally isolated and named by Dr Charlotte Kensil in 1991 and among the components of triterpenoid quillaja saponins, QS-21 possesses an optimal balance of low toxicity and high immunostimulatory efficacy, and has already been used in one commercialised vaccine.
    Chemical Group
    Purified quillaja saponin Administration Route
    • Vaccine Adjuvant
    Market Application
    • Human Vaccines
    Functions
    • Vaccine Adjuvant
    Physical Form
    • Water-soluble lyophilised powder
  • Excipient: Super Refined™ Polysorbate 20

    Product Excipient: Super Refined™ Polysorbate 20

    Super Refined Polysorbates solubilise and stabilise the most sensitive active ingredients across dosage forms including injectable and oral. Super Refining removes impurities (including primary and secondary oxidation products) from an excipient without altering its chemical composition, helping to reduce API interaction and degradation. The benefits of Super Refined Polysorbates over standard pharmaceutical polysorbates include: • Better API stability and finished formulation integrity • Reduced potential for cellular irritation • Improved taste profile when used in oral liquid dosage forms

    Chemical Description
    • Polysorbate 20
    Pharmacopoeia Compliance
    • FDA-IID Listed
    • JP
    • PhEur
    • USP/NF
    Chemical Group
    • Ester
    • Polysorbate
    • Sorbitan ester
    Administration Route
    • Auricular
    • Nasal
    • Ophthalmic
    • Oral
    • Parenteral
    • Rectal and Vaginal
    • Topical
    Functions
    • Emulsifier
    • Plasticiser
    • Solubiliser
    • Wetting agent
    Market Application
    • Human Pharmaceutical
    • Veterinary Health
    Physical Form
    • Clear, essentially colourless liquid
  • Vaccine Adjuvant: Alhydrogel®

    Product Vaccine Adjuvant: Alhydrogel®

    • Alhydrogel is a range of aluminium hydroxide gel products which have been specifically developed for use as an adjuvant in human and veterinary vaccines
    • The gel is a suspension of boehmite-like (aluminium oxyhydroxide) hydrated nano/micron size crystals in loose aggregates
    • The products have very low conductivity due to the absence of buffering ions.
    • They have a positive charge at neutral pH and effectively adsorb negatively charged antigens
    • The primary purpose of the adjuvant in vaccines is to boost the antibody-mediated (Th2) immune response to the antigens.
    • Alhydrogel products can be combined with other adjuvant types (such as monophosphoryl lipids) to achieve a balanced Th1/Th2 immune response.
    • Alhydrogel is produced in classified clean rooms to prevent contamination, sterilised and aseptically filled in a grade A clean room.
    Chemical Group
    • Aluminium oxyhydroxide
    Administration Route
    • Vaccine Adjuvant
    Market Application
    • Blood plasma fractionation
    • Human vaccines
    • Veterinary vaccines
    Functions
    • Vaccine Adjuvant
    Physical Form
    • A gel-like aqueous suspension. A supernatant forms when the product is left idle.
  • Super Refined™ Pharmaceutical Excipients for Topical Applications

    Product Super Refined™ Pharmaceutical Excipients for Topical Applications

    There is a growing need to address the challenges that can affect topical drug delivery, such as: API instability, poor API solubilisation and skin irritation that reduces patient compliance. Croda’s Super Refined™ excipients can maximise the value of topical drug products and address formulation concerns, such as: · Improving API and formulation stability · Increasing oxidative stability · Decreasing cellular irritation · Maximising drug targeting on the skin surface For more information please contact us.
  • Excipient: Super Refined™ DEGEE

    Product Excipient: Super Refined™ DEGEE

    Super Refined DEGEE is ideal for use in topical and transdermal applications to enhance the permeation of poorly water-soluble API’s through various layers of the skin, thereby improving drug delivery. It can also be used as a co-solvent in self-emulsifying drug delivery systems (SEDDS), or self-microemulsifying drug delivery systems (SMEDDS), to stabilise poorly water-soluble API’s in oral formulations, which can lead to an improvement in the delivery and bioavailability of the SEDDS or SMEDDS system.

    Chemical Description
    Diethylene Glycol Monoethyl Ether

    Pharmacopoeia Compliance
    • FDA-IID Listed
    • PhEur
    • USP/NF
    Chemical Group
    • Ether
    Administration Route
    • Auricular
    • Nasal
    • Ophthalmic
    • Oral
    • Rectal and Vaginal
    • Topical
    Functions
    • Excipient
    • Penetration enhancer
    • Self-emulsifying drug delivery
    • Solubiliser
    • Solvent
    Market Application
    • Human Pharmaceutical
    Physical Form
    • Liquid
  • Excipient: Super Refined™ P35 Caster Oil

    Product Excipient: Super Refined™ P35 Caster Oil

    Super Refined P35 Castor Oil is a castor oil derivative, resulting from the reaction of glycerol ricinoleate and 35 mols of ethylene oxide. This product is a liquid nonionic solubiliser and emulsifier, characteristic of a slightly yellow hue, and is intended for use in parenteral, ophthalmic, oral, and topical applications.

    Chemical Description
    • Polyoxyl 35 Castor Oil
    Pharmacopoeia Compliance
    • FDA-IID Listed
    • JP
    • PhEur
    • USP/NF
    Chemical Group
    • Ethoxylate
    Administration Route
    • Ophthalmic
    • Oral
    • Parenteral
    • Rectal and Vaginal
    • Topical
    Functions
    • Emulsifier
    • Excipient
    • Nonionic surfactant
    • Self-emulsifying drug delivery
    • Solubiliser
    Market Application
    • Human Pharmaceutical
    Physical Form
    • Liquid
  • Super Refined™ Pharmaceutical Excipients for Oral Applications

    Product Super Refined™ Pharmaceutical Excipients for Oral Applications

    Oral drug development often faces numerous challenges including: poor solubility, formulation instability and ineffective drug delivery. The selection of the right oral excipient during early phase development is critical to creating a successful oral drug product.

    Croda’s Super Refined™ excipients deliver multiple benefits when formulating an oral drug product, such as:
    • Increased API stability and performance
    • Improved gelatine capsule stability
    • Reduced taste, odour and colour impact
    • Expanded options for SEDDS and SMEDDS
    • Improved drug shelf life
    • Improved bioavailability
    • Decreased formulation development time and time to market
    For more information please contact us.


  • Vaccine Adjuvant: Quil-A®

    Product Vaccine Adjuvant: Quil-A®

    • Quil-A is a highly purified and concentrated saponin adjuvant purified from bark extract of the Quillaja saponaria Molina tree which has been specifically developed for use as an adjuvant in vaccines
    • Quil-A saponin was originally purified and characterised by Dr. Pharm
    • Kristian Dalsgaard in 1974 and adapted for commercial scale production
    • It consists of a complex mixture of approximately 25 different saponin molecules which have the triterpenoid backbone in common
    • It is a very versatile adjuvant due to its ability to induce a balanced immune response to protect against both intracellular (Th1) and extracellular (Th2) pathogens
    • When combined under specific circumstances with cholesterol, phosphatidylcholine and amphipathic antigen, saponins can form stable immune stimulating complexes (ISCOMs)
    • These complexes are spherical, nano-scale cage-like structures, which display immune-stimulatory properties
    • ISCOMs can be used to induce a stronger and longer-lasting immune response
    Chemical Group
    Purified quillaja saponin Administration Route
    • Vaccine Adjuvant
    Market Application
    • Active component of ISCOM
    • Active component of nanoparticle adjuvants
    • Raw material for other saponin fractions
    • Veterinary vaccines
    Functions
    • Vaccine Adjuvant
    Physical Form
    • Water-soluble lyophilised powder

Croda Europe Limited resources

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    Group aiming to achieve a 50% reduction in absolute GHG emissions based on 2006 levels by 2030 and an 80% reduction by 2050.
  • Brochure The Power of Purity

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  • Brochure Vaccine Adjuvants

    To this day, our focus has been to successfully develop, manufacture and market high-quality adjuvants for our pharmaceutical customers. This heritage makes our vaccine adjuvants unique in the industry. A heritage we are proud of. 

    Our industry-leading, Alhydrogel®, Adju-Phos® and Quil-A® are widely recognised in the vaccine industry for their unmatched track record when it comes to a proven history of safe and effective use.
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  • Brochure Avanti Formulations brochure

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  • Brochure Croda Mill Hall press release

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    To find out more, please visit: https://www.croda.com/en-gb/news/2021/08/croda-expands-its-high-purity-pharmaceutical-excipients-manufacturing-capability
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