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High purity excipients for oral drug delivery

Oral drug development of both new and existing chemical entities often face numerous challenges including poor solubility, formulation instability and ineffective drug delivery. Regardless of the challenge, the ultimate goal is to create successful drug products with shortened development timelines. The selection of the right oral excipient during early phase development is critical to achieve this goal.

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Super Refined™ excipients for oral drug delivery

Our proprietary Super Refining process yields highly purified excipients that can maximise drug product value and are indicated to stabilise, solubilise and optimise the active ingredients in the formulation.

Oral drug value:

  • Enhanced drug performance and stability
  • Improved shelf life
  • Increased patient compliance
  • Improved bioavailability
  • Decreased formulation development time
  • Decreased time to market.

Benefits and features of high purity excipients for oral drug delivery: 

Improved API stability 

Stabilisation of an API is crucial to successful drug development. As API degradation can be initiated and accelerated by impurities that can be introduced by excipients in the formulation, carefully selecting the right oral excipient can be essential to formulation success.

Increased gelatine capsule stability

Over time, the impurities found in commonly used solvents and fillers in gelatine capsules can preferentially absorb moisture from the gelatine shell. The moisture absorption can cause the gelatine to crosslink which, ultimately, cause the capsule to harden. The hardening of the capsule can result in either cracking or longer disintegration times leading to unacceptable drug efficacy.

Improved taste impact

The impact of an excipient on the taste of an oral drug can significantly affect patient compliance and repeat purchase.

Reduced colour impurities

The Super Refining process yields a highly purified excipient with a reduction in both colour and overall impurity levels. The purification of oral excipients yields improved drug appearance as well as improved stability of the excipient; the API and drug formulation. 

Super Refined™ pharmaceutical excipients

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Super Refined™ excipients

Our Super refined™ range of excipients ensure your formulations are stable, effective and consistent.

Creation of SEDDS and SMEDDS

Self-emulsifying drug delivery systems (SEDDS) and self-microemulsifying drug delivery systems (SMEDDS) are lipid-based formulations that aim to deliver hydrophobic drugs that typically are associated with poor water solubility and low bioavilability.

Formulation benefits for ophthalmic drug delivery - reduced peroxide levels

Low moisture

Formulation benefits for ophthalmic drug delivery - reduced cellular irritation

Low peroxide levels

Formulation benefits for ophthalmic drug delivery - Reduced endotoxin levels

Multicompendial

USP/NF, Ph.Eur., JPE and ChP
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Oral excipient offering:

Croda offers a breadth of high purity ingredients that lend themselves well to solubilising a poorly water soluble drug, stabilising it once it’s in solution, and creating SEDDS and SMEDDS formulations. The list is constantly growing, and we strive to work with our customers to provide them with a solution they need!

Crodasol™ HS HP

Crodasol™ HS HP

Crodasol HS HP is a high purity nonionic surfactant which provides excellent solubilisation properties. Compliant to the PhEur monograph, it is a mixture of monoesters and diesters of...

Croduret™ 40

Croduret™ 40

Crodurets are vegetable-derived nonionic surfactants that differ in their degrees of ethoxylation. Widely used in a variety of oral formulations, they are virtually tasteless solubilisers for vitamins...

Super Refined™ CCMG 400

Super Refined™ CCMG 400

Super Refined CCMG 400 is a multi-compendial, high purity mixture of caprylocaproyl polyoxylglycerides. It is ideal for use as a surfactant or co-solvent in self-emulsifying drug delivery systems...

Super Refined™ GMCC

Super Refined™ GMCC

Super Refined™ GMCC is a high purity mixture of monoglycerides and diglycerides of caprylic and capric acids. It is used to produce stable emulsions and to modify viscosity. It functions as a...

Super Refined™ L18 POG

Super Refined™ L18 POG

Super Refined™ L18 POG is a high purity mixture of mono-, di-, and triesters of glycerol, and mono- and diesters of polyethylene glycols, with the predominant fatty acid concentration stemming from...

Super Refined™ O18 POG

Super Refined™ O18 POG

Super Refined™ O18 POG is a high purity mixture of mono-, di-, and triesters of glycerol, and mono- and diesters of polyethylene glycols with the predominant fatty acid concentration stemming from...

Super Refined™ P35 Castor Oil

Super Refined™ P35 Castor Oil

Super Refined P35 Castor Oil is a multi-compendial, high purity castor oil derivative, resulting from the reaction of glycerol ricinoleate and 35 mols of ethylene oxide. It is intended for use in...

Super Refined™ PGML

Super Refined™ PGML

Super Refined™ PGML is a high purity mixture of propylene glycol and esters of lauric (C12) acid. More specifically, as part of the Type II classification, it has at least a 90% concentration of...

Super Refined™  Polysorbate 20

Super Refined™ Polysorbate 20

Super Refining removes impurities, preventing adverse interactions with APIs and enhancing the stability of pharmaceutical formulations. Super Refined Polysorbates offer the complete solution when...

Super Refined™ Polysorbate 60

Super Refined™ Polysorbate 60

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...

Super Refined™  Polysorbate 80

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...

Explore our product offering

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We offer high purity, multi-compendial, pharmaceutical excipients for small molecule drug delivery. Our portfolio of high purity excipient products and speciality chemistries solve formulation challenges and enhance drug delivery across a variety of administration routes and dosage forms.

Super Refined™ excipients

Super Refined excipients are stripped of a number of oxidative impurities, such as peroxides, aldehydes, and catalyst residues. The removal of these problematic species helps to reduce negative API & excipient interactions, maintaining both the stability of the drug and the final formulation. In addition, the removal of these impurities can minimise cellular irritation, reduce taste impact, and potentially decrease allergenicity. 

We have a large variety of products, ranging from various polysorbates, polyethylene glycols (PEG), esters, vegetable oils, and more. 
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man using eye drop

Ophthalmic drug delivery

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Parenteral drug delivery

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Topical drug delivery

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Penetration enhancer

Transdermal drug delivery

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